chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Oral discomfort, Peripheral swelling, Pruritus
Clinical narrative: weird feeling in my mouth; red, however like broken blood vessels near mouth and cheek; Lips still feel strange.; Itchy, left had; Itchy left had and swollen; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 06Apr2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic reaction to antibiotics and penicillin allergy. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), cannabis sativa (CANNABIS), lisinopril (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) all from an unknown date for an unspecified indication. 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 06Apr2021 at 16:00 the patient experienced weird feeling in mouth, sat for 20 min, checked out. Took off mask and was red, however like broken blood vessels near mouth and cheek. Itchy left hand and swollen. Lips still feel strange. No shortness of breath or swelling. Patient took Benadryl. The events resulted in emergency room/department or urgent care. The clinical outcome of events oral discomfort, redness of face, lip discomfort, itching, swollen arm was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Fatigue, Musculoskeletal chest pain
Clinical narrative: Slight fatigue; muscle aches; sharp bone pain when tossing/turning at night; Sharp Pain in elbow; Sharp Pain in ribs when rolling over in bed.; Fever; Night sweats (very alarming); This is a spontaneous report from a contactable consumer, 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 03Apr2021 at 11:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included Sensitive to adhesives (like band aids). Concomitant medications included ibuprofen (ADVIL) for unknown indication taken 2 days before she took the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 13:00 the patient experienced slight fatigue, muscle aches, sharp bone pain when tossing or turning at night, sharp pain in elbow, sharp pain in ribs when rolling over in bed, fever 101-103.5 and night sweats but then she felt great the next morning. The patient did not receive any treatment for the events. On 04Apr2021, the patient underwent body temperature and the result was 101-103.5. 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 slight fatigue, muscle aches, sharp bone pain when tossing or turning at night, sharp pain in elbow, sharp pain in ribs when rolling over in bed, fever and night sweats were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Night sweats, Pyrexia
Clinical narrative: Slight fatigue; muscle aches; sharp bone pain when tossing/turning at night; Sharp Pain in elbow; Sharp Pain in ribs when rolling over in bed.; Fever; Night sweats (very alarming); This is a spontaneous report from a contactable consumer, 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 03Apr2021 at 11:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included Sensitive to adhesives (like band aids). Concomitant medications included ibuprofen (ADVIL) for unknown indication taken 2 days before she took the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 13:00 the patient experienced slight fatigue, muscle aches, sharp bone pain when tossing or turning at night, sharp pain in elbow, sharp pain in ribs when rolling over in bed, fever 101-103.5 and night sweats but then she felt great the next morning. The patient did not receive any treatment for the events. On 04Apr2021, the patient underwent body temperature and the result was 101-103.5. 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 slight fatigue, muscle aches, sharp bone pain when tossing or turning at night, sharp pain in elbow, sharp pain in ribs when rolling over in bed, fever and night sweats were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bursal fluid accumulation, Joint swelling
Clinical narrative: My left elbow swelling, collecting fluid.; collecting fluid.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6955) via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient previously had no known allergies. Medical history included plaque psoriasis. Concomitant medications included secukinumab (COSENTYX) 150 mg/ml 2 pen from unknown date, for unknown indication. 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 24Mar2021 at 18:00 the patient experienced, left elbow swelling and collecting fluid (bursal fluid accumulation). It was unknown if the patient received any treatment for the reported adverse  events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event elbow swelling and collecting fluid (bursal fluid accumulation) was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Muscle tightness, Pruritus, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204 ??? ENG204??) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient previously had shellfish, iodine, sulfa drugs and experienced shellfish allergy, iodine allergy and sulfonamide allergy. The patient was allergic to chemicals (dye). The patient previously took codeine and ibuprofen and experienced drug allergy to codeine and ibuprofen. Concomitant medications taken within two weeks included meloxicam 15mg everyday (MANUFACTURER UNKNOWN) from unknown date for unknown indication and escitalopram oxalate 15mg every night (LEXAPRO) from unknown date for unknown indication. 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 20Mar2021 at 12:05, five minutes after vaccine the patient felt her throat and neck very tight but 8 could breathe and swallow. Also got sensation in her brain like there were ants crawling in her brain on 20Mar2021. On 20Mar2021 at 12:15, 15 minutes after the vaccine the patient felt itching to her chest and back. No rash developed just itching that got intense every jow and then. The itching lasted three days. The patient did not receive any treatment for the adverse events. The clinical outcome of the events itching to chest and back was resolved after three days on 23Mar2021 and of neck very tight, throat tight, ants crawling in brain was resolved on an unknown date in 2021 at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Lip swelling, Oral discomfort, Tongue discomfort
Clinical narrative: Lip swelling; Burning lips; Blood pressure elevated; Burning of tongue radiating down throat; This is a spontaneous report from a contactable other health care professional, the pharmacist. A 80-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via intramuscular route of administration in the left arm on 15Mar2021 (at the age of 80-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidemia and penicillin allergy. The patient previously received codeine (MANUFACTURER UNKNOWN), vicodin (MANUFACTURER UNKNOWN)  on an unspecified date for an unknown indication and experienced drug allergy. It was unknownif the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 09:20, the patient complained of burning of tongue radiating down throat, denies chest pain, tightness, tingling, or difficulty swallowing. On 15Mar2021 at 9:44, the patient blood pressure was elevated and the patient was sent home with daughter. On 15Mar2021 at 10:18, the patient experienced lip swelling and burning, it was reported that the patient ate food. It was reported that on 15Mar2021 at 11:28, the patient verbalized improvement of symptoms. Therapeutic measures were taken as a result of reported adverse events burning of tongue radiating down throat, blood pressure was elevated, lip swelling and burning included treatment with BENADRYL 25mg, once daily, dexamethasone (MANUFACTURER UNKNOWN) 4mg once daily, peptic (MANUFACTURER UNKNOWN) 20mg once daily. It was stated that the patient was advised to continue with BENADRYL 25mg every 8 hours once a day for2 days and to follow up with her primary care provider the next day. 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 burning of tongue radiating down throat, blood pressure was elevated, lip swelling and burning were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pain
Clinical narrative: Body ache; upset stomach; Headache; Chills; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. 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 left arm on 05Mar2021 at 13:00(at the age of 61-year-old), as a single dose for COVID-19 immunisation. Prior to the 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 05Apr2021 at 00:30, the patient experienced body ache, upset stomach, headache, chills and tiredness. The patient did not receive any treatment for the event. The clinical outcome of the event body ache, upset stomach, headache, chills, tiredness was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Feeling cold, Heart rate decreased, Hyperhidrosis
Clinical narrative: all over prickly skin; sweating all over; low pulse; feeling cold; vomiting; Diarrhea; feeling very weak.; This is a spontaneous report from a contactable consumer, the patient. A 82-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiovascular disease and thyroid. The patient received unspecified medication within two weeks of vaccination. The patient previously took PLAVAX on unknown date for unknown 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 four weeks prior to the vaccination. On 01Apr2021 at 21:00 the patient experienced all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak. 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 event all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vomiting
Clinical narrative: all over prickly skin; sweating all over; low pulse; feeling cold; vomiting; Diarrhea; feeling very weak.; This is a spontaneous report from a contactable consumer, the patient. A 82-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiovascular disease and thyroid. The patient received unspecified medication within two weeks of vaccination. The patient previously took PLAVAX on unknown date for unknown 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 four weeks prior to the vaccination. On 01Apr2021 at 21:00 the patient experienced all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak. 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 event all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Severe rash on left forearm, rashes onright forearm, rash on neck, back andleft thigh; Difficulty breathing; Itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the right arm on 08Feb2021 at 11:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, blocked arteries (stent).  Concomitant medications included mold & pollen allergy injections, Synthr and alirocumab (PRALUENT). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E1 3248) via an unspecified route of administration in the left arm on 18Jan2021 at 10:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation and sulfamethoxazole, trimethoprim (BACTRIM) and nicotinic acid (NIACIN) on an unknown date 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 four weeks prior to the vaccination. On 10Feb2021, the patient experienced severe rash on left forearm, rash on right forearm, neck, back and thigh, difficulty in breathing and itching. Symptoms began a day or two after the second vaccine, continued for two months, and still continue at this point. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of severe rash on left forearm, rash on right forearm, neck, back and thigh, difficulty in breathing and itching were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: Diarrhea; Headaches; Fever; This is a spontaneous report from a contactable physician. A 68-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 on an unknown date (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, rheumatoid arthritis and coronary artery disease. The patient had no known allergies. Concomitant medications taken within two weeks included hydroxychloroquine (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), linagliptin (TRADJENTA), pantoprazole (MANUFACTURER UNKNOWN), diltiazem (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), isosorbide (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. 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 06Apr2021 at 12:00, the patient experienced diarrhea, headaches and fever. Therapeutic measures were taken as a result of the adverse events which included treatment with imodium, tylenol from unknown date. 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 the event diarrhea, headaches and fever was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Urine output increased
Clinical narrative: Have to urinate tremendous amount in 45 min intervals; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 31Mar2021 at 10:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Patient had no medical history. The patient previously received Z-pak and experienced allergy. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 10Mar2021 at 10:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to 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. On 01Apr2021, after the second vaccine, the patient had to urinate tremendous amount in 45 minute intervals. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event had to urinate tremendous amount in 45 minute intervals was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Sleep disorder, Vaccination site mass
Clinical narrative: Hard bump directly under the the injection site.; Trouble sleeping; red area about 3-4 inches around site injection,; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received unknown dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, blood pressure high, ascending aortic aneurysm, COVID-19 started on an unknown date. The patient received an unspecified medication within 2 weeks of vaccination. The patient previously received trimethoprim; sulfamethoxazole (bactrim) and amoxycillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the 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 18Mar2021 at 06:00, appx. 40 hours after shot, the patient had a red area about 3-4 inches around site injection (not a rash), hard bump directly under the injection site and was not itchy and also had a trouble sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received the treatment with cold compress for the reported adverse events. The clinical outcome of the event hard bump directly under the injection site, trouble sleeping and red area about 3-4 inches around site injection was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Erythema, Feeling hot, Hypoaesthesia
Clinical narrative: Red dots all over lips and nose, face red (same as sunburn); Numb right arm; Left arm only numb at injection site; Very hot head and neck; Dizziness; Anxiety; Nasal congestion; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder. The patient was not allergic to food, medications, or other products. Concomitant medications included nicotinic acid (NIACIN), garlic extract and cayenne pepper. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 13:30, the patient experienced red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion. The patient did not receive any treatment for the event. 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 red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion were resolved on 06Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site hypoaesthesia
Clinical narrative: Red dots all over lips and nose, face red (same as sunburn); Numb right arm; Left arm only numb at injection site; Very hot head and neck; Dizziness; Anxiety; Nasal congestion; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder. The patient was not allergic to food, medications, or other products. Concomitant medications included nicotinic acid (NIACIN), garlic extract and cayenne pepper. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 13:30, the patient experienced red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion. The patient did not receive any treatment for the event. 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 red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion were resolved on 06Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; Diarrhea; Bronchospasm; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 01Apr2021 at 08:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, diverticulitis, sepsis. The patient had previously experienced milk allergy, fish allergy and allergy to nuts (walnuts allergy). The patient previously took Cipro and Flagyl and experienced drug allergy to Cipro and Flagyl. Concomitant medications taken within two weeks included aciclovir (ACYCLOVIR), propranolol (MANUFACTURER UNKNOWN) and testosterone cipionate (DEPOTESTOSTERONE) all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 10:00 (at the age of 60-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 01Apr2021 at 14:00, the patient experienced headache, diarrhea, bronchospasm chills and fatigue. Therapeutic measures were taken as a result of the adverse events and included treatment with Ibuprofen from an unknown date. 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 the events headache, diarrhea, bronchospasm chills and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), fish oil (MANUFACTURER UNKNOWN), vitamin D nos (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient had no allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 18Jan2021.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 09Feb2021, the patient experienced extreme exhaustion. 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 event. The clinical outcome of the event extreme exhaustion was resolved at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Had a slight cold when received vaccine; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733), via an unspecified route of administration in the left arm on 28Mar2021 at 12:30 hours (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included crohns disease and osteoporosis and the patient had a history of allergy to dairy and gluten. The patient received unspecified other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced a slight cold. On 02Apr2021, 5 days after the vaccine the patient underwent lab tests and procedures which included SARS-2 COVID (nasal swab) test and the result was positive. The patient did not receive any treatment for the event. Adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event slight cold was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid positive PCR test taken on 4/4, with results on 4/6; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Mar2021 as a single dose for COVID-19 immunisation. No relevant medical history was reported. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known 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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021 the patient turned COVID positive for PCR test. On 04Apr2021, the patient underwent PCR test (Nasal Swab) and the result was positive as on 06Apr2021. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event COVID -19 was not recovered at the time of this report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting; diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old 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 02Apr2021 at 15:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications, or other products. The patient did not receive any medication within two weeks prior to the COVID-19 vaccine. 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 04Apr2021 at 14:30 the patient experienced vomiting and diarrhea 2 days after the first dose. 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 events experienced included treatment with over-the-counter emodium. The clinical outcome of the event vomiting and diarrhea was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Severe headache; fever; chills; extreme fatigue; nausea; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 03Apr2021 at 08:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history, allergies and concomitant medications were not provided. 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. On 03Apr2021 at 12:00 the patient experienced severe headache, fever, chills, extreme fatigue, nausea and loss of appetite. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic and emergency room or department or urgent care. The clinical outcome of the events severe headache, fever, chills, extreme fatigue, nausea and loss of appetite was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe headache; fever; chills; extreme fatigue; nausea; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 03Apr2021 at 08:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history, allergies and concomitant medications were not provided. 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. On 03Apr2021 at 12:00 the patient experienced severe headache, fever, chills, extreme fatigue, nausea and loss of appetite. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic and emergency room or department or urgent care. The clinical outcome of the events severe headache, fever, chills, extreme fatigue, nausea and loss of appetite was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Oral discomfort, Oral mucosal eruption, Oropharyngeal pain
Clinical narrative: like she had a slight burn from a hot coffee; sore throat; rash like spots in mouth; Raspy voice; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the arm left on 19Feb2021 at 14:30 as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient was not allergic to medications, food, or other products. 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. One to two days post vaccination at 15:30 in Feb2021 the patient experienced sore throat, and almost rash like spots in her mouth like she had a slight burn from a hot coffee and raspy voice for 24 hours. The patient did not receive any treatment for the events. The clinical outcomes of the events sore throat, rash like spots in mouth, and slight burn were recovered on an unknown date in 2021, and raspy voice was recovered after 24 hours on an unknown date in Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dysphagia, Heart rate
Clinical narrative: VS: BP 188/80, HR 76, RR 16, Temp 97.7 SpO2 100% RA, Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles" 9:15 BP repeated 172/89, other vitals unchanged; Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles"; Pt verbalized "I am nervous because I'm afraid of needles"; 9:00 Pt c/o abnormal feeling to throat. However pt couldn't describe feeling clearly. Denies throat itchiness/pain, tightness, or tingling.; VS: BP 188/80, HR 76, RR 16, Temp 97.7 SpO2 100% RA, Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles" 9:15 BP repeated 172/89, other vitals unchanged; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an intramuscular route of administration in the left arm on 15Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as unknown. It was unknown if patient had any known allergies to food, medicine or other products. Other medications taken within two weeks was reported as not available. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 09:00, the patient complained of abnormal feeling to throat. However the patient couldn't describe feeling clearly. She denied throat itchiness/pain, tightness, or tingling. The patient underwent tests for blood pressure and the result was 188/80 (units unspecified), heart rate was 76 (units unspecified), respiratory rate was 16 (units unspecified), body temperature was 97.7 (units unspecified) and pulse oximetry SpO2 was 100% RA.  The patient drank 1 cup water and at 09:06 Drank 8 ounce water with swallowing difficulties The patient verbalized she was nervous because she was afraid of needles. On 15Mar2021 at 09:15, the patient again underwent test for blood pressure and the result was 172/89 (units unspecified), other vitals unchanged. On 15Mar2021 at 09:18 the patient had left symptoms free. 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, emergency room/department or urgent care. The clinical outcome of the events abnormal feeling to throat, blood pressure at 09:00 and blood pressure at 09:15, swallowing difficulty and nervousness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Oropharyngeal discomfort, Oxygen saturation, Respiratory rate
Clinical narrative: VS: BP 188/80, HR 76, RR 16, Temp 97.7 SpO2 100% RA, Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles" 9:15 BP repeated 172/89, other vitals unchanged; Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles"; Pt verbalized "I am nervous because I'm afraid of needles"; 9:00 Pt c/o abnormal feeling to throat. However pt couldn't describe feeling clearly. Denies throat itchiness/pain, tightness, or tingling.; VS: BP 188/80, HR 76, RR 16, Temp 97.7 SpO2 100% RA, Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles" 9:15 BP repeated 172/89, other vitals unchanged; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an intramuscular route of administration in the left arm on 15Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as unknown. It was unknown if patient had any known allergies to food, medicine or other products. Other medications taken within two weeks was reported as not available. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 09:00, the patient complained of abnormal feeling to throat. However the patient couldn't describe feeling clearly. She denied throat itchiness/pain, tightness, or tingling. The patient underwent tests for blood pressure and the result was 188/80 (units unspecified), heart rate was 76 (units unspecified), respiratory rate was 16 (units unspecified), body temperature was 97.7 (units unspecified) and pulse oximetry SpO2 was 100% RA.  The patient drank 1 cup water and at 09:06 Drank 8 ounce water with swallowing difficulties The patient verbalized she was nervous because she was afraid of needles. On 15Mar2021 at 09:15, the patient again underwent test for blood pressure and the result was 172/89 (units unspecified), other vitals unchanged. On 15Mar2021 at 09:18 the patient had left symptoms free. 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, emergency room/department or urgent care. The clinical outcome of the events abnormal feeling to throat, blood pressure at 09:00 and blood pressure at 09:15, swallowing difficulty and nervousness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Injection site pain; Injection site redness; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the left arm on 02Apr2021 at 00:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had history of allergies to sulfa-based antibiotics. Concomitant medication included tamsulosin (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Apr2021 at 13:00, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site redness, feeling unwell. The patient reported that the events lasted for 72 hours or so. No therapeutic measures were taken as a result of 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 injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site redness, feeling unwell were resolved with lasting effects on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.