chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: 24 hrs after vaccine "I" had a low grade fever.; 24 hrs after vaccine "I" had a low grade fever, chills; 24 hrs after vaccine "I" had a low grade fever, chills, body aches; 24 hrs after vaccine "I" had a low grade fever, chills, body aches, tiredness; 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: EW0158) via an unspecified route of administration in the left arm on 24Apr2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 12:00, 24 hours after vaccine, the patient had a low grade fever, chills, body aches and tiredness. On the same day, the patient underwent body temperature test and the result was not reported. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, chills, body aches and tiredness were resolved on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular (late) menstruation; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via unspecified route of administration on an unknown date (at the age of 27-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via unspecified route of administration on an unknown date (at the age of 27-year-old); both as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced irregular (late) menstruation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event irregular (late) menstruation was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 27-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0164), at the age of 27, via an unspecified route of administration, in left arm, on May 3, 2021, at 09:30, single dose, for COVID-19 immunisation. No medical history reported. The patient has no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8733), at the age of 26, via an unspecified route of administration, in left arm, on Apr 1, 2021, at 09:30, single dose, for COVID-19 immunisation. On May 4, 2021, at 06:30, patient experienced rash on bilateral forearms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of rash over forearms: resolving (at the time of report). No follow-up attempts needed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Menstrual disorder, Nausea, Pain in extremity
Clinical narrative: 4 hours after my tongue swelled up; throat in my left side swelled up; 12 hours later left arm hurt; 24 hours later numbness on my spine middle section; nausea; dizziness 1-4 days; period texture and color change-black and chalky texture; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the left arm on 03May2021 at 17:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and seafood allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 21:15, 4 hours after the vaccination, the patient's tongue swelled up and throat in her left side, 12 hours later left arm hurt, 24 hours later numbness on her spine middle section, nausea, dizziness 1-4 days, period texture and color change-black and chalky texture. 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 events patient's tongue swelled up and throat in her left side, left arm hurt, numbness on her spine middle section, nausea, dizziness, period texture and color change-black and chalky texture was resolved with sequelae on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: 4 hours after my tongue swelled up; throat in my left side swelled up; 12 hours later left arm hurt; 24 hours later numbness on my spine middle section; nausea; dizziness 1-4 days; period texture and color change-black and chalky texture; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the left arm on 03May2021 at 17:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and seafood allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 21:15, 4 hours after the vaccination, the patient's tongue swelled up and throat in her left side, 12 hours later left arm hurt, 24 hours later numbness on her spine middle section, nausea, dizziness 1-4 days, period texture and color change-black and chalky texture. 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 events patient's tongue swelled up and throat in her left side, left arm hurt, numbness on her spine middle section, nausea, dizziness, period texture and color change-black and chalky texture was resolved with sequelae on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Paraesthesia, Swelling face
Clinical narrative: Face started tingling like someone sticking me with pins; Mouth started swelling; Face started swelling around mouth and cheeks; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 15Apr2021 at 11:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included juvenile asthma as a child that no longer affected her and known allergies to tree nuts cosmetics and perfumes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D3), boron (MANUFACTURER UNKNOWN), prunus cerasus (TART CHERRY) and Ascorbic acid, Pyridoxine hydrochloride, Biotin, Folic acid, Colecalciferol, Retinol, Pantothenic acid, Riboflavin, Phytomenadione, Nicotinamide, Betacarotene, Iron, Magnesium, Manganese, Potassium, Chromium, Copper, Zinc, Calcium, Iodine, Phosphorus, Selenium, Vitamin b12 nos, Xantofyl, Lycopene, Vitamin b1 nos, Vitamin e nos (CENTRUM SILVER); all for unknown indication, on unknown date and unknown if ongoing. 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: ER2613) via an unspecified route of administration in the right arm on 22Mar2021 at 01:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation and the patient also previously received guaifenesin/pseudoephedrine hydrochloride (SUDAFED), alendronate sodium (FOSAMAX) and experienced drug allergy. On 15Apr2021 at 11:15, after waiting 15 at site, the patient started driving home and her face started tingling like someone sticking her with pins, mouth started swelling and face started swelling around mouth and cheeks. This was all in a matter of 15 to 30 minutes. The patient reported that she always carried diphenhydramine hydrochloride (BENADRYL), because of allergic reactions to different things. The events had not resulted in doctor/other health care 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 taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the events face started tingling like someone sticking her with pins, mouth started swelling and face started swelling around mouth and cheeks was resolved on 15Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Mildly sore throat; Had a very swollen axillary (armpit) lymph node on right side (same side as the injection); This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on 06May2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure/cholesterol, which were treated with unspecified medications and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included valsartan (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously 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 15Apr2021 at 23:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 06:00, the next morning after vaccination, the patient had a very swollen axillary (armpit) lymph node on right side (same side as the injection). The node felt like a bag of fluid was under the surface. On 10May2021, the 4th morning after vaccination, it was still present but seemed to be getting smaller the last 2 days and the patient had a mildly sore throat. The events resulted in doctor or other healthcare professional office/clinic visit. 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 had a very swollen axillary (armpit) lymph node on right side (same side as the injection) and mildly sore throat was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 27-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 27, via an unspecified route of administration, on May 4, 2021, at 12:00, single dose, for COVID-19 immunisation. Medical history not reported. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On May 5, 2021, at 16:00, patient has had a headache every day since vaccination. The event did not result in a visit to the doctors or other healthcare professional office/clinic/emergency room/department or urgent care. Therapeutic measures not taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of headache every day since vaccination: unknown (at the time of report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Pain in extremity
Clinical narrative: Sore arm; Diarrhea; Headache; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 75-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 11May2021 at 12:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, chronic obstructive pulmonary disease (COPD), osteoarthritis, allergy to penicillin and hymenopter venom and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included clopidogrel bisulfate (PLAVIX), escitalopram oxalate (LEXAPRO), hydrochlorothiazide (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN); all 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 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 20Apr2021 at 12:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. On 12May2021 at 07:30, the patient experienced sore arm, diarrhea, headache and malaise. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm, diarrhea, headache and malaise were resolving 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in jaw and neck on the left side of head; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07May2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease, bi-polar, post-traumatic stress disorder (PTSD), gastroesophageal reflux disease (GERD), COVID-19 and allergies to pineapples. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), isosorbide (MANUFACTURER UNKNOWN) and clopidogrel (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took fluoxetine hydrochloride (PROZAC) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 16Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 01:45, the patient experienced swollen lymph nodes in his jaw and neck on the left side of his head. The doctor took a look, and told there were no signs of infection and told it was likely a reaction to the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. 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 swollen lymph nodes in jaw and neck on the left side of head was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rosacea, Skin warm
Clinical narrative: Facial rash, redness and hot to the touch. Roseacia like; redness; hot to the touch; Roseacia like; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0164) in the left arm on 11May2021 at 11:00(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included colitis ulcerative. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN), methylprednisolone (MEDROL), guaifenesin, pseudoephedrine hydrochloride (SUDAFED), fluticasone propionate (FLONASE) and montelukast sodium (SINGULAR) started on an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation On 12May2021 at 07:00 the patient experienced facial rash, redness, hot to the touch and roseacia like. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events facial rash, redness, hot to the touch and roseacia like 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: Fatigue, Headache, Nausea, Pain, Vaccination site pain
Clinical narrative: 48 hour after: Body aches; 48 hour after: Headache; 48 hour after: Nausea; 48 hour after: Injection site pain; 48 hour after: Fatigue; 1 week after: severe bouts of vertigo throughout day, daily for about a week now; This is a spontaneous report from a contactable consumer, the patient. A 55-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 01May2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to coconut. 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 escitalopram oxalate (LEXAPRO) and multivitamins (BAYER FLINTSTONES CHILDREN'S MULTIVITAMIN), both taken for an unknown indication on 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 right arm on 10Apr2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 03May2021, 48 hours after vaccination, the patient experienced body aches, headache, nausea, injection site pain and fatigue. On an unknown date in May2021, one week after the vaccination, the patient experienced severe bouts of vertigo throughout day, daily for about a week till the time of this report. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, headache, nausea, injection site pain, fatigue and bouts of vertigo throughout day, daily for about a week till the time of this report was not resolved 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 48 hour after: Body aches; 48 hour after: Headache; 48 hour after: Nausea; 48 hour after: Injection site pain; 48 hour after: Fatigue; 1 week after: severe bouts of vertigo throughout day, daily for about a week now; This is a spontaneous report from a contactable consumer, the patient. A 55-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 01May2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to coconut. 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 escitalopram oxalate (LEXAPRO) and multivitamins (BAYER FLINTSTONES CHILDREN'S MULTIVITAMIN), both taken for an unknown indication on 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 right arm on 10Apr2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 03May2021, 48 hours after vaccination, the patient experienced body aches, headache, nausea, injection site pain and fatigue. On an unknown date in May2021, one week after the vaccination, the patient experienced severe bouts of vertigo throughout day, daily for about a week till the time of this report. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, headache, nausea, injection site pain, fatigue and bouts of vertigo throughout day, daily for about a week till the time of this report was not resolved 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymph node pain, Pain in extremity
Clinical narrative: experiencing redness and mild pain on my entire arm of the injection site.; Mild pain on entire arm of the injection site.; Lymph node under arm was sore and hurts to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO167) via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, potassium low, anemia and allergy to sulfa medications. 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 lisinopril (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) all from unknown date for unknown indication and unknown if ongoing. On 09May2021 at 07:00, the patient experienced redness, mild pain on entire arm of the injection site and lymph node under arm was sore and hurt to the touch. 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 the patient experienced redness, mild pain on entire arm of the injection site, lymph node under arm was sore and hurts to the touch was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 40, via an unspecified route of administration, in the left arm, on Mar 10, 2021, at 15:00, single dose, for COVID-19 immunisation. No medical history or no known allergies reported. The patient did not take any concomitant medications. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On May 10, 2021, patient had period-type bleeding every two weeks. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of having period-type bleeding every two weeks: not resolved (at the time of report). No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: Haven't had an appetite; Uneasy feeling in stomach, but have not vomited; Diarrhea; Chills; Fever; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old male patient 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 29Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and allergy to mango. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. Any other vaccines received by the patient within four weeks prior to the COVID-19 vaccine was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced chills and fever. On 03May2021, the Monday following the injection, the patient did not have an appetite and had an uneasy feeling in stomach, but did not vomit. The patient also presented with diarrhea. On 30Apr2021, the Friday prior, the patient had chills and a fever, but felt better over the weekend, but was hit again on Monday and wasn't let up since. The patient felt it lasted too long to be something common. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 07May2021, the patient underwent SARS-CoV-2 test via nasal Swab and the result was negative. The clinical outcome of the events did not have an appetite, uneasy feeling in stomach, but did not vomit, diarrhea, chills and fever was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Haven't had an appetite; Uneasy feeling in stomach, but have not vomited; Diarrhea; Chills; Fever; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old male patient 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 29Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and allergy to mango. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. Any other vaccines received by the patient within four weeks prior to the COVID-19 vaccine was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced chills and fever. On 03May2021, the Monday following the injection, the patient did not have an appetite and had an uneasy feeling in stomach, but did not vomit. The patient also presented with diarrhea. On 30Apr2021, the Friday prior, the patient had chills and a fever, but felt better over the weekend, but was hit again on Monday and wasn't let up since. The patient felt it lasted too long to be something common. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 07May2021, the patient underwent SARS-CoV-2 test via nasal Swab and the result was negative. The clinical outcome of the events did not have an appetite, uneasy feeling in stomach, but did not vomit, diarrhea, chills and fever was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema
Clinical narrative: Redness increased from a small circle around the injection site to a slightly bigger one over the last 24 hours; Dose 1: 27Apr2021, Dose 2: 10May2021; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 10May2021 at 09:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included that the patient had surgery on 4/5 (DI (double incision) mastectomy plus nipple graft) and allergy to avocado. Concomitant medications included paracetamol/ oxycodone hydrochloride (PERCOCET), venlafaxine (MANUFACTURER UNKNOWN) and testosterone (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 27Apr2021 at 10:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 00:00, the patient had redness which increased from a small circle around the injection site to a slightly bigger one over the last 24 hours. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event redness increased from a small circle around the injection site to a slightly bigger one over the last 24 hours was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pain
Clinical narrative: Several days later still very achy; I have diarrhea; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 20:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included blood clotting. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 10May2021 at 00:00, the patient experienced several days later still very achy, "i have diarrhea" and upset stomach. 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 several days later still very achy, "i have diarrhea" and upset stomach was not recovered at the time of reporting.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Dysphagia, Hypertension, Swollen tongue
Clinical narrative: Left side of tongue felt swollen; Had difficulty swallowing; Felt anxious; Blood pressure was a little high; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL9266) via an unspecified route of administration in the right arm on 02Mar2021 at 16:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included uterine cancer, radiation and complete hysterectomy in 2004, gallbladder removed in 2021, osteoporosis, high blood pressure, high cholesterol and allergy to computed tomography (CT) scan dye, red dye, muscle relaxants. 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. On 02Mar2021 at 16:15, the patients left side of tongue felt swollen, she had difficulty swallowing and felt anxious. The patient stayed onsite with paramedic checking vitals for 40 minutes, blood pressure was a little high. After the 40 minutes adverse event started subsiding. Unfortunately, the patient had filled out Vsafe as soon as she signed up thinking she was going to be fine. It cannot be revised once submitted. Days later the patient contacted her primary care physician (PCP) plus an additional doctor asking if she should get second dose of vaccine both advised her not to get it. The patients adverse event could have gone into anaphylaxis shock. The events did not result in doctor or other health care 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 tongue felt swollen, had difficulty swallowing and felt anxious, blood pressure was a little high was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: General symptom
Clinical narrative: 18 hrs of symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Medical history included allergies to sulfa. The patient's concomitant medications were not reported. The patient had no prior medical history, relevant drug history, drug or alcohol abuse and family history. The patient previously took bactrim and experienced drug hypersensitivity, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 28Dec2020 as dose 1, single for covid-19 immunization and experienced positive Covid test, bad reaction. On an unspecified date, the patient experienced 18 hrs of symptoms. On 29Jan2021, the patient experienced vaccine reaction. It was reported that the first vaccine resulted in a bad reaction resulting in positive covid test. The second shot was 18hrs of symptoms and the patient had fully recovered. The patient was not admitted to hospital and emergency room visit was not required. Patient was not deceased. No specific tests were required. No treatment or surgery was received. The event was recovered on an unknown date. There was no causal relationship between the event and bnt162b2 a reasonable possibility.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Cough, Fatigue, Gastrointestinal pain, Headache
Clinical narrative: Severe and persistent fatigue; GI pain; Shooting headaches; Flu-like symptoms including an off and on dry cough, sore throat and overall aches; Flu-like symptoms including an off and on dry cough, sore throat and overall aches; Flu-like symptoms including an off and on dry cough, sore throat and overall aches; Flu-like symptoms including an off and on dry cough, sore throat and overall aches; This is a spontaneous report from a contactable consumer, the patient. A 46-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 19Mar2021 at 12:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, bartonellosis and unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included levothyroxine sodium (SYNTHROID) 50 mg 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 26Feb2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 19Mar2021 at 13:30, since the second shot, the patient experienced severe and persistent fatigue, gastrointestinal (GI) pain, sometimes so extreme that she had to lay down for hours, shooting headaches and overall flu-like symptoms including an off and on dry cough, sore throat and overall aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment as lung x-ray with unknown results, CT scan with unknown results and 1 week of physician bedrest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe and persistent fatigue, GI pain, shooting headaches and flu-like symptoms including an off and on dry cough, sore throat and overall aches was resolving 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oropharyngeal pain, Pain, X-ray
Clinical narrative: Severe and persistent fatigue; GI pain; Shooting headaches; Flu-like symptoms including an off and on dry cough, sore throat and overall aches; Flu-like symptoms including an off and on dry cough, sore throat and overall aches; Flu-like symptoms including an off and on dry cough, sore throat and overall aches; Flu-like symptoms including an off and on dry cough, sore throat and overall aches; This is a spontaneous report from a contactable consumer, the patient. A 46-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 19Mar2021 at 12:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, bartonellosis and unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included levothyroxine sodium (SYNTHROID) 50 mg 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 26Feb2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 19Mar2021 at 13:30, since the second shot, the patient experienced severe and persistent fatigue, gastrointestinal (GI) pain, sometimes so extreme that she had to lay down for hours, shooting headaches and overall flu-like symptoms including an off and on dry cough, sore throat and overall aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment as lung x-ray with unknown results, CT scan with unknown results and 1 week of physician bedrest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe and persistent fatigue, GI pain, shooting headaches and flu-like symptoms including an off and on dry cough, sore throat and overall aches was resolving 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Ear pain, Fatigue
Clinical narrative: Headache; Body aches; Earache; Chills; Diarrhea; Fatigue; Trouble breathing; Sore throat; Swelled lymph nodes in neck; 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: EW0179) via an unspecified route of administration in the right arm on 03May2021 at 14:30 (at the age of 56-years old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications (reported as Na). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE0153) via an unspecified route of administration in the right arm on 12Apr2021 at 13:00 as a single dose for COVID-19 immunisation. On 04May2021 at 05:00, the patient experienced headache, body aches, earache, chills, diarrhea, fatigue, trouble breathing, sore throat and swelled lymph nodes in neck. These symptoms had not gone away for 10 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, earache, chills, diarrhea, fatigue, trouble breathing, sore throat and swelled lymph nodes in neck was not resolved 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: Headache, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: Headache; Body aches; Earache; Chills; Diarrhea; Fatigue; Trouble breathing; Sore throat; Swelled lymph nodes in neck; 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: EW0179) via an unspecified route of administration in the right arm on 03May2021 at 14:30 (at the age of 56-years old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications (reported as Na). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE0153) via an unspecified route of administration in the right arm on 12Apr2021 at 13:00 as a single dose for COVID-19 immunisation. On 04May2021 at 05:00, the patient experienced headache, body aches, earache, chills, diarrhea, fatigue, trouble breathing, sore throat and swelled lymph nodes in neck. These symptoms had not gone away for 10 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, earache, chills, diarrhea, fatigue, trouble breathing, sore throat and swelled lymph nodes in neck was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.