chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Inappropriate schedule of product administration, Incorrect dose administered, Myalgia
Clinical narrative: fever for 2 days / started / the / night she received the adjuvant component; muscle pain / experiencing muscle, back, and joint pain; joint pain / experiencing muscle, back, and joint pain; back pain is excruciating /  muscle, back, and joint pain; arm pain / pain has been "excruciating" in the left arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In January 2021, the patient received Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, muscle pain, joint pain, back pain and pain in arm. On an unknown date, the outcome of the fever and muscle pain were not recovered/not resolved and the outcome of the joint pain, back pain and pain in arm were unknown.   It was unknown if the reporter considered the fever, muscle pain, joint pain, back pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient stated after one week was called back in to get the complete 1st dose of the Shingrix and reported experiencing soreness in the arms, and a slight fever that occurred that same night after getting the complete dose.  The patient stated that the pain was still ongoing and that was suffering every day it was affecting joints and her back pain was excruciating.  The reporter consented to follow up. Not all information was available.  The patient did give permission to follow up with their HCP. This case linked with US2021AMR016885 and US2021016995, reported by same reporter. Notes:As the patient called back to complete dose os Shingrix the patient received initially received adjuvant suspension and now received only liquid portion so not capture rechangelled a positive.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016885:same patient (FU2 and 1st dose case), same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Product preparation issue, Pyrexia, Underdose
Clinical narrative: fever for 2 days / started / the / night she received the adjuvant component; muscle pain / experiencing muscle, back, and joint pain; joint pain / experiencing muscle, back, and joint pain; back pain is excruciating /  muscle, back, and joint pain; arm pain / pain has been "excruciating" in the left arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In January 2021, the patient received Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, muscle pain, joint pain, back pain and pain in arm. On an unknown date, the outcome of the fever and muscle pain were not recovered/not resolved and the outcome of the joint pain, back pain and pain in arm were unknown.   It was unknown if the reporter considered the fever, muscle pain, joint pain, back pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient stated after one week was called back in to get the complete 1st dose of the Shingrix and reported experiencing soreness in the arms, and a slight fever that occurred that same night after getting the complete dose.  The patient stated that the pain was still ongoing and that was suffering every day it was affecting joints and her back pain was excruciating.  The reporter consented to follow up. Not all information was available.  The patient did give permission to follow up with their HCP. This case linked with US2021AMR016885 and US2021016995, reported by same reporter. Notes:As the patient called back to complete dose os Shingrix the patient received initially received adjuvant suspension and now received only liquid portion so not capture rechangelled a positive.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016885:same patient (FU2 and 1st dose case), same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: fever for 2 days / started / the / night she received the adjuvant component; muscle pain / experiencing muscle, back, and joint pain; joint pain / experiencing muscle, back, and joint pain; back pain is excruciating /  muscle, back, and joint pain; arm pain / pain has been "excruciating" in the left arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In January 2021, the patient received Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, muscle pain, joint pain, back pain and pain in arm. On an unknown date, the outcome of the fever and muscle pain were not recovered/not resolved and the outcome of the joint pain, back pain and pain in arm were unknown.   It was unknown if the reporter considered the fever, muscle pain, joint pain, back pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient stated after one week was called back in to get the complete 1st dose of the Shingrix and reported experiencing soreness in the arms, and a slight fever that occurred that same night after getting the complete dose.  The patient stated that the pain was still ongoing and that was suffering every day it was affecting joints and her back pain was excruciating.  The reporter consented to follow up. Not all information was available.  The patient did give permission to follow up with their HCP. This case linked with US2021AMR016885 and US2021016995, reported by same reporter. Notes:As the patient called back to complete dose os Shingrix the patient received initially received adjuvant suspension and now received only liquid portion so not capture rechangelled a positive.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016885:same patient (FU2 and 1st dose case), same reporter
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Burning sensation, C-reactive protein, Electromyogram, Full blood count
Clinical narrative: Patient received vaccine at wrong site over left elbow rather than shoulder IM and developed an ulnar neuropathy.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Neck pain, Pain in extremity, Product administered at inappropriate site, Radial nerve injury
Clinical narrative: Patient received vaccine at wrong site over left elbow rather than shoulder IM and developed an ulnar neuropathy.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Patient received vaccine at wrong site over left elbow rather than shoulder IM and developed an ulnar neuropathy.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Magnetic resonance imaging, Neuropathy peripheral
Clinical narrative: Patient received vaccine at wrong site over left elbow rather than shoulder IM and developed an ulnar neuropathy.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site pain
Clinical narrative: numbness that started on the right side of nose,right face, jaw, and right tip of the tongue; numbness that started on the right side of nose,right face, jaw, and right tip of the tongue; bruise in her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 61 unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced: numbness that started on the right side of nose, right face, jaw, and right tip of the tongue (non-serious), and bruise in her arm (non-serious).  The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: numbness that started on the right side of nose,right face, jaw, and right tip of the tongue; numbness that started on the right side of nose,right face, jaw, and right tip of the tongue; bruise in her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 61 unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced: numbness that started on the right side of nose, right face, jaw, and right tip of the tongue (non-serious), and bruise in her arm (non-serious).  The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Pain in extremity, Vaccination site pain
Clinical narrative: numbness that started on the right side of nose,right face, jaw, and right tip of the tongue; numbness that started on the right side of nose,right face, jaw, and right tip of the tongue; bruise in her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 61 unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced: numbness that started on the right side of nose, right face, jaw, and right tip of the tongue (non-serious), and bruise in her arm (non-serious).  The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Feeling abnormal, Head discomfort, Hyperacusis
Clinical narrative: lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Oedema peripheral, Oropharyngeal pain, Pain
Clinical narrative: lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Discomfort, Feeling abnormal, Head discomfort, Hyperacusis
Clinical narrative: lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Sleep disorder
Clinical narrative: lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash (spots) appeared on legs, stomach and arms; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. Medical history included ongoing esophageal cancer. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), chemotherapy and radiotherapy, both for esophageal cancer. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021, the patient experienced rash (spots) appeared on legs, stomach and arms, and that rash does not itch, burn or cause discomfort. No treatment was received for the adverse event. The clinical outcome of the rash (spots) appeared on legs, stomach and arms was not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fingers. "Inner tremors" that has not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fingers. "Inner tremors" that has not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fingers. "Inner tremors" that has not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Essential tremor, Muscle spasms, Pain in extremity, Thyroid function test
Clinical narrative: Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fingers. "Inner tremors" that has not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Balance disorder, Body temperature fluctuation, Feeling cold
Clinical narrative: Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fingers. "Inner tremors" that has not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Laboratory test, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fingers. "Inner tremors" that has not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sciatica, Tremor
Clinical narrative: Extreme pain in bilateral lower extremities causing patient not to be able to walk. Cramping in fingers. "Inner tremors" that has not resolved.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Cardiac monitoring, Echocardiogram, Electrocardiogram, Palpitations
Clinical narrative: Cardiac arrythmia occurring twice each for a period of approximately 1-2 hours. Each time the arrythmia resolved on its own.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Cardiac monitoring
Clinical narrative: Cardiac arrythmia occurring twice each for a period of approximately 1-2 hours. Each time the arrythmia resolved on its own.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Pyrexia
Clinical narrative: Received vaccine on 02/26/21.  By next day developed L facial swelling, erythema, pruritis and c/o hives;  Seen in local ER and given steroids.  Unclear other treatment as records not available.  Asked PCP to get and submit.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Received vaccine on 02/26/21.  By next day developed L facial swelling, erythema, pruritis and c/o hives;  Seen in local ER and given steroids.  Unclear other treatment as records not available.  Asked PCP to get and submit.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Swelling face, Urticaria
Clinical narrative: Received vaccine on 02/26/21.  By next day developed L facial swelling, erythema, pruritis and c/o hives;  Seen in local ER and given steroids.  Unclear other treatment as records not available.  Asked PCP to get and submit.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient and her mother returned to the clinic and misrepresented the patient's age on the VAR in order for her to receive the second dose of Moderna vaccine below the approved age.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Deafness, Fatigue, Feeling abnormal
Clinical narrative: hearing loss right ear after 1st Covid vaccine, within 2 hrs. subjectively lost 80% of right side hearing.   after 4+ has somewhat recovered hearing approx half of subjective loss.   Of note:  20+ year ago lost hearing on LEFT "from a virus"  and that was permanent.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Sinus congestion
Clinical narrative: hearing loss right ear after 1st Covid vaccine, within 2 hrs. subjectively lost 80% of right side hearing.   after 4+ has somewhat recovered hearing approx half of subjective loss.   Of note:  20+ year ago lost hearing on LEFT "from a virus"  and that was permanent.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: hearing loss right ear after 1st Covid vaccine, within 2 hrs. subjectively lost 80% of right side hearing.   after 4+ has somewhat recovered hearing approx half of subjective loss.   Of note:  20+ year ago lost hearing on LEFT "from a virus"  and that was permanent.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Confusional state, Dysarthria, Headache, Pain
Clinical narrative: little stroke; hands and feet started to swell/ swelling of the hands and feet; headache to a point where I don't remember yesterday. I have no reconnection of anything that took place yesterday; headache to a point where I don't remember yesterday. I have no reconnection of anything that took place yesterday/ memory loss that was really bizarre; Had 99.9 fever; arm hurts/ my arm is better but it still sore; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6205) via an unspecified route of administration on 03Mar2021 09:00 at a single dose for COVID-19 immunisation. Medical history included hip replacement (in November). There were no concomitant medications. The patient had the Pfizer vaccine (first dose) on 03Mar2021 at 9 am in the morning on 04Mar2021and she had a terrible reaction, her hands and feet started to swell. She experienced a headache to a point where she doesn't remember yesterday. "I have no reconnection of anything that took place yesterday. I had the normal side effects, I had 99.9 fever which is a normal, my arm hurts which is normal but it was the swelling of the hands and feet and the memory loss that was really bizarre." Consumer added, "I have also alerted my physicians, my doctors and Local Hospital and the pharmacy that administered the shot. I am kind of worried I wonder maybe I had a little stroke or something because I am 60 years old and I can't remember anything." Patient had blood work done two weeks ago (Feb2021), everything came back normal. When probed for outcome of the events, consumer stated, " It still persisting, I still have a terrible headache and of course, my arm is better but it still sore, I think that's could be probably expected." She just wanted to make sure that somebody knew what happened because her doctor called today was pretty upset. Outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: little stroke; hands and feet started to swell/ swelling of the hands and feet; headache to a point where I don't remember yesterday. I have no reconnection of anything that took place yesterday; headache to a point where I don't remember yesterday. I have no reconnection of anything that took place yesterday/ memory loss that was really bizarre; Had 99.9 fever; arm hurts/ my arm is better but it still sore; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6205) via an unspecified route of administration on 03Mar2021 09:00 at a single dose for COVID-19 immunisation. Medical history included hip replacement (in November). There were no concomitant medications. The patient had the Pfizer vaccine (first dose) on 03Mar2021 at 9 am in the morning on 04Mar2021and she had a terrible reaction, her hands and feet started to swell. She experienced a headache to a point where she doesn't remember yesterday. "I have no reconnection of anything that took place yesterday. I had the normal side effects, I had 99.9 fever which is a normal, my arm hurts which is normal but it was the swelling of the hands and feet and the memory loss that was really bizarre." Consumer added, "I have also alerted my physicians, my doctors and Local Hospital and the pharmacy that administered the shot. I am kind of worried I wonder maybe I had a little stroke or something because I am 60 years old and I can't remember anything." Patient had blood work done two weeks ago (Feb2021), everything came back normal. When probed for outcome of the events, consumer stated, " It still persisting, I still have a terrible headache and of course, my arm is better but it still sore, I think that's could be probably expected." She just wanted to make sure that somebody knew what happened because her doctor called today was pretty upset. Outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Blood test, Body temperature, Cerebrovascular accident, Headache
Clinical narrative: little stroke; hands and feet started to swell/ swelling of the hands and feet; headache to a point where I don't remember yesterday. I have no reconnection of anything that took place yesterday; headache to a point where I don't remember yesterday. I have no reconnection of anything that took place yesterday/ memory loss that was really bizarre; Had 99.9 fever; arm hurts/ my arm is better but it still sore; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6205) via an unspecified route of administration on 03Mar2021 09:00 at a single dose for COVID-19 immunisation. Medical history included hip replacement (in November). There were no concomitant medications. The patient had the Pfizer vaccine (first dose) on 03Mar2021 at 9 am in the morning on 04Mar2021and she had a terrible reaction, her hands and feet started to swell. She experienced a headache to a point where she doesn't remember yesterday. "I have no reconnection of anything that took place yesterday. I had the normal side effects, I had 99.9 fever which is a normal, my arm hurts which is normal but it was the swelling of the hands and feet and the memory loss that was really bizarre." Consumer added, "I have also alerted my physicians, my doctors and Local Hospital and the pharmacy that administered the shot. I am kind of worried I wonder maybe I had a little stroke or something because I am 60 years old and I can't remember anything." Patient had blood work done two weeks ago (Feb2021), everything came back normal. When probed for outcome of the events, consumer stated, " It still persisting, I still have a terrible headache and of course, my arm is better but it still sore, I think that's could be probably expected." She just wanted to make sure that somebody knew what happened because her doctor called today was pretty upset. Outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: little stroke; hands and feet started to swell/ swelling of the hands and feet; headache to a point where I don't remember yesterday. I have no reconnection of anything that took place yesterday; headache to a point where I don't remember yesterday. I have no reconnection of anything that took place yesterday/ memory loss that was really bizarre; Had 99.9 fever; arm hurts/ my arm is better but it still sore; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6205) via an unspecified route of administration on 03Mar2021 09:00 at a single dose for COVID-19 immunisation. Medical history included hip replacement (in November). There were no concomitant medications. The patient had the Pfizer vaccine (first dose) on 03Mar2021 at 9 am in the morning on 04Mar2021and she had a terrible reaction, her hands and feet started to swell. She experienced a headache to a point where she doesn't remember yesterday. "I have no reconnection of anything that took place yesterday. I had the normal side effects, I had 99.9 fever which is a normal, my arm hurts which is normal but it was the swelling of the hands and feet and the memory loss that was really bizarre." Consumer added, "I have also alerted my physicians, my doctors and Local Hospital and the pharmacy that administered the shot. I am kind of worried I wonder maybe I had a little stroke or something because I am 60 years old and I can't remember anything." Patient had blood work done two weeks ago (Feb2021), everything came back normal. When probed for outcome of the events, consumer stated, " It still persisting, I still have a terrible headache and of course, my arm is better but it still sore, I think that's could be probably expected." She just wanted to make sure that somebody knew what happened because her doctor called today was pretty upset. Outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Fibrin D dimer normal, Laboratory test normal, Palpitations, Troponin normal
Clinical narrative: chest was a little tight; short of breath; 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes/patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150; This is a spontaneous report from a contactable Nurse (patient herself). A non-pregnant 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: E16198), via an unspecified route of administration, administered at Right arm on 02Mar2021 15:00 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history included: Diabetes, hypertension, asthma, vitamin D deficiency, known allergies: Serevent inhaler. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included lisinopril, cefixime (FLEXERIL), colecalciferol (VITAMIN D). On 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes. Then at 15:00, the patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150, chest was a little tight and short of breath. No chest pain. Patient went to hospital.  The patient was hospitalized in Mar2021 for all events. Patient still get heart racing on and off. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for all events. The outcome of the events was Not recovered.; Sender's Comments: Pending the investigational results and clinical diagnosis, the company does not attribute the events palpitation, chest tight and short of breath to BNT162B2. The underlying hypertension, diabetes and asthma are considered as risk factors for developing the events.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Palpitations
Clinical narrative: chest was a little tight; short of breath; 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes/patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150; This is a spontaneous report from a contactable Nurse (patient herself). A non-pregnant 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: E16198), via an unspecified route of administration, administered at Right arm on 02Mar2021 15:00 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history included: Diabetes, hypertension, asthma, vitamin D deficiency, known allergies: Serevent inhaler. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included lisinopril, cefixime (FLEXERIL), colecalciferol (VITAMIN D). On 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes. Then at 15:00, the patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150, chest was a little tight and short of breath. No chest pain. Patient went to hospital.  The patient was hospitalized in Mar2021 for all events. Patient still get heart racing on and off. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for all events. The outcome of the events was Not recovered.; Sender's Comments: Pending the investigational results and clinical diagnosis, the company does not attribute the events palpitation, chest tight and short of breath to BNT162B2. The underlying hypertension, diabetes and asthma are considered as risk factors for developing the events.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood pressure increased, Cardiac stress test, Chest pain, Computerised tomogram
Clinical narrative: High blood pressure; Severe Chest pain; Red rash on back and chest; Severe migraine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 26Feb2021 at a single dose for COVID-19 immunization. Medical history included migraine and allergies to sulfa and certain antibiotics (unspecified) from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. Concomitant medication included sumatriptan (manufacturer unknown) and steroid injection (unspecified) in both knees taken for an unspecified indication, start and stop date were not reported. The patient experienced severe chest pain, red rash on back and chest, severe migraine and high blood pressure all on 26Feb2021 at 17:30. The event involved an emergency room/department or urgent care visit and hospitalization for 4 days. The patient received treatment (unspecified) for the events. The patient received Toradol for migraine. The patient had a nasal swab on 26Feb2021 and 02Mar2021, both with the result of negative. The patient has not recovered from the events.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Magnetic resonance imaging, Migraine, Neck pain
Clinical narrative: High blood pressure; Severe Chest pain; Red rash on back and chest; Severe migraine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 26Feb2021 at a single dose for COVID-19 immunization. Medical history included migraine and allergies to sulfa and certain antibiotics (unspecified) from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. Concomitant medication included sumatriptan (manufacturer unknown) and steroid injection (unspecified) in both knees taken for an unspecified indication, start and stop date were not reported. The patient experienced severe chest pain, red rash on back and chest, severe migraine and high blood pressure all on 26Feb2021 at 17:30. The event involved an emergency room/department or urgent care visit and hospitalization for 4 days. The patient received treatment (unspecified) for the events. The patient received Toradol for migraine. The patient had a nasal swab on 26Feb2021 and 02Mar2021, both with the result of negative. The patient has not recovered from the events.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hypertension, Migraine, Rash erythematous
Clinical narrative: High blood pressure; Severe Chest pain; Red rash on back and chest; Severe migraine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 26Feb2021 at a single dose for COVID-19 immunization. Medical history included migraine and allergies to sulfa and certain antibiotics (unspecified) from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. Concomitant medication included sumatriptan (manufacturer unknown) and steroid injection (unspecified) in both knees taken for an unspecified indication, start and stop date were not reported. The patient experienced severe chest pain, red rash on back and chest, severe migraine and high blood pressure all on 26Feb2021 at 17:30. The event involved an emergency room/department or urgent care visit and hospitalization for 4 days. The patient received treatment (unspecified) for the events. The patient received Toradol for migraine. The patient had a nasal swab on 26Feb2021 and 02Mar2021, both with the result of negative. The patient has not recovered from the events.   Information on the lot/batch number has been requested.