chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysstasia, Headache, Hypoaesthesia, Insomnia
Clinical narrative: Temperature of 102; Extreme tremors in extremities; Could not get up; Headache; Vision has been blurry; Numbness/tingling in hands and arms; Numbness/tingling in hands and arms/ Occasionaltingling in legs and feet; Can't sleep; This is a spontaneous report from a contactable consumer, the patient. A 40-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 right arm on 10May2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8732) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 22:30, exactly 12 hours after second injection, the patient's temperature was of 102 (unit unspecified) that lasted for 4 days and extreme tremors in extremities to the point she could not get up for 8 hours. It was reported that headache accompanied these. Ever since, the patient's vision was blurry and had numbness/tingling in hands and arms that was always there, sometimes bad enough that she could not sleep and occasional tingling in legs and feet. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 24Aug2021, the patient underwent binax now nasal swab COVID test and the result was negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event temperature of 102 was recovered on 14May2021. The clinical outcome of the events extreme tremors in extremities, could not get up, headache, vision has been blurry, numbness/tingling in hands and arms, numbness/tingling in hands and arms/ occasional tingling in legs and feet and can't sleep was not recovered at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, SARS-CoV-2 test, Tremor, Vision blurred
Clinical narrative: Temperature of 102; Extreme tremors in extremities; Could not get up; Headache; Vision has been blurry; Numbness/tingling in hands and arms; Numbness/tingling in hands and arms/ Occasionaltingling in legs and feet; Can't sleep; This is a spontaneous report from a contactable consumer, the patient. A 40-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 right arm on 10May2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8732) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 22:30, exactly 12 hours after second injection, the patient's temperature was of 102 (unit unspecified) that lasted for 4 days and extreme tremors in extremities to the point she could not get up for 8 hours. It was reported that headache accompanied these. Ever since, the patient's vision was blurry and had numbness/tingling in hands and arms that was always there, sometimes bad enough that she could not sleep and occasional tingling in legs and feet. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 24Aug2021, the patient underwent binax now nasal swab COVID test and the result was negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event temperature of 102 was recovered on 14May2021. The clinical outcome of the events extreme tremors in extremities, could not get up, headache, vision has been blurry, numbness/tingling in hands and arms, numbness/tingling in hands and arms/ occasional tingling in legs and feet and can't sleep was not recovered at the time of this report.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bradykinesia, Diarrhoea, Dysphagia, Fatigue
Clinical narrative: Felt like throat was swollen; Difficulty chewing any food; Moved slower then normal.; Difficulty swallowing; Could not perform sexual intercourse.; Felt really drained of energy all day long.; Felt really tired all day and night, at times I couldn't keep my eyes open.; Diarrhea; Fever; This is a spontaneous report from a contactable consumer, the patient. A 32-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 30Aug2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included mental health issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included aripiprazole (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 31Aug2021 at 15:00, the patient felt really tired all day and night, at times the patient could not keep the eyes open, felt really drained of energy all day long. The patient also had diarrhea, fever, moved slower than normal, difficulty chewing any food, difficulty swallowing, felt like throat was swollen and was unable to perform sexual intercourse. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events felt really tired all day and night, at times could not keep the eyes open, felt really drained of energy all day long, diarrhea, fever, moved slower than normal, difficulty chewing any food, difficulty swallowing, felt like throat was swollen and could not perform perform sexual intercourse were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Mastication disorder, Pharyngeal swelling, Pyrexia, Sexual inhibition
Clinical narrative: Felt like throat was swollen; Difficulty chewing any food; Moved slower then normal.; Difficulty swallowing; Could not perform sexual intercourse.; Felt really drained of energy all day long.; Felt really tired all day and night, at times I couldn't keep my eyes open.; Diarrhea; Fever; This is a spontaneous report from a contactable consumer, the patient. A 32-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 30Aug2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included mental health issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included aripiprazole (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 31Aug2021 at 15:00, the patient felt really tired all day and night, at times the patient could not keep the eyes open, felt really drained of energy all day long. The patient also had diarrhea, fever, moved slower than normal, difficulty chewing any food, difficulty swallowing, felt like throat was swollen and was unable to perform sexual intercourse. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events felt really tired all day and night, at times could not keep the eyes open, felt really drained of energy all day long, diarrhea, fever, moved slower than normal, difficulty chewing any food, difficulty swallowing, felt like throat was swollen and could not perform perform sexual intercourse were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had a sore arm which is normal for me because I had it with the first one; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE mRNA, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (Age at vaccination was 61 years) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was inquiring about side effect information regarding the Pfizer COVID-19 vaccine. Patient states She had recently gotten vaccinated, her first dose a little over 3 weeks ago and her second dose Wednesday. On Wednesday night, she had a sore arm which was normal for her because she had it with the first one. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Maternal exposure timing unspecified
Clinical narrative: Deep chest pain; Maternal drug exposure; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Aug2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included fish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 28Aug2021, two days after second dose of vaccination, the patient experienced deep chest pain. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event.  The clinical outcome of the event deep chest pain was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymphs - neck; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Sep2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 05Sep2021 at 08:00, the patient experienced swollen lymphs - neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymphs - neck was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Neuropathy peripheral
Clinical narrative: My left leg, especially my foot, I have been experiencing some really bad neuropathy in it; Little bit of neuropathy in my left foot; I got my booster shot about five or six days ago; This is a spontaneous report from a Non contactable consumer (patient, self-reported). A 58-year-old patient of an unspecified gender received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as unknown, a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the patient didn't really have a phone number right now, anyway the patient just wanted to ask, the patient got booster shot about five or six days ago. The first two shots, the patient didn't have any problem at all and right now, from the past two days, the patient got the shot on left arm and the patient did not know if this has any correlation but the patient's left leg, especially my foot, I have been experiencing some really bad neuropathy in it, just like 'nothing (voice breaking) in my foot'." (Shot name not clarified, hence suspect captured as Unspecified Shot and is this a Pfizer product tab left unchecked). When paraphrased the concern, the patient stated, "Yes, little bit of neuropathy in my left foot. The patient had a little bit of neuropathy from the past few days since I got it." Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in Mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Sep2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to melons. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Jul2021 at 17:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 03Sep2021 at 20:00, the patient experienced metallic taste in her mouth. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in mouth was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pyrexia, Vaccination site pruritus
Clinical narrative: Day 3 itchy injection site and showed rash after itching at injection site.; Day 3 itchy injection site and showed rash after itching at injection site.; Day 2-4 low grade fever; Headache; Joint pain; Achy; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the right arm on 03Sep2021 at 09:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included unspecified antibiotics for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Sep2021 at 07:00, day 2-4 the patient experienced low grade fever, headache, joint pain and achy. On 05Sep2021, day 3 patient experienced itchy injection site and showed rash after itching at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, headache, joint pain, achy, itchy injection site and showed rash after itching at injection site was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Day 3 itchy injection site and showed rash after itching at injection site.; Day 3 itchy injection site and showed rash after itching at injection site.; Day 2-4 low grade fever; Headache; Joint pain; Achy; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the right arm on 03Sep2021 at 09:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included unspecified antibiotics for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Sep2021 at 07:00, day 2-4 the patient experienced low grade fever, headache, joint pain and achy. On 05Sep2021, day 3 patient experienced itchy injection site and showed rash after itching at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, headache, joint pain, achy, itchy injection site and showed rash after itching at injection site was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Pyrexia, Tremor
Clinical narrative: Fever; Chills; Shakes; Vomiting; Abdominal cramping; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 04Sep2021 at 14:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), unspecified probiotics and zinc (MANUFACTURER UNKNOWN); all 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: FC3180) via an unspecified route of administration in the left arm on 07Aug2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 00:00, the patient experienced fever, chills, shakes, vomiting, abdominal cramping and diarrhea. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the events fever, chills, shakes, vomiting, abdominal cramping and diarrhea were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Chills; Shakes; Vomiting; Abdominal cramping; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 04Sep2021 at 14:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), unspecified probiotics and zinc (MANUFACTURER UNKNOWN); all 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: FC3180) via an unspecified route of administration in the left arm on 07Aug2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 00:00, the patient experienced fever, chills, shakes, vomiting, abdominal cramping and diarrhea. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the events fever, chills, shakes, vomiting, abdominal cramping and diarrhea were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Gait disturbance, Hangover
Clinical narrative: Weak and dizzy; Weak and dizzy; tired; couldn't lift left arm without pain; unsteady on my feet; felt like a hangover; trouble with perception driving home; This is a spontaneous report from a contactable consumer (patient) reported himself that a 76-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: el949), via an unknown route of administration in left arm on 11Feb2021 at 11:00 (at the age of 76-years-old) as dose 1, single for COVID-19 immunisation. Facility type vaccine was other. The patient's medical history included high blood pressure, GERD (Gastrooesophageal reflux disease) and high cholesterol; all were from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included carvedilol (CARVEDILOL), potassium (POTASSIUM), pantoprazole (PANTOPRAZOLE) and acetylsalicylic acid (ASPIRIN 81); all were taken for an unknown indication from an unknown date. No other vaccine in four weeks. On 11Feb2021 at 23:15, the patient experienced weak and dizzy, unsteady on my feet, tired, felt like a hangover, had some trouble with perception driving home. By the evening couldn't lift left arm without pain. These symptoms came in waves all day long. At times had to lie down, and at time felt better, then worse. Today feeling better about 80% ok. Still cannot lift arm but somewhat better. No COVID prior vaccination. No covid tested post vaccination. No treatment received. Still cannot lift arm but somewhat better. Question is should I take the second shot in three weeks considering the side effects. The outcome of the events was recovering.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Imperception, Pain in extremity
Clinical narrative: Weak and dizzy; Weak and dizzy; tired; couldn't lift left arm without pain; unsteady on my feet; felt like a hangover; trouble with perception driving home; This is a spontaneous report from a contactable consumer (patient) reported himself that a 76-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: el949), via an unknown route of administration in left arm on 11Feb2021 at 11:00 (at the age of 76-years-old) as dose 1, single for COVID-19 immunisation. Facility type vaccine was other. The patient's medical history included high blood pressure, GERD (Gastrooesophageal reflux disease) and high cholesterol; all were from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included carvedilol (CARVEDILOL), potassium (POTASSIUM), pantoprazole (PANTOPRAZOLE) and acetylsalicylic acid (ASPIRIN 81); all were taken for an unknown indication from an unknown date. No other vaccine in four weeks. On 11Feb2021 at 23:15, the patient experienced weak and dizzy, unsteady on my feet, tired, felt like a hangover, had some trouble with perception driving home. By the evening couldn't lift left arm without pain. These symptoms came in waves all day long. At times had to lie down, and at time felt better, then worse. Today feeling better about 80% ok. Still cannot lift arm but somewhat better. No COVID prior vaccination. No covid tested post vaccination. No treatment received. Still cannot lift arm but somewhat better. Question is should I take the second shot in three weeks considering the side effects. The outcome of the events was recovering.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Mass, Pain in extremity
Clinical narrative: immense arm pain/very large welt/red mass on my arm. It is very warm to the touch; immense arm pain/very large welt/red mass on my arm. It is very warm to the touch; immense arm pain/very large welt/red mass on my arm. It is very warm to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular at left arm on 19Feb2021 at 09:00 am (lot number: EN6201) (age at vaccination 36-year-old) as dose 2, single for COVID-19 immunisation. The patient had allergy to sulfa from an unknown date and unknown if ongoing. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular at left arm on 21Jan2021 at 09:00 am (lot number: EL3248) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history was not reported. The patient concomitant medication included levothyroxine. 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 experienced immense arm pain/very large welt/red mass on the arm and It is very warm to the touch on 14Feb2021 at 04:00 am. The patient stated 2nd dose was on 11Feb2021, on 14Feb2021 she woke up with immense arm pain and when looked at it, she had a very large welt/red mass on my arm. It was very warm to the touch. She knew arm pain was a side effect and with Moderna, redness can appear but she did not see that redness was an effect with Pfizer. The redness continues to grow in size. The patient had not received any treatment for the events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Mid-grade gout flare left ankle; This is a spontaneous report from a contactable other hcp (patient). A 51-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm left on 15Jan2021 10:00 (Batch/Lot Number: EL1289) as SINGLE for covid-19 immunization administered at hospital. The patient medical history included obesity, high blood pressure and high uric acid from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not have COVID-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. On 19Jan2021 08:00 (Three days after first dose), the patient experienced mid-grade gout flare left ankle which resulted patient in Doctor or other healthcare professional office/clinic visit. The patient treatment received was unknown. The patient had not tested positive for COVID-19 since the vaccination. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Painful arm; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Vaccine Reporting System . A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 13:45 (Batch/Lot Number: En6201) (at the age of 43 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no known allergies. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced painful arm on 13Feb2021 with outcome of unknown, with no treatment.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Decreased immune responsiveness, Diarrhoea, Headache
Clinical narrative: trouble in her stomach; been feeling "weak and had headaches".; been feeling "weak and had headaches".; immune system might be "weakened"; gastritis and reflux; vomited; diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. On 13Feb2021, the patient vomited and had diarrhea and felt a bit better 14Feb2021. On an unspecified date, the patient explained she had trouble in her stomach and specified being known for gastritis and reflux for which she took pills every day. The patient added she had been feeling weak and had headaches. The patient added she vomited and had diarrhea yesterday and felt a bit better today. The patient said maybe she ate something that bothered her. The patient then said her immune system might be weakened as a result of her recent symptoms. Therapeutic measures taken for events had trouble in her stomach and gastritis and reflux. The patient mentioned she has the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow and asked if it is ok to receive it. The outcome of the events diarrhea and vomited was recovering and other events were unknown.  Follow-up attempts are completed. No further information is expected..
Sex: F
Vaccine: COVID19
Symptoms: Reflux gastritis, Vomiting
Clinical narrative: trouble in her stomach; been feeling "weak and had headaches".; been feeling "weak and had headaches".; immune system might be "weakened"; gastritis and reflux; vomited; diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. On 13Feb2021, the patient vomited and had diarrhea and felt a bit better 14Feb2021. On an unspecified date, the patient explained she had trouble in her stomach and specified being known for gastritis and reflux for which she took pills every day. The patient added she had been feeling weak and had headaches. The patient added she vomited and had diarrhea yesterday and felt a bit better today. The patient said maybe she ate something that bothered her. The patient then said her immune system might be weakened as a result of her recent symptoms. Therapeutic measures taken for events had trouble in her stomach and gastritis and reflux. The patient mentioned she has the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow and asked if it is ok to receive it. The outcome of the events diarrhea and vomited was recovering and other events were unknown.  Follow-up attempts are completed. No further information is expected..
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Vomiting
Clinical narrative: Extreme vomiting.; Diarrhea; Headache; Body Ache; This is a spontaneous report from a contactable consumer.   A 35-years-old female patient non pregnant received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Leg Right on 09Feb2021 13:00 (At the age of 35 years) as dose 2, single for covid-19 immunisation. The patient previously took the BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Left leg on 19Jan2021 13:00, as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was known to the allergies Penicillin, codine and iodine and experienced drug hypersensitivity. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for contraception, start and stop date were not reported. The patient received other medications within 2 weeks of vaccination Generic yaz birth control. On 13Feb2021 04:00Am, the patient had experienced Extreme vomiting, Diarrhea, headache and body aches. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: Headache; injection site pain; nausea; fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for herself (patient). A 52-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch no: not reported/Lot Number: EL9261; expiration date: unknown) via unspecified route of administration administered in left arm on 13Feb2021 03:45 PM (at the age of 52-year-old) as Dose 1, Single for covid-19 immunization. The patient medical history was reported as none, and patient received no other concomitant medications in two weeks. Patient had no known allergies. The patient did not take other vaccinations within 4 weeks and other medications within 2 weeks, prior to vaccination. Patient wasn't tested for COVID-19 prior to vaccination and not tested post vaccination. On 13Feb2021 at 09:00 PM, the patient experienced headache, injection site pain, nausea and fatigue. No treatment was received in response to events. The outcome of all the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: feeling dizzy; Tired; Headache; This is a spontaneous case from a contactable consumer (patient, self-reported). A 46-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Feb2021 at 12:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroidism and known allergies: onions. Concomitant medications included levothyroxine sodium and vitamin b complex (B-COMPLEX). The patient did not receive any other vaccine in four weeks. The patient was diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient reported that she felt great yesterday. On 14Feb2021 at 4:15, she awoke feeling dizzy today, tried to sleep and had crazy dreams. When she tried to make the bed, she had a whoosh of dizziness and fell on the bed. Bent over to tie her shes, stood up and started to walk like she just got off the gravitron at the fair and would have hit the floor if the wall wasn't in her way. Tried again with the same result. Gave up and went back to bed after 3 advil. Slept for 5 hours. She still had a bear of a headache and just took 3 more advil and a warm shower. She could walk now, but stull felt like she should report. The patient did not receive treatment for feeling dizzy. The patient underwent lab tests and procedures included COVID (nasal swab) with negative result on 05Feb2021. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little hurt in the arm; This is a spontaneous report from a contactable consumer via medical information team.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date as a dose 2, single and dose 1, single for COVID-19 immunization. The patient had medical history of dialysis and concomitant medication were not reported. On an unspecified date the patient mentioned that she received the 2nd dose on Saturday at 9am. Patient reported that she had no symptoms other than the "normal ones" like a little hurt in the arm. Patient had experienced this with the 1st dose as well. Patient had gone for dialysis on Monday at 7am and queried if this will affect the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Very swollen and tender lymph nodes under left arm pit; Very swollen and tender lymph nodes under left arm pit; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 at 14:30 (at the age of 42-year-old) as a single dose for Covid-19 immunisation. Medical history included crohn's disease from an unspecified date. The patient's concomitant medications were not reported. The patient previously took doxycycline, sulfamethoxazole trimethoprim (BACTRIUM DS), levofloxacin (LEVAQUIN) and experienced allergies. The patient did not receive any other vaccines in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient experienced very swollen and tender lymph nodes under left arm pit on 14Feb2021 at 08:00 am. No treatment received for events. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Headache; Sore Throat; Arm Pain; Fatigue; Body Aches; This is a spontaneous report received from a non-contactable consumer (Patient). A 25-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided) via an unspecified route of administration at left arm on 13Feb2021 02:45 (at the age of 25-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided) via an unspecified route of administration at left arm on 23Jan2021 02:45 (at the age of 25-year-old) as dose 1, single for COVID-19 immunisation. Patient did not receive any other vaccines within four weeks time and patient did not take any other medications in two weeks. Patient was not had COVID prior to vaccination and patient did not tested COVID positive post vaccination. Patient was not pregnant at the time vaccination. The patient experienced headache, sore throat, arm pain, fatigue and body aches on 13Feb2021 at 20:00. Patient was not received treatment. Outcome of events was recovering.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for a day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 11:15 (Batch/Lot Number: EL3247) (at the age of 43 years) as dose 2, single for covid-19 immunisation. The patient medical history was none and concomitant medications were not reported.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 21Jan2021 (Batch/Lot Number: EL3247) (at the age of 43 years) for covid-19 immunisation. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. There were no known allergies. The patient experienced sore arm for a day on 11Feb2021 with outcome of recovered with no treatment.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular at left arm on 13Feb2021 at 10:30 am (lot number: EN9809) (age at vaccination 52-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included COVID-19 with lost of smell and taste on 18Dec2020. The patient laboratory investigations included COVID test was positive on 18Dec2020 and 31Dec2020. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. The patient medical history and concomitant medications were none. Since the vaccination, has the patient not been tested for COVID-19. The patient experienced soreness at injection site on 13Feb2021. The patient had not received any treatment for the events. The outcome of the events was recovered. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular at left arm on 06Mar2021 at 5:00 pm (lot number: EN6206) as dose 2, single for COVID-19 immunisation.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Body pains; Fatigue; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization and was administered in hospital. The patient medical history included covid from an unknown date and unknown if ongoing. The patient allergies was unknown. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on unspecified date at single dose for covid-19 immunization and was administered in hospital. On an unspecified date, the patient developed body pains and fatigue after second Pfizer vaccine shot. AE resulted in doctor or other healthcare professional office/clinic visit and was not hospitalized. The patient treatment received was unknown. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.