chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Gait inability, Pain in extremity, Peripheral swelling
Clinical narrative: had a lot of swelling; have pain in her right leg, from the knee all the way to her ankle area (front and back sides); couldn't walk on her right leg; pain in the knee in her vein; pain in the knee in her vein; swelling in leg; hot in leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration, administered in Left Deltoid on 14Apr2021 (age at the time of vaccination 73-years-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced have pain in her right leg, from the knee all the way to her ankle area (front and back sides). On 24Apr2021 patient had a lot of swelling. On unspecific date in Apr2021 the patient reported couldn't walk on her right leg, pain in the knee in her vein, swelling in leg, and hot in leg. Patient states she is going to HCP on 07May2021. States whether she can take the second short of vaccine. Patient was asking whether she have to consult doctor. Therapeutic measures were taken as a result of have pain in her right leg, from the knee all the way to her ankle area (front and back sides), and had a lot of swelling includes topical gel and CBD OIL. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vascular pain
Clinical narrative: had a lot of swelling; have pain in her right leg, from the knee all the way to her ankle area (front and back sides); couldn't walk on her right leg; pain in the knee in her vein; pain in the knee in her vein; swelling in leg; hot in leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration, administered in Left Deltoid on 14Apr2021 (age at the time of vaccination 73-years-old), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced have pain in her right leg, from the knee all the way to her ankle area (front and back sides). On 24Apr2021 patient had a lot of swelling. On unspecific date in Apr2021 the patient reported couldn't walk on her right leg, pain in the knee in her vein, swelling in leg, and hot in leg. Patient states she is going to HCP on 07May2021. States whether she can take the second short of vaccine. Patient was asking whether she have to consult doctor. Therapeutic measures were taken as a result of have pain in her right leg, from the knee all the way to her ankle area (front and back sides), and had a lot of swelling includes topical gel and CBD OIL. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever that is now around 100 degrees; chills; body aches; feel tired; This is a spontaneous report from a contactable consumer (patient brother). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number was EW0171), (Age at vaccination 17yrs) via an unspecified route of administration, administered in Arm Left on 03May2021 08:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy of allergic to peanut from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 03May2021 the patient experienced feel tired, On 04May2021 fever that is now around 100 degrees, chills, body aches. Patient received no treatment for the event. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The response was received that Spoke from the FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION PFIZER-BIONTECH COVID-19 VACCINE Prescribing Information Section 6.1 (Revised: 06Apr2021) to let caller know that fever, fatigue, chills, new or worsened muscle pain, and new or worsened joint pain were commonly reported side effects reported in the clinical trials. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Body temperature, Body temperature increased, Headache, Hypersensitivity
Clinical narrative: A little bit of a fever; Really bad cold symptoms; Allergy symptoms were not going away; Bad runny nose; Congestion; Sinus pressure/headache; Sinus pressure/headache; Itchy throat; Losing my voice; Temperature today was 100 °F; This is a spontaneous report from a contactable consumer (patient). A 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 02May2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 18 years). Medical history included hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not received any prior vaccinations within 4 weeks. The patient prior to receiving the vaccine, she was having allergy symptoms, however, she stated that she would take an allergy pill and the symptoms would go away. On Sunday on May2021 after her first dose of the vaccine she noticed that what she thought allergy symptoms were not going away. She reported a bad runny nose, congestion, headache, sinus pressure/headache, itchy throat, losing my voice, and temperature today was 100 degree F. She has been taking medicine and drinking Theraflu but continues to feel worse and not better. She wanted to know if these are normal side effects or if she should see a doctor. Caller questioned that should the patient ask to be tested for COVID-19. Caller went and got shot on Sunday 2May2021 and later that day on 02May2021 she got really bad cold symptoms and they haven't gone away. Caller stated that she has taking medicine. Today she checked to see if she had a fever and she had a little bit of a fever. Caller asked if these are normal side effects or does she need to get checked out. Caller stated her symptoms are not going away. she has had allergies before and she was able to control them with over the counter allergy pills but that night they did not work. Caller stated that she didn't think to check for fever yesterday, but that she checked today on 04May2021 and has a bit of a fever. Yesterday she felt bad but today she got a little better, but today is still bad. The patient received treatment for really bad cold symptoms. The patient underwent lab tests and procedures which included body temperature: 100 Fahrenheit on May2021. The patient did not visited Emergency Room/Physician Office. The clinical outcome of the event allergy symptoms were not going away, bad runny nose, congestion, sinus pressure/headache, itchy throat, losing my voice, temperature today was 100 degree F was unknown, really bad cold symptoms outcome was recovered on an unspecified date, a little bit of a fever outcome was recovering.     No follow-up attempts are needed. No further information is expected
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Paranasal sinus discomfort, Pyrexia, Rhinorrhoea
Clinical narrative: A little bit of a fever; Really bad cold symptoms; Allergy symptoms were not going away; Bad runny nose; Congestion; Sinus pressure/headache; Sinus pressure/headache; Itchy throat; Losing my voice; Temperature today was 100 °F; This is a spontaneous report from a contactable consumer (patient). A 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 02May2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 18 years). Medical history included hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not received any prior vaccinations within 4 weeks. The patient prior to receiving the vaccine, she was having allergy symptoms, however, she stated that she would take an allergy pill and the symptoms would go away. On Sunday on May2021 after her first dose of the vaccine she noticed that what she thought allergy symptoms were not going away. She reported a bad runny nose, congestion, headache, sinus pressure/headache, itchy throat, losing my voice, and temperature today was 100 degree F. She has been taking medicine and drinking Theraflu but continues to feel worse and not better. She wanted to know if these are normal side effects or if she should see a doctor. Caller questioned that should the patient ask to be tested for COVID-19. Caller went and got shot on Sunday 2May2021 and later that day on 02May2021 she got really bad cold symptoms and they haven't gone away. Caller stated that she has taking medicine. Today she checked to see if she had a fever and she had a little bit of a fever. Caller asked if these are normal side effects or does she need to get checked out. Caller stated her symptoms are not going away. she has had allergies before and she was able to control them with over the counter allergy pills but that night they did not work. Caller stated that she didn't think to check for fever yesterday, but that she checked today on 04May2021 and has a bit of a fever. Yesterday she felt bad but today she got a little better, but today is still bad. The patient received treatment for really bad cold symptoms. The patient underwent lab tests and procedures which included body temperature: 100 Fahrenheit on May2021. The patient did not visited Emergency Room/Physician Office. The clinical outcome of the event allergy symptoms were not going away, bad runny nose, congestion, sinus pressure/headache, itchy throat, losing my voice, temperature today was 100 degree F was unknown, really bad cold symptoms outcome was recovered on an unspecified date, a little bit of a fever outcome was recovering.     No follow-up attempts are needed. No further information is expected
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: A little bit of a fever; Really bad cold symptoms; Allergy symptoms were not going away; Bad runny nose; Congestion; Sinus pressure/headache; Sinus pressure/headache; Itchy throat; Losing my voice; Temperature today was 100 °F; This is a spontaneous report from a contactable consumer (patient). A 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 02May2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 18 years). Medical history included hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not received any prior vaccinations within 4 weeks. The patient prior to receiving the vaccine, she was having allergy symptoms, however, she stated that she would take an allergy pill and the symptoms would go away. On Sunday on May2021 after her first dose of the vaccine she noticed that what she thought allergy symptoms were not going away. She reported a bad runny nose, congestion, headache, sinus pressure/headache, itchy throat, losing my voice, and temperature today was 100 degree F. She has been taking medicine and drinking Theraflu but continues to feel worse and not better. She wanted to know if these are normal side effects or if she should see a doctor. Caller questioned that should the patient ask to be tested for COVID-19. Caller went and got shot on Sunday 2May2021 and later that day on 02May2021 she got really bad cold symptoms and they haven't gone away. Caller stated that she has taking medicine. Today she checked to see if she had a fever and she had a little bit of a fever. Caller asked if these are normal side effects or does she need to get checked out. Caller stated her symptoms are not going away. she has had allergies before and she was able to control them with over the counter allergy pills but that night they did not work. Caller stated that she didn't think to check for fever yesterday, but that she checked today on 04May2021 and has a bit of a fever. Yesterday she felt bad but today she got a little better, but today is still bad. The patient received treatment for really bad cold symptoms. The patient underwent lab tests and procedures which included body temperature: 100 Fahrenheit on May2021. The patient did not visited Emergency Room/Physician Office. The clinical outcome of the event allergy symptoms were not going away, bad runny nose, congestion, sinus pressure/headache, itchy throat, losing my voice, temperature today was 100 degree F was unknown, really bad cold symptoms outcome was recovered on an unspecified date, a little bit of a fever outcome was recovering.     No follow-up attempts are needed. No further information is expected
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Swelling face
Clinical narrative: swollen feet; knees are swollen; My cheeks has swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient itself).A 73-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, Expiry Date: Unknown) via intramuscular in left arm on 26Apr2021 at 09:10 (at the age of 73-year-old) as dose 1, single COVID-19 immunization. Medical history included High Blood Pressure. The patient's concomitant medications were reported as yes. Consumer stated, got first shot of Pfizer this morning at 9:10 this Monday morning and after 6 PM at dinner and consumer realized that cheeks has swollen. Consumer not in pain first shot was there beside and have been out over a day. Consumer came home an hour ago and at dinner and noticed got shoes off, noticed feet was swollen, both of feet are swollen, the right foot was swollen, and the left foot was swollen and then those knees was swollen. Consumer stated for concomitant medications as yes, taking a lot of medications. On an unspecified date, patient experienced swollen feet, knees are swollen, my cheeks has swollen. The patient was not received any treatment for events. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Menstruation irregular
Clinical narrative: Second menstruation one week after ending normal menses; Headache; Exhaustion; Stomach ache; Diarrhea; Leg cramps; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included oral lichen planus and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included alprazolam (XANAX) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 16:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously took omeprazole (PRILOSEC) and codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 23Apr2021, the patient had second menstruation one week after ending normal menses and commencing 3 days after second dose. On an unknown date in Apr2021, the patient experienced leg cramps, headache, exhaustion, stomach ache and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event second menstruation one week after ending normal menses was resolved on 28Apr2021, after the duration of 5 days. The clinical outcome of the events headache, exhaustion, stomach ache and diarrhea was resolved on an unknown date in Apr2021, after the duration of 2 days. The clinical outcome of the event leg cramps was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Second menstruation one week after ending normal menses; Headache; Exhaustion; Stomach ache; Diarrhea; Leg cramps; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included oral lichen planus and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included alprazolam (XANAX) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 16:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously took omeprazole (PRILOSEC) and codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 23Apr2021, the patient had second menstruation one week after ending normal menses and commencing 3 days after second dose. On an unknown date in Apr2021, the patient experienced leg cramps, headache, exhaustion, stomach ache and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event second menstruation one week after ending normal menses was resolved on 28Apr2021, after the duration of 5 days. The clinical outcome of the events headache, exhaustion, stomach ache and diarrhea was resolved on an unknown date in Apr2021, after the duration of 2 days. The clinical outcome of the event leg cramps was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: 12 hours after 2nd shot I had Serious chills (teeth chattering)myalgia, mild fever and headache (1 am 23Apr).; 12 hours after 2nd shot I had serious chills (teeth chattering), myalgia, mild fever and headache (1 am 23Apr). I had low grade fever and myalgia for24 additional hours.; 12 hours after 2nd shot I had serious chills (teeth chattering), myalgia, mild fever and headache (1 am 23Apr). I had low grade fever and myalgia for 24 additional hours.; Headache; This is a spontaneous report from a contactable consumer, the patient.  A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included lamotrigine (LAMICTAL), colecalciferol (VITAMIN D3), pyridoxine hydrochloride (VITAMIN B6) and unspecified postnatal vitamins; all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8738) via an unspecified route of administration in the left arm on 01Apr2021 at 13:45 (at the age of 38-years-old), as a single dose for COVID-19 immunisation.  On 23Apr2021 at 01:00, 12 hours after the second vaccination, the patient experienced serious chills (teeth chattering), myalgia, mild fever and headache. The patient had low grade fever and myalgia for 24 additional hours. On 29Apr2021 at 01:00, 6.5 days after the second vaccination, the patient had the exact symptoms listed above. The patient was currently 12 hours in and still had myalgia. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with paracetamol (TYLENOL) and ibuprofen (ADVIL).  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events serious chills (teeth chattering), mild fever /low grade fever and headache were resolving and that of myalgia was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe pain in both hands; This is a spontaneous report from a contactable nurse, the patient.  A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: el0140) via intramuscular route of administration in the arm left on 09Jan2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included graves' disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ej1685) via intramuscular route of administration in the arm left on 18Dec2021 at 10:00 as a single dose for COVID-19 immunization. On 18Mar2021 at 08:00 the patient felt severe pain in both hands for the past month. The patient had no history of this. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in both hands was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder discomfort, Feeling hot, Flushing, Muscle spasms, Nausea
Clinical narrative: muscle spasms; felt incredibly nauseous; puking; severe bladder discomfort; overheated and felt flushed without any fever; needing to pee every hour; she was also overheated and felt flushed; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included gastritis, irritable bowel syndrome (IBS), polyps, asthma and allergy to fruits, vegetables, nuts and seeds. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL) started on an unknown date for unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021, 6 hours after vaccination, the patient experienced muscle spasms and felt incredibly nauseous, at around 5:00, the patient began puking every hour and needing to pee every hour, she couldn't stand without vomiting but she had to in order to keep peeing. She felt severe bladder discomfort, she was also overheated and felt flushed without any fever. She still cannot eat without severe nausea and vomiting. She felt like this was important to note due to the fact she had a heightened risk of stomach cancer, so anyone with the same digestive issues should be prepared to have this reaction just in case it effects them similarly. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle spasms, felt incredibly nauseous, puking every hour and needing to pee every hour, severe bladder discomfort and overheated and felt flushed without any fever was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Polyuria, Vomiting
Clinical narrative: muscle spasms; felt incredibly nauseous; puking; severe bladder discomfort; overheated and felt flushed without any fever; needing to pee every hour; she was also overheated and felt flushed; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included gastritis, irritable bowel syndrome (IBS), polyps, asthma and allergy to fruits, vegetables, nuts and seeds. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL) started on an unknown date for unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021, 6 hours after vaccination, the patient experienced muscle spasms and felt incredibly nauseous, at around 5:00, the patient began puking every hour and needing to pee every hour, she couldn't stand without vomiting but she had to in order to keep peeing. She felt severe bladder discomfort, she was also overheated and felt flushed without any fever. She still cannot eat without severe nausea and vomiting. She felt like this was important to note due to the fact she had a heightened risk of stomach cancer, so anyone with the same digestive issues should be prepared to have this reaction just in case it effects them similarly. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle spasms, felt incredibly nauseous, puking every hour and needing to pee every hour, severe bladder discomfort and overheated and felt flushed without any fever was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: extreme headache/severe headache; my left hand has swelling pretty significantly and it is in a lot of pain; my left hand has swelling pretty significantly and it is in a lot of pain; Joint pain; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; This is a spontaneous report from a contactable consumer. This 49-year-old female consumer (patient) reported for herself that: A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: unknown, NDC/UPC number and Expiry Date: Unknown), via an unspecified route of administration on 28Apr2021 as DOSE 2, SINGLE (at the age of 49-years-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included pantoprazole. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0158), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization.  On 29Apr2021 after the second dose of vaccination, the patient experienced extreme headache/severe headache, left hand has swelling pretty significantly and it is in a lot of pain, Joint pain, left hand had swollen up significantly and it is itching very badly, red, warm to touch. It was reported that, When probed for the concern, Patient stated she just had the second vaccine shot yesterday and had extreme headache today and her left hand has swelling pretty significantly and it is in a lot of pain so patient did not know whether she should just ice it or is it a known side effect and it is in pain even if she try to make a fist it hurts so I just do not know whether she should be going to ER or whether it will just by. Patient woke up early this morning with very severe headache, joint pain and my left hand had swollen up significantly and it is itching very badly, red, warm to touch and the swelling seems to keep growing and I can barely close my hand. So patient was assuming it the reactions, patient did not know whether Patient should be going to the doctor or is it a known side effect. It was very painful. Patient took treatment Excedrin Migraine which helped a little bit but she still have the headache but in the right side of the head. The outcome of the events my left hand has swelling pretty significantly and it is in a lot of pain was not recovered, while the outcome of other events was reported as unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm
Clinical narrative: extreme headache/severe headache; my left hand has swelling pretty significantly and it is in a lot of pain; my left hand has swelling pretty significantly and it is in a lot of pain; Joint pain; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; This is a spontaneous report from a contactable consumer. This 49-year-old female consumer (patient) reported for herself that: A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: unknown, NDC/UPC number and Expiry Date: Unknown), via an unspecified route of administration on 28Apr2021 as DOSE 2, SINGLE (at the age of 49-years-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included pantoprazole. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0158), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization.  On 29Apr2021 after the second dose of vaccination, the patient experienced extreme headache/severe headache, left hand has swelling pretty significantly and it is in a lot of pain, Joint pain, left hand had swollen up significantly and it is itching very badly, red, warm to touch. It was reported that, When probed for the concern, Patient stated she just had the second vaccine shot yesterday and had extreme headache today and her left hand has swelling pretty significantly and it is in a lot of pain so patient did not know whether she should just ice it or is it a known side effect and it is in pain even if she try to make a fist it hurts so I just do not know whether she should be going to ER or whether it will just by. Patient woke up early this morning with very severe headache, joint pain and my left hand had swollen up significantly and it is itching very badly, red, warm to touch and the swelling seems to keep growing and I can barely close my hand. So patient was assuming it the reactions, patient did not know whether Patient should be going to the doctor or is it a known side effect. It was very painful. Patient took treatment Excedrin Migraine which helped a little bit but she still have the headache but in the right side of the head. The outcome of the events my left hand has swelling pretty significantly and it is in a lot of pain was not recovered, while the outcome of other events was reported as unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Headache, Nausea
Clinical narrative: Worst headache; Severe nausea; Couldn't eat or drink; Horrible Chills; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 27Apr2021 at 09:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included high Blood Pressure (BP) controlled with medication. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 06Apr2021 at 09:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021, the patient experienced the worst headache she ever experienced (on a scale of 1 to 10 for pain, she rated a 12), severe nausea where the patient could not eat or drink and horrible chills. The patient reported that if this vaccine needs a booster, she would take her chances with COVID. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events worst headache, severe nausea where the patient could not eat or drink and horrible chills were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: Severe ear ache consistently; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the right arm on an unknown date (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The medical history included fish allergy and immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination which included hpv vaccine (MANUFACTURER UNKNOWN) in left arm for immunization on an unknown date. The concomitant medications included olly sleep vitamin (unspecified), fry's women gummy vitamin (unspecified) and naproxen sodium (ALEVE), all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 27Apr2021, the patient experienced severe ear ache consistently. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event ear ache and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe ear ache consistently was not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia
Clinical narrative: The left side of my face went numb; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 07Apr2021 at 13:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On an unknown date in Apr2021, the patient had her left side face went numb and she had diarrhoea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the left side face went numb and had diarrhoea was resolved on unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Sweats; Fatigue; Nausea; Diarrhea; Fever; Chills; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 23Apr2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to pork/porcine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, the patient experienced sweats, fatigue, "HA", nausea, diarrhea, fever and chills. The events resulted in emergency room/department or urgent care. On 28Apr2021, the patient underwent polymerase chain reaction (PCR) SARS-CoV-2 test (nasal swab), and the result was unknown. Therapeutic measures were not taken for the events. Since the vaccination, had the patient been tested for COVID-19. The clinical outcome of the events sweats, fatigue, "HA", nausea, diarrhea, fever and chills was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Sweats; Fatigue; Nausea; Diarrhea; Fever; Chills; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 23Apr2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to pork/porcine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, the patient experienced sweats, fatigue, "HA", nausea, diarrhea, fever and chills. The events resulted in emergency room/department or urgent care. On 28Apr2021, the patient underwent polymerase chain reaction (PCR) SARS-CoV-2 test (nasal swab), and the result was unknown. Therapeutic measures were not taken for the events. Since the vaccination, had the patient been tested for COVID-19. The clinical outcome of the events sweats, fatigue, "HA", nausea, diarrhea, fever and chills was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: Throat congestion 2 days after, felt like swallowed a marble, lasted for 2-3 days; This is a spontaneous report from a contactable consumer. An elderly male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included amlodipine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced throat congestion two days after on 23Mar2021, it felt like he had swallowed a marble, and lasted for 2-3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event throat congestion two days after, felt like swallowed a marble, lasted for 2-3 days was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Cough, Dyspnoea, Insomnia
Clinical narrative: Temp went up to 101; hardly slept; she was unable to work; Whole body aches; Small blister on lower lip; lip soreness; coughing; wheezing; having difficulty breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular on 28Apr2021 09:00 (at the age of 62-Years-old) (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Epicondylitis of arms and knees. Concomitant medication included losartan taken for unspecified indication and folic acid taken for an unspecified indication and Oxtrexup within 2 weeks of vaccination. The patient received first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, intramuscular administered in left arm on 07Apr2021 09:00 (at the age of 62-Years-old) (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. On 29Apr2021, the patient temperature went up to 101, temperature went up to 101 around 3am this morning, down to 100 at 7:46am, for 2 days and body aches, hardly slept and low-grade fever from 99-100 for 5 days. Small blister on lower lip appeared on 2d day after vaccine, coughing and wheezing started on 2nd day after vaccine and still as of today have needed to use nebulizer every day as patient had difficulty breathing. She used Neosporin on lips for blisters on lower lip - not visible now but can still feel lip soreness. As of today, Thursday, May 6, Still coughing and having difficulty breathing and needing to nebulize. Patient took Tylenol and drank fluids, etc. The patient underwent lab tests and procedures which included body temperature and showed 101 Fahrenheit on Mar2021, sars-cov-2 test was negative on Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Patient was diagnosed with COVID-19 Prior to vaccination. Patient was not tested for COVID-19, since the vaccination. Therapeutic measures were taken as a result of events. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.