chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site pain
Clinical narrative: a sore deltoid at and surrounding the injection point (pain level 2 out of 10); This is a spontaneous report received from a contactable consumer (patient) in response to the mail trail sent regarding the confirmation of below mentioned query sent in cross referenced case. The response included that:    A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) via an unspecified route of administration on 19Feb2021 11:30 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) via an unspecified route of administration, on 28Jan2021 at 08:15 as dose 1, single for covid-19 immunization and experienced sore leg at approx. 18:00 that evening (pain level 3 out of 10 similar to growing pains, more of a nuisance). On 19Feb2021, the patient experienced a sore deltoid at and surrounding the injection point (pain level 2 out of 10) which lasted approx. 24 hrs. Upon follow up 08Mar2021 response include when patient was aware of second dose AE "a sore deltoid at and surrounding the injection point". When it happened and is it on 19Feb2021. First dose AE "sore leg" awareness date was 28Jan2021, but patient reported on 11Feb2021 which is delay and second dose's AE ""a sore deltoid at and surrounding the injection point", if the onset date was 19Feb2021, but patient reported it on 23Feb2021, which will also mean delay. Patients need to report within 24 hours please help for delay comment. Patient stated, I received the 2nd COVID-19 vaccine on 19Feb2021 at 11:30 and I only experienced a sore deltoid at and surrounding the injection point (pain level 2 out of 10), which lasted approx. 24 hrs.  and to be clear my deltoid was sore on 19Feb2021 and was not sore the next day. I no longer have a sore deltoid. The patient underwent lab tests and procedures which included pain assessment: 2 out of 10 on 19Feb2021. The outcome of the event was recovered on 20Feb2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Chills; Injection site pain; light headed approximately 6 hours after the shot was administered; inappropriate schedule of drug administered; This is a spontaneous report from a non-contactable consumer, the patient. An 89-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on an unknown date in Feb2021 (at the age of 89-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. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on an unknown date in Feb2021 as a single dose for COVID-19 immunisation. On 18Feb2021, the patient experienced chills, injection site pain and light headed approximately 6 hours after the shot was administered. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, injection site pain and light headed was resolved on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lethargy, Muscular weakness, Sluggishness
Clinical narrative: Feeling lightheaded; Lethargic; Arm weakness; Sluggish when answering questions; This is a spontaneous report from a non-contactable healthcare professional. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 22Feb2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received influenza vaccine (MANUFACTURER UNKNOWN) (reported as H1N1 vaccine) for an unknown indication on an unknown date and experienced allergy to vaccine. On an unknown date in Feb2021, following the injection, the patient reported feeling lightheaded, lethargic, arm weakness, and she was sluggish when answering questions. The events resulted in emergency room/department or urgent care. The clinical outcome of the events feeling lightheaded, lethargic, arm weakness and sluggish when answering questions was unknown at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hot flush, Pain in extremity
Clinical narrative: Right arm soreness; Diarrhea; Hot flash; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 24Feb2021 at 11:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included arterial spasm. The patient previously received collagen (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lysine (MANUFACTURER UNKNOWN), diltiazem hydrochloride (CARTIA XT), calcium (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and acetylsalicylic acid (ASPIRIN); all medications from an unknown date, unknown if ongoing and for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 at 10:30, the patient experienced right arm soreness, diarrhea and hot flash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm soreness, diarrhea and hot flash were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Ocular discomfort
Clinical narrative: eye pain; headache; Pressure in the eyes; This is a spontaneous report from a contactable consumer (patient).  A 30-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in left arm on 19Feb2021 at 12:15 PM (age at vaccination: 30-Year-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL), taken for an unspecified indication, start and stop date were not reported. The patient did not receive any vaccine within four weeks prior to covid-19 vaccine. The patient was not diagnosed with covid-19 prior vaccination and not tested for covid-19 post vaccination. The patient was not allergic to any of the medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in left arm on 29Jan2021 at 12:15 PM (age at vaccination: 30-Year-old), as DOSE 1, SINGLE for COVID-19 immunisation and experienced headache. On 20Feb2021 at 13:00, the patient experienced headache, pressure in the eyes and eyes felt sore. It started with a headache that reached the eye area after about 24 hrs of taking the vaccine. The headache was present after the first dose, but without the eye pain. Events persisted for 2.5 days. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date in Feb2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: Muscle pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Feb2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19). The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unknown indication from an unknown date and unknown if ongoing. On 23Feb2021, the patient experienced muscle pain in lower right arm from elbow on down which started 2.5 weeks after the vaccination. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. On an unknown date in Feb2021, the patient underwent COVID-19 virus test and the result was unknown. The clinical outcome of the event muscle pain was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness in my left arm.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received the 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 13:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, hypertension, pet dander allergy, dust allergy, eggs allergy, pollen allergy and apples allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID -19 vaccine. Concomitant medications included metformin (MANUFACTURER UNKNOWN), olmesartan (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and metoprolol (MANUFACTURER UNKNOWN); all for unknown indication from an unknown dates and unknown if ongoing.  It was reported that the patient was a Pfizer colleague and had received the first dose of the vaccine at the Pfizer clinic. On 24Feb2021, the patient experienced injection site soreness in his left arm. It was mild on the previous day more intense on the day of report. The patient did not  experienced any further adverse events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse event which included the treatment with TYLENOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site soreness in left arm was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 19Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Feb2021, the patient experienced headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was resolved on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a non-contactable pharmacist, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 22Feb2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to melons. 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 metformin hydrochloride (METFORMIN ER) for an unknown indication from an unknown date and unknown if it was ongoing. On 22Feb2021, the patient experienced soreness at injection site. Therapeutic measures were not taken as a result of the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness at injection site was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number reported as EN5318; Expiration Date reported as May2021) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number reported as EL3248, Expiration Date was not reported). The patient's medical history and concomitant medications were not reported. The reporter stated that, she experienced some dehydration the following day after her first dose. She called to see if that was a side effect. The next day she was fine. The only side effect she experienced was minimal soreness at the injection site after both doses on an unspecified date. If she had serious side effect, she would have completed the questionnaire. The outcome for the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient had no known allergies to food, medications and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue and headache was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased, Pain in extremity, Poor quality sleep
Clinical narrative: Slept poorly that night and felt like heart rate may have been slightly elevated.; Anxiety; soreness in arm greater than normal flu shot, but it is subsiding; Slept poorly that night; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 24Feb2021 at 09:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included heart diease, raynauds and allergy to pre-surgical wipes which caused significant rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), amlodipine (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN) taken for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Feb2021 at 22:00, the patient slept poorly that night and felt like heart rate may had been slightly elevated. The patient was not a great sleeper and had heart disease so considered it possibly related to anxiety. On same day, patient experienced soreness in arm greater than normal when had flu shot, but it was subsiding. The patient was feeling better currently and heart rate seemed normal. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slept poorly that night and felt like heart rate may have been slightly elevated, possibly related to anxiety and soreness in arm greater than normal was recovered on an unknown date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included rosuvastatin calcium (CRESTOR), ascorbic acid (VITAMIN C) and vitamin d nos (VITAMIN D), all for an unknown indication from an unknown dates and unknown if ongoing. On 25Feb2021, the patient experienced headache, nausea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea and fatigue was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Skin burning sensation
Clinical narrative: slight headache; sore muscles; tired feeling all day; felt like a bee sting; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the right arm on 24Feb2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had no known allergies. 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 multivitamins, not every day of the week. The patient previously received first dose of BNT162b2 (COMIRNATY, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 24Feb2021 at 09:30, second shot when administered the patient felt like a bee sting for about 5 minutes and sore arm. Next morning, on 25Feb2021 the patient experienced slight headache, sore muscles and tired feeling all day. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt like a bee sting, sore arm, slight headache, sore muscles and tired feeling all day were recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (father) reported that a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced dizziness 5 days after the second shot on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included migraine, obesity, asthma and allergy to antibiotic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), erenumab (AIMOVIG), naproxen sodium (ALEVE), rizatriptan benzoate (MAXALT) and melatonin (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Feb2021 at 11:00, the patient experienced metallic taste in mouth. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event metallic taste in mouth was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926) via an intramuscular route of administration in the arm left on 04Feb2021 at 16:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. 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 were not reported.  On 04Feb2021, after first dose of vaccination the patient had got arm sore for 4 or 5 days for her 1st dose. It was reported that it was helpful but different than other vaccination(details unspecified). It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm sore was resolved on an unknown date in Feb2021.  The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an intramuscular route of administration in the arm left on 25Feb2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: "I" have swollen lymph nodes.; What should I do to help with pain; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 17Feb2021(at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 29Jan2021(at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021, the patient had swollen lymph nodes and lymph node pain. The patient did not know when his swollen lymph nodes would return to normal and what would help his pain. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes and lymph node pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Tender lymph nodes in armpit; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history includes allergy to sulfa. 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 fish oil (MANUFACTURER UNKNOWN); progesterone (MANUFACTURER UNKNOWN), withania somnifera (ASHWAGANDHA) and multivitamins (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. On 27Feb2021, the patient experienced tender lymph nodes in armpit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tender lymph nodes in armpit was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands under right arm (same arm as vaccinated); This is a spontaneous report from a contactable other healthcare professional, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Feb2021 at 12:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as not applicable. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Jan2021 at 12:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced swollen glands under right arm (same arm as vaccinated). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen glands under right arm was recovered on unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Vaccination site erythema
Clinical narrative: About 18 hours after receiving the second dose of the vaccine, started to experience severe body aches from my neck to my knees. The body aches continued until about 48 hours after vaccination.; Redness at the injection site in left arm; Developed a swollen lymph node lump at the base of left armpit.; About 24 hours after receiving the second dose of the vaccine, began to experience chills. Was unable to control the body temperature even by taking hot showers and wearing multiple layers of clothing underneath blankets in bed.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 at 13:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa-based medications (sulfonamide allergy) and penicillin-based medications (penicillin allergy). 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. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 06Feb2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 07:30, about 18 hours after receiving the second dose of the vaccine, the patient started to experience severe body aches from neck to knees. The body aches continued until about 48 hours after vaccination. On 28Feb2021, about 24 hours after receiving the second dose of the vaccine, the patient began to experience chills. The worst of the chills came at about 30 hours posts vaccination. The patient was unable to control body temperature even by taking hot showers and wearing multiple layers of clothing underneath blankets in bed. Throughout this time on 28Feb2021 at 07:30, the patient also experienced redness at the injection site in left arm, and developed a swollen lymph node lump at the base of left armpit. That swelling still had not dissipated after 72 hours since vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe body aches from neck to knees was resolved on 01Mar2021 48 hours after vaccination; while that of the events chills, redness at the injection site in left arm and swollen lymph node lump at the base of left armpit was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in the left arm on 01Mar2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion hydrobromide (APLENZIN) and sertraline (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Mar2021 at 00:00, the patient experienced injection site soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site soreness was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Severely swollen supraclavicular & axillary lymph nodes on the left side; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 27Feb2021, the patient experienced severely swollen supraclavicular and axillary lymph nodes on the left side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severely swollen supraclavicular and axillary lymph nodes on the left side was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strange bitter taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 02Mar2021 at 11:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history reported as not applicable. The patient did not have known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Mar2021, after about 15 minutes (also reported as 11:45), the patient experienced strange bitter taste in mouth and somewhat metallic in nature. It had been another 15 or so minutes and still it was there. The patient did not eat or drink anything hours before and he had still did not drink anything. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event strange bitter taste in mouth was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder spasm, Dysuria
Clinical narrative: Painful urination and bladder spasms; Painful urination and bladder spasms; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 02Mar2021 at 09:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, pre-diabetic, kidney stones, diverticulosis and obesity. 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 COVID-19 vaccine. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), fexofenadine (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); all taken for an unspecified indication, from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 09Jan2021 at 00:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 02Mar2021, at 00:00, the patient experienced painful urination and bladder spasms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful urination and bladder spasms was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Eosinophil count decreased
Clinical narrative: Routine blood draw on 24Feb2021 showed Eosinophil value as 0; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 08Feb2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, high cholesterol and atrial fibrillation. The patient had no known allergies to medications, food or other products. 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.  The patient received unspecified medications within two weeks of vaccination. On 24Feb2021, the patient experienced routine blood draw that showed eosinophil value as 0. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. On 24Feb2021, the patient underwent blood test and the result was found to be eosinophil value as 0. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event routine blood draw showed Eosinophil value as 0 was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: About an hour after receiving the first vaccination on 1/15/2021, she experienced pain in arm.; Body aches; Fatigue; Nausea; Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jan2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included bunionectomy, eczema, ichthiosis vulgaris(mild), wear contacts and penicillin allergy. 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 hydroxyzine (MANUFACTURER UNKNOWN), dexamfetamine (D-AMPHETAMINE) and linaclotide (LINZESS); all for an unknown indication from an unknown date and unknown if ongoing. On 15Jan2021, about an hour after receiving the first vaccination the patient experienced pain in arm, body aches, fatigue, nausea, and headache. The patient realized that these were common side effects and just monitored the symptoms. They started to go away the next day on 16Jan2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 07Feb2021, the patient underwent SAR-COV-2 Test (Rapid AG) via nasal swab and the result was Negative. On 07Feb2021, the patient underwent SAR-COV-2 Test (Panther) via nasal swab and the result was Negative. On 12Feb2021, the patient underwent SAR-COV-2 Test (Rapid AG) via nasal swab and the result was Negative. On 12Feb2021, the patient underwent SAR-COV-2 Test (Panther) via nasal swab and the result was Negative. On 23Feb2021, the patient underwent SAR-COV-2 Test (Rapid AG) via nasal swab and the result was Negative. On 23Feb2021, the patient underwent SAR-COV-2 Test (Panther) via nasal swab and the result was Negative. The clinical outcome of the events pain in arm, body aches, fatigue, nausea, and headache were resolved on 16Jan2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021(at the age of 28-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: About an hour after receiving the first vaccination on 1/15/2021, she experienced pain in arm.; Body aches; Fatigue; Nausea; Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jan2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included bunionectomy, eczema, ichthiosis vulgaris(mild), wear contacts and penicillin allergy. 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 hydroxyzine (MANUFACTURER UNKNOWN), dexamfetamine (D-AMPHETAMINE) and linaclotide (LINZESS); all for an unknown indication from an unknown date and unknown if ongoing. On 15Jan2021, about an hour after receiving the first vaccination the patient experienced pain in arm, body aches, fatigue, nausea, and headache. The patient realized that these were common side effects and just monitored the symptoms. They started to go away the next day on 16Jan2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 07Feb2021, the patient underwent SAR-COV-2 Test (Rapid AG) via nasal swab and the result was Negative. On 07Feb2021, the patient underwent SAR-COV-2 Test (Panther) via nasal swab and the result was Negative. On 12Feb2021, the patient underwent SAR-COV-2 Test (Rapid AG) via nasal swab and the result was Negative. On 12Feb2021, the patient underwent SAR-COV-2 Test (Panther) via nasal swab and the result was Negative. On 23Feb2021, the patient underwent SAR-COV-2 Test (Rapid AG) via nasal swab and the result was Negative. On 23Feb2021, the patient underwent SAR-COV-2 Test (Panther) via nasal swab and the result was Negative. The clinical outcome of the events pain in arm, body aches, fatigue, nausea, and headache were resolved on 16Jan2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021(at the age of 28-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.