chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: After my first vaccine my right earstarted ringing.; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation and also the patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 12:45 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. The patient did not receive any other medications within four weeks prior to the COVID-19 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 24Mar2021 at 07:30, the patient experienced after first vaccine his right ear started ringing. No therapeutic measures were taken as a result of adverse event. The event 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 after fist dose right ear started ringing was recovered on 26Mar2021.     No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Facial paresis, Hypoaesthesia
Clinical narrative: Numbness to mouth and tongue right side; Numbness to right side of face; Numbness to right side of face, including eye; Eye watering; 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: ER8733) via an unspecified route of administration in the left arm on 06Apr2021 at 13:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and asthma. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 08:00, the patient experienced numbness to mouth and tongue right side, numbness to right side of face, including eye and eye watering. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events included treatment with Prednisone (MANUFACTURER UNKNOWN) on unknown date in 2021 and unknown if ongoing. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent SARS-CoV-2 test and the result was found to be negative. The clinical outcome of the events numbness to mouth and tongue right side, numbness to right side of face, including eye and eye watering was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia eye, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: Numbness to mouth and tongue right side; Numbness to right side of face; Numbness to right side of face, including eye; Eye watering; 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: ER8733) via an unspecified route of administration in the left arm on 06Apr2021 at 13:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and asthma. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 08:00, the patient experienced numbness to mouth and tongue right side, numbness to right side of face, including eye and eye watering. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events included treatment with Prednisone (MANUFACTURER UNKNOWN) on unknown date in 2021 and unknown if ongoing. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent SARS-CoV-2 test and the result was found to be negative. The clinical outcome of the events numbness to mouth and tongue right side, numbness to right side of face, including eye and eye watering was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Lacrimation increased, SARS-CoV-2 test
Clinical narrative: Numbness to mouth and tongue right side; Numbness to right side of face; Numbness to right side of face, including eye; Eye watering; 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: ER8733) via an unspecified route of administration in the left arm on 06Apr2021 at 13:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and asthma. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 08:00, the patient experienced numbness to mouth and tongue right side, numbness to right side of face, including eye and eye watering. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events included treatment with Prednisone (MANUFACTURER UNKNOWN) on unknown date in 2021 and unknown if ongoing. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent SARS-CoV-2 test and the result was found to be negative. The clinical outcome of the events numbness to mouth and tongue right side, numbness to right side of face, including eye and eye watering was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Rash
Clinical narrative: small rash on waist; 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: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have any allergies to medications, food, or other products. Concomitant medication included vitamins; taken for unknown indication on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. On 12Apr2021 at 07:00, the patient experienced small rash on waist. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event small rash on waist was not recovered at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Confusional state, Electrocardiogram, Fatigue, Product administered to patient of inappropriate age
Clinical narrative: Experiencing seizure like episodes; daughter experiencing  confusion of not knowing where she is at or who with; lasts a couple mins happens; Sometimes body will shake especially right side where she received her shot. Arm or leg will just start to shake where she has no control when she is awake.; This is a spontaneous report from a contactable consumer. A 16-year-old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (lot EW0158) on 08Apr2021 single dose at right arm for COVID-19 immunization at the age of 16 years old. Medical history was not provided. Concomitant drugs included nortriptyline hydrochloride (NORTRIPTYLIN) and ethinylestradiol, levonorgestrel (SETLAKIN) for Birth control. Past drug event included known allergies: amoxicillin sodium, clavulanate potassium (AUGMENTIN). On 10Apr2021, the patient experienced confusion of not knowing where she was at or who with; lasted a couple mins happens every once in a while. She was experiencing seizure like episodes. especially at night. Once she closed her eyes, she started to shake like she was having a seizure. Sometimes body will shake especially right side where she received her shot. Arm or leg will just start to shake where she has no control when she is awake. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received.  The outcome of the events was not resolved.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Seizure, Tremor
Clinical narrative: Experiencing seizure like episodes; daughter experiencing  confusion of not knowing where she is at or who with; lasts a couple mins happens; Sometimes body will shake especially right side where she received her shot. Arm or leg will just start to shake where she has no control when she is awake.; This is a spontaneous report from a contactable consumer. A 16-year-old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (lot EW0158) on 08Apr2021 single dose at right arm for COVID-19 immunization at the age of 16 years old. Medical history was not provided. Concomitant drugs included nortriptyline hydrochloride (NORTRIPTYLIN) and ethinylestradiol, levonorgestrel (SETLAKIN) for Birth control. Past drug event included known allergies: amoxicillin sodium, clavulanate potassium (AUGMENTIN). On 10Apr2021, the patient experienced confusion of not knowing where she was at or who with; lasted a couple mins happens every once in a while. She was experiencing seizure like episodes. especially at night. Once she closed her eyes, she started to shake like she was having a seizure. Sometimes body will shake especially right side where she received her shot. Arm or leg will just start to shake where she has no control when she is awake. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received.  The outcome of the events was not resolved.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I have mild tinnitus. But a few days after the 2nd shot, the volume of the tinnitus doubled.; This is a spontaneous report from a contactable consumer, the patient. A 69-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 right arm on 02Mar2021 at 09:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (reported as low thyroid) and tinnitus. Concomitant medications taken within two weeks of vaccination included levothyroxine sodium 0.25 (unspecified units) (SYNTHROID), loratadine (CLARITIN), cyanocobalamin (B12) and vitamin d nos (VITAMIN D), all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 06Feb2021 at 09:00 (at the age of 69-years-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. The patient has had mild tinnitus. But a few days after the second shot, the volume of the tinnitus doubled on an unknown date in Mar2021 at 06:00. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event a few days after the second shot, the volume of the tinnitus doubled was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: left leg and arm became numb; left leg and arm became numb; tingling; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 16:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOC). The patient had no allergy to medications, food, or other products. Concomitant medications included vrm4 (MANUFACTURER UNKNOWN), vivi ((MANUFACTURER UNKNOWN), MEDI CLAY, VAC CHORD, LYMPHTONE II, thyroid, magnesium citrate (THYTROPHIN PMG), CXACX, RENATROPHIN PMG, FUNG DX and pseudoephedrine hydrochloride, fexofenadine hydrochloride (ALLEGRA D) from unknown dates and unknown if ongoing 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 08Apr2021 at 16:30, 15 minutes after the vaccination the patient experienced numbness in left leg and arm and tingling. Therapeutic measures were not taken as a result of the events numbness in left leg and arm and tingling. 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 event numbness in left leg and arm was resolved on an unknown date in Apr2021 and tingling was resolved on 09Apr2021 at 00.30, after the duration of 8 hours.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 19:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had known allergies to penicillin (pcn). Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), Vitamins nos (MVI) and fish oil (MANUFACTURER UNKNOWN) all from unknown dates, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date 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 11Apr2021 at 08:00, the patient experienced nausea, vomiting and chills. 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 reported events. The clinical outcome of the events nausea, vomiting and chills was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Diarrhoea, Nausea
Clinical narrative: Temperature of 101-102 for 36 hours; Temperature of 101-102 for 36 hours despite ibuprophen, beginning with chills; Extreme diarrhea for 24 hours with persistant diarrhea for an additional 5 days; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 12:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies; both from unknown dates. The patient had known allergy to cephalexin. Prior to the vaccination, it was unknown whether the patient was diagnosed for COVID-19. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), loratadine (CLARITIN) and assorted over the counter (OTC) vitamins (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 27Mar2021 at 12:15, the patient experienced temperature of 101-102 for 36 hours despite ibuprofen, beginning with chills, extreme diarrhea for 24 hours with persistent diarrhea for an additional 5 days and nausea. On 27Mar2021, the patient's body temperature was reported as 101-102 (unit unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of temperature of 101-102 which included treatment with ibuprofen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event temperature of 101-102 was recovered on 29Mar2021. The clinical outcome of the events chills and nausea was recovered on an unknown date in 2021; while that of the extreme diarrhea for 24 hours with persistent diarrhea for an additional 5 days was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Temperature of 101-102 for 36 hours; Temperature of 101-102 for 36 hours despite ibuprophen, beginning with chills; Extreme diarrhea for 24 hours with persistant diarrhea for an additional 5 days; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 12:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies; both from unknown dates. The patient had known allergy to cephalexin. Prior to the vaccination, it was unknown whether the patient was diagnosed for COVID-19. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), loratadine (CLARITIN) and assorted over the counter (OTC) vitamins (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 27Mar2021 at 12:15, the patient experienced temperature of 101-102 for 36 hours despite ibuprofen, beginning with chills, extreme diarrhea for 24 hours with persistent diarrhea for an additional 5 days and nausea. On 27Mar2021, the patient's body temperature was reported as 101-102 (unit unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of temperature of 101-102 which included treatment with ibuprofen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event temperature of 101-102 was recovered on 29Mar2021. The clinical outcome of the events chills and nausea was recovered on an unknown date in 2021; while that of the extreme diarrhea for 24 hours with persistent diarrhea for an additional 5 days was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Swelling of throat; non severe allergic  reaction; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8734) via an unspecified route of administration in the right arm on 06Apr2021 at 14:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, seasonal allergies. The patient had known allergies to kombucha tea drank one time had non-severe allergic reaction. Concomitant medications included ascorbic acid/calcium carbonate/ calcium pantothenate/ calcium phosphate/chromium/ cyanocobalamin/ folic acid/ magnesium carbonate/ magnesium hydroxide/ manganese gluconate/ nicotinic acid/ potassium bicarbonate/ potassium carbonate/ potassium phosphate dibasic/ pyridoxine hydrochloride/ quercetin/ riboflavin sodium phosphate/ sodium bicarbonate,/sodium phosphate, thiamine hydrochloride/ thioctic acid/ zinc ascorbate (EMERGEN C),vitamin d (MANUFACTURER UNKNOWN), biotin/ cysteine/ silicon dioxide (ELON MATRIX) and malus spp/ vinegar extract (APPLE CIDER VINEGAR), all 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 06Apr2021 at 16:00, the patient experienced swelling of throat and non-severe allergic reaction. Did not require hospital or doctor office visit. 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 as a result of reported events which included treatment diphenhydramine (BENADRYL). The clinical outcomes of swelling of throat and non-severe allergic reaction were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pharyngeal swelling
Clinical narrative: Swelling of throat; non severe allergic  reaction; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8734) via an unspecified route of administration in the right arm on 06Apr2021 at 14:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, seasonal allergies. The patient had known allergies to kombucha tea drank one time had non-severe allergic reaction. Concomitant medications included ascorbic acid/calcium carbonate/ calcium pantothenate/ calcium phosphate/chromium/ cyanocobalamin/ folic acid/ magnesium carbonate/ magnesium hydroxide/ manganese gluconate/ nicotinic acid/ potassium bicarbonate/ potassium carbonate/ potassium phosphate dibasic/ pyridoxine hydrochloride/ quercetin/ riboflavin sodium phosphate/ sodium bicarbonate,/sodium phosphate, thiamine hydrochloride/ thioctic acid/ zinc ascorbate (EMERGEN C),vitamin d (MANUFACTURER UNKNOWN), biotin/ cysteine/ silicon dioxide (ELON MATRIX) and malus spp/ vinegar extract (APPLE CIDER VINEGAR), all 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 06Apr2021 at 16:00, the patient experienced swelling of throat and non-severe allergic reaction. Did not require hospital or doctor office visit. 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 as a result of reported events which included treatment diphenhydramine (BENADRYL). The clinical outcomes of swelling of throat and non-severe allergic reaction were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on left arm and down left side of torso; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female 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 06Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 16:00, the patient experienced rash on left arm and down left side of torso. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with valcyclovir (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on left arm and down left side of torso was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular
Clinical narrative: Mid-cycle spotting; Early period; Heavy period; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GR8727) via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known 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 25Mar2021 at 09:00, the patient experienced mid-cycle spotting, followed by a very early, heavy period. Patient reported that it never happened before. Never spotted before, period was never early, and it was heavier than it's ever been. 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 events mid-cycle spotting, followed by a very early, heavy period was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Mid-cycle spotting; Early period; Heavy period; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GR8727) via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known 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 25Mar2021 at 09:00, the patient experienced mid-cycle spotting, followed by a very early, heavy period. Patient reported that it never happened before. Never spotted before, period was never early, and it was heavier than it's ever been. 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 events mid-cycle spotting, followed by a very early, heavy period was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Swollen tongue
Clinical narrative: Left side of face and chin swelled.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 16:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS), knee injury and blood clots. Patient has allergy to Ceclor and clams/scallops. Concomitant medications include apixaban (ELIQUIS), dimethyl fumarate (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and vitamin d (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date and unknown if ongoing. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 16:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 17:15 the patient's left side of face and chin swelled. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left side of face and chin swelled was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Left side of face and chin swelled.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 16:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS), knee injury and blood clots. Patient has allergy to Ceclor and clams/scallops. Concomitant medications include apixaban (ELIQUIS), dimethyl fumarate (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and vitamin d (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date and unknown if ongoing. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 16:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 17:15 the patient's left side of face and chin swelled. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left side of face and chin swelled was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood culture, Chest X-ray, Chills, Computerised tomogram
Clinical narrative: Fever up to 101.6 that lasted for 7 days; throbbing headache for 7 days; severe back pain; chills; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 18Mar2021(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included vitamin d nos (VITAMIN D) (5000 IU) and over the counter (OTC) fish oil capsule (MANUFACTURER UNKNOWN), both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue and included treatment with intravenous (IV) medications in emergency, Ibuprofen 600 milligram. Since the vaccination, the patient had been tested for COVID-19, which included RT-PCR test via nasal swab on 05Apr2021 and the result was negative. The clinical outcome of the events fever up to 101.6 (unspecified units) that lasted for seven days and throbbing headache for seven days was resolved on 10Apr2021. The clinical outcome of the events severe back pain, chills, extreme fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Culture urine, Full blood count, Headache, Metabolic function test, Pyrexia
Clinical narrative: Fever up to 101.6 that lasted for 7 days; throbbing headache for 7 days; severe back pain; chills; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 18Mar2021(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included vitamin d nos (VITAMIN D) (5000 IU) and over the counter (OTC) fish oil capsule (MANUFACTURER UNKNOWN), both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue and included treatment with intravenous (IV) medications in emergency, Ibuprofen 600 milligram. Since the vaccination, the patient had been tested for COVID-19, which included RT-PCR test via nasal swab on 05Apr2021 and the result was negative. The clinical outcome of the events fever up to 101.6 (unspecified units) that lasted for seven days and throbbing headache for seven days was resolved on 10Apr2021. The clinical outcome of the events severe back pain, chills, extreme fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory viral panel, Urine analysis
Clinical narrative: Fever up to 101.6 that lasted for 7 days; throbbing headache for 7 days; severe back pain; chills; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 18Mar2021(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included vitamin d nos (VITAMIN D) (5000 IU) and over the counter (OTC) fish oil capsule (MANUFACTURER UNKNOWN), both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue and included treatment with intravenous (IV) medications in emergency, Ibuprofen 600 milligram. Since the vaccination, the patient had been tested for COVID-19, which included RT-PCR test via nasal swab on 05Apr2021 and the result was negative. The clinical outcome of the events fever up to 101.6 (unspecified units) that lasted for seven days and throbbing headache for seven days was resolved on 10Apr2021. The clinical outcome of the events severe back pain, chills, extreme fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Fever up to 101.6 that lasted for 7 days; throbbing headache for 7 days; severe back pain; chills; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 18Mar2021(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included vitamin d nos (VITAMIN D) (5000 IU) and over the counter (OTC) fish oil capsule (MANUFACTURER UNKNOWN), both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue and included treatment with intravenous (IV) medications in emergency, Ibuprofen 600 milligram. Since the vaccination, the patient had been tested for COVID-19, which included RT-PCR test via nasal swab on 05Apr2021 and the result was negative. The clinical outcome of the events fever up to 101.6 (unspecified units) that lasted for seven days and throbbing headache for seven days was resolved on 10Apr2021. The clinical outcome of the events severe back pain, chills, extreme fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever up to 101.6 that lasted for 7 days; throbbing headache for 7 days; severe back pain; chills; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 18Mar2021(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included vitamin d nos (VITAMIN D) (5000 IU) and over the counter (OTC) fish oil capsule (MANUFACTURER UNKNOWN), both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of fever up to 101.6 (unspecified units) that lasted for seven days, throbbing headache for seven days, severe back pain, chills, extreme fatigue and included treatment with intravenous (IV) medications in emergency, Ibuprofen 600 milligram. Since the vaccination, the patient had been tested for COVID-19, which included RT-PCR test via nasal swab on 05Apr2021 and the result was negative. The clinical outcome of the events fever up to 101.6 (unspecified units) that lasted for seven days and throbbing headache for seven days was resolved on 10Apr2021. The clinical outcome of the events severe back pain, chills, extreme fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Tiredness; Headache; Muscle Pain; Chills; Joint Pain; Low Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and the patient was on medication since summer 2019. The patient had no known allergies.  Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), theanine (L-THEANINE), zinc (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and vitamin b complex (B COMPLEX); all from an unknown date for unknown indication and unknown if ongoing. On 11Apr2021 at 07:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, low fever, nausea and was feeling unwell.  The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of tiredness, headache, muscle pain, chills, joint pain, low fever, nausea and feeling unwell was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Tiredness; Headache; Muscle Pain; Chills; Joint Pain; Low Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and the patient was on medication since summer 2019. The patient had no known allergies.  Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), theanine (L-THEANINE), zinc (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and vitamin b complex (B COMPLEX); all from an unknown date for unknown indication and unknown if ongoing. On 11Apr2021 at 07:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, low fever, nausea and was feeling unwell.  The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of tiredness, headache, muscle pain, chills, joint pain, low fever, nausea and feeling unwell was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.