chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular period. Menstrual cycle started the day after vaccination, week and a half early; This is a spontaneous report from a non-contactable consumer, 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 in the left arm on 15Apr2021 (at the age of 25-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 13:00, the patient experienced irregular period. Menstrual cycle started the day after vaccination, which was a week and a half early. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event irregular period, which was a week and a half early was 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Severe headaches; Fevers; Chills; Loss of appetite; Diarrhea; Left arm pains and swelling; Left arm pains and swelling; Pounding heart beats; Chest discomforts; Left neck and shoulder stiffness; Joint pains; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously 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 22Mar2021 at 14:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 20:00, the patient experienced severe headaches, fevers, chills, loss of appetite, diarrhea, left arm pains and swelling, pounding heart beats, chest discomforts, left neck and shoulder stiffness and joint pains. 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 events which included treatment with OTC ibuprofen (MORTIN), paracetamol (TYLENOL) and unspecified flu/cold medicines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headaches, fevers, chills, loss of appetite, diarrhea, left arm pains and swelling, pounding heart beats, chest discomforts, left neck and shoulder stiffness and joint pains were recovering 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: Severe headaches; Fevers; Chills; Loss of appetite; Diarrhea; Left arm pains and swelling; Left arm pains and swelling; Pounding heart beats; Chest discomforts; Left neck and shoulder stiffness; Joint pains; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously 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 22Mar2021 at 14:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 20:00, the patient experienced severe headaches, fevers, chills, loss of appetite, diarrhea, left arm pains and swelling, pounding heart beats, chest discomforts, left neck and shoulder stiffness and joint pains. 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 events which included treatment with OTC ibuprofen (MORTIN), paracetamol (TYLENOL) and unspecified flu/cold medicines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headaches, fevers, chills, loss of appetite, diarrhea, left arm pains and swelling, pounding heart beats, chest discomforts, left neck and shoulder stiffness and joint pains were recovering 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe headaches; Fevers; Chills; Loss of appetite; Diarrhea; Left arm pains and swelling; Left arm pains and swelling; Pounding heart beats; Chest discomforts; Left neck and shoulder stiffness; Joint pains; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously 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 22Mar2021 at 14:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 20:00, the patient experienced severe headaches, fevers, chills, loss of appetite, diarrhea, left arm pains and swelling, pounding heart beats, chest discomforts, left neck and shoulder stiffness and joint pains. 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 events which included treatment with OTC ibuprofen (MORTIN), paracetamol (TYLENOL) and unspecified flu/cold medicines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headaches, fevers, chills, loss of appetite, diarrhea, left arm pains and swelling, pounding heart beats, chest discomforts, left neck and shoulder stiffness and joint pains were recovering 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Migraine, Muscle spasms, Myalgia
Clinical narrative: Migraine; Nosebleed; extreme Charlie Horse type pain in my legs; some muscle pain for several more in legs andupper arms.; This is a spontaneous report from a contactable nurse. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 14Apr2021 at 10:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included adapalene (DIFFERIN) from an unknown date for an unknown indication and was unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 at 02:00, in the early morning hours after getting the vaccine, the patient experienced extreme Charlie Horse type pain in the leg which abruptly woke the patient and was hurt badly for about an hour. It was slowly calmed down but later on the same day, the patient had some muscle pain for several more in her legs and upper arms. On 16Apr2021, day two, the patient had a migraine which was not normal for the patient and also had a nosebleed. It was reported that she did not have a nosebleed for many years. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and the 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 extreme Charlie Horse type pain in legs and muscle pain recovered on an unknown date in Apr2021 while that of the event migraine and nosebleed was recovered on 16Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstruation irregular, Pain
Clinical narrative: very tired; Menstrual cycle hasn't been the same since receiving the vaccine. It's always been normal up until then.; Sore all over; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318 ) via an unspecified route of administration in the left arm on 02Mar2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6189) via an unspecified route of administration in the left arm on 09Feb2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 05Mar2021, the patient became very tired and sore all over. It was also reported that menstrual cycle hasn't been the same since receiving the vaccine. It's always been normal up until then. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very tired, sore all over and menstrual cycle hasn't been the same since receiving the vaccine was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal chest pain
Clinical narrative: it hurts down the ribcage; side hurts; couldn't lift her arm up; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as for immunization.  The patient's medical history and concomitant medications were not reported.  The patient reported when she got the pneumonia shot, she got the thing where she couldn't lift her arm up and it hurts down the ribcage. She was not sure if it effects the lungs more. Her side hurts when she gets the pneumonia vaccine. Outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 41-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 41, via an unspecified route of administration, on Apr 6, 2021, at 09:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 6, 2021, at 19:00, patient experienced diarrhea that has not subsided yet. The event did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of events. Since the vaccination, patient has not tested for COVID-19. The outcome of diarrhea: not recovered (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea with vomiting 72 hours later; nausea with vomiting 72 hours later; Fever, chills for 12-24 hours.; chills for 12-24 hours; Recurring diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the left arm on 13Apr2021 at 13:30 (at the age of 34-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 patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included prenatal vitamins (unspecified) 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: Ep7634) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 23:45, the patient experienced fever, chills for 12-24 hours and recurring diarrhea. On 16Apr2021, 72 hours later the patient experienced nausea with vomiting. 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 fever and chills was recovered on 14Apr2021, while the clinical outcome of the event recurring diarrhea, nausea with vomiting was not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Disorientation, Dizziness, Fatigue, Nausea
Clinical narrative: Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 17:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to food, medications, 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. The concomitant medications taken within two weeks of vaccination was reported as  birth control (formulation unspecified). On 14Apr2021, the patient immediately felt dizzy and still had bouts of dizziness 3 days later, felt severely disoriented (got lost and confused on way home) on the first day. The patient also experienced fatigue, mild nausea, some leg pain and diarrhea. 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 immediately felt dizzy and still have bouts of dizziness 3 days later, severely disoriented (got lost and confused on way home), fatigue, mild nausea, some leg pain and diarrhea was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 17:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to food, medications, 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. The concomitant medications taken within two weeks of vaccination was reported as  birth control (formulation unspecified). On 14Apr2021, the patient immediately felt dizzy and still had bouts of dizziness 3 days later, felt severely disoriented (got lost and confused on way home) on the first day. The patient also experienced fatigue, mild nausea, some leg pain and diarrhea. 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 immediately felt dizzy and still have bouts of dizziness 3 days later, severely disoriented (got lost and confused on way home), fatigue, mild nausea, some leg pain and diarrhea was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain in extremity
Clinical narrative: Pain in arm both times.; After second dose, severe cough developed 2 days after.; This is a spontaneous report from a contactable consumer or other non hcp, the patient reported that:  A 32-years-old male patient received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot Number: SW0151), dose 2, administered in Arm Left on 14Apr2021 17:15 as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6207), dose 1 administered in Arm Left on 17Mar2021 12:00 as dose 1, single for covid-19 immunisation. Medical history included bicuspid aortic valve from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the second dose, on 15Apr2021 20:15 patient experienced pain in arm both times and severe cough developed two days after. No treatment received. No other vaccine in four weeks. Patient did not have covid prior to vaccination. He was not tested for covid post vaccination. No known allergies were reported. The outcome of the events was not recovered.  Follow-up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: breaking out with hives; This is a spontaneous report from a Pfizer-sponsored program. This is a report from contactable 52-year-old female consumer (patient herself), she received 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 on 18Apr2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 52 years). The patient medical history included celiac disease. The patient concomitant medications were not reported. On 18Apr2021, two hours afterward the patient experienced breaking out with hives. It was reported that, she took Benadryl (Batch/Lot number: Unknown, Expiry Date: Unknown) twice, but still, she continues to break out in hives on 19Apr2021 morning also. Therapeutic measures were taken as a result of breaking out with hives includes Benadryl. The outcome of the event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: (Fever) highest was about 100.8; Chills; Ache; every muscle is aching in his body; This is a Spontaneous report from a Contactable Consumer (patient's mother)  A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: Not reported), via an unspecified route of administration on 12Apr2021 (at the age of 38-year-old) as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient's concomitant medications were not reported. The patients mother stated that patient was asked to get 3 doses first shot of Pfizer biotech vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection), via an unspecified route of administration on 22Mar2021 (at the age of 38-year-old) for Covid-19 immunization. The patient first dose was effective and had typical side effects such as a very sore arm and he was very tired on the next day (23Mar2021). The patient experienced the side effects for 25 to 30 hours and then has been fine since then. As the clinic was shut down by state for not keeping the logs of temperature control, the patient was suggested to consider the first shot as invalid and to pretend that he dint get that first and second dose of either Pfizer or the Moderna. The patient was advised to take 3 vaccine shots. The patient received second dose from another facility and experienced much more intense side effects such as fever for about 12 to 15 hours that went up and down and the highest was about 100.8 degrees, chills and every muscle is aching in his body. This lasted for 1.5 days after the dose then went away. The patient was treated with Ibuprofen 200 mg for muscle and ache in body. All the events were recovered on an unspecified date.   No Follow up attempts are possible: Information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Magnetic resonance imaging, Mammogram, Premature menarche, Ultrasound scan
Clinical narrative: Premature menstrual cycles/periods; Nipple discharge of left breast; This is a spontaneous report from a contactable nurse. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the arm left on 22Feb2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The medical history and known allergies were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the arm left on 01Feb2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 21:00, the patient experienced premature menstrual cycles/periods and nipple discharge of left breast. On an unknown date, the patient underwent mammogram, ultrasound and magnetic resonance imaging (MRI) and the result was unknown. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events premature menstrual cycles/periods and nipple discharge of left breast was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: Moderate to severe menstrual cramps; This is a spontaneous report from a contactable consumer, the patient. A 40-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 left arm on 05Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included rivastigmine hydrogen tartrate (RIVERA), fish oil (MANUFACTURER UNKNOWN), and multivitamin; all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 08:00, the patient experienced moderate to severe menstrual cramps. The 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate to severe menstrual cramps was not recovered 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia
Clinical narrative: Headache; muscle aches; fatigue; mild upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 47-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 right arm on 17Apr2021 at 10:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included grave's disease post partial thyroid ablation and mild hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), tilactase (LACTASE) and vitamin d not otherwise specified (VITAMIN D); all for an unknown indication from an unknown dates and unknown if ongoing. The patient previously 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 27Mar2021 at 10:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 15:30, the patient experienced headache, muscle aches, fatigue, fever and mild upset stomach. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were 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 headache, muscle aches, fatigue, fever and mild upset stomach were resolving 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic, Vaccination site rash, Vaccination site swelling
Clinical narrative: Left arm/shoulder around injection site swollen; Small dime sized rash around the injection; Arm pain to the touch; Rash was itchy; 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: EW0161) via an unspecified route of administration in the left arm  on 13Apr2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included May-Thurner syndrome, birth control pills, occasional ibuprofen use and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (generic ORTHO TRI-CYCLEN); as birth control pills 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 received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. On 14Apr2021 at 17:00, the patient experienced left arm/shoulder around injection site swollen, a small dime sized rash around the injection and arm pain to the touch. This was about 24 hours later, a little more. After a few days, on an unknown date in Apr2021, the rash was itchy. 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 events eft arm/shoulder around injection site swollen, small dime sized rash around the injection, arm pain to the touch and rash was itchy was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Period was the heaviest/ Had significantly heavier flow, and lasted 2 days longer than usual; It started a little bit early; 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 left arm on 02Apr2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic ovarian cysts. 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 amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), famotidine (PEPCID), omeprazole (PRILOSEC), finasteride (MERINA), fexofenadine hydrochloride (ALLEGRA) and curcuma longa rhizome (TURMERIC); all for unspecified indication from an unknown date and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and miconazole nitrate (MONISTAT), for unknown indication on an unknown date and experienced drug allergy. On 05Apr2021, the patient experienced her period was the heaviest it had been in years. It was usually extremely light, as the patient had a finasteride (MERINA) IUD. It started a little bit early, had significantly heavier flow, and lasted 2 days longer than usual. 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 been tested for COVID-19. On 05Apr2021, the patient underwent nasal swab test and result was negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event heaviest period, started a little bit early and lasted 2 days longer than usual was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Nausea, Pain
Clinical narrative: Severe headache worse than a migraine; High temperature; Chills; Sore arm; Achy body; Nausea; Not able to sleep for 36 hours; This is a spontaneous report from a 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: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included epileptic seizure disorder. The patient had unspecified allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took unknown medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 10:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, at 00:00 the patient experienced severe headache worse than (then) a migraine, high temperature, chills, sore arm, achy body, nausea, not able to sleep for 36 hours. The patient also reported that effects lasted 48 hours. 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 and included selfcare. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache worse than a migraine, high temperature, chills, sore arm, achy body, nausea, not able to sleep for 36 hours were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe headache worse than a migraine; High temperature; Chills; Sore arm; Achy body; Nausea; Not able to sleep for 36 hours; This is a spontaneous report from a 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: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included epileptic seizure disorder. The patient had unspecified allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took unknown medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 10:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, at 00:00 the patient experienced severe headache worse than (then) a migraine, high temperature, chills, sore arm, achy body, nausea, not able to sleep for 36 hours. The patient also reported that effects lasted 48 hours. 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 and included selfcare. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache worse than a migraine, high temperature, chills, sore arm, achy body, nausea, not able to sleep for 36 hours were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza like illness, Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node on my left arm where the shot was was swollen and tender; lymph node on my left arm where the shot was was swollen and tender; Flu like symptoms; started off with a fever chills and night sweats; started off with a fever chills and night sweats; pain in my head; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, arthritis, erosive arthritis and allergy to Pistachios. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC), calcium (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and cyanocobalamin (B12); all for unknown indication from unknown date and unknown if ongoing. The patient previously received prochlorperazine maleate (COMPAZINE) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 22:00, at night, the patient started out feeling like flu like symptoms and started off with a fever chills and night sweats, then pain in head and nausea. On 17Apr2021, on the second day, the patient noticed the lymph node on her left arm where the shot was swollen and tender. As of today (18Apr2021) it has been 48 hours since the shots and still not 100%. The highest the fever got is 101 and maintain the fever of 99.9 or 99.1 the rest of the time. On an unknown date, the patient underwent Body temperature and the result was 101 (units unspecified). On an unknown date, the patient underwent Body temperature and the result was 99.9 or 99.1 (units unspecified). The 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling like flu like symptoms, fever chills, night sweats, pain in head, nausea and lymph node on left arm where the shot was swollen and tender was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Pyrexia
Clinical narrative: lymph node on my left arm where the shot was was swollen and tender; lymph node on my left arm where the shot was was swollen and tender; Flu like symptoms; started off with a fever chills and night sweats; started off with a fever chills and night sweats; pain in my head; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, arthritis, erosive arthritis and allergy to Pistachios. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC), calcium (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and cyanocobalamin (B12); all for unknown indication from unknown date and unknown if ongoing. The patient previously received prochlorperazine maleate (COMPAZINE) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 22:00, at night, the patient started out feeling like flu like symptoms and started off with a fever chills and night sweats, then pain in head and nausea. On 17Apr2021, on the second day, the patient noticed the lymph node on her left arm where the shot was swollen and tender. As of today (18Apr2021) it has been 48 hours since the shots and still not 100%. The highest the fever got is 101 and maintain the fever of 99.9 or 99.1 the rest of the time. On an unknown date, the patient underwent Body temperature and the result was 101 (units unspecified). On an unknown date, the patient underwent Body temperature and the result was 99.9 or 99.1 (units unspecified). The 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling like flu like symptoms, fever chills, night sweats, pain in head, nausea and lymph node on left arm where the shot was swollen and tender was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Muscle aches; Joint pain; Headache; Extreme dizziness; Extreme fatigue; Dose 1: 01Apr2021 and Dose 2: 15Apr2021; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation.  It was unknown, if the patient was pregnant at the time of this report. 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 vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:45 as a single dose for COVID-19 immunisation. On 16Apr2021 at 04:30, the patient experienced muscle aches, joint pain, headache, extreme dizziness and extreme fatigue. The 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle aches, joint pain, headache, extreme dizziness and extreme fatigue 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.