chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: My face, neck, chest and arms suddenly broke out in red, hot hives; Tongue started to swell; BP, it was 290/150; My face, neck, chest and arms suddenly broke out in red; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534), via an unspecified route of administration, in right arm on 23Mar2021 10:45 (at the age of 54-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and penicillin allergy. Concomitant medications included probiotics, vitamin B complex and levothyroxine. The patient was vaccinated at a hospital and was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), via an unspecified route of administration, in right arm on 02Mar2021 11:15 as dose 1, single for COVID-19 immunization. The patient's face, neck, chest and arms suddenly broke out in red, hot hives, tongue started to swell and blood pressure was 290/150 on 27Mar2021 14:30. The events resulted in emergency room visit. The events were treated with  IV Benadryl, Prednisone and Pepcid. The outcome of the evens was recovered in 2021.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Erythema, Hypertension, Swollen tongue, Urticaria
Clinical narrative: My face, neck, chest and arms suddenly broke out in red, hot hives; Tongue started to swell; BP, it was 290/150; My face, neck, chest and arms suddenly broke out in red; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534), via an unspecified route of administration, in right arm on 23Mar2021 10:45 (at the age of 54-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and penicillin allergy. Concomitant medications included probiotics, vitamin B complex and levothyroxine. The patient was vaccinated at a hospital and was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), via an unspecified route of administration, in right arm on 02Mar2021 11:15 as dose 1, single for COVID-19 immunization. The patient's face, neck, chest and arms suddenly broke out in red, hot hives, tongue started to swell and blood pressure was 290/150 on 27Mar2021 14:30. The events resulted in emergency room visit. The events were treated with  IV Benadryl, Prednisone and Pepcid. The outcome of the evens was recovered in 2021.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, slow heart beat and heart palpitations. The patient had no known allergies to medications, food or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) of 100mg, magnesium (MANUFACTURER UNKNOWN) and ascorbic acid, tocopheryl acetate, zinc, xantofyl, zeaxanthin (AREDS); all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 12:00, the patient experienced tinnitus. 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 event. The clinical outcome of tinnitus was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Peripheral swelling, Physical examination
Clinical narrative: Swelling in calves; Tingling/pins and needles in feet and lower calves; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8734) via an unspecified route of administration in the left arm on 29Mar2021 at 18:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included meniere's disease and anxiety. The patient did not have any allergies to food, medications, or other products. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ). 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 29Mar2021 at 22:00, 4 hours after injection, the patient started feeling tingling in feet (pins and needles) and lower calves, the patient had swelling in calves two days later on 31Mar2021. Swelling subsided but tingling in feet persisted a week later. It was accompanied with swollen lymph nodes in groin area on an unknown date in Mar2021. Tingling increased with physical activity such as walking or temperature changes (hot shower etc). The events resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event swelling in calves (calf swelling) was recovered on an unknown date in 2021. The clinical outcome of the events swollen lymph nodes and tingling in feet and lower claves were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Peripheral swelling
Clinical narrative: Swelling in calves; Tingling/pins and needles in feet and lower calves; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8734) via an unspecified route of administration in the left arm on 29Mar2021 at 18:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included meniere's disease and anxiety. The patient did not have any allergies to food, medications, or other products. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ). 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 29Mar2021 at 22:00, 4 hours after injection, the patient started feeling tingling in feet (pins and needles) and lower calves, the patient had swelling in calves two days later on 31Mar2021. Swelling subsided but tingling in feet persisted a week later. It was accompanied with swollen lymph nodes in groin area on an unknown date in Mar2021. Tingling increased with physical activity such as walking or temperature changes (hot shower etc). The events resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event swelling in calves (calf swelling) was recovered on an unknown date in 2021. The clinical outcome of the events swollen lymph nodes and tingling in feet and lower claves were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: injection site itch; Around 1:00pm spiked a fever of 101.3; pretty large chills; arm hurts; Body felt very achy; injection site was red, swollen, and firm and hot to touch.; injection site was red, swollen; This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included doxepin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE) all from an unknown date and for unknown indication taken within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Mar2021 at 15:15 (at the age of 38-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 2Apr2021 at 09:00, day after second dose in the morning the patient noticed injection site was red(vaccination site erythema), swollen(vaccination site swelling), and firm and hot to touch, body felt very achy(itchy) and arm hurts(pain in the arm). On 2Apr2021 around 13:00 spiked a fever of 101.3(fever) this included pretty large chills(chills), fever which persisted through the night and woke up at 100.3 and  fever finally broke around 11:45 next day injection site was still very firm, red, and is starting to itch (and sensitive).Therapeutic measures included treatment with Tylenol  taken throughout the day after fever spiked. The adverse 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 injection site was red, swollen, and firm and hot to touch, body felt very achy and arm hurts, fever of 101.3 this included pretty large chills, fever which persisted through the night and woke up at 100.3 and fever finally broke around 11:45, injection site starting to itch were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: injection site itch; Around 1:00pm spiked a fever of 101.3; pretty large chills; arm hurts; Body felt very achy; injection site was red, swollen, and firm and hot to touch.; injection site was red, swollen; This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included doxepin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE) all from an unknown date and for unknown indication taken within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Mar2021 at 15:15 (at the age of 38-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 2Apr2021 at 09:00, day after second dose in the morning the patient noticed injection site was red(vaccination site erythema), swollen(vaccination site swelling), and firm and hot to touch, body felt very achy(itchy) and arm hurts(pain in the arm). On 2Apr2021 around 13:00 spiked a fever of 101.3(fever) this included pretty large chills(chills), fever which persisted through the night and woke up at 100.3 and  fever finally broke around 11:45 next day injection site was still very firm, red, and is starting to itch (and sensitive).Therapeutic measures included treatment with Tylenol  taken throughout the day after fever spiked. The adverse 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 injection site was red, swollen, and firm and hot to touch, body felt very achy and arm hurts, fever of 101.3 this included pretty large chills, fever which persisted through the night and woke up at 100.3 and fever finally broke around 11:45, injection site starting to itch were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Injection site pruritus, Pain in extremity, Pruritus
Clinical narrative: injection site itch; Around 1:00pm spiked a fever of 101.3; pretty large chills; arm hurts; Body felt very achy; injection site was red, swollen, and firm and hot to touch.; injection site was red, swollen; This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included doxepin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE) all from an unknown date and for unknown indication taken within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Mar2021 at 15:15 (at the age of 38-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 2Apr2021 at 09:00, day after second dose in the morning the patient noticed injection site was red(vaccination site erythema), swollen(vaccination site swelling), and firm and hot to touch, body felt very achy(itchy) and arm hurts(pain in the arm). On 2Apr2021 around 13:00 spiked a fever of 101.3(fever) this included pretty large chills(chills), fever which persisted through the night and woke up at 100.3 and  fever finally broke around 11:45 next day injection site was still very firm, red, and is starting to itch (and sensitive).Therapeutic measures included treatment with Tylenol  taken throughout the day after fever spiked. The adverse 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 injection site was red, swollen, and firm and hot to touch, body felt very achy and arm hurts, fever of 101.3 this included pretty large chills, fever which persisted through the night and woke up at 100.3 and fever finally broke around 11:45, injection site starting to itch were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: injection site itch; Around 1:00pm spiked a fever of 101.3; pretty large chills; arm hurts; Body felt very achy; injection site was red, swollen, and firm and hot to touch.; injection site was red, swollen; This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included doxepin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE) all from an unknown date and for unknown indication taken within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Mar2021 at 15:15 (at the age of 38-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 2Apr2021 at 09:00, day after second dose in the morning the patient noticed injection site was red(vaccination site erythema), swollen(vaccination site swelling), and firm and hot to touch, body felt very achy(itchy) and arm hurts(pain in the arm). On 2Apr2021 around 13:00 spiked a fever of 101.3(fever) this included pretty large chills(chills), fever which persisted through the night and woke up at 100.3 and  fever finally broke around 11:45 next day injection site was still very firm, red, and is starting to itch (and sensitive).Therapeutic measures included treatment with Tylenol  taken throughout the day after fever spiked. The adverse 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 injection site was red, swollen, and firm and hot to touch, body felt very achy and arm hurts, fever of 101.3 this included pretty large chills, fever which persisted through the night and woke up at 100.3 and fever finally broke around 11:45, injection site starting to itch were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Malaise, Nausea, Pain in extremity, Vomiting
Clinical narrative: nauseous; vomiting; tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the arm left on 30Mar2021 at 11:45(at the age of 56-years-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. 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 30Mar2021 at 13:15, the patient experienced nauseous, vomiting and tinnitus. Prior to vaccination, the patient had very minor barely noticeable tinnitus in left ear. Since vaccination and still 1week later patient had very loud bothersome tinnitus in left ear. The patient suspect causes by inflammatory immune response to the vaccine. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit.  The clinical outcome of the events nauseous, vomiting and tinnitus were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Vomiting
Clinical narrative: nauseous; vomiting; tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the arm left on 30Mar2021 at 11:45(at the age of 56-years-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. 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 30Mar2021 at 13:15, the patient experienced nauseous, vomiting and tinnitus. Prior to vaccination, the patient had very minor barely noticeable tinnitus in left ear. Since vaccination and still 1week later patient had very loud bothersome tinnitus in left ear. The patient suspect causes by inflammatory immune response to the vaccine. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit.  The clinical outcome of the events nauseous, vomiting and tinnitus were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Tinnitus, Vomiting
Clinical narrative: nauseous; vomiting; tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the arm left on 30Mar2021 at 11:45(at the age of 56-years-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. 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 30Mar2021 at 13:15, the patient experienced nauseous, vomiting and tinnitus. Prior to vaccination, the patient had very minor barely noticeable tinnitus in left ear. Since vaccination and still 1week later patient had very loud bothersome tinnitus in left ear. The patient suspect causes by inflammatory immune response to the vaccine. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit.  The clinical outcome of the events nauseous, vomiting and tinnitus were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Chills; low grade fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in left arm on 02Apr2021 at 16:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6200) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. 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 03Apr2021 at 06:00, following second vaccination, the patient woke up with chills, low grade fever and headache lasting about 24 hours. 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 chills, low grade fever and headache was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; low grade fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in left arm on 02Apr2021 at 16:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6200) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. 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 03Apr2021 at 06:00, following second vaccination, the patient woke up with chills, low grade fever and headache lasting about 24 hours. 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 chills, low grade fever and headache was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Significant ear ringing approximately 9 hours after vaccination and this has continued to some degree since; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 10:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not applicable. The patient previously received acetyl salicylic acid (ASPIRIN), Ibuprofen (IBUPROFEN) and doxycycline hyclate (DOXYCYCLINE)  for unknown indication on an unknown date and experienced drug allergy. Concomitant medications included colecalciferol (VITAMIN D3) and ascorbic acid, biotin, calcium, calcium phosphate dibasic, chromic chloride, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, pantothenic acid, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, sodium metasilicate, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, vitamin d not otherwise specified, zinc oxide (CENTRUM SILVER) from unknown date for unknown indication within two weeks prior to COVID-19 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 27Mar2021 at 19:00 the patient experienced significant ear ringing approximately 9 hours after vaccination and this had been continued to some degree since then. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported  event. The clinical outcome of the event significant ear ringing was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pharyngeal swelling, Swollen tongue, Throat tightness
Clinical narrative: Tongue swollen; Soreness at the injection site; Throat started to feel swollen; This is a spontaneous report from a contactable consumer, the patient. A 49-years-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 arm left on 31Mar2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient medical history included known allergies to acetylsalicylic acid (ASPIRIN) and clarithromycin (BIAXIN). Concomitant medications included gliclazide (CLARITIN), guaifenesin, pseudoephedrine hydrochloride (SUDAFED), mometasone furoate (FLONASE) and Multi vitamin (MANUFACTURER UNKNOWN) all from unknown dates, for unspecified indication. 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 31Mar2021 at 14:40 about 10 minutes after the injection (vaccination), the patient experienced tongue and throat started to feel swollen and immediately took some chewable benadryl and after about 10-15 minutes it seemed to level off and stop getting worse, but did not really go away for several hours and also had soreness at the injection site for about 3 days. Patient received chewable Benadryl as therapeutic measures as a result of reported events tongue swollen and throat started to feel swollen. 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 event tongue swollen and throat started to feel swollen was unknown. The clinical outcome of the event soreness at the injection site was recovered on 02Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swollen tongue, Vaccination site pain
Clinical narrative: Tongue swollen; Soreness at the injection site; Throat started to feel swollen; This is a spontaneous report from a contactable consumer, the patient. A 49-years-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 arm left on 31Mar2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient medical history included known allergies to acetylsalicylic acid (ASPIRIN) and clarithromycin (BIAXIN). Concomitant medications included gliclazide (CLARITIN), guaifenesin, pseudoephedrine hydrochloride (SUDAFED), mometasone furoate (FLONASE) and Multi vitamin (MANUFACTURER UNKNOWN) all from unknown dates, for unspecified indication. 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 31Mar2021 at 14:40 about 10 minutes after the injection (vaccination), the patient experienced tongue and throat started to feel swollen and immediately took some chewable benadryl and after about 10-15 minutes it seemed to level off and stop getting worse, but did not really go away for several hours and also had soreness at the injection site for about 3 days. Patient received chewable Benadryl as therapeutic measures as a result of reported events tongue swollen and throat started to feel swollen. 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 event tongue swollen and throat started to feel swollen was unknown. The clinical outcome of the event soreness at the injection site was recovered on 02Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nausea, Paraesthesia oral
Clinical narrative: Nausea; Dizziness/Lightheadedness; Tingling of the tongue; Elevated BP; This is a spontaneous report from a contactable consumer, the patient. A 30-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 04Apr2021 at 11:00 am (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies to medications, food or other products. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and drospirenone, ethinylestradiol (LORYNA) on an unknown dates, for unknown indications. 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 04Apr2021 at 11:15 am, i.e. after 10 mins of vaccination (as reported) the patient experienced nausea, lightheadedness, dizziness, tingling of the tongue. The nursing staff was immediately notified by the patient and was monitored for BP (blood pressure) and O2 (oxygen saturation test). The result of the tests was elevated BP (but remained within normal range) and for oxygen saturation it was unknown. The patient was provided with apple juice for sugar. Symptoms resolved within 15 minutes. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, lightheadedness, dizziness, elevated blood pressure and tingling of the tongue was recovered on 04Apr2021.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Nausea, Oxygen saturation
Clinical narrative: Nausea; Dizziness/Lightheadedness; Tingling of the tongue; Elevated BP; This is a spontaneous report from a contactable consumer, the patient. A 30-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 04Apr2021 at 11:00 am (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies to medications, food or other products. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and drospirenone, ethinylestradiol (LORYNA) on an unknown dates, for unknown indications. 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 04Apr2021 at 11:15 am, i.e. after 10 mins of vaccination (as reported) the patient experienced nausea, lightheadedness, dizziness, tingling of the tongue. The nursing staff was immediately notified by the patient and was monitored for BP (blood pressure) and O2 (oxygen saturation test). The result of the tests was elevated BP (but remained within normal range) and for oxygen saturation it was unknown. The patient was provided with apple juice for sugar. Symptoms resolved within 15 minutes. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, lightheadedness, dizziness, elevated blood pressure and tingling of the tongue was recovered on 04Apr2021.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Nausea; Dizziness/Lightheadedness; Tingling of the tongue; Elevated BP; This is a spontaneous report from a contactable consumer, the patient. A 30-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 04Apr2021 at 11:00 am (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies to medications, food or other products. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and drospirenone, ethinylestradiol (LORYNA) on an unknown dates, for unknown indications. 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 04Apr2021 at 11:15 am, i.e. after 10 mins of vaccination (as reported) the patient experienced nausea, lightheadedness, dizziness, tingling of the tongue. The nursing staff was immediately notified by the patient and was monitored for BP (blood pressure) and O2 (oxygen saturation test). The result of the tests was elevated BP (but remained within normal range) and for oxygen saturation it was unknown. The patient was provided with apple juice for sugar. Symptoms resolved within 15 minutes. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, lightheadedness, dizziness, elevated blood pressure and tingling of the tongue was recovered on 04Apr2021.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Mar2021 at 10:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. The patient was allergic to REGLAN and codeine (MANUFACTURER UNKNOWN) and also allergic to mangoes (fruit allergy). Concomitant medications included levothyroxine 75milligrams (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 28Mar2021 at 14:30, the patient experienced severe tinnitus, prior she had manageable tinnitus. 3 days after the vaccine, the tinnitus suddenly got much louder. It was severe and debilitating and has not subsided, she experienced fullness in the ears. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event severe tinnitus and fullness in the ears were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Mar2021 at 10:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. The patient was allergic to REGLAN and codeine (MANUFACTURER UNKNOWN) and also allergic to mangoes (fruit allergy). Concomitant medications included levothyroxine 75milligrams (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 28Mar2021 at 14:30, the patient experienced severe tinnitus, prior she had manageable tinnitus. 3 days after the vaccine, the tinnitus suddenly got much louder. It was severe and debilitating and has not subsided, she experienced fullness in the ears. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event severe tinnitus and fullness in the ears were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Swelling at sites of facial fillers; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on 03Apr2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovary syndrome (PCOS), depression and attention deficit hyperactivity disorder (ADHD). The patient had no known allergies to medications, food or other products. Concomitant medications included ascorbic acid (VITAMIN C), spironolactone (MANUFACTURER UNKNOWN), bromelain (MANUFACTURER UNKNOWN), birth control; all from an unknown date for unknown indication. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the left arm on 12Mar2021 at 17:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 21:00, the patient experienced swelling at sites of facial fillers. The event resulted in doctor or other health care professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the reported event. The clinical outcome of swelling at sites of facial fillers was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Pruritus, Rash
Clinical narrative: three additional spots about 1/2 inch in diameter appeared; skin rash /bump appeared on my right wrist; skin rash / bump appeared on my right wrist and was very itchy; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 at 17:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and did not take any concomitant medications. The patient had no known allergies to medications, food or other products. 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 4 weeks prior to the COVID vaccine. On 30Mar2021 at 12:00, the patient experienced the first skin rash / bump that appeared on the right wrist and was very itchy. It expanded to an area about 1 inch x 2 inches and a week later continued to be itchy. On 04Apr2021, three additional spots about 1/2 inch in diameter appeared on and around the patients right nipple and later that day, three other spots about 1/2 inch in diameter appeared on his left shoulder. The chest and shoulder spots were only slightly itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the events skin rash and itchy rash and included treatment with Zyrtec which helps reduce the itching. The patient reported that he only takes 1/8 of a pill (Zyrtec) because a whole pill was too strong for him. The clinical outcome of the events skin rash / bump that appeared on the right wrist and was very itchy and three additional spots about 1/2 inch in diameter on and around the right nipple and on the left shoulder was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: three additional spots about 1/2 inch in diameter appeared; skin rash /bump appeared on my right wrist; skin rash / bump appeared on my right wrist and was very itchy; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 at 17:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and did not take any concomitant medications. The patient had no known allergies to medications, food or other products. 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 4 weeks prior to the COVID vaccine. On 30Mar2021 at 12:00, the patient experienced the first skin rash / bump that appeared on the right wrist and was very itchy. It expanded to an area about 1 inch x 2 inches and a week later continued to be itchy. On 04Apr2021, three additional spots about 1/2 inch in diameter appeared on and around the patients right nipple and later that day, three other spots about 1/2 inch in diameter appeared on his left shoulder. The chest and shoulder spots were only slightly itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the events skin rash and itchy rash and included treatment with Zyrtec which helps reduce the itching. The patient reported that he only takes 1/8 of a pill (Zyrtec) because a whole pill was too strong for him. The clinical outcome of the events skin rash / bump that appeared on the right wrist and was very itchy and three additional spots about 1/2 inch in diameter on and around the right nipple and on the left shoulder was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.