chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Mild fever; chills; diarrhea; joint pain; fatigue; injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 09Apr2021 at 14:00 as a single dose for COVID-19 immunisation. Medical history included atopy and allergy to penicillin and sulfa. Concomitant medications included vitamin c (MANUFACTURER UNKNOWN) and butchers broom (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 at 11:00, the patient experienced mild fever, chills, diarrhea, joint pain, fatigue and injection site soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events mild fever, chills, diarrhea, joint pain, fatigue and injection site soreness were recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild fever; chills; diarrhea; joint pain; fatigue; injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 09Apr2021 at 14:00 as a single dose for COVID-19 immunisation. Medical history included atopy and allergy to penicillin and sulfa. Concomitant medications included vitamin c (MANUFACTURER UNKNOWN) and butchers broom (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 at 11:00, the patient experienced mild fever, chills, diarrhea, joint pain, fatigue and injection site soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events mild fever, chills, diarrhea, joint pain, fatigue and injection site soreness were recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Severe pain under arm (armpit); Swelling on under arm (armpit) area; Body aches; Fever; This is a spontaneous report from a contactable consumer, the patient. A 50-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 arm left on 04Apr2021 at 08:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 18Mar2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy on an unknown date. The patient did not receive any other medicines within 2 weeks of the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 at 19:45, the patient experienced severe pain and swelling on under arm (armpit) area and fever and body aches. Pain and swelling persisted in under arm area on side of vaccination area (left armpit). 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 event(s). The clinical outcome of the events severe pain and swelling on under arm (armpit) area and fever and body aches were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Weakness; Vaccination site pain; Tiredness; Headache; Muscle pain; Chills; Fever (got to 102.2 degrees); Nausea; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy, food allergy (Gluten), and allergy to some antibiotics. Concomitant medications included paracetamol (TYLENOL), hormone replacement therapy (MANAFACTURER UNKNOWN), thyroid (MANAFACTURER 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: EN6207) via an unspecified route of administration in the left arm on 21Mar2021 at 09:45 (at the age of 53-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 11Apr2021 at 11:00, the patient experienced Injection site pain, tiredness, headache, muscle pain, chills, fever got to 102.2 degrees, nausea and weakness. The patient did not receive any treatment for the events. On 11Apr2021, the patient underwent body Temperature measurement and the result was 102.2 degrees (UNSPECIFIED UNITS). 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 Injection site pain, tiredness, headache, muscle pain, chills, fever got to 102.2 degrees, nausea and weakness was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Weakness; Vaccination site pain; Tiredness; Headache; Muscle pain; Chills; Fever (got to 102.2 degrees); Nausea; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy, food allergy (Gluten), and allergy to some antibiotics. Concomitant medications included paracetamol (TYLENOL), hormone replacement therapy (MANAFACTURER UNKNOWN), thyroid (MANAFACTURER 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: EN6207) via an unspecified route of administration in the left arm on 21Mar2021 at 09:45 (at the age of 53-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 11Apr2021 at 11:00, the patient experienced Injection site pain, tiredness, headache, muscle pain, chills, fever got to 102.2 degrees, nausea and weakness. The patient did not receive any treatment for the events. On 11Apr2021, the patient underwent body Temperature measurement and the result was 102.2 degrees (UNSPECIFIED UNITS). 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 Injection site pain, tiredness, headache, muscle pain, chills, fever got to 102.2 degrees, nausea and weakness was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dry throat, Headache, Lip swelling
Clinical narrative: lips swollen; tongue itchy; throat sore; Sleepy; arm pain; head hurt; joints hurt; chills; throat scratchy; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153), via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included long QT Syndrome, asthma, Attention-Deficit and Hyperactivity Disorder (ADHD), anorexia, sensory processing, misophonia and sensitive to some products and chemicals. Concomitant medications included ethinylestradiol, levonorgestrel (LARISSIA), lorazepam MANUFACTURER UNKNOWN), nadoloL MANUFACTURER UNKNOWN), Melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient was allergic to sensitive to - Dodecyl Gallate, Formaldehyde, Fragrance Mix I or II (most botanicals REMOVED), Fragrance STRICTLY AVOIDED (Products will be free of B Peru, Benzoic acid, Benzaldehyde, Benzyl Alcohol, Sodium Benzoate, Cinnamates, Octocrylene), Hydroperoxides of Limonene, Limonene, MCI / MI, Oil Free (Oil containing products will be removed from list but list WILL contain Petrolatum and Paran), Propolis, Propyl Gallate, Thiuram mix, Tixocortol-21-Pivalate. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  On 08Mar2021, the patient received first dose of Diphtheria, tetanus, Pertussis - Tdap via left arm, four weeks prior to the vaccination. On 09Apr2021 at 16:15, the patient experienced arm pain right away and her head hurt and was sleepy, friday night her joints hurt and wasn't hungry but did eat some toast. The patient also reported that she had chills and throat was scratchy. She had been drinking water and Gatorade, Overnight she threw up after taking Tylenol but did ok. On Sunday, she woke up and her lips were swollen, but the tip of her tongue was itchy but hadn't gotten worse and her throat hurts. Monday lips are still swollen, tongue still itchy throat still sore. On an unspecified date, the patient received TYLENOL as a treatment for the adverse events. The clinical outcomes of the events arm pain right, head hurt sleepy, joints hurt, chills throat scratchy, lips were swollen, tongue was itchy and tongue, itchy and throat sore were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Somnolence, Tongue pruritus
Clinical narrative: lips swollen; tongue itchy; throat sore; Sleepy; arm pain; head hurt; joints hurt; chills; throat scratchy; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153), via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included long QT Syndrome, asthma, Attention-Deficit and Hyperactivity Disorder (ADHD), anorexia, sensory processing, misophonia and sensitive to some products and chemicals. Concomitant medications included ethinylestradiol, levonorgestrel (LARISSIA), lorazepam MANUFACTURER UNKNOWN), nadoloL MANUFACTURER UNKNOWN), Melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient was allergic to sensitive to - Dodecyl Gallate, Formaldehyde, Fragrance Mix I or II (most botanicals REMOVED), Fragrance STRICTLY AVOIDED (Products will be free of B Peru, Benzoic acid, Benzaldehyde, Benzyl Alcohol, Sodium Benzoate, Cinnamates, Octocrylene), Hydroperoxides of Limonene, Limonene, MCI / MI, Oil Free (Oil containing products will be removed from list but list WILL contain Petrolatum and Paran), Propolis, Propyl Gallate, Thiuram mix, Tixocortol-21-Pivalate. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  On 08Mar2021, the patient received first dose of Diphtheria, tetanus, Pertussis - Tdap via left arm, four weeks prior to the vaccination. On 09Apr2021 at 16:15, the patient experienced arm pain right away and her head hurt and was sleepy, friday night her joints hurt and wasn't hungry but did eat some toast. The patient also reported that she had chills and throat was scratchy. She had been drinking water and Gatorade, Overnight she threw up after taking Tylenol but did ok. On Sunday, she woke up and her lips were swollen, but the tip of her tongue was itchy but hadn't gotten worse and her throat hurts. Monday lips are still swollen, tongue still itchy throat still sore. On an unspecified date, the patient received TYLENOL as a treatment for the adverse events. The clinical outcomes of the events arm pain right, head hurt sleepy, joints hurt, chills throat scratchy, lips were swollen, tongue was itchy and tongue, itchy and throat sore were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Started menstrual cycle - i have been in menopause for 3 years; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 at vaccination age of 53-year-old via an unspecified route of administration, administered in the left arm on 28Mar2021 at 12:30 (Lot Number: ER8734) as dose 1, single for covid-19 immunization. The patient medical history was none. The patient did not have covid-19 prior to vaccination. The patient has no known allergies. The patient's concomitant medications were none. The patient received the vaccine in a pharmacy or drug store. The patient did not have other vaccine in four weeks. On 08Apr2021 08:00, the patient started a menstrual cycle, but the patient has been in menopause for 3 years. The patient did not require treatment for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was recovered on an unspecified date in 2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia, Sensitive skin
Clinical narrative: Fever; headache; skin sensitivity; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0162), via an unspecified route of administration in the left arm on 10Apr2021 at 17:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 50-years-old) 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 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 13:00, the patient experienced fever, headache, skin sensitivity and joint pain. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events fever, headache, skin sensitivity and joint pain was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: About 20 minutes afterwards my face kind of went numb a little bit, like around my cheeks and my lips they felt numb; Pretty significant ear pain in my left or jaw pain in left joint of my jaw; Pretty significant ear pain in my left or jaw pain in left joint of my jaw; Little bit of a rash on my face; Rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes I think; Exhaustion; Nausea; Different things, it kind of make sense for like as if I was experiencing COVID; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced about 20 minutes afterwards my face kind of went numb a little bit, like around my cheeks and my lips they felt numb, pretty significant ear pain in my left or jaw pain in left joint of my jaw, little bit of a rash on my face, rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes I think, exhaustion, nausea, different things, it kind of make sense for like as if was experiencing COVID. Consumer stated that when had first dose of vaccine, experienced about 20 minutes afterwards her face kind of went numb a little bit, like around her cheeks and lips felt numb and had a little bit of a rash on her face and had like some pretty significant ear pain in left or jaw pain in left joint of jaw. And then 2 days later, had a very rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes as per patient thought, based on her watch. Then after that like exhaustion and nausea and you know different things, it kind of make sense for like as if was experiencing COVID but wanted to see with those symptoms does it make sense." Consumer further stated that received her first dose and had some interesting responses and was trying to decide whether it was safe for her. Consumer wanted to know was it still okay for her to get the second dose. On an unspecified date, the patient underwent lab tests and procedures which included heart rate: increased (like around 200 beats per minutes). The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Pain in jaw, Rash
Clinical narrative: About 20 minutes afterwards my face kind of went numb a little bit, like around my cheeks and my lips they felt numb; Pretty significant ear pain in my left or jaw pain in left joint of my jaw; Pretty significant ear pain in my left or jaw pain in left joint of my jaw; Little bit of a rash on my face; Rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes I think; Exhaustion; Nausea; Different things, it kind of make sense for like as if I was experiencing COVID; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced about 20 minutes afterwards my face kind of went numb a little bit, like around my cheeks and my lips they felt numb, pretty significant ear pain in my left or jaw pain in left joint of my jaw, little bit of a rash on my face, rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes I think, exhaustion, nausea, different things, it kind of make sense for like as if was experiencing COVID. Consumer stated that when had first dose of vaccine, experienced about 20 minutes afterwards her face kind of went numb a little bit, like around her cheeks and lips felt numb and had a little bit of a rash on her face and had like some pretty significant ear pain in left or jaw pain in left joint of jaw. And then 2 days later, had a very rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes as per patient thought, based on her watch. Then after that like exhaustion and nausea and you know different things, it kind of make sense for like as if was experiencing COVID but wanted to see with those symptoms does it make sense." Consumer further stated that received her first dose and had some interesting responses and was trying to decide whether it was safe for her. Consumer wanted to know was it still okay for her to get the second dose. On an unspecified date, the patient underwent lab tests and procedures which included heart rate: increased (like around 200 beats per minutes). The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Lethargy, Nasal congestion, Oropharyngeal pain
Clinical narrative: Severe sore throat; Nasal congestion; Body aches; Dry cough; Mid-grade fever; Lethargy; Symptomology very similar to typical flu; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 09:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food or other products. The patient did not receive any medications within two weeks of 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. On 09Apr2021 at 13:00, the patient experienced severe sore throat, nasal congestion, body aches, dry cough, mid-grade fever, lethargy and symptomology very similar to typical flu. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events severe sore throat, nasal congestion, body aches, dry cough, mid-grade fever, lethargy and symptomology very similar to typical flu was recovering 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: Pain, Pyrexia
Clinical narrative: Severe sore throat; Nasal congestion; Body aches; Dry cough; Mid-grade fever; Lethargy; Symptomology very similar to typical flu; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 09:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food or other products. The patient did not receive any medications within two weeks of 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. On 09Apr2021 at 13:00, the patient experienced severe sore throat, nasal congestion, body aches, dry cough, mid-grade fever, lethargy and symptomology very similar to typical flu. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events severe sore throat, nasal congestion, body aches, dry cough, mid-grade fever, lethargy and symptomology very similar to typical flu was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling cold, Oropharyngeal pain, Rash
Clinical narrative: light headed; feels like fighting a cold; sore throat; a rashby my left elbow; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, and blood pressure high. The patient had no known allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN, amlodipine (MANUFACTURER UNKNOWN), and insulin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced a sore throat, rash by left elbow, fatigue. On 07Apr2021 at 07:00, the patient experienced when turned head to look in a different direction became light headed, body felt like fighting a cold. The patient did not receive any treatment 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 sore throat, rash by left elbow, fatigue, light headed, body felt like fighting a cold was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Small rash on left arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 02:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, allergies and peritoneal mesothelioma. The patient was allergic to BACTRIM (Sulfa). Concomitant medications included pentosan polysulfate sodium (ELMIRON), montelukast sodium (SINGULAIR) and antihistamine (MANUFACTURER UNKNOWN) all for unknown indications, started from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 48-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 19:00, the patient experienced small rash on left arm about 4 hours after injection. Therapeutic measures were not taken as a result of this event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event small rash on left arm was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: More fatigue than usual.; This is a spontaneous report from a contactable consumer, the patient.  A 75-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 left arm on 06Apr2021 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, hypertension and vertigo. Concomitant medications included metformin (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN), terazosin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN) and ulinastatin (STATIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 16Mar2021 (at the age of 75-years-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 06Apr2021, the patient experienced more fatigue than usual. No therapeutic measures were taken as a result of the events. The clinical outcome of the event more fatigue than usual was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bilateral tinnitus.  Left ear tinnitus is worsethan right side.; This is a spontaneous report from a contactable healthcare professional. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 28Mar2021 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included mixed hyperlipidemia. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 19:00, the patient experienced bilateral tinnitus since he got Pfizer COVID vaccine. The patient denied hearing loss and dizziness. Left ear tinnitus was worse than right side. The patient denied sleep issues. No intervention was needed, would continue to monitor. The patient advised it was his decision whether or not he should get the second COVID vaccine. The patient denied any history of tinnitus. The event resulted 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. The clinical outcome of the event bilateral tinnitus, left ear tinnitus is worse than right side was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Intermenstrual bleeding
Clinical narrative: Menstrual spotting outside of regular menstrual cycle and lower right abdominal cramping; Menstrual spotting outside of regular menstrual cycle and lower right abdominal cramping several hour after receiving Covid Vaccine; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 11Apr2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included ocular myasthenia gravis and graves' disease. The patient had no known allergies. Concomitant medications included mycophenolate mofetil (MANUFACTURER UNKNOWN) started on unknown dates and for unspecified indications and unknown if ongoing. The patient receives other vaccines within 4 weeks prior to the COVID vaccine included hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9) started on 5April2021 and unknow if ongoing for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21March2021 at 12:30 (at the age of 35-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. On 11Apr2021 at 20:00 the patient experienced menstrual spotting outside of regular menstrual cycle and lower right abdominal cramping several hours after receiving 2 dose of vaccine. Therapeutic measures were not taken as a result of the event(s). 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 event Menstrual spotting outside of regular menstrual cycle and lower right abdominal cramping were recovering, 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: Tinnitus
Clinical narrative: "I have a high pitched ringing in my ears"; This is a spontaneous report from a contactable consumer, the patient. A 67-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 67-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history and no known allergies to food, medications or other products. Concomitant medications included omega-3-acid ethyl ester (LOVAZA); for unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 the patient experienced a high-pitched ringing in ears. It was diagnosed as tinnitus by ENT. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event "I have a high-pitched ringing in my ears" was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body hives began 4 days post shot, spread from torso to extremities; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Patient had no allergies to medications, food or other products. Concomitant medications included tadalafil (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 13:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 , four days post shot the patient experienced full body hives which began to spread from torso to extremities and lasted roughly four days. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event full body hives which began to spread from torso to extremities was resolved on 09Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; its is warm; Neared a fever; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and heart arrhythmia. The patient did not have any allergies to food, medications, or other products. Concomitant medications included levonorgestrel (LILETTA) Intrauterine Device (IUD), iron (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 19Mar2021 at 14:45 (at the age of 21-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 medications or vaccines within 4 weeks prior to the vaccination. On 10Apr2021 at 09:00, the patient experienced swollen, semi-itchy, painful and red at injection site and had a knot/bump on it and was warm and painful to touch. It had slowly gotten bigger every day since receiving the vaccine and the patient neared a fever the day after receiving the vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen, semi-itchy, painful and red at injection site with a knot/bump, warm and painful to touch and fever were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; Swollen, semi-itchy, painful, and red injection site; its is warm; Neared a fever; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and heart arrhythmia. The patient did not have any allergies to food, medications, or other products. Concomitant medications included levonorgestrel (LILETTA) Intrauterine Device (IUD), iron (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 19Mar2021 at 14:45 (at the age of 21-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 medications or vaccines within 4 weeks prior to the vaccination. On 10Apr2021 at 09:00, the patient experienced swollen, semi-itchy, painful and red at injection site and had a knot/bump on it and was warm and painful to touch. It had slowly gotten bigger every day since receiving the vaccine and the patient neared a fever the day after receiving the vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen, semi-itchy, painful and red at injection site with a knot/bump, warm and painful to touch and fever were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: . By The evening my armwas incredibly sore. I could not lift aglass of water with the arm thatreceived the shot; Pounding headache for about 20 hour; Small fever for about 24 hours; Very tired; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 10Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications were not reported. 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 10Apr2021 at 18:00, the patient experienced arm was incredibly sore, could not lift a glass of water with the arm that received the shot, pounding headache for about 20 hours, a small fever for about 24 hours, tired. Patient also stated that she had no/little side effects after the first dose. The patient did not receive any treatment 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 arm was incredibly sore, tired recovered on an unspecified date in Apr2021. Whereas, pounding headache, small fever recovered on 11Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illusion
Clinical narrative: 38 hours after the shot, at 10pm at night, after waking up from falling asleep on the couch, I saw what I thought was a softball size "swarm of gnats/flies" in the corner of the room with trailing flies.  After staring at it, it disppeared and disper; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0150) via an unspecified route of administration in the right arm on 31Mar2021 at 08:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis b carrier. The patient previously received penicillin type medications (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced penicillin allergy. Concomitant medications included tenofovir disoproxil fumarate (TENOFOVIR) for unknown indication on an unknown date. 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 01Apr2021, 38 hours after the shot, at 22:00 in the night, the patient woke up from falling asleep on the couch, then what the patient saw was a softball size "swarm of gnats/flies" in the corner of the room with trailing flies.  After staring at it, it had disappeared and dispersed from her vision after about 40 seconds. No therapeutic measures were taken as a result of reported event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event optical illusion of a softball size "swarm of gnats/flies" in the corner of the room with trailing flies was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.