chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Fever; chills; injection site pain; 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: EL3247), via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to 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 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient experienced fever, chills and injection site pain (vaccination site pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever, chills, and injection site pain were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Peripheral swelling
Clinical narrative: sharp pain; Developed swelling on both arms on elbow joints and on knee joints.; Developed swelling on both arms on elbow joints and on knee joints.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: SMPHO ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and asthma. The patient had a history of allergy to penicillin and sulfa drugs. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: SMPHO EN6202) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 11:30, the patient had experienced swelling of both arms, elbow joints, knee joints and at 16:30 (after 06 hours of vaccination), she had experienced sharp pain which ran through the right side of the body. The patient did not receive any treatment for the adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events developed swelling on both arms on elbow joints and on knee joints and sharp pain was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 15Mar2021 at 15:00 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The patient medical history included asthma, COVID-19. The patient previously received unspecified sulfonamide medications (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), celecoxib (CELEXA), fexofenadine (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and daily vita (MANUFACTURER UNKNOWN), all medications for unspecified indications. The patient did not receive other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received other vaccine (unspecified) on the same date 01Mar2021.  On 17Mar2021 at 07:00, the patient experienced daily hair loss and clumps of hair was falling out during shampooing and while brushing hair. It was noticeable daily shedding of hair on clothing and while running fingers through hair. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the reported event. The clinical outcome of the event hair loss was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pharyngeal swelling, Throat irritation, Tonsillar hypertrophy
Clinical narrative: throat is swollen; Scratchy throat; Tonsils feel enlarged; have a dry cough; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included underactive thyroid and obesity. The concomitant medications included levothyroxine sodium (SYNTHROID) 75 mcg and phentermine (UNKNOWN MANUFACTURER). The patient had no known allergies to food, medications or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not tested for COVID-19. The patient has not tested for COVID-19 post vaccination. On 24Mar2021, at 10:30 , the patient experienced swollen and scratchy throat. She can't seem to clear her throat. Her tonsils felt enlarged and had a dry cough. The patient did not receive any treatment for reported events. The clinical outcome of swollen throat, itchy throat, enlarged tonsils and dry cough was not recovered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts possible. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Nausea; headache; lack of appetite; muscle aches; soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration on 24Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have allergies to medications, food, or other products. The patient experienced nausea, headache, lack of appetite, muscle aches, and soreness at injection site on 25Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the event nausea, headache, lack of appetite, muscle aches and vaccination site pain were unknown. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Swelling, Vaccination site pruritus
Clinical narrative: Itch at injection site; swelling; small red splotches noted on right back, right arm, right leg; large area on upper arm with raised red patches, and continued itching; large area on upper arm with raised red patches, and continued itching; This is a spontaneous report received from a non-contactable nurse, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL0142), via an unspecified route of administration in the left arm on unspecified date in Jan2021, as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified). Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), atenolol, chlorthalidone (MANUFACTURER UNKNOWN), and amitriptyline hydrochloride (AMITRIPT): all for unspecified indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Feb2021, the patient experienced itch at injection site two weeks after vaccination and over 3 weeks swelling and large area on upper arm with raised red patches and continued itching. The patient also experienced small red splotches noted on right back, right arm and right leg. Therapeutic measures were taken as a result of the reported events and included treatment with topical hydro cream with BENADRYL and unspecified oral medication. 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 vaccination site pruritus, swelling, patchy rash and red blotches was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Influenza, Pain
Clinical narrative: flu (fever, fatigue, headache, ache and pain); poor sleep; 100+ degree (F) fever; headache.; just fatigued; general aches; This is a spontaneous report from a non-contactable consumer. A 56-year-old adult male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: UNKNOWN), via an unspecified route of administration on 25Mar2021 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EN 6205), via an unspecified route of administration on 04Mar2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation. The patient was not tested with COVID-19 prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced 100+ degree (F) fever, the night of receiving 2nd dose of the vaccine for several hours during the night, along with some general aches and pains and headache, generally, characterized the symptoms as mild flu symptoms. The fever was gone by morning, felt better, just fatigued, likely from poor sleep due to the flu symptoms. No treatment was taken for the adverse 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 of flu like symptoms, poor sleep, generalised body pain, headache and fatigue was resolved.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: flu (fever, fatigue, headache, ache and pain); poor sleep; 100+ degree (F) fever; headache.; just fatigued; general aches; This is a spontaneous report from a non-contactable consumer. A 56-year-old adult male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: UNKNOWN), via an unspecified route of administration on 25Mar2021 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EN 6205), via an unspecified route of administration on 04Mar2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation. The patient was not tested with COVID-19 prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced 100+ degree (F) fever, the night of receiving 2nd dose of the vaccine for several hours during the night, along with some general aches and pains and headache, generally, characterized the symptoms as mild flu symptoms. The fever was gone by morning, felt better, just fatigued, likely from poor sleep due to the flu symptoms. No treatment was taken for the adverse 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 of flu like symptoms, poor sleep, generalised body pain, headache and fatigue was resolved.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Pharyngeal swelling
Clinical narrative: difficulty breathing; difficulty swallowing; swelling of her throat; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of bnt162b2 (Solution for injection, Lot number: EN6204, Expiration date Jun2021), intramuscularly administered in Arm Right on 10Mar2021 08:30 (at the age of 47-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications was not reported. She got the vaccine because her son had a multiple organ transplant. She wanted to get it and be able to get back to work. She wanted to protect herself and her son. The patient experienced difficulty breathing, difficulty swallowing, swelling of her throat on 10Mar2021. Emergency Room visit on 10Mar2021 at 15:00 and The Emergency Department gave her Benadryl and let her go home that same day. Therapeutic measures were taken as a result of difficulty breathing, difficulty swallowing, swelling of her throat. On 10Mar2021, the clinical outcome of the events was resolved.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Condition aggravated, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: has been in bed x16 days; his breathing is worse; he had the weird prickly headache again; he is really having a hard time breathing; tired; has no appetite; the patient said he feels like he has been hit by a big truck.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 16Mar2021 at 12:45 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 23Feb2021 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization and experienced having a hard time breathing; in bed for 8 days and couldn't get out of bed; couldn't hardly eat, and had no appetite; really bad headache, a prickly headache; sweating but wasn't running a fever; really tired; and he was in bed for 8 days and couldn't get out of bed. The patient's medical history included COPD, diagnosed at least 10 years ago; and High Blood Pressure, Diagnosed maybe 15 years ago. The patient's concomitant medications included Felodipine for High Blood Pressure, 5mg once a day; Pro-Air for COPD, 90mcg PRN, Rescue Inhaler as needed, been on for at least 5 years; Spiriva for COPD, 2.5mcg 2 puffs a day, been on for at least 5 years; Breo for COPD, 200mcg one puff a day; and Albuterol for COPD, 0.083% use 1 vial, up to 4 times a day as needed. On 16Mar2021, the patient experienced he had the weird prickly headache again; he is really having a hard time breathing; has been in bed x16 days; tired; has no appetite; the patient said he feels like he has been hit by a big truck; and on an unspecified date his breathing is worse. The treatment received by the patient was started taking Advil a couple of days ago and it is dulling it. States she read that he should not be taking anything right away because the body needs to react to vaccine. States he is using his normal medications and increasing the frequency of his nebulizer. The outcome of event his breathing is worse was unknown and for all other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: has been in bed x16 days; his breathing is worse; he had the weird prickly headache again; he is really having a hard time breathing; tired; has no appetite; the patient said he feels like he has been hit by a big truck.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 16Mar2021 at 12:45 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 23Feb2021 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization and experienced having a hard time breathing; in bed for 8 days and couldn't get out of bed; couldn't hardly eat, and had no appetite; really bad headache, a prickly headache; sweating but wasn't running a fever; really tired; and he was in bed for 8 days and couldn't get out of bed. The patient's medical history included COPD, diagnosed at least 10 years ago; and High Blood Pressure, Diagnosed maybe 15 years ago. The patient's concomitant medications included Felodipine for High Blood Pressure, 5mg once a day; Pro-Air for COPD, 90mcg PRN, Rescue Inhaler as needed, been on for at least 5 years; Spiriva for COPD, 2.5mcg 2 puffs a day, been on for at least 5 years; Breo for COPD, 200mcg one puff a day; and Albuterol for COPD, 0.083% use 1 vial, up to 4 times a day as needed. On 16Mar2021, the patient experienced he had the weird prickly headache again; he is really having a hard time breathing; has been in bed x16 days; tired; has no appetite; the patient said he feels like he has been hit by a big truck; and on an unspecified date his breathing is worse. The treatment received by the patient was started taking Advil a couple of days ago and it is dulling it. States she read that he should not be taking anything right away because the body needs to react to vaccine. States he is using his normal medications and increasing the frequency of his nebulizer. The outcome of event his breathing is worse was unknown and for all other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Limb discomfort, Lymphadenopathy, Pharyngeal swelling, Throat tightness
Clinical narrative: My throat feels like it has swollen.; It feels real tight in the back of my throat; I have a cough drop in; feel like the lymph nodes are swollen; Arm is getting trouble; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patients medical history and patients concomitant medications were not reported. The patient experienced throat felt like it had swollen, it felt real tight in the back of throat on an unspecified date, the patient could breathe through nose and speak ok. Patient had a cough drop in, felt like the lymph nodes were swollen, Arm was getting trouble on an unspecified date. The patient was using Chloraseptic spray for the cough drop. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Dyspnoea, Headache, Malaise
Clinical narrative: feels very sick; bad headache; so weak; so sleepy; belly ache; shortness of breath; nausea; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry dates were not provided), via unspecified route of administration, on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the first dose of Pfizer COVID vaccine on 26Mar2021, initially patient was fine but now (unknown date in 2021) feels very sick, bad headache, so weak, so sleepy, belly ache, shortness of breath and nausea the last 3-4 days and patient was not getting any better. Patient took tylenol but it did not work. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: feels very sick; bad headache; so weak; so sleepy; belly ache; shortness of breath; nausea; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry dates were not provided), via unspecified route of administration, on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the first dose of Pfizer COVID vaccine on 26Mar2021, initially patient was fine but now (unknown date in 2021) feels very sick, bad headache, so weak, so sleepy, belly ache, shortness of breath and nausea the last 3-4 days and patient was not getting any better. Patient took tylenol but it did not work. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer or other non hcp. An elderly male patient with unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), dose 2 via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunisation. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), dose 1 via an unspecified route of administration on 03Mar2021 for single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness on 25Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Limb mass, Rash, Therapeutic response unexpected
Clinical narrative: it was calming down some until I received my second vaccine on March 24th at the same location.; arms now look like I am an IV drug user and the rash on my back is getting larger.; Both hands are loaded with bumps as well as both arms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, 66-year-old age at the time of vaccination), via an unspecified route of administration on 24Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included arthritis and eczema (I have Eczema and on occasion will get a flare up lasting a few days). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since, the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products: None. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202, 66-year-old age at the time of vaccination), via an unspecified route of administration, administered on left arm on 03Mar2021 at 10:30 AM as single for covid-19 immunisation and experienced rash and pustules. On an unknown date in Mar2021 patient claimed that "it was calming down some until I received my second vaccine on March 24th at the same location", arms now look like I am an IV drug user and the rash on my back is getting larger and both hands are loaded with bumps as well as both arms. He had an appointment with a Dermatologist on 07Apr2021. Treatment was not given for the events. Event outcome was resolving for "it was calming down some until I received my second vaccine on March 24th at the same location" and not resolved for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: weakness; sore arm; This is a spontaneous report received from Pfizer-sponsored program. A contactable consumer (patient) reported that: a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, after first dose the patient experienced weakness, and sore arm. The outcome of the events asthenia, pain in extremity was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia, Pyrexia
Clinical narrative: Tingling; Spasm -legs; body fever; This is a spontaneous report from a contactable Nurse. This 52-year-old (age at the time of vaccination) female Nurse reported in response to HCP follow-up letter sent in cross reference case that included who received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration on 14Jan2021, as a dose 2, single for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE dose 1 (Lot number EJ1685 expiry date was not reported) via intramuscular route of administration on 20Dec2020 10:00 in left arm as a single dose for covid-19 immunisation. The patient provided information to you regarding the reported adverse event(s) with the use of the product and considered the Pfizer product had a causal effect to the adverse event. Patient's height was reported as 5foot 3inch and weight as 134 lb. Patient experienced tingling, spasm-legs, body fever o 17Jan2021. After 3 days of 2nd dose - still experiencing until now- 2nd vaccination date 14Jan2021. Vaccination Facility Type was reported as workplace clinic. Vaccine was not administered at Facility. Patient was not deceased. Treatment as muscle relaxant was required for the events. The events required visit to physician's office (urgent care). The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 01Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 11Mar2021 as dose 1, single for covid-19 immunisation. On an unspecified date Apr2021, the patient was diagnosed with UTI (urinary tract infection) and she was prescribed with antibiotics. She wanted to know if the medication would interfere with the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea several times during day and night, explosive most of the time; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 19Feb2021, 13:45 (Batch/Lot number was not reported) (at the age of 71 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes which is under control. The patient has no known allergies and did not have COVID prior vaccination. Concomitant medications included metformin and venlafaxine hydrochloride (EFFEXOR). The patient did not receive other vaccines in four weeks. On 20Feb2021 (also reported as 19Feb2021, 12:00 AM) the patient experienced severe diarrhea several times during day and night, explosive most of the time. The patient stopped metformin but observed no difference. It was reported that the event started right after first shot. The patient was not tested for COVID post vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included endoscopy. The patient has not recovered from the events. The patient also received the second dose of BNT162B2 on 11Mar2021 (Batch/Lot number was not reported) for COVID-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal congestion, Sneezing
Clinical narrative: allergy; sneezing; congested nose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Apr2021 dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date for covid-19 immunization. Approximately on an unknown date in Apr2021, the patient experienced allergy, sneezing and congested nose. He wanted to know if he can take Zyrtec. Caller stated he had taken the 2nd dose on Saturday and his allergies were acting up. Caller did not end up taking Zyrtec after the vaccine. Caller didn't know if it would be safe to take Zyrtec after the fact in case it would affect the efficacy of the vaccine. The outcome of the events was unknown. No PQC involved.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: sore arm after pfizer covid 19 vaccine and woke up twice during the night post vaccine; sore arm after pfizer covid 19 vaccine and woke up twice during the night post vaccine; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A female patient of an unspecified age (63 was reported and unspecified units) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after pfizer covid 19 vaccine and woke up twice during the night post vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Illness, Nausea
Clinical narrative: Patient still don't feel great, was sick all night and was sicker, almost think patient was sicker than when patient had Covid; patient still very very nauseous; patient still had a headache and still had a lot of nausea; patient was like incapacitated; patient felt better patient felt awful, patient felt physically awful, that didn't made patient felt any better; This is a spontaneous report from a contactable consumer (the patient, reported for self). An unspecified age and gender patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date were not reported), via unspecified route of administration, on 02Apr2021, as single dose, for COVID-19 immunization. The patient's medical history included I had Covid back in December on an unspecified date in Dec2020 and mononuclear infusion. Concomitant medications were not reported. Patient still don't feel great, was sick all night and was sicker, almost think patient was sicker than when patient had Covid, patient still very nauseous, patient still had a headache and still had a lot of nausea, patient was like incapacitated, that doesn't made patient felt better patient felt awful, patient felt physically awful, that didn't made patient felt any better and all were on an unknown date on an unspecified date in 2021. Patient stated that I got the Pfizer vaccine yesterday (02Apr2021) and I do have a couple of questions I am an intern I did call my doctor on another phone but I just wanted to know because I had Covid back in December and also had Mononuclear infusion so I waited for 90 days to get my Pfizer but I would I still don't feel great I was sick all night, I was sicker I almost think I was sicker than when I had Covid and I am still very nauseous, I mean I don't have any respiratory I don't have anything I need to go an ER for but I still had a headache and I still have a lot of nausea. Patient stated, I don't need to say you one more you are sorry because that doesn't make me feel better I feel awful, I feel physically awful, that doesn't make me feel any better. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Patient still don't feel great, was sick all night and was sicker, almost think patient was sicker than when patient had Covid; patient still very very nauseous; patient still had a headache and still had a lot of nausea; patient was like incapacitated; patient felt better patient felt awful, patient felt physically awful, that didn't made patient felt any better; This is a spontaneous report from a contactable consumer (the patient, reported for self). An unspecified age and gender patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date were not reported), via unspecified route of administration, on 02Apr2021, as single dose, for COVID-19 immunization. The patient's medical history included I had Covid back in December on an unspecified date in Dec2020 and mononuclear infusion. Concomitant medications were not reported. Patient still don't feel great, was sick all night and was sicker, almost think patient was sicker than when patient had Covid, patient still very nauseous, patient still had a headache and still had a lot of nausea, patient was like incapacitated, that doesn't made patient felt better patient felt awful, patient felt physically awful, that didn't made patient felt any better and all were on an unknown date on an unspecified date in 2021. Patient stated that I got the Pfizer vaccine yesterday (02Apr2021) and I do have a couple of questions I am an intern I did call my doctor on another phone but I just wanted to know because I had Covid back in December and also had Mononuclear infusion so I waited for 90 days to get my Pfizer but I would I still don't feel great I was sick all night, I was sicker I almost think I was sicker than when I had Covid and I am still very nauseous, I mean I don't have any respiratory I don't have anything I need to go an ER for but I still had a headache and I still have a lot of nausea. Patient stated, I don't need to say you one more you are sorry because that doesn't make me feel better I feel awful, I feel physically awful, that doesn't make me feel any better. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID-19 virus as positive after the 1st dose of vaccine.; I was not feeling good.; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored Program.   A 58-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EP7533; Expiration Date: 31Jul2021), via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 02Apr2021 the patient got a COVID test as she was not feeling good and the patient diagnosed with COVID-19 (03Apr2021). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Apr2021. The clinical outcome of the events was unknown.  Follow-up (22Jun2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Neck pain, Pain in extremity, Vaccination site discomfort
Clinical narrative: Headache; Arm ache, ache down my leg on the left side this all on the left side and even my foot; Chills; Head was hurting down to my neck; I got a scab on where she shot me in the arm and its hurting out from the inside so its underneath where my you know where my armpit is and on the outside and sometimes up to my neck; Its still where she put the needle in has the sensation in there/as soon as she stuck me with needle it felt real thick; I got a scab on where she shot me in the arm and its hurting out from the inside so its underneath where my you know where my armpit is and on the outside and sometimes up to my neck; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number, UPC number: Unknown), via an unspecified route of administration in Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the Pfizer Vaccine shot 2 weeks ago. In Mar2021, patient had quite a bit of side effects with getting that shot and finally about 3-4 days most of it had gone away. Patient had headache, arm ache, 'side' ache down leg on the left side this all on the left side and even foot. Also had chills and that took till Monday to kind of get rid of that but patient still had headache about two three days after that and patient had been having arm hurt like felt the vaccine was going in as soon as she stuck me with needle it felt real thick and everything and what patient was concerned about now is while head was hurting down to neck was patient's left arm is still hurting. Patient got a scab on where she shot in the arm and its hurting out from the inside so its underneath where armpit is and on the outside and sometimes up to neck and was wondering aches and was going to go back to get the shot next Saturday which would be 3 weeks and have been concerned about this and of course my friends and family concerned about what is the problem why patient was still having this. Patient talked with friends and they haven't had anything like this. Patient had been almost the whole thing on your list and was still having problems and if patient was to get the vaccine shot next week on which arm should get because it was still where she put the needle in has the sensation in there as well and like a scab. Patient has never had the shot that has scab on it, don't know whatever it was big needle or just what but was concerned about it and did speak with doctor's nurse about it and saw what patient can about it but she didn't give any real information you know what to do. So patient called to help. The outcome of events headache and pain in extremity was not recovered; event chills was recovered on 29Mar2021; while the outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site scab
Clinical narrative: Headache; Arm ache, ache down my leg on the left side this all on the left side and even my foot; Chills; Head was hurting down to my neck; I got a scab on where she shot me in the arm and its hurting out from the inside so its underneath where my you know where my armpit is and on the outside and sometimes up to my neck; Its still where she put the needle in has the sensation in there/as soon as she stuck me with needle it felt real thick; I got a scab on where she shot me in the arm and its hurting out from the inside so its underneath where my you know where my armpit is and on the outside and sometimes up to my neck; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number, UPC number: Unknown), via an unspecified route of administration in Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the Pfizer Vaccine shot 2 weeks ago. In Mar2021, patient had quite a bit of side effects with getting that shot and finally about 3-4 days most of it had gone away. Patient had headache, arm ache, 'side' ache down leg on the left side this all on the left side and even foot. Also had chills and that took till Monday to kind of get rid of that but patient still had headache about two three days after that and patient had been having arm hurt like felt the vaccine was going in as soon as she stuck me with needle it felt real thick and everything and what patient was concerned about now is while head was hurting down to neck was patient's left arm is still hurting. Patient got a scab on where she shot in the arm and its hurting out from the inside so its underneath where armpit is and on the outside and sometimes up to neck and was wondering aches and was going to go back to get the shot next Saturday which would be 3 weeks and have been concerned about this and of course my friends and family concerned about what is the problem why patient was still having this. Patient talked with friends and they haven't had anything like this. Patient had been almost the whole thing on your list and was still having problems and if patient was to get the vaccine shot next week on which arm should get because it was still where she put the needle in has the sensation in there as well and like a scab. Patient has never had the shot that has scab on it, don't know whatever it was big needle or just what but was concerned about it and did speak with doctor's nurse about it and saw what patient can about it but she didn't give any real information you know what to do. So patient called to help. The outcome of events headache and pain in extremity was not recovered; event chills was recovered on 29Mar2021; while the outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: Rash on my legs, right arm where put the vaccine and it itches and it does not want to go away; Rash on my legs; Rash on right arm where put the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) at unknown dose single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Reported stated "I had received vaccine (unspecified vaccine) of yours (Pfizer) back on 21Mar2021 and for the past week I had not the first week but the following week in 2021, I have been having a rash on my legs, my right arm where put the vaccine and it itches and it does not want to go away and I have been calling you people, my doctor said to call Pfizer, find may be about sort of side effect or maybe you have to hold on for the second shot and my second shot is next week, so what can you tell me, what can you do for me Is this going on for week and half this rash on my arm" The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.