chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Chills, Computerised tomogram, Headache
Clinical narrative: Immediately after the 2nd Moderna booster I had severe muscle spasms starting in my R shouder rotator cull area; the spasms continued across my upper back, shoulders , neck and into my head/scalp. I almost fell down in the pharmacy area, but was able to get to a chair near the shot area, then to proceed a few steps toward the coffee area, ger a decaf coffee and rest at a table for about 10 min. I was on my lunch break from university where I was currently teaching and needed to get back to students in the painting studio - but never made it back. I was helped to my car and was able to drive about a 1/2 mile to our hospital where I was checked into Emergency. I was there having multiple tests until after 9 pm. The hospital was concerned about stroke symptoms, the continuing muscle spasms through my upper body Right side. I was discharged with medicine for the spasms, but then had to return several days later with fever, chills, nausea, headache and full-blown COVID.  I had to stay at home for two weeks, needing to have the university hire a substitute faculty member to finish the course I  teach. I also needed to hire a helper for my basic home tasks and some personal care. I am still needing weekly check-ups and physical therapy for the muscle spasms and rampant inflammation on my right side above my legs.
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immediate post-injection reaction, Impaired work ability, Inflammation, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: Immediately after the 2nd Moderna booster I had severe muscle spasms starting in my R shouder rotator cull area; the spasms continued across my upper back, shoulders , neck and into my head/scalp. I almost fell down in the pharmacy area, but was able to get to a chair near the shot area, then to proceed a few steps toward the coffee area, ger a decaf coffee and rest at a table for about 10 min. I was on my lunch break from university where I was currently teaching and needed to get back to students in the painting studio - but never made it back. I was helped to my car and was able to drive about a 1/2 mile to our hospital where I was checked into Emergency. I was there having multiple tests until after 9 pm. The hospital was concerned about stroke symptoms, the continuing muscle spasms through my upper body Right side. I was discharged with medicine for the spasms, but then had to return several days later with fever, chills, nausea, headache and full-blown COVID.  I had to stay at home for two weeks, needing to have the university hire a substitute faculty member to finish the course I  teach. I also needed to hire a helper for my basic home tasks and some personal care. I am still needing weekly check-ups and physical therapy for the muscle spasms and rampant inflammation on my right side above my legs.
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Neck pain, Neurological symptom, Pyrexia, X-ray
Clinical narrative: Immediately after the 2nd Moderna booster I had severe muscle spasms starting in my R shouder rotator cull area; the spasms continued across my upper back, shoulders , neck and into my head/scalp. I almost fell down in the pharmacy area, but was able to get to a chair near the shot area, then to proceed a few steps toward the coffee area, ger a decaf coffee and rest at a table for about 10 min. I was on my lunch break from university where I was currently teaching and needed to get back to students in the painting studio - but never made it back. I was helped to my car and was able to drive about a 1/2 mile to our hospital where I was checked into Emergency. I was there having multiple tests until after 9 pm. The hospital was concerned about stroke symptoms, the continuing muscle spasms through my upper body Right side. I was discharged with medicine for the spasms, but then had to return several days later with fever, chills, nausea, headache and full-blown COVID.  I had to stay at home for two weeks, needing to have the university hire a substitute faculty member to finish the course I  teach. I also needed to hire a helper for my basic home tasks and some personal care. I am still needing weekly check-ups and physical therapy for the muscle spasms and rampant inflammation on my right side above my legs.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait disturbance, Inflammation, Pain in extremity
Clinical narrative: basically cannot walk; pain in the right forefoot from walking which occured everyday, involved both feet, it also involved the heel of both feet; foot inflammation; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (foot inflammation), GAIT DISTURBANCE (basically cannot walk) and PAIN IN EXTREMITY (pain in the right forefoot from walking which occured everyday, involved both feet, it also involved the heel of both feet) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: J and J (First dose, 041A21A) on 01-Apr-2021 and flu vaccine (within 1 month prior to Moderna COVID-19 vaccine) in September 2021. Past adverse reactions to the above products included No adverse event with J and J and flu vaccine.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced INFLAMMATION (foot inflammation) and PAIN IN EXTREMITY (pain in the right forefoot from walking which occured everyday, involved both feet, it also involved the heel of both feet). On an unknown date, the patient experienced GAIT DISTURBANCE (basically cannot walk). The patient was treated with CELECOXIB at a dose of 200 milligram in morning and evening. At the time of the report, INFLAMMATION (foot inflammation), GAIT DISTURBANCE (basically cannot walk) and PAIN IN EXTREMITY (pain in the right forefoot from walking which occured everyday, involved both feet, it also involved the heel of both feet) had not resolved.            Patient height was reported as 6 feet and 1 inches. No Concomitant medications were provided.  It was reported that patient had first sign of foot inflammation that still currently experiencing came about on 11 Nov 2021 as pain in the right forefoot from walking which occurred everyday. By mid Dec 2021 involved both feet and by mid Mar 2022, also involved the heel of both feet.  Patient did not seek medical care, did not experienced similar event in the past and symptoms were worsened. Patient never had COVID positive test or diagnosis.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Inflammation, Pain in extremity
Clinical narrative: basically cannot walk; pain in the right forefoot from walking which occured everyday, involved both feet, it also involved the heel of both feet; foot inflammation; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (foot inflammation), GAIT DISTURBANCE (basically cannot walk) and PAIN IN EXTREMITY (pain in the right forefoot from walking which occured everyday, involved both feet, it also involved the heel of both feet) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: J and J (First dose, 041A21A) on 01-Apr-2021 and flu vaccine (within 1 month prior to Moderna COVID-19 vaccine) in September 2021. Past adverse reactions to the above products included No adverse event with J and J and flu vaccine.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced INFLAMMATION (foot inflammation) and PAIN IN EXTREMITY (pain in the right forefoot from walking which occured everyday, involved both feet, it also involved the heel of both feet). On an unknown date, the patient experienced GAIT DISTURBANCE (basically cannot walk). The patient was treated with CELECOXIB at a dose of 200 milligram in morning and evening. At the time of the report, INFLAMMATION (foot inflammation), GAIT DISTURBANCE (basically cannot walk) and PAIN IN EXTREMITY (pain in the right forefoot from walking which occured everyday, involved both feet, it also involved the heel of both feet) had not resolved.            Patient height was reported as 6 feet and 1 inches. No Concomitant medications were provided.  It was reported that patient had first sign of foot inflammation that still currently experiencing came about on 11 Nov 2021 as pain in the right forefoot from walking which occurred everyday. By mid Dec 2021 involved both feet and by mid Mar 2022, also involved the heel of both feet.  Patient did not seek medical care, did not experienced similar event in the past and symptoms were worsened. Patient never had COVID positive test or diagnosis.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Facial paresis, Hemiparesis, Muscular weakness, SARS-CoV-2 test positive
Clinical narrative: 6/10 37y.o. male who presents with 4 weeks of RLE pain and swelling. Pt states pain started in his calf and began progressively worsening.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Pain in extremity, Peripheral swelling, SARS-CoV-2 test positive
Clinical narrative: 6/10 37y.o. male who presents with 4 weeks of RLE pain and swelling. Pt states pain started in his calf and began progressively worsening.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 23 days after refrigerator shelf life.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L021A) for COVID-19 prophylaxis.     Concurrent medical conditions included Colon cancer (Malignant tumor of colon), Alcohol abuse, Colon neoplasm, Allergy to antibiotic (Amoxicillin) and Allergy to antibiotic (Biaxin). Concomitant products included ALBUTEROL SULFATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), ATENOLOL, OMEPRAZOLE, PHENTERMINE and DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication.    On 06-May-2022 at 12:09 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2022 at 12:09 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 23 days after refrigerator shelf live; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf live) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     The patient had no known drug allergy.  Concurrent medical conditions included Alcohol abuse, Dementia, Depressive disorder, Heart disease, unspecified, Hypertensive, Diabetes mellitus and CVA. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL, CINNAMOMUM CASSIA BARK (CINNAMON [CINNAMOMUM CASSIA BARK]), ERGOCALCIFEROL, FLUOXETINE, GLIPIZIDE, EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL, MECLIZINE [MECLOZINE], METFORMIN, OMEPRAZOLE, PRAVASTATIN and LIRAGLUTIDE (VICTOZA) for an unknown indication.    On 06-May-2022 at 9:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2022 at 9:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf live). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf live) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 23 days after refrigerator shelf life; vaccine given 23 days after refrigerator shelf life; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccine given 23 days after refrigerator shelf life) and EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     Patient had no known drug allergies.  Concurrent medical conditions included Depressive disorder, Migraine and Diabetes mellitus. Concomitant products included ACETAZOLAMIDE, AMITRIPTYLINE, ATORVASTATIN, VALPROATE SEMISODIUM (DIVALPROEX), HYDROXYZINE HCL, LEVETIRACETAM, MARIJUANA, PROPRANOLOL and SUMATRIPTAN for an unknown indication.    On 06-May-2022 at 3:37 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2022 at 3:37 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine given 23 days after refrigerator shelf life). At the time of the report, PRODUCT STORAGE ERROR (vaccine given 23 days after refrigerator shelf life) and EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information provided.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine given 23 days after refrigerator shelf life; vaccine given 23 days after refrigerator shelf life; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccine given 23 days after refrigerator shelf life) and EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     Patient had no known drug allergies.  Concurrent medical conditions included Depressive disorder, Migraine and Diabetes mellitus. Concomitant products included ACETAZOLAMIDE, AMITRIPTYLINE, ATORVASTATIN, VALPROATE SEMISODIUM (DIVALPROEX), HYDROXYZINE HCL, LEVETIRACETAM, MARIJUANA, PROPRANOLOL and SUMATRIPTAN for an unknown indication.    On 06-May-2022 at 3:37 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2022 at 3:37 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine given 23 days after refrigerator shelf life). At the time of the report, PRODUCT STORAGE ERROR (vaccine given 23 days after refrigerator shelf life) and EXPIRED PRODUCT ADMINISTERED (vaccine given 23 days after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information provided.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis. The patient does not have any known drug allergies.  Concurrent medical conditions included Asthma, Colon cancer (Malignant tumor of colon), Heart disease, unspecified, Hypertensive (Hypertensive disorder), Hypercholesterolemia, Diabetes mellitus and Kidney disorder (Kidney disease). Concomitant products included Cholecalciferol; Ketoconazole; Nexplanon; Omeprazole; and Vitamin D3 for an unknown indication. On 06-May-2022 at 5:07 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-May-2022 at 5:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis. The patient does not have any known drug allergies.  Concurrent medical conditions included Asthma, Colon cancer (Malignant tumor of colon), Heart disease, unspecified, Hypertensive (Hypertensive disorder), Hypercholesterolemia, Diabetes mellitus and Kidney disorder (Kidney disease). Concomitant products included Cholecalciferol; Ketoconazole; Nexplanon; Omeprazole; and Vitamin D3 for an unknown indication. On 06-May-2022 at 5:07 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-May-2022 at 5:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza, Injection site rash, Myalgia, Pyrexia
Clinical narrative: Rash that appeared on her stomach and a samml cirvle rash on her arm; Big red circle hot rash; Big red circle itchy rash; Heat rash; Inappropriate age at vaccine administration; Cold; Pain radiated to her lower back; she can not get comfortable; Bad muscle aches/pain radiated to her lower back.; Pain in her legs/gradually got worse; Flu Like symptoms; Shivers/Cold; Headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 14th June 2022, the patient experienced rash, red rash, itchy rash and heat rash. In June 2022, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in leg, cold, back pain and discomfort. The patient was treated with muscle relaxants. On an unknown date, the outcome of the influenza-like symptoms, shivers, headache, tiredness and cold were recovering/resolving and the outcome of the rash, red rash, itchy rash, muscle pain, pain in leg and heat rash were not recovered/not resolved and the outcome of the back pain, discomfort and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the influenza-like symptoms, shivers, headache, tiredness, rash, red rash, itchy rash, muscle pain, pain in leg, heat rash, cold, back pain and discomfort to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient received Shingrix on left arm. The patient stated that over the weekend, she experienced flu like symptoms as shivering/cold, headache, tiredness.  When these symptoms started to subside, patient began experiencing bad muscle aches and pain in her legs which gradually got worse.  Last night (from the day of reporting), the muscle aches/pain radiated to her lower back.  The patient stated the pain in her lower back was unbearable, and she could not get comfortable.  Patient also had a rash that appeared Tuesday morning on her stomach (under her ribs on the right side) which she described as a big red circle, which was itchy and hot.  Patient also stated that she had a small red circle on her arm, which she noticed yesterday. She called her HCP yesterday and the HCP prescribed muscle relaxants, which have not helped. The patient also had a call out to her HCP today (on the day of reporting).  The patient provided consent to follow up with HCP. Additional supportive information: 4 days after receiving Shingrix, the patient experienced rash, redness and itching. Less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in extremity, cold, back pain and discomfort.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash that appeared on her stomach and a samml cirvle rash on her arm; Big red circle hot rash; Big red circle itchy rash; Heat rash; Inappropriate age at vaccine administration; Cold; Pain radiated to her lower back; she can not get comfortable; Bad muscle aches/pain radiated to her lower back.; Pain in her legs/gradually got worse; Flu Like symptoms; Shivers/Cold; Headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 14th June 2022, the patient experienced rash, red rash, itchy rash and heat rash. In June 2022, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in leg, cold, back pain and discomfort. The patient was treated with muscle relaxants. On an unknown date, the outcome of the influenza-like symptoms, shivers, headache, tiredness and cold were recovering/resolving and the outcome of the rash, red rash, itchy rash, muscle pain, pain in leg and heat rash were not recovered/not resolved and the outcome of the back pain, discomfort and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the influenza-like symptoms, shivers, headache, tiredness, rash, red rash, itchy rash, muscle pain, pain in leg, heat rash, cold, back pain and discomfort to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient received Shingrix on left arm. The patient stated that over the weekend, she experienced flu like symptoms as shivering/cold, headache, tiredness.  When these symptoms started to subside, patient began experiencing bad muscle aches and pain in her legs which gradually got worse.  Last night (from the day of reporting), the muscle aches/pain radiated to her lower back.  The patient stated the pain in her lower back was unbearable, and she could not get comfortable.  Patient also had a rash that appeared Tuesday morning on her stomach (under her ribs on the right side) which she described as a big red circle, which was itchy and hot.  Patient also stated that she had a small red circle on her arm, which she noticed yesterday. She called her HCP yesterday and the HCP prescribed muscle relaxants, which have not helped. The patient also had a call out to her HCP today (on the day of reporting).  The patient provided consent to follow up with HCP. Additional supportive information: 4 days after receiving Shingrix, the patient experienced rash, redness and itching. Less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in extremity, cold, back pain and discomfort.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Discomfort, Erythema, Fatigue
Clinical narrative: Rash that appeared on her stomach and a samml cirvle rash on her arm; Big red circle hot rash; Big red circle itchy rash; Heat rash; Inappropriate age at vaccine administration; Cold; Pain radiated to her lower back; she can not get comfortable; Bad muscle aches/pain radiated to her lower back.; Pain in her legs/gradually got worse; Flu Like symptoms; Shivers/Cold; Headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 14th June 2022, the patient experienced rash, red rash, itchy rash and heat rash. In June 2022, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in leg, cold, back pain and discomfort. The patient was treated with muscle relaxants. On an unknown date, the outcome of the influenza-like symptoms, shivers, headache, tiredness and cold were recovering/resolving and the outcome of the rash, red rash, itchy rash, muscle pain, pain in leg and heat rash were not recovered/not resolved and the outcome of the back pain, discomfort and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the influenza-like symptoms, shivers, headache, tiredness, rash, red rash, itchy rash, muscle pain, pain in leg, heat rash, cold, back pain and discomfort to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient received Shingrix on left arm. The patient stated that over the weekend, she experienced flu like symptoms as shivering/cold, headache, tiredness.  When these symptoms started to subside, patient began experiencing bad muscle aches and pain in her legs which gradually got worse.  Last night (from the day of reporting), the muscle aches/pain radiated to her lower back.  The patient stated the pain in her lower back was unbearable, and she could not get comfortable.  Patient also had a rash that appeared Tuesday morning on her stomach (under her ribs on the right side) which she described as a big red circle, which was itchy and hot.  Patient also stated that she had a small red circle on her arm, which she noticed yesterday. She called her HCP yesterday and the HCP prescribed muscle relaxants, which have not helped. The patient also had a call out to her HCP today (on the day of reporting).  The patient provided consent to follow up with HCP. Additional supportive information: 4 days after receiving Shingrix, the patient experienced rash, redness and itching. Less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in extremity, cold, back pain and discomfort.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling cold, Headache, Influenza like illness, Miliaria, Myalgia
Clinical narrative: Rash that appeared on her stomach and a samml cirvle rash on her arm; Big red circle hot rash; Big red circle itchy rash; Heat rash; Inappropriate age at vaccine administration; Cold; Pain radiated to her lower back; she can not get comfortable; Bad muscle aches/pain radiated to her lower back.; Pain in her legs/gradually got worse; Flu Like symptoms; Shivers/Cold; Headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 14th June 2022, the patient experienced rash, red rash, itchy rash and heat rash. In June 2022, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in leg, cold, back pain and discomfort. The patient was treated with muscle relaxants. On an unknown date, the outcome of the influenza-like symptoms, shivers, headache, tiredness and cold were recovering/resolving and the outcome of the rash, red rash, itchy rash, muscle pain, pain in leg and heat rash were not recovered/not resolved and the outcome of the back pain, discomfort and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the influenza-like symptoms, shivers, headache, tiredness, rash, red rash, itchy rash, muscle pain, pain in leg, heat rash, cold, back pain and discomfort to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient received Shingrix on left arm. The patient stated that over the weekend, she experienced flu like symptoms as shivering/cold, headache, tiredness.  When these symptoms started to subside, patient began experiencing bad muscle aches and pain in her legs which gradually got worse.  Last night (from the day of reporting), the muscle aches/pain radiated to her lower back.  The patient stated the pain in her lower back was unbearable, and she could not get comfortable.  Patient also had a rash that appeared Tuesday morning on her stomach (under her ribs on the right side) which she described as a big red circle, which was itchy and hot.  Patient also stated that she had a small red circle on her arm, which she noticed yesterday. She called her HCP yesterday and the HCP prescribed muscle relaxants, which have not helped. The patient also had a call out to her HCP today (on the day of reporting).  The patient provided consent to follow up with HCP. Additional supportive information: 4 days after receiving Shingrix, the patient experienced rash, redness and itching. Less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in extremity, cold, back pain and discomfort.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Product administered to patient of inappropriate age, Pruritus, Rash
Clinical narrative: Rash that appeared on her stomach and a samml cirvle rash on her arm; Big red circle hot rash; Big red circle itchy rash; Heat rash; Inappropriate age at vaccine administration; Cold; Pain radiated to her lower back; she can not get comfortable; Bad muscle aches/pain radiated to her lower back.; Pain in her legs/gradually got worse; Flu Like symptoms; Shivers/Cold; Headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 14th June 2022, the patient experienced rash, red rash, itchy rash and heat rash. In June 2022, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in leg, cold, back pain and discomfort. The patient was treated with muscle relaxants. On an unknown date, the outcome of the influenza-like symptoms, shivers, headache, tiredness and cold were recovering/resolving and the outcome of the rash, red rash, itchy rash, muscle pain, pain in leg and heat rash were not recovered/not resolved and the outcome of the back pain, discomfort and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the influenza-like symptoms, shivers, headache, tiredness, rash, red rash, itchy rash, muscle pain, pain in leg, heat rash, cold, back pain and discomfort to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient received Shingrix on left arm. The patient stated that over the weekend, she experienced flu like symptoms as shivering/cold, headache, tiredness.  When these symptoms started to subside, patient began experiencing bad muscle aches and pain in her legs which gradually got worse.  Last night (from the day of reporting), the muscle aches/pain radiated to her lower back.  The patient stated the pain in her lower back was unbearable, and she could not get comfortable.  Patient also had a rash that appeared Tuesday morning on her stomach (under her ribs on the right side) which she described as a big red circle, which was itchy and hot.  Patient also stated that she had a small red circle on her arm, which she noticed yesterday. She called her HCP yesterday and the HCP prescribed muscle relaxants, which have not helped. The patient also had a call out to her HCP today (on the day of reporting).  The patient provided consent to follow up with HCP. Additional supportive information: 4 days after receiving Shingrix, the patient experienced rash, redness and itching. Less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in extremity, cold, back pain and discomfort.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Rash that appeared on her stomach and a samml cirvle rash on her arm; Big red circle hot rash; Big red circle itchy rash; Heat rash; Inappropriate age at vaccine administration; Cold; Pain radiated to her lower back; she can not get comfortable; Bad muscle aches/pain radiated to her lower back.; Pain in her legs/gradually got worse; Flu Like symptoms; Shivers/Cold; Headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 14th June 2022, the patient experienced rash, red rash, itchy rash and heat rash. In June 2022, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in leg, cold, back pain and discomfort. The patient was treated with muscle relaxants. On an unknown date, the outcome of the influenza-like symptoms, shivers, headache, tiredness and cold were recovering/resolving and the outcome of the rash, red rash, itchy rash, muscle pain, pain in leg and heat rash were not recovered/not resolved and the outcome of the back pain, discomfort and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the influenza-like symptoms, shivers, headache, tiredness, rash, red rash, itchy rash, muscle pain, pain in leg, heat rash, cold, back pain and discomfort to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient received Shingrix on left arm. The patient stated that over the weekend, she experienced flu like symptoms as shivering/cold, headache, tiredness.  When these symptoms started to subside, patient began experiencing bad muscle aches and pain in her legs which gradually got worse.  Last night (from the day of reporting), the muscle aches/pain radiated to her lower back.  The patient stated the pain in her lower back was unbearable, and she could not get comfortable.  Patient also had a rash that appeared Tuesday morning on her stomach (under her ribs on the right side) which she described as a big red circle, which was itchy and hot.  Patient also stated that she had a small red circle on her arm, which she noticed yesterday. She called her HCP yesterday and the HCP prescribed muscle relaxants, which have not helped. The patient also had a call out to her HCP today (on the day of reporting).  The patient provided consent to follow up with HCP. Additional supportive information: 4 days after receiving Shingrix, the patient experienced rash, redness and itching. Less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, shivers, headache, tiredness, muscle pain, pain in extremity, cold, back pain and discomfort.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization for small bowel obstruction with mesenteric ischemia, screeningfor COVID positive asymptomatic, pt had NSTEMI during this hospitalization and died. Treated with Remdesivir.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Asymptomatic COVID-19, Death, Intestinal ischaemia, SARS-CoV-2 test positive
Clinical narrative: Hospitalization for small bowel obstruction with mesenteric ischemia, screeningfor COVID positive asymptomatic, pt had NSTEMI during this hospitalization and died. Treated with Remdesivir.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Small intestinal obstruction
Clinical narrative: Hospitalization for small bowel obstruction with mesenteric ischemia, screeningfor COVID positive asymptomatic, pt had NSTEMI during this hospitalization and died. Treated with Remdesivir.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Inflammation, Injection site inflammation, Injection site pain, Oral pain
Clinical narrative: Right side of her mouth was severely hurting; Shortly after that she became very sleepy; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Shortly after that she became very sleepy) and ORAL PAIN (Right side of her mouth was severely hurting) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced SOMNOLENCE (Shortly after that she became very sleepy). On 11-Jun-2022, the patient experienced ORAL PAIN (Right side of her mouth was severely hurting). The patient was treated with PARACETAMOL (TYLENOL) in June 2022 for Mouth pain, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Shortly after that she became very sleepy) and ORAL PAIN (Right side of her mouth was severely hurting) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided.   Patient received her first dose of Moderna vaccine and shortly after that she became very sleepy, so Patient went to sleep and woke up the next day and the right side of her mouth was severely hurting. Patient stated that she can now only eat soft foods.  Patient reached out to the pharmacy and they told her that there was nothing that they could give her to reject the vaccine and told her to take Tylenol for her pain.  Patient went to her primary care physician on the day of the appointment to discuss the risks of getting the vaccine. Patient was concerned that this would affect her daily life especially since she considered herself to be healthy prior to receiving the vaccine.  Patient consulted with a lawyer and wanted to know what needs to be done to correct the situation before she takes the next steps.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Somnolence, Toothache
Clinical narrative: Right side of her mouth was severely hurting; Shortly after that she became very sleepy; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Shortly after that she became very sleepy) and ORAL PAIN (Right side of her mouth was severely hurting) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced SOMNOLENCE (Shortly after that she became very sleepy). On 11-Jun-2022, the patient experienced ORAL PAIN (Right side of her mouth was severely hurting). The patient was treated with PARACETAMOL (TYLENOL) in June 2022 for Mouth pain, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Shortly after that she became very sleepy) and ORAL PAIN (Right side of her mouth was severely hurting) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided.   Patient received her first dose of Moderna vaccine and shortly after that she became very sleepy, so Patient went to sleep and woke up the next day and the right side of her mouth was severely hurting. Patient stated that she can now only eat soft foods.  Patient reached out to the pharmacy and they told her that there was nothing that they could give her to reject the vaccine and told her to take Tylenol for her pain.  Patient went to her primary care physician on the day of the appointment to discuss the risks of getting the vaccine. Patient was concerned that this would affect her daily life especially since she considered herself to be healthy prior to receiving the vaccine.  Patient consulted with a lawyer and wanted to know what needs to be done to correct the situation before she takes the next steps.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral pain, Somnolence
Clinical narrative: Right side of her mouth was severely hurting; Shortly after that she became very sleepy; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Shortly after that she became very sleepy) and ORAL PAIN (Right side of her mouth was severely hurting) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced SOMNOLENCE (Shortly after that she became very sleepy). On 11-Jun-2022, the patient experienced ORAL PAIN (Right side of her mouth was severely hurting). The patient was treated with PARACETAMOL (TYLENOL) in June 2022 for Mouth pain, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Shortly after that she became very sleepy) and ORAL PAIN (Right side of her mouth was severely hurting) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided.   Patient received her first dose of Moderna vaccine and shortly after that she became very sleepy, so Patient went to sleep and woke up the next day and the right side of her mouth was severely hurting. Patient stated that she can now only eat soft foods.  Patient reached out to the pharmacy and they told her that there was nothing that they could give her to reject the vaccine and told her to take Tylenol for her pain.  Patient went to her primary care physician on the day of the appointment to discuss the risks of getting the vaccine. Patient was concerned that this would affect her daily life especially since she considered herself to be healthy prior to receiving the vaccine.  Patient consulted with a lawyer and wanted to know what needs to be done to correct the situation before she takes the next steps.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Cataract surgery; had a massive blood vessel burst in his right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 11May2021 as dose 2, single (Lot number: EW0165) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FOCUS FORMULA [AVENA SATIVA;CENTELLA ASIATICA;GINKGO BILOBA;MATRICARIA RECUTITA;SCUTELLARIA LATERIFLORA;URTICA DIOICA]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; VITAMIN E [TOCOPHEROL]. Vaccination history included: BNT162b2 (1st dose was administered on 20Apr2021 with lot ER8731.), administration date: 20Apr2021, when the patient was 64-year-old, for Covid-19 immunization.  The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 11May2021, outcome "unknown", described as "had a massive blood vessel burst in his right eye"; CATARACT (medically significant) with onset 14May2022, outcome "unknown", described as "Cataract surgery". Therapeutic measures were not taken as a result of eye haemorrhage. Therapeutic measures were taken as a result of cataract.  Clinical information: The reporter stated that the cataract surgery was done first on 14May2022 and the last one was he thinks the week before that on 07May2022. Patient mentioned he experienced a major blood vessel burst in his right eye within hours of getting the vaccine. stated nothing else in terms of his medications has changed and for his covid, he might be upped his Vitamin C to 1500mg a day, takes Vitamin D and Vitamin E and was already taking those and did not change anything and was taking the same regimen of supplements and takes very limited vitamins D and E supplements and takes a support focus formula that does not have a lot of blood thinner in it and the doctor looked it up before he had surgery done and that had not been an issue and states for the support focus formula, it has Vitamin C, E, b12 folic acetate and B12 and a DHA complex in it and alphalopoic acid in it and had lot 0212E5A, expiry date Dec2025 and UPC 3504606866. Stated he was taking all those supplements for more than 10 years. Stated that he has had no testing or treatment for the reported event and is still waiting to hear from his doctor who is the retinal surgeon.