chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives torso, abdomen, neck and leg; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on the right arm on 22Dec2020 08:30 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy. The patient was not pregnant. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced hives torso, abdomen, neck and leg on 22Dec2020 12:00. Therapeutic measures were taken as a result of hives and included treatment with oral antihistamine. Outcome of the event was recovered on 22Dec2020. The event was considered non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Induration, Lymph node pain, Lymphadenopathy
Clinical narrative: Severely swollen, hard and painful lymph nodes in the L axillary region. / other swollen glands; fever; muscle aches; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 12:00 at a single dose for Covid-19 immunisation. Medical history included Covid-19. Concomitant medication included sertraline hydrochloride (ZOLOFT). Prior to vaccination, patient was diagnosed with COVID-19. The patient received the vaccine at a workplace clinic and experienced severely swollen, hard and painful lymph nodes in the L axillary region, other swollen glands; fever; muscle aches; chills; and headache, all on 18Dec2020 12:00. It was unknown if patient received treatment for the events. The events were reported as non-serious. Outcome of the events was not recovered.    No follow-up activities are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severely swollen, hard and painful lymph nodes in the L axillary region. / other swollen glands; fever; muscle aches; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 12:00 at a single dose for Covid-19 immunisation. Medical history included Covid-19. Concomitant medication included sertraline hydrochloride (ZOLOFT). Prior to vaccination, patient was diagnosed with COVID-19. The patient received the vaccine at a workplace clinic and experienced severely swollen, hard and painful lymph nodes in the L axillary region, other swollen glands; fever; muscle aches; chills; and headache, all on 18Dec2020 12:00. It was unknown if patient received treatment for the events. The events were reported as non-serious. Outcome of the events was not recovered.    No follow-up activities are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry throat, Nausea
Clinical narrative: dizziness; throat dryness; nausea; This is a spontaneous report from a non-contactable healthcare professional . A 23-year-old male patient received bnt162b2 (BNT162B2, lot number:EH9899), intramuscularly in his left arm  on 22Dec2020 11:00 at a single dose for covid-19 immunization (reported as covid-19 vaccination). The patient's medical history included GI symptoms that he was currently being worked up for. Patient reported onset of similar signs around time of vaccine injection. The patient's concomitant medications were not reported. During his 15 minute waiting period after the injection, the patient began to experience dizziness, throat dryness, and nausea. He denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, vomiting, abdominal pain and hypotension. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal
Clinical narrative: I feel weird, kind of spacey; metallic taste; Blood pressure 133/90.; This is a spontaneous report from a contactable nurse.  A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), intramuscular on the left arm on 22Dec2020 14:15 at SINGLE DOSE as COVID-19 vaccination at the hospital.  Medical history included reactive airway disease, attention deficit hyperactivity disorder (ADD) and asthma. The patient also had allergies to sulfa. Concomitant medications included losartan potassium (LOSARTA), methylphenidate hydrochloride (CONCERTA) and unspecified inhaler for asthma.  On 22Dec2020 14:25 (10 minutes after injection), the patient felt weird, kind of spacey and had metallic taste. The patient also had blood pressure of 133/90 (unit of measure not reported) on 22Dec2020 but denies urticaria, itching, pain, shortness of breath, and chest pain. The patient was brought to the emergency room/department or urgent care further evaluation due to the events. It was unknown if treatments were received for the events. Outcome of the events were unknown.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (23Dec2020), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional. A 23-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), first dose via intramuscular on 22Dec2020 15:00 in left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fatigue on 22Dec2020 18:00. The outcome of  the event was unknown. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: now COVID positive with symptoms; now COVID positive with symptoms; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient received the vaccine on 16Dec2020 and now COVID positive with symptoms as of 19Dec2020. The patient asked that should he (she) still get the second vaccine. The outcome of event was unknown.  Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140, expiry date unknown) intramuscular at the left arm on 21Dec2020 13:30 at single dose for COVID-19 immunization. The patient received Covid vaccine in a hospital. Medical history included high blood pressure, penicillin allergies. Concomitant medications included clonidine, bupropion hydrochloride (WELLBUTRIN XL), pantoprazole, topiramate, alprazolam (XANAX), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ascorbic acid (VIT C), fish oil, lactobacillus nos (CULTURELLE), ox bile; all from unspecified date for unspecified indication. The patient previously took ceftriaxone and experienced allergies. The patient did not receive other vaccine in four weeks. The patient has no diagnosis of Covid-19 prior to vaccination. On 22Dec2020 07:00 AM, the patient experienced diarrhea. The patient was not Covid tested post vaccination. No treatment was administered due to diarrhea. The outcome of the event diarrhea was not recovered. The reporter considered the event non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Rash, SARS-CoV-2 test negative
Clinical narrative: Allergic reaction; full body rash; fatigue; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730, intramuscular, first dose on 20Dec2020 at a single dose for immunization. Medical history included diabetes mellitus (DM), depression, gastrooesophageal reflux disease (GERD) and hypercholesterolaemia. The patient had no known allergies. The patient have unspecified concomitant medications. She had other vaccines in two weeks (unspecified).  The patient experienced allergic reaction- full body rash, fatigue on 21Dec2020 with outcome of not recovered. Treatment received for the events included steroid and antihistamines. The events are reported as non-serious. The patient had doctor or other healthcare professional office/clinic visit. She had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 21Dec2020 with negative result.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Body aches; fatigue; headache; not feeling well; Muscle aches; elevated temperature; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine by Pfizer, lot EK5730), intramuscular 20Dec2020 15:15 at single dose in left arm for Covid-19 immunisation. Medical history included High blood pressure and interstitial cystitis interstitial. Concomitant medications included losartan and hyoscyamine sulfate, methenamine, methylthioninium chloride, phenyl salicylate, phosphoric acid sodium (URIBEL). The patient previously took doxycycline and experienced drug allergy.  The patient experienced body aches, fatigue, headache, was not feeling well, muscle aches, elevated temperature, all on 21Dec2020 12:00. The events were reported as non-serious. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient was been tested for COVID-19 via nasal swab on 22Dec2020 with pending results. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Body aches; fatigue; headache; not feeling well; Muscle aches; elevated temperature; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine by Pfizer, lot EK5730), intramuscular 20Dec2020 15:15 at single dose in left arm for Covid-19 immunisation. Medical history included High blood pressure and interstitial cystitis interstitial. Concomitant medications included losartan and hyoscyamine sulfate, methenamine, methylthioninium chloride, phenyl salicylate, phosphoric acid sodium (URIBEL). The patient previously took doxycycline and experienced drug allergy.  The patient experienced body aches, fatigue, headache, was not feeling well, muscle aches, elevated temperature, all on 21Dec2020 12:00. The events were reported as non-serious. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient was been tested for COVID-19 via nasal swab on 22Dec2020 with pending results. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: headache; body aches; chills; fatigue; fever of 102; This is a spontaneous report from a contactable nurse (patient). A 28-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on the left arm on 21Dec2020 07:30 at a single dose for covid-19 immunization. Medical history included anxiety and Covid-19. Prior to vaccination (covid-19 vaccine), patient was diagnosed with COVID-19 (Covid prior vaccination: Yes). The patient has no known allergies. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT), ascorbic acid (VITAMIN C), zinc and colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 at 18:00 hour, the patient experienced headache, body aches, chills, fatigue and fever of 102 around 6pm the same day receiving vaccine. The events were considered non-serious by the reporter. Since the vaccination, the patient has not been tested for COVID-19 (Covid tested post vaccination: No). No treatment was received for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Moderate to severe lower back pain; This is a spontaneous report from a contactable physician (patient). A 38-year-old male patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 18Dec2020 08:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included vitamin C and multivitamins. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. On 18Dec2020 19:00, the patient experienced moderate to severe lower back pain approximately 9-10 hours after receiving vaccine. He was feeling well prior to that, no strenuous activity. Symptoms progressed over 1-2 hours, then resolved over 4 days with tylenol/motrin use. Therapeutic measures were taken as a result of moderate to severe lower back pain. The outcome of the event was recovered on an unspecified date.  The following information on the batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny nose; sore throat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 44-year-old male patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 18Dec2020 at single dose in the left deltoid for COVID Prevention. There were no medical history and concomitant medications. The patient called and stated that he took the COVID vaccine first dose, on Monday, and now he is getting the side effects of running nose and sore throat. Stated that the running nose and sore throat starting this morning on 22Dec2020, right as he woke up, and then it went away, and now it just seems to have gotten worse. He wondered if those are common side effects because he couldn't find them on the facts sheet. He stated that he is just trying to gather more information because he knows that it is currently cold and flu season, and it could also just be allergies. Also he wanted to make sure this is a common side effect, because if not, he has family coming to town to visit him for the holiday and he wants to be safe if he is sick. The outcome of the events was not recovered.  The following information on the batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 21Dec2020 12:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient experienced tachycardia on 22Dec2020 02:30. No treatment received for the event. The outcome of the event was not recovered.  The following information on the batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever (39.1 C); chills; headache; body aches; nausea; This is a spontaneous report from a non-contactable nurse.  A 37-years-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at the left arm on 21Dec2020 10:45  at a single dose for COVID-19 immunization.  Medical history included COVID-19 prior to vaccination.  The patient has no known allergies. There were no concomitant medications.  The patient experienced fever (39.1 C), chills, headache, body aches, nausea on 21Dec2020 20:00 with no treatment.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient recovered from the events on an unknown date.  No follow up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Night sweats, Pain
Clinical narrative: Nausea; body aches; night sweats; headache; tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJI685), intramuscular on the arm (reported as location was in the left and right arm, pending clarification) on 21Dec2020 15:30 at a single dose for COVID-19 immunization. The patient's medical history included celiac disease and wheat, gluten, chicken, nightshades, yeast allergy. The patient was not pregnant. Concomitant medication included vortioxetine hydrobromide (TRINTELLIX). The patient previously took chlorhexidine (CHLORAPREP) and experienced allergies to chlorhexidine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 21Dec2020 17:00, the patient experienced nausea, body aches, night sweats, headache, and tired. Therapeutic measures were taken as a result of the events and included treatment with ondansetron (ZOFRAN) and paracetamol (TYLENOL). Outcome of the events was not recovered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Retching, SARS-CoV-2 test, Vomiting
Clinical narrative: Diarrhea; Vomiting; dry heaves; This is a spontaneous report from a contactable nurse (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular (left arm) on 21Dec2020 17:00 at single dose for Covid-19 immunization. The patient's medical history included high blood pressure. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced diarrhea, vomiting, and dry heaves on 22Dec2020 (06:00 AM). There was no treatment received for the adverse events. The patient has been tested with COVID-19 since the vaccination. The patient had nasal swab (test) on 22Dec2020 with pending result. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for COVID in Dec2020. The patient got the first dose of the vaccine on the day before the date of this report, started coughing on the day before the date of this report and tested positive for COVID on the date of this report.  Caller requested guidance regarding whether he should receive the second vaccine dose, specifically will it be effective.  Caller stated that he was "an ER doc" and understand that he did not get COVID from the vaccine. The patient underwent lab tests and procedures which included tested positive for COVID in Dec2020. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Considering the temporal gap between the vaccination and the event onset, there was not a reasonable possibility that the COVID-19 infection was related to vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Headache, Malaise, Pain
Clinical narrative: "pins and needles type tingling" of the face; Chills; malaise; fever (101F); scratchy throat; headache; lack of appetite; pain of entire body; my feet hurt as soon as they hit the ground; This is a spontaneous report from a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs) from a contactable physician reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that she received vaccine yesterday, 21Dec2020. Approximately 24 hours later, on 22Dec2020, she started experiencing "pins and needles type tingling" of the face, chills, malaise, fever (101F), "scratchy throat", headache, lack of appetite, "pain of entire body" and feet also hurt as soon as they hit the ground. She asked with the reaction that she was having, when do she seeks help and how long does it lasts.  "With the reaction that I'm having, when do I seek help? How long does this last? Are there any reports of fever?  Are these common side effects?" Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Throat irritation
Clinical narrative: "pins and needles type tingling" of the face; Chills; malaise; fever (101F); scratchy throat; headache; lack of appetite; pain of entire body; my feet hurt as soon as they hit the ground; This is a spontaneous report from a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs) from a contactable physician reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that she received vaccine yesterday, 21Dec2020. Approximately 24 hours later, on 22Dec2020, she started experiencing "pins and needles type tingling" of the face, chills, malaise, fever (101F), "scratchy throat", headache, lack of appetite, "pain of entire body" and feet also hurt as soon as they hit the ground. She asked with the reaction that she was having, when do she seeks help and how long does it lasts.  "With the reaction that I'm having, when do I seek help? How long does this last? Are there any reports of fever?  Are these common side effects?" Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Decreased appetite, Dyspnoea, Feeling abnormal
Clinical narrative: "pins and needles type tingling" of the face; Chills; malaise; fever (101F); scratchy throat; headache; lack of appetite; pain of entire body; my feet hurt as soon as they hit the ground; This is a spontaneous report from a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs) from a contactable physician reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that she received vaccine yesterday, 21Dec2020. Approximately 24 hours later, on 22Dec2020, she started experiencing "pins and needles type tingling" of the face, chills, malaise, fever (101F), "scratchy throat", headache, lack of appetite, "pain of entire body" and feet also hurt as soon as they hit the ground. She asked with the reaction that she was having, when do she seeks help and how long does it lasts.  "With the reaction that I'm having, when do I seek help? How long does this last? Are there any reports of fever?  Are these common side effects?" Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Headache, Myalgia, Oxygen saturation decreased, Pain
Clinical narrative: "pins and needles type tingling" of the face; Chills; malaise; fever (101F); scratchy throat; headache; lack of appetite; pain of entire body; my feet hurt as soon as they hit the ground; This is a spontaneous report from a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs) from a contactable physician reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that she received vaccine yesterday, 21Dec2020. Approximately 24 hours later, on 22Dec2020, she started experiencing "pins and needles type tingling" of the face, chills, malaise, fever (101F), "scratchy throat", headache, lack of appetite, "pain of entire body" and feet also hurt as soon as they hit the ground. She asked with the reaction that she was having, when do she seeks help and how long does it lasts.  "With the reaction that I'm having, when do I seek help? How long does this last? Are there any reports of fever?  Are these common side effects?" Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Throat irritation
Clinical narrative: "pins and needles type tingling" of the face; Chills; malaise; fever (101F); scratchy throat; headache; lack of appetite; pain of entire body; my feet hurt as soon as they hit the ground; This is a spontaneous report from a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs) from a contactable physician reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that she received vaccine yesterday, 21Dec2020. Approximately 24 hours later, on 22Dec2020, she started experiencing "pins and needles type tingling" of the face, chills, malaise, fever (101F), "scratchy throat", headache, lack of appetite, "pain of entire body" and feet also hurt as soon as they hit the ground. She asked with the reaction that she was having, when do she seeks help and how long does it lasts.  "With the reaction that I'm having, when do I seek help? How long does this last? Are there any reports of fever?  Are these common side effects?" Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm within an hour; Chills; body aches; fatigue overnight and throughout the next day; slight headache; This is a spontaneous report from a contactable nurse (patient).  A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: Eh9899, via intramuscular route in the right arm, first dose on 21Dec2020 11:00 at a single dose for immunization. Medical history was none. The patient's concomitant medications were not reported. The patient is not pregnant. She has no known allergies. The patient did not have Covid prior vaccination and was not tested post vaccination. She did not receive other vaccines with 4 weeks prior to covid vaccine. The patient experienced sore arm within an hour on 21Dec2020 with outcome of recovering. She also had chills, body aches, fatigue overnight and throughout the next day with outcome of recovering. Almond with slight headache which was recovering. No treatment received for the events. The seriousness of the events was reported as non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial discomfort
Clinical narrative: 12 minutes after vaccination, pt experienced jaw discomfort on left side and sharp intermittent pain in L ear.; 12 minutes after vaccination, pt experienced jaw discomfort on left side and sharp intermittent pain in L ear.; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular at the left arm on 22Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included baclofen, vitamin d3 and pitavastatin. The patient previously took tramadol and experienced drug allergies. On 22Dec2020, 12 minutes after vaccination, the patient experienced jaw discomfort on left side and sharp intermittent pain in L ear. The patient was not hospitalized for the events. It was unknown if patient receive any treatment for the events. The events were reported as non-serious. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever/ got up to 102 degrees Fahrenheit; Body aches; Sore throat; Feels like she has got just a regular cold; This is a spontaneous report from a contactable other hcp (patient). A 59-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 19:00 to an unspecified date at single dose in the right arm for vaccination. Medical history included menopause from an unknown date. Concomitant medication included levothyroxine sodium (SYNTHROID), fenofibric acid, metformin, escitalopram and unspecified hormones for menopause. The nurse practitioner called to report on herself as the patient. She received her first dose of COVID-19 Vaccine on 21Dec2020 around 7:00pm. Starting about 10:00 am today, 22Dec2020, she had onset of fever, body aches and sore throat. She is hoping that this is all a normal part of the COVID-19 Vaccine; but she called to verify if that is all normal because she has to work tomorrow. Stated that her fever got up to 102 degrees Fahrenheit. She mentioned regarding seriousness criteria of all events that they are not serious, that she feels like she has just got a regular cold. She is scheduled to get the second dose of this vaccine 21 days after first dose. Causality of all events reported as yes, she really believes it is related to product. The outcome of the events was not recovered.  The following information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: limited arm movement; arm to be sore; This is a spontaneous report from a contactable consumer or other non hcp.  A 66-years-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. It was reported that it was stated that a couple of years ago, he had a Prevnar 13 vaccine where he had a side effect of limited arm movement on the same arm he received the vaccine. Caller asking if there is anything in the COVID vaccine like there was in the Prevnar 13 vaccine that would cause his arm to be sore? He does not want the same side effect if he gets the COVID Vaccine. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report from a contactable healthcare professional reported for himself. A 41-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685, expiry date: unknown), intramuscular on the left arm on 22Dec2020 01:30 at a single dose for COVID-19 immunization. There was no medical history. The patient's concomitant medications were not reported.  The patient experienced sore arm at injection site on 22Dec2020 02:00. Outcome of the event was not recovered. No treatment was given. Patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The event was considered non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Occupational exposure to SARS-CoV-2, Pain
Clinical narrative: back is achy; Injection site pain; Body achy; body feels like after you have a workout; Muscles are sore; My close coworker who works with me in the same company cubicle as me when we document, tested positive for COVID; This is a spontaneous report from a contactable other health professional (patient). A female patient (Age: 35; unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine on 21Dec2020 and experienced side effect of the vaccine. Stated 'achy feeling. The patient's abdomen and trunk like after a workout.' She move suddenly her back was achy. She had injection site pain. Consumer stated, her close coworker who worked with her in the same company cubicle as she, tested positive for COVID and he had been having symptoms since Saturday. And she was body achy at the time of this report, like she kind of feel like, her body felt like after she had a workout and her muscles are sore. So, she did not know what to do because she do not know if this body achiness is a symptom of COVID or a symptom of the vaccine. And if she went get tested, whether she will show like a positive because she had the vaccine. The outcome of events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Chills, Dizziness, Feeling hot, Feeling of body temperature change
Clinical narrative: she was freezing one minute, and then she was hot the next minute; dizzy; soreness throughout body/achy; stated her eyes feel heavy; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, expiration date: Mar2021, intramuscular in left upper arm from 21Dec2020 10:00 to 21Dec2020 10:00 at 0.3 mL for Covid-19 immunization. Medical history included COVID-19 in Jul2020. She said she had a real bad case of COVID-19, and didn't get over it until Oct2020. The patient's concomitant medications were not reported. The patient stated she received the COVID-19 Vaccine yesterday at her employer, which is a hospital. She said she got the COVID-19 Vaccine at around 10:00AM on 21Dec2020. She said she had a few chills not too long after receiving the COVID-19 Vaccine. She said last night the chills got worse, saying she had chills all night. She said the chills are not as bad now. Reported she is sore and achy, clarifying she has more of a soreness throughout her body. She stated her eyes feel heavy too. Caller asked if what she was experiencing were side effects of the COVID-19 Vaccine and how long were the symptoms going to last. The reporter stated she is not a healthcare professional. She said she works in the surgery area at the hospital, and the hospital was offering the COVID-19 Vaccine yesterday, so she got the vaccine. Reported after receiving the COVID-19 Vaccine, she noticed she felt cool at work. She said last night she felt like she was freezing one minute, and then she was hot the next minute, and kept going back and forth between freezing and hot. She said she woke up at 1:00AM and felt really hot. She said she wished she had a thermometer at the time to check her temperature because she thought she had a fever. She said her husband told her what she was experiencing was part of having the chills. She said when she woke at 1:00AM, she got out of bed to go to the bathroom, and her eyes felt heavy, and she thought she may have been a little dizzy. She said now she doesn't think she was dizzy at the time, but maybe it was because she just woke up and got out of bed. She said she hasn't had any dizziness today. Treatment: Reported she took an Ibuprofen 200mg at 2:00AM and another Ibuprofen 200mg at 8:30AM. She clarified it was Equate Brand Ibuprofen 200mg. The event chills with outcome of recovering; the rest of the events was unknown. Therapeutic measure has been given as a result  of the events.  Information about the lot/batch number and expiration date has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she was freezing one minute, and then she was hot the next minute; dizzy; soreness throughout body/achy; stated her eyes feel heavy; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, expiration date: Mar2021, intramuscular in left upper arm from 21Dec2020 10:00 to 21Dec2020 10:00 at 0.3 mL for Covid-19 immunization. Medical history included COVID-19 in Jul2020. She said she had a real bad case of COVID-19, and didn't get over it until Oct2020. The patient's concomitant medications were not reported. The patient stated she received the COVID-19 Vaccine yesterday at her employer, which is a hospital. She said she got the COVID-19 Vaccine at around 10:00AM on 21Dec2020. She said she had a few chills not too long after receiving the COVID-19 Vaccine. She said last night the chills got worse, saying she had chills all night. She said the chills are not as bad now. Reported she is sore and achy, clarifying she has more of a soreness throughout her body. She stated her eyes feel heavy too. Caller asked if what she was experiencing were side effects of the COVID-19 Vaccine and how long were the symptoms going to last. The reporter stated she is not a healthcare professional. She said she works in the surgery area at the hospital, and the hospital was offering the COVID-19 Vaccine yesterday, so she got the vaccine. Reported after receiving the COVID-19 Vaccine, she noticed she felt cool at work. She said last night she felt like she was freezing one minute, and then she was hot the next minute, and kept going back and forth between freezing and hot. She said she woke up at 1:00AM and felt really hot. She said she wished she had a thermometer at the time to check her temperature because she thought she had a fever. She said her husband told her what she was experiencing was part of having the chills. She said when she woke at 1:00AM, she got out of bed to go to the bathroom, and her eyes felt heavy, and she thought she may have been a little dizzy. She said now she doesn't think she was dizzy at the time, but maybe it was because she just woke up and got out of bed. She said she hasn't had any dizziness today. Treatment: Reported she took an Ibuprofen 200mg at 2:00AM and another Ibuprofen 200mg at 8:30AM. She clarified it was Equate Brand Ibuprofen 200mg. The event chills with outcome of recovering; the rest of the events was unknown. Therapeutic measure has been given as a result  of the events.  Information about the lot/batch number and expiration date has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Feeling abnormal, Heart rate increased
Clinical narrative: Dry mouth; rapid heart rate; fuzzy feeling in middle of forehead; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date was not provided) solution for injection, intramuscular from 21Dec2020 11:15 at a single dose for Covid-19 immunisation. Medical history included PVC's (Premature ventricular contractions). Concomitant medication included ibuprofen. The patient received the dose number 1 of the vaccine at a hospital and experienced dry mouth, rapid heart rate, and fuzzy feeling in middle of forehead on 21Dec2020 11:15. No treatment was administered. The events were reported as non-serious. Patient was not pregnant. Patient was not diagnosed with Covid-19 prior to vaccination and has not been tested. Outcome of the events was recovering.    No follow-up activities are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Visual impairment
Clinical narrative: 4 days after first vaccine started to get left cheek and left arm numbness without weakness. Also had left vision spotting. Different pattern than pts usual migraine
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Left arm pain on first 2 days; extreme fatigue; chills/ All night chills; flu like illness; This is a spontaneous report from a contactable Physician (patient himself). A 40-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 18Dec2020 11:45 at single dose for Covid-19 immunisation in a hospital. Medical history included High cholesterol. Concomitant medication included influenza vaccine (FLU). Prior to vaccination the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 post vaccination. The patient experienced left arm pain on first 2 days (21Dec2020) 12:00, had extreme fatigue, chills described as all night chills and flu like illness on 21Dec2020 12:00. The patient took Tylenol as treatment. The outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Nausea
Clinical narrative: Nausea; injection site soreness; fatigue; chills; general feeling unwell; This is a spontaneous report from a non-contactable healthcare professional. A 33-year-old female patient received bnt162b2 (BNT162B2; reported as COVID-19 vaccine; solution for injection; unknown lot number and expiration date), intramuscular right arm on 21Dec2020 04:30 at single dose for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. On 21Dec2020 at 08:30 PM, the patient experienced nausea, injection site soreness, fatigue, chills and general feeling unwell. The patient did not treatment for the adverse event. The patient had her most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Injection site rash, Nasopharyngitis, Rash, SARS-CoV-2 test negative
Clinical narrative: Cold/Flu/COVID symptoms, skin rash around injection site and left side of back
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Injection site pain, Myalgia
Clinical narrative: Injection site pain; myalgia; abdominal pain; This is a spontaneous report from a contactable physician. A 40-year-old male patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration on 21Dec2020 (19:15 PM) at single dose for COVID-19 immunization. There was no medical history. Concomitant medications were not reported. The patient has not been diagnosed with Covid-19 prior to vaccination. No know allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other vaccine in four weeks and other medications in two weeks. The patient experienced injection site pain, myalgia, and abdominal pain on 22Dec2020 (09:00 AM). There was no treatment received for the adverse event. The patient was not tested for Covid-19 post vaccination. The outcome of events was recovering. This case is reported as non-serious.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Soreness at the injection site, Joint pain, including hip, leg soreness with a  change in mobility.