chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Persistent fever of 101 F and above despite fever reducing medications; Chest pain; Palpitations; Muscle pain; Bone pains; Headache; Nausea; Lack of appetite; Dizziness and feeling faint; Chills; Malaise; This is a spontaneous report from a non-contactable nurse, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Aug2021(at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 27Aug2021 at 00:00, the patient experienced persistent fever with a body temperature of 101 F and above despite fever reducing medications. On 27Aug2021 at 00:00, the patient experienced chest pain, palpitations, muscle and bone pains, headache, nausea, lack of appetite, dizziness, feeling faint, chills and malaise. 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 the event fever which included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent fever, chest pain, palpitations, muscle and bone pains, headache, nausea, lack of appetite, dizziness, feeling faint, chills and malaise were recovering 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: Dizziness, Menopause
Clinical narrative: Initially caused dizziness off and on for about 3 weeks.; Threw "me" into menopause; This is a spontaneous report from a non-contactable consumer, the patient. A 49-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 on 30Apr2021 at 16:00 in the right arm (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included multivitamins (MANUFACTURER UNKNOWN) started on an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced dizziness off and on for about 3 weeks and stated that vaccine threw her into menopause. 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 dizziness off and on for about 3 weeks was resolved on an unknown date in 2021; while that of the event menopause was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Very sore arm that was injected; Extreme fatigue for 24 hours; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Aug2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of the vaccination. On 23Aug2021 at 18:00, the patient experienced very sore arm that was injected, extreme fatigue for 24 hours and mild headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore arm that was injected and mild headache were resolved on an unknown date in Aug2021, while the clinical outcome of extreme fatigue was resolved on 24Aug2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Day 2 the spotting got heavier; Mid-cycle menstrual bleeding (starting 6 hours after receiving the vaccine); This is a spontaneous report from a non-contactable healthcare professional, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Sep2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Sep2021 at 22:30, 6 hours after the vaccination, the patient experienced mid-cycle menstrual bleeding. On 04Sep2021, day 2, the spotting got heavier. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mid-cycle menstrual bleeding and day 2, the spotting got heavier was resolving 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy Rash; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 23Aug2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 31Aug2021, the patient experienced itchy rash. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 itchy rash was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Severe nausea and vomiting; Severe nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 05Sep2021 at 15:00 (at the age of 28-year-old), as a single dose for COVID-19 immunisation. Medical history included heart supraventricular tachycardia (Heart SVT) and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 06Sep2021 at 05:00, the patient experienced severe nausea and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe vomiting and nausea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Having bouts of diarrhea every 2 weeks since getting the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse and diarrhea. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received included multi-vitamin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and unknown if ongoing.  The patient did not receive any other vaccine within four weeks prior to the COVID -19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021, the patient had been having bouts of diarrhea every 2 weeks since getting the vaccine. The patient only had diarrhea once a year before that. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event bouts of diarrhea every 2 weeks since getting the vaccine was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Interchange of vaccine products, Off label use
Clinical narrative: headache; dizziness; a patient received who received the Moderna Covid vaccine as her 1st dose on 01AUG2021 and received the Comirnaty as her 2nd dose today.; a patient received who received the Moderna Covid vaccine as her 1st dose on 01AUG2021 and received the Comirnaty as her 2nd dose today.; This is a spontaneous report from a contactable other hcp(nurse). A 35-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/lot number: EW0191, Expiry date: Sep2025) via intramuscular route in left deltoid, on 08Sep2021 08:40 (age at vaccination: 35-years) as dose 2, single for COVID-19 immunisation. The patient medical history included chronic Lumbar pain from 14Nov2014, Tension Headache from 14Nov2014, Latent TB infection from 03Jan2015, Over weight from 02Mar2015, H. Pylori infection from 10Aug2017. Concomitant medications were not reported. The patient previously received the MODERNA COVID (Lot No. 038B21A, Expiration date: 30Sep2021) via intramuscular route, administered in left deltoid vaccine as her 1st dose on 01Aug2021 03:26 (age at vaccination: 35-years) for covid-19 immunisation and received the COMIRNATY as her 2nd dose today on 08Sep2021. There was no emergency room or physician's office visit due to the adverse events. She does not think it is life threatening but could not decide if it was medically significant or not stating that is why she was calling. The patient experienced a patient received who received the Moderna covid vaccine as her 1st dose on 01Aug2021 and received the Comirnaty as her 2nd dose today on 08Sep2021, headache, dizziness on 14Sep2021. The clinical outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.  Follow-up (08Sep2021): New information received in a follow-up spontaneous report from contactable Nurse. This Nurse reported for a 33-year-old female patient that: details about first and second vaccines (batch/lot number, expiration date, route of administration, anatomical location, time of vaccination)  Follow-up attempts are completed. No further information is expected.  Follow up (20Sep2021): New information received from a contactable Nurse. This nurse reported for a patient in response HCP letter sent which included that: Event verbatim headache' and dizziness' coded as such, start date and stop date time updated, Event onset date was added as 14Sep2021 as per case context, and medical history added.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe shoulder pain; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female 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 08Sep2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergy to avocado, kiwi, banana, mango and latex. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEK); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took measles vaccine; mumps vaccine; rubella vaccine(MMR) and experienced drug allergy. On 08Sep2021 at 17:00, the patient experienced severe shoulder and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe shoulder and arm pain was resolving 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Heart rate increased, Vaccination site pain
Clinical narrative: Chest pain late day 3 into day 4; Rapid heart beat late day 3 into day 4; Injection site pain day 1 and 2; Tiredness day 1 and 2; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 05Sep2021 at 16:00 (at the age of 33-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. Concomitant medications included piroxicam (PAXIL) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Sep2021, the patient experienced injection site pain and tiredness on day 1 and 2. On 08Sep2021, the patient experienced chest pain and rapid heartbeat late on day 3 into day 4. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site pain and tiredness was resolved on 07Sep2021, while that of chest pain and rapid heartbeat was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: Heavier menstruation; Cycle came early; period color darker than normal; This is a spontaneous report from a contactable consumer, the patient. A 43-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 21Jul2021 at 17:00 (at the age of 43-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history of the patient was not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 22Jul2021 at 14:00, the patient experienced heavier menstruation, cycle came early, period color darker than normal and it happened with second dose as well. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavier menstruation, cycle came early and period color darker than normal was recovered on an unknown date in 2021.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling of body temperature change, Myalgia
Clinical narrative: Soreness in neck muscles on the left side.; Feeling hot then cold; Cant get comfortable; This is a spontaneous report from a contactable consumer, the patient. A 31-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 arm right on an unknown date in Sep2021 at 09:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient had allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included paracetamol (TYLENOL) from unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Sep2021 at 09:00, the patient experienced soreness in neck muscles on the left side. She had a feeling of hot then cold and couldn't get comfortable. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events, soreness in neck muscles on the left side and had a feeling of hot then cold, couldn't get comfortable was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Mass, Menstrual disorder, Nasal abscess, Scar
Clinical narrative: I have extremely painful period cramps and symptoms; With both doses, I had a reaction on the right side of my face. Little bumps and "dents".; With both doses, I had a reaction on the right side of my face. Little bumps and "dents".; Since my 2nd dose, my period has either been late or not at all.; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old non-Pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expiry Date was not provided), via an unspecified route of administration, administered in right arm, on 02Apr2021 at 11:00 (age at vaccination was 48-Years) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient known allergies and medical history included Hypothyroidism, asthma. Concomitant medication included Levothyroxine sodium (Synthroid 100 mcg), ASCORBIC ACID (vit C), COLECALCIFEROL (D3), ECHINACEA PURPUREA ROOT, OLEA EUROPAEA LEAF, SAMBUCUS NIGRA FRUIT (Elderberry) and Biotin. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207, Expiry Date was not provided), via an unspecified route of administration, administered in right arm, on 12Mar2021 at 11:45 (age at vaccination was 48-Years) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines in four weeks. Patient did not had COVID prior vaccination. Patient has been tested COVID post vaccination. With both doses, patient had a reaction on the right side of her face. Little bumps and "dents". It eventually went away. The main issue she was having is her period. She had her period before the first dose, March 9th. Her second dose was on April 2nd and she was due for her period on April 4. She got her period every 26 days. She was not on birth control. Since her 2nd dose, her period has either been late or not at all. She saw her primary provider on August 9 and she said she was not going through menopause that a lot of women were having the same issues. She said it could take 4 months to go back to normal but it has been more than 4 months. She had extremely painful period cramps and symptoms when she was supposed to have her period but no menstruation. The patient underwent lab test and procedure included Nasal Swab with negative result on an unspecified date of 2021. COVID test name post vaccination was Rapid test. Adverse Event did not result in anything. Patient did not receive treatment for any event. The outcome of all events was not resolved.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182522 same reporter/patient/product, different dose/event.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Chest discomfort, Dizziness, Immunisation, Off label use
Clinical narrative: Chest tightness; Feeling light headed; Off balance; She developed a rash that burns and hurt all over her body; She developed a rash that burns and hurt all over her body; She developed a rash that burns and hurt all over her body; Booster; Off label use; This is a spontaneous report received from a non-contactable consumer (Patient). A 51-year-old female patient received third dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 18Aug2021 as dose 3 (booster), single for covid-19 immunisation and patient also received co-suspect as ibuprofen (MOTRIN [IBUPROFEN]), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) for an unspecified indication. Medical history included she is allergic to antihistamine from an unknown date. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1 single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2 single for covid-19 immunisation. The patient experienced she developed a rash that burns and hurt all over her body on 19Aug2021, feeling lightheaded, off balance, chest tightness on an unspecified date. booster and off label use on 18Aug2021. Therapeutic measures were taken as a result of she developed a rash that burns and hurt all over her body. The patient reported she has been consulted to 10 different doctors, no one knows how to treat the rash and seeing Dermatologist twice as well. She was asked what to do to treat the rash. How long are the side effects going to last. The patient had a reaction to motrin, everything she takes reacts with the vaccine now and she has always taken motrin for 45 years but when she took one she thought she would end up in the ER. The patient reported she was feeling lightheaded, off balance and chest tightness. The patient reports according to the CDC your not supposed to use steroids, but the Doctor prescribed steroids to be applied 3 times a day and when she applied the steroid to the rash her skin burned and cracked and she is allergic to antihistamine so she cannot use that and trying Neosporin Plus pain relief and it was the only thing that has worked. She had an appointment with a new family doctor on 29Sep2021. She reported the rash comes and goes, the rash was on her arms and breast which is gone but now the rash is in her private area. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Rash, Thermal burn
Clinical narrative: Chest tightness; Feeling light headed; Off balance; She developed a rash that burns and hurt all over her body; She developed a rash that burns and hurt all over her body; She developed a rash that burns and hurt all over her body; Booster; Off label use; This is a spontaneous report received from a non-contactable consumer (Patient). A 51-year-old female patient received third dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 18Aug2021 as dose 3 (booster), single for covid-19 immunisation and patient also received co-suspect as ibuprofen (MOTRIN [IBUPROFEN]), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) for an unspecified indication. Medical history included she is allergic to antihistamine from an unknown date. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1 single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2 single for covid-19 immunisation. The patient experienced she developed a rash that burns and hurt all over her body on 19Aug2021, feeling lightheaded, off balance, chest tightness on an unspecified date. booster and off label use on 18Aug2021. Therapeutic measures were taken as a result of she developed a rash that burns and hurt all over her body. The patient reported she has been consulted to 10 different doctors, no one knows how to treat the rash and seeing Dermatologist twice as well. She was asked what to do to treat the rash. How long are the side effects going to last. The patient had a reaction to motrin, everything she takes reacts with the vaccine now and she has always taken motrin for 45 years but when she took one she thought she would end up in the ER. The patient reported she was feeling lightheaded, off balance and chest tightness. The patient reports according to the CDC your not supposed to use steroids, but the Doctor prescribed steroids to be applied 3 times a day and when she applied the steroid to the rash her skin burned and cracked and she is allergic to antihistamine so she cannot use that and trying Neosporin Plus pain relief and it was the only thing that has worked. She had an appointment with a new family doctor on 29Sep2021. She reported the rash comes and goes, the rash was on her arms and breast which is gone but now the rash is in her private area. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fatigue; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 10Sep2021 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Sep2021, the patient experienced sore arm, fatigue and fever. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm, fatigue and fever was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Musculoskeletal stiffness, Off label use
Clinical narrative: stiffness in her hand; patient reported receiving the covid booster; patient reported receiving the covid booster; This is a spontaneous report from a contactable other hcp. This contactable other hcp reported for a female patient. A 57-years-old female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Sep2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included Rheumatoid Arthritis. There were no concomitant medications. The patient previously received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. On 08Sep201, the patient experienced stiffness in her hand, and on 07Sep2021 patient reported receiving the covid booster. Two days after the COVID booster, she has had improvement with the stiffness in her hand, but it was still present, md is not aware. Advised patient to continue to monitor and if it gets worse to notify the md and also advised to inform md during follow up. The outcome of the event stiffness was recovering.  Follow-up (18Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: Tired; Nauseated; Sneezing; Runny nose; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 09Sep2021 at 12:15 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included anemic and heart murmur. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 09Sep2021 at 19:00, the patient experienced tired, nauseated, sneezing, runny nose and sore throat. 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 tired, nauseated, sneezing, runny nose and sore throat was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: experiencing covid symptoms - sore throat, tightness on the chest and headache; experiencing covid symptoms - sore throat, tightness on the chest and headache; experiencing covid symptoms - sore throat, tightness on the chest and headache; This is a spontaneous report from a contactable consumer. A 54-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 26Aug2021 at 16:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included heart condition. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received unspecified Pfizer vaccine via an unspecified route of administration in the left arm on 01Jul2021 for immunisation. On 08Sep2021, the patient had no reaction, but experiencing COVID symptoms - sore throat, tightness on the chest and headache. On 12Sep2021, the patient underwent PCR test via nasal swab and the result was pending. 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 been tested for COVID-19. The clinical outcome of the events COVID symptoms - sore throat, tightness on the chest and headache was not resolved at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Myalgia
Clinical narrative: Chills; hot; Myalgia; This is a spontaneous report from a contactable physician.  A 73-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: Not reported/Lot Number: EN6201), via intramuscular route of administration, administered in Arm Left on 16Feb2021 (Age at vaccination 73-years-old), as dose 2, single for covid-19 immunization. Medical history included anxiety and increased cholesterol from an unknown date and unknown if ongoing. Concomitant medications included calcium, melatonin, diphenhydramine hydrochloride, paracetamol (TYLENOL PM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 vaccine vaccination. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: Not reported/Lot Number: EL3302), via intramuscular route of administration, administered in Arm Left on 26Jan2021 (Age at vaccination 73-years-old), as DOSE 1, SINGLE for covid-19 immunization and experienced cough, shortness of breath and swelling which resolved in 10-15 minutes. The patient did not require medical intervention, emergency department visit, hospitalization. Patient was not admitted to an intensive care unit as a result of signs and symptoms of the anaphylactic reaction. There was not an organ involvement such as multiorgan involvement, Stridor, Upper airway swelling, Respiratory distress, Tachypnoea, Increased use of accessory respiratory muscles, Recession, Cyanosis, Grunting, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Sneezing, Rhinorrhea, Cardiovascular, Dermatological/mucosal, Generalized urticarcia, Generalized erythema, Angioedema (not hereditary), Generalized pruritus with skin rash, Generalized pruritus without skin rash, Generalized prickle sensation, Red and itchy eyes, Gastrointestinal. As a result of the events patient did not require the initiation of new medication or other treatment or procedure. Outcome following the potential anaphylactic reaction was recovered those were not anaphylactic. There were no laboratory tests or diagnostic studies performed. On an unspecified day and month of 2021, the patient experienced chills, hot and myalgia. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was recovered on unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oropharyngeal pain
Clinical narrative: Breathing issues 20 hours later; Sore throat for 3 weeks; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Aug2021 at 15:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. On 19Aug2021 at 11:30, 20 hours later, the patient experienced breathing issues and on an unknown date in Aug2021, she had sore throat for 3 weeks. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 breathing issues was resolved with sequelae on an unknown date in 2021 while sore throat for 3 weeks was resolved with sequelae in Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives all over legs; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the right arm on an unknown date, 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 previously took ibuprofen (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced broke out in hives all over legs. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event broke out in hives all over legs was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Tinnitus
Clinical narrative: Ringing in worsened; Dizziness worsened; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Sep2020, ringing in ears which was ongoing and dizziness which was ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took cefaclor (CECLOR) and amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in Sep2020, the patient underwent SARS-CoV-2 test and the result was positive. On an unknown date, the patient experienced worsened ringing in ears and dizziness. It was reported that ringing in ears and dizziness developed after COVID-19 positive in Sep2020 and ringing and dizzy spells were improving, but worsened again after receiving vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event worsened ringing in ears and dizziness was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Rash erythematous, SARS-CoV-2 test, Swelling face
Clinical narrative: Facial swelling; red rash on face; short of breath for 2 weeks; stomach cramping; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration on an unknown date (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. On 04Sep2021, the patient experienced facial swelling, red rash on face, short of breath for 2 weeks and stomach cramping. On an unknown date, the patient underwent SARS-CoV-2 test and the result was not reported. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events facial swelling, red rash on face, short of breath for 2 weeks and stomach cramping were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Metamorphopsia
Clinical narrative: Vision distortion; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 09Sep2021 at 13:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included teriflunomide (AUBAGIO) 14mg and phentermine hydrochloride, topiramat (QSYMIA) 7.5mg; both for unspecified indications, from an unknown date and unknown if ongoing. On an unknown date in Sep2021, the patient experienced vision distortion. The events did not result in doctor or other healthcare professional office/clinic, 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 vision distortion was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Headache, Nasopharyngitis, Pain
Clinical narrative: Dry throat; Cough; Cold like symptoms; Headaches; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 15Sep2021 at 09:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin b nos (VITAMIN B), ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), zinc (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all were taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 15Sep2021 at 12:15, the patient experienced dry throat, cough, cold like symptoms, headaches and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events with dextromethorphan, hydrobromide, guaifenesin, paracetamol, pseudoephedrine (DAYQUIL) and ibuprofen (ADVIL) on an unknown date and unknown if ongoing. The clinical outcome of the events dry throat, cough, cold like symptoms, headaches and body aches was resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysmenorrhoea
Clinical narrative: Experiencing painful low back pain and cramping in conjunction to "my" menstrual cycle.; Experiencing painful low back pain and cramping in conjunction to "my" menstrual cycle.; This is a spontaneous report from a non-contactable consumer, the patient. A 41-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 right arm on 26Aug2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and known allergies were reported as none. 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. The patient did not receive any medications within two weeks of vaccination. On 01Sep2021 at 12:00, the patient experienced painful low back pain and cramping in conjunction to her menstrual cycle. The patient reported that nothing other than the vaccine had changed and there was no added stress, exercise, medication, just the vaccine. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful low back pain and cramping in conjunction to menstrual cycle were not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.