chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via unspecified route of administration in right arm on 30Mar2021 (at the age 0f 71-year-old) as single dose for COVID-19 immunisation. Medical history of the patient was reported as none. Concomitant medications were not reported. The patient previously received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER9206) via unspecified route of administration in left arm on 09Mar2021 as single dose for COVID-19 immunisation. It was reported that the patient had no known allergies to food, medications or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. On 31Mar2021 at 15:00, the patient experienced injection site pain (vaccination site pain), tiredness, headache, muscle pain, chills, joint pain, fever and feeling unwell. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever and feeling unwell was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via unspecified route of administration in right arm on 30Mar2021 (at the age 0f 71-year-old) as single dose for COVID-19 immunisation. Medical history of the patient was reported as none. Concomitant medications were not reported. The patient previously received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER9206) via unspecified route of administration in left arm on 09Mar2021 as single dose for COVID-19 immunisation. It was reported that the patient had no known allergies to food, medications or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. On 31Mar2021 at 15:00, the patient experienced injection site pain (vaccination site pain), tiredness, headache, muscle pain, chills, joint pain, fever and feeling unwell. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever and feeling unwell was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 31Mar2021 at 11:15 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included arthritis tail bone, obesity and allergy to cow's milk. Concomitant medications included triamterene (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and aspirin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On 31Mar2021 at 12:00 the patient experienced diarrhea, intermittent bouts about every 30 to 60 minutes apart. First bout roughly 45 minutes after the shot. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. It was unknown if the patient was treated for the event. The clinical outcome of the diarrhea was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Sluggishness
Clinical narrative: sluggish; felt tired; left arm started feeling stiff; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to alcohol (fermentation in champagne, wine). Concomitant medication included unspecified medication for daily birth control. The patient previously 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 09Mar2021 at 13:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination. On 30Mar2021, the patient's left arm started feeling stiff around midnight of the day of vaccination. On 31Mar2021 (reported as next day), the patient felt tired and sluggish especially in the afternoon. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events left arm started feeling stiff, sluggish and felt tired. The clinical outcome of the event left arm started feeling stiff was resolved on an unknown date in Mar2021 while that of felt tired and sluggish was resolved on 31Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Mild prickly sensations on the back of  hands.; burns to wash my hands; 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: EN6206) in the arm right on 11Mar2021 at 10:30(at the age of 52-year-old)  and the patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533) in the arm right on 31Mar2021 at 13:30(at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 18Mar2021, the patient experienced mild prickly sensations on the back of her hands, soon after the booster dose the sensations were more intense and burns to wash hands. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events mild prickly sensations on the back of  hands and burns to wash hands were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: C19 ER873V) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and type 2 diabetic. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 09:45, the patient experienced soreness in arm. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event soreness in arm. The clinical outcome of the event soreness in arm was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dyspnoea, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Painful lymph nodes; swollen lymph nodes; slight shortness of breath; Mild injection site soreness; Pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 31-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 29Mar2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma, hypertension, hashimoto's thyroiditis and fibromyalgia. The patient had no allergies to medications, food, or other products. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA) and paracetamol, oxycodone hydrochloride (PERCOCET) from unknown start dates and for unknown indications. 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 03Mar2021 at 08:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation and experienced very painful, swollen lymph nodes in the armpit and breast on the same side. Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination. On 30Mar2021 at 08:00, the patient experienced very painful lymph nodes, swollen lymph nodes in the armpit and breast on the same side that the vaccine was given. The patient also experienced slight shortness of breath and mild injection site soreness. The patient did not receive any treatment for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of events painful lymph nodes, swollen lymph nodes, slight shortness of breath, pain in armpit and injection site soreness were not recovered.   No follow-up attempts are needed; information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021358975 Same reporter, patient, product/ different dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 40-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 29Mar2021 at 14:00 (at the age of 40-year-old) as a single dose for COVID-19 immunization. The medical history and concomitant medications were reported as none. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination. The patient received the most recent dose of COVID 19 vaccine in a pharmacy or drugstore. On 29Mar2021 at 16:00, the patient experienced headache Grade 2. Therapeutic measures were taken as a result of the event headache and included treatment with ibuprofen PO (per oral). The clinical outcome of the event headache was resolved on an unknown date at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache Grade 2; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 29Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune esophagitis. The patient was allergic to seafood. The patient did not take any concomitant medication. 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-19 vaccine. On 29Mar2021 at 16:00, the patient experienced headache grade 2. Therapeutic measures were taken as a result of headache grade 2 and included treatment with ibuprofen po (MANUFACTURER UNKNOWN) on an unknown date. The adverse 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 clinical outcome of the event headache grade 2 was resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Nausea, Swollen tongue
Clinical narrative: headache; nausea; felt pressure in ears; swollen tongue; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant 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 arm right on 10Mar2021 at 15:30(at the age of 43-years-old) as a single dose for COVID-19 immunization. Medical history included prolactinoma. Patient had allergy to sulfa and codine. Concomitant medications included norethisterone (NORETHINDRONE) .35mg tablet and cabergoline 1/2  (MANUFACTURER UNKNOWN) all used for unknown indication and from an unknown date. Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination. On 10Mar2021 at 15:30 ,within ten minutes of vaccination the patient experienced swollen tongue. She was able to breathe but noticed the increase in swelling of her tongue. On 10Mar2021 at 18:30 the patient experienced headache, nausea and felt pressure in ears. The patient did not receive any treatment for the event. The adverse 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 adverse event. The clinical outcome of headache, nausea, felt pressure in ears and swollen tongue were recovered.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Gout
Clinical narrative: Flare-up of gout; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male 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 25Mar2021 at 09:45 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included coronary angioplasty (cardiac stents) and coronary artery disease (CAD). The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination.  On 28Mar2021 at 20:00, the patient experienced flare-up of gout. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of gout and included treatment with NSAID prescription. On an unknown date, the patient underwent blood testing and the result was unknown. The clinical outcome of the event flare-up of gout was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Livedo reticularis, Migraine, Nausea
Clinical narrative: Splotchy skin (mottled skin),; migraine; fatigue; nausea; dizziness; from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in left arm on 26Mar2021 at 18:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included anaemia and vitamin-D deficiency. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL EXTRA STRENGTH), ferrous sulphate (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in left arm on 05Mar2021 at 18:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  The patient experienced splotchy skin (mottled skin), migraines, fatigue, nausea and dizziness on 28Mar2021 at 20:00. The patient had not received any treatment for the reported events. The adverse events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of splotchy skin (mottled skin), migraines, fatigue, nausea and dizziness were not recovered at the time of this report.   No follow-up attempts needed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Rash on legs; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration in the left arm on 31Mar2021 at 10:45 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 18:45 the patient experienced rash on legs. The patient did not receive any treatment for the event. The clinical outcome of the event rash on both legs was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Chills; body aches; nausea; dizziness; cold fingertips; headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 28Mar2021 at 14:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy in 2001 and allergy to antibiotics; both from unknown dates. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and levothyroxine sodium (SYNTHROID 112mg); both for unspecified indication from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Unknown) via an unspecified route of administration in the right arm on 07Mar2021 at 15:15 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021, the patient experienced chills, body aches, nausea, dizziness, cold fingertips and headache. 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 treatment for the reported events. The clinical outcome of the chills, body aches, nausea, dizziness, cold fingertips and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: Chills; body aches; nausea; dizziness; cold fingertips; headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 28Mar2021 at 14:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy in 2001 and allergy to antibiotics; both from unknown dates. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and levothyroxine sodium (SYNTHROID 112mg); both for unspecified indication from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Unknown) via an unspecified route of administration in the right arm on 07Mar2021 at 15:15 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021, the patient experienced chills, body aches, nausea, dizziness, cold fingertips and headache. 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 treatment for the reported events. The clinical outcome of the chills, body aches, nausea, dizziness, cold fingertips and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Oral herpes, Swollen tongue
Clinical narrative: tingle of cold sore left upper lip; painful bump on right side of tongue; Canker sore middle of lower lip; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 28Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma, diabetes, canker sores oral, cold sores. The patient had environmental allergy and peanut allergy. Concomitant medications included insulin (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), amfetamine aspartate, amfetamine sulfate, dexamfetamine sulfate and dexamfetamine saccharate (ADDERALL), levothyroxine sodium (LEVOXYL), losartan (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) all for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 07Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination. On 29Mar2021, the patient experienced canker sore oral. It was reported that the patient had painful bump on right side of tongue, likely turning into a canker sore on 31Mar2021, might be tingle of cold sore left upper lip this evening on 31Mar2021. The patient mainly worried because these were not reported side effects, but were possibly symptoms of COVID. The patient would like to be able to see complete list of side effects of vaccine. The patient did not receive any treatment for the adverse events. 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 clinical outcome of the event canker sore middle of lower lip, painful bump on right side of tongue and tingle of cold sore left upper lip was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Severe pain in neck.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac diseases. The patient had known allergies to wheat and gluten. Concomitant medications included B Hydroc (MANUFACTURER UNKOWN), vit d (MANUFACTURER UNKNOWN), venlafaxine hydrochloride (EFFEXOR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and pseudoephedrine sulfate, loratadine (CLARITIN D); all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 27Feb2021 at 16:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 13:00, the patient experienced severe pain in neck. Therapeutic measures were taken as a result of reported event and included treatment with chiropractic and acupuncturist appointments. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of neck pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore Left Shoulder; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient reported unspecified medical history. The patient had experienced unspecified allergies. 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. The patient received unspecified medications within 2 weeks of vaccination. On 27Mar2021, the patient experienced Sore Left Shoulder. The patient applied diclofenac sodium(VOTAREN) cream for the treatment of the event. Since the vaccination, the patient not been tested for COVID-19. The clinical outcome of the event sore left shoulder was unknown at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Muscle twitching, Vaccination site pain
Clinical narrative: Sore at injection site; Fatigue; Flu like symptoms; Twitching in my left arm; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534), via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN); experienced drug allergy. Prior to the vaccination, the patient was unknown if 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 four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 30Mar2021 the patient experienced sore at the injection sight and felt super fatigued with flu like symptoms and twitching in the left arm. The adverse 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 treatments for the events of vaccination site pain, fatigue, flu-like symptoms and twitching. The clinical outcomes of the events vaccination site pain, fatigue, flu-like symptoms and twitching were unknown at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Irregular heartbeat; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route administration in the right arm on 26Mar2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive other vaccines within four weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 28Mar2021, the patient experienced irregular heartbeat. The treatment received for the reported event was unknown. The clinical outcome of the event irregular heartbeat was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Fatigue, Nasal congestion, Vaccination site pain
Clinical narrative: Soreness at the injection site; Tired; Swollen ears; Congestion; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), via an unspecified route of administration in the left arm on 25Mar2021 at 14:45 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medication included escitalopram 40 mg (MANUFACTURER UNKNOWN) for an unknown indication from an 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 unknown if diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced soreness at the injection site, tired, swollen ears and congestion. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site pain, tiredness, ear swelling, congestion and treatment included BENADRYL. The clinical outcomes of the events vaccination site pain, tiredness, ear swelling and congestion were resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus began in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El9625) via unspecified route of administration in the right arm on 03Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no allergies to medications, food and other products. Concomitant medication included telmisartan (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ej1685) via unspecified route of administration in the right arm on 13Jan2021, at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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-19 vaccine. On 16Feb2021 at 08:00, the patient experienced event of tinnitus in right ear and that had not gone away as of 31Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for event. The clinical outcome of the event tinnitus in right ear was not resolved (as of 13Mar2021) at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site pain
Clinical narrative: Fatigue; Pain at site of injection; Swollen lymph nodes in lower right of neck; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 27Mar2021 at 13:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included primary lymphedema in lower extremities. Concomitant medication included allergy medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the right arm on 06Mar2021 at 13:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the COVID 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 28Mar2021 at 16:00, the patient experienced fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck. 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 events fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck. The clinical outcomes of the events fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Vaccination site pain
Clinical narrative: Moderate chills; Difficulty sleeping; Mild headache; Mild injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 12:00, the patient experienced mild injection site pain, also experienced the same on 25Mar2021. On 26Mar2021, the patient experienced moderate chills, difficulty sleeping and mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site pain, chills, difficulty sleeping, headache and included treatment with TYLENOL. The clinical outcomes of the events vaccination site pain, chills, difficulty sleeping and headache were resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: Drowsy; Nausea; Low fever; This is a spontaneous report from a contactable consumer, the patient. A 43-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 in the left arm on 29Mar2021 at 11:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have allergies to medications, food, or other products. The patient did not receive other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 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 8Mar2021 at 11:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021 at 16:30, the patient experienced drowsy, nausea and low fever. 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 events. The clinical outcome of drowsiness, nausea and low-grade fever was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over the right side of my neck and on the shoulder of my other arm.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 25Mar2021 at 18:15, (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included shingles since an unknown date and allergy to sulfur. Concomitant medications included dietary supplements (unspecified). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26March2021, 20:45 the patient experienced rash all over the right side of neck and on the shoulder of other arm. The event 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 events. The clinical outcome of the event rash all over the right side of neck and on the shoulder of other arm was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed rash on the 24th of March went to urgent care on 29th of March and was told it was shingles; This is a spontaneous report from a contactable consumer, the patient. An 88-year-old non-pregnant female 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 20Mar2021 at 12:15 (at the age of 88-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 in the left arm on 27Feb2021 at 12:00 (at the age of 88-years-old), as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products. Prior to vaccination, the patient was not 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 four weeks prior to the COVID vaccine. On 24Mar2021, the patient developed rash. On 29Mar2021, the patient went to urgent care and was told that it was shingles. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included treatment with famciclovir (MANUFACTURER UNKNOWN) for the event of shingles. The clinical outcome of the event shingles was recovering at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 30-year-old patient of an unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) in the right arm on 31Mar2021 at 08:30 (at the age of 30-years-old) as a first dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes mellitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient was known allergic to watermelon, walnuts, almonds, bananas. The patient did not receive any other vaccine within four weeks prior to the vaccination.  Concomitant medications included metformin (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and ethinyl estradiol, norgestimate (TRI-SPRINTEC). On 31Mar2021, 10hours after the vaccination, the patient experienced upper lip swelling on the left side of lip. The patient did not receive any treatment for the reported event. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event upper lip swelling was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: Fatigue; Headache; Swollen lymph nodes in armpit; feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 22-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 13Mar2021 at 15:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and scoliosis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications included lisdexamfetamine dimesylate (MANUFACTURER UNKNOWN) and etonogestrel (NEXPLANON), both taken for unknown indication from unknown date. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 12:00, the patient experienced fatigue, headache, swollen lymph nodes in armpit and was feeling unwell. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of events fatigue, headache, swollen lymph nodes in armpit and feeling unwell were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Malaise, Vaccination site pain
Clinical narrative: Ocular Pain; Injection site soreness; Chills; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 27Mar2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously received dilaudid (UNKNOWN MANUFACTURER) and codeine (UNKNOWN MANUFACTURER) and experienced drug allergy. Prior to vaccination, the patient was not 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 four weeks prior to the COVID vaccine. On 27Mar2021 at 21:30, the patient experienced injection site soreness, ocular pain, chills and malaise. 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 events injection site soreness, ocular pain, chills and malaise. The clinical outcomes of the events injection site soreness, ocular pain, chills and malaise were resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.