chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Electrocardiogram, Tinnitus
Clinical narrative: Arrhythmia; Tinnitus; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included arrhythmia well controlled by medication, chronic vertigo from ear injury well controlled by medication, all from an unknown date and unknown if ongoing. Known allergies: AVELOX, walnuts, pineapple.  The patient did not experienced COVID-19 prior vaccination, the patient has not tested positive to COVID-19 since vaccination. Concomitant medications included diltiazem hydrochloride (CARDIZEM CD); rosuvastatin calcium (CRESTOR); pizotifen malate (SANDOMIGRAN); lysine and curcuma longa rhizome (TURMERIC CURCUMIN), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in left arm on 09Mar2021 at 11:00 (Lot number: EN6206) for COVID-19 immunization and experienced arrhythmia 2 minutes after first vaccine. The patient experienced tinnitus 10 hours after 2nd vaccine and continuing 25 days later and arrhythmia episode 6 days after 2nd vaccine. The events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Tinnitus
Clinical narrative: Arrhythmia; Tinnitus; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included arrhythmia well controlled by medication, chronic vertigo from ear injury well controlled by medication, all from an unknown date and unknown if ongoing. Known allergies: AVELOX, walnuts, pineapple.  The patient did not experienced COVID-19 prior vaccination, the patient has not tested positive to COVID-19 since vaccination. Concomitant medications included diltiazem hydrochloride (CARDIZEM CD); rosuvastatin calcium (CRESTOR); pizotifen malate (SANDOMIGRAN); lysine and curcuma longa rhizome (TURMERIC CURCUMIN), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in left arm on 09Mar2021 at 11:00 (Lot number: EN6206) for COVID-19 immunization and experienced arrhythmia 2 minutes after first vaccine. The patient experienced tinnitus 10 hours after 2nd vaccine and continuing 25 days later and arrhythmia episode 6 days after 2nd vaccine. The events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear, nose and throat examination, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 13:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to penicillin. The patient did not receive any medication within 2 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 24Mar2021, first night after receiving the vaccine, the patient experienced ringing in both ears (tinnitus in both ears). The ringing disappeared until 05Apr2021 and came back on the evening of 05Apr2021 and was present for 15 days straight. The patient did not have any prior history of audio issues or tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with Flonase, and the patient reported that it did not do anything. The clinical outcome of the event ringing in both ears was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 13:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to penicillin. The patient did not receive any medication within 2 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 24Mar2021, first night after receiving the vaccine, the patient experienced ringing in both ears (tinnitus in both ears). The ringing disappeared until 05Apr2021 and came back on the evening of 05Apr2021 and was present for 15 days straight. The patient did not have any prior history of audio issues or tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with Flonase, and the patient reported that it did not do anything. The clinical outcome of the event ringing in both ears was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 03Apr2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lamotrigine (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 20:45, the patient experienced tinnitus in left ear. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus in left ear was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Myalgia, Nausea, Pyrexia
Clinical narrative: Vomiting; Fever (101); Muscle aches; Chills; Light headedness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 28Mar2021 at 10:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and birth control  (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 the patient experienced light headedness and nausea right after vaccine, after about 36 hours later on 29Mar2021 patient started vomiting. The patient also had a fever 101(unspecified units), muscle aches and chills. On 29Mar2021 patient checked her body temperature and it was 101 (unspecified units). Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light headedness, nausea were resolved on unknown date in 2021. The clinical outcome of the events fever 101(unspecified units), muscle aches and chills were resolved on 02Apr2021. The clinical outcome of the event vomiting was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Fever (101); Muscle aches; Chills; Light headedness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 28Mar2021 at 10:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and birth control  (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 the patient experienced light headedness and nausea right after vaccine, after about 36 hours later on 29Mar2021 patient started vomiting. The patient also had a fever 101(unspecified units), muscle aches and chills. On 29Mar2021 patient checked her body temperature and it was 101 (unspecified units). Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light headedness, nausea were resolved on unknown date in 2021. The clinical outcome of the events fever 101(unspecified units), muscle aches and chills were resolved on 02Apr2021. The clinical outcome of the event vomiting was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dizziness, Myalgia, Nausea
Clinical narrative: Vomiting; Fever (101); Muscle aches; Chills; Light headedness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 28Mar2021 at 10:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and birth control  (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 the patient experienced light headedness and nausea right after vaccine, after about 36 hours later on 29Mar2021 patient started vomiting. The patient also had a fever 101(unspecified units), muscle aches and chills. On 29Mar2021 patient checked her body temperature and it was 101 (unspecified units). Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light headedness, nausea were resolved on unknown date in 2021. The clinical outcome of the events fever 101(unspecified units), muscle aches and chills were resolved on 02Apr2021. The clinical outcome of the event vomiting was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever (101); Muscle aches; Chills; Light headedness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 28Mar2021 at 10:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and birth control  (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 the patient experienced light headedness and nausea right after vaccine, after about 36 hours later on 29Mar2021 patient started vomiting. The patient also had a fever 101(unspecified units), muscle aches and chills. On 29Mar2021 patient checked her body temperature and it was 101 (unspecified units). Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light headedness, nausea were resolved on unknown date in 2021. The clinical outcome of the events fever 101(unspecified units), muscle aches and chills were resolved on 02Apr2021. The clinical outcome of the event vomiting was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash on the arm of the injection; minimal itching; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6200) via an unspecified route of administration in the right arm on 25Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol, irritable bowel syndrome, gastroparesis and essential tremor. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included propranolol hydrochloride (PROPRANOL) and atorvastatin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took bupropion hydrochloride (WELLBUTRIN) from an unknown date for an unspecified indication and experienced drug allergy. On 31Mar2021, the patient experienced COVID arm; about a week after getting the vaccine, got a rash on the arm of the injection, it cleared up on its own within a few days without incident, and with minimal itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events COVID arm; about a week after getting the vaccine, got a rash on the arm of the injection, and with minimal itching recovered on an unknown date 2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on the arm of the injection; minimal itching; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6200) via an unspecified route of administration in the right arm on 25Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol, irritable bowel syndrome, gastroparesis and essential tremor. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included propranolol hydrochloride (PROPRANOL) and atorvastatin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took bupropion hydrochloride (WELLBUTRIN) from an unknown date for an unspecified indication and experienced drug allergy. On 31Mar2021, the patient experienced COVID arm; about a week after getting the vaccine, got a rash on the arm of the injection, it cleared up on its own within a few days without incident, and with minimal itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events COVID arm; about a week after getting the vaccine, got a rash on the arm of the injection, and with minimal itching recovered on an unknown date 2021.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Immediate post-injection reaction, Nausea, Retching, Tremor
Clinical narrative: Nausea; Dry heaving; Head fog; Really bad corse tremors; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease, gastro-oesophageal reflux disease (gerd), heart block (reported as level one heart blockage), cardiac valve leak (reported as leak in valve of heart), heart murmur, fully hysterectomy (reported as fully hysterectomy), tonsillectomy, adenoidectomy (reported as , tonsils and adenoids removed). The patient had seasonal allergy and contrast media allergy. Concomitant medications taken within two weeks of vaccination included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), vitamin d nos (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN) and estradiol (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 15Apr2021 at 13:00, the patient experienced nausea, dry heaving, head fog, really bad corse tremors. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of  nausea, dry heaving, head fog, really bad corse tremors and included treatment with benadryl, pepcid, zofran. The clinical outcome of the events nausea, dry heaving, head fog, really bad corse tremors was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Nausea, Retching, Tremor
Clinical narrative: Nausea; Dry heaving; Head fog; Really bad corse tremors; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease, gastro-oesophageal reflux disease (gerd), heart block (reported as level one heart blockage), cardiac valve leak (reported as leak in valve of heart), heart murmur, fully hysterectomy (reported as fully hysterectomy), tonsillectomy, adenoidectomy (reported as , tonsils and adenoids removed). The patient had seasonal allergy and contrast media allergy. Concomitant medications taken within two weeks of vaccination included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), vitamin d nos (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN) and estradiol (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 15Apr2021 at 13:00, the patient experienced nausea, dry heaving, head fog, really bad corse tremors. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of  nausea, dry heaving, head fog, really bad corse tremors and included treatment with benadryl, pepcid, zofran. The clinical outcome of the events nausea, dry heaving, head fog, really bad corse tremors was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Influenza, Pain, Pyrexia, Tinnitus
Clinical narrative: fever, chills and aches - normal side effects - subsided; fever, chills and aches - normal side effects - subsided; fever, chills and aches - normal side effects - subsided; Pain under right arm; swollen lymph also listed as side effect - not subsided; Ringing in my ears; Random pin prick sensation not described as possible side effects - not subsided; 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: EW0162) via an unspecified route of administration in the arm right on 15Apr2021 at 14:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 16Apr2021 at 08:00, the patient experienced fever, chills, aches, pain under right arm, swollen lymph, ringing in ears and random pin prick sensation. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills and aches was recovered on an unknown date in Apr2021, while that of pain under right arm, swollen lymph, ringing in ears and random pin prick sensation 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: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Chills, Lymphadenopathy, Pain, Paraesthesia
Clinical narrative: fever, chills and aches - normal side effects - subsided; fever, chills and aches - normal side effects - subsided; fever, chills and aches - normal side effects - subsided; Pain under right arm; swollen lymph also listed as side effect - not subsided; Ringing in my ears; Random pin prick sensation not described as possible side effects - not subsided; 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: EW0162) via an unspecified route of administration in the arm right on 15Apr2021 at 14:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 16Apr2021 at 08:00, the patient experienced fever, chills, aches, pain under right arm, swollen lymph, ringing in ears and random pin prick sensation. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills and aches was recovered on an unknown date in Apr2021, while that of pain under right arm, swollen lymph, ringing in ears and random pin prick sensation 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: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: fever, chills and aches - normal side effects - subsided; fever, chills and aches - normal side effects - subsided; fever, chills and aches - normal side effects - subsided; Pain under right arm; swollen lymph also listed as side effect - not subsided; Ringing in my ears; Random pin prick sensation not described as possible side effects - not subsided; 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: EW0162) via an unspecified route of administration in the arm right on 15Apr2021 at 14:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 16Apr2021 at 08:00, the patient experienced fever, chills, aches, pain under right arm, swollen lymph, ringing in ears and random pin prick sensation. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills and aches was recovered on an unknown date in Apr2021, while that of pain under right arm, swollen lymph, ringing in ears and random pin prick sensation was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives 2 hours later; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)  via an unspecified route of administration in the right arm on 19Apr2021 at 13:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 15:30, the patient experienced hives 2 hours later. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with ZYRTEC and prednisone. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives 2 hours later was recovered with sequelae on 19Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site vesicles, Tinnitus
Clinical narrative: Tinnitus; rash with blister on Right forearm; This is a spontaneous report from a contactable physician. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration in the right arm on 26Mar2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of the COVID-19 vaccine. The patient previously took morphine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 27Mar2021, the patient experienced tinnitus, rash with blister on right forearm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus, rash with blister on right forearm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash vesicular, Tinnitus
Clinical narrative: Tinnitus; rash with blister on Right forearm; This is a spontaneous report from a contactable physician. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration in the right arm on 26Mar2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of the COVID-19 vaccine. The patient previously took morphine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 27Mar2021, the patient experienced tinnitus, rash with blister on right forearm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus, rash with blister on right forearm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation
Clinical narrative: Burning sensation in lower legs/ Burning legs; Pins and needles in feet/ Paresthesia in arms; Like a sunburn; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 21Apr2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8370) via an unspecified route of administration in the right arm on 29Mar2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 21Apr2021 at 13:00, the patient experienced pins and needles in feet, burning sensation in lower legs, like a sunburn, paraesthesia in arms and burning legs. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcomes of event pins and needles in feet, burning sensation in lower legs, like a sunburn, paraesthesia in arms and burning legs were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Paraesthesia, Sunburn
Clinical narrative: Burning sensation in lower legs/ Burning legs; Pins and needles in feet/ Paresthesia in arms; Like a sunburn; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 21Apr2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8370) via an unspecified route of administration in the right arm on 29Mar2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 21Apr2021 at 13:00, the patient experienced pins and needles in feet, burning sensation in lower legs, like a sunburn, paraesthesia in arms and burning legs. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcomes of event pins and needles in feet, burning sensation in lower legs, like a sunburn, paraesthesia in arms and burning legs were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Eye swelling, Feeling hot, Pruritus, Tachycardia
Clinical narrative: Throat constriction & scratchiness; Throat constriction & scratchiness; over heating; dizziness; itching of head, face, arms; This is a spontaneous report from a contactable consumer (patient). A 40 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8736), via an unspecified route, administered in Left Arm on 20Apr2021 at 13:15 (40-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient had known allergies (too many to list in this space). The patient's concomitant medications included hydroxyzine; methylprednisolone (MEDROL); famotidine (PEPCID) and more than space allowed within in two weeks. The patient previously took polyethylene glycol compound and experienced known allergy to PEG. Facility type vaccination was reported as Hospital. The patient had not received any other vaccine in four weeks prior to vaccination. The patient was not diagnosed with Covid prior to vaccination. Since vaccination the patient was not tested for Covid. On 20Ap2021, the patient experienced throat constriction and scratchiness, overheating, dizziness, itching of head, face, arms. The patient was administered with epinephrine, steroids and transported by ambulance to ER. She had a known allergy to PEG and was premedicated by her allergist trying to avoid or at least lessen a reaction. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Throat constriction & scratchiness; Throat constriction & scratchiness; over heating; dizziness; itching of head, face, arms; This is a spontaneous report from a contactable consumer (patient). A 40 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8736), via an unspecified route, administered in Left Arm on 20Apr2021 at 13:15 (40-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient had known allergies (too many to list in this space). The patient's concomitant medications included hydroxyzine; methylprednisolone (MEDROL); famotidine (PEPCID) and more than space allowed within in two weeks. The patient previously took polyethylene glycol compound and experienced known allergy to PEG. Facility type vaccination was reported as Hospital. The patient had not received any other vaccine in four weeks prior to vaccination. The patient was not diagnosed with Covid prior to vaccination. Since vaccination the patient was not tested for Covid. On 20Ap2021, the patient experienced throat constriction and scratchiness, overheating, dizziness, itching of head, face, arms. The patient was administered with epinephrine, steroids and transported by ambulance to ER. She had a known allergy to PEG and was premedicated by her allergist trying to avoid or at least lessen a reaction. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Pruritus, Throat irritation, Throat tightness
Clinical narrative: Throat constriction & scratchiness; Throat constriction & scratchiness; over heating; dizziness; itching of head, face, arms; This is a spontaneous report from a contactable consumer (patient). A 40 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8736), via an unspecified route, administered in Left Arm on 20Apr2021 at 13:15 (40-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient had known allergies (too many to list in this space). The patient's concomitant medications included hydroxyzine; methylprednisolone (MEDROL); famotidine (PEPCID) and more than space allowed within in two weeks. The patient previously took polyethylene glycol compound and experienced known allergy to PEG. Facility type vaccination was reported as Hospital. The patient had not received any other vaccine in four weeks prior to vaccination. The patient was not diagnosed with Covid prior to vaccination. Since vaccination the patient was not tested for Covid. On 20Ap2021, the patient experienced throat constriction and scratchiness, overheating, dizziness, itching of head, face, arms. The patient was administered with epinephrine, steroids and transported by ambulance to ER. She had a known allergy to PEG and was premedicated by her allergist trying to avoid or at least lessen a reaction. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on the right side of her back and stomach; This is a spontaneous report from a contactable consumer, the patient. A 47-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 26Mar2021 at 11:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had  allergies to some unspecified antibiotics. Concomitant medications included caffeine, paracetamol (EXCEDRIN) and ibuprofen (MOTRIN) all were from unknown date and 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 vaccine within four weeks prior to the COVID vaccine. On 10Apr2021, the patient had shingles on the right side of her back and stomach. The adverse 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 valacyclovir . The clinical outcome of the event shingles on the right side of her back and stomach was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Swollen and itchy left eye; Swollen and itchy left eye; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 29-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks of COVID vaccine. Concomitant medications included ethinylestradiol; ferrous fumarate; norethisterone acetate (JUNEL FE) from an unknown date for an unknown indication and unknown if ongoing. On 20Apr2021 at 15:00, the patient experienced swollen and itchy left eye. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of swollen and itchy left eye and included treatment with Benadryl and antibacterial cream. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events swollen and itchy left eye was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Tiredness; Nausea; Headache; Fever; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 26Mar2021 at 12:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's hypothyroidism and allergic to penicillin family of medicines, allergic to eggs, dairy (cow's milk), tomatoes (food allergy), wheat (allergy to grains) and soy. Concomitant medications included levothyroxine sodium (SYNTHROID) and montelukast (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in left arm on 05Mar2021 at 14:45 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 26Mar2021 at 20:30, the patient experienced pain, redness, swelling in arm at injection site began about 1-3 hours after injection. Tiredness, nausea, headache, fever, chills, muscle aches began in that order about 8-11 hours after injection and lasted for about 12 hours. After which, only pain and swelling in arm at injection side as well as tiredness, headache and muscle aches remained and lasted for approximately two days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events the events redness, nausea, fever, chills recovered on 27Apr2021 at 08:30; while that of the events pain and swelling in arm at injection side as well as tiredness, headache and muscle aches were recovered on 28Apr2021.  No follow-up attempts are needed. No further information is expected.