chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Pallor, Presyncope
Clinical narrative: feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown.  Information about Lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pharyngeal swelling, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Sore throat- swollen on the outside; Sore throat- swollen on the outside; Lymph nodes; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/expiry: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Taltz for psoriasis (pending clarification). It was reported that "day after HA etc" on an unspecified date; sore throat- swollen on the outside. "Lymph nodes?"  was also reported.  It was reported that the patient still sore (sore throat) and tested negative for COVID and strep throat. "Psoriasis TALTs med? - Second dose?" was also stated.  For their vaccine storage, it was reported that the state sent them. It had to be used within 5 days after removal - and stored under refrigeration, asking if it can be extended for at least a day would be helpful. The pharmacist was asking for extended stability of thawed vials in the refrigerator.    Information on the lot/batch number has been requested.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Irritability, Rash
Clinical narrative: I am nursing.  My son (7 months old) developed a rash and fussiness.  No fever.  I do not have any symptoms myself.; rash; fussiness; This is a spontaneous report from a contactable physician. This physician reported events for 2 patients (herself and baby). This is the baby report. A 7-month old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), transmammary on 22Dec2020 14:30 at a single dose for COVID-19 immunisation.  Medical history was none. Concomitant medication included levothyroxine. The patient's mother reported that "I am nursing. My son (7 months old) developed a rash and fussiness. No fever. I do not have any symptoms myself". The events started from 06Jan2021. Patient's mother had no COVID prior vaccination. No COVID  tested post vaccination. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient's mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient's mother was not diagnosed with COVID-19. Since the vaccination, the patient's mother had not been tested for COVID-19. Clinical outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007817 mother/baby case
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Cough, Headache
Clinical narrative: muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains that got progressively worse over the next 24 hours; body pain/body aches; I also have shaking chills; throbbing headache; tender anterior cervical lymphadenopathy; runny nose; dry cough; chest tightness; First dose of bnt162b2 on 18Dec2020/ second dose on 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient (pregnant: No) received of bnt162b2 (Pfizer), via an unspecified route of administration in left arm on 04Jan2021 07:15 at single dose (second dose), via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose (first dose dose) for COVID-19 immunization. Medical history included asthma, allergies from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. Around 12 hours after the second dose, the patient started feeling muscle and joint pains that got progressively worse over the next 24 hours. She had to miss 1 work day so far due to body pain despite alternating taking ibuprofen and paracetamol (APAP) around the clock. It was now 48 hours after the vaccine, and she still have severe body aches. She also had shaking chills, throbbing headache, tender anterior cervical lymphadenopathy, runny nose, dry cough and chest tightness. Of note, she was a healthcare worker and tested negative for COVID PCR immediately after she received my second dose of the vaccine. She was tested due to a low-suspicion possible workplace exposure 5 days prior. She had no symptoms before the vaccine. The patient underwent lab tests and procedures which included nasal swab test: negative on 04Jan2021. The events were reported as non-serious. The adverse event didn't result in emergency room visit or physician office visit. No treatment received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control pills.  Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the had patient been tested for COVID-19. The outcome of events was resolving.   Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Myalgia, Pain, Rhinorrhoea
Clinical narrative: muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains that got progressively worse over the next 24 hours; body pain/body aches; I also have shaking chills; throbbing headache; tender anterior cervical lymphadenopathy; runny nose; dry cough; chest tightness; First dose of bnt162b2 on 18Dec2020/ second dose on 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient (pregnant: No) received of bnt162b2 (Pfizer), via an unspecified route of administration in left arm on 04Jan2021 07:15 at single dose (second dose), via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose (first dose dose) for COVID-19 immunization. Medical history included asthma, allergies from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. Around 12 hours after the second dose, the patient started feeling muscle and joint pains that got progressively worse over the next 24 hours. She had to miss 1 work day so far due to body pain despite alternating taking ibuprofen and paracetamol (APAP) around the clock. It was now 48 hours after the vaccine, and she still have severe body aches. She also had shaking chills, throbbing headache, tender anterior cervical lymphadenopathy, runny nose, dry cough and chest tightness. Of note, she was a healthcare worker and tested negative for COVID PCR immediately after she received my second dose of the vaccine. She was tested due to a low-suspicion possible workplace exposure 5 days prior. She had no symptoms before the vaccine. The patient underwent lab tests and procedures which included nasal swab test: negative on 04Jan2021. The events were reported as non-serious. The adverse event didn't result in emergency room visit or physician office visit. No treatment received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control pills.  Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the had patient been tested for COVID-19. The outcome of events was resolving.   Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains that got progressively worse over the next 24 hours; body pain/body aches; I also have shaking chills; throbbing headache; tender anterior cervical lymphadenopathy; runny nose; dry cough; chest tightness; First dose of bnt162b2 on 18Dec2020/ second dose on 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient (pregnant: No) received of bnt162b2 (Pfizer), via an unspecified route of administration in left arm on 04Jan2021 07:15 at single dose (second dose), via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose (first dose dose) for COVID-19 immunization. Medical history included asthma, allergies from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. Around 12 hours after the second dose, the patient started feeling muscle and joint pains that got progressively worse over the next 24 hours. She had to miss 1 work day so far due to body pain despite alternating taking ibuprofen and paracetamol (APAP) around the clock. It was now 48 hours after the vaccine, and she still have severe body aches. She also had shaking chills, throbbing headache, tender anterior cervical lymphadenopathy, runny nose, dry cough and chest tightness. Of note, she was a healthcare worker and tested negative for COVID PCR immediately after she received my second dose of the vaccine. She was tested due to a low-suspicion possible workplace exposure 5 days prior. She had no symptoms before the vaccine. The patient underwent lab tests and procedures which included nasal swab test: negative on 04Jan2021. The events were reported as non-serious. The adverse event didn't result in emergency room visit or physician office visit. No treatment received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control pills.  Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the had patient been tested for COVID-19. The outcome of events was resolving.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test
Clinical narrative: lower back cramps; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on an unspecified date at a single dose for COVID-19 immunization at a nursing home/senior living facility. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the right arm on 17Dec2020 for COVID-19 immunization. The patient experienced lower back cramps on 07Jan2021 and was treated with ibuprofen.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient been tested for COVID-19? since vaccination and was negative via a nasal swab on 06Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was recovering from the event.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: fatigue; patient received the second dose in less than 21 days from  the first dose; tenderness in the arm; This is a spontaneous report from contactable nurse, the patient.  A 58-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization.  Medical history included hypothyroidism, depression, and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), and multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 on 17Dec2020 at 08:00 (Lot Number: EK5730; at the age of 58-years-old) for COVID-19 immunization in the left arm and experienced severe arm pain. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 04Jan2021, the patient had tenderness in the arm. The patient took acetaminophen (MANUFACTURER UNKNOWN) which helped. On 05Jan2021, the patient experienced fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the tenderness in the arm and fatigue were recovered on unknown dates in Jan2021.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: chills; headache; feeling tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231 and expiry date unknown) intramuscular at left arm on 06Jan2021 08:00 at single dose for Covid-19 immunization in a hospital facility. Medical history was none. The patient previously took cephalexin and experienced allergies. Historical vaccines included first dose of BNT162B2 (lot number EH9899) on 16Dec2020 08:00 (29 years old) and was administered in a hospital facility intramuscularly at the left arm; the patient did not receive any other vaccines in four weeks prior to Covid-19 vaccination and has no Covid prior to the vaccination. On 06Jan2021 21:00 several hours after taking the second vaccine, the patient developed chills, headache, and was feeling tired. The patient was not Covid tested post vaccination. The patient did not received treatment due to the events. The outcome of the events chills, headache, and feeling tired was recovering. The reporter considered the events non-serious; did not result in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; headache; body aches; This is a spontaneous report from a non-contactable other healthcare professional reporting for herself. A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), via an unspecified route of administration on 05Jan2021 14:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (results unknown). The patient experienced fever, headache, body aches an unspecified date in Jan2021. Event outcome was unknown. The reporter assessed the events as non-serious.  No follow up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza, Malaise, Oropharyngeal pain
Clinical narrative: I've felt like I have the flu for the past 3 days; aches/pains; sore throat; sinus pressure; extreme fatigue; sleeping most of the day making it hard to work; feeling worse, not better; fogginess; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 04Jan2021 at 08:00 at 0.3 ml single for COVID-19 immunisation. The patient was not pregnant. Vaccine location was left arm. Relevant medical history included depression, anxiety, endometriosis. No known allergies. Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), and colecalciferol (VITAMIN D). The patient was vaccinated at Workplace clinic, age at vaccination was 31-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient stated that on 05Jan2021 ''I've felt like I have the flu for the past 3 days-aches/pains, sore throat, sinus pressure, fogginess, extreme fatigue; I'm sleeping most of the day making it hard to work; feeling worse, not better, each day; trying OTC meds- loratadine pseudoephedrine sulfate (CLARITIN D) and chlorphenamine maleate, paracetamol, pseudoephedrine hydrochloride (TYLENOL COLD); plan to call doctor if not feeling better by day 5''. The patient had not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paranasal sinus discomfort, Somnolence
Clinical narrative: I've felt like I have the flu for the past 3 days; aches/pains; sore throat; sinus pressure; extreme fatigue; sleeping most of the day making it hard to work; feeling worse, not better; fogginess; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 04Jan2021 at 08:00 at 0.3 ml single for COVID-19 immunisation. The patient was not pregnant. Vaccine location was left arm. Relevant medical history included depression, anxiety, endometriosis. No known allergies. Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), and colecalciferol (VITAMIN D). The patient was vaccinated at Workplace clinic, age at vaccination was 31-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient stated that on 05Jan2021 ''I've felt like I have the flu for the past 3 days-aches/pains, sore throat, sinus pressure, fogginess, extreme fatigue; I'm sleeping most of the day making it hard to work; feeling worse, not better, each day; trying OTC meds- loratadine pseudoephedrine sulfate (CLARITIN D) and chlorphenamine maleate, paracetamol, pseudoephedrine hydrochloride (TYLENOL COLD); plan to call doctor if not feeling better by day 5''. The patient had not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: aches/pains shooting down my right leg; severe lower back pain; This is a spontaneous report from a contactable nurse. This 54- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK5730), via an Intramuscular route of administration, on 06Jan2021 at 09:00 AM (at the age of 54-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the right arm. The patient reported allergies to food. The patient does not have any medical history. Concomitant medication included omeprazole ((MANUFACTURER UNKNOWN) 20 mg QD, diclofenac (MANUFACTURER UNKNOWN) 75 mg EC tablet QD. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 3:00AM, 18 hours after 1st dose, she experienced severe lower back pain with aches/pains shooting down my right leg. Nine hours, after the injection I took 1 gm of Tylenol. At 3 am, I took another 1 gm of Tylenol with some relief. At 8 am took 400 mg of Motrin with some relief-aches/pain still there. No paralysis or weakness. The patient received Tylenol and Motrin as treatment for the events. The clinical outcome of the events aches/pains shooting down my right leg and severe lower back pain was not recovered. Patient was not tested for COVID-19 since having the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report from a contactable Healthcare Professional (patient).This 42- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EL3246), via an Intramuscular route of administration, on 06Jan2021 09:15AM (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. Medical history included: Mitral valve prolapse.  Concomitant medications were not reported.  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EH9899) via an Intramuscular route of administration, on 18Dec2020 at 03:30 PM (at the age of 42-years-old) as a single dose for COVID-19 vaccination, anatomically located on the right arm. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 01:30 AM, she experienced chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit. The patient did not receive treatment for the events. The clinical outcome of the events chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Malaise
Clinical narrative: fatigue; Pain in  injection site; headache; diaphoretic; nauseous; felt like I was gong to pass out; dry heaves; ringing in my ears; vision changes; unwellness; This is a spontaneous report from a Non-contactable nurse, the patient. A 33 (units unknown) adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date 11:15 as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain in injection site which began later in the evening, a little soreness only and a little bit of a headache; and fatigue and feeling unwell. The next morning the patient experienced feeling diaphoretic, nauseous, felt like she was going to pass out, vision changes, ringing in ears and dry heaves. It was reported she was doing every she could do to keep consciousness and did not feel better until she had the dry heaves. The clinical outcome of the events visual changes, ringing in the ears and dry heaves was recovered; fatigue and unwellness was not recovered; vaccination site pain, headache, diaphoretic, nauseous, and dizziness was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching, Tinnitus, Vaccination site pain, Visual impairment
Clinical narrative: fatigue; Pain in  injection site; headache; diaphoretic; nauseous; felt like I was gong to pass out; dry heaves; ringing in my ears; vision changes; unwellness; This is a spontaneous report from a Non-contactable nurse, the patient. A 33 (units unknown) adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date 11:15 as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain in injection site which began later in the evening, a little soreness only and a little bit of a headache; and fatigue and feeling unwell. The next morning the patient experienced feeling diaphoretic, nauseous, felt like she was going to pass out, vision changes, ringing in ears and dry heaves. It was reported she was doing every she could do to keep consciousness and did not feel better until she had the dry heaves. The clinical outcome of the events visual changes, ringing in the ears and dry heaves was recovered; fatigue and unwellness was not recovered; vaccination site pain, headache, diaphoretic, nauseous, and dizziness was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: headache; muscle pain; chills; fever; injection site redness and swelling; injection site redness and swelling; Injections site pain; tiredness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via intramuscular on 05Jan2021 10:30 in left arm at single dose for covid-19 immunization.  Medical history included hypothyroidism, arthritis, hypertension, eczema. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was known allergies: daptomycin and cefdinir (OMNICEF). The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included clonidine, levothyroxine sodium (SYNTHYROID), ibuprofen. The patient experienced injections site pain, tiredness, headache, muscle pain, chills, fever, injection site redness and swelling on 06Jan2021 11:00 with outcome of recovering.  Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse event. Events were reported as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: headache; muscle pain; chills; fever; injection site redness and swelling; injection site redness and swelling; Injections site pain; tiredness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via intramuscular on 05Jan2021 10:30 in left arm at single dose for covid-19 immunization.  Medical history included hypothyroidism, arthritis, hypertension, eczema. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was known allergies: daptomycin and cefdinir (OMNICEF). The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included clonidine, levothyroxine sodium (SYNTHYROID), ibuprofen. The patient experienced injections site pain, tiredness, headache, muscle pain, chills, fever, injection site redness and swelling on 06Jan2021 11:00 with outcome of recovering.  Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse event. Events were reported as non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: slight headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EH9899, unknown expiration), intramuscularly on left arm, on 06Jan2021 at 09:00, at single dose, for COVID-19 immunization.  Medical history included penicillin allergy. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), fenofibrate (FENOFIBRATE), atorvastatin, and indapamide (INDAPAMID).  On 06Jan2021 at 10:00 AM, the patient experienced sore arm and slight headache that last one day (07Jan2021). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination.  No treatment was received for the events. It was unknown if the patient received any other vaccines within 4 weeks prior to COVID vaccine. The patient recovered from the events on 07Jan2021. The events were assessed as non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Migraine, Pain
Clinical narrative: I had body chills fever 103 degree Celsius; body aches; Diarrhea; migraine headache; shivering; This is a spontaneous report from a contactable health care professional, the patient.  A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK9231) intramuscular in the left arm on 05Jan2021 at 5:30 PM (at the age of 31-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), intramuscular, left arm  on 17Dec2020 for COVID-19 immunization. On 06Jan2021 at 05:00 AM, the patient experienced body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering.  The events was reported as non-serious. The patient underwent lab test  which included body temperature: 103 degree Celsius. The patient did not receive any treatment for the body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering. The clinical outcome of the events body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering was  recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had body chills fever 103 degree Celsius; body aches; Diarrhea; migraine headache; shivering; This is a spontaneous report from a contactable health care professional, the patient.  A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK9231) intramuscular in the left arm on 05Jan2021 at 5:30 PM (at the age of 31-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), intramuscular, left arm  on 17Dec2020 for COVID-19 immunization. On 06Jan2021 at 05:00 AM, the patient experienced body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering.  The events was reported as non-serious. The patient underwent lab test  which included body temperature: 103 degree Celsius. The patient did not receive any treatment for the body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering. The clinical outcome of the events body chills fever (103 degree Celsius), body aches, diarrhea, migraine headache, shivering was  recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Has been itching like crazy/rash/ super itchy at night; This contactable physician reported similar events for two patients. This is the 2nd of two reports (guy he works with).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), via an unspecified route of administration and date at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The physician also stated that the patient which the reporter worked with had something similar event experienced (AER 2021008113). It was elaborated that the patient had rash and it was super itchy at night noted on an unknown date.  The patient received the same lot number and has been itching like crazy. They have both been trying to figure out what to do. It was clear as mud. Then, last week (Jan2021) they saw each other, and they were both having the same issue and suffering separately. They had no exposure to anything similar besides the vaccine. The patient did a steroid pack, which his itchiness went away and got better while he was on it. When he stopped it, the itchiness came back. It reminds him when he got poison ivy in medical school. It was the same scenario. It holds off on steroids, then comes back after you are no longer taking them. He said that the antihistamine he took, and the steroid cream did not help. He took brand new loratadine (CLARITIN) which was same for the cream. He used multiple tubes of cream and applied it twice a day. It says you could use it up to 6 times a day, which he was working so would use twice a day. If he was not working, he would apply it more. The outcome the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021008113 same reporter/drug, similar events, different patient
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Nausea, Pyrexia, Upper respiratory tract congestion
Clinical narrative: Nausea; vomiting; Fever with chills; Myalgias; Upper respiratory tract congestion; Injection site pain; patient received the second dose of BNT162B2 on 05Jan2021; This is a spontaneous report from a contactable physician (patient himself). A 25-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248), via intramuscular on 05Jan2021 13:00 in left arm at single dose for covid-19 immunization.  Medical history included none. Allergies to medications, food, or other products was no. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 18Dec2020 10:00 for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered was in hospital. The patient experienced nausea, vomiting, fever with chills, myalgias, upper respiratory tract congestion and injection site pain, all on 06Jan2021 03:00 with outcome of not recovered. Treatment of paracetamol (TYLENOL) was received for the events. All events were reported as non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Nausea; vomiting; Fever with chills; Myalgias; Upper respiratory tract congestion; Injection site pain; patient received the second dose of BNT162B2 on 05Jan2021; This is a spontaneous report from a contactable physician (patient himself). A 25-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248), via intramuscular on 05Jan2021 13:00 in left arm at single dose for covid-19 immunization.  Medical history included none. Allergies to medications, food, or other products was no. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 18Dec2020 10:00 for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered was in hospital. The patient experienced nausea, vomiting, fever with chills, myalgias, upper respiratory tract congestion and injection site pain, all on 06Jan2021 03:00 with outcome of not recovered. Treatment of paracetamol (TYLENOL) was received for the events. All events were reported as non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730, expiry: 31Mar2021), intramuscular on the left arm on 06Jan2021 13:00 at SINGLE DOSE for COVID-19 immunization  It was reported that the patient was visiting COVID-19 patients. There were no concomitant medications. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EK5730, expiry: 31Mar2021) intramuscular on the left arm on 16Dec2020 as COVID-19 immunization. The patient reported that he received the second dose of the Pfizer BioNTech COVID-19 vaccine yesterday (06Jan2021) and was having a minor reaction. He has chills and fever and fever this morning (07Jan2021) and wanted to know if it's okay to take over the counter ibuprofen or acetaminophen (TYLENOL). Outcome of the events were not recovered.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Nausea, Pain in extremity, Poor quality sleep
Clinical narrative: fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in his right arm/soreness in his legs/legs were hurting; did not sleep good; sick to his stomach; This is a spontaneous report from a contactable consumer (patient himself). A 58-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via intramuscular on 06Jan2021 15:00 in right arm at 0.3 mL (30mcg), single for preventative. There were no medical history and concomitant medications. Patient had the first dose of BNT162B2 vaccine on 19Dec2020 for covid-19 immunization. No investigation assessment was received. Patient had the second Pfizer COVID19 vaccine shot yesterday around 15:00 on 06Jan2021. He was asking if it was normal to be sore, patient had a little fatigue on 07Jan2021 and be sick to his stomach in Jan2021. The soreness in his right arm started last night (06Jan2021). He experienced soreness in his legs. He did not sleep good and his legs were hurting last night through the night. As of now his legs do not seem as bad. Patient went to work this morning and then he left work to go back home. He ate a cake and milk before he left for work. He threw up a little on 07Jan2021. It did not take much for him to gag, he even gags when brushing his teeth. Right now and within the last hour, he had not felt sick to his stomach. Outcome of soreness in his right arm/soreness in his legs/legs were hurting was not recovered, of fatigue was recovering, of sick to his stomach was recovered on 07Jan2021, of other events was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in his right arm/soreness in his legs/legs were hurting; did not sleep good; sick to his stomach; This is a spontaneous report from a contactable consumer (patient himself). A 58-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via intramuscular on 06Jan2021 15:00 in right arm at 0.3 mL (30mcg), single for preventative. There were no medical history and concomitant medications. Patient had the first dose of BNT162B2 vaccine on 19Dec2020 for covid-19 immunization. No investigation assessment was received. Patient had the second Pfizer COVID19 vaccine shot yesterday around 15:00 on 06Jan2021. He was asking if it was normal to be sore, patient had a little fatigue on 07Jan2021 and be sick to his stomach in Jan2021. The soreness in his right arm started last night (06Jan2021). He experienced soreness in his legs. He did not sleep good and his legs were hurting last night through the night. As of now his legs do not seem as bad. Patient went to work this morning and then he left work to go back home. He ate a cake and milk before he left for work. He threw up a little on 07Jan2021. It did not take much for him to gag, he even gags when brushing his teeth. Right now and within the last hour, he had not felt sick to his stomach. Outcome of soreness in his right arm/soreness in his legs/legs were hurting was not recovered, of fatigue was recovering, of sick to his stomach was recovered on 07Jan2021, of other events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: I have had a sore arm; I also have been having a low-grade fever the highest it has been 99.5; Body aches; Chills; This is a spontaneous report from a contactable nurse reporting for self.  A 36-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot#  EK923, via an unspecified route of administration on 05Jan2021 08:45 as a single dose (dose 1), left arm (age at vaccination: 36 years old), for COVID-19 immunization.  The patient was not pregnant at the time of vaccination. There was no other vaccine administered in the 4 weeks prior to the COVID vaccine. Medical history included multiple sclerosis and hypothyroidism . The patient was receiving unspecified concomitant medications ("10 meds").The patient previously took copaxone and experienced drug allergy.  The patient reported having a sore arm, but also had been having a low-grade fever. The highest it had been was 99.5. The patient also had body aches and chills. These symptoms started couple hours after the injection (on 05Jan2021) and have been with the patient since then. The events were reported as non-serious. There was no hospitalization or treatment received for the events. The outcome of the events sore arm, low grade fever, body aches, and chills was not recovered. The patient had not been COVID-19 tested post vaccination.