chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Induration, Injection site pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: left deltoid was sore; left armpit was sore; It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest; left armpit is noticeably more swollen than right armpit; swollen, hard, lymph node which is not fixed when I palpate it; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 22Dec2020 at 12:00 at the age of 30 years at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks and she did not receive other medications in two weeks. Relevant medical history included allergy to sulfa based medication. Concomitant medications were none. On 29Dec2020 at 17:00, the patient experienced left deltoid was sore, left armpit was sore, soreness was radiating down her left side and into her left chest, left armpit was noticeably more swollen than right armpit and swollen, hard, lymph node which was not fixed when she palpated it. The patient reported that for 2 days after the vaccination her left deltoid was sore which went away. Then, approximately 7-8 days after the vaccination, she noticed her left armpit was sore. This has persisted and the patient could feel a swollen, hard, lymph node which was not fixed when she palpated it. Her left armpit was noticeably more swollen than her right armpit (which wass normal appearing). It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient did not receive corrective treatments for the reported events. At the time of the report, she had not recovered from the events.  The information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Tenderness
Clinical narrative: left deltoid was sore; left armpit was sore; It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest; left armpit is noticeably more swollen than right armpit; swollen, hard, lymph node which is not fixed when I palpate it; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 22Dec2020 at 12:00 at the age of 30 years at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks and she did not receive other medications in two weeks. Relevant medical history included allergy to sulfa based medication. Concomitant medications were none. On 29Dec2020 at 17:00, the patient experienced left deltoid was sore, left armpit was sore, soreness was radiating down her left side and into her left chest, left armpit was noticeably more swollen than right armpit and swollen, hard, lymph node which was not fixed when she palpated it. The patient reported that for 2 days after the vaccination her left deltoid was sore which went away. Then, approximately 7-8 days after the vaccination, she noticed her left armpit was sore. This has persisted and the patient could feel a swollen, hard, lymph node which was not fixed when she palpated it. Her left armpit was noticeably more swollen than her right armpit (which wass normal appearing). It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient did not receive corrective treatments for the reported events. At the time of the report, she had not recovered from the events.  The information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Vaccination site pain
Clinical narrative: left deltoid was sore; left armpit was sore; It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest; left armpit is noticeably more swollen than right armpit; swollen, hard, lymph node which is not fixed when I palpate it; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 22Dec2020 at 12:00 at the age of 30 years at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks and she did not receive other medications in two weeks. Relevant medical history included allergy to sulfa based medication. Concomitant medications were none. On 29Dec2020 at 17:00, the patient experienced left deltoid was sore, left armpit was sore, soreness was radiating down her left side and into her left chest, left armpit was noticeably more swollen than right armpit and swollen, hard, lymph node which was not fixed when she palpated it. The patient reported that for 2 days after the vaccination her left deltoid was sore which went away. Then, approximately 7-8 days after the vaccination, she noticed her left armpit was sore. This has persisted and the patient could feel a swollen, hard, lymph node which was not fixed when she palpated it. Her left armpit was noticeably more swollen than her right armpit (which wass normal appearing). It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient did not receive corrective treatments for the reported events. At the time of the report, she had not recovered from the events.  The information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Immediate post-injection reaction, Myalgia, Paraesthesia
Clinical narrative: flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contactable consumer (patient).  A 47-year-old female patient first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EKS730, intramuscular Left arm from 18Dec2020 16:00 to 18Dec2020 16:00 as single dose for COVID-19 immunisation.  Medical history included osteoarthritis.  Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL). On 18Dec2020 16:30, immediately after injection, the patient experienced small amount of tingling to left hand, face warm, and flushed, which resolved within 30 minutes without intervention. The outcome of the events was recovered. No treatment was received for the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Paraesthesia
Clinical narrative: flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contactable consumer (patient).  A 47-year-old female patient first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EKS730, intramuscular Left arm from 18Dec2020 16:00 to 18Dec2020 16:00 as single dose for COVID-19 immunisation.  Medical history included osteoarthritis.  Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL). On 18Dec2020 16:30, immediately after injection, the patient experienced small amount of tingling to left hand, face warm, and flushed, which resolved within 30 minutes without intervention. The outcome of the events was recovered. No treatment was received for the events.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash on body; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 04Jan2021 14:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to sulfa drug. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cipro [ciprofloxacin] and experienced allergy to cipro. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's husband noticed a rash on the patient's body when the patient was getting into pajamas for bed. She took a shower and paracetamol (TYLENOL) and went to bed. She woke up in the morning and rash was gone. The mother reported she became pregnant while taking bnt162b2. Last menstrual period date was 13Aug2020. The mother was 20 weeks pregnant at the onset of the event. The mother was due to deliver on 20May2021. Outcome of the rash was recovered. The events were considered non-serious by the reporter.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Off label use, Product use issue, Rash
Clinical narrative: rash on body; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 04Jan2021 14:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to sulfa drug. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cipro [ciprofloxacin] and experienced allergy to cipro. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's husband noticed a rash on the patient's body when the patient was getting into pajamas for bed. She took a shower and paracetamol (TYLENOL) and went to bed. She woke up in the morning and rash was gone. The mother reported she became pregnant while taking bnt162b2. Last menstrual period date was 13Aug2020. The mother was 20 weeks pregnant at the onset of the event. The mother was due to deliver on 20May2021. Outcome of the rash was recovered. The events were considered non-serious by the reporter.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: 1150 Post injection my tongue started to feel numb and tingling.   Tongue started to swell.  Over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks, and underneath my eyes on both sides.  Because it kept slowly progressing I took 25 mg oral Benadryl. About 20 minutes after the Benadryl I noticed that my tongue didn?t feel or look as swollen.  Within an hour I would say 95% better.   I just had some trace numbness on my cheeks bilaterally.  Symptoms returned again about 12 hours later. Again took Benadryl, this time 50 mg. All symptoms have resolved
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral, Swollen tongue
Clinical narrative: 1150 Post injection my tongue started to feel numb and tingling.   Tongue started to swell.  Over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks, and underneath my eyes on both sides.  Because it kept slowly progressing I took 25 mg oral Benadryl. About 20 minutes after the Benadryl I noticed that my tongue didn?t feel or look as swollen.  Within an hour I would say 95% better.   I just had some trace numbness on my cheeks bilaterally.  Symptoms returned again about 12 hours later. Again took Benadryl, this time 50 mg. All symptoms have resolved
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Cardiac monitoring, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Swollen tongue, Tongue discomfort
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dysphonia, Heart rate, Heart rate increased
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Palpitations, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cheilitis, Cough, Dizziness, Dysphonia, Glossodynia
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Hypoaesthesia oral, Injection site paraesthesia, Lip swelling, Oropharyngeal pain
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Tachycardia
Clinical narrative: Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Pruritus, Somnolence, Urticaria
Clinical narrative: with hives noted to abd, chest, and back area.; redness noted to arm as and around injection site.; patient presented digging at areas and reported itching.; patient reports feeling sleepy.; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Eh9899) via Intramuscular on 29Dec2020 at single dose in left arm for COVID-19 immunisation. Medical history and concomitant medications were not reported. Mass vaccine Clinic being held at patients work location. Patient was initially monitored for 15 minutes but returned later at 13:53 (also reported as 14: 53, pending clarification) with hives noted to abd, chest, back area. Redness noted ta arm to around injection site. Patient presented digging at areas and reported itching. Vitals taken and due to presentation patient was given 50mg Diphenhydramine to L gluteal area. Staff present continued to monitor and take vitals for an additional 30 minutes. Patient's redness and largely reduced and itching. Patient reported feeling sleepy. Left In care at charge nurse at facility.  Spoke with patient the next day to check on the patient and she reported that the patient said she see. Additional information was the patient slept well but was feeling fine. Treatment for events "with hives noted to abd, chest, and back area" "redness noted to arm as and around injection site" "patient presented digging at areas and reported itching" was included Diphenhydramine. Outcome of events "redness noted to arm as and around injection site" and "patient presented digging at areas and reported itching" was recovered on 29Dec2020, while outcome of other events was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Somnolence, Urticaria, Vaccination site erythema, Vital signs measurement
Clinical narrative: with hives noted to abd, chest, and back area.; redness noted to arm as and around injection site.; patient presented digging at areas and reported itching.; patient reports feeling sleepy.; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Eh9899) via Intramuscular on 29Dec2020 at single dose in left arm for COVID-19 immunisation. Medical history and concomitant medications were not reported. Mass vaccine Clinic being held at patients work location. Patient was initially monitored for 15 minutes but returned later at 13:53 (also reported as 14: 53, pending clarification) with hives noted to abd, chest, back area. Redness noted ta arm to around injection site. Patient presented digging at areas and reported itching. Vitals taken and due to presentation patient was given 50mg Diphenhydramine to L gluteal area. Staff present continued to monitor and take vitals for an additional 30 minutes. Patient's redness and largely reduced and itching. Patient reported feeling sleepy. Left In care at charge nurse at facility.  Spoke with patient the next day to check on the patient and she reported that the patient said she see. Additional information was the patient slept well but was feeling fine. Treatment for events "with hives noted to abd, chest, and back area" "redness noted to arm as and around injection site" "patient presented digging at areas and reported itching" was included Diphenhydramine. Outcome of events "redness noted to arm as and around injection site" and "patient presented digging at areas and reported itching" was recovered on 29Dec2020, while outcome of other events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: she woke up sick and was having the same symptoms as her husband so she was positive; she woke up sick and was having the same symptoms as her husband so she was positive; This is a spontaneous report from a contactable pharmacist reported for herself.  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Caller stated that she was a pharmacist and on Tuesday last week that she received the Pfizer BioNTech Vaccine. Stated that her husband tested positive yesterday (on 29Dec2020). Stated that she was positive that she was positive because that was her husband. Stated that she woke up sick and was having the same symptoms as her husband so she was positive. Stated that she was due for second dose in 2 weeks. Stated that she received the vaccine last week and was negative. The patient underwent lab tests and procedures which included covid test: negative in Dec2020. The outcome of the events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test negative
Clinical narrative: she woke up sick and was having the same symptoms as her husband so she was positive; she woke up sick and was having the same symptoms as her husband so she was positive; This is a spontaneous report from a contactable pharmacist reported for herself.  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Caller stated that she was a pharmacist and on Tuesday last week that she received the Pfizer BioNTech Vaccine. Stated that her husband tested positive yesterday (on 29Dec2020). Stated that she was positive that she was positive because that was her husband. Stated that she woke up sick and was having the same symptoms as her husband so she was positive. Stated that she was due for second dose in 2 weeks. Stated that she received the vaccine last week and was negative. The patient underwent lab tests and procedures which included covid test: negative in Dec2020. The outcome of the events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.