chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: severe, painful  swelling in lower extremities, left ankle worse than right. subsided by next morning.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Muscle spasms
Clinical narrative: A couple weeks after my fourth vaccine I started developing acute muscle spasms in my leg, which persist. Two days ago I started having numbness and lost of strength and muscle use in right arm.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer Covid-19 vaccine administered on 04/07/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen, warm to touch arm
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: 5-11 COVID vaccine not diluted. 0.2mL of undiluted vaccine administered to left arm. After drawing up 5th dose of vial LVN noticed there was not sufficient amount for all 10 doses. LVN realized the vial was not diluted. LVN notified MD.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: 5-11 Covid vaccine not diluted 0.2 ml of undiluted was administered to left arm. After drawing up 5th dose LVN notice there was no sufficient amount for 10th doses. LVN noticed vial was not diluted. LVN notified MD. MD verbalized that they will contact parents.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bronchitis, Chest discomfort, Cough, Dyspnoea
Clinical narrative: Within a week after first booster shot I delevoped a continuous cough especially at night it lasted a solid 6 weeks before subsiding. Multiple muscles have  become very tight especially in the chest. Visited the doctor twice during this time and was diagnosis with bronchitis and then a sinus inflection.  A week later multiple teeth were aching.  Dentist diagnosis the problem as tighten jaw muscles.  Applying a cold pack behind the ear eliminated the pain.  The tooth aches returned later and the cold pack worked again. My husband and I took the same booster shot at the same time.  We are both very healthy and did not have any negative affects from the previous two shots. Within days after the booster shots we both started coughing and it lasted for weeks.  . It has been over four months since the booster shots and we do not feel well with aches, pains, coughing, lack of energy, and hard to breath.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle tightness, Pain, Sinusitis, Toothache
Clinical narrative: Within a week after first booster shot I delevoped a continuous cough especially at night it lasted a solid 6 weeks before subsiding. Multiple muscles have  become very tight especially in the chest. Visited the doctor twice during this time and was diagnosis with bronchitis and then a sinus inflection.  A week later multiple teeth were aching.  Dentist diagnosis the problem as tighten jaw muscles.  Applying a cold pack behind the ear eliminated the pain.  The tooth aches returned later and the cold pack worked again. My husband and I took the same booster shot at the same time.  We are both very healthy and did not have any negative affects from the previous two shots. Within days after the booster shots we both started coughing and it lasted for weeks.  . It has been over four months since the booster shots and we do not feel well with aches, pains, coughing, lack of energy, and hard to breath.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: 5-11 Covid vaccine not diluted. 0.2mL of undiluted vaccine administered to left arm. After drawing 5 doses LVN noticed there was not sufficient amount left for 10 doses. LVN realized the vial was not diluted. MD notified.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: 5-11 Covid vaccine not diluted. 0.2mL of undiluted vaccine administered to left arm. After drawing 5 doses LVN noticed there was not sufficient amount left for 10 doses. LVN realized the vial was not diluted. MD notified
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Oropharyngeal pain, Quarantine, SARS-CoV-2 test positive
Clinical narrative: I have tested positive for Covid using Antigen test on May 27, 2022.  This is less than one month since my 4th dose of the Pfizer vaccine. I do not understand why this has happened.  I have done nothing unusual. I am retired. I am now quarantined for 5 or more days. The symptoms of nasal congestion and sore throat are deminishing.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Corneal abrasion, Eye pain
Clinical narrative: Woke up on 5-18-22 and felt intense pain in left eye as soon as I opened it.  Any movement of the eye caused pain.  Had no issues the day prior or during the night, happened suddenly and unexpectedly.  Saw my eye care physician and was diagnosed with a corneal abrasion.  Was treated with antibiotic eye drops and a "band-aid contact".  Was reassessed on 5-25-22 and eye was completely healed.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Confusional state, Cough, Cyst
Clinical narrative: Armpit behind injection site felt like it has a aching cyst, severe headache, ringing in ears, confusion, severe joint pain in knees, elbows, mid back, cough, ankles, neck, eye sockets, nausea, feverish, difficulty staying asleep because of headache, nausea and joint pain. Dizzy/wobbly, slight couch.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Headache, Nausea, Neck pain, Pain
Clinical narrative: Armpit behind injection site felt like it has a aching cyst, severe headache, ringing in ears, confusion, severe joint pain in knees, elbows, mid back, cough, ankles, neck, eye sockets, nausea, feverish, difficulty staying asleep because of headache, nausea and joint pain. Dizzy/wobbly, slight couch.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sleep disorder, Tinnitus
Clinical narrative: Armpit behind injection site felt like it has a aching cyst, severe headache, ringing in ears, confusion, severe joint pain in knees, elbows, mid back, cough, ankles, neck, eye sockets, nausea, feverish, difficulty staying asleep because of headache, nausea and joint pain. Dizzy/wobbly, slight couch.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Injection site erythema, Injection site pain
Clinical narrative: PATIENT CAME TO THE PHARMACY AND REPORT THAT THERE IS REDNES AREA AROUND THE INJECTION SITE AND PAIN SENSATION WHEN TOUCH. THE PHARMACIST COUNSELED PATIENT THAT SHE CAN TAKE OTC PAIN MEDICATION SUCH AS TYLENOL OR ADVIL FOR A DAY OR TWO TO HELP WITH THE PAINS. THE PHARMACIST ALSO CALL PATIENT'S PCP AND REPORT ON THE ADVERSE REACTION.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Crying, Dyspnoea, Fatigue
Clinical narrative: I woke up the day following vaccination with chest pain, trouble breathing, a fever, body aches, my left arm so sore I couldn't lift it, and a headache so severe that as a grown man I had bouts of tearing up/crying on my  hands and knees. I thought my brain was swelling up against my skull. I was in so much pain I was afraid but avoided going to a hospital because I cannot afford it. My primary care doctor told me that "everyone in her office" got this sick after getting vaccinated and that I would be fine in 48 hours in all likelihood. On the fifth day after vaccination I still had chest pain, trouble breathing, and fatigue but other symptoms had subsided. I normally run dogs multiple days per week, and do intensive yoga and weightlifting 4-5 days per week. More than 7 days after vaccination I hardly have the energy to do basic tasks and get winded / can feel my pulse in my temples after going up or down a small flight of stairs in my house.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fear, Headache, Mobility decreased, Pain, Pain in extremity
Clinical narrative: I woke up the day following vaccination with chest pain, trouble breathing, a fever, body aches, my left arm so sore I couldn't lift it, and a headache so severe that as a grown man I had bouts of tearing up/crying on my  hands and knees. I thought my brain was swelling up against my skull. I was in so much pain I was afraid but avoided going to a hospital because I cannot afford it. My primary care doctor told me that "everyone in her office" got this sick after getting vaccinated and that I would be fine in 48 hours in all likelihood. On the fifth day after vaccination I still had chest pain, trouble breathing, and fatigue but other symptoms had subsided. I normally run dogs multiple days per week, and do intensive yoga and weightlifting 4-5 days per week. More than 7 days after vaccination I hardly have the energy to do basic tasks and get winded / can feel my pulse in my temples after going up or down a small flight of stairs in my house.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tearfulness
Clinical narrative: I woke up the day following vaccination with chest pain, trouble breathing, a fever, body aches, my left arm so sore I couldn't lift it, and a headache so severe that as a grown man I had bouts of tearing up/crying on my  hands and knees. I thought my brain was swelling up against my skull. I was in so much pain I was afraid but avoided going to a hospital because I cannot afford it. My primary care doctor told me that "everyone in her office" got this sick after getting vaccinated and that I would be fine in 48 hours in all likelihood. On the fifth day after vaccination I still had chest pain, trouble breathing, and fatigue but other symptoms had subsided. I normally run dogs multiple days per week, and do intensive yoga and weightlifting 4-5 days per week. More than 7 days after vaccination I hardly have the energy to do basic tasks and get winded / can feel my pulse in my temples after going up or down a small flight of stairs in my house.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dyspnoea, Headache, Pain
Clinical narrative: Difficulty breathing, headache, cold sweats, body soreness and weakness
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS GIVEN/ ADMINSTERED EXPIRED DOSE OF MEDICATION.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Coordination abnormal, Fine motor skill dysfunction, Hypoaesthesia, Impaired work ability
Clinical narrative: Stabbing pain in left scapula radiating down left shoulder, arm, hand, and fingers, Sunday morning at 6:15 AM, went to Urgent Health, shot of Toridol, Rx Lidoderm patches, then went to Medical Center for x-rays of C-spine, chest, shoulder, shot of Morphine, Rx Flexerol, Dr.  Rx Gabapentin, Relafen, Dr. gave MRI C-spine, cervical disc replacement, Rx Percocet, Dr. gave MRI Bracial Plexus, Diagnosis of Parsonage/Turner syndrome, Rx Gabapentin x
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site hypoaesthesia, Injection site muscle weakness, Injection site pain, Intervertebral disc operation, Magnetic resonance imaging abnormal
Clinical narrative: Stabbing pain in left scapula radiating down left shoulder, arm, hand, and fingers, Sunday morning at 6:15 AM, went to Urgent Health, shot of Toridol, Rx Lidoderm patches, then went to Medical Center for x-rays of C-spine, chest, shoulder, shot of Morphine, Rx Flexerol, Dr.  Rx Gabapentin, Relafen, Dr. gave MRI C-spine, cervical disc replacement, Rx Percocet, Dr. gave MRI Bracial Plexus, Diagnosis of Parsonage/Turner syndrome, Rx Gabapentin x
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Musculoskeletal pain, Neuralgic amyotrophy, Pain
Clinical narrative: Stabbing pain in left scapula radiating down left shoulder, arm, hand, and fingers, Sunday morning at 6:15 AM, went to Urgent Health, shot of Toridol, Rx Lidoderm patches, then went to Medical Center for x-rays of C-spine, chest, shoulder, shot of Morphine, Rx Flexerol, Dr.  Rx Gabapentin, Relafen, Dr. gave MRI C-spine, cervical disc replacement, Rx Percocet, Dr. gave MRI Bracial Plexus, Diagnosis of Parsonage/Turner syndrome, Rx Gabapentin x
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Spinal X-ray, Surgery, X-ray limb
Clinical narrative: Stabbing pain in left scapula radiating down left shoulder, arm, hand, and fingers, Sunday morning at 6:15 AM, went to Urgent Health, shot of Toridol, Rx Lidoderm patches, then went to Medical Center for x-rays of C-spine, chest, shoulder, shot of Morphine, Rx Flexerol, Dr.  Rx Gabapentin, Relafen, Dr. gave MRI C-spine, cervical disc replacement, Rx Percocet, Dr. gave MRI Bracial Plexus, Diagnosis of Parsonage/Turner syndrome, Rx Gabapentin x
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: Pfizer-BioNTech COVID vaccine booster resulted in patient feeling dizzy and hot right after receiving the third booster shot followed by syncope and seizure. Patient then had a second syncopal episode and seizure shortly after.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Tenderness
Clinical narrative: Second Covid-19 booster (Pfizer): Underarm(axillary) tenderness, soreness, pain on same side as injection persists more than 7 days. Although described in product literature with 16.7% incidence, this adverse reaction inadequately publicized. 69 y/o female is concerned about tenderness being adjacent to breast.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine adminsted too soon, patient notified, no adverse reaction noted or reported at time patient notified of error via Telephone. pt. was notified of this close not being a valid booster. would need a repeat in 5 months. patient verbalized understanding
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness, Nausea, vomiting
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Fully COVID vaccinated, positive on admission, passed away due to hypoxic respiratory failure secondary to COVID
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, SARS-CoV-2 test positive
Clinical narrative: Narrative:  fully vaccinated, admitted with weakness and confusion who was found to COVID positive accidentally
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Dyspnoea, Sepsis
Clinical narrative: Narrative:  Fully COVID vaccinated, admitted for shortness of breath and sepsis due to leg celluliits
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 3:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 3:28 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 78.11.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 12-Jan-2021, the Excursion time was 08 AM and 09 AM, temperature was 34, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. The vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile Dysfunction
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Ataxia, COVID-19, Drug ineffective, Electrocardiogram
Clinical narrative: covid test post vaccination: covid test date=11May2022; covid test result=Positive; covid test post vaccination: covid test date=11May2022; covid test result=Positive; Horrific pain on L side of head/face.; Horrific pain on L side of head/face.; Blacked out from pain. out 20 minutes plus.; Left suffering with Ramsay Hunt Syndrome; Sever Ataxia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL 8982) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tonsillar Cancer 2012", start date: 2012 (unspecified if ongoing), notes: Tonsillar Cancer 2012. There were no concomitant medications. The following information was reported: LOSS OF CONSCIOUSNESS (disability, medically significant) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Blacked out from pain. out 20 minutes plus."; HEADACHE (disability), FACIAL PAIN (disability) all with onset 25Jan2021 at 23:45, outcome "not recovered" and all described as "Horrific pain on L side of head/face."; HERPES ZOSTER OTICUS (disability, medically significant) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Left suffering with Ramsay Hunt Syndrome"; ATAXIA (disability) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Sever Ataxia"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test post vaccination: covid test date=11May2022; covid test result=Positive". The events "horrific pain on l side of head/face.", "blacked out from pain. out 20 minutes plus.", "left suffering with ramsay hunt syndrome" and "sever ataxia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acupuncture: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (11May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of headache, facial pain, loss of consciousness, herpes zoster oticus, ataxia.  Clinical course: No other vaccine with in four weeks, No other medications with  in two weeks. Covid test name post vaccination: Health Covid-19 Antigen Rapid Test, No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Herpes zoster oticus, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: covid test post vaccination: covid test date=11May2022; covid test result=Positive; covid test post vaccination: covid test date=11May2022; covid test result=Positive; Horrific pain on L side of head/face.; Horrific pain on L side of head/face.; Blacked out from pain. out 20 minutes plus.; Left suffering with Ramsay Hunt Syndrome; Sever Ataxia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL 8982) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tonsillar Cancer 2012", start date: 2012 (unspecified if ongoing), notes: Tonsillar Cancer 2012. There were no concomitant medications. The following information was reported: LOSS OF CONSCIOUSNESS (disability, medically significant) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Blacked out from pain. out 20 minutes plus."; HEADACHE (disability), FACIAL PAIN (disability) all with onset 25Jan2021 at 23:45, outcome "not recovered" and all described as "Horrific pain on L side of head/face."; HERPES ZOSTER OTICUS (disability, medically significant) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Left suffering with Ramsay Hunt Syndrome"; ATAXIA (disability) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Sever Ataxia"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test post vaccination: covid test date=11May2022; covid test result=Positive". The events "horrific pain on l side of head/face.", "blacked out from pain. out 20 minutes plus.", "left suffering with ramsay hunt syndrome" and "sever ataxia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acupuncture: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (11May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of headache, facial pain, loss of consciousness, herpes zoster oticus, ataxia.  Clinical course: No other vaccine with in four weeks, No other medications with  in two weeks. Covid test name post vaccination: Health Covid-19 Antigen Rapid Test, No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: covid test post vaccination: covid test date=11May2022; covid test result=Positive; covid test post vaccination: covid test date=11May2022; covid test result=Positive; Horrific pain on L side of head/face.; Horrific pain on L side of head/face.; Blacked out from pain. out 20 minutes plus.; Left suffering with Ramsay Hunt Syndrome; Sever Ataxia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL 8982) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tonsillar Cancer 2012", start date: 2012 (unspecified if ongoing), notes: Tonsillar Cancer 2012. There were no concomitant medications. The following information was reported: LOSS OF CONSCIOUSNESS (disability, medically significant) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Blacked out from pain. out 20 minutes plus."; HEADACHE (disability), FACIAL PAIN (disability) all with onset 25Jan2021 at 23:45, outcome "not recovered" and all described as "Horrific pain on L side of head/face."; HERPES ZOSTER OTICUS (disability, medically significant) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Left suffering with Ramsay Hunt Syndrome"; ATAXIA (disability) with onset 25Jan2021 at 23:45, outcome "not recovered", described as "Sever Ataxia"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test post vaccination: covid test date=11May2022; covid test result=Positive". The events "horrific pain on l side of head/face.", "blacked out from pain. out 20 minutes plus.", "left suffering with ramsay hunt syndrome" and "sever ataxia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acupuncture: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (11May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of headache, facial pain, loss of consciousness, herpes zoster oticus, ataxia.  Clinical course: No other vaccine with in four weeks, No other medications with  in two weeks. Covid test name post vaccination: Health Covid-19 Antigen Rapid Test, No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Cardiac arrest, Death, Pulmonary embolism, Thrombosis
Clinical narrative: My sister took the Johnson and Johnson COVID 19 vaccine on May 1, 2021. She died on June 1, 2021 from a pulmonary embolism, from a blood clot that traveled from somewhere else.  She nor our family have a history of blood clots.  Her vaccine card indicates she took the J&J vaccine on 5/1/2021, lot number 1808982 from a facility known as "FD."
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 6 weeks after Paxlovid treatment.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID 6 weeks after Paxlovid treatment.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID 6 weeks after Paxlovid treatment.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-Apr-2022 to 11-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID 6 weeks after Paxlovid treatment.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. The patient received second dose of COVID-19 vaccine at left arm on 01 May 2021. The patient previously received a COVID-19 Vaccine.  Device Date :18 May 2022  Company Comment: This spontaneous case concerns a 57-year-old female patient, with no reported medical history, who experienced unexpected, non-serious AESI COVID-19 on an unknown date after receiving mRNA-1273. It was reported that patient was treated with Nirmatrelvir/Ritonavir (Paxlovid) for around 6 days, then she tested positive for COVID-19 6 weeks later. The ongoing COVID-19 pandemic could be a contributory factor. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old female patient, with no reported medical history, who experienced unexpected, non-serious AESI COVID-19 on an unknown date after receiving mRNA-1273. It was reported that patient was treated with Nirmatrelvir/Ritonavir (Paxlovid) for around 6 days, then she tested positive for COVID-19 6 weeks later. The ongoing COVID-19 pandemic could be a contributory factor. The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test, Vaccination failure, Wheezing
Clinical narrative: She tested positive for Covid after receiving Covid-19 vaccines; She tested positive for Covid after receiving Covid-19 vaccines; wheezing; coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 at 14:00 as dose 1, single (Lot number: EW0158), in right arm and on 30Apr2021 at 14:00 as dose 2, single (Lot number: EW0172) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested positive for Covid after receiving Covid-19 vaccines"; WHEEZING (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; X-ray: Unknown results.  Clinical course: The patient received vaccine in Apr2021 an she was sick with Covid. She started feeling sick on the March holiday and that following Saturday the 14Apr she did a test to be safe and the test was positive and the they made her stay home this week and then she tested herself and test have been negative since Monday. She said she never flew out of the area or traveled. The patient also reported that when she got the vaccine that was when everyone was getting the vaccines and her health insurance didn't give the vaccine so she went to a church and she said she submitted information. She said Pfizer has a copy of her Covid-19 cards.  She said traveling nurses were giving the vaccines. She said she was sick as a dog and she is coughing, wheezing and she gets x-rays today to make sure she was not getting pneumonia. Caller asked call handler to hold so she can get the paper with the vaccine information.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: She tested positive for Covid after receiving Covid-19 vaccines; She tested positive for Covid after receiving Covid-19 vaccines; wheezing; coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 at 14:00 as dose 1, single (Lot number: EW0158), in right arm and on 30Apr2021 at 14:00 as dose 2, single (Lot number: EW0172) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested positive for Covid after receiving Covid-19 vaccines"; WHEEZING (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; X-ray: Unknown results.  Clinical course: The patient received vaccine in Apr2021 an she was sick with Covid. She started feeling sick on the March holiday and that following Saturday the 14Apr she did a test to be safe and the test was positive and the they made her stay home this week and then she tested herself and test have been negative since Monday. She said she never flew out of the area or traveled. The patient also reported that when she got the vaccine that was when everyone was getting the vaccines and her health insurance didn't give the vaccine so she went to a church and she said she submitted information. She said Pfizer has a copy of her Covid-19 cards.  She said traveling nurses were giving the vaccines. She said she was sick as a dog and she is coughing, wheezing and she gets x-rays today to make sure she was not getting pneumonia. Caller asked call handler to hold so she can get the paper with the vaccine information.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Investigation
Clinical narrative: She tested positive for Covid after receiving Covid-19 vaccines; She tested positive for Covid after receiving Covid-19 vaccines; wheezing; coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 at 14:00 as dose 1, single (Lot number: EW0158), in right arm and on 30Apr2021 at 14:00 as dose 2, single (Lot number: EW0172) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested positive for Covid after receiving Covid-19 vaccines"; WHEEZING (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; X-ray: Unknown results.  Clinical course: The patient received vaccine in Apr2021 an she was sick with Covid. She started feeling sick on the March holiday and that following Saturday the 14Apr she did a test to be safe and the test was positive and the they made her stay home this week and then she tested herself and test have been negative since Monday. She said she never flew out of the area or traveled. The patient also reported that when she got the vaccine that was when everyone was getting the vaccines and her health insurance didn't give the vaccine so she went to a church and she said she submitted information. She said Pfizer has a copy of her Covid-19 cards.  She said traveling nurses were giving the vaccines. She said she was sick as a dog and she is coughing, wheezing and she gets x-rays today to make sure she was not getting pneumonia. Caller asked call handler to hold so she can get the paper with the vaccine information.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Back pain, Blood test, Cardiac stress test, Computerised tomogram
Clinical narrative: Heart Palpitations; Insomnia; Small fiber neuropathy; Anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FH8027) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergy"; Augmentin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 07May2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 16Apr2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: ANXIETY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered"; PALPITATIONS (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered", described as "Heart Palpitations"; INSOMNIA (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered"; SMALL FIBRE NEUROPATHY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered", described as "Small fiber neuropathy". The patient was hospitalized for palpitations, insomnia, small fibre neuropathy, anxiety (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown results; Lumbar puncture: Small fiber neuropathy. Therapeutic measures were taken as a result of palpitations, insomnia, small fibre neuropathy, anxiety. Clinical course: Other medication in 2weeks: No. Adverse event: Heart Palpitations Insomnia (5 weeks) Small fiber neuropathy (as detected by the lumbar puncture and skin biopsy) Anxiety. AE resulted in: [Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. AE treatment: Gabapentin 600 mg 3/day, Propafenone 225mg 2/day.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Feeling hot, Insomnia
Clinical narrative: Heart Palpitations; Insomnia; Small fiber neuropathy; Anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FH8027) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergy"; Augmentin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 07May2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 16Apr2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: ANXIETY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered"; PALPITATIONS (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered", described as "Heart Palpitations"; INSOMNIA (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered"; SMALL FIBRE NEUROPATHY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered", described as "Small fiber neuropathy". The patient was hospitalized for palpitations, insomnia, small fibre neuropathy, anxiety (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown results; Lumbar puncture: Small fiber neuropathy. Therapeutic measures were taken as a result of palpitations, insomnia, small fibre neuropathy, anxiety. Clinical course: Other medication in 2weeks: No. Adverse event: Heart Palpitations Insomnia (5 weeks) Small fiber neuropathy (as detected by the lumbar puncture and skin biopsy) Anxiety. AE resulted in: [Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. AE treatment: Gabapentin 600 mg 3/day, Propafenone 225mg 2/day.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lipids, Muscle tightness, Myocarditis, Neck pain, Pain in extremity
Clinical narrative: Heart Palpitations; Insomnia; Small fiber neuropathy; Anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FH8027) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergy"; Augmentin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 07May2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 16Apr2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: ANXIETY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered"; PALPITATIONS (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered", described as "Heart Palpitations"; INSOMNIA (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered"; SMALL FIBRE NEUROPATHY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered", described as "Small fiber neuropathy". The patient was hospitalized for palpitations, insomnia, small fibre neuropathy, anxiety (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown results; Lumbar puncture: Small fiber neuropathy. Therapeutic measures were taken as a result of palpitations, insomnia, small fibre neuropathy, anxiety. Clinical course: Other medication in 2weeks: No. Adverse event: Heart Palpitations Insomnia (5 weeks) Small fiber neuropathy (as detected by the lumbar puncture and skin biopsy) Anxiety. AE resulted in: [Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. AE treatment: Gabapentin 600 mg 3/day, Propafenone 225mg 2/day.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Skin burning sensation
Clinical narrative: Heart Palpitations; Insomnia; Small fiber neuropathy; Anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FH8027) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergy"; Augmentin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 07May2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 16Apr2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: ANXIETY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered"; PALPITATIONS (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered", described as "Heart Palpitations"; INSOMNIA (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered"; SMALL FIBRE NEUROPATHY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered", described as "Small fiber neuropathy". The patient was hospitalized for palpitations, insomnia, small fibre neuropathy, anxiety (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown results; Lumbar puncture: Small fiber neuropathy. Therapeutic measures were taken as a result of palpitations, insomnia, small fibre neuropathy, anxiety. Clinical course: Other medication in 2weeks: No. Adverse event: Heart Palpitations Insomnia (5 weeks) Small fiber neuropathy (as detected by the lumbar puncture and skin biopsy) Anxiety. AE resulted in: [Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. AE treatment: Gabapentin 600 mg 3/day, Propafenone 225mg 2/day.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Biopsy skin, Insomnia, Lumbar puncture, Palpitations
Clinical narrative: Heart Palpitations; Insomnia; Small fiber neuropathy; Anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FH8027) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergy"; Augmentin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 07May2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 16Apr2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: ANXIETY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered"; PALPITATIONS (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered", described as "Heart Palpitations"; INSOMNIA (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "recovered"; SMALL FIBRE NEUROPATHY (hospitalization, disability, life threatening) with onset 29Nov2021 at 09:30, outcome "not recovered", described as "Small fiber neuropathy". The patient was hospitalized for palpitations, insomnia, small fibre neuropathy, anxiety (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown results; Lumbar puncture: Small fiber neuropathy. Therapeutic measures were taken as a result of palpitations, insomnia, small fibre neuropathy, anxiety. Clinical course: Other medication in 2weeks: No. Adverse event: Heart Palpitations Insomnia (5 weeks) Small fiber neuropathy (as detected by the lumbar puncture and skin biopsy) Anxiety. AE resulted in: [Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. AE treatment: Gabapentin 600 mg 3/day, Propafenone 225mg 2/day.