chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Numbness in lower extremities; Mild body aches; Fever; A large swollen gland located near collar bone on the left side of body.; Severe headache; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6207) via an unspecified route of administration on 29Mar2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN 6203) via an intramuscular route of administration in the left arm on 08Mar2021 at 12:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 05:00, the patient experienced severe headache, fever, mild body aches occurred the day after second vaccination and experienced a large swollen gland located near collar bone on the left side of her body and numbness in lower extremities. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of severe headache, fever, mild body aches, large swollen gland and numbness in lower extremities were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: body ache; sore hands and feet; sore hands and feet; tired; Fever; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included arthritis, prediabetes and penicillin allergy. Concomitant medications included norethisterone (CAMILA) and citalopram hydrobromide (CELEXA); both for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 22:45, the patient experienced body ache, sore hands and feet, tired and fever. The patient underwent lab tests and procedures which included body temperature on 31Mar2021 and the result was 101.4 (units unspecified). The clinical outcome of the event general body pain, hand pain, sore feet, tiredness and fever was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Achy; headache; Chills; Nauseous; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 23Mar2021 at 17:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 06:00, the patient experienced achy, headache, chills and nauseous. The clinical outcome of the events achy, headache, chills and nauseous was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Metalic taste and smell- still have metallic taste and smell; Metalic smell; This is a spontaneous report from a contactable other healthcare professional. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 03Feb2021(at the age of 42-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 26Feb2021 at 07:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included Hepatitis B and COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included entecavir (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 18Feb2021, the patient experienced metallic taste and smell. The patient still had metallic taste and smell at the time of reporting as on 02April2021. 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 events. The clinical outcome of the event metallic taste and smell was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal spasm, Urticaria
Clinical narrative: Esophageal spasms lasting three hours; Hives over full body 7 days after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration on 24Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, 7 days after injection, at 04:00, the patient experienced hives over full body which lasted for 48 hours and esophageal spasm which lasted for 3 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events hives and esophageal spasm which included treatment with Benadryl. The clinical outcome of the event esophageal spasm was recovered on 30Mar2021 at 07:00 while hives recovered on 01Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Hyperhidrosis
Clinical narrative: Body aches; Slight stomach pain; Sweats; Excruciating headache; Fever 101.7; Chills; This is a spontaneous report from a contactable consumer, the patient. A 57-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 31Mar2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:00, the patient experienced body aches, slight stomach pain, sweats, excruciating headache, fever, chills. On 31Mar2021, the patient underwent lab tests and procedures, which included body temperature which was 101.7. It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of body aches, slight stomach pain, sweats, excruciating headache, fever, chills was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Slight stomach pain; Sweats; Excruciating headache; Fever 101.7; Chills; This is a spontaneous report from a contactable consumer, the patient. A 57-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 31Mar2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:00, the patient experienced body aches, slight stomach pain, sweats, excruciating headache, fever, chills. On 31Mar2021, the patient underwent lab tests and procedures, which included body temperature which was 101.7. It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of body aches, slight stomach pain, sweats, excruciating headache, fever, chills was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Slight stomach pain that continued toget worse throughout the day.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included penicillin allergy. The patient was allergic to amoxicillin. The patient did not receive any other medications within 2 weeks of vaccination prior to the COVID-19 vaccination. 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 10Feb2021 at 14:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021, next morning after vaccination, the patient woke up with a slight stomach pain that continued to get worse throughout the day at random times with no consistencies. The patient would feel fine then the sharp pain would start again. At some points, the pain had the patient doubling over and whimpering because it hurt so bad. The patient had the runs twice in the morning but that was it. Patient felt it very odd considering she had no history of stomach issues or any issues really. She tried seeing if this was a common side effect on the CDC website and it didn't really confirm stomach pain, just pain in general. The adverse event resulted in calling Teladoc who thought it was gastritis or some kind of stomach virus that might have been a reaction from the vaccine considering the pain was peaking exactly 24 hours from the time of vaccination. Therapeutic treatment taken as a result of stomach pain was tylenol in the morning, which didn't help and tums a few hours later which helped make the pain less intense The clinical outcome of the event stomach ache was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Fatigue; Headache; Back ache; This is a spontaneous report from a non-contactable consumer, the patient. A 29-years-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the arm right on 31Mar2021 at 12:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The relevant medical history was not reported. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 10:00 the patient experienced sore arm, fatigue, headache and back ache. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm, fatigue, headache and back ache was recovered on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Moderate headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-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 arm left on 01Apr2021 at 12:30(at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Patient received other medication within 2 weeks which included birth control pills (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. Patient did not report any allergy to food, medications or other products. 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 arm left on 10Mar2021 at 10:15(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 03:00, the patient experienced sore arm and moderate headache. Therapeutic measures were taken as a result of events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) started on unknown date. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm and moderate headache was recovering at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Intense Intense pain at site immediately.; then about 18 hours later a severe stinging (like a bee sting) on the instep of left foot that is till happening.  Does not respond to Motrin; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the left arm on 01Apr2021 at 09:00 (at the age of 63-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. Concomitant medications included losartan potassium (LOSARTIN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the left arm on 11Mar2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 09:00, the patient experienced Intense pain at site immediately then about 18 hours later a severe stinging (like a bee sting) on the instep of left foot that is till happening. Does not respond to Motrin. The patient received ibuprofen (MOTRIN) as treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site pain and pain in extremity was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Brief spells of fever like warming of body multiple times throughout day.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on 01Apr2021 (at the age of 30-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. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient had brief spells of fever-like warming of body multiple times throughout day. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event brief spells of fever-like warming of body multiple times throughout day was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Rash, Swelling, Vaccination site pain
Clinical narrative: Swelling; Redness; Vaccination site pain; Tiredness; Rash 4 inch circle since shot; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP0955) via an unspecified route in the right arm on 25Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included osteopenia, sulphur and shellfish allergy. The past drug history of the patient included gabapentin started on an unknown date for an unknown indication. The patient received lovastatin (MANUFACTURER UNKNOWN) started on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the right arm on 04Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain in arm; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 15:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included linum usitatissimum seed oil (FLAXSEED OIL) and multivitamin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced pain in arm and headache. The clinical outcome of the events pain in arm and headache was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Minor arm pain; Extreme middle & low back pain; Hip Pain; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 30Mar2021 at 12:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, back pain, sacroiliitis, herniated disc and muscle spasms. Concomitant medications included sitagliptin phosphate (JANUVIA), valaciclovir hydrochloride (VALTREX), empagliflozin (JARDIANCE) and glipizide (GLUCOTROL) all from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, at 05:00 the patient experienced minor arm pain, extreme middle & low back pain and hip pain. The patient received pain meds as a treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events minor arm pain, extreme middle & low back pain and hip pain was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: Felt extremely loopy; Tingling down both arms; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) in the right arm on 05Mar2021 at 16:30 and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) in the right arm on 26Mar2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol succinate (TOPROL), diltiazem hydrochloride (DILTIZEM), losartan (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not have a history of allergies to medications, food or other products. On 05Mar2021 (as soon as injected), the patient felt extremely loopy and tingling down both arms, still had tingling in both arms from elbows to finger tips which was not constant but it was happened every day at different times since injection. The tingling after second dose was more noticeable and after 7 days patient still have it.  Adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event extremely loopy was resolved after 2 hours on 05Mar2021. The clinical outcome of event tingling in both arms from elbows to finger tips was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I believe it caused my menstrual cycle to start about 9 days early. Usually it is about 26 days and this time it was 17 days. My second dose was 1 week before my period started.; This is a spontaneous report from a contactable pharmacist, the patient. A 38-year-old non-pregnant female patient received her second 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 13:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included multivitamin, vitamin D (MANUFACTURER UNKNOWN), leuprorelin acetate (LUPRON) and acetylsalicylic acid (ASPIRIN) all from an unknown date for an unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6200) via an unspecified route of administration in the right arm on 24Feb2021 at 15:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 07:00, 1 week after the second dose of vaccination, the patient believed that vaccination caused her menstrual cycle to start about 9 days early. The patient reported that usually her cycle is of 26 days and this time it was 17 days. The patient reported that on cycle day 10 and had very regular cycles at the time of the report. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event irregular periods was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Severe nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZERER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, the patient experienced severe nausea and diarrhea. It was unknown whether the adverse event resulted in a visit to the doctors 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. The clinical outcome of the event severe nausea and diarrhea was not recovered 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: Lymphadenopathy
Clinical narrative: Enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful.; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 26Mar2021 at 07:45 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy nos. The patient received other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful. It was unknown if the patient received treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event enlarged supraclavicular lymph node on L side noted 4/1/21 (size of a pea), non-painful was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Five days of nausea; five days of nausea and severe diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history and concomitant medications. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, the patient experienced five days of nausea and severe diarrhea. 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 events. The clinical outcome of the events nausea and severe diarrhea was recovered on 28Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chills; fever; fatigue; very bad headache; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 29Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had unspecified allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 08:00, the patient experienced chills, fever, fatigue and very bad headache. The patient did not receive any treatment for the events. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event chills, fever, fatigue and very bad headache were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Positive affects to report. Symptoms of Systemic Sclerosis disease diminished for the 1st time since onset in 2019 - less fatique, clear head (much less "brain fog") and no aura from migraine onset fo; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 (at the age of 67-years-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history included systemic sclerosis, fatigue, foggy feeling in head and migraine. The patient had allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 14:00, the patient experienced unexpected beneficial therapeutic response. It was reported that the symptoms of systemic sclerosis disease diminished for the first time since onset in 2019 - less fatigue, clear head (much less brain fog) and no aura from migraine onset for two days. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event unexpected beneficial therapeutic response was recovered on an unknown date in 2021 at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: swollen lymph nodes; Difficulty opening mouth wide and swallowing; Mild sore throat; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 28Mar2021 at 09:30(at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00 the patient experienced Sore throat and difficulty opening mouth wide and swallowing. On 02Apr2021, the patient experienced swollen lymph nodes. The patient did not receive any treatment for the events. The clinical outcome of the event Sore throat, difficulty opening mouth wide and swallowing and swollen lymph nodes was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lip swelling
Clinical narrative: Immediately felt dizziness; Lower lip swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19 on an unknown date in Jun2020. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and vitamin b12 (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 01Apr2021 at 15:15, immediately after the vaccination the patient experienced felt dizziness and lower lip swelling. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the dizziness and lip swelling was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual bleeding; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. The patient previously took codeine and experienced drug allergy. Concomitant medications included ethinylestradiol, etynodiol diacetate (ZOVIA), valaciclovir hydrochloride (VALTREX) and fluoxetine hydrochloride (PROZAC). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 05Mar2021 at 15:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021, the patient experienced irregular menstrual bleeding. The adverse event did not result in a visit to the doctors 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. The clinical outcome of the event irregular menstrual bleeding was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Menstrual cycle delayed; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 26Mar2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 12:00, the patient experienced menstrual cycle delayed. It was reported that the patient had a very stable cycle of 28 days and was due on sunday 28Mar but as of 02Apr at 03.00, her cycle had still not started. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of menstrual cycle delayed was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Fatigue, Pain in extremity
Clinical narrative: Fatigue; Slow thinking; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration in the left arm on 11Mar2021 at 09:15 (at the age of 33-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 11:00, the patient experienced fatigue, slow thinking and sore arm. 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 events. The clinical outcome of the events fatigue, slow thinking and sore arm was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip swelling; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was allergic to aspirin. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced lip swelling. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measure taken as a result of the event experienced included benadryl (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the event lip swelling was resolving at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Felt sleepy the day after the first dose; This is a spontaneous report from a non-contactable consumer. A 50-year-old non-pregnant female patient received unknown dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient received any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient not been tested for COVID-19. On 01Apr2021 the patient experienced  sleepy the day after the first dose. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event felt sleepy was recovered on unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenopathy, Thinking abnormal
Clinical narrative: Have songs playing in my head; Unwanted thoughts; Sleeplessness; Swollen glands; This is a spontaneous report from a contactable consumer, the patient. A 40-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 right arm on 31Mar2021 at 22:30 (at the age of 40-year-old ) as a single dose for COVID-19 immunisation. Medical history included epilepsy. Concomitant medication included lamotrigine (LAMICTAL) taken from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 at 23:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 22:45, the patient experienced sleeplessness, unwanted thoughts, swollen glands and had songs playing in his head (thinking abnormal). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event sleeplessness, unwanted thoughts, swollen glands and thinking abnormal were not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.