chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling like a bump and pink around the injection site; swelling like a bump and pink around the injection site/swelling at the injection site; swelling like a bump and pink around the injection site; her arm was sore the first two days but then cleared up/ her injection site on her arm hurt; rash; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ED6203, Expiration date: unknown) via an unspecified route of administration at left arm (at the age of 64-years-old) on 09Mar2021 13:45 as single dose for covid-19 immunisation. Medical history included inflammatory eye problem and ileostomy (50 years). Concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine. The patient did not receive Prior Vaccinations (within 4 weeks). On 09Mar2021, her arm was sore the first two days but then cleared up. The patient wanted to know if there were any reports of this happening a week after the shot. During the night that day her injection site on her arm hurt for a couple of days and then that completely went away. Patient wanted to know if the symptoms would get worse and the patient also had arm hurt. The patient stated that a week after her first dose, she had swelling like a bump and pink around the injection site, swelling at the injection site on 17Mar2021. On an unspecified date in Mar2021, the patient had rash. She was planning to receive the second dose on 30Mar2021. Outcome for the events vaccination site pain, Vaccination site swelling, vaccination site erythema was recovering and for the event vaccination site mass and rash was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Chills 8 hours after shot; Arm soreness; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medications included lopreeza (MANUFACTURER UNKNOWN) 0.5 mg and melatonin (MANUFACTURER UNKNOWN) 1mg on an unknown date for unknown indication. On 19Mar2021 at 00:00, the patient experienced chills 8 hours after shot and arm soreness. The patient did not receive treatment for the reported events. The clinical outcome of the events chills and arm soreness were recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Eye pain, Feeling hot, Influenza like illness
Clinical narrative: Eyes burning; Extreme sensitivity to light; Eyes hurt; Extreme shivering; Body burning in various areas; Flu like symptoms; This is a spontaneous report received from a contactable consumer. A 66 years old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID 19 MRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration, administered left arm, on 17Mar2021(at age of 66 years old) at 10:30 as a single dose for COVID 19 immunisation. The patient was allergic to drugs nitrofurantoin, pseudoephedrine and iodine and had high blood pressure. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 MRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration on unknown anatomical location, on 24Feb2021 at 10:15am (at age of 66 years old) as a single dose for COVID 19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient concomitant medications included Atenolol (MANUFACTURER UNKNOWN), KLONOPIN and Loratidine (MANUFACTURER UNKNOWN) from unknown dates for unknown indication. On 17Mar2021 at 12:00, the patient experienced eyes burning, extreme sensitivity to light, eyes hurt (cant turn them without pain), headache, extreme shivering for two hours or so, about 12 hours after vaccine, body burning in various areas (not all area) flu like symptoms and eyes were still hurting at the time of report. The clinical outcome of the event eyes burning, photosensitivity, eyes pain, headache, chills, extreme feeling hot of and influenza like symptoms was not recovered. No follow up attempts are possible; information about lot number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Eyes burning; Extreme sensitivity to light; Eyes hurt; Extreme shivering; Body burning in various areas; Flu like symptoms; This is a spontaneous report received from a contactable consumer. A 66 years old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID 19 MRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration, administered left arm, on 17Mar2021(at age of 66 years old) at 10:30 as a single dose for COVID 19 immunisation. The patient was allergic to drugs nitrofurantoin, pseudoephedrine and iodine and had high blood pressure. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 MRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration on unknown anatomical location, on 24Feb2021 at 10:15am (at age of 66 years old) as a single dose for COVID 19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient concomitant medications included Atenolol (MANUFACTURER UNKNOWN), KLONOPIN and Loratidine (MANUFACTURER UNKNOWN) from unknown dates for unknown indication. On 17Mar2021 at 12:00, the patient experienced eyes burning, extreme sensitivity to light, eyes hurt (cant turn them without pain), headache, extreme shivering for two hours or so, about 12 hours after vaccine, body burning in various areas (not all area) flu like symptoms and eyes were still hurting at the time of report. The clinical outcome of the event eyes burning, photosensitivity, eyes pain, headache, chills, extreme feeling hot of and influenza like symptoms was not recovered. No follow up attempts are possible; information about lot number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Lip swelling, Sensory loss
Clinical narrative: Swollen lower lips, feeling a sensation of numbness and burn.; feeling a sensation of numbness; feeling a sensation of burn; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration on 18Mar2021 at 13:30 in left arm for COVID-19 immunisation. Medical history of the patient included chronic pelvic pain and endometriosis. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration on 25Feb2021 at 11:00 in left arm for COVID-19 immunisation. The patient had no allergies to medication, food or other products. The patient did not receive any other vaccine within 4 weeks of receiving COVID-19 vaccine. The patient did not have COVID-19 test prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccination. The patient experienced swollen lower lips, feeling of a sensation of numbness and burn on 19Mar2021. Therapeutic measures taken as a result of events included unknown medication for allergies prior to vaccination. The clinical outcome of swollen lower lips, feeling a sensation of numbness and burn was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Injection site pain; headache; muscle pain; chills; joint pain; nausea; feeling unwell; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration in right arm on 16Mar2021 at 09:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, obesity and heart palpitations. Prior to vaccination, the patient was not diagnosed with COVID-19. The concomitant medication included irbesartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN), from unspecified dates for unknown indications. The patient had no known allergies. The patient experienced vaccination site pain, headache, muscle pain, chills, joint pain, nausea, feeling unwell and sore throat on 17Mar2021 at 09:00. Post vaccination, the patient underwent Nasal Swab test for COVID-19 on 19Mar2021 and the result was pending. It was unknown if the patient received any treatment for vaccination site pain, headache, muscle pain, chills, joint pain, nausea, feeling unwell and sore throat. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of vaccination site pain, headache, muscle pain, chills, joint pain, nausea, feeling unwell and sore throat was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Vaccination site pain, Viral test
Clinical narrative: Injection site pain; headache; muscle pain; chills; joint pain; nausea; feeling unwell; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration in right arm on 16Mar2021 at 09:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, obesity and heart palpitations. Prior to vaccination, the patient was not diagnosed with COVID-19. The concomitant medication included irbesartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN), from unspecified dates for unknown indications. The patient had no known allergies. The patient experienced vaccination site pain, headache, muscle pain, chills, joint pain, nausea, feeling unwell and sore throat on 17Mar2021 at 09:00. Post vaccination, the patient underwent Nasal Swab test for COVID-19 on 19Mar2021 and the result was pending. It was unknown if the patient received any treatment for vaccination site pain, headache, muscle pain, chills, joint pain, nausea, feeling unwell and sore throat. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of vaccination site pain, headache, muscle pain, chills, joint pain, nausea, feeling unwell and sore throat was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache (lasted one week; not normal for patient to have headaches); fever (100.5 degrees starting 24 hours after, lowered to 99.5 degrees by 48 hours after, and remained at 99.3-ish (average) for a week); fatigue; arm soreness; This is a spontaneous report received from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 06Mar2021 at 15:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history was not provided. Concomitant medications included etonogestrel/ethinyl estradiol  (NUVARING), cetirizine (MANUFACTURER UNKNOWN), calcium citrate(CITRACAL), multivitamin (MANUFACTURER UNKNOWN), fiber (MANUFACTURER UNKNOWN) all from unknown dates for unknown indication. Allergies to medications, food, or other products was reported with antibiotic ointment, seasonal allergies. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Mar2021 the patient experienced headache, fever (100.5 degrees starting 24 hours after, lowered to 99.5 degrees by 48 hours after, and remained at 99.3-ish (average) for a week), fatigue and arm soreness. The patient did not receive any treatment for events. The clinical outcome of headache, fever, fatigue and arm soreness was recovered.   No follow-up attempts are needed; information about lot/batch number is requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Chills,; body aches; 99.3 fever; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EL3247) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcers. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), aleve (MANUFACTURER UNKNOWN) and dexilant (MANUFACTURER UNKNOWN) for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 13:30 as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests which included body temperature on 19Mar2021 and the result was 99.3 (unspecified units). The patient experienced chills, body aches and 99.3 fever on 19Mar2021 at 12:00. The patient did not receive any treatment for the adverse events. The clinical outcome of chills, body aches and fever were resolving.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy, Nausea, Pain in extremity
Clinical narrative: Lethargy; nausea; sore arm; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 73-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route of administration on 03Mar2021(at the age of 73-years-old) at 11:00 as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthmatic allergies and known allergies to sulfa, penicillin, molds, pollen, nuts. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), levocetirizine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 since the vaccination. The patient experienced joint pain, lethargy, nausea, sore arm on 03Mar2021. The patient did not receive treatment for reported adverse events. The clinical outcome of the events joint pain, lethargy, nausea and sore arm was recovered on an unknown date in Mar2021.   No further information is expected. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Hypersensitivity, Nausea
Clinical narrative: face is burning/ if her cheeks are on fire; was aching all over/body aches; whole face was itching/her arm was itching; her arm has never stopped hurting/arm is killing in her/sore arm; headache; nausea; extreme fatigue; had a little fever; took benadryl because she thought it was an allergic reaction; This is a spontaneous report received from a contactable consumer or other non-health care professional. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1 st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter had her first dose of the vaccine. The patient arm was killing in her, yesterday she had nausea, extreme fatigue, body aches, was aching all over and had a little fever and all of that. The caller took benadryl because she thought it was an allergic reaction and her arm was itching, face was itching and burning, she took a Benadryl, allertec and applied a cold compress to her face, face was on fire, arm pain was an 8/10 so she has been taking Tylenol. Since then, she wanted to know if this was an allergic reaction. The caller felt like it had calmed down since she took the benadryl and allertec. Patient had a headache, her arm had never stopped hurting and sore arm the first two days. The patient thought the benadryl was a trigger to this. She said she took Benadryl, and Alertex to treat the symptoms. She wanted to know if having these side effects 2 weeks after the 1st dose was normal and if these side effects have been reported before. The outcome of events was unknown.    Information about lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: face is burning/ if her cheeks are on fire; was aching all over/body aches; whole face was itching/her arm was itching; her arm has never stopped hurting/arm is killing in her/sore arm; headache; nausea; extreme fatigue; had a little fever; took benadryl because she thought it was an allergic reaction; This is a spontaneous report received from a contactable consumer or other non-health care professional. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1 st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter had her first dose of the vaccine. The patient arm was killing in her, yesterday she had nausea, extreme fatigue, body aches, was aching all over and had a little fever and all of that. The caller took benadryl because she thought it was an allergic reaction and her arm was itching, face was itching and burning, she took a Benadryl, allertec and applied a cold compress to her face, face was on fire, arm pain was an 8/10 so she has been taking Tylenol. Since then, she wanted to know if this was an allergic reaction. The caller felt like it had calmed down since she took the benadryl and allertec. Patient had a headache, her arm had never stopped hurting and sore arm the first two days. The patient thought the benadryl was a trigger to this. She said she took Benadryl, and Alertex to treat the symptoms. She wanted to know if having these side effects 2 weeks after the 1st dose was normal and if these side effects have been reported before. The outcome of events was unknown.    Information about lot/batch number requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Lightheaded; Tiredness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route in left arm on 19Mar2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included heart failure, hypertension, afib (atrial fibrillation) and Depakote allergy. Past drug history included Depakote from an unspecified date. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), MOBIC, furosemide (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and NORVAS taken within two weeks of vaccination for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 15:30, the patient experienced tiredness, lightheaded and nausea. No treatment was received for the events. The clinical outcome of tiredness, lightheaded and nausea was recovering.   Information about lot number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Vomiting; Headache; temperature; major fatigue; Chiills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non pregnant female patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 17Mar2021 at 15.00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfate allergy. Patient was taking concomitant medication however drug was unspecified . The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient had been tested for COVID-19 nasal swab test on 22Jan2021 which resulted negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 07:00, the patient experienced vomiting, headache, temperature, body aches, chills and major fatigue. The patient took Tylenol as therapeutic measure for the events. The clinical outcome of vomiting, headache, temperature, body aches, chills and major fatigue were recovering.   Information about batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Vomiting; Headache; temperature; major fatigue; Chiills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non pregnant female patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 17Mar2021 at 15.00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfate allergy. Patient was taking concomitant medication however drug was unspecified . The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient had been tested for COVID-19 nasal swab test on 22Jan2021 which resulted negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 07:00, the patient experienced vomiting, headache, temperature, body aches, chills and major fatigue. The patient took Tylenol as therapeutic measure for the events. The clinical outcome of vomiting, headache, temperature, body aches, chills and major fatigue were recovering.   Information about batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Polymerase chain reaction, Rash
Clinical narrative: rash from my left jaw to my groin that completely covered my torso front and back; Entire torso front and back tomy thighs turned completely red; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the right arm on 04Mar2021 at 18:45hrs as a single dose for COVID-19 immunisation. Relevant medical history included asthma, ocular and skin rosacea. Concomitant medications included fexofenadine(ALLEGRA) taken for an unknown indication, albuterol inhaler(MANUFACTURER UNKNOWN) taken for asthma and multi-vitamin taken for an unknown indication. The patient had history of allergies to codeine, sulfa, z pak and vicodin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent a nasal swab test (PCR test) on 10Mar2021 for COVID-19 and the result found to be positive. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced a rash two days after the vaccination on 06Mar2021. The patient reported that the rash extended from the left jaw to the groin region that completely covered his torso front and back. On an unspecified date in Mar2021, the patient reported that the rash faded away and the entire torso front and back to his thighs turned completely red as if the patient had a sunburn. The patient did not have any pain or itching. The adverse events resulted in a doctors or other healthcare professional visit. Therapeutic measures included intake of BENADRYL. The clinical outcome for the event rash was resolved on 08Mar2021 and the clinical outcome for the event entire torso front and back to thighs turned completely red was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Malaise
Clinical narrative: Not feeling good 4 days after shot; Dry mouth on and off since shot.; This is a spontaneous report from a contactable patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH mRNA COVID-19 vaccine; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 17:30 hours (at the age of 60-year-old) for COVID-19 immunisation. Medical history was not reported. Concomitant medications reported as clonazepam (MANUFACTURER UNKNOWN) taken within prior two weeks of vaccination. The patient was reported to be allergic to codeine and dilladid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 15Mar2021 at 18:00 hours, the patient experienced dry mouth on and off and on 19Mar2021, the patient was feeling unwell. No therapeutic measures were taken by the patient for the events. The clinical outcome of event dry mouth was not recovered, while the outcome of feeling unwell was unknown at the time of report. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fatigue; Nausea; Headache; High fever; This is a spontaneous report received from a contactable patient. A 64-year-old adult non pregnant female patient received  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration on left arm on 18Mar2021 at 0100 (at the age of 64 year) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not provided. The patient previously received treatment with codeine (MANUFACTURER UNKNOWN) from an unspecified date and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On the next day of vaccination, on 19Mar2021, the patient experienced fatigue, nausea, headache and high fever. The patient received treatment with paracetamol (TYLENOL) in response to the events. The clinical outcome of the events fatigue, nausea, headache and high fever was not recovered at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Rheumatoid factor negative
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 47-years-old Caucasian male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the left arm in Feb2021 (at the age of 46-years-old) as a single dose for COVID-19 immunization. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunization. The patient medical history included Benign prostatic hyperplasia (BPH); Eagle's Syndrome, bilateral styloidectomy; and previous paraesophageal hiatal hernia repair. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 since the vaccination. The patient had not tested for COVID-19. No allergies to medications, food, or other products. Concomitant medication included tamsulosin 0.4mg (MANUFACTURER UNKNOWN). On 07Mar2021 08:00, the patient experienced arthritic-like pain in multiple joints beginning in the days preceding the second dose of the vaccine and becoming more severe following the second dose. The pain was specifically in hands, feet, ankles and knees, but originating in the hands bilaterally. This might be coincidental timing, but could possibly be related to vaccine. The adverse event led to doctor or other healthcare professional clinic visit. The patients blood tests showed C-reactive protein at 14 mg/L, negative ANA and negative RF. The patient was prescribed diclofenac. The clinical outcome of arthritic-like pain was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Flatulence, Headache
Clinical narrative: Exhausted; stomach cramps; gassy; diarrhea; headaches; sweaty; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 16Mar2021 at 1345 as a single dose for COVID-19 immunisation. Concomitant medications taken within two weeks of vaccination included gabapentin (MANUFACTURER UNKNOWN), rosuvastatin calcium (MANUFACTURER unknown) and sertraline (MANUFACTURER UNKNOWN) and hydroc ( MANUFACTURER UNKNOWN ) all since an unknown date. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route of administration in the left arm on 02Feb2021 at 1245, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and also did not receive any other vaccine within four weeks of vaccination. The patient had undergone nasal swab, COVID-19 quick test on 07Dec2020 and tested negative. Since the vaccination, patient had not tested for COVID-19. On 16Mar2021, the patient experienced exhausted, stomach cramps, gassy, diarrhea, headaches, sweaty and sore arm. The clinical outcome of all events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Exhausted; stomach cramps; gassy; diarrhea; headaches; sweaty; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 16Mar2021 at 1345 as a single dose for COVID-19 immunisation. Concomitant medications taken within two weeks of vaccination included gabapentin (MANUFACTURER UNKNOWN), rosuvastatin calcium (MANUFACTURER unknown) and sertraline (MANUFACTURER UNKNOWN) and hydroc ( MANUFACTURER UNKNOWN ) all since an unknown date. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route of administration in the left arm on 02Feb2021 at 1245, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and also did not receive any other vaccine within four weeks of vaccination. The patient had undergone nasal swab, COVID-19 quick test on 07Dec2020 and tested negative. Since the vaccination, patient had not tested for COVID-19. On 16Mar2021, the patient experienced exhausted, stomach cramps, gassy, diarrhea, headaches, sweaty and sore arm. The clinical outcome of all events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Stomach cramp; sweating; nausea; dizzy weak; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient did not had any medical history and not had allergies to medications, food, or other products. The patient's concomitant medications were not reported. She did not received any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 13:45, the patient experienced stomach cramp, sweating, nausea and dizzy weak. Therapeutic measures were taken as the result of events was unknown. The clinical outcome of the events stomach cramp, sweating, nausea and dizzy weak was unknown at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Both arms broke out with a rash of little fine bumps; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Feb2021 at 02:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 00:00, the patient's both arms broke out with a rash of little fine bumps. The patient did not receive any treatment for the event both arms broke out with a rash of little fine bumps. The clinical outcome of the event both arms broke out with a rash of fine bumps was not resolved at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Cough, Dyspnoea, Headache
Clinical narrative: Developed a swollen lymph node under right arm.; itchy throat; Started with itchy nose; cough; nausea; headache; Temp 99.5.; heavy chest; hard breathing; Body aches occurred overnight; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL22613), via an unspecified route of administration in the right arm on 18Mar2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression/anxiety, and heart burn. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURE UNKNOWN), fluoxetine (MANUFACTURE UNKNOWN), norgestimate and ethinyl estradiol (TRI-LO SPRINTEC) and omeprazole (OMEPRA), all for unknown indications from unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration in the right arm on 25Feb2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced itchy nose and throat that developed into cough, nausea, and headache. Temp 99.5 and developed into heavy chest and hard breathing. Body aches occurred overnight and into the morning of 19Mar2021. Coughing, nausea, and body aches continued, and developed a swollen lymph node under right arm. The patient did not receive treatment for the reported adverse events. The clinical outcome of itchy nose, itchy throat, headache, temperature 99.5, heavy chest, hard breathing, swollen lymph node under right arm were recovering, and body aches, nausea, cough was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pruritus, Pyrexia
Clinical narrative: Developed a swollen lymph node under right arm.; itchy throat; Started with itchy nose; cough; nausea; headache; Temp 99.5.; heavy chest; hard breathing; Body aches occurred overnight; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL22613), via an unspecified route of administration in the right arm on 18Mar2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression/anxiety, and heart burn. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURE UNKNOWN), fluoxetine (MANUFACTURE UNKNOWN), norgestimate and ethinyl estradiol (TRI-LO SPRINTEC) and omeprazole (OMEPRA), all for unknown indications from unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration in the right arm on 25Feb2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced itchy nose and throat that developed into cough, nausea, and headache. Temp 99.5 and developed into heavy chest and hard breathing. Body aches occurred overnight and into the morning of 19Mar2021. Coughing, nausea, and body aches continued, and developed a swollen lymph node under right arm. The patient did not receive treatment for the reported adverse events. The clinical outcome of itchy nose, itchy throat, headache, temperature 99.5, heavy chest, hard breathing, swollen lymph node under right arm were recovering, and body aches, nausea, cough was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Developed a swollen lymph node under right arm.; itchy throat; Started with itchy nose; cough; nausea; headache; Temp 99.5.; heavy chest; hard breathing; Body aches occurred overnight; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL22613), via an unspecified route of administration in the right arm on 18Mar2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression/anxiety, and heart burn. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURE UNKNOWN), fluoxetine (MANUFACTURE UNKNOWN), norgestimate and ethinyl estradiol (TRI-LO SPRINTEC) and omeprazole (OMEPRA), all for unknown indications from unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration in the right arm on 25Feb2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced itchy nose and throat that developed into cough, nausea, and headache. Temp 99.5 and developed into heavy chest and hard breathing. Body aches occurred overnight and into the morning of 19Mar2021. Coughing, nausea, and body aches continued, and developed a swollen lymph node under right arm. The patient did not receive treatment for the reported adverse events. The clinical outcome of itchy nose, itchy throat, headache, temperature 99.5, heavy chest, hard breathing, swollen lymph node under right arm were recovering, and body aches, nausea, cough was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Constant headache; Severe neck pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9269), via intramuscular route in the left arm on 09Mar2021 at 12:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety and depression. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluoxetine (MANAFACTURER UNKNOWN) 40 mg for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9269), via intramuscular route in the left arm on 15Feb2021 at 12:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, the patient experienced constant headache and severe neck pain that moves for over a week. The patient did not receive any treatment for the reported events. The clinical outcome of the events head ache and neck pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: STINGING AND TINGLING DOWN ARM AFTER INJECTION; STINGING  AND VERYSORE UPPER LEFT ARM; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number -unknown), in the left arm via an unspecified route of administration on 18Mar2021 as single dose (at the age of 61-years-old) for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma and Immune deficiency. The patient had history of drug allergy to penicillin, biaxin, bactrim, levoquin, codine, opioids and doxycycline. The concomitant medication included XOLAIR since an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she was not tested positive for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced stinging and tingling down arm after the injection(paraesthesia) and had very sore upper left arm (pain in extremity). The clinical outcome of the events paraesthesia and pain in extremity was not resolved at the time of the report.  Information about lot number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence
Clinical narrative: Reactivation of postherpetic neuralgia that had previously been resolved for more than one year; This is a spontaneous report from a contactable consumer, the patient. A 35-Year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via unspecified route of administration in left arm on 18Mar2021 at 12:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included occipital neuralgia and post herpetic neuralgia. Concomitant medications included escitalopram (LEXAPRO) and topiramate (TOPIMAX), from an unknown date for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, at 07:30, the patient experienced reactivation of post herpetic neuralgia that had previously been resolved for more than one year. The patient did not receive any treatment for the event. The clinical outcome of the event disease recurrence was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.