chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Fever (100.3); Headache; Tiredness; Sore arm; Chills; Softball sized, red, sore, swollen circle around injection site for several days (still present at this time).; Softball sized, red, sore, swollen circle around injection site for several days (still present at this time); Softball sized, red, sore, swollen circle around injection site for several days (still present at this time).; Softball sized, red, sore, swollen circle around injection site for several days (still present at this time); This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old 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 07Apr2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood pressure high (HBP). The patient did not receive any medication within two weeks of vaccination. The patient previously took tetracycline and lisinopril on unknown dates for unknown indications and experienced drug allergy. 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 17Mar2021 at 10:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 00:15, the patient experienced fever (100.3), headache, tiredness, sore arm and chills for 2 days. The patient also experienced softball sized, red, sore, swollen circle around injection site for several days (still present at the time of report). On 08Apr2021 at 00:15, the patient's body temperature was measured and the result was (100.3 unspecified units). 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 for the reported events. The clinical outcome of the events fever (100.3), headache, tiredness, sore arm and chills were recovered on 10Apr2021 after a duration of 2 days. The events of softball sized, red, sore and swollen circle around injection site for several days were recovering at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever (100.3); Headache; Tiredness; Sore arm; Chills; Softball sized, red, sore, swollen circle around injection site for several days (still present at this time).; Softball sized, red, sore, swollen circle around injection site for several days (still present at this time); Softball sized, red, sore, swollen circle around injection site for several days (still present at this time).; Softball sized, red, sore, swollen circle around injection site for several days (still present at this time); This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old 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 07Apr2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood pressure high (HBP). The patient did not receive any medication within two weeks of vaccination. The patient previously took tetracycline and lisinopril on unknown dates for unknown indications and experienced drug allergy. 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 17Mar2021 at 10:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 00:15, the patient experienced fever (100.3), headache, tiredness, sore arm and chills for 2 days. The patient also experienced softball sized, red, sore, swollen circle around injection site for several days (still present at the time of report). On 08Apr2021 at 00:15, the patient's body temperature was measured and the result was (100.3 unspecified units). 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 for the reported events. The clinical outcome of the events fever (100.3), headache, tiredness, sore arm and chills were recovered on 10Apr2021 after a duration of 2 days. The events of softball sized, red, sore and swollen circle around injection site for several days were recovering at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 09Apr2021, the patient experienced metallic taste in mouth for 8-10 hours. 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 event. The clinical outcome of the event metallic taste in mouth was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Rash, Urticaria
Clinical narrative: Fatigued; Elevated heart rate; Broke out into a full body rash, everywhere, but my palms and soles, and face on 4/7; Hives; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included emtricitabine, tenofovir alafenamide fumarate, bictegravir sodium (BIKTARVY). 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: EN6208) via an unspecified route of administration in the left arm on 14Mar2021 at 15:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation.  On 07Apr2021, the patient experienced hives and broke out into a full body rash, everywhere but her palms, soles, and face were 4/7. The patient was given prednisone to stop the hives, but they came back the same night. On 08Apr2021, the patient was fatigued, and had an elevated heart rate. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event hives and included treatment with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events broke out into a full body rash, everywhere, but her palms, soles, and face were 4/7, hives, fatigued and elevated heart rate was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hyperacusis, Parosmia
Clinical narrative: World smells of mold/earthy; Everyday sounds seem way too loud; Immediate metallic taste all food taste metallic; This is a spontaneous report from a contactable consumer, the patient. A 57-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 07Apr2021 at 17:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously took malarone on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 17:00, the patient experienced immediate metallic taste, all food tasted metallic. On 09Apr2021 (Friday morning), the patient began to experience world smelled of mold/earthy and everyday sounds seemed way too loud; the metallic taste lessened by Friday, but still overridden the taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events metallic taste, world smells of mold/earthy and everyday sounds seem way too loud were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm where received the vaccine started to feel burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 20Mar2021 at 17:45 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history was not available. The patient did not have a history of allergies to any food or medications or other products. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), amfetamine sulfate (AMPHETAMINE SALTS) and omeprazole magnesium (OMEPRAZOLE) for  an unknown indication on an unknown date.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient left arm where he received the vaccine started to feel burning sensation the same way it did the day after my vaccine up to 2 weeks later. It was reported that it wasn't hurting to the point it did the days after. It wasn't tender to touch and he could not locate the burn when touching it. It was strange as if he had received a small dose of the vaccine into arm again. This did not affect mobility or anything like that. It was just strange that he felt that same burn weeks later. The patient asked his wife who received her does 15 minutes before patient from the same batch and she did not experience the event. No therapeutic measures were taken for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the event left arm where received the vaccine started to feel burning sensation was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Myalgia, Sinus pain
Clinical narrative: Headaches; Shortness of breath; Cough; Muscle aches; Drowsiness; Sinus pain; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 11Apr2021 at 08:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included levonorgestrel (KYLEENA IUD) from an unknown date for unknown indication. The patient previously 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 14Mar2021 at 08:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 13:00, the patient experienced headaches, shortness of breath, cough, muscle aches, drowsiness and sinus pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of headaches, shortness of breath, cough, muscle aches, drowsiness and sinus pain were recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Headaches; Shortness of breath; Cough; Muscle aches; Drowsiness; Sinus pain; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 11Apr2021 at 08:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included levonorgestrel (KYLEENA IUD) from an unknown date for unknown indication. The patient previously 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 14Mar2021 at 08:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 13:00, the patient experienced headaches, shortness of breath, cough, muscle aches, drowsiness and sinus pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of headaches, shortness of breath, cough, muscle aches, drowsiness and sinus pain were recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Pain, Pain in extremity
Clinical narrative: arm sore; fever; extreme body aches; headache; tiredness; slept alot; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO153) via an unspecified route of administration in the left arm on 09Apr2021 at 16:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, thyroid and COVID-19. The patient did not have any known allergies. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 22:00, the patient experienced arm sore, fever, extreme body aches, headache, tiredness, slept a lot and felt like her COVID that she had. 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. The clinical outcome of the events arm sore, fever, extreme body aches, headache, tiredness and slept a lot were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm sore; fever; extreme body aches; headache; tiredness; slept alot; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO153) via an unspecified route of administration in the left arm on 09Apr2021 at 16:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, thyroid and COVID-19. The patient did not have any known allergies. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 22:00, the patient experienced arm sore, fever, extreme body aches, headache, tiredness, slept a lot and felt like her COVID that she had. 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. The clinical outcome of the events arm sore, fever, extreme body aches, headache, tiredness and slept a lot were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: about 12 hours after, heart rate 20 to 30 bpm higher than normal for 24 hours; Normal resting in upper 60s. Most of the day was between upper 80s and upper 90s.; Fatigue; More thirsty than normal; Arm much more sore after 2nd dose; Mild diarrhea; Mild headache for more than 24 hours starting 6 hours after shot; This is a spontaneous report from a contactable consumer, the patient. A 46-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737), via an unspecified route of administration in the arm left on 10Apr2021 10:30 as dose 2, single (at the age of 46-years-old) for covid-19 immunization. Medical history included brain tumor, respiratory tract congestion, cough from congestion and bandaid adhesive allergy. The concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6207), via an unspecified route of administration in the arm left on 19Mar2021 07:15 PM as dose 1, single for covid-19 immunization and experienced heart rate was elevated and mild sore arm. On an unknown date in Apr 2021, about 8 hours after the second shot of vaccine, the patient experienced mild headache which was lasted for more than 24 hours, patient got frequent headaches so might or might not be related and about 12 hours after heart rate was 20 to 30 bpm higher than normal for 24 hours: normal resting in upper 60s. Most of the day was between upper 80s and upper 90s. The patient also experienced fatigue, more thirsty than normal, arm much sore after 2nd dose and mild diarrhea on an unknown date in Apr 2021. The patient was not received the treatment for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient not tested for COVID-19. The patient was not received any other medications within 2 weeks while not received any other vaccines within 4 weeks. The outcome of the events heart rate increased and pain in extremity was recovered while outcome of the other events was recovering.  No follow-up attempts were needed. No further information was expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thirst
Clinical narrative: about 12 hours after, heart rate 20 to 30 bpm higher than normal for 24 hours; Normal resting in upper 60s. Most of the day was between upper 80s and upper 90s.; Fatigue; More thirsty than normal; Arm much more sore after 2nd dose; Mild diarrhea; Mild headache for more than 24 hours starting 6 hours after shot; This is a spontaneous report from a contactable consumer, the patient. A 46-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737), via an unspecified route of administration in the arm left on 10Apr2021 10:30 as dose 2, single (at the age of 46-years-old) for covid-19 immunization. Medical history included brain tumor, respiratory tract congestion, cough from congestion and bandaid adhesive allergy. The concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6207), via an unspecified route of administration in the arm left on 19Mar2021 07:15 PM as dose 1, single for covid-19 immunization and experienced heart rate was elevated and mild sore arm. On an unknown date in Apr 2021, about 8 hours after the second shot of vaccine, the patient experienced mild headache which was lasted for more than 24 hours, patient got frequent headaches so might or might not be related and about 12 hours after heart rate was 20 to 30 bpm higher than normal for 24 hours: normal resting in upper 60s. Most of the day was between upper 80s and upper 90s. The patient also experienced fatigue, more thirsty than normal, arm much sore after 2nd dose and mild diarrhea on an unknown date in Apr 2021. The patient was not received the treatment for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient not tested for COVID-19. The patient was not received any other medications within 2 weeks while not received any other vaccines within 4 weeks. The outcome of the events heart rate increased and pain in extremity was recovered while outcome of the other events was recovering.  No follow-up attempts were needed. No further information was expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pruritus, Pyrexia
Clinical narrative: Intense body aches primarily located in legs; Severe chills for four hours; Fever; Itchy palms which spread to hands then started up wrist.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took bacitracin (MANUFACTURER UNKNOWN) and polymyxin b sulfate, neomycin sulfate (NEOSPORIN) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, about 10 hours after second shot, the patient experienced severe chills for four hours, fever for 16 hours, intense body aches primarily located in legs (for 24 hours). Managed by paracetamol (TYLENOL). Approximately 40 hours after 2d shot developed itchy palms which spread to hands then started up wrist. Took diphenhydramine (BENADRYL) and it ceased the itching. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of chills, fever and body aches which included paracetamol (TYLENOL) and for itchy, diphenhydramine (BENADRYL) was taken. The clinical outcome of severe chills, fever, intense body aches primarily located in legs and itchy palms were recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Nausea
Clinical narrative: Nauseated; Initial dizziness; Headache; Slight chest pain; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient 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 01Apr2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, overweight and high blood pressure (hbp). Known allergies of patient were reported as not applicable. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), rizatriptan (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:15, the patient experienced initial dizziness and headache, slight chest pain, decreased over time. On 07Apr2021, the patient woke up dizzy and nauseated to the point that the patient couldn't go to work, still felt dizzy and nauseated if the patient moved quickly, but it had reduced in severity. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events initial dizziness, headache, slight chest pain and nauseated were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Vaccination site pain
Clinical narrative: Had very light bleeding for about a week and a half/ I have NEVER had periods for this long or this frequent; Slightly sore arm at the injection site; This is a spontaneous report from a contactable female consumer (patient). A 30-year-old non pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EP6955) via an unspecified route of administration in right arm on 26Mar2021 12:45 pm (age at vaccination: 30 years) as dose 2, single for COVID-19 immunisation. Medical history included PCOS from an unknown date and unknown if ongoing. Concomitant medications were reported as none. Historical vaccine includes first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6200) via an unspecified route of administration in right arm on 05Mar2021 12:45 pm (age at vaccination: 30 years) as dose 1, single for COVID-19 immunisation and the patient had had my period for almost 5 weeks straight, heavier bleeding than usual, Much stronger cramps. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. On an unspecified date on Mar2021, after second dose of vaccination, the patient had very light bleeding for about a week and a half. The patient had started another period and this one seems to be similar to the one she had after the first dose. She stated that she should note that she have NEVER had periods for this long or this frequent. The patient PCOS so her body is used to not having them for months. Even after going a year without one while pregnant and nursing, it still only lasted 5 days. The patient had no other symptoms other than a slightly sore arm at the injection site. Treatment was not received for the adverse event. The outcome of the events were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever (102F); Body aches; Warm/painful injection site; Warm/painful injection site; Arm pain; limited arm mobility; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 09Apr2021 at 19:00(at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 31-year-old) as a single dose for Covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:00 the patient experienced fever (102F), body aches, warm/painful injection site, arm pain and limited arm mobility. On 10Apr2021, the patient underwent Body temperature and the result was 102F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event fever (102F), body aches, warm/painful injection site, arm pain and limited arm mobility was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Fever (102F); Body aches; Warm/painful injection site; Warm/painful injection site; Arm pain; limited arm mobility; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 09Apr2021 at 19:00(at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 31-year-old) as a single dose for Covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:00 the patient experienced fever (102F), body aches, warm/painful injection site, arm pain and limited arm mobility. On 10Apr2021, the patient underwent Body temperature and the result was 102F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event fever (102F), body aches, warm/painful injection site, arm pain and limited arm mobility was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives on shins, neck, scalp, upper back and forearms. The hives started after the first vaccine and got much worse after the second.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EPG955) via an unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 59-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included estradiol, norethisterone acetate (ACTIVELLA) from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 10:00, the patient broke out in hives on shins, neck, scalp, upper back and forearms. The hives started after the first vaccine and got much worse after the second. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of broke out in hives on shins, neck, scalp, upper back and forearms and included treatment with topical anti itch ointment and oral histamines. The clinical outcome of broke out in hives on shins, neck, scalp, upper back and forearms was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Chills; Headache; Slight nausea; Sore left arm, where shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 14:00 (at the age of 57-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 to medications, food or other products. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN) 0.4 mg daily. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Marr2021 at 02:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 at 04:00 the patient experienced chills, headache, slight nausea and sore left arm (where shot was administered). 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 reported events. The clinical outcome of the events chills, headache, slight nausea and sore left arm were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema flareup after first injection; This is a spontaneous report from a contactable consumer. A female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if patient had any allergies to medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 after the first injection the patient experienced eczema flareup. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event eczema flareup after first injection was unknown at the time of the report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Felt sore all over; Arm was sore; Headache; This is a spontaneous report from a contactable other healthcare professional. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep 6955) via intramuscular route of administration in the left arm on 11Apr2021 at 14:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma. The patient had no allergy to medications, food, or other products. The patient received birth control medications (unspecified) within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via intramuscular route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 21:00, the patient's arm was sore. She had a headache and felt sore all over. Therapeutic measures were not taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events arm was sore, headache and felt sore all over were resolving 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: Blood glucose increased, Blood pressure increased, Blood pressure measurement, Bone pain, Disorientation
Clinical narrative: Very sore; Bones hurt; Blurry vision; Couldn't speak clearly; Blood sugar was 160.; Blood pressure was 140/96; Felt a rush of heat from the area of vaccination to chest neck and head.; Hard time breathing; Disoriented; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient was not aware of any allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 15:00, the patient experienced immediately after the shot, felt a rush of heat from the area of vaccination left arm to chest, neck and head. Had a hard time breathing, got disoriented, couldn't clearly express what she was feeling, couldn't speak clearly. checked blood pressure and it was 140/96 and blood sugar was 160. Patient reported that she was not diabetic, got lost in a familiar territory and had to use a GPS, to get home. On 13Apr2021, the patient experienced very sore, bones hurt and had blurry vision, and continued having high blood pressure and high blood sugar. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with losartan and metformin. On 12Apr2021, the patient underwent Blood pressure and the result was 140/96 (UNSPECIFIED UNITS). On 12Apr2021, the patient underwent Blood sugar and the result was 160 (UNSPECIFIED UNITS). The clinical outcome of the events a rush of heat from the area of vaccination left arm to chest, neck and head, hard time breathing, got disoriented, couldn't clearly express what she was feeling, couldn't speak clearly. checked blood pressure and it was 140/96 and blood sugar was 160. very sore, bones hurt and had blurry vision, and continued having high blood pressure and high blood sugar was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Pain, Speech disorder, Vision blurred
Clinical narrative: Very sore; Bones hurt; Blurry vision; Couldn't speak clearly; Blood sugar was 160.; Blood pressure was 140/96; Felt a rush of heat from the area of vaccination to chest neck and head.; Hard time breathing; Disoriented; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient was not aware of any allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 15:00, the patient experienced immediately after the shot, felt a rush of heat from the area of vaccination left arm to chest, neck and head. Had a hard time breathing, got disoriented, couldn't clearly express what she was feeling, couldn't speak clearly. checked blood pressure and it was 140/96 and blood sugar was 160. Patient reported that she was not diabetic, got lost in a familiar territory and had to use a GPS, to get home. On 13Apr2021, the patient experienced very sore, bones hurt and had blurry vision, and continued having high blood pressure and high blood sugar. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with losartan and metformin. On 12Apr2021, the patient underwent Blood pressure and the result was 140/96 (UNSPECIFIED UNITS). On 12Apr2021, the patient underwent Blood sugar and the result was 160 (UNSPECIFIED UNITS). The clinical outcome of the events a rush of heat from the area of vaccination left arm to chest, neck and head, hard time breathing, got disoriented, couldn't clearly express what she was feeling, couldn't speak clearly. checked blood pressure and it was 140/96 and blood sugar was 160. very sore, bones hurt and had blurry vision, and continued having high blood pressure and high blood sugar was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: tingling feeling down right arm; shooting pain in upper back and shoulder (right side); shooting pain in upper back and shoulder (right side); shake; ringing in her ears; pupils were completely dilated; felt warm to the touch; momentary light-headed feeling; vision began to blackout, then her vision when to all white; vision began to blackout, then her vision when to all white; This is a spontaneous report from a contactable consumer.   A 16-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 17:30 (Batch/Lot Number: ER8733 7/21 6023043) as DOSE 1, SINGLE (at the age of 16 years) for covid-19 immunisation.  Medical history included anxiety from an unknown date. No Known allergies. Patient did not have COVID prior vaccination. There was no COVID tested post vaccination. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) taken for an unspecified indication, start and stop date were not reported; sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced vision began to blackout, then her vision when to all white (medically significant) on 01Apr2021 with outcome of recovered , vision began to blackout, then her vision when to all white on 01Apr2021 with outcome of recovered , immediate tingling feeling down right arm following vaccination on 01Apr2021 17:30 with outcome of recovered , A few minutes (3-5) later shooting pain in upper back and shoulder on 01Apr2021 with outcome of recovered , shake  on 01Apr2021 with outcome of recovered , ringing in her ears on 01Apr2021 with outcome of recovered , pupils were completely dilated on 01Apr2021 with outcome of recovered , felt warm to the touch on 01Apr2021 with outcome of recovered. An ambulance was called. Approximately 10 minutes later she began to feel better and did not go to the hospital. 4 hours later she had a momentary light-headed feeling 01Apr2021 with outcome of recovered.  No other vaccine given in four weeks.  No treatment was given.