chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non-pregnant female patient received  bnt162b2 (BNT162B2, Formulation:Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Apr2021 (at the age of 56-year-old) as Dose 2, Single for covid-19 immunization. The patient received first dose of BNT162B2 (Lot number: EN6206) via an unspecified route of administration in Mar2021 09:15 at left arm as Dose 1, Single for Covid-19 immunization and experienced Pain in neck, down arm, numbness in arm, loss of range of motion, weakness. Dr. believes Parsonage Turner Syndrom. Medical history included hypothyroidism, hypertension and penicillin allergy. Concomitant medications included Losartan and Synthroid. It was reported that patient was not received any vaccine in four weeks. The patient had no covid prior to vaccination nor been tested covid post vaccination. On an unknown date, the patient experienced fever, chills and body aches. The patient received Prednisone as therapy for the events. The patient was recovering at the time of report.  No follow-up attempts were required; information about lot/batch number cannot be obtained. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: I still had a red mark on the arm; This is a spontaneous report from a non-contactable consumer(patient).     A patient of unspecified age and gender received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included neoplasm malignant from an unknown date.  The patient had a red mark on the arm on an unspecified date. The patient have a lot of Problem in hearing you there's a lot of fan in the background. Chemo medications and she had the first vaccine (Further clarification was unknown hence captured as unspecified vaccine) shot on the 14th and have another on the 6th but patient have a red mark on the arm of the size of quarter and the oncologist want me to have the vaccine. So the patient had the first shot but patient concerned since the patient was a cancer patient that still had a red mark on the arm. The patient do not know if should have the second shot or not. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: headache; slight fever; some swelling in a lymph node in the armpit near the arm of injection; This is a spontaneous report from a non-contactable consumer (patient) communicated to a Pfizer sales representative. A 48-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 48-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified dose on an unspecified date (at the age of 48-years-old) for COVID-19 immunisation. On an unspecified date, the patient experienced headache, slight fever and some swelling in a lymph node in the armpit near the arm of injection after the administration of the second dose. Outcome of events were unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Decreased appetite, Dyspnoea, Electrocardiogram
Clinical narrative: not been sleeping; shortnessof breath; tired; Dose 2: Appetite is gone; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0169), via an unspecified route of administration, administered in Arm Left on 28Apr2021 11:00 AM (at the age of 54-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had the first dose on 07Apr2021 in her left arm, lot: EW0158 for Covid-19 immunization and experienced Shortness of breath, awful cough, decreased appetite and tired. No prior Vaccinations (within 4 weeks). The patient's concomitant medications were not reported. On 28Apr2021 dose 2: appetite is gone, shortness of breath, tired. On an unspecified date, not been sleeping. She had her first dose of the Covid-19 Vaccine on 07Apr2021 and her second dose yesterday 28Apr2021. The patient happened to be tired on 28Apr2021. After the 15 min of second dose patient experienced shortness of breath and felt like she was gasping for air, due to this she was she laying down. Her appetite was gone and she has an issue breathing. The patient underwent lab tests and procedures which included chest x-ray: negative, computerised tomogram: negative on an unspecified date, electrocardiogram: normal, fibrin d dimer: normal, full blood count: normal, ultrasound scan: negative, the patient got negative for Covid. The outcome of shortness of breath was recovering, the outcome of dose 2: appetite is gone, was not recovered. The outcome of not been sleeping and tired was unknown.   PSCC Communication: Caller provides multiple times for second dose administration, clarifies second dose was given at 11:15 AM. Referred caller to her physician for medical advice.Caller disconnected while on hold. Medical Information agent states she will call them back with the number provided.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer, Full blood count, Insomnia, Ultrasound scan
Clinical narrative: not been sleeping; shortnessof breath; tired; Dose 2: Appetite is gone; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0169), via an unspecified route of administration, administered in Arm Left on 28Apr2021 11:00 AM (at the age of 54-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had the first dose on 07Apr2021 in her left arm, lot: EW0158 for Covid-19 immunization and experienced Shortness of breath, awful cough, decreased appetite and tired. No prior Vaccinations (within 4 weeks). The patient's concomitant medications were not reported. On 28Apr2021 dose 2: appetite is gone, shortness of breath, tired. On an unspecified date, not been sleeping. She had her first dose of the Covid-19 Vaccine on 07Apr2021 and her second dose yesterday 28Apr2021. The patient happened to be tired on 28Apr2021. After the 15 min of second dose patient experienced shortness of breath and felt like she was gasping for air, due to this she was she laying down. Her appetite was gone and she has an issue breathing. The patient underwent lab tests and procedures which included chest x-ray: negative, computerised tomogram: negative on an unspecified date, electrocardiogram: normal, fibrin d dimer: normal, full blood count: normal, ultrasound scan: negative, the patient got negative for Covid. The outcome of shortness of breath was recovering, the outcome of dose 2: appetite is gone, was not recovered. The outcome of not been sleeping and tired was unknown.   PSCC Communication: Caller provides multiple times for second dose administration, clarifies second dose was given at 11:15 AM. Referred caller to her physician for medical advice.Caller disconnected while on hold. Medical Information agent states she will call them back with the number provided.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a Pfizer-sponsored program and a contactable other HCP. A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever. The outcome of the event was unknown.  No follow-up attempts were possible; information about lot/batch could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: mild fever; severe body aches; joint pain; a lot of pain; This is a spontaneous report from a Pfizer-sponsored program Support and a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 as Dose 2, Single for covid-19 immunization. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced mild fever, severe body aches, joint pain a lot of pain. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dehydration, Diarrhoea, Dizziness
Clinical narrative: headache; extreme fatigue; sore arm the first 24 hours; vomiting and could not keep even water down; diarrhea; 101 fever; full body chills; dizziness; dehydration; I have no appetite; This is a spontaneous report from a non-contactable consumer (Patient). A 32-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0167) via an unspecified route of administration, administered in left arm on 29Apr2021 at 04:45 PM as dose 2, single for COVID-19 immunization (at age of 32 years) at pharmacy or drug store. The patient medical history had included sulfa allergy. Concomitant medications included etonogestrel (NEXPLANON), spironolactone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination and 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. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EP7533) via an unspecified route of administration into left arm on 01Apr2021 at 04:00 PM (at age of 32 years) as dose 1, single for COVID-19 immunization and experienced sore arm, headache, fatigue, full week of head cold (sneezing, runny nose, congestion). On 30Apr2021 at 07:00 PM, the patient experienced headache, extreme fatigue and sore arm the first 24 hours. Right at the 48 hour mark - vomiting and could not keep even water down, diarrhea, 101 fever, full body chills. 65 hours in then, dizziness, headache, and fatigue likely due to dehydration as she had no appetite. The patient did not receive any treatment for the AE. The clinical outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: headache; extreme fatigue; sore arm the first 24 hours; vomiting and could not keep even water down; diarrhea; 101 fever; full body chills; dizziness; dehydration; I have no appetite; This is a spontaneous report from a non-contactable consumer (Patient). A 32-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0167) via an unspecified route of administration, administered in left arm on 29Apr2021 at 04:45 PM as dose 2, single for COVID-19 immunization (at age of 32 years) at pharmacy or drug store. The patient medical history had included sulfa allergy. Concomitant medications included etonogestrel (NEXPLANON), spironolactone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination and 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. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EP7533) via an unspecified route of administration into left arm on 01Apr2021 at 04:00 PM (at age of 32 years) as dose 1, single for COVID-19 immunization and experienced sore arm, headache, fatigue, full week of head cold (sneezing, runny nose, congestion). On 30Apr2021 at 07:00 PM, the patient experienced headache, extreme fatigue and sore arm the first 24 hours. Right at the 48 hour mark - vomiting and could not keep even water down, diarrhea, 101 fever, full body chills. 65 hours in then, dizziness, headache, and fatigue likely due to dehydration as she had no appetite. The patient did not receive any treatment for the AE. The clinical outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: After the first dose, almost at 3 weeks I began to feel mild itching between my fingers, between the joints. behind the ears, behind the head, on the feet and knees.; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on an unspecified date (at the age of 56-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received both doses of the Pfizer Covid 19 vaccine, and he received the second dose on 28Apr2021. After the first dose, almost at 3 weeks patient began to feel mild itching between fingers, between the joints. behind the ears, behind the head, on the feet and knees on unspecified date. Not everywhere at the same time. Before the second dose, on 22Apr2021 patient had surgery on one of the fingers in his left hand, at first, he thought the anesthesia had caused him the allergy. After receiving the second dose patient still felt itchy, but this time the itching was a little stronger. Consumer went to the doctor, to the ER and they gave him the allergy medication, but it didn't work for him. Patient still had the itching and if he gets hit anywhere on the body, instead of feeling pain, he felt itching. Patient's wife also received both doses of the vaccine and she had a rash between her fingers and itching at the top of her hand. Consumer asked was this serious and will it go away. Therapeutic measures were taken as a result of event. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphagia, Migraine, Nausea
Clinical narrative: Sneezing; Dry cough; His nose was dripping.; Bad migraine; Fever; Chills; Felt like they couldn't eat or swallow; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Apr2021 (age at vaccination: 54-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 29Apr2021, the patient had fever since the night he took the vaccine, chills, felt like they couldn't eat or swallow, nauseous. On 05May2021, he experienced bad migraine. On 06May2021, he had sneezing, dry cough and his nose was dripping. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinitis, Sneezing
Clinical narrative: Sneezing; Dry cough; His nose was dripping.; Bad migraine; Fever; Chills; Felt like they couldn't eat or swallow; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Apr2021 (age at vaccination: 54-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 29Apr2021, the patient had fever since the night he took the vaccine, chills, felt like they couldn't eat or swallow, nauseous. On 05May2021, he experienced bad migraine. On 06May2021, he had sneezing, dry cough and his nose was dripping. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Headache, Illness
Clinical narrative: A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on May 1, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. The patient previously received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On an unspecified date in May 2021, patient was sick. She did not feel well for 24 hours: GI issues, fever, chills, night sweats, headache and loss of appetite. The outcome of did not feel well for 24 hours' recovered on an unspecified date May 2021; while of remaining events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Night sweats, Pyrexia
Clinical narrative: A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on May 1, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. The patient previously received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On an unspecified date in May 2021, patient was sick. She did not feel well for 24 hours: GI issues, fever, chills, night sweats, headache and loss of appetite. The outcome of did not feel well for 24 hours' recovered on an unspecified date May 2021; while of remaining events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I got a small reaction to it, there is a rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0165), via an unspecified route of administration on 29Apr2021 (age at the time of vaccination was 47 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified in 2021, the patient got a small reaction to it, there was a rash. The patient stated he just had got, he took his first vaccination dose on Thursday, and he guessed, he got a small reaction to it, there was a rash. Reporter seriousness for I got a small reaction to it, there is a rash was reported as unspecified. This report was not related to a study or programme. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Gastrointestinal pain, Lymphadenopathy, Pain
Clinical narrative: Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0175), via an unspecified route of administration, administered in Arm Right on 01May2021 16:00 (at the age of 41-year-old) as Dose 2, Single for covid-19 immunization. The patient received first dose of BNT162B2 (Lot number:ER8731) via an unspecified route of administration, administered in Arm Right on 01May10Apr2021 16:00 (at the age of 41-year-old) as Dose 1, Single for covid-19 immunization. Medical history was none (no). Patient had no known allergies. The patient did not receive any other vaccine within 4 weeks. The patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. The patient's concomitant medications were not reported. On 11Apr2021, the patient experienced second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature of 100.6 and body temperature of 102.6. On an unknown date, the patient had recovered from all the events.   No follow-up attempts were needed. No further information was expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; Second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0175), via an unspecified route of administration, administered in Arm Right on 01May2021 16:00 (at the age of 41-year-old) as Dose 2, Single for covid-19 immunization. The patient received first dose of BNT162B2 (Lot number:ER8731) via an unspecified route of administration, administered in Arm Right on 01May10Apr2021 16:00 (at the age of 41-year-old) as Dose 1, Single for covid-19 immunization. Medical history was none (no). Patient had no known allergies. The patient did not receive any other vaccine within 4 weeks. The patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. The patient's concomitant medications were not reported. On 11Apr2021, the patient experienced second shot: 102.6 fever, swollen lymph node, fatigue, aches, GI cramping. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature of 100.6 and body temperature of 102.6. On an unknown date, the patient had recovered from all the events.   No follow-up attempts were needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: My wife also received both doses of the vaccine and she has a rash between her fingers and itching at the top of her hand.; My wife also received both doses of the vaccine and she has a rash between her fingers and itching at the top of her hand.; This is a spontaneous report from a contactable consumer. This consumer reported for his wife. A 38-year-old female patient received BNT162B2 (Pfizer Covid 19 vaccine Formulation: Solution for injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and received BNT162B2 (Pfizer COVID-19 vaccine Formulation: Solution for injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received both doses of the vaccine and she has a rash between her fingers and itching at the top of her hand. on an unspecified date. Outcome of both events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; a light fever; light headache; This is a spontaneous report from a contactable consumer or other non hcp.  A 9-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter is scheduled to receive the second dose and asked if she experiences side effects, should she drink hot or cold stuff. Reporter stated her friend (Patient) received the Pfizer Covid-19 vaccine and on an unspecified date experienced chills, a light fever, and a light headache that lasted for a day. The outcome of the events was recovered.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from contactable consumer (patient). A patient, of an unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Apr 4, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient got the Pfizer shot Apr 4, 2021 and scheduled to get the second shot; but patient had a question about the first shot. The patient had red bumps on chest 4 hours after vaccination Apr 4, 2021. The patient was afraid to get second shot because of the same possible reaction. The outcome of event: unknown. No follow-up attempts needed. Information about batch/lot number could not be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: had a rash on both elbows like eczema; a rash on both elbows like eczema. Stated that it was  bumpy and itchy; This is a spontaneous report from a contactable Consumer. This Consumer(Patient) reported that.  A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8734), via an unspecified route of administration, administered in left arm (as reported left shoulder) as dose 1, single on 08Apr2021 10:30 (at the age of 63-year-old) for covid-19 immunisation. No medical history reported. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Stated that he got the first 08Apr2021 and the second on 29Apr2021. Provided a lot number for the second shot of EW0153. Stated that both shots were to the left shoulder. Caller stated that he received both shots and the first time he had a rash on both elbows like eczema and was bumpy and itchy on 09Apr2021 06:00. Stated that after the second shot it continued on both elbows and to the groin and belly area. Stated that it was clearing up and was not getting any worse. Stated that he had a wellness check on 28Apr2021. Stated that he showed the doctor his elbows. Stated that the doctor stated that it looked like psoriasis. Stated that the doctor told him that he could prescribe something. Therapeutic measures were taken as a result of events with Gold Bond lotion on it which makes the itching better. Event eczema (rash) both elbows were resulted in physician office. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on belly/groin; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old male patient (consumer) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in Arm Left on 29Apr2021 (At the Age of 63-Years-Old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was reported none. The patient's concomitant medications were not reported. The patient(consumer) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 10:30 (At the Age of 63-Years-Old) as DOSE 1, SINGLE for covid-19 immunization. On 30Apr2021 06:00 the patient experienced rash on belly and rash on groin. Patient wanted to report side effects that he received both shots. Patient reported after the second shot it continued on both elbows and to the groin and belly area. Patient reported it is clearing up and is not getting any worse. Patient reported he had a wellness check on 28April. Patient reported that he showed the doctor his elbows. The doctor mentioned that it looked like psoriasis. Patient Reported that the doctor told him that he could prescribe something. Is for Pfizer COVID-19 vaccine. Patient reported he put lotion on it which makes the itching better. The outcome for belly rash and groin rash was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Swelling in her throat; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling in her throat. The patient was there for the second vaccine and the caller wanted someone to tell him what they should do as far as giving her the second vaccine. The caller said the patient was going to try to see a doctor to see if she can do the shot in a clinical setting in case she have a problem there would more likely be better interventions there. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Inflammation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient medical history and concomitant medications not reported. Historical vaccine included the 1st dose of BNT162B2 (Comirnaty, solution for injection), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On an unspecified date, patient experienced shoulder pain, inflammation and a lump down her armpit. She wanted to know if the side effects are reported with vaccination; and if swollen lymph nodes is a reported side effect of the vaccination. Referred to her physician for diagnosis and treatment recommendations. The outcome of the events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I am having a problem of mild fever; I am currently just up to  99.4 Fahrenheit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 21-year-old patient of an unspecified gender received bnt162b2 (BNT162B2 formulation: solution for injection), dose 2 via an unspecified route of administration on 05May2021 (Batch/Lot Number: EW0176) as DOSE 2, SINGLE (at the age of 21-year-old) for covid-19 immunization. Medical history included ongoing eczema (skin problems like some allergies like eczema). Concomitant medication (other products) included cetirizine taken for eczema, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 14Apr2021 (Batch/lot number: EW0151) (at the age of 21-year-old) for covid-19 immunization. The patient experienced a problem of mild fever; currently just up to 99.4 Fahrenheit on May2021. The patient asking should take some medicine like Tylenol or something else. The patient also stated don't know much if I just should drink water or take Tylenol because currently just up to 99.4 Fahrenheit. The patient did not receive any treatment. The outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Ear pain, Hyperhidrosis
Clinical narrative: Severe migraine-like headache during most of the fever; Back of neck pain/stiffness; Back of neck pain/stiffness; Left ear was aching inside like an earache pain; burning pain for 2 days; dry cough that was not persistent, lasting 2 days; sweats; 13 hours after the 2nd dose I woke up with a fever of 102; extreme chills; Left lymph node under armpit swollen and burning pain for 2 days.; Congestion and stuffy nose 8 hours after 2nd dose; This is a spontaneous report from a contactable consumer, the patient.  A 26-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0176), via an unspecified route of administration, in arm left on 02May2021 at 13:00 as dose 2, single (age at vaccination 26 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER8734), via an unspecified route of administration, in arm left on 10Apr2021 at 15:45 as dose 1, single (age at vaccination 26 years) for covid-19 immunisation. 13 hours after the 2nd dose, on 03May2021 at 02:00 she woke up with a fever of 102 and extreme chills and sweats. The chills went away after about an hour on 03May2021 at 03:00, the fever did not break for 36 hours. Tylenol was not bringing the fever down. The patient had severe migraine-like headache during most of the fever, with sensitivity to both light and sound, back of neck pain/stiffness, left ear was aching inside like an earache pain, left lymph node under armpit was swollen and had burning pain (for 2 days) on 03May2021 at 02:00. On 02May2021 at 21:00 the patient had congestion and stuffy nose that started 8 hours after 2nd dose, followed by dry cough that was not persistent, on 03May2021 at 02:00, lasting 2 days. She almost went to an urgent care for the fever/headache pains as they were resistant to OTC pain relievers. Decided to wait it out, thankfully fever broke after 36 hours. The patient did not take therapeutic treatment for the events other than fever. The patient underwent lab tests which included body temperature: 102 Fahrenheit on 03May2021. The patient was not tested for COVID post vaccination. The outcome for chills was recovered on 03May2021 at 03:00 and for the other events was recovered on an unknown date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Musculoskeletal stiffness, Nasal congestion, Neck pain
Clinical narrative: Severe migraine-like headache during most of the fever; Back of neck pain/stiffness; Back of neck pain/stiffness; Left ear was aching inside like an earache pain; burning pain for 2 days; dry cough that was not persistent, lasting 2 days; sweats; 13 hours after the 2nd dose I woke up with a fever of 102; extreme chills; Left lymph node under armpit swollen and burning pain for 2 days.; Congestion and stuffy nose 8 hours after 2nd dose; This is a spontaneous report from a contactable consumer, the patient.  A 26-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0176), via an unspecified route of administration, in arm left on 02May2021 at 13:00 as dose 2, single (age at vaccination 26 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER8734), via an unspecified route of administration, in arm left on 10Apr2021 at 15:45 as dose 1, single (age at vaccination 26 years) for covid-19 immunisation. 13 hours after the 2nd dose, on 03May2021 at 02:00 she woke up with a fever of 102 and extreme chills and sweats. The chills went away after about an hour on 03May2021 at 03:00, the fever did not break for 36 hours. Tylenol was not bringing the fever down. The patient had severe migraine-like headache during most of the fever, with sensitivity to both light and sound, back of neck pain/stiffness, left ear was aching inside like an earache pain, left lymph node under armpit was swollen and had burning pain (for 2 days) on 03May2021 at 02:00. On 02May2021 at 21:00 the patient had congestion and stuffy nose that started 8 hours after 2nd dose, followed by dry cough that was not persistent, on 03May2021 at 02:00, lasting 2 days. She almost went to an urgent care for the fever/headache pains as they were resistant to OTC pain relievers. Decided to wait it out, thankfully fever broke after 36 hours. The patient did not take therapeutic treatment for the events other than fever. The patient underwent lab tests which included body temperature: 102 Fahrenheit on 03May2021. The patient was not tested for COVID post vaccination. The outcome for chills was recovered on 03May2021 at 03:00 and for the other events was recovered on an unknown date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Severe migraine-like headache during most of the fever; Back of neck pain/stiffness; Back of neck pain/stiffness; Left ear was aching inside like an earache pain; burning pain for 2 days; dry cough that was not persistent, lasting 2 days; sweats; 13 hours after the 2nd dose I woke up with a fever of 102; extreme chills; Left lymph node under armpit swollen and burning pain for 2 days.; Congestion and stuffy nose 8 hours after 2nd dose; This is a spontaneous report from a contactable consumer, the patient.  A 26-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0176), via an unspecified route of administration, in arm left on 02May2021 at 13:00 as dose 2, single (age at vaccination 26 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER8734), via an unspecified route of administration, in arm left on 10Apr2021 at 15:45 as dose 1, single (age at vaccination 26 years) for covid-19 immunisation. 13 hours after the 2nd dose, on 03May2021 at 02:00 she woke up with a fever of 102 and extreme chills and sweats. The chills went away after about an hour on 03May2021 at 03:00, the fever did not break for 36 hours. Tylenol was not bringing the fever down. The patient had severe migraine-like headache during most of the fever, with sensitivity to both light and sound, back of neck pain/stiffness, left ear was aching inside like an earache pain, left lymph node under armpit was swollen and had burning pain (for 2 days) on 03May2021 at 02:00. On 02May2021 at 21:00 the patient had congestion and stuffy nose that started 8 hours after 2nd dose, followed by dry cough that was not persistent, on 03May2021 at 02:00, lasting 2 days. She almost went to an urgent care for the fever/headache pains as they were resistant to OTC pain relievers. Decided to wait it out, thankfully fever broke after 36 hours. The patient did not take therapeutic treatment for the events other than fever. The patient underwent lab tests which included body temperature: 102 Fahrenheit on 03May2021. The patient was not tested for COVID post vaccination. The outcome for chills was recovered on 03May2021 at 03:00 and for the other events was recovered on an unknown date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Headache, Illness
Clinical narrative: Trouble breathingbut not enough to rush to the hospital. Her 02 didn't go below 93 percent; She had stomach problems and pain in stomach, and an over all feeling of being sick; Exhaustion; over all feeling of sick; headache; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on Monday 05May2021 (at the age of 68-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included ongoing rheumatoid arthritis Diagnosed 16 years ago, ongoing systemic lupus erythematosus Diagnosed 15 years ago, influenza immunisation from an unknown date and unknown if ongoing. She stated she gets the flu shot every year she was fine. She was taking Remicade IV infusion at the hospital but had to stop because she had an allergic reaction to it. This was a few months ago. The patient concomitant medication(s) included ongoing methotrexate, ongoing prednisone and ongoing hydrochlorothiazide from unknown date. No other additional vaccines administered on same Date of the Pfizer suspect; no prior vaccinations received (within 4 weeks). She received at hospital and therefore, does not have a lot/exp. Historical Vaccine include bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in left arm on Monday 15Apr2021 at 12:15pm (at the age of 68-year-old) as DOSE 1, SINGLE for COVID-19 immunization. She states she went and had second shot Wednesday 05May2021 at noon and by midnight she was very very sick. On 06May2021 at 01:00am in the morning symptoms started, she was having trouble breathing, but not enough to rush to the hospital. Her 02 didn't go below 93 percent. She had stomach problems and pain in stomach, and an overall feeling of being sick. This went on 4 days. On the 3rd day she didn't have trouble breathing but her stomach and headache were still ongoing. She first thought maybe had some kind of sickness before she got the shot and it just appeared. Adverse Events does not require a visit to Emergency Room and Physician Office. Outcome of the event trouble breathing was recovered on 07May2021, while for all other events it was recovering.   No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527283 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Rhinorrhoea
Clinical narrative: not feeling well; cough; runny nose; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on 17Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had her first dose, and second dose is due tomorrow, 08May2021. However, from unspecified date the patient is not feeling well, had a bad cough and runny nose and her doctor told her that she should not get the second dose of the vaccine tomorrow. The Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: After first dose experienced fever, weariness.; After first dose experienced fever, weariness.; This is a spontaneous report from contactable consumer via Pfizer Sales Representative.  An adult female patient of unknown age (approx. 50 years old) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation.  Medical history included covid-19 infection on an unspecified date. The patient's concomitant medications were not reported. The patient she got two doses of Pfizer vaccine. After first dose she experienced fever, weariness. She was recommended not to have both doses administered but she decided to take both. It was reported that the event took place after use of product. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation and had back pain and continuous fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.