chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Immunisation, Off label use, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Booster dose administered; Off- label use; A few days after dose 2 had sore arm; Shortly after that I developed pink eye; This is a spontaneous report from a contactable consumer, the patient. A 87-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Feb2021 at 11:00 (at the age of 87-years-old) and a third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Feb2021 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. Medical history included two coronary stents, left anterior descending artery (LAD), two knees and allergic to penicillin. Concomitant medications included Statins and olmesartan (MANUFACTURER UNKNOWN) for 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 vaccines within four weeks prior to the vaccination. 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 15Feb2021, a few days after dose number two the patient had sore arm. Shortly after that developed pink eye. Therapeutic measures were taken as a result of pink eye and included treatment with antibiotic eye drops. Since the vaccination, the patient had been tested for COVID-19. On 15Feb2021, the patient underwent COVID-19 test via nasal swab and the result found to be negative. The clinical outcome of the events a few days after dose number two the patient had sore arm; shortly after that developed pink eye 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm near area of injection; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to 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 02Mar2021 at 19:00, the patient experienced sore arm near area of injection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm near area of injection was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram, Dizziness, Dysarthria, Headache
Clinical narrative: Slurred speech; Aphasia; Irregular migraine provoked by vaccine; The evening of 16Feb2021, felt slightly dizzy with a moderate headache.; The evening of 16Feb2021, felt slightly dizzy with a moderate headache.; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 16Feb2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, ruptured uterus with exsanguination, hypertension, COVID-19 and known allergy to sulfa. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously also received prednisone (MANUFACTURER UNKNOWN), celecoxib (CELEBREX) and gabapentin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN) and topiramate (TOPAMAX); all for 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: EL9261) via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  On 16Feb2021 at 20:30, the evening of the day of vaccination, the patient felt slightly dizzy with a moderate headache. On 17Feb2021 at 06:30, after the patient woke up, the patient experienced slurred speech with aphasia, the patient was unable to speak clearly and the words that did come out were not the correct words. The patient was trying to convey and was taken to ER at that time. Diagnosis was an irregular migraine provoked by vaccine. On 17Feb2021, the patient underwent computerized tomography and magnetic resonance imaging scan and the results were negative. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the event which included emergency room visit, computerized tomography and magnetic resonance imaging scan and neurology appointment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt slightly dizzy with a moderate headache, irregular migraine provoked by vaccine, slurred speech and aphasia was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Migraine
Clinical narrative: Slurred speech; Aphasia; Irregular migraine provoked by vaccine; The evening of 16Feb2021, felt slightly dizzy with a moderate headache.; The evening of 16Feb2021, felt slightly dizzy with a moderate headache.; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 16Feb2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, ruptured uterus with exsanguination, hypertension, COVID-19 and known allergy to sulfa. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously also received prednisone (MANUFACTURER UNKNOWN), celecoxib (CELEBREX) and gabapentin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN) and topiramate (TOPAMAX); all for 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: EL9261) via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  On 16Feb2021 at 20:30, the evening of the day of vaccination, the patient felt slightly dizzy with a moderate headache. On 17Feb2021 at 06:30, after the patient woke up, the patient experienced slurred speech with aphasia, the patient was unable to speak clearly and the words that did come out were not the correct words. The patient was trying to convey and was taken to ER at that time. Diagnosis was an irregular migraine provoked by vaccine. On 17Feb2021, the patient underwent computerized tomography and magnetic resonance imaging scan and the results were negative. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the event which included emergency room visit, computerized tomography and magnetic resonance imaging scan and neurology appointment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt slightly dizzy with a moderate headache, irregular migraine provoked by vaccine, slurred speech and aphasia was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: "I" have Rheumatoid Arthritis. It's been3 days since "my" vaccine and all of "my" RA symptoms are gone!!! "I" haven't felt this good for about a year!! "My" inflammation is completely nonexistent right now!; "I" have Rheumatoid Arthritis. It's been3 days since "my" vaccine and all of "my" RA symptoms are gone!!! "I" haven't felt this good for about a year!! "My" inflammation is completely nonexistent right now!; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG198) via an unspecified route of administration in the left arm on 27Feb2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, degenerative disc disease and known allergies to penicillin. 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 vaccine. The patient received unspecified medication within two weeks of vaccination. On 28Feb2021, It was reported that the patient had rheumatoid arthritis. It had been 3 days since her vaccine and all of her rheumatoid arthritis symptoms were gone (pre-existing condition improved and unexpected therapeutic benefit). The patient had not felt this good for about a year. Her inflammation was completely non-existent at the time of reporting. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events patient had rheumatoid arthritis. It had been 3 days since her vaccine and all of her rheumatoid arthritis symptoms were gone (pre-existing condition improved and unexpected therapeutic benefit). The patient hadn't felt this good for about an year. Her inflammation was completely non-existent right now was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Chills, Discomfort, Disorientation
Clinical narrative: Lesser effects day 2 but lymph nodesall over started hurting; Sore behind ears and pain worse on left side; pain at injection arm and armpit; pain at injection arm and armpit; Bad insomnia since then, waking up unable to go back to sleep, normally don't have insomnia.; Extremely heavy feeling in my head then whole body; Extremely heavy feeling in my head then whole body; woozy felt; disoriented or drunk; Weakness, having trouble standing withoutleaning on something.; Slight chills; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198,) via an unspecified route of administration in the left arm on 28Feb2021 at 12:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergic rhinitis, conjunctivitis, attention deficit hyperactivity disorder (ADHD), depression, anxiety, pollen allergy (tree pollens), allergy to molds, strong seasonal allergies and had loop electrosurgical excision procedure (LEEP) procedure 10 days before the vaccination. 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 bupropion (MANUFACTURER UNKNOWN), atomoxetine (MANUFACTURER UNKNOWN), and many more unspecified medications; all from an unknown date and unknown if ongoing for an unknown indication. The patient previously received cefaclor (CECLOR) and experienced allergy. On 28Feb2021 at 15:45, the patient had an extremely heavy feeling in the head and then to the whole body and also felt woozy, disoriented or drunk, weakness due to which trouble standing without leaning on something and slight chills and all these effects occurred very fastly. On 01Mar2021, day 2, the patient had lesser effects however the patient experienced lymph nodes all over hurting, sore behind ears and pain worse on the left side, pain at injection arm and armpit. On the same day, the patient also experienced bad insomnia since vaccination due to which the patient woke up but was unable to go back to sleep and was reported that normally the patient did not have insomnia. The events resulted in doctor or other healthcare professional office/clinic visits. Therapeutic measures were taken as a result of the events included the psychiatrist's suggestion to off bupropion medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely heavy feeling in the head then to the whole body, felt woozy, disoriented or drunk, weakness trouble standing without leaning on something, slight chills, lymph nodes all over hurting, especially sore behind ears/ pain worse on the left side, pain at injection arm and armpit and bad insomnia were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Insomnia, Lymph node pain, Pain
Clinical narrative: Lesser effects day 2 but lymph nodesall over started hurting; Sore behind ears and pain worse on left side; pain at injection arm and armpit; pain at injection arm and armpit; Bad insomnia since then, waking up unable to go back to sleep, normally don't have insomnia.; Extremely heavy feeling in my head then whole body; Extremely heavy feeling in my head then whole body; woozy felt; disoriented or drunk; Weakness, having trouble standing withoutleaning on something.; Slight chills; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198,) via an unspecified route of administration in the left arm on 28Feb2021 at 12:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergic rhinitis, conjunctivitis, attention deficit hyperactivity disorder (ADHD), depression, anxiety, pollen allergy (tree pollens), allergy to molds, strong seasonal allergies and had loop electrosurgical excision procedure (LEEP) procedure 10 days before the vaccination. 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 bupropion (MANUFACTURER UNKNOWN), atomoxetine (MANUFACTURER UNKNOWN), and many more unspecified medications; all from an unknown date and unknown if ongoing for an unknown indication. The patient previously received cefaclor (CECLOR) and experienced allergy. On 28Feb2021 at 15:45, the patient had an extremely heavy feeling in the head and then to the whole body and also felt woozy, disoriented or drunk, weakness due to which trouble standing without leaning on something and slight chills and all these effects occurred very fastly. On 01Mar2021, day 2, the patient had lesser effects however the patient experienced lymph nodes all over hurting, sore behind ears and pain worse on the left side, pain at injection arm and armpit. On the same day, the patient also experienced bad insomnia since vaccination due to which the patient woke up but was unable to go back to sleep and was reported that normally the patient did not have insomnia. The events resulted in doctor or other healthcare professional office/clinic visits. Therapeutic measures were taken as a result of the events included the psychiatrist's suggestion to off bupropion medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely heavy feeling in the head then to the whole body, felt woozy, disoriented or drunk, weakness trouble standing without leaning on something, slight chills, lymph nodes all over hurting, especially sore behind ears/ pain worse on the left side, pain at injection arm and armpit and bad insomnia were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Lesser effects day 2 but lymph nodesall over started hurting; Sore behind ears and pain worse on left side; pain at injection arm and armpit; pain at injection arm and armpit; Bad insomnia since then, waking up unable to go back to sleep, normally don't have insomnia.; Extremely heavy feeling in my head then whole body; Extremely heavy feeling in my head then whole body; woozy felt; disoriented or drunk; Weakness, having trouble standing withoutleaning on something.; Slight chills; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198,) via an unspecified route of administration in the left arm on 28Feb2021 at 12:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergic rhinitis, conjunctivitis, attention deficit hyperactivity disorder (ADHD), depression, anxiety, pollen allergy (tree pollens), allergy to molds, strong seasonal allergies and had loop electrosurgical excision procedure (LEEP) procedure 10 days before the vaccination. 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 bupropion (MANUFACTURER UNKNOWN), atomoxetine (MANUFACTURER UNKNOWN), and many more unspecified medications; all from an unknown date and unknown if ongoing for an unknown indication. The patient previously received cefaclor (CECLOR) and experienced allergy. On 28Feb2021 at 15:45, the patient had an extremely heavy feeling in the head and then to the whole body and also felt woozy, disoriented or drunk, weakness due to which trouble standing without leaning on something and slight chills and all these effects occurred very fastly. On 01Mar2021, day 2, the patient had lesser effects however the patient experienced lymph nodes all over hurting, sore behind ears and pain worse on the left side, pain at injection arm and armpit. On the same day, the patient also experienced bad insomnia since vaccination due to which the patient woke up but was unable to go back to sleep and was reported that normally the patient did not have insomnia. The events resulted in doctor or other healthcare professional office/clinic visits. Therapeutic measures were taken as a result of the events included the psychiatrist's suggestion to off bupropion medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely heavy feeling in the head then to the whole body, felt woozy, disoriented or drunk, weakness trouble standing without leaning on something, slight chills, lymph nodes all over hurting, especially sore behind ears/ pain worse on the left side, pain at injection arm and armpit and bad insomnia were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Pain
Clinical narrative: Mild body aches; Mild upset stomach; Mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 01Mar2021 at 14:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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 ibuprofen (ADVIL) for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the right arm on 08Feb2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021 at 13:00, the patient experienced mild body aches, mild upset stomach and mild fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild body aches, mild upset stomach and mild fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Illness, Migraine, Parosmia
Clinical narrative: migraine; sick; awful smell and taste; awful smell and taste; This is a spontaneous report from a contactable other healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Feb2021 at 15:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included adhd (attention deficit hyperactivity disorder), depression and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine/saccharate/dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN) and vitamin d nos (MANUFACTURER UNKNOWN); all for 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: UNKNOWN) via an unspecified route of administration on 23Jan2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The previously received ciprofloxacin (CIPRO) on unknown date for unknown indication and experienced drug allergy. On 18Feb2021 at 12:00, after second shot, the patient had experienced migraine about a week later and got sick and since the patient had an awful smell and taste that was present often, when the patient had COVID-19 she experienced smell and taste was affected it took about a month or so to get her taste back somewhat and smell had never been the same. The events did not result in doctor or other healthcare professional office/clinic, 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 migraine, sick, awful smell and taste was not recovered 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oral pain, SARS-CoV-2 test
Clinical narrative: Pain under tongue and on the sides of tongue; Mouth pain; This is a spontaneous report from a contactable consumer, the patient. A 20-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 01Mar2021 at 09:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known 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 take any concomitant medications. 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 08Feb2021 at 10:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021, at 11:00 the patient experienced mouth pain, specifically pain under tongue and on the sides of tongue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Mar2021, the patient underwent saliva rapid test and the result was negative. The clinical outcome of the event mouth pain and pain under tongue and on the sides of tongue were not recovered 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: his wife is experiencing a severe diarrhea after she took the 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced experienced severe diarrhea after she took the 1st dose. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle soreness at injection site (left arm); This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. 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 medications. On 03Mar2021 at 01:00, the patient experienced muscle soreness at injection site (left arm). 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. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event muscle soreness at injection site (left arm) was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: ''My'' armpit started to hurt and it moved into my left breast. It hurt to the touch or to move; ''I'' read up on it and they call it Lymphadenopathy; 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: EN6203) via an unspecified route of administration in the left arm on 01Mar2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. 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 vaccine within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. On 02Mar2021 at 11:00, the patient experienced armpit started to hurt and it moved into her left breast. It hurt to the touch or to move. On 03Mar2021, the patient still felt it but not as bad. The patient would see how she felt throughout the day. She read up on it and called it Lymphadenopathy. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events armpit started to hurt and lymphadenopathy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Muscle tightness, Muscular weakness, Pain in extremity
Clinical narrative: Extreme pain, weakness and tightness in themuscles of legs; Weakness and tightness in themuscles of legs; Weakness and tightness in themuscles of legs; For 48 hours, could barely walk,; Makes it difficult to get up from a seated position; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 24Feb2021 at 09:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included herniated discs in neck and penicillin allergy. Concomitant medications included cannabis sativa (MARIJUANA) 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 vaccines within four weeks prior to the vaccination. On 24Feb2021 at 23:00, the patient experienced extreme pain, weakness and tightness in the muscles of her legs. For 48 hours, the patient could barely walk. The patient thought of going to Emergency Room (ER), but did not want COVID exposure. The pain was gone, but leg muscles remained very tight and made it difficult to get up from a seated position and the patient hoped legs would recover. 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 event extreme pain, weakness and tightness in the muscles of legs was resolved on an unknown date in 2021; while that of the events weakness and tightness in the muscles of legs, for 48 hours could barely walk and makes it difficult to get up from a seated position was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site right arm muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 02Mar2021 at 15:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included Type 2 diabetes. 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. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and sitagliptin phosphate (JANUVIA); both from unknown dates for unknown indications and unknown if ongoing. On 03Mar2021 at 00:00, the patient experienced injection site right arm muscle pain. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site right arm muscle pain was unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Moderate sore arm; Moderate headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 11:30(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included intracranial hypertension and asthma. The patient had no known allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetazolamide (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 15:00, the patient experienced moderate sore arm and moderate headache. The events did not result in doctor or other health care professional office/clinic visit, and 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 moderate sore arm and moderate headache was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Left arm sore to touch; Heavy feeling; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 did not take any concomitant medications. On 02Mar2021 at 16:00, the patient experienced left arm sore to touch and heavy feeling. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event Left arm sore to touch and heavy feeling was not recovered at time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Soreness on at the injection site; drowsiness during they day of theinjection; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 02Mar2021 at 10:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. 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. On 02Mar2021, the patient experienced Soreness on at the injection site and drowsiness during the day of the injection. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Soreness on at the injection site and drowsiness was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Low grade headache; Very tired; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 26Feb2021 at 08:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR); taken for 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 vaccines within four weeks prior to the vaccination. On 01Mar2021, the patient experienced low grade headache on monday/tuesday/wednesday the following week (as reported) and felt very tired. 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 low grade headache and very tired were unknown 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain
Clinical narrative: Prolonged weakness through body; Major headache on right side; Chills; Body aches throughout; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 20Feb2021 at 15:30 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. 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 were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 29Jan2021 at 09:15 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. On 21Feb2021 at 11:00, the patient experienced prolonged weakness through body, major headache on right side, chills and body aches throughout. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 prolonged weakness through body, major headache on right side, chills and body aches throughout was recovering 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: Decreased appetite, Headache, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Headache; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 24Feb2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, obesity and allergy to strawberries (fruit 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. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received zolpidem tartrate (AMBIEN) for unknown indication on an unknown date and experienced drug allergy. On 24Feb2021 at 10:30, the patient experienced nausea, vomiting, headache and loss of appetite. 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 event nausea, vomiting, headache and loss of appetite was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pain, Pain in extremity
Clinical narrative: Weakness; Nausea; Body aches; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG 202) via an unspecified route of administration in the left arm on 25Feb2021 at 02:30 (at the age of 67-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, the patient experienced weakness, nausea, body aches and arm soreness. 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 weakness, nausea, body aches and arm soreness was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal pain; Runny diarrhea; This is a spontaneous report from a non-contactable other healthcare professional. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 24Feb2021 at 16:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus syndrome, congestive heart failure (CHF), sjogren's, rheumatoid arthritis, raynauds, endometriosis, depression, cardiomyopathy, penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient received a long list of unspecified medications within two weeks of vaccination. The patient previously received hydroxyzine hydrochloride (HYDROXIZINE) and hydromorphone hydrochloride (DILAUDID) for an unknown indication on unknown date and experienced drug allergy. On 25Feb2021 at 16:00, the patient experienced abdominal pain and runny diarrhea. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were 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 abdominal pain and runny diarrhea was not recovered 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm left on 02Mar2021 at 13:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL) and dietary supplements; from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 13:15, the patient experienced nausea and dizziness. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea and dizziness were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.