chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Heart rate increased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Rapid heartbeat; Nausea; Fever; Extreme pain in arm; Painful swelling under arm/breast and in neck; Burning feeling in arm; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient had no known allergies to medications, food, or other products. Concomitant medications included valuation (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and furosemide (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. 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 an unknown date in Apr2021, the patient experienced rapid heartbeat, nausea, fever, extreme pain/burning feeling in arm and painful swelling under arm/breast and in neck. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rapid heartbeat, nausea, fever, extreme pain/burning feeling in arm and painful swelling under arm/breast and in neck was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Rapid heartbeat; Nausea; Fever; Extreme pain in arm; Painful swelling under arm/breast and in neck; Burning feeling in arm; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient had no known allergies to medications, food, or other products. Concomitant medications included valuation (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and furosemide (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. 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 an unknown date in Apr2021, the patient experienced rapid heartbeat, nausea, fever, extreme pain/burning feeling in arm and painful swelling under arm/breast and in neck. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rapid heartbeat, nausea, fever, extreme pain/burning feeling in arm and painful swelling under arm/breast and in neck was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Lump on my upper right arm at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the right arm on 31Mar2021 at 11:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and sulfa (sulfonamide) allergy. The patient received unspecified medications within two weeks of the vaccination. The patient previously received codeine and experienced a drug allergy. 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 right arm on 10Mar2021 at 11:00 (at the age of 76-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 COVID-19 vaccination. On 03Apr2021 at 11:00, the patient experienced a lump on her upper right arm at injection site. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event lump on the upper right arm at injection site. The clinical outcome of the event lump on upper right arm at injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Chills; body aches; fever; Tired; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA), both from unknown dates for unknown indications and unknown if ongoing. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6215) via an unspecified route of administration in the left arm on 10Mar2021 at 11:45 (at the age of 60-year-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 02Apr2021 at 20:30, on the evening of second vaccine, the patient was tired. On 03Apr2021 at 01:30, the patient experienced chills, body aches and fever and it lasted until the evening of 04Apr2021. On 05Apr2021 the patient was still tired and on 06Apr2021 she was better. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events chills, body aches and fever was resolved on the evening of 04Apr2021 and the event tired was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Feeding disorder, Headache
Clinical narrative: Fatigue; Mild headaches; stomach unsettling; unable to eat normal meals; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Apr2021 at 11:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 05Apr2021, the patient experienced fatigue, mild headaches, stomach unsettling and unable to eat normal meals. 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 events fatigue, mild headaches, stomach unsettling and unable to eat normal meals was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Headache; stiff neck; dry mouth; moderate injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew01vz) via an unspecified route of administration in the right arm on 07Apr2021 at 10:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient previously took the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via an unspecified route of administration in the left arm on 17Mar2021 at 10:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included subacute small fiber sensory neuropathy and partial paralysis. Patient previously received penicillin for an unknown indication on an unknown date and experienced drug allergy. Concomitant medication included pregabalin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:45,  the patient had headache, stiff neck, dry mouth and moderate injection site pain. 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 events of headache, stiff neck, dry mouth and moderate injection site pain was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Pins and needles; Prickling over entire body; All over body itching; This is a spontaneous report from a contactable consumer, the patient. A 45-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 06Apr2021 at 16:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included crohn's disease, inflammatory arthritis and fibromyalgia. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication, BENADRYL on an unknown date for unknown indication, vitamin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and TYLENOL on an 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 20:00, the patient experienced all over body itching, pins and needles, prickling over entire body at once for two days so far. The patient went to sleep itching and wake up itching under skin, like thousands of little bugs crawling under skin. Started about four hours after injection. Therapeutic measures were taken as a result of events and included treatment with tylenol, benadryl, and 20 mg prednisone on an unknown date. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events prickling over entire body, body itching, pins and needles was not resolved.  No follow-up attempts are needed; Information regarding lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Ear pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarged lymph gland on right side of neck; swelling and pain under chin; mandible to right ear; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: BV02123480) via an unspecified route of administration in the left arm on 25Mar2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, parathyroid disorder, sarcoidosis and gout. The patient had no known allergies to food, medications or other products. Concomitant medications included levothyroxine sodium (SYNTHROID, 125 unspecified units) azilsartan medoxomil, chlortalidone (EDARBYCLOR, 40 unspecified units) for unknown indication from unknown date and unknown if ongoing. 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 27Mar2021 at 08:00, third day after the vaccination in the left arm, the patient experienced enlarged lymph gland on right side of neck, swelling and pain under chin and mandible to right ear. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of AEs and included treatment with CT scan with contrast and Clindamycin. On 29Mar2021, the patient underwent CT scan with contrast and the result was Level 2 lymph node near tail of right parotid 12 x21mm x 19mm per CT of soft tissue neck with contrast. The clinical outcome of the event enlarged lymph gland on right side of neck, swelling and pain under chin and mandible to right ear was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Eyes were nearly swollen shut; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 13:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) on unknown date for birth control. 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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 06:00 the patient experienced eyes were nearly swollen shut .The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event eyes were nearly swollen shut was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Headache, Nausea
Clinical narrative: nausea; Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 03Apr2021 at 11:15 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included metformin (MANUFACTURER UNKNOWN) glibenclamide (GLYBURIDE) losartan (MANUFACTURER UNKNOWN) amlodipine (MANUFACTURER UNKNOWN) and escitalopram oxalate (CITALO) all were from unknown date and for unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient had reported no known allergies. 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 04Apr2021, the patient experienced severe headache and nausea. The adverse event resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. The patient underwent CT scan of head, blood work, on an unknown date and the results of the test were not reported. Therapeutic measures were taken as a result of adverse events and included treatment with reglan, benadryl and morphine. The clinical outcome of the events severe headache and nausea was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pityriasis rosea, Sneezing
Clinical narrative: Rash on body (diagnosed as pityriasis rosea by doctor) which spread to other areas; fatigue; chills; sneezing; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration in the left arm on 21Mar2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021, the patient experienced rash on body (diagnosed as pityriasis rosea by doctor) which spread to other areas, fatigue, chill and sneezing. The events pityriasis rosea, fatigue, chills and sneezing resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of pityriasis rosea, fatigue, chills and sneezing and included treatment with Valtrax. The clinical outcome of the events pityriasis rosea, fatigue, chills and sneezing was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Fatigue, Feeling abnormal, Muscle spasms
Clinical narrative: Muscle cramps; Pain in lower back moved to buttocks; Fatigue; Diarrhea; Back ache; Fogginess in head; Stiff neck; Felt like a fever; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Apr2021 at 14:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, restless legs syndrome, penicillin allergy and anxiety. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), sleeping aid (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC) all for unknown indication from an unknown date. 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 07Apr2021 at 08:00,Next morning fatigue, diarrhea, back ache, stiff neck, fogginess in head. Felt like she had a fever. Better by evening. On 08Apr2021, 2nd morning after shot, woke up feeling even worse - severe back pain, fogginess in head, fatigue, diarrhea again. Pain in lower back moved to buttocks - muscle cramps. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events fatigue, diarrhea, back ache, stiff neck, fogginess in head, felt like a fever, muscle cramps and pain in buttocks were resolving at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Muscle cramps; Pain in lower back moved to buttocks; Fatigue; Diarrhea; Back ache; Fogginess in head; Stiff neck; Felt like a fever; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Apr2021 at 14:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, restless legs syndrome, penicillin allergy and anxiety. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), sleeping aid (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC) all for unknown indication from an unknown date. 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 07Apr2021 at 08:00,Next morning fatigue, diarrhea, back ache, stiff neck, fogginess in head. Felt like she had a fever. Better by evening. On 08Apr2021, 2nd morning after shot, woke up feeling even worse - severe back pain, fogginess in head, fatigue, diarrhea again. Pain in lower back moved to buttocks - muscle cramps. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events fatigue, diarrhea, back ache, stiff neck, fogginess in head, felt like a fever, muscle cramps and pain in buttocks were resolving at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema nodosum, Mobility decreased
Clinical narrative: Erythema nodosum: painful, redlumps on lower legs, shin and kneearea; Erythema nodosum: painful, red lumps on lower legs, shin and knee area. Increasing in size and limiting mobility until beginning steroid treatment with primary physician; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 23Feb2021(at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, arthritis, allergy and penicillin allergy. The patient previously took vancomycin and experienced allergy to it. Concomitant medications included cetirizine hydrochloride (ZYRTEC), triamcinolone acetonide (NASACORT) and omeprazole (MANUFACTURER UNKNOWN). 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 01Mar2021, the patient experienced erythema nodosum (painful, red lumps on lower legs, shin and knee area) which was increasing in size and limiting mobility. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with oral steroids. The clinical outcome of the events erythema nodosum (painful, red lumps on lower legs, shin and knee area) which is increasing in size and limiting mobility was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 20Feb2021 at 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included High Blood Pressure (HBP), Benign Prostatic Hyperplasia (BPH) and allergy to sulfa-based antibiotics. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), doxazosin mesilate (CARDURA) and doxazosin (MANUFACTURER UNKNOWN), all taken from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 30Jan2021 at 10:45 (at the age of 67-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 22Feb2021, two days after the second vaccination, the patient experienced hives on arms and legs, some of these were quite large (larger than a 50 cent coin). 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. The clinical outcome of the event hives on arms and legs was resolved on 27Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: burning primarily on feet and hands; Itching primarily on feet and hands; Hives primarily on feet and hands; This is a spontaneous report from a contactable other- healthcare professional, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included graves disease, blood pressure high (HBP) and overweight. The patient received other unspecified medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received penicillin and levofloxacin (LEVOQUIN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 06Apr2021 at 13:00, the patient broke out in burning and itching hives primarily on feet and hands. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with MEDROL dose pack. The clinical outcome of the events broke out in burning and itching hives primarily on feet and hands were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Urticaria
Clinical narrative: Hives all over body that started on my face, neck andshoulders and spread down my body over; Get irritated; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included basal cell skin cancer and was going through radiation treatments at the time of reporting. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient experienced hives all over body that started on face, neck and shoulders and spread down the body over the next few days, they were not extremely itchy but those in close contact with hair or tight clothing to get irritated. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives which included treatment with diphenhydramine (BENADRYL), cimetidine (TAGAMET) and cortisone (MANUFACTURER UNKNOWN) cream. The clinical outcomes of hives all over body and got irritated were not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: About 28 hours post dose 2 headache; Fever chills; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El3248) via an unspecified route of administration in the right arm on 04Mar2021 at 12:30 (at the age of 51-year-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 26Mar2021 at 16:00, about 28 hours post second dose of vaccination the patient experienced headache, fever chills and malaise. 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 adverse events and included treatment with TYLENOL. The clinical outcome of the event headache, fever chills and malaise were recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Began spotting the day after first vaccination.; 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: ED7534) via an unspecified route of administration in the right arm on 17Mar2021 at 14:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no allergies to food, medications or other products. Concomitant medications included ethinylestradiol, levonorgestrel (LEVONOR/EE TAB 0.15-0.03 91) from unspecified dates for birth control. 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 18Mar2021, the patient experienced spotting the day after her first vaccination, which continued for two weeks after receiving the shot. The patient reported that she was on a continuous dosing of birth control pills and she was not supposed to get her period for another seven weeks when the spotting began. She continued to take the birth control pills as prescribed, but still continued to spot for the two weeks after the first shot. The patient did not receive any treatment for the events. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event spotting was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Weight decreased
Clinical narrative: Severe rash; Weight loss; Fatigue; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El0k10) via an unspecified route of administration in the right arm on 22Dec2020 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin and sulfa (sulfonamide) allergy. Concomitant medication was 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 COVID-19 vaccination. On 12Jan2021 at 00:00, the patient experienced severe rash, weight loss and fatigue. 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 the event severe rash which included treatment with BENADRYL. The clinical outcome of the event's severe rash, weight loss and fatigue were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea
Clinical narrative: headache that evolved into a serious migraine.; woke up with a headache that evolved into aserious migraine; felt nauseous from the pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW9150) via an unspecified route of administration in the left arm on 31Mar2021 at 13:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, polycystic ovarian syndrome(PCOS), depression and allergy to red dye #40. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), escitalopram oxalate (LEXAPRO), deogestrel, ethinyl estradiol (VIORELE), lansoprazole (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D), all from unknown dates and for unknown indications. 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 COVID-19 vaccination. On 01Apr2021 at 13:00, the patient experienced headache that evolved into a serious migraine, which kept the patient in bed for half the day and also felt nauseous from the pain. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events headache, migraine and felt nauseous were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: POSITIVE SIDE EFFECT one weekafter first dose, my lungs started tofeel better, breathing was easier.; This is a spontaneous report from a contactable consumer. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm right on 13Mar2021 at 08:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, endometriosis and environmental allergy. Concomitant medications included salbutamol (ALBUTEROL) taken for an unknown indication started from an unknown date. The patient previously took pseudoephedrine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient was allergic to narcotics. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. 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 19Mar2021, the patient experienced POSITIVE SIDE EFFECT one week after first dose, his lungs started to feel better, breathing was easier. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of this event. The clinical outcome of the event unexpected therapeutic benefit was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: chills; whole body aches; feet burning; fast heart beat; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 10:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19, cholesterol, thalassemia and blood pressure high. Concomitant medications included lisinopril(MANUFACTURER UNKNOWN), omeprazole magnesium (OMEPRAZOLE), atorvastatin (MANUFACTURER UNKNOWN) and vitamins(MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Mar2021 at 11:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.  On 07Apr2021 at 20:00, the patient experienced chills, whole body aches, feet burning, fast heartbeat, headache  and fatigue. 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 occurred events. The clinical outcome of the event chills, whole body aches, feet burning, fast heartbeat, headache and fatigue was recovered on unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chills; whole body aches; feet burning; fast heart beat; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 10:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19, cholesterol, thalassemia and blood pressure high. Concomitant medications included lisinopril(MANUFACTURER UNKNOWN), omeprazole magnesium (OMEPRAZOLE), atorvastatin (MANUFACTURER UNKNOWN) and vitamins(MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Mar2021 at 11:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.  On 07Apr2021 at 20:00, the patient experienced chills, whole body aches, feet burning, fast heartbeat, headache  and fatigue. 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 occurred events. The clinical outcome of the event chills, whole body aches, feet burning, fast heartbeat, headache and fatigue was recovered on unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 2 weeks after second dose began experiencing continuous itchiness over most of my body and it still continues today; This is a spontaneous report from a contactable consumer, the patient. A 87-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266,) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (reported as high blood pressure). The patient did not have allergy to any medications, food, or other products. Concomitant medications taken within two weeks prior to the vaccination included lorazepam 1 milligram (MANUFACTURER UNKNOWN) up to four times per day and hydrochlorothiazide 6.25 milligram, bisoprolol fumarate 2.5 milligram (BISOPROLOL FUMARATE & HCTZ) one and a half per day; both from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267) via an unspecified route of administration in the left arm on 26Jan2021 at 09:30 (at the age of 87-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 02Mar2021, two weeks after second dose, the patient  began experiencing continuous itchiness over most of her body and it still continued on the day of report. The patient reported she had been using the following medications for many years with no side effects: lorazepam 1 milligram up to four times per day., and bisoprololfumarate/ HCTZ tab 2.5/6.25 milligram, one and a half per day. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event two weeks after second dose began experiencing continuous itchiness over most of body and it still continued on the day of report was not resolved 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: Lymphadenopathy, Pyrexia, SARS-CoV-2 test
Clinical narrative: High fever; Swollen lymph node; This is a spontaneous report from a contactable nurse, the patient. A 48-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 06Apr2021 at 14:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, legs restless, anxiety, depression, hypertension and COVID-19. Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), semaglutide (OZEMPIC), propranolol (MANUFACTURER UNKNOWN), pramipexole dihydrochloride monohydrate (MIRAPEX) and citalopram (MANUFACTURER UNKNOWN) all are for an unknown indication and started from an unspecified date. The patient did not have a history of allergies to medications, food, or other products. 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 07Apr2021 at 19:00, the patient experienced high fever and swollen lymph node. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events high fever and swollen lymph node was recovering, at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Nausea, Neck pain, Pain
Clinical narrative: I woke up with fever; Severe headache; Eye and neck pain; Eye and neck pain; Body aches; Nausea; Vomited; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 06Apr2021 at 14:30(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, clotting disorder, MTHFR gene mutation, shellfish allergy and MSG allergy. Concomitant medications included apixaban (ELIQUIS) and levothyroxine sodium (SYNTHROID 112); for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 04Mar2021 at 15:00 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 07Apr2021 at 05:00, in the morning the patient woke up with fever, severe headache, eye pain, neck pain, body aches, and then nausea. The patient vomited throughout the day violently and took promethazine for the nausea and immediately vomited that up. Before deciding to go the hospital, the patient tried promethazine suppository for nausea and 1 vicodin (these medications prescribed for a surgical procedure) and took them 3 times during the day as vomiting recurred after drug wore off. The medications offered some relief. On 08Apr2021, the patient had low grade headache and body aches and light nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with promethazine (MANUFACTURER UNKNOWN) and acetaminophen-hydrocodone (VICODIN). The clinical outcome of the events fever, severe headache, eye pain, neck pain, body aches, nausea and vomited were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.