chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mania
Clinical narrative: Brain fog; Depression; Anxiety; Elevated mood; Manic episode; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient 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 an unknown date in Mar2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lamotrigine (LAMOTRIGIN) 250mg/day for unknown indication on unknown date and unknown if ongoing. The patient previously received iodine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 05Mar2021, the patient experienced brain fog, depression, anxiety, headaches and elevated mood approaching a manic episode. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events and included treatment with psychotherapy and anxiety medication. Since the vaccination, the patient had not been tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, depression, anxiety, headaches and elevated mood approaching a manic episode was not recovered at the time of this report. The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain in extremity, Pruritus
Clinical narrative: next day I experienced chills; low-grade fever; arm pain; bump at the injection site; extremely fatigued; I broke out into hives; took a Benadryl to stop the itching; This is a spontaneous report from a contactable consumer (patient). A 23-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0175, Expiration date: Unknown), dose 2 via an unspecified route of administration, administered in left arm on 27Apr2021 14:45 (at the age of 23-years-old) as dose 2, single for covid-19 immunisation in doctor's office/urgent care. It was reported that, other vaccine was administered 27Apr2021 but it was not clear. No other vaccine administered in four weeks. The patient did not have Covid prior vaccination. The patient was not tested for Covid post vaccination. No known allergies were reported. Medical history included obesity. Concomitant medication(s) included ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for an unspecified indication, start and stop date were not reported; vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ep7533, Expiration date: Unknown), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 11:15 (at the age of 23-years-old) as dose 2, single for covid-19 immunisation in doctor's office/urgent care. On 27Apr2021 at 22:30, the patient experienced she broke out into hives, took a benadryl to stop the itching. On 28Apr2021, the patient experienced she experienced chills, low-grade fever, arm pain, bump at the injection site and extremely fatigued. The patient underwent lab tests and procedures which included body temperature: low-grade on 28Apr2021. Therapeutic measures were taken as a result of itching with Benadryl. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vaccination site mass
Clinical narrative: next day I experienced chills; low-grade fever; arm pain; bump at the injection site; extremely fatigued; I broke out into hives; took a Benadryl to stop the itching; This is a spontaneous report from a contactable consumer (patient). A 23-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0175, Expiration date: Unknown), dose 2 via an unspecified route of administration, administered in left arm on 27Apr2021 14:45 (at the age of 23-years-old) as dose 2, single for covid-19 immunisation in doctor's office/urgent care. It was reported that, other vaccine was administered 27Apr2021 but it was not clear. No other vaccine administered in four weeks. The patient did not have Covid prior vaccination. The patient was not tested for Covid post vaccination. No known allergies were reported. Medical history included obesity. Concomitant medication(s) included ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for an unspecified indication, start and stop date were not reported; vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ep7533, Expiration date: Unknown), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 11:15 (at the age of 23-years-old) as dose 2, single for covid-19 immunisation in doctor's office/urgent care. On 27Apr2021 at 22:30, the patient experienced she broke out into hives, took a benadryl to stop the itching. On 28Apr2021, the patient experienced she experienced chills, low-grade fever, arm pain, bump at the injection site and extremely fatigued. The patient underwent lab tests and procedures which included body temperature: low-grade on 28Apr2021. Therapeutic measures were taken as a result of itching with Benadryl. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin lesion
Clinical narrative: bumps in her face, ears (improved) and nose; i do experience a little pain when it rains; This is a spontaneous report from a contactable healthcare professional and consumer. A 63-year-old female patient received BNT162B2 (BNT162B2, PFIZER COVID-19 Vaccine, Soultion for injection, Batch/lot number and expiration date: was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced small bumps in her face on an unspecified date. i do experience a little pain when it rains on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible.; information about lot/batch no cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Day 8 at injection site noticed a 2-3in circle in diameter, warm, itchy and elevated.; Day 8 at injection site noticed a 2-3in circle in diameter, warm, itchy and elevated.; Day 8 at injection site noticed a 2-3in circle in diameter, warm, itchy and elevated.; 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: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 16:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and had allergy to the antibiotic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), rizatriptan benzoate (MAXALT) and paracetamol (TYLENOL); all on unknown dates, for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 22Apr2021 at 18:00, on day 8, the patient noticed at the injection site, a 2-3in circle in diameter, warm, itchy and elevated. 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 for the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a 2-3incircle in diameter, warm and itchy was not recovered at the time of this report.  The clinical outcome of the events 2-3in circle in diameter, warm, itchy and elevated was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sores; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included oral herpes simplex virus (HSV), always asymptomatic which was diagnosed in 2009 (12 years). 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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, the patient's immune system seemed to have triggered the formation of a cold sore after second dose of vaccine. The patient was unsure whether she would now have symptomatic oral HSV moving forward. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event cold sore was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 70-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 18Apr2021 at 15:15 (at the age of 70-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 20:00, the patient experienced tiredness (fatigue). The event 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 the reported event. The clinical outcome of the event tiredness 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: After second vaccination woke up the following day with sever head aches which lasted until the next morning; Body aches lasting 2 days; Extreme tiredness, missed 2.5 days of work; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 21Apr2021 at 11:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included RA (Rheumatoid Arthritis) and fibromyalgia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), calcium folinate (LEUCOVORIN CALCIUM), fish oil (OMEGA 3) and glucose (MANUFACTURER UNKNOWN); all for unknown indications from unknown date. The patient did not receive any other vaccine 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: EN6201) via an unspecified route of administration in the left arm on 31Mar2021 at 13:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 05:30 after the second vaccination the patient woke up the following day with severe headaches which lasted until the next morning, body aches lasting 2 days and extreme tiredness. The patient missed 2.5 days of work. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was recovered on 23Apr2021. The clinical outcome of the event body aches was recovered on 24Apr2021, while that of the event tiredness was recovering 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: Chills, Diplopia, Ear pain, Fatigue, Headache
Clinical narrative: aches; minor ear ache; double vision; fatigue; chills; Headache; This is a spontaneous report from a non-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: EW0151) via an unspecified route of administration in the left arm on 22Apr2021 at 17:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, norgestimate (TRI LO MARZIA) on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 01Apr2021 at 18:00 (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 vaccination. On 23Apr2021 at 07:30, the patient experienced headache, fatigue, aches, chills, minor ear ache, double vision. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, aches, chills, minor ear ache, double vision was unknown 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: Pain
Clinical narrative: aches; minor ear ache; double vision; fatigue; chills; Headache; This is a spontaneous report from a non-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: EW0151) via an unspecified route of administration in the left arm on 22Apr2021 at 17:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, norgestimate (TRI LO MARZIA) on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 01Apr2021 at 18:00 (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 vaccination. On 23Apr2021 at 07:30, the patient experienced headache, fatigue, aches, chills, minor ear ache, double vision. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, aches, chills, minor ear ache, double vision was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 09:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder (thyroid problem) . Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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, (at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced dizziness and nausea. Since the vaccination the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of 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 events dizziness and nausea was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Visual impairment
Clinical narrative: Having numbness in right arm and face and neck on right side; And some vision issues; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the right arm on 15Apr2021 at 16:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (reported as Low thyroid). Concomitant medications taken within trwo weeks of vaccination included gemfibrozil (LOPID) (reported as Synthetic lopid), omeprazole (PRILOSEC), tramadol (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE) and calcium vi; all from unknown date for unknown indication. The patient previously took metronidazole (FLAGYL) and experienced drug allergy. The patient previously took fentanyl (MANUFACTURER UNKNOWN) and experienced drug allergy. 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. The patient was having numbness in right arm and face and neck on right side. Started two days after vaccine on 17Apr2021. And some vision issues. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events having numbness in right arm and face and neck on right side, some vision issues was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain in extremity
Clinical narrative: Increased back pain; sore arm; Muscle aches; This is a spontaneous report from a non-contactable other healthcare professional. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 10Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain from nursing injury. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications included rivaroxaban (XARELTO); taken for an unknown indication on 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 an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, day after second dose, the patient had sore arm, muscle aches and increased back pain. 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 sore arm, muscle aches and increased back pain and included treatment with acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, muscle aches and increased back pain were recovered an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Vaccination site erythema, Vaccination site mass
Clinical narrative: Today the caller fell carrying a package; She hit right where the vaccine was and its red; she hit right on where she got the vaccine and an instant knot came up on her arm; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, in left arm on 21Apr2021 as dose 1, single for covid-19 immunisation. Medical history included stroke. The patient's concomitant medications were not reported. patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), for covid-19 immunisation. She got her second dose yesterday 21Apr2021 and everything was fine on her left arm. On 22Apr2021 today patient fell carrying a package and she hit right on where she got the vaccine, and an instant knot came up on her arm. She hit right where the vaccine was, and its red. Patient inquired if it could be a blood clot. Patient had a history of a stroke, so she was scared. The outcome of the events was unknown.  Communication: The caller declines to file a safety report, no further information or details were captured at this time. The caller was provided with phone number, and hours of operation prior to cold transfer due to a high call volume.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms in left hand 7-10 times a day; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 10Mar2021 at 15:45 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient did not have any 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 included cetirizine hydrochloride (ZYRTEC), esomeprazole magnesium(MANUFACTURER UNKNOWN) 20mg; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 12Mar2021 at 00:00, the patient experienced muscle spasms in left hand 7-10 times a day. Onset occurred directly after second vaccination and has not gone away. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event muscle spasms in left hand 7-10 times a day was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Terrible migraine on front left head; This is a spontaneous report from a contactable consumer, the patient. A 48-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 22Apr2021 at 18:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included systemic lupus erythematosus (SLE) and rheumatoid arthritis. 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 previously 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 25Mar2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation.  On 23Apr2021 at 07:00, the patient experienced terrible migraine on front left head. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event terrible migraine on front left head 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: pain that is going into his arm and to his heart; the pain is traveling to the chest; pain in his right arm into his chest; Feverish; running nose and sneezing; running nose and sneezing; This is a spontaneous report from a contactable consumer. This 49-year-old consumer (patient) reported that: A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm right on 29Apr2021 (age at vaccination was 49-year-old) as dose 2, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0158 and Expiry date was not reported), dose 1 via an unspecified route of administration in right arm on 08Apr2021 (age at vaccination was 49-year-old) as dose 1, single dose for covid-19 immunisation. The call began with the caller's wife. She began to explain her husband's symptoms and stated that her husband had the first dose of the vaccine and didn't feel any symptoms, but he got the second shot on his right arm and is complaining that the pain is traveling to the chest. he had pain that is going into his arm and to his heart. It is on the right arm where he got the vaccine and into the chest. Is this something to be concerned about. The caller wants to know if this is a side effect. The caller looked it up online and didn't see anything about the pain traveling to the chest. This event happened after the second vaccine. No verbal response given to this caller. She passed the phone to her husband, the caller, and he explained further. He stated that the first shot on the left arm was not painful and the pain went away within a day. With the second one he is having pain on his arm that is still hurting and traveling down. He states it is where the collar bone is and is traveling down. After referring him for evaluation for chest pain he stated he doesn't know if it is really chest pain, but it is on top of his breast. He wanted to know if this is a normal side effect and if there is any medication, he can take for it. After the verbal response he stated he will go ahead and call the doctor and continue to monitor this. On 29Apr2021 the patient experienced the pain is traveling to the chest, pain in his right arm into his chest, feverish, running nose and sneezing, on an unspecified date patient experienced pain that is going into his arm and to his heart. pain in his right arm into his chest was reported as worsened. Outcome of the events pain is traveling to the chest and pain in his right arm into his chest was not recovered, pain that is going into his arm and to his heart was unknown and rest of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: pain that is going into his arm and to his heart; the pain is traveling to the chest; pain in his right arm into his chest; Feverish; running nose and sneezing; running nose and sneezing; This is a spontaneous report from a contactable consumer. This 49-year-old consumer (patient) reported that: A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm right on 29Apr2021 (age at vaccination was 49-year-old) as dose 2, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0158 and Expiry date was not reported), dose 1 via an unspecified route of administration in right arm on 08Apr2021 (age at vaccination was 49-year-old) as dose 1, single dose for covid-19 immunisation. The call began with the caller's wife. She began to explain her husband's symptoms and stated that her husband had the first dose of the vaccine and didn't feel any symptoms, but he got the second shot on his right arm and is complaining that the pain is traveling to the chest. he had pain that is going into his arm and to his heart. It is on the right arm where he got the vaccine and into the chest. Is this something to be concerned about. The caller wants to know if this is a side effect. The caller looked it up online and didn't see anything about the pain traveling to the chest. This event happened after the second vaccine. No verbal response given to this caller. She passed the phone to her husband, the caller, and he explained further. He stated that the first shot on the left arm was not painful and the pain went away within a day. With the second one he is having pain on his arm that is still hurting and traveling down. He states it is where the collar bone is and is traveling down. After referring him for evaluation for chest pain he stated he doesn't know if it is really chest pain, but it is on top of his breast. He wanted to know if this is a normal side effect and if there is any medication, he can take for it. After the verbal response he stated he will go ahead and call the doctor and continue to monitor this. On 29Apr2021 the patient experienced the pain is traveling to the chest, pain in his right arm into his chest, feverish, running nose and sneezing, on an unspecified date patient experienced pain that is going into his arm and to his heart. pain in his right arm into his chest was reported as worsened. Outcome of the events pain is traveling to the chest and pain in his right arm into his chest was not recovered, pain that is going into his arm and to his heart was unknown and rest of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Maternal exposure during pregnancy, Pyrexia
Clinical narrative: Fever of 101*F; Chills; Fatigue; dose 2 administration date 30Apr2021; Last menstrual date 24Oct2020, gestational period 27 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old 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 30Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. 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 in the left arm on 09Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30 Apr 2021 00:00 Since the patient had received the vaccine during pregnancy there was maternal exposure during pregnancy, second trimester. On 01May2021, the patient experienced fever of 101*F, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of fever of 101*F, chills and fatigue were recovered on 01May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myalgia, Palpitations
Clinical narrative: Night of 2nd dose: chest pain, muscle painSince then I've had paplitations and chest pain daily; Night of 2nd dose: chest pain, muscle painSince then I've had paplitations and chest pain daily; Night of 2nd dose: chest pain, muscle painSince then I've had paplitations and chest pain daily; This is a spontaneous report from a contactable other hcp (patient). A 28-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E23248) via intramuscular, administered in Arm Right on 21Jan2021 15:00 (at the age of 28-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing. Concomitant medication(s) included loratadine, fluticasone, ibuprofen all these taken for an unspecified indication, start and stop date 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. Patient had no known allergies. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E10142) via intramuscular, administered in Arm Left on 31Dec2020 11:00 (at the age of 28-year-old) as DOSE 1, SINGLE for covid-19 immunisation. On 21Jan2021 22:00 the patient experienced night of 2nd dose: chest pain, muscle pain since then I've had palpitations and chest pain daily. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the resulted events. The clinical outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Dizziness; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 14:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, allergy to nuts and fruit allergy (Berries). 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. Patient did not receive any medication within two weeks of the COVID vaccine. The patient previously took levofloxacin (LEVAQUIN) from an unknown date for an unspecified indication and experienced drug allergy. On 31Mar2021 at 09:00, the patient experienced dizziness; it began a few days after the 1st dose. It was intermittent but at week four, it was getting a bit worse and was occasionally accompanied by tinnitus which lasted 20-30 mins at a time, had only 3 or so bouts of tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, it was intermittent but at week four, it was getting a bit worse and was occasionally accompanied by tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: The patient reported a knot/bump in her arm at the injection site.; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 64-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included insulin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. On an unknown date in Apr2021, the patient experienced a knot/bump in the arm at the injection site. 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 knot/bump in the arm at the injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event knot/bump in the arm at the injection site was unknown at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: Soreness at injection site; Gastrointestinal discomfort; Resolution of symptoms from a prior COVID-19 infection; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, 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. Concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced soreness at injection site and gastrointestinal discomfort. It was reported that the patient was feeling much better 36 hours after the shot than before the shot, including resolution of symptoms from a prior COVID-19 infection (shortness of breath, lethargy, brain fog) that had been lingering for months prior to the vaccination. 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. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events soreness at injection site and gastrointestinal discomfort was resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Vertigo
Clinical narrative: severe vertigo; dizziness; 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: EP6955) via an unspecified route of administration in the left arm  on 29Mar2021 at 12:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient received other vaccine within 4 weeks of vaccination which included  varicella zoster vaccine (MANUFACTURER UNKNOWN) on 10Mar2021 for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Apr2021 at 04:00, the patient experienced severe vertigo and dizziness. On 07Apr2021, 14Apr2021 and on 21Apr2021, the patient underwent lab test and procedures which included COVID-19 virus test (Dxterity)  and the results were negative. Therapeutic measures were not taken as a result of the event. 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. The clinical outcome of the event severe vertigo and dizziness was resolved on 14Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: debilitating vertigo occurring every 3-5 days after vaccine administration; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 30Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse. A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729 ), via intramuscular, administered in Deltoid Left on 08Apr2021 15:02 as dose 1, single for covid-19 immunization.  Medical history included lyme disease from 2013 to 2015. Concomitant medication included cetirizine hydrochloride (ALLER TEC) taken for Environmental allergies from May2020 and ongoing.  On 13Apr2021, the patient experienced serve debilitating vertigo occurring every 3-5 days after vaccine administration. It was reported that vertigo is happening to others getting the Pfizer Covid vaccine. The event involved physician office visit. The event was assessed as serious. Persistent/significant disability/ incapacity. Therapeutic measures were taken as a result of the event includes meclizine and ondansetron. The outcome of the event was recovered on 30May2021 with sequelae.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between event Vertigo and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.