chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Feeling abnormal, Malaise
Clinical narrative: first two weeks, daily and all day fatigue requiring multiple naps. General sense of not well. Elevated temperature, three days mid first 2 weeks.  Intermittent brain fog. next weeks, ongoing to today, intermittent fatigue, intermittent need for naps, intermittent brain fog.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BEYOND USE DATE
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: Since receiving the vaccine I developed a canker sore in my mouth evert menstrual cycle.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dermal cyst, Hyperaesthesia, Pain
Clinical narrative: A sebaceous cyst on the left arm has become sore and sensitive to touch since the vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Eye pain, Fatigue, Fluid intake reduced, Headache
Clinical narrative: Almost immediately, my arm began to throb at the site of injection. Then the pain began to go down my arm to my hand. And my head began to throb. Within the next hour, I had pain from my jaw, down through my neck, and all the way down my arm to my fingertips. It was sharp piercing pain. This pain lasted for 2 days. I began to get more tired as the day went on and I could not lift my arm at all.  I slept most of the day and could not eat or drink very much. I woke up the next morning with a 102 fever, severe nausea (to the point of not being able to eat or drink for almost 3 days). I was on the verge of vomiting. The 102 fever lasted 24 hours, then the fever hovered around 100 to 100.5 for the next 24 hours. On the third day when the fever broke, I had hives. Along with all the symptoms, I had a severe headache on the right side of my head by my right eye and at the base of my skull on the right side. This headache began minutes after the vaccine and continued to get worse. On the third day after the vaccine, Monday, May 23, I went to bed with such a severe headache and a numbness on the tight side of my face below my eye. I honestly thought I would dies of a clot in my sleep. It is now May 330, 10 days later and I still have the headache around my right eye that comes and gos in severity.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Hypoaesthesia, Injection site reaction, Mobility decreased, Nausea
Clinical narrative: Almost immediately, my arm began to throb at the site of injection. Then the pain began to go down my arm to my hand. And my head began to throb. Within the next hour, I had pain from my jaw, down through my neck, and all the way down my arm to my fingertips. It was sharp piercing pain. This pain lasted for 2 days. I began to get more tired as the day went on and I could not lift my arm at all.  I slept most of the day and could not eat or drink very much. I woke up the next morning with a 102 fever, severe nausea (to the point of not being able to eat or drink for almost 3 days). I was on the verge of vomiting. The 102 fever lasted 24 hours, then the fever hovered around 100 to 100.5 for the next 24 hours. On the third day when the fever broke, I had hives. Along with all the symptoms, I had a severe headache on the right side of my head by my right eye and at the base of my skull on the right side. This headache began minutes after the vaccine and continued to get worse. On the third day after the vaccine, Monday, May 23, I went to bed with such a severe headache and a numbness on the tight side of my face below my eye. I honestly thought I would dies of a clot in my sleep. It is now May 330, 10 days later and I still have the headache around my right eye that comes and gos in severity.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Almost immediately, my arm began to throb at the site of injection. Then the pain began to go down my arm to my hand. And my head began to throb. Within the next hour, I had pain from my jaw, down through my neck, and all the way down my arm to my fingertips. It was sharp piercing pain. This pain lasted for 2 days. I began to get more tired as the day went on and I could not lift my arm at all.  I slept most of the day and could not eat or drink very much. I woke up the next morning with a 102 fever, severe nausea (to the point of not being able to eat or drink for almost 3 days). I was on the verge of vomiting. The 102 fever lasted 24 hours, then the fever hovered around 100 to 100.5 for the next 24 hours. On the third day when the fever broke, I had hives. Along with all the symptoms, I had a severe headache on the right side of my head by my right eye and at the base of my skull on the right side. This headache began minutes after the vaccine and continued to get worse. On the third day after the vaccine, Monday, May 23, I went to bed with such a severe headache and a numbness on the tight side of my face below my eye. I honestly thought I would dies of a clot in my sleep. It is now May 330, 10 days later and I still have the headache around my right eye that comes and gos in severity.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Almost immediately, my arm began to throb at the site of injection. Then the pain began to go down my arm to my hand. And my head began to throb. Within the next hour, I had pain from my jaw, down through my neck, and all the way down my arm to my fingertips. It was sharp piercing pain. This pain lasted for 2 days. I began to get more tired as the day went on and I could not lift my arm at all.  I slept most of the day and could not eat or drink very much. I woke up the next morning with a 102 fever, severe nausea (to the point of not being able to eat or drink for almost 3 days). I was on the verge of vomiting. The 102 fever lasted 24 hours, then the fever hovered around 100 to 100.5 for the next 24 hours. On the third day when the fever broke, I had hives. Along with all the symptoms, I had a severe headache on the right side of my head by my right eye and at the base of my skull on the right side. This headache began minutes after the vaccine and continued to get worse. On the third day after the vaccine, Monday, May 23, I went to bed with such a severe headache and a numbness on the tight side of my face below my eye. I honestly thought I would dies of a clot in my sleep. It is now May 330, 10 days later and I still have the headache around my right eye that comes and gos in severity.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient likely was administered 0.25 mls of adult pfizer vaccine rather than full 0.3 mls. Patient will be in Friday to repeat dose.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Urticaria
Clinical narrative: I know that sometimes with the booster side effects can be headache and tiredness I did have those. However, my injection site has a welt the size of a half dollar which is unusual for me. Another symptom to report is dry mouth, I was drinking plenty of water but felt my mouth was severally dry.
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Urticaria
Clinical narrative: About 10-15 min after vaccines on the way out patient developed defuse urticaria to face and chest.  8 mg  dexamethasone given and monitored in office with resolution of urticaria after about 45 min.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Bone pain, Cyst, Joint range of motion decreased
Clinical narrative: First thing I noticed was a pain like my humorous was going to snap in half while moving in bed. Within a few more days I started to lose range of motion and constant pain in my shoulder. I was unable to put my bra on or reach across or stretch my left arm out. By the time week 2 rolled around, I struggled to be able to prepare dinner plates for my children. I sit with a heat pad on my should constantly for some relief. Finally went to my dr and he gave a cortisone shot. This was roughly a month after the vaccine. Cortisone shot was great at first. I finally was pain free and able to move around. My dr recommended physical therapy. First cortisone shot lasted 1 week. Went to physical therapy. Physical therapist agrees that there was something going on with the lose of range of motion. Went bad to dr to follow up with report from PT. Was given a second cortisone shot. Lasted 2 weeks. Dr ordered xray, which came back clear. Requested MRI. MRI shows tear in Labrum and an adjacent 1cm cyst. Referred to pain management and to an orthopedic surgeon. Appt with Orthopedic Surgeon is June 23 2022 for next steps. Possible surgery to repair tear.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, X-ray normal
Clinical narrative: First thing I noticed was a pain like my humorous was going to snap in half while moving in bed. Within a few more days I started to lose range of motion and constant pain in my shoulder. I was unable to put my bra on or reach across or stretch my left arm out. By the time week 2 rolled around, I struggled to be able to prepare dinner plates for my children. I sit with a heat pad on my should constantly for some relief. Finally went to my dr and he gave a cortisone shot. This was roughly a month after the vaccine. Cortisone shot was great at first. I finally was pain free and able to move around. My dr recommended physical therapy. First cortisone shot lasted 1 week. Went to physical therapy. Physical therapist agrees that there was something going on with the lose of range of motion. Went bad to dr to follow up with report from PT. Was given a second cortisone shot. Lasted 2 weeks. Dr ordered xray, which came back clear. Requested MRI. MRI shows tear in Labrum and an adjacent 1cm cyst. Referred to pain management and to an orthopedic surgeon. Appt with Orthopedic Surgeon is June 23 2022 for next steps. Possible surgery to repair tear.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chemotherapy, Chest pain, Computerised tomogram, Desmoplastic small round cell tumour
Clinical narrative: Prior to vaccination, I was a healthy 21 yo.  In June 2021, I was diagnosed with Desmoplastic Small Round Cell Tumors.  I began to have rib and chest pain, went to the ED and was told I have lymphoma,  The pain became  much worse within days of going to the ED.  I was then admitted to a hospital that reported it was a germ cell tumor, hodgkins lymphoma.  Due to the inconsistency in the diagnoses, I went to Hospital, where I received the correct diagnosis based on the pathology report,  I have endured 5 weeks of aggressive radiation, 5x a week, then began chemo, which I was to receive 14 rounds, but had only completed 11 due to mets to the testicles, I am currently getting enrolled into a clinical trial,
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Germ cell neoplasm, Hodgkin's disease, Lymphoma, Magnetic resonance imaging, Metastases to testicle
Clinical narrative: Prior to vaccination, I was a healthy 21 yo.  In June 2021, I was diagnosed with Desmoplastic Small Round Cell Tumors.  I began to have rib and chest pain, went to the ED and was told I have lymphoma,  The pain became  much worse within days of going to the ED.  I was then admitted to a hospital that reported it was a germ cell tumor, hodgkins lymphoma.  Due to the inconsistency in the diagnoses, I went to Hospital, where I received the correct diagnosis based on the pathology report,  I have endured 5 weeks of aggressive radiation, 5x a week, then began chemo, which I was to receive 14 rounds, but had only completed 11 due to mets to the testicles, I am currently getting enrolled into a clinical trial,
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pathology test, Radiotherapy
Clinical narrative: Prior to vaccination, I was a healthy 21 yo.  In June 2021, I was diagnosed with Desmoplastic Small Round Cell Tumors.  I began to have rib and chest pain, went to the ED and was told I have lymphoma,  The pain became  much worse within days of going to the ED.  I was then admitted to a hospital that reported it was a germ cell tumor, hodgkins lymphoma.  Due to the inconsistency in the diagnoses, I went to Hospital, where I received the correct diagnosis based on the pathology report,  I have endured 5 weeks of aggressive radiation, 5x a week, then began chemo, which I was to receive 14 rounds, but had only completed 11 due to mets to the testicles, I am currently getting enrolled into a clinical trial,
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Chills, Erythema, Fatigue, Illness
Clinical narrative: Within approx. 6 hours of receiving vaccines patient experienced flu-like symptoms (fever, chills, aches); recovered within a day.  Has never had an adverse reaction to prior Moderna vaccines (1st - 4/5/21, 2nd 6/3/21).  Within approx 10-14 days after receiving Moderna booster, began to experience an intense itch (at first in groin area - mistook for yeast infection but creams only seemed to make worse), then the itch spread to any & all body parts as an intensely itchy, red & raised welts (hives).  Seemed to be no pattern to where hives would occur except that simply scratching the skin could instigate raised hives & continued scratching makes it much worse.  If ignored, will fade within the hour or less but will recur elsewhere without respite; some form of global migrating dermatographic urticaria?  All areas of body seem susceptible (including scalp, soles, palms, ears - excepting does not occur directly on the face - no eyelids/cheeks/lips, forehead...)  Most OTC antihistamines did not mitigate the hives, but just 1/2 zyrtec (generic) almost made them disappear when taken daily; if this does is missed, hives become apparent again & gradually worsen as when first appeared.   Patient tired of taking Zyrtic daily due to perceived side effects & discontinued in April 2022 - hives were still present & just bearable if itching resisted.  In May 2022, family tested postive at home for Covid-19 (patient was asymptomatic except for tiredness), but hives all but ceased to exist during the week of illness in the household.  Within a week of illness in the household, hives have now returned, but at a lesser intensity.  Patient manages without medication at the moment.
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Influenza like illness, Pain, Pruritus, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Within approx. 6 hours of receiving vaccines patient experienced flu-like symptoms (fever, chills, aches); recovered within a day.  Has never had an adverse reaction to prior Moderna vaccines (1st - 4/5/21, 2nd 6/3/21).  Within approx 10-14 days after receiving Moderna booster, began to experience an intense itch (at first in groin area - mistook for yeast infection but creams only seemed to make worse), then the itch spread to any & all body parts as an intensely itchy, red & raised welts (hives).  Seemed to be no pattern to where hives would occur except that simply scratching the skin could instigate raised hives & continued scratching makes it much worse.  If ignored, will fade within the hour or less but will recur elsewhere without respite; some form of global migrating dermatographic urticaria?  All areas of body seem susceptible (including scalp, soles, palms, ears - excepting does not occur directly on the face - no eyelids/cheeks/lips, forehead...)  Most OTC antihistamines did not mitigate the hives, but just 1/2 zyrtec (generic) almost made them disappear when taken daily; if this does is missed, hives become apparent again & gradually worsen as when first appeared.   Patient tired of taking Zyrtic daily due to perceived side effects & discontinued in April 2022 - hives were still present & just bearable if itching resisted.  In May 2022, family tested postive at home for Covid-19 (patient was asymptomatic except for tiredness), but hives all but ceased to exist during the week of illness in the household.  Within a week of illness in the household, hives have now returned, but at a lesser intensity.  Patient manages without medication at the moment.
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Scratch, Skin swelling, Urticaria
Clinical narrative: Within approx. 6 hours of receiving vaccines patient experienced flu-like symptoms (fever, chills, aches); recovered within a day.  Has never had an adverse reaction to prior Moderna vaccines (1st - 4/5/21, 2nd 6/3/21).  Within approx 10-14 days after receiving Moderna booster, began to experience an intense itch (at first in groin area - mistook for yeast infection but creams only seemed to make worse), then the itch spread to any & all body parts as an intensely itchy, red & raised welts (hives).  Seemed to be no pattern to where hives would occur except that simply scratching the skin could instigate raised hives & continued scratching makes it much worse.  If ignored, will fade within the hour or less but will recur elsewhere without respite; some form of global migrating dermatographic urticaria?  All areas of body seem susceptible (including scalp, soles, palms, ears - excepting does not occur directly on the face - no eyelids/cheeks/lips, forehead...)  Most OTC antihistamines did not mitigate the hives, but just 1/2 zyrtec (generic) almost made them disappear when taken daily; if this does is missed, hives become apparent again & gradually worsen as when first appeared.   Patient tired of taking Zyrtic daily due to perceived side effects & discontinued in April 2022 - hives were still present & just bearable if itching resisted.  In May 2022, family tested postive at home for Covid-19 (patient was asymptomatic except for tiredness), but hives all but ceased to exist during the week of illness in the household.  Within a week of illness in the household, hives have now returned, but at a lesser intensity.  Patient manages without medication at the moment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Palpitations, Pyrexia
Clinical narrative: Racing and fluttering heart and shortness of breath. Fever
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Iliotibial band syndrome
Clinical narrative: patient explains that a week later (after the first dose), her IT band snapped in her right hip; This spontaneous case was reported by a patient and describes the occurrence of ILIOTIBIAL BAND SYNDROME (patient explains that a week later (after the first dose), her IT band snapped in her right hip) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Rheumatoid arthritis: Methotrexate in 2015; for Product used for unknown indication: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII and Methotrexate. Concurrent medical conditions included Drug allergy (Hydroxychloroquine) and Rheumatoid arthritis (Recent change in status was reported as Worse.).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ILIOTIBIAL BAND SYNDROME (patient explains that a week later (after the first dose), her IT band snapped in her right hip). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ILIOTIBIAL BAND SYNDROME (patient explains that a week later (after the first dose), her IT band snapped in her right hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.   This case was linked to MOD-2022-576771, MOD-2022-576823 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to NSAIDs), Celiac disease and Hypothyroidism.    On 01-Nov-2021 at 7:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-Mar-2022 to 20-Mar-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2022, SARS-CoV-2 test: positive (Positive) Positive. On 26-Mar-2022, SARS-CoV-2 test: negative (Negative) tested negative finally again after 5 days.         Concomitant medications were not reported.  It was reported Paxlovid rebound. Patient had tested negative after treatment and then positive again after 5 days later. It was very symptomatic. Patient had tested negative finally again after 5 days after that.  Patient reported say it was 15-16 from initial positive test.  The device date was reported 24-May-2022.  Company Comment: This spontaneous case concerns a 39-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious AESI of COVID-19 that occurred 4 months and 25 days after receiving mRNA-1273 vaccine as 3rd dose. The event was supported with positive SARS-CoV-2 test. Patient reported Paxlovid rebound, tested negative after treatment regimen but five days later became symptomatic and tested positive. Patient was then again tested negative 15-16 days from initial positive test. At the time of report, the outcome of event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non- serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 39-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious AESI of COVID-19 that occurred 4 months and 25 days after receiving mRNA-1273 vaccine as 3rd dose. The event was supported with positive SARS-CoV-2 test. Patient reported Paxlovid rebound, tested negative after treatment regimen but five days later became symptomatic and tested positive. Patient was then again tested negative 15-16 days from initial positive test. At the time of report, the outcome of event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non- serious based on medical judgement.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Dizziness, Dysstasia, Fall
Clinical narrative: I waited after the vaccine for about 25 minutes and when I got up to leave I started to get dizzy and falling over, my mom had to catch me. I went home and was having issues staying awake and standing up. After about two hours I was losing strength in my right leg. The next day I went to urgent care. They advised they thought it was a side effect of the vaccine. I was given a note to miss work for a week. A week later I had a follow with my Primary Care Physician and he had me start doing physical therapy for 3-4 months. I did a blood test which came back normal.  I wasn't able to go to work. I was put on limited work for only 5 hours. I was told I would not be able to lift more that 20 pounds. After 10 months I had to resign from my position.    I did another blood test last month and it showed muscle degeneration. They did an electronic nerve test in my leg and it showed some signs of nerve damage since I could not feel the pulses, but the nerves were responding during the test.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Muscle atrophy, Nerve conduction studies abnormal, Nerve injury, Somnolence
Clinical narrative: I waited after the vaccine for about 25 minutes and when I got up to leave I started to get dizzy and falling over, my mom had to catch me. I went home and was having issues staying awake and standing up. After about two hours I was losing strength in my right leg. The next day I went to urgent care. They advised they thought it was a side effect of the vaccine. I was given a note to miss work for a week. A week later I had a follow with my Primary Care Physician and he had me start doing physical therapy for 3-4 months. I did a blood test which came back normal.  I wasn't able to go to work. I was put on limited work for only 5 hours. I was told I would not be able to lift more that 20 pounds. After 10 months I had to resign from my position.    I did another blood test last month and it showed muscle degeneration. They did an electronic nerve test in my leg and it showed some signs of nerve damage since I could not feel the pulses, but the nerves were responding during the test.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aphasia, Asthenia, Autopsy, Communication disorder, Death
Clinical narrative: Pfizer-BioNTech and Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer-BioNTech Vaccines on 1/20/2021 and 2/8/2021. Per report, after second vaccine, patient experienced chillls, shaking, fever of 102.6, could not focus, and low energy.  Patient received Moderna Vaccine on 12/10/2021. Per patient's daughter, patient had a lowgrade fever on 12/10/21. Patient's fever then broke on 12/11/2021. Patient stopped breathing on the way to the emergency department and the patient expired on 12/12/2021.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeding disorder, Fluid intake reduced, Gait inability, Hypersomnia, Incoherent
Clinical narrative: Pfizer-BioNTech and Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer-BioNTech Vaccines on 1/20/2021 and 2/8/2021. Per report, after second vaccine, patient experienced chillls, shaking, fever of 102.6, could not focus, and low energy.  Patient received Moderna Vaccine on 12/10/2021. Per patient's daughter, patient had a lowgrade fever on 12/10/21. Patient's fever then broke on 12/11/2021. Patient stopped breathing on the way to the emergency department and the patient expired on 12/12/2021.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Pyrexia, Respiratory arrest, Resuscitation, Tremor
Clinical narrative: Pfizer-BioNTech and Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer-BioNTech Vaccines on 1/20/2021 and 2/8/2021. Per report, after second vaccine, patient experienced chillls, shaking, fever of 102.6, could not focus, and low energy.  Patient received Moderna Vaccine on 12/10/2021. Per patient's daughter, patient had a lowgrade fever on 12/10/21. Patient's fever then broke on 12/11/2021. Patient stopped breathing on the way to the emergency department and the patient expired on 12/12/2021.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Death, Disturbance in attention, Interchange of vaccine products
Clinical narrative: Pfizer-BioNTech and Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer-BioNTech Vaccines on 1/20/2021 and 2/8/2021. Per report, after second vaccine, patient experienced chillls, shaking, fever of 102.6, could not focus, and low energy.  Patient received Moderna Vaccine on 12/10/2021. Per patient's daughter, patient had a lowgrade fever on 12/10/21. Patient's fever then broke on 12/11/2021. Patient stopped breathing on the way to the emergency department and the patient expired on 12/12/2021.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Respiratory arrest, Tremor
Clinical narrative: Pfizer-BioNTech and Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer-BioNTech Vaccines on 1/20/2021 and 2/8/2021. Per report, after second vaccine, patient experienced chillls, shaking, fever of 102.6, could not focus, and low energy.  Patient received Moderna Vaccine on 12/10/2021. Per patient's daughter, patient had a lowgrade fever on 12/10/21. Patient's fever then broke on 12/11/2021. Patient stopped breathing on the way to the emergency department and the patient expired on 12/12/2021.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via Pfizer (other manufacturer) concerned a 65 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, hashimoto's thyroiditis and sulfa drug allergy. The patient was not pregnant. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported, 1 total, administered on right arm on an unspecified date in MAR-2021 for prophylactic vaccination.  The patient additionally received non-company suspect vaccine included: elasomeran (Spikevax) (Dose number in series 2) (form of admin, route of admin and batch number were not reported and expiry: unknown) dose was not reported, administered on left arm on 26-OCT-2021 for prophylactic vaccination. Concomitant medications included etanercept and levothyroxine.  The patient was prescribed Paxlovid following a positive Covid test (confirmed clinical vaccination failure) (Dose number in series 1) after experiencing symptoms of high fever, cough and intense headache (confirmed covid-19 infection) (Dose number in series 2). The patient began taking Paxlovid on 03-MAY-2022 and completed the 5-day treatment on 08-MAY-2022 for covid-19 treatment. The patient tested and received negative tests using the rapid tests on 08-MAY-2022 and 10-MAY-2022.  On 14-MAY-2022, the patient had a runny nose, a slight cough and a mild headache and she tested again and received a strong positive result. The patient had no fever, nor the intense fatigue that she experienced previously when tested positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000232592.; Sender's Comments: V0:20220548056-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via Pfizer (other manufacturer) concerned a 65 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, hashimoto's thyroiditis and sulfa drug allergy. The patient was not pregnant. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported, 1 total, administered on right arm on an unspecified date in MAR-2021 for prophylactic vaccination.  The patient additionally received non-company suspect vaccine included: elasomeran (Spikevax) (Dose number in series 2) (form of admin, route of admin and batch number were not reported and expiry: unknown) dose was not reported, administered on left arm on 26-OCT-2021 for prophylactic vaccination. Concomitant medications included etanercept and levothyroxine.  The patient was prescribed Paxlovid following a positive Covid test (confirmed clinical vaccination failure) (Dose number in series 1) after experiencing symptoms of high fever, cough and intense headache (confirmed covid-19 infection) (Dose number in series 2). The patient began taking Paxlovid on 03-MAY-2022 and completed the 5-day treatment on 08-MAY-2022 for covid-19 treatment. The patient tested and received negative tests using the rapid tests on 08-MAY-2022 and 10-MAY-2022.  On 14-MAY-2022, the patient had a runny nose, a slight cough and a mild headache and she tested again and received a strong positive result. The patient had no fever, nor the intense fatigue that she experienced previously when tested positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000232592.; Sender's Comments: V0:20220548056-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included: drug allergy and concurrent conditions included: hyperprolactinemia and other pre-existing medical conditions included: the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 180525 expiry: unknown) dose was not reported, 1 total, administered on 19-MAR-2021 in left arm for prophylactic vaccination. Age at time of vaccination 37 years old. Concomitant medications included cabergoline, cetirizine hydrochloride and fluticasone propionate. The patient received three doses of additional non-company suspect vaccine Pfizer BioNTech (tozinameran) (Dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, first dose administered on 16-SEP-2021, second dose administered on 07-OCT-2021 and third dose (form of admin and route of admin were not reported batch number: FK9896 expiry: unknown) dose was not reported, administered in left arm on 19-MAR-2022 for prophylactic vaccination.  On an unspecified date, the patient had Covid symptoms (suspected covid-19 infection) (dose number in series 2) which led to suspected clinical vaccination failure (Dose number in series 1) for which patient took Paxlovid from 07-MAY-2022 till 11-MAY-2022. On 16-MAY-2022, the patient experienced return of Covid symptoms sore throat, fatigue and body aches (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220542331- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included: drug allergy and concurrent conditions included: hyperprolactinemia and other pre-existing medical conditions included: the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 180525 expiry: unknown) dose was not reported, 1 total, administered on 19-MAR-2021 in left arm for prophylactic vaccination. Age at time of vaccination 37 years old. Concomitant medications included cabergoline, cetirizine hydrochloride and fluticasone propionate. The patient received three doses of additional non-company suspect vaccine Pfizer BioNTech (tozinameran) (Dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, first dose administered on 16-SEP-2021, second dose administered on 07-OCT-2021 and third dose (form of admin and route of admin were not reported batch number: FK9896 expiry: unknown) dose was not reported, administered in left arm on 19-MAR-2022 for prophylactic vaccination.  On an unspecified date, the patient had Covid symptoms (suspected covid-19 infection) (dose number in series 2) which led to suspected clinical vaccination failure (Dose number in series 1) for which patient took Paxlovid from 07-MAY-2022 till 11-MAY-2022. On 16-MAY-2022, the patient experienced return of Covid symptoms sore throat, fatigue and body aches (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220542331- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body height, Breast pain, Cold sweat, Eye pain, Fatigue
Clinical narrative: had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.; Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Overweight (but not severely obese) and C-section (had a C-Section 18 years ago).   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2021, the patient experienced SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever). At the time of the report, SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-575219 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Limb discomfort, Pain, Pain in extremity, Pyrexia
Clinical narrative: had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.; Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Overweight (but not severely obese) and C-section (had a C-Section 18 years ago).   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2021, the patient experienced SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever). At the time of the report, SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-575219 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Pyrexia, Spinal disorder
Clinical narrative: had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.; Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Overweight (but not severely obese) and C-section (had a C-Section 18 years ago).   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2021, the patient experienced SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever). At the time of the report, SPINAL DISORDER (had the same sensation after the Moderna Booster in the middle of the night/ clarified the feeling felt like a spinal, it didn't feel like it was going through her spine but what happens afterwards.), FEELING ABNORMAL (Clarified the feeling as a shock through her whole body/ clarified that it felt like her legs through her body) and PYREXIA (Had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-575219 (Patient Link).