chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Scan with contrast abnormal, Sensory loss, Speech disorder, Taste disorder
Clinical narrative: Five days after receiving a 3rd dose of Pfizer?s COVID vaccine, patient experienced painful bilateral musculoskeletal back spasms that progressively ascended from the lumbar to cervical region over the course of 4 days.  Previously, he was in his usual state of health with no recent history of infection, rash, travel abroad, exposure to tick bites or trauma.  Patient is a non-smoker and does not consume alcohol/illicit drugs.  First Pfizer Vaccine Dose on 16 Feb 2021 and Second Pfizer Dose on 9 March 2021 with minimal side effects for 36 hours.   By Day 4, various back regions began losing sensation in thoracic dermatomes, with onset of bilateral finger tip tingling (median nerve distribution - 1st thru 3rd digits), altered taste sensation, bilateral facial pain and bilateral dorsal foot and toe numbness.  On Day 5, there was onset of prominent fatigue, oral/buccal numbness, complete loss of taste and rapidly progressive right facial paresis to paralysis within 12 hours.  This prompted an ER visit, with a negative head CT.  By Day 6, there was severe right facial paralysis with left facial paresis and loss of ability to hold water or food in mouth with impaired speech.   Admitted to inpatient neurology on Day 7 of symptom onset (Day 11 after vaccine administration) with bilateral reduced patellar and absent ankle reflexes, lower extremity muscle weakness progression, episodic vertigo with nausea/vomiting and diffuse extremity/back paresthesia or numbness.  On Day 8, there was bilateral complete loss of patellar and ankle reflexes and R > L 4/5 proximal leg weakness.  Preserved upper extremity reflexes and afebrile throughout hospitalization.  Loss of pinprick to mid-calf bilaterally.  Mastication fatigue without dysphagia.  Pulmonary function assessments were within normal limits.  No bladder or bowel involvement at any point.  Lumbar puncture with albumin-cytological dissocation.  Diagnosed with Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barre Syndrome) due to COVID vaccination.  Treated with IVIG over a 5 day period with hypertension elevations.   Symptom plateau half-way through treatment.  Discharge home on hospital day #8 with ability to ambulate short-distance without assistive devices, but with easy muscular fatigue.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Vomiting, White blood cell count normal
Clinical narrative: Five days after receiving a 3rd dose of Pfizer?s COVID vaccine, patient experienced painful bilateral musculoskeletal back spasms that progressively ascended from the lumbar to cervical region over the course of 4 days.  Previously, he was in his usual state of health with no recent history of infection, rash, travel abroad, exposure to tick bites or trauma.  Patient is a non-smoker and does not consume alcohol/illicit drugs.  First Pfizer Vaccine Dose on 16 Feb 2021 and Second Pfizer Dose on 9 March 2021 with minimal side effects for 36 hours.   By Day 4, various back regions began losing sensation in thoracic dermatomes, with onset of bilateral finger tip tingling (median nerve distribution - 1st thru 3rd digits), altered taste sensation, bilateral facial pain and bilateral dorsal foot and toe numbness.  On Day 5, there was onset of prominent fatigue, oral/buccal numbness, complete loss of taste and rapidly progressive right facial paresis to paralysis within 12 hours.  This prompted an ER visit, with a negative head CT.  By Day 6, there was severe right facial paralysis with left facial paresis and loss of ability to hold water or food in mouth with impaired speech.   Admitted to inpatient neurology on Day 7 of symptom onset (Day 11 after vaccine administration) with bilateral reduced patellar and absent ankle reflexes, lower extremity muscle weakness progression, episodic vertigo with nausea/vomiting and diffuse extremity/back paresthesia or numbness.  On Day 8, there was bilateral complete loss of patellar and ankle reflexes and R > L 4/5 proximal leg weakness.  Preserved upper extremity reflexes and afebrile throughout hospitalization.  Loss of pinprick to mid-calf bilaterally.  Mastication fatigue without dysphagia.  Pulmonary function assessments were within normal limits.  No bladder or bowel involvement at any point.  Lumbar puncture with albumin-cytological dissocation.  Diagnosed with Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barre Syndrome) due to COVID vaccination.  Treated with IVIG over a 5 day period with hypertension elevations.   Symptom plateau half-way through treatment.  Discharge home on hospital day #8 with ability to ambulate short-distance without assistive devices, but with easy muscular fatigue.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Eye swelling, Flushing, Lip swelling, Swollen tongue
Clinical narrative: Received first Pfizer vaccine around 11AM. She started getting hives and flush and then started to feel like her eyes and bottom of tongue were swelling. No difficulty breathing or swallowing. Bottom lip feels swollen. She feels a little tight in her chest but this can be baseline for her. Took Zyrtec around 12:30 PM.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Received first Pfizer vaccine around 11AM. She started getting hives and flush and then started to feel like her eyes and bottom of tongue were swelling. No difficulty breathing or swallowing. Bottom lip feels swollen. She feels a little tight in her chest but this can be baseline for her. Took Zyrtec around 12:30 PM.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child was 11 at the time of vaccine.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child was 11 at the time of vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Blood pressure increased, Blood pressure measurement, Dizziness, Feeling abnormal
Clinical narrative: Within minutes of administration, my right arm felt numb, tingling and very cold. After a few more minutes my left arm and feet started to get the same sensation. It felt like pins and needles. I got light-headed and dizzy. My throat felt very itchy and like I needed to cough. My blood pressure went up to 143/78. After approximately 30-45 minutes, I started to feel a bit better but then had a hot flash in my head when I went to leave. After the encouragement of the Occupational Health RN, I went to be seen by my NP. The rest of the day, I felt "off" and not normal. My throat was itchy for 2 days following the vaccine. I took aspirin, Zyrtec, claritin, famotidine and benadryl for 2 days to get rid of the itchy throat.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Heart rate, Hot flush, Hypoaesthesia, Oxygen saturation
Clinical narrative: Within minutes of administration, my right arm felt numb, tingling and very cold. After a few more minutes my left arm and feet started to get the same sensation. It felt like pins and needles. I got light-headed and dizzy. My throat felt very itchy and like I needed to cough. My blood pressure went up to 143/78. After approximately 30-45 minutes, I started to feel a bit better but then had a hot flash in my head when I went to leave. After the encouragement of the Occupational Health RN, I went to be seen by my NP. The rest of the day, I felt "off" and not normal. My throat was itchy for 2 days following the vaccine. I took aspirin, Zyrtec, claritin, famotidine and benadryl for 2 days to get rid of the itchy throat.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Throat irritation, Vital capacity
Clinical narrative: Within minutes of administration, my right arm felt numb, tingling and very cold. After a few more minutes my left arm and feet started to get the same sensation. It felt like pins and needles. I got light-headed and dizzy. My throat felt very itchy and like I needed to cough. My blood pressure went up to 143/78. After approximately 30-45 minutes, I started to feel a bit better but then had a hot flash in my head when I went to leave. After the encouragement of the Occupational Health RN, I went to be seen by my NP. The rest of the day, I felt "off" and not normal. My throat was itchy for 2 days following the vaccine. I took aspirin, Zyrtec, claritin, famotidine and benadryl for 2 days to get rid of the itchy throat.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Hot flush, Hypoaesthesia, Paraesthesia
Clinical narrative: Within minutes of administration, my right arm felt numb, tingling and very cold. After a few more minutes my left arm and feet started to get the same sensation. It felt like pins and needles. I got light-headed and dizzy. My throat felt very itchy and like I needed to cough. My blood pressure went up to 143/78. After approximately 30-45 minutes, I started to feel a bit better but then had a hot flash in my head when I went to leave. After the encouragement of the Occupational Health RN, I went to be seen by my NP. The rest of the day, I felt "off" and not normal. My throat was itchy for 2 days following the vaccine. I took aspirin, Zyrtec, claritin, famotidine and benadryl for 2 days to get rid of the itchy throat.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Throat irritation
Clinical narrative: Within minutes of administration, my right arm felt numb, tingling and very cold. After a few more minutes my left arm and feet started to get the same sensation. It felt like pins and needles. I got light-headed and dizzy. My throat felt very itchy and like I needed to cough. My blood pressure went up to 143/78. After approximately 30-45 minutes, I started to feel a bit better but then had a hot flash in my head when I went to leave. After the encouragement of the Occupational Health RN, I went to be seen by my NP. The rest of the day, I felt "off" and not normal. My throat was itchy for 2 days following the vaccine. I took aspirin, Zyrtec, claritin, famotidine and benadryl for 2 days to get rid of the itchy throat.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Chest X-ray, Dizziness, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: Tongue swelling, rash on thighs & torso,  headache, fever, chest pain, dizziness, blurred vision, fatigue, disruption in menstrual cycle, unable to focus/concentrate,low heart rate,  inflammation in the lymph nodes, hair loss , inflammation in chest,shortness of breath
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Swollen tongue
Clinical narrative: Tongue swelling, rash on thighs & torso,  headache, fever, chest pain, dizziness, blurred vision, fatigue, disruption in menstrual cycle, unable to focus/concentrate,low heart rate,  inflammation in the lymph nodes, hair loss , inflammation in chest,shortness of breath
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Blood test, Chest pain, Disturbance in attention, Dizziness
Clinical narrative: Tongue swelling, rash on thighs & torso,  headache, fever, chest pain, dizziness, blurred vision, fatigue, disruption in menstrual cycle, unable to focus/concentrate,low heart rate,  inflammation in the lymph nodes, hair loss , inflammation in chest,shortness of breath
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Headache, Heart rate decreased
Clinical narrative: Tongue swelling, rash on thighs & torso,  headache, fever, chest pain, dizziness, blurred vision, fatigue, disruption in menstrual cycle, unable to focus/concentrate,low heart rate,  inflammation in the lymph nodes, hair loss , inflammation in chest,shortness of breath
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inflammation, Lymphadenopathy, Menstrual disorder, Pyrexia, Rash
Clinical narrative: Tongue swelling, rash on thighs & torso,  headache, fever, chest pain, dizziness, blurred vision, fatigue, disruption in menstrual cycle, unable to focus/concentrate,low heart rate,  inflammation in the lymph nodes, hair loss , inflammation in chest,shortness of breath
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Vision blurred
Clinical narrative: Tongue swelling, rash on thighs & torso,  headache, fever, chest pain, dizziness, blurred vision, fatigue, disruption in menstrual cycle, unable to focus/concentrate,low heart rate,  inflammation in the lymph nodes, hair loss , inflammation in chest,shortness of breath
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Clubbing, Fatigue, Joint swelling, Muscular weakness, Nodule
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Mild, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pallor, Peripheral swelling, Sensitive skin, Skin discolouration
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Mild, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Synovial cyst
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Mild, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Diarrhoea, Dysphagia, Hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Mild, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Nausea, Throat tightness
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Mild, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt started to feel ill on 9/18 was tested for COVID at clinic on 9/20 with positive results and came to BFV ED for evaluation and treatment Pt met the criteria for Monoclonal antibody tx and referral was made
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Laboratory test, Malaise, SARS-CoV-2 test positive
Clinical narrative: Pt started to feel ill on 9/18 was tested for COVID at clinic on 9/20 with positive results and came to BFV ED for evaluation and treatment Pt met the criteria for Monoclonal antibody tx and referral was made
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Breast mass, Dyspnoea, Heart rate
Clinical narrative: Several days after 2nd dose, heart began to palpitate.  A few days later, discovered lump in left breast (vaccination arm)  which has been diagnosed as invasive ductal carcinoma. On May 26, heart went into AFIB and I was admitted to Health facility.  Heart rate was 180 and in AFIB.  Admitted again to Healthcare facility again on July 15. Heart was in AFIB.  After 2nd dose, I could no longer control my blood pressure nor heart rate and I am now in chemotherapy for breast cancer at Hospital.  All of this after 71 years of good health. I am now on Metoprolol and Eliquis and visiting a chemo center every Wednesday.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate abnormal, Pain, Palpitations
Clinical narrative: Several days after 2nd dose, heart began to palpitate.  A few days later, discovered lump in left breast (vaccination arm)  which has been diagnosed as invasive ductal carcinoma. On May 26, heart went into AFIB and I was admitted to Health facility.  Heart rate was 180 and in AFIB.  Admitted again to Healthcare facility again on July 15. Heart was in AFIB.  After 2nd dose, I could no longer control my blood pressure nor heart rate and I am now in chemotherapy for breast cancer at Hospital.  All of this after 71 years of good health. I am now on Metoprolol and Eliquis and visiting a chemo center every Wednesday.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Blood pressure abnormal, Breast cancer female, Breast mass
Clinical narrative: Several days after 2nd dose, heart began to palpitate.  A few days later, discovered lump in left breast (vaccination arm)  which has been diagnosed as invasive ductal carcinoma. On May 26, heart went into AFIB and I was admitted to Health facility.  Heart rate was 180 and in AFIB.  Admitted again to Healthcare facility again on July 15. Heart was in AFIB.  After 2nd dose, I could no longer control my blood pressure nor heart rate and I am now in chemotherapy for breast cancer at Hospital.  All of this after 71 years of good health. I am now on Metoprolol and Eliquis and visiting a chemo center every Wednesday.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chemotherapy, Heart rate abnormal, Invasive ductal breast carcinoma, Metabolic function test, Palpitations
Clinical narrative: Several days after 2nd dose, heart began to palpitate.  A few days later, discovered lump in left breast (vaccination arm)  which has been diagnosed as invasive ductal carcinoma. On May 26, heart went into AFIB and I was admitted to Health facility.  Heart rate was 180 and in AFIB.  Admitted again to Healthcare facility again on July 15. Heart was in AFIB.  After 2nd dose, I could no longer control my blood pressure nor heart rate and I am now in chemotherapy for breast cancer at Hospital.  All of this after 71 years of good health. I am now on Metoprolol and Eliquis and visiting a chemo center every Wednesday.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: patient received 2nd Dose of moderna, 3 days later arm became red, warm to the touch, went to pcp was diagnosed cellulitis
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: patient received 2nd Dose of moderna, 3 days later arm became red, warm to the touch, went to pcp was diagnosed cellulitis
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Urticaria, Varicella
Clinical narrative: doctor said  it was a chicken pox type reaction; firm red, whitish raised blister; red spots all over my body; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax in September 2013). Concurrent medical conditions included shingles (4 outbreaks of shingles starting in 1970).   On 26th August 2021 12:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th August 2021, less than 2 months after receiving Shingrix, the patient experienced chickenpox and blister. On 26th August 2021 11:30, the patient experienced red spotty rash. The patient was treated with benadryl (nos) (Benadryl), non-drug therapy (Hot Compresses) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the chickenpox, blister and red spotty rash were recovered/resolved.   It was unknown if the reporter considered the chickenpox, blister and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received 1st dose of Shingrix and after 11 hours in evening had 10 or 11 red spots all over her body(one or two spots on each arm, one or two on each leg and one of my chest). Then patient developed a firm red, whitish raised blister, she called doctor and the doctor said it was a chickenpox type reaction. The patient took Benadryl and used hot and ice compress, all the spots and blister went away in 6 or 7 days. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Induration, Rash, Rash erythematous, Rash macular
Clinical narrative: doctor said  it was a chicken pox type reaction; firm red, whitish raised blister; red spots all over my body; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax in September 2013). Concurrent medical conditions included shingles (4 outbreaks of shingles starting in 1970).   On 26th August 2021 12:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th August 2021, less than 2 months after receiving Shingrix, the patient experienced chickenpox and blister. On 26th August 2021 11:30, the patient experienced red spotty rash. The patient was treated with benadryl (nos) (Benadryl), non-drug therapy (Hot Compresses) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the chickenpox, blister and red spotty rash were recovered/resolved.   It was unknown if the reporter considered the chickenpox, blister and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received 1st dose of Shingrix and after 11 hours in evening had 10 or 11 red spots all over her body(one or two spots on each arm, one or two on each leg and one of my chest). Then patient developed a firm red, whitish raised blister, she called doctor and the doctor said it was a chickenpox type reaction. The patient took Benadryl and used hot and ice compress, all the spots and blister went away in 6 or 7 days. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash papular, Varicella
Clinical narrative: doctor said  it was a chicken pox type reaction; firm red, whitish raised blister; red spots all over my body; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax in September 2013). Concurrent medical conditions included shingles (4 outbreaks of shingles starting in 1970).   On 26th August 2021 12:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th August 2021, less than 2 months after receiving Shingrix, the patient experienced chickenpox and blister. On 26th August 2021 11:30, the patient experienced red spotty rash. The patient was treated with benadryl (nos) (Benadryl), non-drug therapy (Hot Compresses) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the chickenpox, blister and red spotty rash were recovered/resolved.   It was unknown if the reporter considered the chickenpox, blister and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received 1st dose of Shingrix and after 11 hours in evening had 10 or 11 red spots all over her body(one or two spots on each arm, one or two on each leg and one of my chest). Then patient developed a firm red, whitish raised blister, she called doctor and the doctor said it was a chickenpox type reaction. The patient took Benadryl and used hot and ice compress, all the spots and blister went away in 6 or 7 days. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Muscle spasms, Rash erythematous
Clinical narrative: Shingles; Fluid filled blisters; red raised rash; Fatigue; Headache; Shooting pain in body; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th September 2021, 1 days after receiving Shingrix, the patient experienced fatigue, headache and shooting pain. On 26th September 2021, the patient experienced red rash. On 27th September 2021, the patient experienced shingles and blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the fatigue, headache, shooting pain, red rash, shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, shooting pain, red rash, shingles and blister to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the dose of Shingrix and the next day on the 24th September 2012, she began to experience fatigue, headache and shooting pain in her body. By 26 September 2021, she had developed a red raised rash and by 27th September 2021 was diagnosed with shingles and had fluid filled blisters.  None of these symptoms have resolved. She reported that she was currently being treated with valacyclovir.  She also stated that she had reported this online in the VAERS system. The reporter consented to follow up. The reporter had requested to contact from safety department concerning her case by phone call or personalized follow up letter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal rigidity, Fatigue, Headache, Herpes zoster, Mobility decreased
Clinical narrative: Shingles; Fluid filled blisters; red raised rash; Fatigue; Headache; Shooting pain in body; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th September 2021, 1 days after receiving Shingrix, the patient experienced fatigue, headache and shooting pain. On 26th September 2021, the patient experienced red rash. On 27th September 2021, the patient experienced shingles and blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the fatigue, headache, shooting pain, red rash, shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, shooting pain, red rash, shingles and blister to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the dose of Shingrix and the next day on the 24th September 2012, she began to experience fatigue, headache and shooting pain in her body. By 26 September 2021, she had developed a red raised rash and by 27th September 2021 was diagnosed with shingles and had fluid filled blisters.  None of these symptoms have resolved. She reported that she was currently being treated with valacyclovir.  She also stated that she had reported this online in the VAERS system. The reporter consented to follow up. The reporter had requested to contact from safety department concerning her case by phone call or personalized follow up letter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash, Rash erythematous, Rash papular
Clinical narrative: Shingles; Fluid filled blisters; red raised rash; Fatigue; Headache; Shooting pain in body; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th September 2021, 1 days after receiving Shingrix, the patient experienced fatigue, headache and shooting pain. On 26th September 2021, the patient experienced red rash. On 27th September 2021, the patient experienced shingles and blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the fatigue, headache, shooting pain, red rash, shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, shooting pain, red rash, shingles and blister to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the dose of Shingrix and the next day on the 24th September 2012, she began to experience fatigue, headache and shooting pain in her body. By 26 September 2021, she had developed a red raised rash and by 27th September 2021 was diagnosed with shingles and had fluid filled blisters.  None of these symptoms have resolved. She reported that she was currently being treated with valacyclovir.  She also stated that she had reported this online in the VAERS system. The reporter consented to follow up. The reporter had requested to contact from safety department concerning her case by phone call or personalized follow up letter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Fatigue, Headache, Herpes zoster, Pain
Clinical narrative: Shingles; Fluid filled blisters; red raised rash; Fatigue; Headache; Shooting pain in body; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th September 2021, 1 days after receiving Shingrix, the patient experienced fatigue, headache and shooting pain. On 26th September 2021, the patient experienced red rash. On 27th September 2021, the patient experienced shingles and blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the fatigue, headache, shooting pain, red rash, shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, shooting pain, red rash, shingles and blister to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the dose of Shingrix and the next day on the 24th September 2012, she began to experience fatigue, headache and shooting pain in her body. By 26 September 2021, she had developed a red raised rash and by 27th September 2021 was diagnosed with shingles and had fluid filled blisters.  None of these symptoms have resolved. She reported that she was currently being treated with valacyclovir.  She also stated that she had reported this online in the VAERS system. The reporter consented to follow up. The reporter had requested to contact from safety department concerning her case by phone call or personalized follow up letter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Shingles; Fluid filled blisters; red raised rash; Fatigue; Headache; Shooting pain in body; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th September 2021, 1 days after receiving Shingrix, the patient experienced fatigue, headache and shooting pain. On 26th September 2021, the patient experienced red rash. On 27th September 2021, the patient experienced shingles and blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the fatigue, headache, shooting pain, red rash, shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, shooting pain, red rash, shingles and blister to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the dose of Shingrix and the next day on the 24th September 2012, she began to experience fatigue, headache and shooting pain in her body. By 26 September 2021, she had developed a red raised rash and by 27th September 2021 was diagnosed with shingles and had fluid filled blisters.  None of these symptoms have resolved. She reported that she was currently being treated with valacyclovir.  She also stated that she had reported this online in the VAERS system. The reporter consented to follow up. The reporter had requested to contact from safety department concerning her case by phone call or personalized follow up letter.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Fever, tremors following shot for 36 hours. Rib cage bruising and petechiae one month after shot. Extremely low platelet count  (9) discovered during pre-OP blood work for scheduled hernia surgery (July 13th). Admitted to hospital for treatment IV-IGG which rasied the count to 247. Discharged on July 15th. Weekly follow-up with the hemotologist doctor on Prednisone. Treatment began at 60 mg/d and has been reduced to 7.5 mg/d. Platelet count has dropped accordingly. Today's blood count (Oct 4th) was 16. New proposed treatment with Rituxan is scheuled IV.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bone contusion, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Fever, tremors following shot for 36 hours. Rib cage bruising and petechiae one month after shot. Extremely low platelet count  (9) discovered during pre-OP blood work for scheduled hernia surgery (July 13th). Admitted to hospital for treatment IV-IGG which rasied the count to 247. Discharged on July 15th. Weekly follow-up with the hemotologist doctor on Prednisone. Treatment began at 60 mg/d and has been reduced to 7.5 mg/d. Platelet count has dropped accordingly. Today's blood count (Oct 4th) was 16. New proposed treatment with Rituxan is scheuled IV.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever, tremors following shot for 36 hours. Rib cage bruising and petechiae one month after shot. Extremely low platelet count  (9) discovered during pre-OP blood work for scheduled hernia surgery (July 13th). Admitted to hospital for treatment IV-IGG which rasied the count to 247. Discharged on July 15th. Weekly follow-up with the hemotologist doctor on Prednisone. Treatment began at 60 mg/d and has been reduced to 7.5 mg/d. Platelet count has dropped accordingly. Today's blood count (Oct 4th) was 16. New proposed treatment with Rituxan is scheuled IV.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic valve replacement, Blood culture, Body temperature increased, Cardiac valve abscess, Cerebral thrombosis
Clinical narrative: Numerous Blood clots Left Below the knee amputation Stroke Endocarditis Aortic valve replacement Abscess to aorta Heart attack due to embolism Coded three times Pneumonia Sepsis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Chest X-ray, Computerised tomogram, Echocardiogram abnormal, Embolism
Clinical narrative: Numerous Blood clots Left Below the knee amputation Stroke Endocarditis Aortic valve replacement Abscess to aorta Heart attack due to embolism Coded three times Pneumonia Sepsis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endocarditis, Full blood count, Infection, Intracardiac thrombus, Myocardial infarction
Clinical narrative: Numerous Blood clots Left Below the knee amputation Stroke Endocarditis Aortic valve replacement Abscess to aorta Heart attack due to embolism Coded three times Pneumonia Sepsis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, Scan, Thrombosis, Ultrasound scan
Clinical narrative: Numerous Blood clots Left Below the knee amputation Stroke Endocarditis Aortic valve replacement Abscess to aorta Heart attack due to embolism Coded three times Pneumonia Sepsis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic valve replacement, Cardiac valve abscess, Cardio-respiratory arrest, Cerebrovascular accident, Embolism
Clinical narrative: Numerous Blood clots Left Below the knee amputation Stroke Endocarditis Aortic valve replacement Abscess to aorta Heart attack due to embolism Coded three times Pneumonia Sepsis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endocarditis, Leg amputation, Myocardial infarction, Pneumonia, Sepsis
Clinical narrative: Numerous Blood clots Left Below the knee amputation Stroke Endocarditis Aortic valve replacement Abscess to aorta Heart attack due to embolism Coded three times Pneumonia Sepsis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Numerous Blood clots Left Below the knee amputation Stroke Endocarditis Aortic valve replacement Abscess to aorta Heart attack due to embolism Coded three times Pneumonia Sepsis
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis
Clinical narrative: Unknown brand of COVID vaccine as I did not order nor give it to the patient. May be correlation rather than causation as these things do happen, but patient had her second MRNA dose  on Tuesday and reported miscarriage on Saturday.  She did report some light spotting earlier that week prior to the miscarriage. Was seen in ED for abdominal pain and vaginal bleeding.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Full blood count, Human chorionic gonadotropin, Maternal exposure before pregnancy, Metabolic function test
Clinical narrative: Unknown brand of COVID vaccine as I did not order nor give it to the patient. May be correlation rather than causation as these things do happen, but patient had her second MRNA dose  on Tuesday and reported miscarriage on Saturday.  She did report some light spotting earlier that week prior to the miscarriage. Was seen in ED for abdominal pain and vaginal bleeding.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan vagina, Urine analysis
Clinical narrative: Unknown brand of COVID vaccine as I did not order nor give it to the patient. May be correlation rather than causation as these things do happen, but patient had her second MRNA dose  on Tuesday and reported miscarriage on Saturday.  She did report some light spotting earlier that week prior to the miscarriage. Was seen in ED for abdominal pain and vaginal bleeding.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dysphonia, Inflammation, Malaise, Pruritus
Clinical narrative: vomiting / red eyes / blood clots / itchy / plaque burns / inflammations all body from eyes to  toes / deformation body
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Vaginal haemorrhage, Vomiting
Clinical narrative: vomiting / red eyes / blood clots / itchy / plaque burns / inflammations all body from eyes to  toes / deformation body
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deformity, Inflammation, Ocular hyperaemia, Pruritus, Skin plaque
Clinical narrative: vomiting / red eyes / blood clots / itchy / plaque burns / inflammations all body from eyes to  toes / deformation body
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thermal burn, Thrombosis, Vomiting
Clinical narrative: vomiting / red eyes / blood clots / itchy / plaque burns / inflammations all body from eyes to  toes / deformation body
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: breakout in August 2021/ suspected vaccination failure; breakout in August 2021; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had a breakout in march 2021 refer case US2021AMR203693 and pass 20 years had a shingles breakout each year and have been anxiously awaiting the vaccine refer case US2021AMR203687).   On 25th February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In August 2021, between 5 and 7 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient had 2nd Shingrix vaccination, had a breakout in August 2021. No contact details were available. The reporter did not consent to follow up  This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. This was 1 of 3 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203687:Same patient, possible breakout 2020 post-1st dose US-GLAXOSMITHKLINE-US2021AMR203693:Same patient, 2nd dose and breakout March2021
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Joint range of motion decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient reported pain and unable to lift arm up. Patient believed shot was administred too high. Patient has not seen doctor or anything yet.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Injection site pain, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient reported pain and unable to lift arm up. Patient believed shot was administred too high. Patient has not seen doctor or anything yet.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased
Clinical narrative: During routine labs patient was found to have thrombocytopenia on 9/15/2021 with Plts of 13. This was confirmed by a re-draw. Previous labs show Plts of 180 5/10/2021. His history shows normal levels.   He was admitted. Seen by Heme. Started on Prednisone. Discharged on 9/18/2021 with Plts trending upward (88 on day of discharge).
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Platelet count decreased, Thrombocytopenia, White blood cell count normal
Clinical narrative: During routine labs patient was found to have thrombocytopenia on 9/15/2021 with Plts of 13. This was confirmed by a re-draw. Previous labs show Plts of 180 5/10/2021. His history shows normal levels.   He was admitted. Seen by Heme. Started on Prednisone. Discharged on 9/18/2021 with Plts trending upward (88 on day of discharge).
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Eye irritation, Eye swelling, Paraesthesia, Sleep disorder
Clinical narrative: Apprx 5 hrs after vaccination, developed burning sensation in face and eyes, awoke from sleep later that evening with very swollen eyelids.  No other skin sxms, resp sxms, CP, GI or neuro sxms.  Swelling resolved with cool compresses and OTC Benadryl over several hrs.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Eye irritation, Swelling of eyelid
Clinical narrative: Apprx 5 hrs after vaccination, developed burning sensation in face and eyes, awoke from sleep later that evening with very swollen eyelids.  No other skin sxms, resp sxms, CP, GI or neuro sxms.  Swelling resolved with cool compresses and OTC Benadryl over several hrs.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Feeling hot, Headache, Injection site pain
Clinical narrative: Patient had common injection site reaction from the date of vaccination until Thursday 9/30.  At that point the reaction had disappeared.  However, on Saturday 10/2 the patient found a rash on her arm that was in a different location that the injection site reaction.  The reaction was red splotches that were reddish/pink, slightly warm and painful. The red splotches also were migrating up and down the arm.  The reaction was reported to the pharmacy 10/4 by the patient. She was advised to contact her PCP.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Pain, Rash, Rash pruritic
Clinical narrative: Patient had common injection site reaction from the date of vaccination until Thursday 9/30.  At that point the reaction had disappeared.  However, on Saturday 10/2 the patient found a rash on her arm that was in a different location that the injection site reaction.  The reaction was red splotches that were reddish/pink, slightly warm and painful. The red splotches also were migrating up and down the arm.  The reaction was reported to the pharmacy 10/4 by the patient. She was advised to contact her PCP.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site reaction, Pain, Rash, Rash macular
Clinical narrative: Patient had common injection site reaction from the date of vaccination until Thursday 9/30.  At that point the reaction had disappeared.  However, on Saturday 10/2 the patient found a rash on her arm that was in a different location that the injection site reaction.  The reaction was red splotches that were reddish/pink, slightly warm and painful. The red splotches also were migrating up and down the arm.  The reaction was reported to the pharmacy 10/4 by the patient. She was advised to contact her PCP.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: Patient had common injection site reaction from the date of vaccination until Thursday 9/30.  At that point the reaction had disappeared.  However, on Saturday 10/2 the patient found a rash on her arm that was in a different location that the injection site reaction.  The reaction was red splotches that were reddish/pink, slightly warm and painful. The red splotches also were migrating up and down the arm.  The reaction was reported to the pharmacy 10/4 by the patient. She was advised to contact her PCP.