chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pyrexia, Somnolence, Tinnitus
Clinical narrative: Dose received 3/dose number = 3; I had a fever about 102 degrees; Felt absolutely terrible/could not get out of bed; Also started having bad tinnitus that lasted a few months; I had a really bad headache; Was completely exhausted; Couldnt stay awake; Had the chills; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 32-years-old) and third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Nov2021 at 17:30 (at the age of 32-years-old), both as single doses for COVID-19 immunisation. Medical history included tinnitus and flu. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, immediately after the second shot, the patient started having bad tinnitus that lasted a few months. The patient reported that he had tinnitus earlier in his life, about 15 years before this, but hadn't had it since. On 10Apr2021, the day after his second shot the patient had fever, about 102 degrees, felt absolutely terrible. On an unknown date in 2021, the patient could not get out of bed, had a really bad headache, was completely exhausted and couldn't stay awake, the patient also experienced chills and diarrhea and the patient felt worse than he did when he had the flu a couple of years ago. It was reported that after his booster shot (3rd dose), the patient experienced exact same way all over again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, felt absolutely terrible, could not get out of bed, really bad headache, was completely exhausted and couldn't stay awake, chills, diarrhea and tinnitus was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath, exhaling moredifficult than inhaling,; Chest heaviness; This is a spontaneous report from a contactable consumer, the patient. A 55-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 on 01Nov2021 (at the age of 55-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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Nov2021 the patient experienced shortness of breath, exhaling was more difficult than inhaling and chest heaviness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events shortness of breath, exhaling more difficult than inhaling and chest heaviness was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Decreased appetite, Fatigue, Immunisation
Clinical narrative: Achy joint pain, sharp stabs of pain in joints; unsteady; nauseated; extreme tiredness; loss of appetite continuing for at least two days starting about 10 hours after injection.; The patient received a third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 20Nov2021 at 11:30 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, breast cancer which was treated, kidney cancer which was resolved and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medication included influenza vaccine (INFLUENZA) (Flu shot) for immunization on 16Nov2021. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 77-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. On 20Nov2021 at 21:30, about 10 hours after the vaccination, the patient experienced achy joint pain, sharp stabs of pain in joints, unsteady, nauseated, extreme tiredness and loss of appetite continuing for at least two days. 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 achy joint pain, sharp stabs of pain in joints, unsteady, nauseated, extreme tiredness and loss of appetite was not resolved at the time of this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Achy joint pain, sharp stabs of pain in joints; unsteady; nauseated; extreme tiredness; loss of appetite continuing for at least two days starting about 10 hours after injection.; The patient received a third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 20Nov2021 at 11:30 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, breast cancer which was treated, kidney cancer which was resolved and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medication included influenza vaccine (INFLUENZA) (Flu shot) for immunization on 16Nov2021. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 77-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. On 20Nov2021 at 21:30, about 10 hours after the vaccination, the patient experienced achy joint pain, sharp stabs of pain in joints, unsteady, nauseated, extreme tiredness and loss of appetite continuing for at least two days. 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 achy joint pain, sharp stabs of pain in joints, unsteady, nauseated, extreme tiredness and loss of appetite was not resolved at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Migraine
Clinical narrative: Migraine; Extremely fatigued; Unexplained bruises I noticed 2 on my left arm Saturday and one on my stomach/Monday 2 more bruises on my left arm; This is a spontaneous report from a contactable consumer, the patient. A 35-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 10Nov2021 at 15:30 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), migraines controlled with medication, ischemic colitis episodes, anxiety and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient received unspecified concomitant medications (reported as yes my normal medications) within two weeks of vaccination. On 13Nov2021, the patient experienced unexplained bruises, noticed 2 on left arm and one on stomach then on 14Nov2021 and 15Nov2021, the patient experienced, migraine, was extremely fatigued and, 2 more bruises on left arm on 15Nov2021. The patient did not bump anything or injured self. The event resulted in doctor or other healthcare professional office/clinic visit. 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 unexplained bruises, noticed 2 on left arm and one on the stomach, migraine, extremely fatigued and 2 more bruises on left arm 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Booster; mild-to moderate right arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient) via pfizer colleague. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FHBO29 and expiry date was not reported) via unspecified route of administration into the arm right, at the age of 55-year-old, on 21Nov2021 13:21 as dose 3 (booster), single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, and then dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild-to moderate right arm pain at the injection site on 21Nov2021 13:21. The outcome of the event was recovered on 22Nov2021 10:00.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Immunisation
Clinical narrative: Fever; Chills; Muscle spasms; Joint pain; Profuse sweating; Tiredness; Pain at injection site; Lymphadenopathy; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via intramuscular route of administration in the left arm on 22Nov2021 at 08:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. 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 COVID vaccine. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via intramuscular route of administration in the left arm on 24Apr2021 at 15:00 (at the age of 21-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via intramuscular route of administration in the right arm on 15May2021 at 15:15 (at the age of 21-years-old), both as a single dose for COVID-19 immunisation. On 22Nov2021 at 12:00, the patient experienced fever, chills, muscle spasms, joint pain, profuse sweating, tiredness, pain at injection site and lymphadenopathy. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, muscle spasms, joint pain, profuse sweating, tiredness, pain at injection site and lymphadenopathy was unknown at the time of this report.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle spasms, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Muscle spasms; Joint pain; Profuse sweating; Tiredness; Pain at injection site; Lymphadenopathy; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via intramuscular route of administration in the left arm on 22Nov2021 at 08:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. 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 COVID vaccine. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via intramuscular route of administration in the left arm on 24Apr2021 at 15:00 (at the age of 21-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via intramuscular route of administration in the right arm on 15May2021 at 15:15 (at the age of 21-years-old), both as a single dose for COVID-19 immunisation. On 22Nov2021 at 12:00, the patient experienced fever, chills, muscle spasms, joint pain, profuse sweating, tiredness, pain at injection site and lymphadenopathy. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, muscle spasms, joint pain, profuse sweating, tiredness, pain at injection site and lymphadenopathy was unknown at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Insomnia, Nausea
Clinical narrative: Arm pain; Fatigue; Nausea; Insomnia; Fever; Skin sensitivity; Body aches; Light headed; Chills; 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: UNKNOWN) via an unspecified route of administration in the left arm on 21Nov2021 at 11:30(at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history includes anxiety and polycystic ovarian syndrome (PCOS). The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR), magnesium oxide (MGO), multivitamin (MANUFACTURER UNKNOWN) and vitamin D Nos (VIT D). The patient received influenza vaccine (MANUFACTURER UNKNOWN) on 27Oct2021 within four weeks prior to the COVID vaccine. On 21Nov2021 at 13:00, the patient experienced arm pain, fatigue, nausea, insomnia, fever, skin sensitivity, body aches, light headed and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, fatigue, nausea, insomnia, fever, skin sensitivity, body aches, light headed and chills was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Sensitive skin
Clinical narrative: Arm pain; Fatigue; Nausea; Insomnia; Fever; Skin sensitivity; Body aches; Light headed; Chills; 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: UNKNOWN) via an unspecified route of administration in the left arm on 21Nov2021 at 11:30(at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history includes anxiety and polycystic ovarian syndrome (PCOS). The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR), magnesium oxide (MGO), multivitamin (MANUFACTURER UNKNOWN) and vitamin D Nos (VIT D). The patient received influenza vaccine (MANUFACTURER UNKNOWN) on 27Oct2021 within four weeks prior to the COVID vaccine. On 21Nov2021 at 13:00, the patient experienced arm pain, fatigue, nausea, insomnia, fever, skin sensitivity, body aches, light headed and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, fatigue, nausea, insomnia, fever, skin sensitivity, body aches, light headed and chills was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 100 to 103 since injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Nov2021 at 20:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 09Nov2021 at 22:00, the patient had fever of 100 to 103 since injection. On the same day, the patient underwent body temperature test and the result was 100 to 103 (unspecified units). The event 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 fever of 100 to 103 since injection was not resolved at the time of the report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red, swollen, warm to the touch injection site; Red, swollen, warm to the touch injection site; Red, swollen, warm to the touch injection site; Injection site with pain and itching; Injection site with pain and itching; Administration date 18Nov2021; dose received =3; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in the right arm on 18Nov2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included clotting disorder and hypertension. 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 received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN6197) via an unspecified route of administration in the right arm on an unknown date in 08Mar2021 (at the age of 62-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 an unknown date in 2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient previously took butorphanol tartrate (STADOL) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 21Nov2021, the patient experienced red, swollen, warm to the touch, injection site with pain and itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events red, swollen, warm to the touch, injection site with pain and itching which included treatment with unspecified antihistamines, paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN) on an unknown date in 2021. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red, swollen, warm to the touch injection site and injection site with pain and itching was recovering at the time of this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Red, swollen, warm to the touch injection site; Red, swollen, warm to the touch injection site; Red, swollen, warm to the touch injection site; Injection site with pain and itching; Injection site with pain and itching; Administration date 18Nov2021; dose received =3; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in the right arm on 18Nov2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included clotting disorder and hypertension. 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 received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN6197) via an unspecified route of administration in the right arm on an unknown date in 08Mar2021 (at the age of 62-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 an unknown date in 2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient previously took butorphanol tartrate (STADOL) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 21Nov2021, the patient experienced red, swollen, warm to the touch, injection site with pain and itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events red, swollen, warm to the touch, injection site with pain and itching which included treatment with unspecified antihistamines, paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN) on an unknown date in 2021. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red, swollen, warm to the touch injection site and injection site with pain and itching was recovering at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Alopecia, Emotional disorder
Clinical narrative: About 5 weeks after receiving my second dose the hair on my head started falling out.  My hair is continuing to fall out; I am extremely distraught and upset; I am extremely distraught and upset; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 17Jun2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW001) via an unspecified route of administration in the left arm on 27May2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 02Aug2021, (also reported as about 5 weeks after receiving the second dose), the patient's hair on her head started falling out. The patient's hair was continuing to fall out and she went to her dermatologist who indicated that it was a result of the Pfizer COVID-19 vaccine. The dermatologist stated she has seen an unprecedented amount of hair loss from her patients and a strong correlation to those presenting with hair loss and receiving the vaccine. On an unknown date in 2021, the patient was extremely distraught and upset to be loosing her hair and required Pfizer to inform her how her hair loss will be halted and if/when her hair would come back. She was instructed to take hair loss supplements and required Pfizer to reimburse her for the out of pocket expenses for the hair loss supplement. The event hair on head started falling out 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 taken as a result of the event hair on head started falling out with hair loss supplements. Therapeutic measures were not taken as a result of the events extremely distraught and upset to be loosing her hair. The clinical outcome of the events hair on head started falling out and extremely distraught and upset to be loosing her hair was not resolved at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site mass
Clinical narrative: I got a large lump at the injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: En8733 and expiry date was not reported) via unspecified route of administration into the arm left, at the age of 34-year-old, on 04Apr2021 11:00, as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history includes penicillin allergy, high blood pressure and asthma. The patient concomitant medications in two weeks includes cetirizine hydrochloride (ZYRTEC), famotidine, amlodipine, losartan, albumin human (ALBUTEIN). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6208 and expiry date was not reported), via an unspecified route of administration into the arm left, on 14Mar2021 11:00, at the age of 34-year-old, as dose 1, single for covid-19 immunization. The patient didn't receive any other vaccine in four weeks. The patient was tested with Covid-19 antigen (nasal swab) and had negative result on 22Nov2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jul2021 01:00, the patient experienced large lump at the injection site 3 months after second dose. The patient didn't receive any treatment in response to the event. The outcome of the event was not recovered at the time of report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via unspecified route of administration, at the age of 53-year-old, on 13Sep2021, as dose number unknown, single for COVID-19 immunization. The patient medical history includes systemic lupous erythematous, organ for system involvement unspecified. The patient concomitant medications were not reported. On an unspecified date in 2021,the patient experienced sick. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anger, Confusional state, Depressed mood, Depression
Clinical narrative: Brain fog; Depression; Anger; Sadness; Confusion; Headache; Tiredness; Stomach pain; Body aches even my legs; Body aches even my legs; 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: FJ8757) via an unspecified route of administration in the right arm on 19Nov2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included quetiapine fumarate (SEROQUEL) and duloxetine (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. On 20Nov2021, the patient experienced brain fog, depression, anger, sadness, confusion, headache, tiredness, stomach pain and body aches even in legs. 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 brain fog, depression, anger, sadness, confusion, headache, tiredness, stomach pain and body aches even in legs was resolving at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: Brain fog; Depression; Anger; Sadness; Confusion; Headache; Tiredness; Stomach pain; Body aches even my legs; Body aches even my legs; 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: FJ8757) via an unspecified route of administration in the right arm on 19Nov2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included quetiapine fumarate (SEROQUEL) and duloxetine (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. On 20Nov2021, the patient experienced brain fog, depression, anger, sadness, confusion, headache, tiredness, stomach pain and body aches even in legs. 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 brain fog, depression, anger, sadness, confusion, headache, tiredness, stomach pain and body aches even in legs was resolving at the time of this report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe lower back pain; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (BNT162B2, Pfizer BioNtech, mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:15 as (Age at vaccination 47 years) DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease, intervertebral disc protrusion. Concomitant medications included simvastatin (SIMVASTATIN), esomeprazole magnesium (ESOMEPRAZOLE MAGNESIUM), chlorthalidon (CHLORTHALIDON). No Allergies for medication. Prior to the COVID vaccine, patient was not received any other vaccines within 4 weeks and patient was received other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient was not tested for COVID-19. On 04Mar2021 03:00, The patient experienced severe lower back pain.  Therapeutic measures were taken as a result of severe lower back pain. Tylenol treatment was received for the adverse event. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Eating disorder, Nausea, Pain, Sleep disorder
Clinical narrative: Severe intractable pain; nausea; vomiting; Inability to walk unassisted; Unable to tolerate food or liquids; could not get out of bed; slept most of the day; This is a spontaneous report from a contactable Other HCP (Patient).   A 49-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203) via unknown route of administration administered in left arm on 02Mar2021 1:30 PM (at age of 49 years) at single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included HTN, Post-Bariatric Hypoglycemia had allergic to PCN, SULFA, ERYC. Concomitant medication included Lisinopril (LISINOPRIL), Lexapro (ESCITALOPRAM OXALATE), Ativan (LORAZEPAM), Wellbutrin (BUPROPION HYDROCHLORIDE), Trulicity (DULAGLUTIDE) all taken for unspecified indication. Patient did not receive other vaccine in four weeks. Didn't had covid prior vaccination. Not tested covid post vaccination. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El9265) via unknown route of administration administered in left arm on 09Feb2021 1:30 PM (at age of 49 years) at single dose for COVID-19 immunisation. Patient experienced severe intractable pain, nausea, vomiting, Inability to walk unassisted, Unable to tolerate food or liquids, could not get out of bed and slept most of the day on 02Mar2021 09:00 PM. Treated in ER with Zofran, Tramadol, morphine and dilaudid, before she had some relief. It was reported that she tried some liquids, but it started a cycle of nausea and vomiting that lasted the whole day. Finally, today, Friday (dose was Tuesday), she tolerated some apple juice and tea. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Walking disability
Clinical narrative: Severe intractable pain; nausea; vomiting; Inability to walk unassisted; Unable to tolerate food or liquids; could not get out of bed; slept most of the day; This is a spontaneous report from a contactable Other HCP (Patient).   A 49-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203) via unknown route of administration administered in left arm on 02Mar2021 1:30 PM (at age of 49 years) at single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included HTN, Post-Bariatric Hypoglycemia had allergic to PCN, SULFA, ERYC. Concomitant medication included Lisinopril (LISINOPRIL), Lexapro (ESCITALOPRAM OXALATE), Ativan (LORAZEPAM), Wellbutrin (BUPROPION HYDROCHLORIDE), Trulicity (DULAGLUTIDE) all taken for unspecified indication. Patient did not receive other vaccine in four weeks. Didn't had covid prior vaccination. Not tested covid post vaccination. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El9265) via unknown route of administration administered in left arm on 09Feb2021 1:30 PM (at age of 49 years) at single dose for COVID-19 immunisation. Patient experienced severe intractable pain, nausea, vomiting, Inability to walk unassisted, Unable to tolerate food or liquids, could not get out of bed and slept most of the day on 02Mar2021 09:00 PM. Treated in ER with Zofran, Tramadol, morphine and dilaudid, before she had some relief. It was reported that she tried some liquids, but it started a cycle of nausea and vomiting that lasted the whole day. Finally, today, Friday (dose was Tuesday), she tolerated some apple juice and tea. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Breast discomfort, Vaccination site erythema
Clinical narrative: Got a reaction, very bad on the, next to the breast, it is getting like a ball in there and red on the, where they put the vaccine on the arm; Got a reaction, very bad on the, next to the breast, it is getting like a ball in there and red on the, where they put the vaccine on the arm; This is a spontaneous report from a non contactable consumer, this consumer reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient got the vaccine on the 6th(unspecified) and he got a reaction, very bad on the next to the breast, it is getting like a ball in there and red on the, where they put the vaccine on the arm. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle rigidity
Clinical narrative: described his experience as severe debilitating back ache; inability to bend; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old male patient received bnt162b2 (BNT162B2; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021(at the age of 46 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown, if the patient had covid prior vaccination, if covid tested post vaccination, other medical history. The patient experienced described his experience as severe debilitating back ache on an unspecified date, inability to bend on an unspecified date. Therapeutic measures were taken as a result of events as, the patient says he took Advil. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Severe Chills Nausea & vomiting/throwing up; Severe Chills Nausea & vomiting; Severe Chills Nausea & vomiting; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Deltoid Right on 22Mar2021 10:00 (at the age of 60 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. Concomitant medication included cefixime (FLEXERIL [CEFIXIME]); ibuprofen; diphenhydramine hydrochloride (BENADRYL), were taken for an unspecified indication, start and stop date were not reported. The patient had Pfizer Covid on 22Mar2021, at 10:00 and tonight he has had severe chills (23Mar2021 at 22:30) for about an hour and then in the middle of the night he started vomiting (24Mar2021) purposely. Today or tonight or this morning he has had extreme nausea (24Mar2021) and vomiting.  He just won't stop vomiting. The patient was treated with Dramamine/N for nausea and vomiting and also took Ibuprofen. The patient vomiting was slowing down, but it was not done, so slightly improved and the reason being was because he has been throwing up all night, not taking anything in. So, that was the only reason he was improving. He still has chills. The outcome of the event chills was not recovered, the event nausea was unknown, and the event vomiting was recovering. . No follow-up attempts are needed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Condition aggravated, Discomfort, Hypoaesthesia, Lymph node pain
Clinical narrative: serious discomfort in my lymph nodes; It is causing serious discomfort; bad reaction to the 2nd dose; started after the first shot and got worse after the second; numbness in my left thigh; tingling/pain in my left leg; tingling/pain in my left leg; This is a spontaneous report from a contactable consumer or other non-health care professional (patient reported for self). A 51-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, administered in arm left (reported as left arm) on 02Apr2021 16:00 (at the age of 51-year-old) as dose 2, single for covid-19 immunization administered in other facility (Reason why batch/lot is Unknown: Unknown). Patient's relevant medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included lamotrigine (LAMICTAL) and buspirone hydrochloride (BUSPAR), both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with covid-19. Patient had earlier received, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration, administered in arm left on 12Mar2021 16:00 as dose 1, single for covid-19 immunization and experienced "tingling/pain in my left leg" (Paraesthesia, Pain in extremity) on 12Mar2021 23:30. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Patient reported that, patient was having tingling/pain in the left leg (thigh) on unspecified date in 2021. It mostly occurred when patient was laying down. It started after the 1st shot and now after the 2nd had gotten worse. Patient had a bad reaction to the 2nd dose (Apr 2021) and it's been a week and patient was still having serious discomfort in the lymph nodes (03Apr2021). Patient also reported that patient was having numbness in the left thigh. It started after the first shot and got worse after the second (condition aggravated on unspecified date in Apr 2021). It was causing serious discomfort on 03Apr2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid test (sars-cov-2 test) resulted as negative on 05Apr2021 and nasal swab (sars-cov-2 test) resulted as negative on 27Apr2021. The patient did not receive any treatment for the adverse events. Device date noted as 11May2021. Outcome of the event "bad reaction" was unknown; outcome of all the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: serious discomfort in my lymph nodes; It is causing serious discomfort; bad reaction to the 2nd dose; started after the first shot and got worse after the second; numbness in my left thigh; tingling/pain in my left leg; tingling/pain in my left leg; This is a spontaneous report from a contactable consumer or other non-health care professional (patient reported for self). A 51-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, administered in arm left (reported as left arm) on 02Apr2021 16:00 (at the age of 51-year-old) as dose 2, single for covid-19 immunization administered in other facility (Reason why batch/lot is Unknown: Unknown). Patient's relevant medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included lamotrigine (LAMICTAL) and buspirone hydrochloride (BUSPAR), both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with covid-19. Patient had earlier received, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration, administered in arm left on 12Mar2021 16:00 as dose 1, single for covid-19 immunization and experienced "tingling/pain in my left leg" (Paraesthesia, Pain in extremity) on 12Mar2021 23:30. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Patient reported that, patient was having tingling/pain in the left leg (thigh) on unspecified date in 2021. It mostly occurred when patient was laying down. It started after the 1st shot and now after the 2nd had gotten worse. Patient had a bad reaction to the 2nd dose (Apr 2021) and it's been a week and patient was still having serious discomfort in the lymph nodes (03Apr2021). Patient also reported that patient was having numbness in the left thigh. It started after the first shot and got worse after the second (condition aggravated on unspecified date in Apr 2021). It was causing serious discomfort on 03Apr2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid test (sars-cov-2 test) resulted as negative on 05Apr2021 and nasal swab (sars-cov-2 test) resulted as negative on 27Apr2021. The patient did not receive any treatment for the adverse events. Device date noted as 11May2021. Outcome of the event "bad reaction" was unknown; outcome of all the other events was not recovered.  No follow-up attempts are needed. No further information is expected.