chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches; Joint pain; Headache; Extreme dizziness; Extreme fatigue; Dose 1: 01Apr2021 and Dose 2: 15Apr2021; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation.  It was unknown, if the patient was pregnant at the time of this report. Medical history was 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. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:45 as a single dose for COVID-19 immunisation. On 16Apr2021 at 04:30, the patient experienced muscle aches, joint pain, headache, extreme dizziness and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle aches, joint pain, headache, extreme dizziness and extreme fatigue was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Severe headache with nausea; Severe headache with nausea; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267100001) via an unspecified route of administration in the left arm on 16Apr2021 at 09:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and known allergies. The patient previously received nicotinic acid (NIACIN) on an unspecified date, for an unknown indication and experienced drug allergy. 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 insulin (MANUFACTURER UNKNOWN), atorvastatin calcium (LIPITOR), metformin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267100001) via an unspecified route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 20:00, the patient experienced severe headache with nausea, lasting 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL) and sumatriptan (IMITREX). The clinical outcome of the events severe headache with nausea were recovered on 18Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Eye irritation, Eye pruritus, Eye swelling, Eyelid margin crusting
Clinical narrative: Swollen eyes; swollen lids and underneath.; Eyes were leaking in the corners; Eyes (a bit crusty); Eyes burning; Eyes itching; face was breaking out like crazy as if had acne.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol high, type 2 diabetes mellitus, arthritis and allergy to nuts. The patient previously took hydromorphone hydrochloride(DILAUDID) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included 6 prescription and 2 OTC (Over the counter) (MANUFACTURER UNKNOWN) for unknown indication, from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6207) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 the patient woke up with swollen eyes, lids and underneath. Eyes were leaking in the corners (a bit crusty), burning and itching. The rest of her face had broken out like crazy as if the patient had acne. The 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 adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen eyes, lids and underneath, eyes were leaking in the corners (a bit crusty), burning and itching and the rest of her face had broken out like crazy as if the patient had acne was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling of eyelid
Clinical narrative: Swollen eyes; swollen lids and underneath.; Eyes were leaking in the corners; Eyes (a bit crusty); Eyes burning; Eyes itching; face was breaking out like crazy as if had acne.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol high, type 2 diabetes mellitus, arthritis and allergy to nuts. The patient previously took hydromorphone hydrochloride(DILAUDID) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included 6 prescription and 2 OTC (Over the counter) (MANUFACTURER UNKNOWN) for unknown indication, from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6207) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 the patient woke up with swollen eyes, lids and underneath. Eyes were leaking in the corners (a bit crusty), burning and itching. The rest of her face had broken out like crazy as if the patient had acne. The 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 adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen eyes, lids and underneath, eyes were leaking in the corners (a bit crusty), burning and itching and the rest of her face had broken out like crazy as if the patient had acne was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My period showed up early.; My period showed up early and is VERY VERY heavy and painful; My period showed up early and is VERY VERY heavy and painful.; This is a spontaneous report from a non-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: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (sulfa meds). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. On 17Apr2021 at 00:00, the patient's period showed up early and was very very heavy and painful, which was unusual for the patient. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period showed up early, was very very heavy and painful was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ill-defined disorder, Pruritus, Rash macular
Clinical narrative: Covid toe on second and third toe of each foot; Blotchy patches on forehead and nose; Itching and burning when warm.; Itching and burning when warm.; This is a spontaneous report from a contactable nurse. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 15:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included hypothyroidism. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for hypothyroidism from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 27Feb2021 at 15:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 02Apr2021, the patient experienced COVID toe on second and third toe of each foot, itching and burning when warm and also blotchy patches on forehead and nose. The patient reported that she understood skin issues were more common with skin exposure to cold and she walked every day in cold weather. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 COVID toe on second and third toe of each foot, itching and burning when warm and blotchy patches on forehead and nose were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose; 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: UNKNOWN) on an unknown date (at the age of 35-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included methylenetetrahydrofolate reductase gene mutation(MTHFR), cervical intraepithelial  neoplasia (CIN3 in cervix) and obese. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not 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. The patient reported bloody noses for a week after first and second dose. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 event bloody nose was recovered after a week of vaccination on an unknown date.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cyanosis, Dizziness, Fatigue, Headache
Clinical narrative: Chills; Blue lips; Fever; Lots of shaking; Headache; Dizziness; Nausea; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 08:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown start date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 08:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 20:00, the patient experienced fever, chills with lots of shaking, blue lips, headache, dizziness, nausea and exhaustion. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills with lots of shaking, blue lips, headache, dizziness, nausea and exhaustion was not resolved at the time of reporting.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Chills; Blue lips; Fever; Lots of shaking; Headache; Dizziness; Nausea; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 08:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown start date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 08:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 20:00, the patient experienced fever, chills with lots of shaking, blue lips, headache, dizziness, nausea and exhaustion. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills with lots of shaking, blue lips, headache, dizziness, nausea and exhaustion was not resolved at the time of reporting.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rash, Rash pruritic
Clinical narrative: Itchy and painful rash; preventing from sleeping in the evenings.; Severe skin rashes on the torso andneck, back of the head.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6Z07) via an unspecified route of administration in the left arm on 30Mar2021(at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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. On 03Apr2021, 4 days after the vaccination, the patient experienced severe skin rashes on the torso and neck, back of the head. On 04Apr2021 the patient experienced Itchy and painful rash which preventing from sleeping in the evenings. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with triamcinolone acetonide 0.1 % (MANUFACTURER UNKNOWN) topical cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe skin rashes on the torso and neck, back of the head, Itchy and painful rash and preventing from sleeping in the evenings was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia, Erythema, Lymphadenopathy
Clinical narrative: Within five minutes of taking the shot "my" neck starting swelling (cervical lymph node) and was having problems swallowing.; Within five minutes of taking the shot "my" neck starting swelling (cervical lymph node) and was having problems swallowing; Also experienced extreme cotton mouth; face and body turned red.; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 17Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The medical history included thyroid disorder. 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 4 weeks prior to the COVID-19 vaccine. The concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates 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. On 17Apr2021, within five minutes of taking the shot, the patient's neck started swelling (cervical lymph node) and was having problems in swallowing. The patient also experienced extreme cotton mouth, face and body turned red. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and treated it as an allergic reaction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events neck swelling (cervical lymph node), problems swallowing, extreme cotton mouth, face and body turned red was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Fatigue; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 medications included oxybutynin (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm 24Mar2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 20:00, the patient experienced fatigue and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue and diarrhea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Pyrexia
Clinical narrative: Joint aches; Fever; Chills; No energy/ weakness; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Apr2021 at 08:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 12Apr2021 at 08:30, the patient experienced joint aches, fever, chills, no energy/ weakness and dizziness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events joint aches, fever, chills, no energy/ weakness and dizziness was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Aches; Chills; Headache; Low-grade fever; This is a spontaneous report from a contactable consumer, the patient. A 17-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 11Apr2021 at 13:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included Low IgA, low C4 Compliment and sluggish t-cells and seasonal allergies. The patient previously took codeine (MANUFACTURER UNKNOWN) and cephlasporin (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and multivitamin (MANUFACTURER UNKNOWN) used for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PF2613) via an unspecified route of administration in the left arm on 21Mar2021 at 13:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. On 11Apr2021, after receiving second dose, the patient started feeling aches, chills, headache and low-grade fever on Sunday night and continued until 18:30 on Monday (12Apr2021). On 13Apr2021, the patient felt about 90% better and continued to feel well until mid-day on Friday (16Apr2021). All of the post vaccine symptoms have reappeared. The patient had aches, chills, low-grade fever and headache. These are the same exact symptoms as patient had after the vaccine. The patient is on her third day of these symptoms. 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 been tested for COVID-19. On 17Apr2021, the patient followed up with doctor and underwent rapid and polymerase chain reaction (PCR) COVID test via nasal swab and the result for both the tests was negative. The clinical outcome of the events aches, chills, headache and low-grade fever was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Condition aggravated, Fatigue, Feeling cold
Clinical narrative: Low-grade fever; Extreme chills; Feeling cold; Switching off with hot flashes; Nausea; Dry heaving; Back became extremely sore and painful; Back became extremely sore and painful / have a disc herniation at the L5-S1 level.; Left arm (place of injection) remain sore; Tired; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 15:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 which was confirmed via positive antibody test as blood test performed on 23Dec2020, disc herniation at the L5-S1 level and penicillin allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC) and lisdexamfetamine mesilate (VYVANSE); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, after the vaccination, the patient became tired. After 9 hours, the patient started developing a low-grade fever. Over the course of the following six hours, the patient's body was experiencing extreme chills, feeling cold and switching off with hot flashes that came along with nausea and dry heaving. The patient's back became extremely sore and painful. The morning after, the patient's body had returned to a normal temperature but her back and left arm (place of injection) remain sore. The 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 events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events tired, low-grade fever, extreme chills, feeling cold, switching off with hot flashes, nausea, dry heaving, back became extremely sore and painful / have a disc herniation at the L5-S1 level and left arm (place of injection) remain sore was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Pyrexia, Retching, Vaccination site pain
Clinical narrative: Low-grade fever; Extreme chills; Feeling cold; Switching off with hot flashes; Nausea; Dry heaving; Back became extremely sore and painful; Back became extremely sore and painful / have a disc herniation at the L5-S1 level.; Left arm (place of injection) remain sore; Tired; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 15:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 which was confirmed via positive antibody test as blood test performed on 23Dec2020, disc herniation at the L5-S1 level and penicillin allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC) and lisdexamfetamine mesilate (VYVANSE); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, after the vaccination, the patient became tired. After 9 hours, the patient started developing a low-grade fever. Over the course of the following six hours, the patient's body was experiencing extreme chills, feeling cold and switching off with hot flashes that came along with nausea and dry heaving. The patient's back became extremely sore and painful. The morning after, the patient's body had returned to a normal temperature but her back and left arm (place of injection) remain sore. The 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 events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events tired, low-grade fever, extreme chills, feeling cold, switching off with hot flashes, nausea, dry heaving, back became extremely sore and painful / have a disc herniation at the L5-S1 level and left arm (place of injection) remain sore was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Episcleritis
Clinical narrative: Redness of right eye and left eye which was diagnosed as episcleritis; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration on 16Mar2021 (at the age of 17-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 06Apr2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included uveitis, migraines and depression. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included adalimumab (HUMIRA), methotrexate (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN) and folic acid (MANUFACTURER UNKNOWN), all taken for unknown indication from an unknown date and unknown if ongoing. On 22Mar2021, about 6 days after the first dose of COVID-19 vaccine, the patient noticed redness of right eye which was diagnosed as episcleritis and started eye drops with mild improvement. On15Apr2021, about nine days after the second dose of COVID-19 vaccine, the patient noticed redness of left eye episcleritis which was improving with steroid drops. 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 loteprednol (MANUFACTURER UNKNOWN) eye drops and artificial tears. The clinical outcome of the event redness of right eye and left eye which was diagnosed as episcleritis was resolving at this time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever 100.7; Chills; Body aches; Shakes; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 14Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 20:00, the patient experienced fever 100.7, chills, body aches, shakes and headache. On 14Apr2021 at 20:00, the patient underwent body temperature test and the result was found to be 100.7 (units unspecified). 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 fever 100.7, chills, body aches, shakes and headache were recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Fever 100.7; Chills; Body aches; Shakes; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 14Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 20:00, the patient experienced fever 100.7, chills, body aches, shakes and headache. On 14Apr2021 at 20:00, the patient underwent body temperature test and the result was found to be 100.7 (units unspecified). 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 fever 100.7, chills, body aches, shakes and headache were recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 59-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 left arm on 13Mar2021 at 11:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included heart attack on an unknown date in 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 11:45, 48 hours after 1st vaccine, the patient experienced severe tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe tinnitus and included treatment with ear wax removal which did not correct the issue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe tinnitus was not recovered at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Swollen feeling armpit on right side; Right arm feels tingly or swollen, as if blood has rushed to it or it has woken up from being an asleep limb; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 15Apr2021 at 09:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient was pregnant. The patient did not have any medical history and known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included pantoprazole (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 25Mar2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 21:15, the patient had swollen feeling armpit on right side and right arm felt tingly or swollen, as if blood had rushed to it or it had woken up from being an asleep limb. It was not numb and the patient could still move and function normally. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen feeling armpit on right side and right arm feels tingly or swollen, as if blood has rushed to it or it has woken up from being an asleep limb was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: "I" had a fever of 101 the following day with the chills. It lasted about 24 hours.; "I" had a fever of 101 the following day with the chills. It lasted about 24 hours.; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 15Apr2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The medical history included penicillin allergy. 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 medications within two weeks of vaccination. 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. On 16Apr2021 at 09:00,the following day the patient experienced fever of 101 and chills. The patient reported that it lasted for about 24 hours. On 16Apr2021, the patient underwent body temperature test and the result was found to be 101(unspecified unit). 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 events fever of 101 and chills was recovered on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Mild allergic reaction; General swelling of the whole body and pronounced swelling of the feet, particularly the left foot.; This is a spontaneous report from a contactable consumer or other non-health care professional (parents). A 16-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 16-years), administered in arm left on 14Apr2021 at 15:00 as dose 2, single for COVID-19 immunization. Medical history included depression, anxiety from an unknown date and unknown if ongoing. Concomitant medications included melatonin (MELATONIN), mirtazapine (MIRTAZAPINE), fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 24Mar2021 at 14:00 as dose 1, single for COVID-19 immunization. The patient previously took epinephrine and diphenhydramine for known allergies of history of stress induced allergic reactions. The patient did not receive any other vaccine in four weeks. The facility type vaccine was reported as other. The patient was not tested for covid post vaccination. It was unknown if patient had covid prior vaccination. On 14Apr2021 at 17:00, the patient experienced mild allergic reaction, general swelling of the whole body and pronounced swelling of the feet, particularly the left foot. The treatment was received for the adverse events with diphenhydramine. Treated with repeated doses of benadryl(diphenhydramine) which seemed effective in stopping the progression of the swelling. Swelling eventually receded over the following 4 days. The clinical outcome of the event mild allergic reaction was reported as unknown while for the event general swelling of the whole body and pronounced swelling of the feet, particularly the left foot was reported as recovering.  No follow up attempts are Possible. Information about lot/batch number cannot be obtained  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Haematoma, Myalgia
Clinical narrative: Hematoma around 2x2 inches approximately 4 to 6 inches below the injection site; Muscle ache/pain; Shoulder pain; This is a spontaneous report from a non-contactable healthcare professional. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 50-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 18Apr2021, the patient experienced hematoma around 2x2 inches approximately 4 to 6 inches below the injection site, muscle ache/pain and shoulder pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hematoma around 2x2 inches approximately 4 to 6 inches below the injection site, muscle ache/pain and shoulder pain was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.