chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Fatigue, Headache, Pain
Clinical narrative: Fatigue; Sore arm; Aches; Headache; The night of the 2nd vaccine I had extreme pain in my right breast, the extreme pain comes and goes but Im still having this issue 22 days after.; It is very painful and also hurts around the right side of my back.; This is a spontaneous report from a contactable healthcare professional, the patient. A 54-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 arm right on 18Mar2021(at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, hashimoto's disease and COVID-19. Concomitant medications included alprazolam (XANAX), levothyroxine, liothyronine (NP THYROID) and poloxamer (UNI) and Bio-identical hormones for unknown indication and from an unknown date. The patient previously took codeine (MANUFACTURER UNKNOWN) and cipro (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm right on 24Feb2021 at 14:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced fatigue, sore arm, aches, headache but they passed after approximately 24 hrs. The night of the 2nd vaccine the patient had extreme pain in the right breast, the extreme pain came and went. But the patient still had this issue 22 days after. It was very painful and also hurt around the right side of the back. 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. The clinical outcome of the events fatigue, sore arm, aches and headache  was recovered in 24 hours on an unknown date in Mar2021, while that of the events extreme pain in the right breast and hurt around the right side of the back was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Fatigue; Sore arm; Aches; Headache; The night of the 2nd vaccine I had extreme pain in my right breast, the extreme pain comes and goes but Im still having this issue 22 days after.; It is very painful and also hurts around the right side of my back.; This is a spontaneous report from a contactable healthcare professional, the patient. A 54-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 arm right on 18Mar2021(at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, hashimoto's disease and COVID-19. Concomitant medications included alprazolam (XANAX), levothyroxine, liothyronine (NP THYROID) and poloxamer (UNI) and Bio-identical hormones for unknown indication and from an unknown date. The patient previously took codeine (MANUFACTURER UNKNOWN) and cipro (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm right on 24Feb2021 at 14:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced fatigue, sore arm, aches, headache but they passed after approximately 24 hrs. The night of the 2nd vaccine the patient had extreme pain in the right breast, the extreme pain came and went. But the patient still had this issue 22 days after. It was very painful and also hurt around the right side of the back. 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. The clinical outcome of the events fatigue, sore arm, aches and headache  was recovered in 24 hours on an unknown date in Mar2021, while that of the events extreme pain in the right breast and hurt around the right side of the back was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysphagia, Pharyngeal swelling, Swollen tongue
Clinical narrative: throat swelled on the right side; tongue swelled; TONGUE SWELLED MAKING IT DIFFICULT TO SWALLOW.; NOW HAVE LOST MY SENSE OF TASTE AS A RESULT OF THIS REACTION.; This is a spontaneous report from a contactable consumer, the patient. A 66-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 right arm on 20Mar2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and drug allergy (Narcotics allergy). Concomitant medications included furosemide (LASIX), and meloxicam (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unspecified date at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 12:00 the patient experienced throat swelled on right side and tongue swelled, making it difficult to swallow. Had lost my sense of taste as a result of this reaction. The patient did not receive any treatment for the events. The clinical outcome of the events throat swelled on right side and tongue swelled, making it difficult to swallow. Had lost my sense of taste as a result of this reaction was recovered with sequelae.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches and pain; fever; This is a spontaneous report from a contactable consumer. A 52-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 on 08Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history and concomitant medications. It was unknown if the patient had any allergies to medications, food or other products. 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 unspecified date as a single dose for COVID-19 immunisation. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On an unspecified date in 2021, the patient experienced aches and pain, and fever. Therapeutic measures were taken as a result of the events with ADVIL. The clinical outcome of the events aches and pain and fever were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: severe headache; chattering teeth and chills; Joint aches in wrist, elbow, knees and ankles; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 17Mar2021 at 02:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient previously received levofloxacin (LEVAQUIN) on an unspecified date for an unspecified indication and experienced drug allergy.  Concomitant medications included calcium citrate, colecalciferol  (CITRACAL MAX) and calcium ascorbate, gelatine hydrolysate (YOUTHEORY COLLAGEN) all for unknown indication, from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 01:00, the patient reported that initially she experienced severe headache within 12hrs, chattering teeth tupe chills no fever and also joint aches in wrist, elbow, knees and ankles. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events headache, teeth chattering, and joint ache were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Dyspnoea, Heart rate, Oxygen saturation
Clinical narrative: Pretty unpleasant shortness of breath- like a band around my chest - can't take a deep breath; enough chest pain to be concerning in the area of my heart; shaking; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8787) via an unspecified route of administration in the left arm on 07Apr2021 at 14:30(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included sliding hiatal hernia with acid reflux, hypoglycemia, cholesterol high, intermittent high BP over the last year (blood pressure high) and food allergy (onion, bell pepper). The patient previously took Vicodin on an unknown date and for unknown indication and experienced drug allergy. The patient previously took Xanax on an unknown date and for unknown indication and experienced drug allergy. The patient previously took Paxil on an unknown date and for unknown indication and experienced drug allergy. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN,20mg), vitamin d nos (MANUFACTURER UNKNOWN), mefenamic acid (ADVIL), acetylsalicylic acid (ASPIRIN) and cyanocobalamin (B12) all from unknown date and for unknown indication. Prior to the vaccination, it was unknow whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:30 the patient experienced Pretty unpleasant shortness of breath - like a band around her chest - can't take a deep breath; enough chest pain to be concerning in the area of her heart, and her heart feels like it's full of cement; shaking. No therapeutic measures were taken as a result of the events. On 09Apr2021, the patient checked Blood pressure and the result was 126/69(units unspecified). On 09Apr2021, the patient checked Pulse and the result was 78(units unspecified). On 09Apr2021, the patient checked Pulse oximetry and the result was 94-96(units unspecified).The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Pretty unpleasant shortness of breath- like a band around my chest - can't take a deep breath, enough chest pain to be concerning in the area of my heart and shaking were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Pretty unpleasant shortness of breath- like a band around my chest - can't take a deep breath; enough chest pain to be concerning in the area of my heart; shaking; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8787) via an unspecified route of administration in the left arm on 07Apr2021 at 14:30(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included sliding hiatal hernia with acid reflux, hypoglycemia, cholesterol high, intermittent high BP over the last year (blood pressure high) and food allergy (onion, bell pepper). The patient previously took Vicodin on an unknown date and for unknown indication and experienced drug allergy. The patient previously took Xanax on an unknown date and for unknown indication and experienced drug allergy. The patient previously took Paxil on an unknown date and for unknown indication and experienced drug allergy. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN,20mg), vitamin d nos (MANUFACTURER UNKNOWN), mefenamic acid (ADVIL), acetylsalicylic acid (ASPIRIN) and cyanocobalamin (B12) all from unknown date and for unknown indication. Prior to the vaccination, it was unknow whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:30 the patient experienced Pretty unpleasant shortness of breath - like a band around her chest - can't take a deep breath; enough chest pain to be concerning in the area of her heart, and her heart feels like it's full of cement; shaking. No therapeutic measures were taken as a result of the events. On 09Apr2021, the patient checked Blood pressure and the result was 126/69(units unspecified). On 09Apr2021, the patient checked Pulse and the result was 78(units unspecified). On 09Apr2021, the patient checked Pulse oximetry and the result was 94-96(units unspecified).The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Pretty unpleasant shortness of breath- like a band around my chest - can't take a deep breath, enough chest pain to be concerning in the area of my heart and shaking were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gingival pain, Gingival swelling, Myalgia
Clinical narrative: fatigue; chills; sore muscles; nausea; Swollen and sensitive gums; achy feeling; Swollen and sensitive gums; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 09:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included non-celiac gluten sensitivity and heart palpitations (SVT). The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. 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 right arm on 16Mar2021 at 09:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 12:00, the patient experienced swollen and sensitive gums, nausea, fatigue, achy feeling, sore muscles, chills. 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. The clinical outcome of the event swollen and sensitive gums, nausea, fatigue, achy feeling, sore muscles, chills was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: fatigue; chills; sore muscles; nausea; Swollen and sensitive gums; achy feeling; Swollen and sensitive gums; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 09:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included non-celiac gluten sensitivity and heart palpitations (SVT). The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. 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 right arm on 16Mar2021 at 09:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 12:00, the patient experienced swollen and sensitive gums, nausea, fatigue, achy feeling, sore muscles, chills. 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. The clinical outcome of the event swollen and sensitive gums, nausea, fatigue, achy feeling, sore muscles, chills was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Pain, SARS-CoV-2 test
Clinical narrative: Body aches; Unable to work; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on 07Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and 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 on unspecified date in 2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced body aches, fatigue and was unable to work. On an unknown date, after the vaccination the patient underwent lab test and procedure which included covid-19 test and the result was found to be negative. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events body aches, fatigue and unable to work was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Severe Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729) via an unspecified route of administration in left arm on 09Apr2021 at 13:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 at 13:45, the patient experienced severe headache and nausea. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events severe headache and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash, Tinnitus, Urticaria
Clinical narrative: Rash; Rash, progressing to allergic hives on trunk, legs, arms within the 3 days after my second COVID shot; Also, extreme fatigue; Increase of existing tinnitus; This is a spontaneous report from a contactable pharmacist, the patient. A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 66-year-old) as a single dose for COVID-19 immunization. Medical history included seasonal and environmental allergies, increased cholesterol, dust allergy, pollen allergy, bee sting allergy and egg yolks allergy. Concomitant medications included montelukast sodium (SINGULAIR) , rosuvastatin calcium (CRESTOR) , zeaxanthin (LUTEIN) and vitamin d nos (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 11Mar2021 at 13:30 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced rash, progressing to allergic hives on trunk, legs, arms within the 3 days after the second COVID shot. The patient also experienced extreme fatigue and increase of existing tinnitus on 02Apr2021.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of  the events which included treatment with diphenhydramine (BENADRYL) 50 mg every 4 hours from an unknown date. The clinical outcome of the events rash, progressing to allergic hives on trunk, legs, arms within the 3 days after the second COVID shot, extreme fatigue and increase of existing tinnitus was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: Left side of top and bottom lips swelling; Left side of top and bottom lips some numbness; Bottom lip swelling; Bottom lip some numbness; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the right arm on 05Apr2021 at 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, breast cancer, heartbeats irregular and sulfa (sulfonamide) allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), propranolol hydrochloride (PROPRANOLOL) and exemestane (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. 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 on 15Mar2021 at 11:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05Apr2021 at 23:30, 12 hours after the second shot, the patient experienced bottom lip swelling and some numbness which lasted for about 36 hours. On 08Apr2021 at 23:45, 72 hours after the shot, the patient experienced a second episode of left side of top and bottom lip swelling and some numbness. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events bottom lip swelling (onset date: 05Apr2021) and some numbness (onset date: 05Apr2021) were resolved on 07Apr2021 at 11:30, while the clinical outcome of the events top and bottom lip swelling (onset date: 08Apr2021) and some numbness (onset date: 08Apr2021) were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Malaise, Pain
Clinical narrative: Full body aches; severe abdominal pain; Started with pain, tenderness and soreness atinjection site; Chills; Fever; Headache; Feel ill; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had seasonal allergies specifically to juniper pollen. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken daily for seasonal allergy from an unknown date. 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 16:45, the patient experienced pain, tenderness and soreness at injection site, full body aches, chills, fever, headache, severe abdominal pain and felt ill. The patient reported that less than 12 hours after injection felt really bad, started with pain, tenderness and soreness at injection site, that was followed by full body aches, chills, fever, headache and severe abdominal pain that has been over 24 hours since injection and the patient still felt ill. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain, tenderness and soreness at injection site, full body aches, chills, fever, headache, severe abdominal pain and felt ill were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Full body aches; severe abdominal pain; Started with pain, tenderness and soreness atinjection site; Chills; Fever; Headache; Feel ill; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had seasonal allergies specifically to juniper pollen. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken daily for seasonal allergy from an unknown date. 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 16:45, the patient experienced pain, tenderness and soreness at injection site, full body aches, chills, fever, headache, severe abdominal pain and felt ill. The patient reported that less than 12 hours after injection felt really bad, started with pain, tenderness and soreness at injection site, that was followed by full body aches, chills, fever, headache and severe abdominal pain that has been over 24 hours since injection and the patient still felt ill. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain, tenderness and soreness at injection site, full body aches, chills, fever, headache, severe abdominal pain and felt ill were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: 2 days after first dose a lump on collar bone on injection side developed which is about 1/2 inch diameter and has stayed the same size but not went away.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, diverticulosis, early glaucoma and joint pain. The patient did not have any allergies to medications, food, or other products. Concomitant medication included hydroxychloroquine (MANUFACTURER UNKNOWN), naproxen (NAPROXENE), diclofenac (VOLTAREN), acetylsalicylic acid, ascorbic acid (ASPIRIN); all since unknown dates and for unknown indications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 after two days of vaccination, the patient experienced a lump on collar bone on injection side developed which is about half inch diameter and had stayed the same size but not went away. 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 event. The clinical outcome of the event lump on collar bone on injection side was not recovered, at this time of report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5206,) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever; Hives like blister on wrist and on the back neck; Rash similar to hives on hand and back; This is a spontaneous report from a contactable consumer, the patient. A 33-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 08Apr2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient has not had any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 08Apr2021 at 14:00, two hours after vaccination, the patient experienced rash similar to hives on hand and back. On 09Apr2021, the patient experienced fever and hives like blister on wrist and on the back neck. 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. The clinical outcome of the events rash similar to hives on hand and back, fever and hives like blister on wrist and on the back neck was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall, Influenza, Lymphadenopathy
Clinical narrative: Flu symptoms, swollen neck lymph nodes, the vertigo, dizziness, loss of balance, falling; the vertigo; loss of balance; Falling; dizziness; swollen neck lymph nodes; This is a spontaneous report from a contactable physician, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021(at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included HIV positive (HIV-positive x 35 years - stabilized). The patient concomitant medication included unspecified HIV medications. The patient did not have any allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 05Mar2021 at 12:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:00 the patient experienced flu symptoms, swollen neck lymph nodes, vertigo, dizziness, loss of balance, falling. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events flu symptoms, swollen neck lymph nodes, vertigo, dizziness, loss of balance, falling was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Flu symptoms, swollen neck lymph nodes, the vertigo, dizziness, loss of balance, falling; the vertigo; loss of balance; Falling; dizziness; swollen neck lymph nodes; This is a spontaneous report from a contactable physician, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021(at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included HIV positive (HIV-positive x 35 years - stabilized). The patient concomitant medication included unspecified HIV medications. The patient did not have any allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 05Mar2021 at 12:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:00 the patient experienced flu symptoms, swollen neck lymph nodes, vertigo, dizziness, loss of balance, falling. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events flu symptoms, swollen neck lymph nodes, vertigo, dizziness, loss of balance, falling was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Migraine, Myalgia
Clinical narrative: Back pain; Back pain and achiness; Migraine; Swelling at the site of injection; Headache; Nausea; Fever; Muscle ache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 17:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, gastroesophageal reflux disease (GERD), fractured vertebrae and bulging disc. The patient has no known allergies to food, medications, or other products. Concomitant medications included optavia diet nutrition bars and shakes and naloxone hydrochloride; buprenorphine hydrochloride (SUBOXONE) for an unknown indication from an unknown date. 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 left arm on 09Mar2021 at 18:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 22:00, the patient experienced swelling at the site of injection, back pain and achiness, headache, migraine, nausea, fever, muscle ache and chills. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events swelling at the site of injection, back pain and achiness, headache, migraine, nausea, fever, muscle ache, and chills was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: Back pain; Back pain and achiness; Migraine; Swelling at the site of injection; Headache; Nausea; Fever; Muscle ache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 17:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, gastroesophageal reflux disease (GERD), fractured vertebrae and bulging disc. The patient has no known allergies to food, medications, or other products. Concomitant medications included optavia diet nutrition bars and shakes and naloxone hydrochloride; buprenorphine hydrochloride (SUBOXONE) for an unknown indication from an unknown date. 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 left arm on 09Mar2021 at 18:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 22:00, the patient experienced swelling at the site of injection, back pain and achiness, headache, migraine, nausea, fever, muscle ache and chills. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events swelling at the site of injection, back pain and achiness, headache, migraine, nausea, fever, muscle ache, and chills was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Shingles; Swollen lymph nodes (neck); Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6207) via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included cancer. . The patient has no known allergies to food, medications or other products. The patient did not receive other medications within two weeks of vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6200) via an unspecified route of administration in the left arm on 22Jan2021 at 14:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation (inappropriate schedule of vaccine administered). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced shingles and swollen lymph nodes in neck. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events  shingles and swollen lymph nodes in neck were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Dizziness; pain at site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 12:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included ibuprofen (ADVIL), biotin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN), all started from an unknown date for unspecified indication. The patient did not have any allergies to medications, food, or other products. 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 right arm on 15Mar2021 at 13:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 17:30, the patient experienced dizziness and pain at site. 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. The clinical outcome of the events dizziness and pain at site was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.