chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Tinnitus
Clinical narrative: Right ear started popping; patient started to feel fullness in her right ear; right ear started high pitched ringing ( tinnitus); She then lost hearing in her right ear; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 15Mar2021 15:00 (lot number: EN6207) at the age of 59 years old, as single dose for COVID-19 immunization. Medical history reported as none. The patient was not pregnant at the time of vaccination. Concomitant medications included hydrochlorothiazide, metoprolol tartrate (METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE); losartan; levothyroxine sodium (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. 2 days after 1st dose (17Mar2021 04:00), the patient started to feel fullness in her right ear. She thought at first perhaps it was water, but feeling continued. Right ear started popping a few days later. She called her primary care physician and made appointment to come in. Primary care could see nothing wrong, no inflammation in ear or fluid. That following weekend (Mar2021) after primary care visit, her right ear started high pitched ringing (tinnitus). She then lost hearing in her right ear. She went to urgent care who also saw nothing but referred her to ENT doctor. 2 days later at ENT audiologist reported significant hearing loss in her right ear. She is currently prescribed prednisone with no change. She never had a reaction to any shot ever previously. She also have never had any hearing issues or tinnitus ever in her life. The only time she had anything is from the Pfizer shot. She has been advised by her doctor to hold off on second dose. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. The patient was not diagnosed with COVID prior and after vaccination. The patient has no known allergies. No other vaccines received four weeks prior to COVID vaccine. The patient has not recovered from the events.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Ear discomfort, Tinnitus
Clinical narrative: Right ear started popping; patient started to feel fullness in her right ear; right ear started high pitched ringing ( tinnitus); She then lost hearing in her right ear; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 15Mar2021 15:00 (lot number: EN6207) at the age of 59 years old, as single dose for COVID-19 immunization. Medical history reported as none. The patient was not pregnant at the time of vaccination. Concomitant medications included hydrochlorothiazide, metoprolol tartrate (METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE); losartan; levothyroxine sodium (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. 2 days after 1st dose (17Mar2021 04:00), the patient started to feel fullness in her right ear. She thought at first perhaps it was water, but feeling continued. Right ear started popping a few days later. She called her primary care physician and made appointment to come in. Primary care could see nothing wrong, no inflammation in ear or fluid. That following weekend (Mar2021) after primary care visit, her right ear started high pitched ringing (tinnitus). She then lost hearing in her right ear. She went to urgent care who also saw nothing but referred her to ENT doctor. 2 days later at ENT audiologist reported significant hearing loss in her right ear. She is currently prescribed prednisone with no change. She never had a reaction to any shot ever previously. She also have never had any hearing issues or tinnitus ever in her life. The only time she had anything is from the Pfizer shot. She has been advised by her doctor to hold off on second dose. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. The patient was not diagnosed with COVID prior and after vaccination. The patient has no known allergies. No other vaccines received four weeks prior to COVID vaccine. The patient has not recovered from the events.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular
Clinical narrative: low grade fever; severe throat pain; red purplish dots on skin; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9267 or FL9667) intramuscularly on 16Feb2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, diabetes, acid reflux, and spasmatic esophagus, all ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril-hydrochlorothiazide from an unknown date for high blood pressure, rosuvastatin (CRESTOR) from an unknown date for cholesterol, metformin from an unknown date for "prediabetics," and amoxicillin (AMOXYCILLIN) from 22Jan2021 to 05Feb2021 for ear infection. On 17Feb2021, the patient experienced red purplish dots on skin. On 18Feb2021, the patient experienced severe throat pain and low-grade fever. The events were reported as non-serious. The patient underwent lab tests and procedures which included a COVID-19 test on 10Mar2021 with a result of negative. The patient received treatment for fever with paracetamol (TYLENOL). The outcomes of red purplish dots on skin, severe throat pain, and fever were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, Skin disorder
Clinical narrative: low grade fever; severe throat pain; red purplish dots on skin; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9267 or FL9667) intramuscularly on 16Feb2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, diabetes, acid reflux, and spasmatic esophagus, all ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril-hydrochlorothiazide from an unknown date for high blood pressure, rosuvastatin (CRESTOR) from an unknown date for cholesterol, metformin from an unknown date for "prediabetics," and amoxicillin (AMOXYCILLIN) from 22Jan2021 to 05Feb2021 for ear infection. On 17Feb2021, the patient experienced red purplish dots on skin. On 18Feb2021, the patient experienced severe throat pain and low-grade fever. The events were reported as non-serious. The patient underwent lab tests and procedures which included a COVID-19 test on 10Mar2021 with a result of negative. The patient received treatment for fever with paracetamol (TYLENOL). The outcomes of red purplish dots on skin, severe throat pain, and fever were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Body height, Burning sensation, Erythema, Macule
Clinical narrative: low grade fever; severe throat pain; red purplish dots on skin; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9267 or FL9667) intramuscularly on 16Feb2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, diabetes, acid reflux, and spasmatic esophagus, all ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril-hydrochlorothiazide from an unknown date for high blood pressure, rosuvastatin (CRESTOR) from an unknown date for cholesterol, metformin from an unknown date for "prediabetics," and amoxicillin (AMOXYCILLIN) from 22Jan2021 to 05Feb2021 for ear infection. On 17Feb2021, the patient experienced red purplish dots on skin. On 18Feb2021, the patient experienced severe throat pain and low-grade fever. The events were reported as non-serious. The patient underwent lab tests and procedures which included a COVID-19 test on 10Mar2021 with a result of negative. The patient received treatment for fever with paracetamol (TYLENOL). The outcomes of red purplish dots on skin, severe throat pain, and fever were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pruritus, Vaccination site pain, Weight
Clinical narrative: low grade fever; severe throat pain; red purplish dots on skin; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9267 or FL9667) intramuscularly on 16Feb2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, diabetes, acid reflux, and spasmatic esophagus, all ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril-hydrochlorothiazide from an unknown date for high blood pressure, rosuvastatin (CRESTOR) from an unknown date for cholesterol, metformin from an unknown date for "prediabetics," and amoxicillin (AMOXYCILLIN) from 22Jan2021 to 05Feb2021 for ear infection. On 17Feb2021, the patient experienced red purplish dots on skin. On 18Feb2021, the patient experienced severe throat pain and low-grade fever. The events were reported as non-serious. The patient underwent lab tests and procedures which included a COVID-19 test on 10Mar2021 with a result of negative. The patient received treatment for fever with paracetamol (TYLENOL). The outcomes of red purplish dots on skin, severe throat pain, and fever were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: profound hearing loss; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced profound hearing loss. The patient stated that he was deaf in his left ear. The patient was not taking prednisone and he was not sure what else the doctor can do as far as an MRI. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Intestinal resection, Small intestinal obstruction, Vomiting
Clinical narrative: Small intestinal obstruction; vomiting; Indigestion; extreme stomach pain; don't feel well enough; This is a spontaneous case is received from a contactable consumer reported for herself from a Pfizer Sponsored Program. A 51-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP6955 and Expiry date: 30Jun2021) via an unspecified route of administration on 18Mar2021 as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. The patient did not have any adverse events prior to vaccination. Patient received the first dose of the Pfizer vaccine and had some adverse events front the first dose. She doesn't feel well enough to receive the second shot of the vaccine. On 18Mar2021 night patient experienced vomiting, indigestion, extreme stomach pain with the outcome unknown. Patient would like to reschedule her second dose if possible because she was hospitalized. On 20Mar2021 she went to the emergency room was diagnosed with small bowel obstructions and had surgery. She spent 10 days in the hospital and is currently recovering after the surgery of small bowel resection at the point of obstruction. She was released from the hospital on 1Apr2021. The patient underwent lab tests and procedures which included blood test: nil, x-ray: nil. Therapeutic measures were taken as a result of small intestinal obstruction (small intestinal obstruction).  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test, Dyspepsia, Malaise, Small intestinal obstruction
Clinical narrative: Small intestinal obstruction; vomiting; Indigestion; extreme stomach pain; don't feel well enough; This is a spontaneous case is received from a contactable consumer reported for herself from a Pfizer Sponsored Program. A 51-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP6955 and Expiry date: 30Jun2021) via an unspecified route of administration on 18Mar2021 as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. The patient did not have any adverse events prior to vaccination. Patient received the first dose of the Pfizer vaccine and had some adverse events front the first dose. She doesn't feel well enough to receive the second shot of the vaccine. On 18Mar2021 night patient experienced vomiting, indigestion, extreme stomach pain with the outcome unknown. Patient would like to reschedule her second dose if possible because she was hospitalized. On 20Mar2021 she went to the emergency room was diagnosed with small bowel obstructions and had surgery. She spent 10 days in the hospital and is currently recovering after the surgery of small bowel resection at the point of obstruction. She was released from the hospital on 1Apr2021. The patient underwent lab tests and procedures which included blood test: nil, x-ray: nil. Therapeutic measures were taken as a result of small intestinal obstruction (small intestinal obstruction).  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: Small intestinal obstruction; vomiting; Indigestion; extreme stomach pain; don't feel well enough; This is a spontaneous case is received from a contactable consumer reported for herself from a Pfizer Sponsored Program. A 51-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP6955 and Expiry date: 30Jun2021) via an unspecified route of administration on 18Mar2021 as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. The patient did not have any adverse events prior to vaccination. Patient received the first dose of the Pfizer vaccine and had some adverse events front the first dose. She doesn't feel well enough to receive the second shot of the vaccine. On 18Mar2021 night patient experienced vomiting, indigestion, extreme stomach pain with the outcome unknown. Patient would like to reschedule her second dose if possible because she was hospitalized. On 20Mar2021 she went to the emergency room was diagnosed with small bowel obstructions and had surgery. She spent 10 days in the hospital and is currently recovering after the surgery of small bowel resection at the point of obstruction. She was released from the hospital on 1Apr2021. The patient underwent lab tests and procedures which included blood test: nil, x-ray: nil. Therapeutic measures were taken as a result of small intestinal obstruction (small intestinal obstruction).  Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: debilitating headache; Pressure in both ears; Tinnitus, a constant ringing in his ears; the pressure was so painful in one of his ears/felt like it was physically painful; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732 and expiration date not provided), via an unspecified route of administration, in arm left, on 01Apr2021 14:00 (at the age of 42-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. Medical history and concomitant medications were reported as "no". No relevant family medical history. The patient experienced pressure in both ears on 01Apr2021; tinnitus, a constant ringing in his ears on 01Apr2021; the pressure was so painful in one of his ears/felt like it was physically painful on 01Apr2021; and debilitating headache on 06Apr2021. The patient had the vaccine on 01Apr2021 (reported as "last Thursday"), and the same night, he developed pressure in his ears and tinnitus, basically a constant ringing in his ears. The pressure was so painful in one of his ears that it felt like it was physically painful. He compared it to a child having their first ear ache- it was maybe something like that combined with a really bad headache. He clarified he had a debilitating headache, and it was probably so bad that he considered for a moment going to go to the hospital but he did not, instead he took three ibuprofen (ADVIL) and that helped. Patient had not been to the doctor yet in regards to his symptoms, and stated he had a scheduled appointment Friday with an ENT doctor. Patient didn't have pressure in ears before the vaccine. He had constant ringing in his ears that doesn't subside. There's a link between his symptoms and the vaccine. He was in completely normal shape before he decided to get the vaccine. Patient's weight was 225-230 lbs (unknown date). The outcome of the events "pressure in both ears", "tinnitus, a constant ringing in his ears" was not recovered, of other events was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Headache, Tinnitus, Weight
Clinical narrative: debilitating headache; Pressure in both ears; Tinnitus, a constant ringing in his ears; the pressure was so painful in one of his ears/felt like it was physically painful; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732 and expiration date not provided), via an unspecified route of administration, in arm left, on 01Apr2021 14:00 (at the age of 42-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. Medical history and concomitant medications were reported as "no". No relevant family medical history. The patient experienced pressure in both ears on 01Apr2021; tinnitus, a constant ringing in his ears on 01Apr2021; the pressure was so painful in one of his ears/felt like it was physically painful on 01Apr2021; and debilitating headache on 06Apr2021. The patient had the vaccine on 01Apr2021 (reported as "last Thursday"), and the same night, he developed pressure in his ears and tinnitus, basically a constant ringing in his ears. The pressure was so painful in one of his ears that it felt like it was physically painful. He compared it to a child having their first ear ache- it was maybe something like that combined with a really bad headache. He clarified he had a debilitating headache, and it was probably so bad that he considered for a moment going to go to the hospital but he did not, instead he took three ibuprofen (ADVIL) and that helped. Patient had not been to the doctor yet in regards to his symptoms, and stated he had a scheduled appointment Friday with an ENT doctor. Patient didn't have pressure in ears before the vaccine. He had constant ringing in his ears that doesn't subside. There's a link between his symptoms and the vaccine. He was in completely normal shape before he decided to get the vaccine. Patient's weight was 225-230 lbs (unknown date). The outcome of the events "pressure in both ears", "tinnitus, a constant ringing in his ears" was not recovered, of other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicitis, Blood test, Chills, Computerised tomogram
Clinical narrative: appendicitis; sweating; 1/2 later developed chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 22Mar2021 14:30 (Lot Number: er8727; expiration date: 31Jul21) as a single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERDs), migraine and unspecified allergies. The patient was not diagnosed with Covid prior vaccination. Concomitant medications included unspecified medication. The patient did not receive other vaccine in four weeks. On 24Mar2021 (36 hours after the shot), the patient developed stomach pains, sweating and nausea, 1/2 later (unspecified) developed chills. The pain and nausea continued for 4 days admitted to hospital (unspecified date) and being treated for appendicitis. The patient was hospitalized for 4 days. The treatment included antibiotics with surgery pending. The patient has not been Covid tested post vaccination. The patient inquired if she should get the second dose. The patient mentioned that her physician stated that you can't get the vaccine for 90 days after having the Covid virus. She inquired about the efficacy after having 1 dose of the vaccine. She further reported that she received her first Covid vaccine dose on 22Mar2021 and on 24Mar2021 she began having stomach pains and later diagnosed with appendicitis. She added that she has been trying to do her own investigation on if she should receive the second dose as her HCP's have been unable to provide guidance. She mentioned that she has been trying to determine if it will be safe to get the second dose given that she experienced appendicitis after the first dose. The events resulted in emergency room visit. The outcome of the event was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: appendicitis; sweating; 1/2 later developed chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 22Mar2021 14:30 (Lot Number: er8727; expiration date: 31Jul21) as a single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERDs), migraine and unspecified allergies. The patient was not diagnosed with Covid prior vaccination. Concomitant medications included unspecified medication. The patient did not receive other vaccine in four weeks. On 24Mar2021 (36 hours after the shot), the patient developed stomach pains, sweating and nausea, 1/2 later (unspecified) developed chills. The pain and nausea continued for 4 days admitted to hospital (unspecified date) and being treated for appendicitis. The patient was hospitalized for 4 days. The treatment included antibiotics with surgery pending. The patient has not been Covid tested post vaccination. The patient inquired if she should get the second dose. The patient mentioned that her physician stated that you can't get the vaccine for 90 days after having the Covid virus. She inquired about the efficacy after having 1 dose of the vaccine. She further reported that she received her first Covid vaccine dose on 22Mar2021 and on 24Mar2021 she began having stomach pains and later diagnosed with appendicitis. She added that she has been trying to do her own investigation on if she should receive the second dose as her HCP's have been unable to provide guidance. She mentioned that she has been trying to determine if it will be safe to get the second dose given that she experienced appendicitis after the first dose. The events resulted in emergency room visit. The outcome of the event was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Chills, Hyperhidrosis
Clinical narrative: appendicitis; sweating; 1/2 later developed chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 22Mar2021 14:30 (Lot Number: er8727; expiration date: 31Jul21) as a single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERDs), migraine and unspecified allergies. The patient was not diagnosed with Covid prior vaccination. Concomitant medications included unspecified medication. The patient did not receive other vaccine in four weeks. On 24Mar2021 (36 hours after the shot), the patient developed stomach pains, sweating and nausea, 1/2 later (unspecified) developed chills. The pain and nausea continued for 4 days admitted to hospital (unspecified date) and being treated for appendicitis. The patient was hospitalized for 4 days. The treatment included antibiotics with surgery pending. The patient has not been Covid tested post vaccination. The patient inquired if she should get the second dose. The patient mentioned that her physician stated that you can't get the vaccine for 90 days after having the Covid virus. She inquired about the efficacy after having 1 dose of the vaccine. She further reported that she received her first Covid vaccine dose on 22Mar2021 and on 24Mar2021 she began having stomach pains and later diagnosed with appendicitis. She added that she has been trying to do her own investigation on if she should receive the second dose as her HCP's have been unable to provide guidance. She mentioned that she has been trying to determine if it will be safe to get the second dose given that she experienced appendicitis after the first dose. The events resulted in emergency room visit. The outcome of the event was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: menstrual cycle for 5 weeks and heavy bleeding; menstrual cycle for 5 weeks; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 13:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Facility type vaccine: Health Clinic. The patient's medical history included early menopause. The patient was not pregnant at the time of vaccination, was not pregnant at the time of reporting. Concomitant medications (other medications in two weeks) included progesterone and estradiol (ESTROGEN); both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took penicillin and experienced drug allergy (Known allergies: penicillin). The patient reported that since 2nd vaccine she has had a menstrual cycle for 5 weeks and heavy bleeding. The onset of the events was reported as 27Feb2021 13:00. The events resulted in: Doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The outcome of the events was not recovered. The patient had no COVID prior vaccination, and she had not tested post vaccination.  Information about Lot/Batch number is requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: menstrual cycle for 5 weeks and heavy bleeding; menstrual cycle for 5 weeks; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 13:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Facility type vaccine: Health Clinic. The patient's medical history included early menopause. The patient was not pregnant at the time of vaccination, was not pregnant at the time of reporting. Concomitant medications (other medications in two weeks) included progesterone and estradiol (ESTROGEN); both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took penicillin and experienced drug allergy (Known allergies: penicillin). The patient reported that since 2nd vaccine she has had a menstrual cycle for 5 weeks and heavy bleeding. The onset of the events was reported as 27Feb2021 13:00. The events resulted in: Doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The outcome of the events was not recovered. The patient had no COVID prior vaccination, and she had not tested post vaccination.  Information about Lot/Batch number is requested.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Blood test normal, Chest pain, Computerised tomogram normal, Ear, nose and throat examination normal
Clinical narrative: I HAVE CAPILLARY LEAKAGE.; I HAVE GIANT HIVES; This is a spontaneous report from consumer, the patient. A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 16-JAN-2021 06:15 PM and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 13-FEB-2021 12:15 PM at single dose for COVID-19 immunization. The patient medical history included allergies to Erythromycin Erythrocyn possibly Augmentin which was administered for spitting blood and he reported that he was spitting blood and had giant wild hives all over his body. 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 Concomitant medications were not reported. Historical vaccines included patient received. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 18Jan2021 12:00, the patient experienced capillary leakage and had giant hives. Therapeutic measures were taken, and treatment included CT scans sinus and chest 2 ent blood test. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoptysis, Pain, Rash, Sputum culture, Urine analysis
Clinical narrative: I HAVE CAPILLARY LEAKAGE.; I HAVE GIANT HIVES; This is a spontaneous report from consumer, the patient. A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 16-JAN-2021 06:15 PM and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 13-FEB-2021 12:15 PM at single dose for COVID-19 immunization. The patient medical history included allergies to Erythromycin Erythrocyn possibly Augmentin which was administered for spitting blood and he reported that he was spitting blood and had giant wild hives all over his body. 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 Concomitant medications were not reported. Historical vaccines included patient received. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 18Jan2021 12:00, the patient experienced capillary leakage and had giant hives. Therapeutic measures were taken, and treatment included CT scans sinus and chest 2 ent blood test. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Capillary disorder, Urticaria
Clinical narrative: I HAVE CAPILLARY LEAKAGE.; I HAVE GIANT HIVES; This is a spontaneous report from consumer, the patient. A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 16-JAN-2021 06:15 PM and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 13-FEB-2021 12:15 PM at single dose for COVID-19 immunization. The patient medical history included allergies to Erythromycin Erythrocyn possibly Augmentin which was administered for spitting blood and he reported that he was spitting blood and had giant wild hives all over his body. 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 Concomitant medications were not reported. Historical vaccines included patient received. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 18Jan2021 12:00, the patient experienced capillary leakage and had giant hives. Therapeutic measures were taken, and treatment included CT scans sinus and chest 2 ent blood test. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Malaise
Clinical narrative: Exposed to his son who tested positive for Covid; This is a spontaneous report from Pfizer sponsored. A contactable consumer (patient) reported for herself that female of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: UNKNOWN) received on 03Mar 2021. Reporter stated that she received her 1st dose on 03Mar2021 and received her 2nd dose on 06Apr2021 which was beyond 21 days. Patient was also exposed to his son who tested positive for Covid. Event Exposure to SARS-CoV-2 was considered non-serious as reported. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to his son who tested positive for Covid; This is a spontaneous report from Pfizer sponsored. A contactable consumer (patient) reported for herself that female of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: UNKNOWN) received on 03Mar 2021. Reporter stated that she received her 1st dose on 03Mar2021 and received her 2nd dose on 06Apr2021 which was beyond 21 days. Patient was also exposed to his son who tested positive for Covid. Event Exposure to SARS-CoV-2 was considered non-serious as reported. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Urticaria
Clinical narrative: felt a little tingly; Sat down for 15 mins and could not stand up because I was too dizzy; was breaking out in hives on my face and chest; my throat started closing; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8734) at single dose on 06Apr2021 12:00 in left arm for COVID-19 immunisation. Medical history included fibromyalgia; asthma (controlled). Patient had known allergies to CT contrast and codeine (when taken with albuterol). Concomitant medications in two weeks included pregabalin (LYRICA), baclofen, nortriptyline, vitamin D3. There was no other vaccine in four weeks. Patient got the shot and felt a little tingly and sat down for 15 mins and could not stand up because she was too dizzy. Her daughter (also there receiving the shot) grabbed paramedics to check if this was common. The paramedics helped walk her to their triage room set up maybe 50 yards away. By the time they got there, patient was breaking out in hives on her face and chest. The paramedics started setting up an IV and that was when her throat started closing. Patient was given a shot of EPI while they finished the IV and gave her a bunch of other things in the IV. Patient got another shot of EPI in the ambulance on the way to the hospital and was put on an EPI drip while admitted. Patient stayed in the hospital while they tried several times to take her off EPI, but was not successful until the end of the third day (Thursday night) when she was sent home. Patient returned to hospital Monday and currently still under medical care at home. All adverse events start date was 06Apr2021 12:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The seriousness criteria was hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized 3 days for the events, treatment included medication intervention. There was no covid prior vaccination, covid was tested post vaccination. Novel corona virus test via nasal swab on 13Jun2020 and 22Jun2020 were both negative; COVID-19 RT PCR via nasal swab on 21Jan2021 was negative. The outcome of events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia, SARS-CoV-2 test, Throat tightness, Urticaria
Clinical narrative: felt a little tingly; Sat down for 15 mins and could not stand up because I was too dizzy; was breaking out in hives on my face and chest; my throat started closing; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8734) at single dose on 06Apr2021 12:00 in left arm for COVID-19 immunisation. Medical history included fibromyalgia; asthma (controlled). Patient had known allergies to CT contrast and codeine (when taken with albuterol). Concomitant medications in two weeks included pregabalin (LYRICA), baclofen, nortriptyline, vitamin D3. There was no other vaccine in four weeks. Patient got the shot and felt a little tingly and sat down for 15 mins and could not stand up because she was too dizzy. Her daughter (also there receiving the shot) grabbed paramedics to check if this was common. The paramedics helped walk her to their triage room set up maybe 50 yards away. By the time they got there, patient was breaking out in hives on her face and chest. The paramedics started setting up an IV and that was when her throat started closing. Patient was given a shot of EPI while they finished the IV and gave her a bunch of other things in the IV. Patient got another shot of EPI in the ambulance on the way to the hospital and was put on an EPI drip while admitted. Patient stayed in the hospital while they tried several times to take her off EPI, but was not successful until the end of the third day (Thursday night) when she was sent home. Patient returned to hospital Monday and currently still under medical care at home. All adverse events start date was 06Apr2021 12:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The seriousness criteria was hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized 3 days for the events, treatment included medication intervention. There was no covid prior vaccination, covid was tested post vaccination. Novel corona virus test via nasal swab on 13Jun2020 and 22Jun2020 were both negative; COVID-19 RT PCR via nasal swab on 21Jan2021 was negative. The outcome of events was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chest pain, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: developed a strong headache; fatigued; fever; a lot of arm pain; dizziness; irritable bowels; loss of appetite; odd ribcage/breast pain on the side of the injection (left side). It feels like deep shooting pains.; This is a spontaneous report received from a contactable consumer reported for herself. A currently 55 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date in left arm at single dose for COVID-19 immunization. Medical history included allergies to tree nuts, nonsteroidal antiinflammatory drugs (NSAIDS) and asthma. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included: cetirizine hydrochloride (ZYRTEC), ascorbic acid (VITAMINS C), (VITAMINS D), (VITAMINS E), probiotic 10, paracetamol (TYLENOL). It was reported about 90 mins after vaccine first dose, patient developed a strong headache (not common for her). She then felt very fatigued and came down with w/a fever that night. The next day (yesterday), the headache was improved still presented but she felt a lot of fatigue and a lot of arm pain (unusual with flu shots, for her). She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. Today (day 2 after vaccine), she was feeling fatigued w/mild headache. Her appetite was very much diminished w/still irritable bowels (loose stools). The reason she was writing was today she also started experiencing an odd ribcage/breast pain on the side of the injection (left side). It feels like deep shooting pains. There was no pain or redness or swelling. Have had no breast issues to date (last mammography was clear-Fall 2018). Have anaphylaxis reactions to NSAIDS and nuts but never to vaccines. Normally, she was very active running, biking & walking daily many miles. Hoping to feel good soon. Treatment was not received for the adverse event. Since the vaccination, the patient has been tested for COVID-19:  Covid Test given after Vaccine. Outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Irritable bowel syndrome, Myalgia, Pyrexia, Tenderness
Clinical narrative: developed a strong headache; fatigued; fever; a lot of arm pain; dizziness; irritable bowels; loss of appetite; odd ribcage/breast pain on the side of the injection (left side). It feels like deep shooting pains.; This is a spontaneous report received from a contactable consumer reported for herself. A currently 55 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date in left arm at single dose for COVID-19 immunization. Medical history included allergies to tree nuts, nonsteroidal antiinflammatory drugs (NSAIDS) and asthma. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included: cetirizine hydrochloride (ZYRTEC), ascorbic acid (VITAMINS C), (VITAMINS D), (VITAMINS E), probiotic 10, paracetamol (TYLENOL). It was reported about 90 mins after vaccine first dose, patient developed a strong headache (not common for her). She then felt very fatigued and came down with w/a fever that night. The next day (yesterday), the headache was improved still presented but she felt a lot of fatigue and a lot of arm pain (unusual with flu shots, for her). She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. Today (day 2 after vaccine), she was feeling fatigued w/mild headache. Her appetite was very much diminished w/still irritable bowels (loose stools). The reason she was writing was today she also started experiencing an odd ribcage/breast pain on the side of the injection (left side). It feels like deep shooting pains. There was no pain or redness or swelling. Have had no breast issues to date (last mammography was clear-Fall 2018). Have anaphylaxis reactions to NSAIDS and nuts but never to vaccines. Normally, she was very active running, biking & walking daily many miles. Hoping to feel good soon. Treatment was not received for the adverse event. Since the vaccination, the patient has been tested for COVID-19:  Covid Test given after Vaccine. Outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.