chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rhinorrhoea
Clinical narrative: full body hives with severe itching; full body hives with severe itching; This is a spontaneous report from a contactable physician (reported for herself). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 10Jan2021 11:30 at single dose for Covid-19 immunization. The patient's medical history reported as none; no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced full body hives with severe itching on 11Jan2021 (16:00). The patient received Loratadine and Benadryl as treatment for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Electrocardiogram abnormal, Palpitations, Tachycardia
Clinical narrative: Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing.  Patient was taken to the medic location.  VS= 192/116, HR 152, O2 sat=99%
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood magnesium, Chest X-ray, Dizziness, Full blood count, Heart rate increased
Clinical narrative: Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing.  Patient was taken to the medic location.  VS= 192/116, HR 152, O2 sat=99%
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immediate post-injection reaction, N-terminal prohormone brain natriuretic peptide, Prothrombin time, SARS-CoV-2 test, Tachycardia
Clinical narrative: Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing.  Patient was taken to the medic location.  VS= 192/116, HR 152, O2 sat=99%
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Troponin I, Urine analysis, White blood cell count decreased
Clinical narrative: Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing.  Patient was taken to the medic location.  VS= 192/116, HR 152, O2 sat=99%
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via an unspecified route of administration on 07Jan2021 10:00 AM at a single dose in the right arm for COVID vaccine. Medical history included high blood pressure. She has no known allergies. Concomitant medications included hydrochlorothiazide (HCTZ), guaifenesin/ paracetamol/ phenylephrine hydrochloride (TYLENOL SINUS), multivitamin, and Almopid (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced extremely tired on 12Jan2021 06:00 AM. Treatment was not received for the event. She had no COVID prior to vaccination. She was not COVID tested post vaccination. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: having lymph node pain right under the arm on the side he got the shot/it is painful and sore; This is a spontaneous report from two contactable consumers (one of which was the patient's sister) reported that a 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the arm on 02Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was experiencing lymph node pain after 10 days (12Jan2021) just under the armpit area (also reported as under the arm on the side he got the shot) bilaterally that radiates down his sides. The patient stated that it was painful and sore. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Discomfort, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 21Dec2020 15:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies. On 23Dec2020 13:00, patient discovered a lump on the bottom of her left armpit, felt a lot of discomfort when touching it. It went away around 02Jan2021. Patient does not have COVID prior vaccination. COVID was tested post vaccination via nasal swab, COVID test date on 07Jan2021, and COVID test result was negative. No treatment was received for the events. The events recovered on 02Jan2021. Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Endotracheal intubation, Intensive care, Swollen tongue
Clinical narrative: severe angioedema resulting in intubation to protect his airway and ICU admission.  pt recieved the 2nd dose at 0755 am, woke up from a nap at 2200 the same night with tongue swelling.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had COVID prior to vaccination. It was unknown if the patient received other vaccines in four weeks or other medications in 2 weeks. The patient experienced muscle aches and headache on 08Jan2021. It was reported that the patient was complaining of continuous muscle aches and headache four days after receiving the vaccination (as reported). The patient has not been tested for COVID post vaccination. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient's daughter) reported that a female patient (aged 102, no unit reported) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's daughter was calling on behalf of her mother, aged 102, received vaccine a week ago last Sunday (03Jan2021), and was tested positive for Covid the next day (04Jan2021). The patient was due for her second vaccine and wanted to know if her mother is still eligible to receive vaccine.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia oral
Clinical narrative: Tingling in tongue and heat tongue.  No v/s provided
Sex: F
Vaccine: COVID19
Symptoms: Animal bite, Off label use, Product use issue
Clinical narrative: dog bite; HCP recommended to update her tetanus shot / second dose of the covid vaccine is scheduled on 20Jan2021; HCP recommended to update her tetanus shot / second dose of the covid vaccine is scheduled on 20Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at single dose for Covid-19 Vaccine and tetanus vaccine (manufacturer unknown) via an unspecified route of administration on unspecified date at single dose for dog bite. The patient's medical history and concomitant medications were not reported.  Last night on unspecified date, the patient got a dog bite and her HCP recommended to update her tetanus shot, however her second dose of the covid vaccine is scheduled on 20Jan2021. She wanted to know if there are any recommendations for this. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: The event dog bite is due to an external factor and is considered unrelated to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose of the Covid 19 vaccine last Wednesday (unspecified date) and is still experiencing fatigue and headache (also reported as "still incredibly fatigued and has a headache") on an unspecified date. She still has these symptoms 6 days after and would like to know if it was normal. The outcome of events was not recovered.  No follow-up attempts are possible. Information of lot/batch cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in arm at 11:02 am  V/S  109/61  p. 64 at 11:10 am  V/S  128/66 p. 68
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Diarrhoea, Ear discomfort
Clinical narrative: ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nasal congestion, Nasopharyngitis
Clinical narrative: ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Rhinorrhoea, Upper respiratory tract congestion
Clinical narrative: ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: cold symptoms; leg pain; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of Covid vaccine on 03Jan2021 and tested positive for COVID on 05Jan2021. She further reported that she is still experiencing some cold symptoms and leg pain on an unspecified date. She is scheduled for second dose on 24Jan2021. She is still on precautions. She does not think she should get it.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Jan2021. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient did not recover from cold symptoms and leg pain while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Hyperhidrosis, Myalgia
Clinical narrative: Fever of 100.3, muscle and joint aches/pains, extreme nausea, diarrhea,  sweats/chills
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever of 100.3, muscle and joint aches/pains, extreme nausea, diarrhea,  sweats/chills
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, SARS-CoV-2 test, Throat irritation, Tongue discomfort
Clinical narrative: lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: E-1284), intramuscular in the right arm on 12Jan2021 at 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergy to IV contrast. The patient was not pregnant at the time of vaccination, had no other vaccine within four weeks, and did not have COVID prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID; reported as other medication within 2 weeks). On 12Jan2021, less than 5 minutes after administration (also reported as at 02:15PM), the patient experienced lightheadedness, throat became scratchy, tongue felt thick, hives, and itching. These were resolved with Benadryl, Pepcid, Zyrtec, and IM steroids (also reported as PO and IM medications). It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not tested positive for COVID post vaccination. Outcome of the events was recovered/resolved (also reported as recovering).  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: E-1284), intramuscular in the right arm on 12Jan2021 at 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergy to IV contrast. The patient was not pregnant at the time of vaccination, had no other vaccine within four weeks, and did not have COVID prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID; reported as other medication within 2 weeks). On 12Jan2021, less than 5 minutes after administration (also reported as at 02:15PM), the patient experienced lightheadedness, throat became scratchy, tongue felt thick, hives, and itching. These were resolved with Benadryl, Pepcid, Zyrtec, and IM steroids (also reported as PO and IM medications). It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not tested positive for COVID post vaccination. Outcome of the events was recovered/resolved (also reported as recovering).  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever 100.5; myalgia; headache; nausea; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) in the left arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 11Jan2021 19:00, the patient experienced fever 100.5, myalgia, headache and nausea. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received her first dose of the COVID-19/now testing positive; received her first dose of the COVID-19/now testing positive; This is a spontaneous report from a contactable other HCP.   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date after vaccination, the patient was now testing positive for Covid-19 at the hospital she works at regularly. She was not sure what test she had done, i.e. antibody or virus. The outcome of events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Maternal exposure during pregnancy, Off label use, Pain
Clinical narrative: Fever of 101.5; headache; body aches; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 06Jan2021 at 12:45 at single dose for COVID-19 immunization. The patient medical history included known allergies to sulfa medications from an unknown date and unknown if ongoing. The patient's concomitant medication included cholecalciferol (D3), cyanocobalamin (B12-VITAMIN), ascorbic acid, beta-carotene, calcium sulfate, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. The patient reported she was pregnant at the time of vaccination. She was at 5 weeks gestational period; last menstrual date was 01Dec2020 and will be due to deliver on 06Sep2021. On 07Jan2020 at 6.00, the patient experienced fever of 101.5 F, headache and body aches. The patient outcome of the events was recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia
Clinical narrative: Fever of 101.5; headache; body aches; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 06Jan2021 at 12:45 at single dose for COVID-19 immunization. The patient medical history included known allergies to sulfa medications from an unknown date and unknown if ongoing. The patient's concomitant medication included cholecalciferol (D3), cyanocobalamin (B12-VITAMIN), ascorbic acid, beta-carotene, calcium sulfate, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. The patient reported she was pregnant at the time of vaccination. She was at 5 weeks gestational period; last menstrual date was 01Dec2020 and will be due to deliver on 06Sep2021. On 07Jan2020 at 6.00, the patient experienced fever of 101.5 F, headache and body aches. The patient outcome of the events was recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This is a spontaneous report from a contactable other hcp. A 56 year old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EH9899), intramuscular on the left arm on 21Dec2020 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. Concomitant medication included progesterone (PROGESTERONE), estradiol (ESTRADIOL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced soreness at injection site, joint pain, muscle pain, chills, low-grade fever and loss of appetite on 21Dec2020. The outcome of the events was recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This is a spontaneous report from a contactable other hcp. A 56 year old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EH9899), intramuscular on the left arm on 21Dec2020 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. Concomitant medication included progesterone (PROGESTERONE), estradiol (ESTRADIOL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced soreness at injection site, joint pain, muscle pain, chills, low-grade fever and loss of appetite on 21Dec2020. The outcome of the events was recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site infection, Vaccination site warmth
Clinical narrative: red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; Enlarged axillary lymph node/Became red and warm at day 10 in same arm; This is a spontaneous report from a contactable nurse (patient herself).  A 28-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine, lot EH9889), via an unspecified route of administration in the left arm on 28Dec2020 11:45 at SINGLE DOSE for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included allergy to latex and COVID prior vaccination: No. No other vaccine in four weeks. Concomitant medication included unspecified oral contraceptive. The patient experienced enlarged axillary lymph node that appeared 8 days after vaccine administration (05Jan2021). It became red and warm at day 10 (07Jan2021) in same arm as vaccine was administered in. Required Keflex 500 mg oral antibiotics for infection. No Covid tested post vaccination. The outcome of events was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Pallor
Clinical narrative: heart rate increased; pale; diaphoretic; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284 and expiry date unknown) intramuscular in the left arm on 12Jan2021 15:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included hypertension, asthma, hysterectomy and tumor debulking (reported as on 21Dec2021). The patient was not pregnant. Concomitant medications included hydrochlorothiazide, asthma medication and antibiotic; all from unspecified date for unspecified indication. The patient previously took erythromycin and experienced allergies. On 12Jan2021 15:45 (also reported as approximately 9 minutes post injection), the patient reported feeling her heart rate increased, was pale and diaphoretic. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events heart rate increased, pale and diaphoretic was recovered on Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: got the first dose of the covid vaccine/tested positive with covid; tested positive with covid; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date, at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications was not reported. She was positive with covid and is asking when she could get the second shot of the vaccine. The outcome of event was unknown.  Information about Lot/Batch has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: fever; Chills; a very big Lymph Node on my left arm armpit; This is a spontaneous report from a contactable other hcp (patient). A 39-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), via an unspecified route of administration on the left arm on 10Jan2021 10:43 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included gabapentin. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry date not reported) on the left arm on 24Dec2020 for COVID-19 immunization. The patient experienced fever, chills, and a very big lymph node on their left arm armpit on 11Jan2021 21:00. The outcome of the events was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: Burn and itching throughout the entire body; Burn and itching throughout the entire body; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) via an unspecified route of administration in the left arm on 11Jan2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included diabetes and known allergies to peanuts. Concomitant medications were not reported. The patient previously had known allergies to amoxicillin. The patient experienced burn and itching throughout the entire body on 11Jan2021 which resulted to emergency room/department or urgent care. Treatment for the events included Benadryl. The patient had no COVID prior to vaccination. He did not have COVID tested post vaccination. The patient had no other vaccine in four weeks. The outcome of the events was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable nurse (patient). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Dec2020 for COVID-19 immunization. Medical history included asthma; hypertension; acid reflux; food allergies; known allergies to peanut, shell fish, IVP dye, penicillin and tree nuts. Patient also had known allergies to erythromycin and ceftriaxone (ROCEPHIN). Concomitant medication was not reported. There was no other vaccine in four weeks. On the first dose of 19Dec2020 just a sore arm (date unspecified). The outcome of event was unknown.   Information on lot/batch no. has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Oxygen saturation, Pharyngeal swelling, Sensation of foreign body, Swollen tongue
Clinical narrative: Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Intermittent episodes of acute sharp back pain; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient (no pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1284 and Expiration Date unknown) via Intramuscularly on 30Dec2020 03:00 PM (Left arm) at single dose for covid-19 immunisation.  Medical history includes mild asthma, B-Cell Thymoma (Resected), multiple allergies. Diagnosed allergies included Sulfa drugs-swelling; Celebrex-Itchy; Clindamycin- Unknown reaction; Doxycycline- Sick to stomach; Iodinated radiocontrast dyes- Iodinated radiocontrast dyes cause generalized swelling (takes diphenhydramine prior to contrast use when needed); Keflex- Rash; TDAP Vaccine; Levofloxacin- Unknown Reaction; Penicillin; Prednisolone- Itchy; Septra- Eyes get glossy and lips swell.The concomitant medication was not reported. There is no other vaccines within 4 weeks prior to the COVID vaccine. About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine (30Dec2020 30Dec2020 08:00 PM), Patient went to Emergency room (ER) with complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition. The outcome of event was recovered on an unknow date without treatment. There is no covid tested post vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Intermittent episodes of acute sharp back pain; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient (no pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1284 and Expiration Date unknown) via Intramuscularly on 30Dec2020 03:00 PM (Left arm) at single dose for covid-19 immunisation.  Medical history includes mild asthma, B-Cell Thymoma (Resected), multiple allergies. Diagnosed allergies included Sulfa drugs-swelling; Celebrex-Itchy; Clindamycin- Unknown reaction; Doxycycline- Sick to stomach; Iodinated radiocontrast dyes- Iodinated radiocontrast dyes cause generalized swelling (takes diphenhydramine prior to contrast use when needed); Keflex- Rash; TDAP Vaccine; Levofloxacin- Unknown Reaction; Penicillin; Prednisolone- Itchy; Septra- Eyes get glossy and lips swell.The concomitant medication was not reported. There is no other vaccines within 4 weeks prior to the COVID vaccine. About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine (30Dec2020 30Dec2020 08:00 PM), Patient went to Emergency room (ER) with complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition. The outcome of event was recovered on an unknow date without treatment. There is no covid tested post vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a contactable nurse (patient). A 47-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL3249), via an unspecified route of administration on 09Jan2021 11:15 at single dose at right arm for covid-19 immunization. Medical history included mild asthma, known allergies: latex, peanuts from an unknown date and unknown if ongoing, and the patient was diagnosed with COVID-19 prior to vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EH9899) at single dose at right arm on 19Dec2020 11:15 am for covid-19 immunization. About 12 hours after the vaccination patient had severe body aches, joint pain, chills, headache, nausea, diarrhea on 09Jan2021 09:00 PM. All symptoms lasted from 12-16 hours, except the diarrhea lasted about 20 hours. Outcome of all events was recovered on 10Jan2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a contactable nurse (patient). A 47-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL3249), via an unspecified route of administration on 09Jan2021 11:15 at single dose at right arm for covid-19 immunization. Medical history included mild asthma, known allergies: latex, peanuts from an unknown date and unknown if ongoing, and the patient was diagnosed with COVID-19 prior to vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EH9899) at single dose at right arm on 19Dec2020 11:15 am for covid-19 immunization. About 12 hours after the vaccination patient had severe body aches, joint pain, chills, headache, nausea, diarrhea on 09Jan2021 09:00 PM. All symptoms lasted from 12-16 hours, except the diarrhea lasted about 20 hours. Outcome of all events was recovered on 10Jan2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: After approx 22 hours, a bit chilled, tired; After approx 22 hours, a bit chilled, tired; Went home, dosed a bit, have 99.4 f temp; This is a spontaneous report from a contactable Other-HCP. This 63-year-old male Other-HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 12Jan2021 02:00 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medications included diltiazem, tamsulosin. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 21Dec2020 08:00 AM for COVID-19 immunization. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. On 13Jan2021 00:00 AM (after approx 22 hours), patient had a bit chilled, tired; he went home, dosed a bit, had 99.4 f temp. No treatment was received. Outcome of events was not recovered.    Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: increased postnasal drip; had a fever of 100.7 orally; bodyaches; headache; chills; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient (not pregnant) received the second dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 09Jan2021 09:30 at single dose in right arm for COVID-19 immunization. Medical history included asthma, hypertension/ Blood pressure, acid reflux, food allergies, Known allergies: tree nuts, peanut, shell fish, Penicillin, Erythromycin, IVP dye, Rocephin. The patient's concomitant medications in two weeks included Blood pressure, acid reflux. The patient previously took the first dose of bnt162b2 on 19Dec2020 for COVID-19 immunization and experienced Sore arm. No other-vaccine-in-four weeks. Second dose on 09Jan2021 within 17 hours had a fever of 100.7 orally, body aches, headache, chills and increased postnasal drip on 10Jan2021 02:30. No treatment received. No covid-prior-vaccination and no covid tested post vaccination. The outcome of the events was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: increased postnasal drip; had a fever of 100.7 orally; bodyaches; headache; chills; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient (not pregnant) received the second dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 09Jan2021 09:30 at single dose in right arm for COVID-19 immunization. Medical history included asthma, hypertension/ Blood pressure, acid reflux, food allergies, Known allergies: tree nuts, peanut, shell fish, Penicillin, Erythromycin, IVP dye, Rocephin. The patient's concomitant medications in two weeks included Blood pressure, acid reflux. The patient previously took the first dose of bnt162b2 on 19Dec2020 for COVID-19 immunization and experienced Sore arm. No other-vaccine-in-four weeks. Second dose on 09Jan2021 within 17 hours had a fever of 100.7 orally, body aches, headache, chills and increased postnasal drip on 10Jan2021 02:30. No treatment received. No covid-prior-vaccination and no covid tested post vaccination. The outcome of the events was recovering.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: This is a spontaneous report from a non-contactable other health professional (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. Medical history was none, the patient was not on any meds. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient experienced shingles, painful rash on the flank on 09Jan2021 with outcome of not recovered. The patient took valacyclovir as treatment. The events resulted in doctor or other healthcare professional office/clinic visit. No follow up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a non-contactable nurse (patient). This 22-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 21Dec2020 10:00 AM at left arm, and 2nd dose on 11Jan2021 07:45 AM at left arm, both at single dose via an unknown route for COVID-19 immunization. Facility type vaccine was hospital. Medical history was not provided. Patient did not have COVID prior vaccination. Concomitant drug in two weeks included polycarbophil calcium (FIBER). Patient did not have other vaccine in four weeks. No COVID tested post vaccination. Patient's left armpit had an aching pain with movement or palpation. It was also swollen. She thought her lymph nodes were swollen. Event onset date was reported as 12Jan2021 05:00 AM. This also happened with first dose and it lasted for two weeks. No treatment received. Outcome of the events was resolving. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain, Rash
Clinical narrative: Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization.  Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Headache, Nasopharyngitis
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient herself).  A 32-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# El1284), via an unspecified route of administration on 30Dec2020 11:45 in right arm at single dose for COVID-19 immunization. Medical history included COVID from 15May2020 to an unknown end date. Known allergies was no. Other medications in two weeks included pantoprazole, cholecalciferol (VIT D3), ascorbic acid (VIT C), zinc, fish oil, curcuma longa (TURMERIC). The patient experienced mild cold like symptoms (runny nose and sore chest) 3 days after vaccine on 02Jan2021, blood spots on right abdomen, chest 3-4 days after vaccine in Jan2021. Constant headache for a week starting 5 days after vaccine on 04Jan2021 and elevated blood pressure, racing heart, and chest pain 5 days after vaccine on 04Jan2021. All events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID positive on 15May2020. The patient had COVID test of nasal swab post vaccination and result with negative. Outcome of events were unknown. No treatment was received for events.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported bleeding cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.