chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: vertigo; left facial tingling; lip tingling/tingling in the left corner of the mouth; he feels hazy/Haziness; facial numbness; heaviness and tingling in the left corner of the mouth; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0140), via an unspecified route of administration on 18Dec2020 08:15 am at single dose for covid-19 immunization. Vaccine location was left deltoid and it was the first dose. The facility type vaccine was hospital. Medical history included raynaud from an unknown date. The patient clarified that Raynaud's is not officially diagnosed. When he was in medical school and would take Methylphenidate to study his fingers would get pale and in cold weather he gets it in his hands. No known allergies. Patient didn't do relevant test. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Physician stated that received COVID-19 Vaccine on Friday. A couple of hours later he had left facial tingling and lip tingling that lasted about an hour. The left facial tingling and the lip tingling started between 9AM and 10AM. It felt like facial numbness and heaviness and tingling in the left corner of the mouth. It was less tingling and more of a heaviness. Vertigo started on the second night (19Dec2020). Whenever he sit back in a chair quickly he has vertigo as well as when he laid back in the bed at night. He took no medications. Throughout the day he felt hazy. Haziness that is consistent. The best way to described it is if you drank a lot of alcohol and were well hydrated. The next morning you feel fine, but there is something there and feels off, but you can't put a finger on it. There was no adverse event require a visit to emergency room or physician office. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events "left facial tingling" and "lip tingling" was recovered on 18Dec2020 and were reported as non-serious. The outcome of event Vertigo was not recovered, it was reported as serious-Medically significant. The outcome of other events was unknown. The drug result of events "Vertigo", "left facial tingling" and "lip tingling" was Related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Vertigo cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; left facial tingling; lip tingling/tingling in the left corner of the mouth; he feels hazy/Haziness; facial numbness; heaviness and tingling in the left corner of the mouth; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0140), via an unspecified route of administration on 18Dec2020 08:15 am at single dose for covid-19 immunization. Vaccine location was left deltoid and it was the first dose. The facility type vaccine was hospital. Medical history included raynaud from an unknown date. The patient clarified that Raynaud's is not officially diagnosed. When he was in medical school and would take Methylphenidate to study his fingers would get pale and in cold weather he gets it in his hands. No known allergies. Patient didn't do relevant test. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Physician stated that received COVID-19 Vaccine on Friday. A couple of hours later he had left facial tingling and lip tingling that lasted about an hour. The left facial tingling and the lip tingling started between 9AM and 10AM. It felt like facial numbness and heaviness and tingling in the left corner of the mouth. It was less tingling and more of a heaviness. Vertigo started on the second night (19Dec2020). Whenever he sit back in a chair quickly he has vertigo as well as when he laid back in the bed at night. He took no medications. Throughout the day he felt hazy. Haziness that is consistent. The best way to described it is if you drank a lot of alcohol and were well hydrated. The next morning you feel fine, but there is something there and feels off, but you can't put a finger on it. There was no adverse event require a visit to emergency room or physician office. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events "left facial tingling" and "lip tingling" was recovered on 18Dec2020 and were reported as non-serious. The outcome of event Vertigo was not recovered, it was reported as serious-Medically significant. The outcome of other events was unknown. The drug result of events "Vertigo", "left facial tingling" and "lip tingling" was Related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Vertigo cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity, Paraesthesia
Clinical narrative: cold tingling sensation in right hand; sore right arm; This is a spontaneous report from a contactable consumer. A 56-years-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 18Dec2020 at a SINGLE DOSE (injection to right arm one time) for COVID-19 immunization. Medical history included Pencillin allergy, diagnosed with a sulfur allergy in her 20s and developed a rash (ongoing). There were no concomitant medications. The patient experienced cold tingling sensation in right hand in hand in same that had the injection, and sore right arm, few minutes after the injection on 18Dec2020. Treatment for sore right arm included, 24 hours after took ALEVE and did gentle stretching exercises. Event outcome was recovered completely on 18Dec2020. Event outcome was recovered on 18Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Nasopharyngitis
Clinical narrative: Head cold; cannot smell or taste anything; cannot smell or taste anything; This is a spontaneous report from a contactable nurse (patient herself, ICU nurse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After receiving the vaccine on 18Dec2020, she had a head cold, she cannot smell or taste anything. Clinical outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Flushing, Throat tightness
Clinical narrative: hoarseness; throat tightness; flushing; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. On 23Dec2020, the patient experienced hoarseness, throat tightness and flushing. Therapeutic measures were taken as a result of the events that included epinephrine, steroid, and Benadryl. Clinical outcome of hoarseness was recovering, while for the other events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received first BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular (left arm) from 21Dec2020 (09:45 AM) to 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history included hypertension, hyperlipidemia, and Type 2 diabetic. No known allergies. Concomitant medications included amlodipine besilate, olmesartan medoxomil (AZOR), atorvastatin calcium (LIPITOR), metformin, insulin glargine, lixisenatide (SOLIQUA), and empagliflozin (JARDIANCE). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 22Dec2020 12:00 with outcome of recovering. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I have some aches which feels like the same I had; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 23Dec2020 at 12:45 AM at single dose for COVID-19 immunization. Medical history included patient diagnosed with COVID-19 in Oct2020. No allergies to medications, food, or other products. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. After vaccination, patient had some aches on 24Dec2020 07:00 AM, which felt like the same she had since she did have Covid the first part of Oct2020. It was reported as non-serious. No treatment was received. Outcome of event was unknown.   Information about Lot/Batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Muscular weakness, Pain
Clinical narrative: severe body aches; chills; fatigue; cervical and left axillary lymphadenopathy; left axillary lymphadenopathy; muscle weakness; This is a spontaneous report from a contactable physician reported for herself.  A 48-year-old female patient received first dose of BNT162B2 (Pfizer product), intramuscular on 21Dec2020 10:15 at single dose on left arm for COVID-19 immunization.  Medical history included High cholesterol, insomnia, ongoing penicillin allergy, covid-19 from 13Nov2020 to an unknown date and pneumonia from an unknown date (the patient was tested positive for covid on 13Nov2020 and was hospitalized on 23Nov2020 with pneumonia).  Concomitant medication included atorvastatin calcium (LIPITOR), zolpidem tartrate (AMBIEN), escitalopram oxalate (LEXAPRO), colecalciferol (VITAMIN D), fish oil (FISH OIL OMEGA 3) , zinc (ZINC), ascorbic acid, dexpanthenol, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopheryl acetate (MVI) and bifidobacterium lactis (PROBIOTIC).  The patient previously took niacin and experienced drug allergy.  The patient received injection at 1015 am at 0300 am on the following day (22Dec2020) she experienced chills, severe body aches, fatigue, cervical and left axillary lymphadenopathy and muscle weakness, woke up the next day and was asymptomatic except the left axillary lymphadenopathy which is still present today on 24Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid tested post vaccination. No treatment was received for the events. The outcome of the event left axillary lymphadenopathy was not resolved while of other events was resolving. The reporter assessed the events as non-serious. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event severe body aches cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms
Clinical narrative: back pains; back spasms; This is a spontaneous report from a contactable physician.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Dec2020 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was not reported if the patient was pregnant nor if any other vaccines were received 4 weeks prior to the vaccination. The patient reported that she had the COVID-19  vaccine last Monday (22Dec2020) and was told to stop taking NSAIDS. Now, she is experiencing back pains, so she wants to know when she could restart taking NSAIDs. She doesn't think her back spasms are from the COVID-19 vaccine. The clinical outcome of the back pains and back spasms was not reported. It was also not reported if the patient had been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation in my fifth digit that radiates up to my arm; This is a spontaneous report from a contactable physician, the patient. This 28-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK5730), intramuscularly in the left arm on 23Dec2020 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. Medical history included asthma from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO). On 24Dec2020 at 06:00, the patient experienced tingling sensation in her fifth digit that radiates up to her arm. No therapeutic measures were taken as a result of the events. The clinical outcome of the tingling sensation was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Small itchy blister/zit like bumps.  Started on back of legs and back.  Now some sporadically showing up on arms, belly, shin.; Small itchy blister/zit like bumps; This is a spontaneous report from a contactable Other Health Care Professional (HCP).  A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/lot number: EJ1685), intramuscularly at an unspecified dose in the left arm on 18Dec2020 at 04:00 (at the age of 48-years-old) for COVID-19 immunization. Medical history included allergy to sulfa drugs from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient was not pregnant at the time of vaccination.The patient was administered the vaccine in the hospital. Concomitant medication included cetirizine hydrochloride cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within four weeks prior to vaccination.  On 21Dec2020 at 20:15,the patient experienced small itchy blister/zit like bumps which started on back of her legs and on her back.  Some are sporadically showing "now" up on arms, belly and shin.The patient did not receive any treatment for the events.The clinical outcomes of small itchy blister/zit like bumps was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Chills, Dyspnoea
Clinical narrative: woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath; woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath; woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath; woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath; take smaller breaths because Rib cage hurts every time she took a deep breath; An hour after the vaccine developed a headache; woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath/mild body aches; back also had moderate pain.; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself (patient).  A 45-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number unknown, intramuscularly on 22DEC2020 13:45 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included drug allergy to vancomycin. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), duloxetine hydrochloride (CYMBALTA), hydrochlorothiazide, levothyroxine.  The patient previously took vancomycin and experienced drug allergy.  The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  An hour after the vaccine the patient developed a headache and mild body aches on 22Dec2020 14:45. Two days after (24Dec2020) she woke up with chills, body/ joint pain, chest pain with mild difficulty to breath. She had to take smaller breaths because her rib cage hurts every time she took a deep breath. Her back also had moderate pain on unspecified date in Dec2020.  The events an hour after the vaccine developed a headache, woke up with chills, body/ joint pain, chest pain with mild difficulty to breath/mild body aches, take smaller breaths because rib cage hurts every time she took a deep breath and back also had moderate pain did not result in death, were was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events an hour after the vaccine developed a headache, woke up with chills, body/ joint pain, chest pain with mild difficulty to breath/mild body aches, take smaller breaths because Rib cage hurts every time she took a deep breath and back also had moderate pain. Outcome of the events an hour after the vaccine developed a headache, woke up with chills, body/ joint pain, chest pain with mild difficulty to breath/mild body aches, take smaller breaths because Rib cage hurts every time she took a deep breath and back also had moderate pain were unknown. After the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal chest pain, Pain
Clinical narrative: woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath; woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath; woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath; woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath; take smaller breaths because Rib cage hurts every time she took a deep breath; An hour after the vaccine developed a headache; woke up with Chills, body/ joint pain, chest pain with mild difficulty to breath/mild body aches; back also had moderate pain.; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself (patient).  A 45-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number unknown, intramuscularly on 22DEC2020 13:45 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included drug allergy to vancomycin. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), duloxetine hydrochloride (CYMBALTA), hydrochlorothiazide, levothyroxine.  The patient previously took vancomycin and experienced drug allergy.  The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  An hour after the vaccine the patient developed a headache and mild body aches on 22Dec2020 14:45. Two days after (24Dec2020) she woke up with chills, body/ joint pain, chest pain with mild difficulty to breath. She had to take smaller breaths because her rib cage hurts every time she took a deep breath. Her back also had moderate pain on unspecified date in Dec2020.  The events an hour after the vaccine developed a headache, woke up with chills, body/ joint pain, chest pain with mild difficulty to breath/mild body aches, take smaller breaths because rib cage hurts every time she took a deep breath and back also had moderate pain did not result in death, were was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events an hour after the vaccine developed a headache, woke up with chills, body/ joint pain, chest pain with mild difficulty to breath/mild body aches, take smaller breaths because Rib cage hurts every time she took a deep breath and back also had moderate pain. Outcome of the events an hour after the vaccine developed a headache, woke up with chills, body/ joint pain, chest pain with mild difficulty to breath/mild body aches, take smaller breaths because Rib cage hurts every time she took a deep breath and back also had moderate pain were unknown. After the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: developed a tingling sensation 45 minutes post vaccination. Came on gradually and increased in sensitivity; Lips also had a tingling sensation similar to a sunburn feeling on lips/But lips Continue  to have a weird sensation to lips; This is a spontaneous report from a contactable nurse (patient). A 49-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EK5730, intramuscularly on 23Dec2020 16:00 (at the age of 49-years-old) as a single dose in the left arm  for COVID-19 immunization. Medical history included hyperactive thyroid for which was treated with radioactive iodine thus makes her hypothyroid. Concomitant medication included levothyroxine sodium (SYNTHROID).  The patient previously took hydrocodone/acetaminophen (VICODIN) and experienced drug allergy. The patient did not have allergies to food.The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Dec2020 16:45 the patient developed a tingling sensation (45 minutes post vaccination). It came on gradually and increased in sensitivity. Her lips also had a tingling sensation similar to a sunburn feeling on lips. Tingling sensation gradually subsided to body lasted 4 hours. Tingling sensation to lips also gradually decreased 6 hours later but lips continue to have a weird sensation to lips. The events developed a tingling sensation 45 minutes post vaccination. Came on gradually and increased in sensitivity, Lips also had a tingling sensation similar to a sunburn feeling on lips/but lips continue  to have a weird sensation to lips did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events tingling sensation 45 minutes post vaccination. Came on gradually and increased in sensitivity, lips also had a tingling sensation similar to a sunburn feeling on lips/but lips continue to have a weird sensation to lips.  Outcome of the event developed a tingling sensation 45 minutes post vaccination. Came on gradually and increased in sensitivity was recovered on 23Dec2020 20:45. Outcome of the event lips also had a tingling sensation similar to a sunburn feeling on lips/but lips continue to have a weird sensation to lips was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: left arm pain at injection site throbbing pain; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for a patient. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EJ1685) intramuscularly on 23Dec2020 at 15:45 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included known allergies to shrimp from an unspecified date and unspecified if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported; however, there were no other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 20:00, the patient experienced left arm pain at injection site throbbing pain. It was reported that the event was non-serious and did not require hospitalization. The patient did not receive any treatment for the event. The clinical outcome of the event left arm pain at injection site throbbing pain was recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Minor rash on chest; This is a spontaneous report from a contactable health professional, the patient. A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 22Dec2020 at 02:00 or 14:00 as reported, pending clarification (at the age of 20-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Dec2020 at 08:00 the patient experienced a minor rash on chest. The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the minor rash on chest was resolving.   Information about lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: numbness of the lower left face, cheek and area around the mouth (peri-oral and mandibular numbness); numbness of the lower left face, cheek and area around the mouth (peri-oral and mandibular numbness); This is a spontaneous report from a contactable physician reporting for a patient.  A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly  on 19Dec2020 (at the age of 37-years old) as a single dose for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported.  It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Dec2020, the patient experienced numbness of the lower left face, cheek and area around the mouth (peri-oral and mandibular numbness). No treatment was received for the adverse events. The patient was recovering from the events.Since the vaccination, has the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Ongoing fever spikes starting on Day 5 from 101-103 along with moderate to severe chills; Ongoing fever spikes starting on Day 5 from 101-103 along with moderate to severe chills; diarrhea; excess fatigue; This is a spontaneous report from a contactable physician.  A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 16Dec2020 12:30 as a single dose (dose 1) in the left arm for COVID-19 vaccination.  The facility where the most recent COVID-19 vaccine was administered was a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included type 2 diabetes mellitus and hyperlipidaemia. There were no allergies to medications, food, or other products. Concomitant medication included metformin, eicosapentaenoic acid ethyl ester (VASCEPA), and losartan.  The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient experienced ongoing fever spikes starting on Day 5 from 101-103 along with moderate to severe chills, diarrhea and excess fatigue. The adverse events' start date & time was reported as 21Dec2020 at 12:30. The events were reported as non-serious. "Today" (24Dec2020) was day 8 and none of these symptoms have improved. The patient underwent treatment for the adverse event which included paracetamol (TYLENOL) and fluids. The outcome of the events fever spikes, moderate to severe chills, diarrhea, and excess fatigue was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia, Parosmia
Clinical narrative: lost my sense of taste/smell.; lost my sense of taste/smell; This is a spontaneous report from a contactable other hcp, the patient. This 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EH9899), intramuscularly in the right arm on 16Dec2020 at 18:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took ceclor for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 24Dec2020 at 12:00, the patient experienced losing her sense of taste and smell. It started changing over the course of the day. Things tasted and smelled different or oddly before the senses going away. No therapeutic measures were taken as a result of the events. The clinical outcome of the loss of sense of taste and smell was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia
Clinical narrative: headache, chills and muscle pain and a slight dizziness; headache, chills and muscle pain and a slight dizziness; headache, chills and muscle pain and a slight dizziness; headache, chills and muscle pain and a slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot: Ek9231 via an unspecified route of administration on 24Dec2020 at 10:00 (at the age of 57-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included an allergy to sulfa drugs as of an unspecified date and unknown if ongoing; Covid-19 diagnosed prior to the vaccination on 24Nov (year unspecified) and not ongoing (patient had recovered from COVID, was sick and quarantined until 04Dec (year unspecified)). The patient was not pregnant at the time of vaccination. Concomitant medications included calcium carbonate/colecalciferol (CALCIUM & VITAMIN D3), garlic [allium sativum], omeprazole magnesium (PRILOSEC), ascorbic acid (VIT C) and an unspecified multi-vitamin; all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took meloxicam and doxycycline; all from unknown dates to unknown dates for unknown indications and experienced allergy. On 24Dec2020 at 23:00 (reported as later in the evening), the patient experienced headache, chills, muscle pain and a slight dizziness. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the headache, chills, muscle pain and a slight dizziness were resolving.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain, Pain in extremity
Clinical narrative: Very sore arm for about one day.; Dizzy for one hour, five hours after the vaccine; Chills and body aches for about one hour 10 hours after vaccine with one hour of fatigue also; Chills and body aches for about one hour 10 hours after vaccine with one hour of fatigue also; Chills and body aches for about one hour 10 hours after vaccine with one hour of fatigue also; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 48-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 21Dec2020 09:15 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  There were no other vaccines within four weeks of the suspect product.  The patient previously took mefloquine hydrochloride (LARIAM) and experienced allergies.  On 21Dec2020 14:15, the patient experienced very sore arm for about one day, dizzy for one hour, five hours after the vaccine.  On 21Dec2020, the patient experienced chills and body aches for about one hour 10 hours after vaccine with one hour of fatigue also.  There was no treatment received for the events.  Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  The outcome of the very sore arm for about one day was recovered in Dec2020 and of dizzy for one hour, five hours after the vaccine and chills and body aches for about one hour 10 hours after vaccine with one hour of fatigue also was recovered on 21Dec2020.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased, Sleep disorder
Clinical narrative: can't raise her arm up; pain at the site of the injection; During the night she couldn't sleep; This is a spontaneous report from a contactable nurse (patient herself) via the Pfizer Sponsored Program. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via an unspecified route of administration on left arm from 23Dec2020 10:10 to 23Dec2020 10:10 as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took tetanus toxoid and got red and was itching (clarified she had a reaction to a tetanus shot several years ago). Reports she received the first dose of COVID 19 vaccine at the hospital where she works on 23Dec2020 at 10:10AM in left upper arm. She started having pain at the site of the injection in the afternoon at around 3PM or 4PM 23Dec2020. During the night she couldn't sleep because of the pain no matter where she turned. The patient states the pain was probably 8 out of 10 on the pain scale. Adds she had no redness or swelling. The pain today (24Dec2020) is still the same and now she can't raise her arm up. No treatment has been applied. No cold or heat applied. The outcome of the event pain at the site of the injection was not recovered; while the other events was unknown.   Information about lot/batch number and expiration date requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; Had soreness in arm; This is a spontaneous report from a non-contactable consumer. A female patient in her 60s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from 23Dec2020 to 23Dec2020 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced had soreness in arm and a headache on 24Dec2020. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Myalgia; Headache; Feeling weak; anorexia; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced fever, myalgia, feeling weak, anorexia and headache in Dec2020.  The patient reported that the symptoms lasted over 48 hours.  The outcome of the events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Vertigo
Clinical narrative: Vertigo; Headache; High temperature; Woke up in the morning with vivid nausea and vomiting and threw up constantly; Woke up in the morning with vivid nausea and vomiting and threw up constantly; Body aches; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (weight: 81.65 Kg, height: 173 cm) received BNT162B2 (Pfizer-Biontech covid-19 vaccine, Lot. EL0140) on 21Dec2020, at single dose, for COVID-19 immunisation. Relevant medical history included pulmonary arterial hypertension. Concomitant medications included furosemide (LASIX) 20 mg, daily and potassium 20 meq, daily. The patient experienced the following reactions: body aches on 22Dec2020; nausea and vomiting on 23Dec2020 at 02:00 described as "she woke up in the morning with vivid nausea and vomiting and threw up constantly all on the 23rd and most of the day 24th"; headache and high temperature on 24Dec2020 and vertigo on 25Dec2020. The patient recovered from nausea and vomiting on an unspecified date, in Dec2020, while clinical outcome of the other events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vertigo; Headache; High temperature; Woke up in the morning with vivid nausea and vomiting and threw up constantly; Woke up in the morning with vivid nausea and vomiting and threw up constantly; Body aches; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (weight: 81.65 Kg, height: 173 cm) received BNT162B2 (Pfizer-Biontech covid-19 vaccine, Lot. EL0140) on 21Dec2020, at single dose, for COVID-19 immunisation. Relevant medical history included pulmonary arterial hypertension. Concomitant medications included furosemide (LASIX) 20 mg, daily and potassium 20 meq, daily. The patient experienced the following reactions: body aches on 22Dec2020; nausea and vomiting on 23Dec2020 at 02:00 described as "she woke up in the morning with vivid nausea and vomiting and threw up constantly all on the 23rd and most of the day 24th"; headache and high temperature on 24Dec2020 and vertigo on 25Dec2020. The patient recovered from nausea and vomiting on an unspecified date, in Dec2020, while clinical outcome of the other events was unknown.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Lethargy, Pain
Clinical narrative: loss of appetite; overall body aches; extreme lethargy; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 81 years old female patient who experienced extreme lethargy (lethargy), loss of appetite (decreased appetite) and overall body aches (pain), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. It was suggested that body aches and fever can last 3 days after vaccination.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 01-Dec-2020, the patient received a 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ565AB and expiry date:30-JUN-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  On 01-Dec-2020, the patient developed extreme lethargy (lethargy), loss of appetite (decreased appetite) and overall body aches (pain) (non-serious events), on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient did not recover from all the reported events.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient left hospital and complained of dizziness outside. Patient brought back to vaccine Pod. Patient's blood pressure taken, patient given snack and water and felt better.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient felt tingling in left hand. Patient's blood pressure taken. Patient monitored by RN and seen  by Resident. As per patient tingling went away
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient complained of dizziness. Patient's blood pressure taken. Patient given water and snack and felt better.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Electrocardiogram, Eye swelling
Clinical narrative: Pt developed palpitations, body shakes, and an abnormal sensation to her face. She reports her, "face felt tingly" and her lips felt swollen. She notes the body shakes may have been secondary to anxiety as this has resolved.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypertension, Laboratory test, Lip swelling, Neutrophil count increased
Clinical narrative: Pt developed palpitations, body shakes, and an abnormal sensation to her face. She reports her, "face felt tingly" and her lips felt swollen. She notes the body shakes may have been secondary to anxiety as this has resolved.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Swollen tongue, Tachycardia, Troponin
Clinical narrative: Pt developed palpitations, body shakes, and an abnormal sensation to her face. She reports her, "face felt tingly" and her lips felt swollen. She notes the body shakes may have been secondary to anxiety as this has resolved.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Electrocardiogram normal, Full blood count normal, Lip swelling, Metabolic function test normal
Clinical narrative: Pt developed palpitations, body shakes, and an abnormal sensation to her face. She reports her, "face felt tingly" and her lips felt swollen. She notes the body shakes may have been secondary to anxiety as this has resolved.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Tremor
Clinical narrative: Pt developed palpitations, body shakes, and an abnormal sensation to her face. She reports her, "face felt tingly" and her lips felt swollen. She notes the body shakes may have been secondary to anxiety as this has resolved.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Peripheral swelling
Clinical narrative: headache, nausea, light headed, swelling of the hands Patient was given 1000mg of acetaminophen and 25mg diphenhydramine. Patient was monitored for 60 minutes.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Night sweats, Pain
Clinical narrative: Fevers, chills, night sweats, fatigue, malaise, body aches
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fevers, chills, night sweats, fatigue, malaise, body aches
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity, Tachycardia
Clinical narrative: Approximately 5 minutes after the injection, I suddenly began experiencing tachycardia (felt like I had way too much coffee). The nurse took my pulse and summoned the attending physician who sat with me for more than 30 minutes. I felt good enough to leave but did experience a somewhat rapid heart rate on and off through the afternoon. Upon leaving, I was told to call my allergist to have my Epi-Pen refilled (my current Epi-Pen had expired), which I did. Eleven hours post injection I'm feeling fine except for the expected arm soreness. In terms of my allergic history, I had previously discontinued allergy shots last year due to repeated systemic reactions to very low dose vials (itchy roof of mouth, swollen throat, etc).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Gaze palsy, Injection site pain, Muscle spasms, Muscular weakness
Clinical narrative: I received my vaccine on 12/18/2020. The side effects I experienced were initially as expected. Mild headache, muscle pain at the injection site.   However, the muscle issues have not subsided, and have actually gotten worse. Day 3 I began having a burning sensation in my underarm area radiating back towards my triceps. Muscle spasms continued to increase and spread to include deltoid, trapezius, and SCM muscles. Yesterday I developed a fever and began having a burning sensation down my triceps muscles and radiating into my forearm (radial side). No visible rash noted. Slight weakness in left arm.