chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful underarm on right side; Swollen and painful underarm on right side; Lymph nodes so tender to touch and movement; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Oct2021 at 16:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received the Influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 23Sep2021 for immunization within four weeks prior to the vaccination. The patient did not receive any other concomitant medications. 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 03Feb2021 (at the age of 49-years-old) and also 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 01Mar2021 (at the age of 49-years-old) both as a single dose for COVID-19 immunisation. On 06Oct2021 at 03:00, the patient experienced swollen and painful underarm on right side and lymph nodes so tender to touch and movement. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and painful underarm on right side and lymph nodes so tender to touch and movement were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Immunisation, Insomnia
Clinical narrative: Vomiting; Headache; Lightheaded; Chills; Body aches; Insomnia; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 07Oct2021 at 07:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient was type 2 diabetic, and was allergic to latex, shellfish, kiwi and pine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included metformin (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY) and ertugliflozin pidolate (STEGLATRO); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second 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. On 07Oct2021 at 11:00, the patient experienced vomiting, headache, lightheaded, chills, body aches and insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events vomiting, headache, lightheaded, chills, body aches and insomnia was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Vomiting; Headache; Lightheaded; Chills; Body aches; Insomnia; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 07Oct2021 at 07:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient was type 2 diabetic, and was allergic to latex, shellfish, kiwi and pine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included metformin (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY) and ertugliflozin pidolate (STEGLATRO); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second 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. On 07Oct2021 at 11:00, the patient experienced vomiting, headache, lightheaded, chills, body aches and insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events vomiting, headache, lightheaded, chills, body aches and insomnia was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Chills; Muscle aches; Booster\ received dose 3; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 06Oct2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 08Feb2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021 at 23:00 the patient experienced fever, nausea and muscle aches. The patient did not receive any treatment for the events. The clinical outcome of the event fever, nausea, chills and muscle aches was resolved on an unknown date in Oct2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Sudden cease of menstruation; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 16Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 22Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced sudden cease of menstruation. The event sudden cease of menstruation resulted in doctor or other healthcare professional office/clinic visit. 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 sudden cease of menstruation was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Rash, Urticaria
Clinical narrative: Hives; Rashes all over my body; Really irritating itch; Dry spots coming all over body; This is a spontaneous report from a contactable healthcare professional, the patient. A 23-year-old 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 27Sep2021 at 10:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Sep2021 at 00:00, the patient experienced hives, rashes all over her body, really irritating itch and dry spots coming all over her body. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified steroids, cream and diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives, rashes all over her body, really irritating itch and dry spots coming all over her body was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful lymph nodes mostly in axilla; Swollen, painful lymph nodes mostly in axilla; Painful achy legs; Headache; Fatigue; Booster dose; Influenza vaccine was taken on the same date of suspect vaccine.; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 06Oct2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The medical history included hashimoto's, irritable bowel syndrome (IBS), polycystic ovarian syndrome (PCOS) and immunization. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within 4 weeks prior to the COVID-19 vaccine included hepatitis b vaccine (MANUFACTURER UNKNOWN) on 16Sep2021 and influenza vaccine (MANUFACTURER UNKNOWN) on 06Oct2021, both for immunization. The concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 30Dec2020 (at the age of 23-years-old) and  the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 22Jan2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021 at 15:15, the patient experienced swollen, painful lymph nodes mostly in axilla, painful achy legs, headache and fatigue. 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 swollen, painful lymph nodes mostly in axilla, painful achy legs, headache and fatigue were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product use issue
Clinical narrative: Swollen, painful lymph nodes mostly in axilla; Swollen, painful lymph nodes mostly in axilla; Painful achy legs; Headache; Fatigue; Booster dose; Influenza vaccine was taken on the same date of suspect vaccine.; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 06Oct2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The medical history included hashimoto's, irritable bowel syndrome (IBS), polycystic ovarian syndrome (PCOS) and immunization. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within 4 weeks prior to the COVID-19 vaccine included hepatitis b vaccine (MANUFACTURER UNKNOWN) on 16Sep2021 and influenza vaccine (MANUFACTURER UNKNOWN) on 06Oct2021, both for immunization. The concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 30Dec2020 (at the age of 23-years-old) and  the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 22Jan2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021 at 15:15, the patient experienced swollen, painful lymph nodes mostly in axilla, painful achy legs, headache and fatigue. 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 swollen, painful lymph nodes mostly in axilla, painful achy legs, headache and fatigue were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Renal pain, Swelling
Clinical narrative: Painful swelling in arm pit.; Aches in kidneys; headaches; Painful swelling in arm pit; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 18:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included gout and arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took codeine(MANUFACTURER UNKNOWN) and experienced drug allergy. On 07Oct2021 at 07:30, the patient experienced painful swelling in arm pit, aches in kidneys and headaches. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful swelling in arm pit, aches in kidneys and headaches were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph node and pain in the left arm pit; Swollen lymph node and pain in the left arm pit; Chills; Fatigue; Booster; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received third booster dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via intramuscular route of administration in the left arm on 06Oct2021 at 13:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via intramuscular route of administration in the left arm on 14Jan2021 at 10:00 (at the age of 30-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via intramuscular route of administration in the left arm on 04Feb2021 at 10:00 (at the age of 30-year-old); both as a single dose for COVID-19 immunisation. On 07Oct2021, for the third dose, the patient experienced swollen lymph node and pain in the left arm pit (same side as injection). This was not experienced during the first or second injection. Additional adverse events included body chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node and pain in the left arm pit, body chills and fatigue was resolving at the time of report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph node left side above collar bone; Swollen lymph node left side above collar bone. Slightly painful; Administration date 05Oct2021, dose number 3; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 05Oct2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. 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 ibuprofen (ADVIL), vitamin d nos (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and ademetionine (SAM-E); all taken for unknown indications 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: Unknown) via an unspecified route of administration on 05Mar2021 (at the age of 49-years-old) and also 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 26Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 27Aug2021, the patient had nasal swab test for COVID-19 and the result was negative. On 05Oct2021, the patient had "administration date 05Oct2021, dose number 3". On 06Oct2021, the patient had swollen lymph node left side above collar bone and was slightly painful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events swollen lymph node left side above collar bone and was slightly painful. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events swollen lymph node left side above collar bone and slightly painful was not resolved while the event "administration date 05Oct2021, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Myalgia, Off label use
Clinical narrative: Pain at injection site; Muscle pain; Headache; Fatigue; drifted in and out of sleep all day; the patient has received third/ booster dose; the patient has received third/ booster dose; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 14:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies environmental.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an intramuscular route of administration in the left arm on 14Jan2021 (at the age of 39-year-old), as a single dose for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an intramuscular route of administration in the left arm on 02Feb2021 (at the age of 39-year-old), as a single dose for COVID-19 immunisation.  On 08Oct2021 at 05:00 the patient experienced pain at injection site, muscle pain when moving that was noted around 5 am, headache and fatigue. Patient also reported that headache was starting to lift after 24hrs, muscle pain and fatigue was still present, pain at injection site was still present when holding arm at shoulder height or above, but there was no pain in neutral position. The patient had called into work around 07:20 am, drifted in and out of sleep all day.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, headache, fatigue and pain at injection site , drifting  in and out of sleep all day were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: Pain at injection site; Muscle pain; Headache; Fatigue; drifted in and out of sleep all day; the patient has received third/ booster dose; the patient has received third/ booster dose; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 14:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies environmental.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an intramuscular route of administration in the left arm on 14Jan2021 (at the age of 39-year-old), as a single dose for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an intramuscular route of administration in the left arm on 02Feb2021 (at the age of 39-year-old), as a single dose for COVID-19 immunisation.  On 08Oct2021 at 05:00 the patient experienced pain at injection site, muscle pain when moving that was noted around 5 am, headache and fatigue. Patient also reported that headache was starting to lift after 24hrs, muscle pain and fatigue was still present, pain at injection site was still present when holding arm at shoulder height or above, but there was no pain in neutral position. The patient had called into work around 07:20 am, drifted in and out of sleep all day.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, headache, fatigue and pain at injection site , drifting  in and out of sleep all day were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Period started after i received the shot and has not stopped; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via intramuscular route of administration in the left arm on 22Sep2021 at 10:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via intramuscular route of administration in the left arm on 01Sep2021 at 10:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 22Sep2021, the patient's period started after she received the shot and has not stopped. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period started after she received the shot and has not stopped was unknown at the time of this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness; Tingling; Weakness; Gait disturbance; This is a spontaneous report from a contactable healthcare professional. A 39-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 on 30Sep2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 as prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether, if the patient had received 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: UNKNOWN) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. The patient previously received morphine (MANUFACTURER UNKNOWN) on an unknown date, for unknown indication and experienced drug allergy. On an unknown date in Sep2021, the patient experienced numbness, tingling, weakness and gait disturbance. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether, the patient had been tested for COVID-19. Therapeutic measures were taken as a result of numbness, tingling, weakness and gait disturbance and included treatment with unspecified medication. The clinical outcome of the events numbness, tingling, weakness and gait disturbance was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: I received my 1st shot in right arm. 3 days later and I've lost more than 50 percent of my strength in that arm to include shoulder. I have zero pain just no strength on my right side; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Oct2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 04Oct2021 at 07:00, 3 days after vaccination, the patient had lost more than 50 percent of his strength in that arm to include shoulder. The patient had zero pain just no strength on his right side. It has been 7 days and no improvement to his right arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lost more than 50 percent of his strength in that arm to include shoulder and had zero pain just no strength on his right side was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain of skin, Sensitive skin
Clinical narrative: Getting sick; Skin sensitivity; Complained about skin sensitivity. Reported that clothes touching her skin and taking a shower was painful; This is a spontaneous report from a contactable consumer. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. 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. On an unknown date, after the second dose, the patient was getting sick and complained about skin sensitivity and reported that, clothes touching her skin and taking a shower was painful. Since the vaccination, it was unknown whether the patient had tested for COVID-19. The clinical outcome of the events getting sick, skin sensitivity and clothes touching her skin and taking a shower was painful was resolved on an unknown date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain
Clinical narrative: Very sore lymph nodes under the arm; Patient received third dose; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 04Oct2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic 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 loratadine (CLARITINE) and ibuprofen (ADVIL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 61-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 62-years-old); as a single dose for COVID-19 immunisation. On 05Oct2021, the patient experienced very sore lymph nodes under the arm where the patient got the vaccine, especially on day2-3 and by day 4, most of the soreness dissipated. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very sore lymph nodes under the arm was resolved on 07Oct2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Skin warm
Clinical narrative: "My" right arm is hot and red near "my" elbow; "My" right arm is hot and red near "my" elbow; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 07Oct2021 at 14:00 (at the age of 35-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 fluoxetine hydrochloride (PROZAC), simvastatin (MANUFACTURER UNKNOWN), aciclovir (ACYCLOVIR), hydrocodone (MANUFACTURER UNKNOWN) and unspecified medications, all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 34-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 03Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient previously took morphine (MANUFACTURER UNKNOWN), pethidine hydrochloride (DEMEROL) and experienced allergy. On 08Oct2021, the patient's right arm was hot and red near her elbow. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm was hot and red near elbow were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Very sore arm; Swollen lymph nodes in armpit; Third dose (booster dose) administered; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the right arm on 07Oct2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other 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 first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685) via intramuscular route of administration in the right arm on 29Dec2020 at 09:00 (at the age of 37-years-old) and also a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ3249) via intramuscular route of administration in the right arm on 19Jan2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021, the patient experienced very sore arm and swollen lymph nodes in armpit on same arm as injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 08Oct2021, the patient underwent Binax Now Rapid test for COVID 19 via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very sore arm and swollen lymph nodes in armpit on same arm as injection were resolving at the time of this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: Severe difficulty breathing lasting 24 nights (and 10 times during the daytime); This is a spontaneous report from a contactable consumer, the patient. An 80-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 17Mar2021 at 13:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included 2 stents placed on an unknown date in 2010. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of 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 25Feb2021 at 15:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. On 19Mar2021 at 01:00, the patient experienced severe difficulty breathing lasting 24 nights (and 10 times during the daytime). The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent nasal swab test and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the event severe difficulty breathing lasting 24 nights (and 10 times during the daytime) was recovered on an unspecified date in Apr2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Fatigue, Nasal congestion
Clinical narrative: Cough; Congestion; Fatigue; Aches; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Apr2021 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. It was unknown if the patient had received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 28Sep2021, the patient experienced cough, congestion, fatigue, aches and loss of taste and smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events cough, congestion, fatigue, aches and loss of taste and smell was 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Cough; Congestion; Fatigue; Aches; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Apr2021 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. It was unknown if the patient had received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 28Sep2021, the patient experienced cough, congestion, fatigue, aches and loss of taste and smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events cough, congestion, fatigue, aches and loss of taste and smell was 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Back ache; Headache; Sore throat; Mouth blisters; Fatigue; Runny nose; Cough; Elevated pulse rate (+20bpm); Loss of appetite; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3189) via an unspecified route of administration in the right arm on 30Sep2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) taken for immunization on 28Sep2021. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 52-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 04Oct2021, the patient experienced back ache, head ache, sore throat, mouth blisters, fatigue, runny nose, cough, elevated pulse rate (+20bpm) and loss of appetite. 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 events. On 04Oct2021, the patient underwent pulse rate test and the result was +20 beats per minute (bpm). Since the vaccination, the patient had been tested for COVID-19. On 01Oct2021, the patient underwent SARS-CoV-2 test (Polymerase Chain Reaction (PCR); other) and the result was negative. The clinical outcome of the events back ache, head ache, sore throat, mouth blisters, fatigue, runny nose, cough, elevated pulse rate (+20bpm) and loss of appetite was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.