chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Aches; 100 degree fever; Tired; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at an age of 58-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. 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 left arm on 03Mar2021 at 17:30 (at an age of 58-years-old), as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 08:00, the patient experienced chills, aches, 100-degree fever, tired and headaches. 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 events. The clinical outcome of chills, aches, 100-degree fever, tired and headaches were not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient developed Shingles 3 days after my 2nd vaccine dose.  .; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old adult patient of unknown gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: En6205) via an unspecified route of administration in the right arm on 07Mar2021 (at the age of 52-years-old) at 11:45, as a single dose for COVID-19 immunisation. Medical history included hypertension and sleep apnea from an unknown date. Concomitant medications included patient received unknown medications within 2 weeks of vaccine. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not tested for COVID-19. Since the vaccination, patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El9266) via an unspecified route of administration, on 14Feb2021(at the age of 52-years-old) at 11:45, as a single dose for COVID-19 immunisation. On 10Mar2021 at 07:00, the patient had shingles, patient never had chickenpox and wondering whether it was possible that the vaccine had contributed to the shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of adverse events included OTC pain medications and hydrocortisone cream. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site redness, warmth and swelling; Injection site redness, warmth and swelling; Injection site redness, warmth and swelling; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; en6206) via an unspecified route of administration in the left arm on 09Mar2021 at 11:45 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism. The patient had known allergies with past drugs naproxen and pentosan polysulfate sodium. 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. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. On 09Mar2021 at 12:00, the patient experienced injection site redness, warmth and swelling spreading 16 days following injection. 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 outcome of vaccination site erythema, vaccination site warmth and vaccination site swelling was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Hypoaesthesia
Clinical narrative: Dry throat; Numbness around nose and upper lip; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration in the left arm on 25Mar2021 at 10:45 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included hashimoto hypothyroidism. The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included LEVOXYL, ADVIL, cyclobenzaprine (MANUFACTURER UNKNOWN); all for an unknown indication. On 25Mar2021 at 11:00, the patient had experienced dry throat, numbness around nose and upper lip. The patient did not receive treatment for the reported events. Adverse 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 dry throat, numbness around nose and upper lip was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness - mild; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the right arm on 24Mar2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included mild high blood pressure and heartburn. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), vitamin A (MANUFACTURER UNKNOWN), vitamin B12 (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) for unknown indications and unspecified medication for heartburn, all from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 at 08:00, the patient experienced injection site soreness-mild. 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 event injection site soreness-mild. The clinical outcome of the event injection site soreness-mild was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Arthralgia, Feeling hot, Rhinorrhoea
Clinical narrative: Pain in between shoulder blades, pain in right shoulder; Warmness in corner of the right eye.; Runny nose; Warmness in the right tricep; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BN6201) via an unspecified route in the left arm on 24Mar2021 at 08:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included difluprednate (DUREZOL) for unknown indication received within two weeks of vaccination. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9265) via an unspecified route of administration in the left arm on 03Mar2021, as a single dose for COVID-19 immunisation. On 24Mar2021 at 19:00, the patient had pain in between shoulder blades, pain in the right shoulder, warmness in corner of the right eye, warmness in the right tricep, and runny nose. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the pain in between shoulder blades, warmness in corner of the right eye, warmness in the right tricep and runny nose was not resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site rash
Clinical narrative: immunisation. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN), ethinylestradiol; norethisterone acetate (JUNEL) and vitamin D (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. Medical history included migraines. The patient did not have any known allergies to medications, food, or other product. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced red circle on skin at injection site, lump under skin at injection site and continues to be sore three days after injection. No therapeutic measures were taken as result of 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 rash, vaccination site pain and vaccination site lump were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Slight fever; Bad headache; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (Lot number: EL3247), at the age of 48-years-old, as a single dose for COVID-19 immunisation. Medical history was reported as none. No allergies to medications, food, or other products. Concomitant medication included with fish oil (OMEGA-3 FISH OIL) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246) via an unspecified route of administration in the left arm on 04Mar2021 (at the age of 48-years-old) at 14:15, as a single dose for COVID-19 immunisation. Patient was not pregnant at the time 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 did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced slight fever and headache on 24Mar2021 at 02:00 am (after getting the vaccine at 14:00 the day before) and progressively getting worse throughout the day. Symptoms started to decrease around 18:00. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Two days after the vaccine shot, patient had no symptoms. The clinical outcome of slight fever and headache were resolved on 25Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paraesthesia oral, Swollen tongue
Clinical narrative: Tongue swelling; lip and cheek tingling; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 74-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 14:15 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included auto-immune chronic idiopathic urticaria and bowel disease. The patient had allergies to a large list of medications, foods and allergens (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included several antihistamines and thyroid medication. On 24Mar2021 at 15:45, (approximately two hours after the shot), the patient developed tongue swelling, lip and cheek tingling and shortness of breath. 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 the tongue swelling, lip and cheek tingling and shortness of breath was resolving 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: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old female patient received an unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199), via an unspecified route of administration on 24Mar2021 at 14:45 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to the vaccination. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) which includes A, B, C, D and E for an unknown indication from unknown date. The patient did not have any allergies to medications, food or other products. 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 25Mar2021 at 08:00, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea and feeling unwell. 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 injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea and feeling unwell were recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old female patient received an unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199), via an unspecified route of administration on 24Mar2021 at 14:45 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to the vaccination. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) which includes A, B, C, D and E for an unknown indication from unknown date. The patient did not have any allergies to medications, food or other products. 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 25Mar2021 at 08:00, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea and feeling unwell. 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 injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea and feeling unwell were recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Arm hurt; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 24 -years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN8204) via an unspecified route of administration in the arm left on 17Mar2021 as a single dose (at the age of 24-years-old) for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and omega 3 (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 (the day after vaccine), the patient experienced headache, fatigue and on 25Mar2021 (8 days after vaccine), the patient experienced arm hurt so bad that patient could not move it. The patient did not receive any treatment for the reported 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 events headache, fatigue and arm hurt were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza, Pain
Clinical narrative: flu symptoms; headache; body aches; slight fever; chills; extreme fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 12:30 (at the age of 50-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications was not reported and known allergies were reported as no. The other vaccination within four weeks prior to the COVID-19 vaccine was reported as no. 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 received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 02Mar2021 at 12:30 (at the age of 50-years-old) for COVID-19 immunisation. Facility where the COVID-19 vaccine was administered was at the hospital. On 24Mar2021at 08:00, the patient experienced flu symptoms, headache, body aches, slight fever, chills and extreme fatigue. No therapeutic measures were taken for the reported 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 experienced flu symptoms, headache, body aches, slight fever, chills and extreme fatigue was recovering at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu symptoms; headache; body aches; slight fever; chills; extreme fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 12:30 (at the age of 50-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications was not reported and known allergies were reported as no. The other vaccination within four weeks prior to the COVID-19 vaccine was reported as no. 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 received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 02Mar2021 at 12:30 (at the age of 50-years-old) for COVID-19 immunisation. Facility where the COVID-19 vaccine was administered was at the hospital. On 24Mar2021at 08:00, the patient experienced flu symptoms, headache, body aches, slight fever, chills and extreme fatigue. No therapeutic measures were taken for the reported 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 experienced flu symptoms, headache, body aches, slight fever, chills and extreme fatigue was recovering at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pruritus
Clinical narrative: Itchy; tiredness; headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient has received concomitant medication (unspecified drug), within 2 weeks of vaccination. The patient had a history of drug allergy to hydrocodone. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecific date in Mar2021 the patient experienced mild headaches, Itchy and extreme tiredness. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, Itchy, and tiredness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives on my right arm and have a small patch on my stomach; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 18Mar2021 at 09:45 (at the age of 39-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. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 17:30, the patient broke out in hives on right arm and had a small patch on stomach. 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 adverse event and included treatment with BENADRYL. The clinical outcome of the event hives was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Fatigue; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient (age unspecified) received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on unknown date in Mar2021 as a single dose for COVID-19 immunisation. Medical history  and concomitant medications were not provided. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient was tested for COVID-19.  On unknown date in Mar2021 the patient experienced fever and fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events fever and fatigue were recovered on unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pain
Clinical narrative: medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN), all for unknown indication received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient received vaccine about 8 weeks after being exposed to COVID and about 4 weeks after recovery, on 22Mar2021 at 14:00, the patient experienced sore arm, fatigue, aches, chills, fever, mild nausea and loss of appetite for 2 days - began about 18 hours after injection, the events were worst about 24-30 hours after, later the events continued to be moderate for about 48 hours, finally recovered after 72 hours. The patient did not receive treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm, fatigue, aches, chills, fever, mild nausea and loss of appetite was recovered on 25Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN), all for unknown indication received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient received vaccine about 8 weeks after being exposed to COVID and about 4 weeks after recovery, on 22Mar2021 at 14:00, the patient experienced sore arm, fatigue, aches, chills, fever, mild nausea and loss of appetite for 2 days - began about 18 hours after injection, the events were worst about 24-30 hours after, later the events continued to be moderate for about 48 hours, finally recovered after 72 hours. The patient did not receive treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm, fatigue, aches, chills, fever, mild nausea and loss of appetite was recovered on 25Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: 23Mar2021 at 09:15 (at the age of 55-year-old) as single dose for COVID 19 immunisation. Medical history and concomitant medication have not been provided. 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 vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in left arm on 02Mar2021 at 09:15 AM (at the age of 55-year-old) as single dose for COVID 19 immunisation. On 23Mar2021 at 09:15, the patient experienced (reported as only for second dose) chills with shivering, shaking and feeling cold for lasted four hours. Chills came back on next day and milder without shivering and shaking. Tiredness, headache continued the next day and also experienced mild pain at side of injection for first 24 hours. Treatment received for the adverse events was reported as no. The clinical outcome of the event chills with shivering, shaking, feeling cold, tiredness, headache and mild pain at side of injection was resolved on an unknown date in Mar2021. No follow up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: 23Mar2021 at 09:15 (at the age of 55-year-old) as single dose for COVID 19 immunisation. Medical history and concomitant medication have not been provided. 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 vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in left arm on 02Mar2021 at 09:15 AM (at the age of 55-year-old) as single dose for COVID 19 immunisation. On 23Mar2021 at 09:15, the patient experienced (reported as only for second dose) chills with shivering, shaking and feeling cold for lasted four hours. Chills came back on next day and milder without shivering and shaking. Tiredness, headache continued the next day and also experienced mild pain at side of injection for first 24 hours. Treatment received for the adverse events was reported as no. The clinical outcome of the event chills with shivering, shaking, feeling cold, tiredness, headache and mild pain at side of injection was resolved on an unknown date in Mar2021. No follow up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: large raised area on left arm.; Very itchy oval 2 3/4 inches by 2 inches; secondary circle of red/ red firm spot on arm about 1 inch in diameter; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The patients medical history was reported as none and had an allergy to pethidine hydrochloride (DEMEROL). The patient took unspecified concomitant medications. 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 12Mar2021, the patient experienced large raised area on left arm, very itchy oval 2 3/4 inches by 2 inches. On unknown date in Mar2021, the patient experienced a secondary red circle but eventually swelling and itching had stopped. The patient still had a red firm spot on arm about 1 inch in diameter and there were no other ill effects. The patient had applied BENADRYL cream as treatment for reported event. The adverse events resulted in emergency room/department or urgent care visit. The clinical outcome of event red firm spot was not resolved while that of raised area on left arm and Itchy were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Low grade fever (100-101); chills; body aches; muscle ache; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination 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 02Mar2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021, the body temperature was measured and was found to be 100-101 (unspecified unit). On 24Mar2021, the patient experienced low grade fever (100-101), chills, body and muscle aches, approx. 12- 24 hours after second dose of vaccination. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment was not taken for the reported events. The clinical outcome of the events low grade fever (100-101), chills, body and muscle aches were resolved on an unknown date in Mar2021.   No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: Adhesive capsulitis in upper right arm; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an unspecified age 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 09Mar2021 as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did receive any other medications within 2 weeks of vaccination. The patient had a history of allergy to clindamycin and Crestor. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 11Mar2021, the patient had experienced adhesive capsulitis in upper right arm. The patient did not receive treatment for the reported events. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of event adhesive capsulitis was not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Headache; Loose stool; This is a spontaneous report from a non-contactable other non-healthcare professional. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) dose via an unspecified route of administration on 22Mar2021 (at the age of 49-year-old) as a single for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to any medications, food, or other products. The patient did not receive any medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 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 22Mar2021, the patient experienced headache and loose stool. The patient did not receive any treatment for the events of headache and loose stool. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of events headache and loose stool was resolved on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Throat clearing
Clinical narrative: Throat clearing; fleeting hot flash; This is a spontaneous report from a non-contactable consumer. A 60-years-old non-pregnant female patient received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration on 24Mar2021(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The Patient was not tested for COVID-19 since the vaccination. On 24Mar2021, the patient experienced throat clearing and fleeting hot flash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported event. The clinical outcome of the Throat clearing and fleeting hot flash was recovered on unknown date.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash macular
Clinical narrative: First dose on 04Mar2021 and Second dose on 22Mar2021; Red Blotchy Rash; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6204), via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoarthritis and asthma. The patient was allergic to penicillin, pecans, bananas and latex. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), adalimumab (HUMIRA), paracetamol (TYLENOL) and pseudoephedrine hydrochloride (SUDAFED); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6202), via an unspecified route of administration in the right arm on 04Mar2021 (at the age of 63-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 tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient experienced red blotchy rash. The patient received first dose on 04Mar2021 and second dose on 22Mar2021 (Inappropriate schedule of vaccine administered). The patient did not receive any treatment for blotchy rash. The clinical outcome of the event red blotchy rash was not recovered and of the inappropriate schedule of vaccine administered was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Abdominal muscles pain only in left side; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 21Mar2021 at 15:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included lactose intolerant. Concomitant medication included pseudoephedrine hydrochloride; cetirizine hydrochloride (ZYRTEC D) for an unknown indication from 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 4 weeks prior to COVID-19 vaccine. On 23Mar2021 at 11:00, the patient experienced abdominal muscles pain only in left side. 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 event abdominal pain. The clinical outcome for the event abdominal pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Haemangioma of skin
Clinical narrative: pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash (urticaria); on day five start of abdominal pain; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cholinergic urticaria, lactose and fructose intolerance. The patient's allergic history included rhinitis, animal fur, mites, dust, NSAIDS (Nonsteroidal Anti-Inflammatory Drugs) causes urticaria. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 18Mar2021, the patient experienced abdominal pain. On 20Mar2021 at 10:00, the patient experienced pain in injection side, fatigue and muscle weakness, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma. Since the vaccination, the patient had been tested negative for COVID-19 on 21Mar2021. As a corrective measure the patient received cetirizine for all the events. The clinical outcomes of the events, pain in injection side, fatigue and muscle weakness, abdominal pain, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma were recovering. No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Postal Code added, Verbatim was updated for medical history. Relevant Med History Rhinitis was deleted as it is the reaction of animal fur, mites, dust allergy, Lab data "Rapid Diagnostic RNA test" deleted as it can be combined with PCR (Nasal Swab), Vaccine Facility Information added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pyrexia, SARS-CoV-2 test, Urticaria, Vaccination site pain
Clinical narrative: pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash (urticaria); on day five start of abdominal pain; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cholinergic urticaria, lactose and fructose intolerance. The patient's allergic history included rhinitis, animal fur, mites, dust, NSAIDS (Nonsteroidal Anti-Inflammatory Drugs) causes urticaria. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 18Mar2021, the patient experienced abdominal pain. On 20Mar2021 at 10:00, the patient experienced pain in injection side, fatigue and muscle weakness, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma. Since the vaccination, the patient had been tested negative for COVID-19 on 21Mar2021. As a corrective measure the patient received cetirizine for all the events. The clinical outcomes of the events, pain in injection side, fatigue and muscle weakness, abdominal pain, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma were recovering. No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Postal Code added, Verbatim was updated for medical history. Relevant Med History Rhinitis was deleted as it is the reaction of animal fur, mites, dust allergy, Lab data "Rapid Diagnostic RNA test" deleted as it can be combined with PCR (Nasal Swab), Vaccine Facility Information added.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; 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: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 16:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received sulfamethoxazole (+) trimethoprim (BACTRIM) for an unspecified indication 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 for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 19:30, the patient experienced sore throat. 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 treatment for the reported event. The clinical outcome of the sore throat was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.