chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Limb discomfort, Nausea
Clinical narrative: Nausea; now she cant move her arm; arm is in pain at the injection site; Tiredness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, Expiration date: Unspecified), via an unspecified route of administration, in left upper arm on 02Feb2021 at 13:00 (at the age of 43-years-old) as 1 ST DOSE, SINGLE DOSE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had past medication doxycycline for acne (last 2 weeks), she has been taking for the past 3 months, the dose was decreased. She was on 135mg and 2 weeks ago she went to 50mg. On 02Feb2021, the patient had experienced tiredness started yesterday at night and has gotten better today and arm is in pain at the injection site. The patient informed that her arm is in pain at the injection site and this started yesterday. It started at 13:00 when she got the shot and during the night it was getting worse and cannot move her arm. On 03Feb2021, the patient experienced nausea started this morning when she woke up. The patient did not received treatment for the events. The outcome of the events tiredness and nausea was recovering while the outcome of the event arm is in pain at the injection site was not recovered. The outcome of the event now she cannot move her arm was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasal congestion, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP (the patient, reported for self).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3246, Expiration date: UNKNOWN), via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunisation.   The patient medical history and concomitant medications were not reported.   Patient stated, on Sunday, the 31st, like in the evening she started getting a little sore throat and then on Monday she had a nasal congestion and watery eyes which was sort of subsiding this morning, the nasal congestion but she was just wondering if that is a side effects or what. Patient confirmed it was the Covid19 vaccine of Pfizer. When paraphrased, patient stated, Initially it was a sore throat and then that subsided on Monday and then basically it was nasal congestion. Consumer was unwilling to complete the report. Hence, limited information available. The reported events were non-serious. The outcome was unknown for event sore throat and recovering for events, Nasal congestion and Watery eyes.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: My sister and I and our husbands we all got the vaccine and had a little sore arm after; her teeth are chattering and the chin is moving up and down; This is a spontaneous report from a contactable consumer (reported for sister). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that my sister and i and our husbands we all got the vaccine and had a little sore arm after and her teeth are chattering and the chin is moving up and down on an unspecified date'. Reporter wants to know if these symptoms are reported with Pfizer COVid-19 vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My sister and I and our husbands we all got the vaccine and had a little sore arm after; This is a spontaneous report from contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. This consumer reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at an unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that "my sister and I and our husbands we all got the vaccine and had a little sore arm after on an unspecified date" my sister noticed this morning her teeth are chattering and the chin is moving up and down. Reporter wants to know if these symptoms are reported with Pfizer COVID-19 vaccine mainly the one her sister had this morning. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111789 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My sister and I and our husbands we all got the vaccine and had a little sore arm after; This is a spontaneous report from contactable consumer. This consumer reported similar events for 3 patients. This report is for 1st of 3 reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at an unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced my sister and i and our husbands we all got the vaccine and had a little sore arm after. Reporter spoke with someone before being transferred to report the side effects. Reporter states "My sister and I and our husbands we all got the vaccine and had a little sore arm after. My sister noticed this morning her teeth are chattering and the chin is moving up and down." Reporter wants to know if these symptoms are reported with Pfizer COVid-19 vaccine mainly the one her sister had this morning. The outcome of the event was unknow.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111789 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness around injection site; Swelling around injection site; Itching around injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (Sunday) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation and patient had nothing at all. On unspecified date, with this second shot she got redness around injection site, swelling around injection site and itching around injection site. The redness/swelling/itching area was about the size of a silver dollar. It was itching more now than when it first started itching. Patient tried warm compresses which did not help with the itching. Patient did not know if she could use something else like alcohol or hydrocortisone on the area so she wanted to call and ask if those options would be ok; or if there was something, she can do to help the itching. She does not want to scratch it. The outcome of all the events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Gait disturbance, Joint stiffness, Neck pain
Clinical narrative: Stiff neck which developed into a neck pain which radiated kind of down to upper part of my neck; Pain under my hand looks like some slight swelling almost once again like if it was arthritis and it is like throbbing a little and it is creating little bit of immobility; Severe leg pain in my left leg, my left upper thigh to a form that I could not walk. I had to hobble and I had to get assistance getting in and on of bed. It almost felt as if it was a severe pinched; Severe leg pain in my left leg, my left upper thigh to a form that I could not walk. I had to hobble and I had to get assistance getting in and on of bed. It almost felt as if it was a severe pinched; Shoulder ache; Pains in my hands, almost similar to arthritis like arthritic pains; My joints, my knuckles were tight and reddish; My joints, my knuckles were tight and reddish; This is a spontaneous report from a contactable consumer(patient). An unspecified age and gender patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that I got the vaccine , the Covid vaccine on 21st and I got a pamphlet here stating the side effects that I may experience. 21st I had the vaccine. The initial vaccine, may be a slight shoulder ache, may be very slightly, nothing. 3-4 days later I started getting pains in my hands, almost similar to arthritis like arthritic pains and my joints, my knuckles were tight and reddish and that kind of dissipated and about 3 days later, that was the 26th. On 29Jan2021, I got severe leg pain in my left leg, my left upper thigh to a form that I could not walk. I had to hobble and I had to get assistance getting in and on of bed. It almost felt as if it was a severe pinched nerve or something like that and I took a couple of Motrin or Aleve (Treatment) and that kind of way also my leg is fine. Then, 3-4 days later, on the 2nd I was filling some paper work and I had my neck down in a bend over situation probably for a very long period of time and I got a very bad stiff neck which developed into a neck pain which radiated kind of down to upper part of my neck and last but not the least, today is 3rd. Last night, I got again pain under my hand looks like some slight swelling almost once again like if it was arthritis and it is like throbbing a little and it is creating little bit of immobility, so to speak and that is it." The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Stiff neck which developed into a neck pain which radiated kind of down to upper part of my neck; Pain under my hand looks like some slight swelling almost once again like if it was arthritis and it is like throbbing a little and it is creating little bit of immobility; Severe leg pain in my left leg, my left upper thigh to a form that I could not walk. I had to hobble and I had to get assistance getting in and on of bed. It almost felt as if it was a severe pinched; Severe leg pain in my left leg, my left upper thigh to a form that I could not walk. I had to hobble and I had to get assistance getting in and on of bed. It almost felt as if it was a severe pinched; Shoulder ache; Pains in my hands, almost similar to arthritis like arthritic pains; My joints, my knuckles were tight and reddish; My joints, my knuckles were tight and reddish; This is a spontaneous report from a contactable consumer(patient). An unspecified age and gender patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that I got the vaccine , the Covid vaccine on 21st and I got a pamphlet here stating the side effects that I may experience. 21st I had the vaccine. The initial vaccine, may be a slight shoulder ache, may be very slightly, nothing. 3-4 days later I started getting pains in my hands, almost similar to arthritis like arthritic pains and my joints, my knuckles were tight and reddish and that kind of dissipated and about 3 days later, that was the 26th. On 29Jan2021, I got severe leg pain in my left leg, my left upper thigh to a form that I could not walk. I had to hobble and I had to get assistance getting in and on of bed. It almost felt as if it was a severe pinched nerve or something like that and I took a couple of Motrin or Aleve (Treatment) and that kind of way also my leg is fine. Then, 3-4 days later, on the 2nd I was filling some paper work and I had my neck down in a bend over situation probably for a very long period of time and I got a very bad stiff neck which developed into a neck pain which radiated kind of down to upper part of my neck and last but not the least, today is 3rd. Last night, I got again pain under my hand looks like some slight swelling almost once again like if it was arthritis and it is like throbbing a little and it is creating little bit of immobility, so to speak and that is it." The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Right arm was very sore and lymph node under arm swelled to the size of a golf ball and was hard for 2-3 days; Right arm was very sore and lymph node under arm swelled to the size of a golf ball and was hard for 2-3 days; This is a spontaneous report from a contactable Other Health Professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 08:15 as 1st dose, single dose for COVID-19 immunization. Medical history included hypothyroidism, metabolic syndrome, insulin resistance from an unknown date and unknown if ongoing. Patient was allergic to Latex and Mushrooms from an unknown date and unknown if ongoing. The patient previously took codeine and experienced allergy. Patient was received any other medications in two weeks (Prescription and over the counter meds). Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 30Jan2021 at 05:00, patient experienced right arm was very sore and lymph node under arm swelled to the size of a golf ball and was hard for 2-3 days. It has gone down now and less than the size of a almond and the soreness is subsiding. The treatment was not received for any event. The outcome of events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non HCP (consumer reported for her Husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization (Reason for no lot number: of COVID-19 Shot: Caller unwilling to complete the report). The patient medical history and concomitant medications were not reported. Reporter confirmed it was the COVID-19 shot from Pfizer. The reporter stated that her husband and I both have shot around noon on Monday and last night he experienced and this morning when he got up experienced dizziness and he was over of it now and seems to be fine. The patient experienced dizziness on an unspecified date. Reporter stated, That would be a side effect, her husband was dizzy during the night and that's the only side effect he has had and the reporter just thought is that important that for Pfizer to know that. Reporter was informed about the Pfizer Medical Information and provided with the number. Further probing was not done as reporter was unwilling to share further information. Hence, limited information available over the call. The clinical outcome of the event dizziness was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: He got a pretty sore arm; Woke up with a severe headache; Muscle ache; Joint pain; Fever; This is a spontaneous report from a contactable nurse. The nurse reported for her husband. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9264 and expiry date were reported as unknown) via an unspecified route of administration on 02Feb2021 at 07:12 as a single dose for COVID-19 immunization. Medical history included COVID-19 from 20Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced pretty sore arm and in midnight he woke up with severe headache, muscle ache, joint pain and fever. No further information could be pro probed as the consumer already filled out the report online and was not willing to file the safety report again. Limited information available on the call. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear; This is a spontaneous report from a contactable other health care professional (patient). A 54-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EL3302), via an unspecified route of administration, administered in arm left on 21Jan2021 (at age of 54-year-old) as single dose, for Covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the was not patient diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EH9899), via an unspecified route of administration, administered in arm left on 30Dec2021 (at age of 54-year-old) as single dose, for Covid-19 immunization. On an unspecified date, the patient experienced ringing in the ear and she had doctor or other healthcare professional office/clinic visit. The patient had not been tested for COVID-19, post vaccination. The patient received treatment with Lipo flavonoid for the event. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms x 48hrs after receiving the 2nd dose of the COVID vaccine.; This is a spontaneous report from a non-contactable pharmacist. A 52-years-old male patient received BNT162B2, (Solution for injection, Batch/Lot Number and Expiration Date was not reported) via an unspecified route of administration on 03Feb2021 05:00 as second dose, single dose for COVID-19 immunization. The patient medical history was not reported. Patient previously received BNT162B2 vaccine. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if covid tested post vaccination. It was unknown if other vaccine given in four weeks. The patient experienced flu like symptoms x 48hrs after receiving the 2nd dose of the covid vaccine on 03Feb2021 12:00. It was unknown if treatment was given. The outcome of the event was recovered on Feb2021.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: chills; lethargic; sleep all the time; mouth feels like it has cotton in it; I'm just tired; head feels strange; This is a spontaneous report from a contactable consumer.  A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 29Jan2021 as 1st dose, single dose for an unspecified indication. The patient previously took humira for psoriasis. The patient's concomitant medications were not reported. The patient experienced chills, lethargic, sleep all the time, mouth feels like it has cotton in it, he was just tired, head feels strange. he talked with a ball player who received the vaccine (unknown which covid vaccine) who felt the same as like him. He got a shot (unknown medication) and felt 100% better afterward. She wanted to know Is it normal to have symptoms 5 days later and is the second dose stronger than the first dose, also wanted to know information for use of the product in immunocompromised patients.The outcome of events was recovering.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: chills; lethargic; sleep all the time; mouth feels like it has cotton in it; I'm just tired; head feels strange; This is a spontaneous report from a contactable consumer.  A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 29Jan2021 as 1st dose, single dose for an unspecified indication. The patient previously took humira for psoriasis. The patient's concomitant medications were not reported. The patient experienced chills, lethargic, sleep all the time, mouth feels like it has cotton in it, he was just tired, head feels strange. he talked with a ball player who received the vaccine (unknown which covid vaccine) who felt the same as like him. He got a shot (unknown medication) and felt 100% better afterward. She wanted to know Is it normal to have symptoms 5 days later and is the second dose stronger than the first dose, also wanted to know information for use of the product in immunocompromised patients.The outcome of events was recovering.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on the arm; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain on the arm for 3 days, no other reactions. Her second dose was intended for Monday, but she received "Pexol chemotherapy", and she was told they would call her to arrange the second dose appointment. She got a call yesterday but they did not schedule her. The outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: swollen arm; some pain; This is a spontaneous report from a contactable consumer (Patient's wife reported for husband).   A 75-year-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 30Jan2021, as a first dose single dose for COVID-19 immunisation. Medical history included over the holidays, in which patient was hospitalized for COVID virus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that reporter and the patient both received their first dose of the COVID vaccine on 30Jan2021. On an unknown date, patient's wife stated that her husband (75 year old, male), did not have a reaction like her and only had a swollen arm and some pain. Patient's wife states that they are in both excellent physical shape, walking and biking daily and she was not on any medication. Caller asked due to her previous reaction from the vaccine, is it absolutely necessary to take the second vaccine or does she have enough immunity from already having the Covid virus and the first vaccine. Caller asked, What about the 6 people in the clinical trial that had Covid, did they get the second dose. Caller stated that she is trying to get an authoritative answer, which is why she directly called Pfizer. Caller asked if there was someone else that could answer her question or if I could pass the question along, so she could receive a recommendation on if she absolutely needs to take the second dose. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  .
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Extreme fatigue; body aches; headache; fever; chills; sinus pressure; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in arm right on 02Feb2021 at 13:30 (at the age of 38-years-old) as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE), administered in right arm on 12Jan2021 at 13:30 for COVID-19 immunization. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 02Feb2021 at 19:00, the patient experienced extreme fatigue, body aches, headache, fever, chills, sinus pressure and joint pain. The patient did not receive treatment for the events. The outcome of all the events was not resolved.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pyrexia
Clinical narrative: Extreme fatigue; body aches; headache; fever; chills; sinus pressure; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in arm right on 02Feb2021 at 13:30 (at the age of 38-years-old) as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE), administered in right arm on 12Jan2021 at 13:30 for COVID-19 immunization. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 02Feb2021 at 19:00, the patient experienced extreme fatigue, body aches, headache, fever, chills, sinus pressure and joint pain. The patient did not receive treatment for the events. The outcome of all the events was not resolved.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Reported that 3 days after receipt of the first dose she "slept around the clock."; This is a spontaneous report from a non-contactable consumer (Patient). A non-pregnant elderly female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: not reported), via an unknown route of administration on an unspecified date in Jan2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient received any other vaccine in four weeks. It was unknown if patient was tested covid positive prior or post vaccination. On an unknown date in 2021 (3 days after receiving first dose), she slept around the clock. It was unknown if patient has received treatment for the event. Outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: infection in the eye; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced infection in the eye after taking the 1st dose. The patient received treatment with Valacyclovir for the event infection in the eye. Outcome of the event infection in the eye was reported as unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia
Clinical narrative: reported left facial pain and numbness from the ear to her mouth; reported left facial pain and numbness from the ear to her mouth; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient might have a possible reaction to the Pfizer COVID-19 vaccine. After receiving the first dose of the vaccine, patient reported left facial pain and numbness from the ear to her mouth on an unspecified date. Caller wanted to know if she should receive the second dose of the vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: eruption of cold sores on my lip and at the opening of my nostril; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm 02Feb2021 02:30 PM as single dose for Covid-19 immunization. Facility type vaccine: Hospital. The patient's medical history included thyroid condition (being treated) and cold sores. The patient sensitivity to latex, egg, wheat, pollen and evergreen (known allergies). Concomitant medications included levothyroxine, powdered collagen/Goli ACV chews (APPLE CIDER VINEGAR) (other medications in two weeks). It was reported that, on 14Feb2021 12:00 PM, the patient did not have a cold sore in over a year, but had a history of getting cold sores when she was stressed out. But, she did get several 13 days after getting the vaccine. She had an eruption of cold sores on lip and at the opening of nostril (never had them in this location before). Covid was not tested prior or post vaccination. The patient did not take any treatment in response to the events. Outcome of the event was recovering.  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: 2nd dose sore arm x 2days, fatigue x 2 days; 2nd dose sore arm x 2days, fatigue x 2 days; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL1696; Expiration Date: Jun2021), intramuscular administered on left deltoid on 12Jan2021 (age at vaccination: 50 years) as single dose for covid-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, via an unspecified route of administration on 18Dec2020 7:45 (24-hour clock) (Batch/Lot Number: EL0140; Expiration Date: was not reported) as single dose for covid-19 immunisation and has experienced muscle aches in legs. On an unspecified date, the patient experienced 2nd dose sore arm x 2days, fatigue x 2 days. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Tachycardia, Throat tightness
Clinical narrative: tachycardia; throat tightness; tingling lips and under tongue; itching face; This is a spontaneous report from a contactable physician. This physician reported for a 43-year-old female patient.  A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; Lot number: EN5318), intramuscular on 11Feb2021 09:30 as 2nd dose, single dose for covid-19 immunization. Medical history included hypothyroidism from an unknown date and ongoing.. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL), levothyroxine (LEVOTHYROXINE). Allergies included Sulfa, iodine contrast media, latex, Levaquin, penicillin. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; Lot number: unknown), via unspecified route on 21Jan2021 (at the age of 42-year-old) 1st dose, single dose for covid-19 immunization. On 11Feb2021 at 09:30, the patient experienced tachycardia, throat tightness, tingling lips and under tongue, itching face. Therapeutic measures were taken as a result of events of Benadryl, Pepcid, prednisone. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events were resolved in 2021.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysgeusia, Fatigue, Head discomfort
Clinical narrative: lightheaded; Throat constriction; metallic taste in mouth and throat; extremely swollen lymph nodes in neck; rash on arms and around ankles; Extreme dizziness; heaviness of head; extreme exhaustion; chills; This is a spontaneous report from a contactable consumer and other healthcare professional. A 45-years old adult female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 04Feb2021 at 07:15 as 1ST DOSE, SINGLE DOSE in left arm for COVID-19 immunization. The patient medical history included vitiligo and migraines and concomitant medication included Aleve. The patient did not take any other vaccine in four weeks. The patient past drug event included Imitrex, Augmentin, and Transderm for Known allergies.  It was reported that patient was not tested for COVID prior to vaccination and COVID tested post vaccination. On 04Feb2021 at 11:15, the patient experienced extreme dizziness, lightheaded, throat constriction, metallic taste in mouth and throat, rash on arms and around ankles, heaviness of head, extreme exhaustion, chills, and extremely swollen lymph nodes in neck. The patient underwent laboratory tests and procedures which included covid test (nasal swab) shows negative on 15Feb2021. The patient took antacid as a treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, SARS-CoV-2 test, Throat tightness
Clinical narrative: lightheaded; Throat constriction; metallic taste in mouth and throat; extremely swollen lymph nodes in neck; rash on arms and around ankles; Extreme dizziness; heaviness of head; extreme exhaustion; chills; This is a spontaneous report from a contactable consumer and other healthcare professional. A 45-years old adult female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 04Feb2021 at 07:15 as 1ST DOSE, SINGLE DOSE in left arm for COVID-19 immunization. The patient medical history included vitiligo and migraines and concomitant medication included Aleve. The patient did not take any other vaccine in four weeks. The patient past drug event included Imitrex, Augmentin, and Transderm for Known allergies.  It was reported that patient was not tested for COVID prior to vaccination and COVID tested post vaccination. On 04Feb2021 at 11:15, the patient experienced extreme dizziness, lightheaded, throat constriction, metallic taste in mouth and throat, rash on arms and around ankles, heaviness of head, extreme exhaustion, chills, and extremely swollen lymph nodes in neck. The patient underwent laboratory tests and procedures which included covid test (nasal swab) shows negative on 15Feb2021. The patient took antacid as a treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: Eye infection; The initial case was missing the following minimum criteria: as there is no indication that the consumer experienced an event under BNT162B2. Upon receipt of follow-up information on (01Mar2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program . A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: el9266) dose 1 via an unspecified route of administration on 19Feb2021 as a single dose for covid-19 immunisation. The patient medical history included eye infection and concomitant medications were not reported. The patient past drug included ciprofloxacin eye drops. On an unspecified date the patient experienced eye infection. The patient reported that she had 1st dose of vaccine on 19Feb2021 and scheduled on 12Mar2021 for 2nd dose. As per caller a few days after getting the vaccine she ended up with an eye infection, but it's not from the vaccine, its because she used eye make up from a year ago and was prescribed Ciprofloxacin eye drops. She want to make sure the eye drops did not reduce the efficacy of the vaccine. The patient also want to know after 1st dose, was there any protection and after how many days. Hearing a lot of news that people say they get sick after 2nd and it gives 70% protection after 1st dose. Also heard people takes Vitamins D or C before getting the vaccine. Her parents were elderly and thinking if they can get only 1 dose. Also has a 23-year-old daughter autistic has seizures but no seizures when under medication. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Throat tightness
Clinical narrative: throat and chest tightness; throat and chest tightness; Vaccine- Related Anxiety; This is a spontaneous report from a non-contactable other HCP. This other HCP reported for a patient that a 29-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date, as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced throat and chest tightness, vaccine- related anxiety on an unspecified date. It was reported as, during her 15-minute waiting period after the injection, the patient began to experience throat and chest tightness on an unspecified date. Did not provide detail about differential diagnosis vaccine- related anxiety (include miscellaneous mental health). Treatment included water and snacks for events. Response towards treatment was good. The patient was discharge, stable to go home and follow up with HCP. The outcome of the events throat and chest tightness was recovering and for vaccine- related anxiety was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: throat tightness; Itching/itching of skin; This is a spontaneous report from a non-contactable other health professional. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. It was reported that, "During 30 minute waiting period after the injection, the patient began to experience throat tightness and itching. Patient complained of itching of skin. Patient denied chills, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, abdominal pain, muscle aches, dizziness and headaches. Previous reactions reported that, she was brought back to bay initially for observation as she reported to pass out when she got shots. Shortly after injection, she developed symptoms above. No vagal issues arose". Treatment given was antihistamines close monitoring. Patient improving and was doing well with medication intervention. Patient has ride. Patient wheeled out to the front. Patient ambulated without difficulty. No dizziness. Instructions given on when she could take her next benadryl dose. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, Nausea, Swelling face
Clinical narrative: slight swelling of face near eyes; faster heartbeat than normal; redness on one side of tongue; nausea; feeling a bit of tightness in the throat; tightness in the chest; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 25Feb2021 at 15:30 (at the age of 62-year-old) as unknown, single dose for COVID-19 immunisation. Medical history included diabetes type II, allergies to nuts and cefzil. Concomitant medications included clindamycin HCL, citalopram, rosuvastatin and pioglitazone hydrochloride (PIOGLIT). The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 26Feb2021 at 03:00, the patient experienced slight swelling of face near eyes, faster heartbeat than normal, redness on one side of tongue, nausea, feeling a bit of tightness in the throat and tightness in the chest. The patient stated none of the symptoms were stopping her from working. The patient took some Benadryl and feeling a bit better. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tongue erythema
Clinical narrative: slight swelling of face near eyes; faster heartbeat than normal; redness on one side of tongue; nausea; feeling a bit of tightness in the throat; tightness in the chest; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 25Feb2021 at 15:30 (at the age of 62-year-old) as unknown, single dose for COVID-19 immunisation. Medical history included diabetes type II, allergies to nuts and cefzil. Concomitant medications included clindamycin HCL, citalopram, rosuvastatin and pioglitazone hydrochloride (PIOGLIT). The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 26Feb2021 at 03:00, the patient experienced slight swelling of face near eyes, faster heartbeat than normal, redness on one side of tongue, nausea, feeling a bit of tightness in the throat and tightness in the chest. The patient stated none of the symptoms were stopping her from working. The patient took some Benadryl and feeling a bit better. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fungal infection, Headache, Muscle atrophy
Clinical narrative: muscle loss; Severe yeast infection; headache; confusion; This is a spontaneous report from a contactable consumer(patient).  A female non-pregnant patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810) as 1st dose, single dose for Covid-19 immunization. Medical history included ongoing High blood pressure, blood glucose abnormal, cholesterol and thyroid. Concomitant medications were not reported. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6202) as 2 nd dose, single dose for covid-19 immunization. The patient had Covid-19 prior vaccination. Post vaccination patient not tested for covid-19. The patient did not receive any other vaccine in four weeks. On 05Feb2021 patient experienced headache, sever yeast infection, muscle loss and confusion. The events resulted in doctor or other healthcare professional office/clinic visit. The events treated with Premarin, Diflucan and Lotrisone. The patient had not yet recovered from events.   No follow -up attempts are possible. No further information is expected.