chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia, Tremor
Clinical narrative: 1-5-2021 uncontrollable Shaking of entire body  Fever started at 99.1 at 9:30 pm  by 11:30  fever was 101.1. I took 2 tylanol at 9:30 and 2 more at 11:30 pm and went to bed the shaking had subsided by  about 11:00pm and woke up about 1 am and the fever was gone.  I woke up at 5 am on 1-6-2021  with the shaking, but no fever and the shaking just lasted about 45 minutes.  I had a headache off and on  1-6-2021 and of course the sore arm.  I was very tired the 2nd day, too.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Tension headache
Clinical narrative: 01/06 -Upon waking: generalized body ache, more intense left arm ache -12PM: intermittent chills without rigors -4PM: diffuse tension headache rated 1/10 -No other signs and symptoms   01/07: no change compared to 01/06.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Limb discomfort, Paraesthesia
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site cellulitis, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Paraesthesia, Rash macular
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cellulitis, Fatigue, Hypersensitivity, Injection site erythema, Injection site mass
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Injection site warmth, Limb discomfort, Paraesthesia
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Injection site mass, Injection site pain
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: fatigue on onset.  7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump.  Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics.  Stated allergic reaction and looked like cellulitis too.  Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Limb discomfort, Paraesthesia
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site cellulitis, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Paraesthesia, Rash macular
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cellulitis, Fatigue, Hypersensitivity, Injection site erythema, Injection site mass
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Injection site warmth, Limb discomfort, Paraesthesia
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Injection site mass, Injection site pain
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside.  Went to see Dr.  marked it...Said apply topical benadryl and ice it (I did not have topical benedry).  Next day it was redder, warm to the touch and had spread.  Went to see another provider and out me on antibiotic.  Allergic reaction and cellulitis.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Body temperature increased, Feeling abnormal, Insomnia
Clinical narrative: Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nervousness, Pain, Restlessness, Tachyphrenia, Tremor
Clinical narrative: Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Back pain, Electrocardiogram, Feeling jittery, Full blood count
Clinical narrative: Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Metabolic function test, Pyrexia, Urine analysis
Clinical narrative: Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Body temperature increased, Feeling abnormal, Insomnia
Clinical narrative: Patient reports low back pain fever and anxiety began 2300 on the day of vaccination.  He states he is unable to sleep and feels an adrenaline rush but denies shortness of breath or chest pain.  The fever and back pain resolved over the subsequent days however the jittery feeling persisted and he presented to the ED 1/6/2021.  Patient was treated to diphenhydramine and symptoms resolved
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nervousness, Pain, Restlessness, Tachyphrenia, Tremor
Clinical narrative: Patient reports low back pain fever and anxiety began 2300 on the day of vaccination.  He states he is unable to sleep and feels an adrenaline rush but denies shortness of breath or chest pain.  The fever and back pain resolved over the subsequent days however the jittery feeling persisted and he presented to the ED 1/6/2021.  Patient was treated to diphenhydramine and symptoms resolved
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Back pain, Electrocardiogram, Feeling jittery, Full blood count
Clinical narrative: Patient reports low back pain fever and anxiety began 2300 on the day of vaccination.  He states he is unable to sleep and feels an adrenaline rush but denies shortness of breath or chest pain.  The fever and back pain resolved over the subsequent days however the jittery feeling persisted and he presented to the ED 1/6/2021.  Patient was treated to diphenhydramine and symptoms resolved
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Metabolic function test, Pyrexia, Urine analysis
Clinical narrative: Patient reports low back pain fever and anxiety began 2300 on the day of vaccination.  He states he is unable to sleep and feels an adrenaline rush but denies shortness of breath or chest pain.  The fever and back pain resolved over the subsequent days however the jittery feeling persisted and he presented to the ED 1/6/2021.  Patient was treated to diphenhydramine and symptoms resolved
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Patient experienced headaches the evening after injection, the day following vaccination patient reports dizziness, shaky legs, and face/throat numbness and tingling. Emergency room visit on 1/4/2021. Patient reports botox lip injections approximately 6 months prior.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient experienced headaches the evening after injection, the day following vaccination patient reports dizziness, shaky legs, and face/throat numbness and tingling. Emergency room visit on 1/4/2021. Patient reports botox lip injections approximately 6 months prior.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpez zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient presented herpes zoster. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE/PQC identified; Caller reports AE related to administration of expired PROQUAD; Excursion occurred 11/17/2020; This spontaneous report was received from a office manager concerning to a 3-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 17-NOV-2020, a dose of the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number reported as T016991 and expiration date as 11-NOV-2021) had a temperature excursion.  On 22-DEC-2020 (discrepant information as onset date was also reported as ''29-DEC-2020''), the patient was vaccinated with an expired (discrepant information as the vaccination date was on 22-DEC-2020 and the vaccine expiration date would be on 11-NOV-2021) and improperly stored dose of the mentioned vaccine at a dose of 0.5 milliliter (ml) for prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  This is one of several reports received from the same reporter.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE details available at this time; Caller reported temperature excursion. / Temperature -13.3C; This spontaneous report was received from a registered nurse concerning to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (ml) for prophylaxis, lot number reported as T017688 and expiration date as 21-MAY-2022 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  The administered vaccine had a temperature excursion of -13.3°C (degrees Celsius) for a time frame of 4 hours and 15 minutes, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013095:
Age: 24.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No further adverse events reported; MMRlI given had expired on 12/17/2020; This spontaneous report was received from a pharmacist concerning to a 24-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 31-DEC-2020, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml) for prophylaxis, lot number reported as R036581, expiration date reported and validated as 17-DEC-2020 (vaccination scheme, route of administration, and anatomical site of vaccination were not provided). It was reported that the vaccine did not experienced temperature excursion. No further adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; post herpetic neuralgia; Information has been received regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided.   On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not provided).  On an unspecified date (reported as "shortly after receiving the vaccine"), the pt suffered herpes zoster and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the vaccine, the pt's symptoms resulted in physical limitations not present prior to using the product, and experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. The pt suffered serious, severe, progressive, permanent, and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reported events were not resolved. The events of herpes zoster and post herpetic neuralgia were considered to be related to zoster vaccine live (ZOSTAVAX) by the reporter.   Upon internal review, the events of herpes zoster and post herpetic neuralgia were considered to be disabling.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The patient experienced intense itching at the injection site.  The reporter did not consent to follow-up. All information was not available.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Neuropathy peripheral
Clinical narrative: anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of anaphylactic reaction and neuropathy peripheral due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase and nerve conduction studies, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is 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, COVID19
Symptoms: Brain oedema, Fatigue, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: brain felt swollen; glands were also swollen; bad headache; minimal arm pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included lupus-like history and chronic Lyme disease. The patient's concomitant medications were not reported. The patient stated she received the first vaccine dose on 30Dec2020 and had minimal arm pain, fatigue that went to a very bad headache on Thursday (31Dec2020). By Friday headache and fatigue were terrible until this morning. Her brain felt swollen and her glands were also swollen on 03Jan2021. The patient stated that she called healthcare professional (HCP) and was told that her body was "having an auto immune response", "due to a lupus like history and a history of chronic Lyme disease and to hydrate well". It was so hard to talk, she was so fatigued. Her doctor compared it to like an encephalopathy. The patient was feeling better today but was concerned about taking the second dose. She works in a facility with a lot of Covid-19 patients. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event brain felt swollen cannot be totally excluded.  Medical history of lupus-like history and chronic Lyme disease may provide plausible alternative explanations for the event. 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, COVID19
Symptoms: Speech disorder
Clinical narrative: brain felt swollen; glands were also swollen; bad headache; minimal arm pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included lupus-like history and chronic Lyme disease. The patient's concomitant medications were not reported. The patient stated she received the first vaccine dose on 30Dec2020 and had minimal arm pain, fatigue that went to a very bad headache on Thursday (31Dec2020). By Friday headache and fatigue were terrible until this morning. Her brain felt swollen and her glands were also swollen on 03Jan2021. The patient stated that she called healthcare professional (HCP) and was told that her body was "having an auto immune response", "due to a lupus like history and a history of chronic Lyme disease and to hydrate well". It was so hard to talk, she was so fatigued. Her doctor compared it to like an encephalopathy. The patient was feeling better today but was concerned about taking the second dose. She works in a facility with a lot of Covid-19 patients. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event brain felt swollen cannot be totally excluded.  Medical history of lupus-like history and chronic Lyme disease may provide plausible alternative explanations for the event. 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, COVID19
Symptoms: Aphasia, Fatigue, Feeling abnormal, Head discomfort, Headache
Clinical narrative: brain felt swollen; glands were also swollen; bad headache; minimal arm pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included lupus-like history and chronic Lyme disease. The patient's concomitant medications were not reported. The patient stated she received the first vaccine dose on 30Dec2020 and had minimal arm pain, fatigue that went to a very bad headache on Thursday (31Dec2020). By Friday headache and fatigue were terrible until this morning. Her brain felt swollen and her glands were also swollen on 03Jan2021. The patient stated that she called healthcare professional (HCP) and was told that her body was "having an auto immune response", "due to a lupus like history and a history of chronic Lyme disease and to hydrate well". It was so hard to talk, she was so fatigued. Her doctor compared it to like an encephalopathy. The patient was feeling better today but was concerned about taking the second dose. She works in a facility with a lot of Covid-19 patients. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event brain felt swollen cannot be totally excluded.  Medical history of lupus-like history and chronic Lyme disease may provide plausible alternative explanations for the event. 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, COVID19
Symptoms: Lymphadenopathy, Nausea, SARS-CoV-2 test, Swelling face
Clinical narrative: brain felt swollen; glands were also swollen; bad headache; minimal arm pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included lupus-like history and chronic Lyme disease. The patient's concomitant medications were not reported. The patient stated she received the first vaccine dose on 30Dec2020 and had minimal arm pain, fatigue that went to a very bad headache on Thursday (31Dec2020). By Friday headache and fatigue were terrible until this morning. Her brain felt swollen and her glands were also swollen on 03Jan2021. The patient stated that she called healthcare professional (HCP) and was told that her body was "having an auto immune response", "due to a lupus like history and a history of chronic Lyme disease and to hydrate well". It was so hard to talk, she was so fatigued. Her doctor compared it to like an encephalopathy. The patient was feeling better today but was concerned about taking the second dose. She works in a facility with a lot of Covid-19 patients. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event brain felt swollen cannot be totally excluded.  Medical history of lupus-like history and chronic Lyme disease may provide plausible alternative explanations for the event. 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Palpitations, Tachycardia
Clinical narrative: a strong, whole body heat, and flushing; a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported similar event for 6 patients. This is 3rd of 6 reports. A 24-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Pfizer employee reporting on behalf of a friend, reported her friend texted her last night, 30Dec2020, at around midnight. The nurse and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. Caller said she had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. Caller said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. Outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 vaccine cannot be excluded for events flushing, feeling hot, tachycardia and palpitations. 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. ,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Palpitations, Tachycardia
Clinical narrative: she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020.  Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid Vaccine, lot EH9099 or EH9899), via an unspecified route of administration in her left deltoid on 22Dec2020 09:32 at single dose for Covid-19 immunisation. Medical history included broken toe for 3 weeks. This was from her taekwondo and doesn't complain. No history of all previous immunization with the Pfizer vaccine considered as suspect drug. There were no additional vaccines administered on same date with Covid-19 vaccine. There were no concomitant medications. On 24Dec2020, she broke out in a rash on different parts of her body. She said the rash would come and go. She said she then had welts appear on different parts of her body and the welts would come and go. She said on the 3rd day, she had rash and welts together only on her trunk. She said on days 4, 5, and 6, she would have either a rash or welts come and go on different parts of her body. She clarified she had the rash and welts on her hands, wrists, ankles, and body. She reported that the rash and welts were serious-medically significant. On 22Dec2020, she had arm soreness and was just inconvenient and uncomfortable. She said she was not saying that what she was experiencing was related to receiving the COVID-19 Vaccine, but she doesn't know what else can be causing the rash and welts. She said she hasn't changed anything she has been eating or doing. She said she was worried about taking the 2nd COVID-19 Vaccine dose. She used Hydrocortisone 1% cream, Equate brand (reported to be expired) and took an oatmeal bath. She also took Benadryl and brand of Zyrtec called Wal-Zyr. Her height was 175cm, weight was 63kg. The rash and welts recovered on 30Dec2020; arm soreness recovered on 23Dec2020.  Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once 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: Body temperature increased, Frustration tolerance decreased, Heart rate increased, Oxygen saturation decreased
Clinical narrative: Saturation down to 84%; Temperature of 101.3; Rapid pulse having some difficulty; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 30Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The reporter is working in long term in Nursing care facility. It was reported that they have a resident who recovered from COVID. They are having some questions following the guidelines stuff, just kind of asking some more questions. Just one of their resident had temperature of 101.3, saturation down to 84%, 'frustration' at 24% and rapid pulse having some difficulty. The patient was put in her bed. The reporter contacted the doctor in house. 'The reporter wanted to see if any of the recommendation were for (incomplete sentence). The long term care facilities recovered COVID, the reporter wanted to know any of the lasting short term and any guideline for treating. They were all recovered COVID, all of two of the resident two weeks or more out and we (Further clarification was unknown) just had the vaccine yesterday' (as reported, pending clarification). Outcome of the events was unknown.  Information on the batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest pain, Erythema, Hyperhidrosis, Palpitations
Clinical narrative: Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Syncope
Clinical narrative: Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.