chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Had a fever of 100.2, chills, achy, general flu like symptoms. The same symptoms when I was diagnosed with Covid-19 on December 18, 2020. I had gotten sick on December 16th. This lasted about 18 to 20 hours.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Decreased appetite, Headache, Immediate post-injection reaction
Clinical narrative: Prior to vaccine took 2 acetominophen.  Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving.  Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic.  Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Malaise, Neck pain, Pain in extremity
Clinical narrative: Prior to vaccine took 2 acetominophen.  Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving.  Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic.  Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Prior to vaccine took 2 acetominophen.  Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving.  Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic.  Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache, 102 Fever, nausea, chills, body aches, extreme fatigue Started 3-13-2021 at 7 pm until 03/14/2021 @ noon Nausea/upset stomach and extreme fatigue until 3/15/2021 Continue to have mild upset stomach and body fatigue with irritated airway
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract irritation
Clinical narrative: Headache, 102 Fever, nausea, chills, body aches, extreme fatigue Started 3-13-2021 at 7 pm until 03/14/2021 @ noon Nausea/upset stomach and extreme fatigue until 3/15/2021 Continue to have mild upset stomach and body fatigue with irritated airway
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Rash
Clinical narrative: Headache, low grade fever, exhaustion, 5-6 inch small rash on spine
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Computerised tomogram, Eye infarction, Magnetic resonance imaging, Ultrasound scan
Clinical narrative: I was hospitalized for loss of vision to left eye. It was diagnosed as a stroke to the eye.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Hypoaesthesia eye
Clinical narrative: PATIENT EXPERIENCE NUMBNESS AND HEAVINESS IN RIGHT EYE CAVITY THAT LASTED MORE THAN 15 MINUTES WHEN SHE REPORTED IT AND CONTINUED FOR AT LEAST 50 MINUTES
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site rash, Polymyalgia rheumatica
Clinical narrative: Fever began 8 hours after inoculation with high of 102.4 S opposed to first dosage of 104.7. Lasted 36 hours Slight chills at onset of fever as opposed to severe shaking and teeth rattling with first dosage. 2 hours Hives on fingers and red rash on injection arm 12 hours after injection   Started as 5? and spread from shoulder to almost elbow. On going with itching controlled by Benadryl  PMR symptoms drastically reduced
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever began 8 hours after inoculation with high of 102.4 S opposed to first dosage of 104.7. Lasted 36 hours Slight chills at onset of fever as opposed to severe shaking and teeth rattling with first dosage. 2 hours Hives on fingers and red rash on injection arm 12 hours after injection   Started as 5? and spread from shoulder to almost elbow. On going with itching controlled by Benadryl  PMR symptoms drastically reduced
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 71 Year old female C/O Headache immediately after receiving the vaccine. States that "Headache is gone, I just wanted to make sure I'm Ok" Vital signs accessed. WNL.  Patient didn't want to go to the hospital or receive further treatment.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Insomnia, Tinnitus
Clinical narrative: Blocked/muffled hearing in left ear; loud, constant ringing (tinnitus) in left ear; loud ringing progressed to right ear; tinnitus is so loud that it wakes me up at night and makes falling asleep difficult
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fatigue, Chills, Low Grade Fever, Headache, Nausea for 20 hours beginning early am of the next day following the adm of vaccine. Minor in intensity, treated with rest, Acetamenophen . They resolved without further incident.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram pelvis, Diarrhoea, Differential white blood cell count, Full blood count
Clinical narrative: After both shots I experienced severe vomiting, diarrhea for several hours. My second shot was on March 5. 3 weeks after the first shot on Feb.3 (taken to hospital emergency room by ambulance ) and One week after my second shot on March 5,  I experienced severe vomiting and diarrhea which I treated at home.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Metabolic function test, Vaccine positive rechallenge, Vomiting
Clinical narrative: After both shots I experienced severe vomiting, diarrhea for several hours. My second shot was on March 5. 3 weeks after the first shot on Feb.3 (taken to hospital emergency room by ambulance ) and One week after my second shot on March 5,  I experienced severe vomiting and diarrhea which I treated at home.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Janssen Covid 19 Vaccine EUA Fever of 100.7 for 6 hours
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Soreness, bright redness, and slight swelling for five days. Applied antibiotic cream and it took three more days for symptoms to disappear.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombophlebitis
Clinical narrative: superficial thrombophlebitis of left calf seen in an urgent care. treated with heat packs/cold packs. encouraged to follow up with clinic because of concerns
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Discomfort, Dizziness, Fatigue, Headache
Clinical narrative: Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area.  These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea.  I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided.  After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Nausea, Neck pain, Pain
Clinical narrative: Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area.  These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea.  I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided.  After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area.  These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea.  I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided.  After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Fatigue, Head discomfort, Headache
Clinical narrative: Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area.  These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea.  I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided.  After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Nausea, Neck pain, Pain
Clinical narrative: Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area.  These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea.  I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided.  After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Approximately after 45 mins of giving the vaccine, he started to feel numbness on the right side of the face. Including the temple, part of the eye and right cheek. 4 days have passed and at the moment he still has that same symptoms. The Clinic cannot treat him, they told him to go to the Emergency Room.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Insomnia, Myalgia, Pain in extremity
Clinical narrative: 101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening intense headache unable to sit due to back pain could not sleep due to pain left underarm is VERY swollen
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: 101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening intense headache unable to sit due to back pain could not sleep due to pain left underarm is VERY swollen
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Hyperhidrosis
Clinical narrative: Severe abdominal pain felt feverish, but normal temp Woke about 4 hours later, covered in sweat.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Nausea, Pain, Pain in extremity
Clinical narrative: Slight arm soreness initially. 12 hours later developed nausea, chills, body aches, temp of 100.5.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Cardiac failure, Chest X-ray, Computerised tomogram
Clinical narrative: Rash started small area on my right arm (opposite arm of injection) - like eczema red; raised; itchy spot. As a couple of days went I got more and more spots. Sent pictures to my Dr - Pityriasis Roseola - Went to see dermatologist - he diagnosed me with the same thing (January 19th). He gave me cream for it - it was all over my entire body by the time I saw him. It was like a red petechiae rash over my whole body. I usd the cream as instructed per doctor. The following week on that Monday, I was short of breath and not feeling right and I worked. But next day I only worked a couple of hours and went home. I started having vomiting and diarrhea - I went to the ER twice - 1st time they diagnosed - Viral infection - and they discharged me and didn't give me anything but told me to rest and they pushed fluids. The second time I went - they gave me medication and they said it might help with the pain in my  abdomen. They didn't do much. I had gone to ER - was there for four and half hours waiting to be seen but didn't get seen. Two days after second ER visit - I went back to the hospital  on January 26 and was admitted for heart failure and that is when cardiac symptoms occurred.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Echocardiogram, Electrocardiogram, Erythema
Clinical narrative: Rash started small area on my right arm (opposite arm of injection) - like eczema red; raised; itchy spot. As a couple of days went I got more and more spots. Sent pictures to my Dr - Pityriasis Roseola - Went to see dermatologist - he diagnosed me with the same thing (January 19th). He gave me cream for it - it was all over my entire body by the time I saw him. It was like a red petechiae rash over my whole body. I usd the cream as instructed per doctor. The following week on that Monday, I was short of breath and not feeling right and I worked. But next day I only worked a couple of hours and went home. I started having vomiting and diarrhea - I went to the ER twice - 1st time they diagnosed - Viral infection - and they discharged me and didn't give me anything but told me to rest and they pushed fluids. The second time I went - they gave me medication and they said it might help with the pain in my  abdomen. They didn't do much. I had gone to ER - was there for four and half hours waiting to be seen but didn't get seen. Two days after second ER visit - I went back to the hospital  on January 26 and was admitted for heart failure and that is when cardiac symptoms occurred.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Pityriasis rosea, Pruritus, Rash, Rash papular
Clinical narrative: Rash started small area on my right arm (opposite arm of injection) - like eczema red; raised; itchy spot. As a couple of days went I got more and more spots. Sent pictures to my Dr - Pityriasis Roseola - Went to see dermatologist - he diagnosed me with the same thing (January 19th). He gave me cream for it - it was all over my entire body by the time I saw him. It was like a red petechiae rash over my whole body. I usd the cream as instructed per doctor. The following week on that Monday, I was short of breath and not feeling right and I worked. But next day I only worked a couple of hours and went home. I started having vomiting and diarrhea - I went to the ER twice - 1st time they diagnosed - Viral infection - and they discharged me and didn't give me anything but told me to rest and they pushed fluids. The second time I went - they gave me medication and they said it might help with the pain in my  abdomen. They didn't do much. I had gone to ER - was there for four and half hours waiting to be seen but didn't get seen. Two days after second ER visit - I went back to the hospital  on January 26 and was admitted for heart failure and that is when cardiac symptoms occurred.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased, Viral infection, Vomiting
Clinical narrative: Rash started small area on my right arm (opposite arm of injection) - like eczema red; raised; itchy spot. As a couple of days went I got more and more spots. Sent pictures to my Dr - Pityriasis Roseola - Went to see dermatologist - he diagnosed me with the same thing (January 19th). He gave me cream for it - it was all over my entire body by the time I saw him. It was like a red petechiae rash over my whole body. I usd the cream as instructed per doctor. The following week on that Monday, I was short of breath and not feeling right and I worked. But next day I only worked a couple of hours and went home. I started having vomiting and diarrhea - I went to the ER twice - 1st time they diagnosed - Viral infection - and they discharged me and didn't give me anything but told me to rest and they pushed fluids. The second time I went - they gave me medication and they said it might help with the pain in my  abdomen. They didn't do much. I had gone to ER - was there for four and half hours waiting to be seen but didn't get seen. Two days after second ER visit - I went back to the hospital  on January 26 and was admitted for heart failure and that is when cardiac symptoms occurred.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Eight days after vaccination, right upper area of injection became red and itchy, progression to swollen, painful and warm.   Area of redness approximately 4" x 3".   This is the third day, pain and swelling have decreased but new onset of extreme fatigue .  There had been nothing unusual  until the eight day.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Eight days after vaccination, right upper area of injection became red and itchy, progression to swollen, painful and warm.   Area of redness approximately 4" x 3".   This is the third day, pain and swelling have decreased but new onset of extreme fatigue .  There had been nothing unusual  until the eight day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness, Feeling abnormal
Clinical narrative: Symptoms: Loss of sense of taste, foggy brain, lightheadedness
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breath sounds normal, Chest X-ray, Fatigue, Full blood count, Myalgia
Clinical narrative: daily fever of 100+ since 2nd dose vaccination on 2/18/21. Fatigue, muscle aches and fever that start at 99 F in morning and rise to 100.5 F in afternoon. From 2/19/21 to 2/24/21 had daily fevers of 101 F.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis, Vaccination complication
Clinical narrative: daily fever of 100+ since 2nd dose vaccination on 2/18/21. Fatigue, muscle aches and fever that start at 99 F in morning and rise to 100.5 F in afternoon. From 2/19/21 to 2/24/21 had daily fevers of 101 F.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Vaccination site reaction
Clinical narrative: Raised red rash 1.5 inch by 2 inch at vaccination  site
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Pain in extremity, Rash
Clinical narrative: Patient seen at Clinic on 3/16/2021 for left arm rash this is spreading, pain, and chills that started on 3/14/21. Patient treated for Cellulitis with Cephalexin 500mg antibiotic for 10 days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Facial pain, Headache, Nausea, Vomiting
Clinical narrative: Diarhea nasua vomiting severe headsche pain in face
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no reaction reported, patient was under 18 when vaccine was administered
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Had a sore arm, fever (99F), body ache and a swelling in the arm pit. Swelling in the armpit still exists
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired VAQTA was aministered; This spontaneous report was received from a registered nurse referring to a 19 year old patient.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 18-FEB-2021 the patient was vaccinated with and expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, lot # S036494 for prophylaxis (dose, route and site of administration were not reported).    The vaccine had expired on 09-JAN-2021.  The vaccine had not had any prior temperature excursions.  The patient did not experienced any adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 18.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: he was 18 years of age; HCP wanted to revaccinate the patient anyway because he was 18 years of age; no additional information; improperly stored PROQUAD was administered to a patient on 03/01/2021; This spontaneous report was received from a nurse who was reporting on 18-year-old male patient. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided. Concomitant vaccines included unspecified hepatitis b virus vaccine, unspecified diphtheria toxoid, pertussis acellular vaccine from GlaxoSmithKline, unspecified poliovirus vaccine inactivated from Sanofi Pasteur and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from Merck/MSD.   On 01-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live  rHA (recombinant Human albumin) (PROQUAD) subcutaneously in the left arm (dose and strength were not provided; lot number T021644 was confirmed to be valid, expiration date 21-DEC-2021) for prophylaxis. The physician wanted to vaccinate patient even the product prescribing information states that the product was indicated for children through 12 years of age (Inappropriate age at vaccine administration, Intentional product misuse). Administered dose of vaccine was stored in temperature of 42.8 Fahrenheit for 96 hours. Data logger was involved. There were no previous excursions reported. No additional information was provided. The follow up with the patient was scheduled, and the vaccine was returned to the UFC program so it was not available for manufacturer. No additional information was provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AEs; expired vaccine was inadvertently given to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 04-MAR-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #S012247 which was verified to be valid with expiration date: 10-FEB-2021) in dose 0.5 milliliter as a prophylaxis (dose number, route of administration and anatomical location were not reported). No temperature excursions were reported, no additional adverse events occurred. The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S012247; expirationdate: 10-FEB-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis, Herpes zoster
Clinical narrative: Dermatitis and herpes zoster.; Dermatitis and herpes zoster.; Information has been received from a lawyer referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date ,the patient experienced dermatitis and herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of  zoster vaccine live (ZOSTAVAX) vaccination, symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. Furthermore, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of dermatitis and herpes zoster was determined to be not recovered.     The reporter considered dermatitis and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: a patient faints after a G9 vaccination; This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for immunisation (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported).         On an unknown date, the patient fainted after the vaccination (syncope). The outcome of syncope was unknown.        Upon internal review, the event syncope was determined to be medically significant.      This is a non-valid case due to lack of patient's identifiers.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's.; temperature excursion for VARlVAX.; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 09-FEB-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T020652 was confirmed to be valid, with expiration date 16-JUN-2022(exact dose, vaccine schedule, route of administration and anatomical location were not provided) for prophylaxis.   The multiple temperature excursions were below -13 Celsius degrees (C) (-13.9 C) for 45 hours. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2103USA003180:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Mobility decreased, Pyrexia
Clinical narrative: Mild reaction / had chills; Mild reation / was a little feverish; Mild reaction / not being well; Mild reaction / Spent time in bed; This case was reported by a consumer and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 20th April 2020) for prophylaxis.   Previously administered products included pneumococcal vaccine with an associated reaction of nonspecific reaction (in 2018). Concurrent medical conditions included hypotension, drug allergy (Allergic to thimerosal, cilantro and codeine) and herbal allergy (cilantro). Concomitant products included medication unknown (Bioidentical Hormones (Generic Ingredient Unknown)).   On 19th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced chills, fever, unwell and mobility decreased. On an unknown date, the outcome of the chills, fever, unwell and mobility decreased were recovered/resolved.   The reporter considered the chills, fever, unwell and mobility decreased to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient was healthy, had no kidney problems, no heart issues and exercises daily. The concomitant medication included thyroid medication. The patient received 1st dose of Shingrix and had mild reactions included chills, was a little feverish, not being well and spent time in bed. The patient that all these events were resolved. The patient stated that the expiration date listed for 1st dose was 20th April 2020 which does not match the expiration date in our system. [Note: pharmacies would often default to a 365 day expiration date]. The patient did not want to share her physician contact information (because the Shingrix injections were given at the pharmacy not the physician office). The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2021AMR010230.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR010230:Same patient, Same reporter. 2nd dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Condition aggravated, Gait disturbance, Influenza like illness
Clinical narrative: not move arm / muscles really hurt / thigh is very painful; flu like symptoms; thighs of both legs are burning and itching.; thighs of both legs are burning and itching.; Meralgia Paresthetica  / flare up; Meralgia Paresthetica  / flare up; thigh pain/Pain in arm/leg pain; It's hard to get to sleep but if I lay on side and put pressure on it that helps; Injection site left arm still hurting / pain radiates to thumb.; fever; chills; body aches/pain radiates to thumb/hurts to walk; could not really move her arm for about 3 days; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meralgia paresthetica.   On 27th December 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, fever, chills, general body pain, mobility decreased, muscle pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated, pain in thigh and difficulty sleeping. On an unknown date, the outcome of the injection site pain, muscle pain and pain in thigh were not recovered/not resolved and the outcome of the fever, chills, general body pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated and difficulty sleeping were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, general body pain, mobility decreased, muscle pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated, pain in thigh and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had fever, chills, body aches, flu like symptoms and could not move arm for 2 days and still muscles really hurt deep inside and injection site left arm still hurting, pain radiates to thumb.  The patient previous condition meralgia peristatic was flaring and right upper outer thigh was very painful and it hurts to walk.  The patient try and sleep the outer thighs of both legs are burning and itching.  The patient had hard to get to sleep but if lay on side and put pressure on it that helps. Pain in arm and legs went away but it's flaring up again. The caller wants to know if condition could be why she experienced these reactions and if she should stay away from the SHINGRIX vaccine. The caller did not know if should get the second dose because she thinks the first dose is what caused the flare up in her condition, Meralgia Paresthetica. The reporter did not consent to follow up.  The caller did report to HCP and HCP was insisting patient still receive the 2nd dose vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: not move arm / muscles really hurt / thigh is very painful; flu like symptoms; thighs of both legs are burning and itching.; thighs of both legs are burning and itching.; Meralgia Paresthetica  / flare up; Meralgia Paresthetica  / flare up; thigh pain/Pain in arm/leg pain; It's hard to get to sleep but if I lay on side and put pressure on it that helps; Injection site left arm still hurting / pain radiates to thumb.; fever; chills; body aches/pain radiates to thumb/hurts to walk; could not really move her arm for about 3 days; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meralgia paresthetica.   On 27th December 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, fever, chills, general body pain, mobility decreased, muscle pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated, pain in thigh and difficulty sleeping. On an unknown date, the outcome of the injection site pain, muscle pain and pain in thigh were not recovered/not resolved and the outcome of the fever, chills, general body pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated and difficulty sleeping were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, general body pain, mobility decreased, muscle pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated, pain in thigh and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had fever, chills, body aches, flu like symptoms and could not move arm for 2 days and still muscles really hurt deep inside and injection site left arm still hurting, pain radiates to thumb.  The patient previous condition meralgia peristatic was flaring and right upper outer thigh was very painful and it hurts to walk.  The patient try and sleep the outer thighs of both legs are burning and itching.  The patient had hard to get to sleep but if lay on side and put pressure on it that helps. Pain in arm and legs went away but it's flaring up again. The caller wants to know if condition could be why she experienced these reactions and if she should stay away from the SHINGRIX vaccine. The caller did not know if should get the second dose because she thinks the first dose is what caused the flare up in her condition, Meralgia Paresthetica. The reporter did not consent to follow up.  The caller did report to HCP and HCP was insisting patient still receive the 2nd dose vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: not move arm / muscles really hurt / thigh is very painful; flu like symptoms; thighs of both legs are burning and itching.; thighs of both legs are burning and itching.; Meralgia Paresthetica  / flare up; Meralgia Paresthetica  / flare up; thigh pain/Pain in arm/leg pain; It's hard to get to sleep but if I lay on side and put pressure on it that helps; Injection site left arm still hurting / pain radiates to thumb.; fever; chills; body aches/pain radiates to thumb/hurts to walk; could not really move her arm for about 3 days; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meralgia paresthetica.   On 27th December 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, fever, chills, general body pain, mobility decreased, muscle pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated, pain in thigh and difficulty sleeping. On an unknown date, the outcome of the injection site pain, muscle pain and pain in thigh were not recovered/not resolved and the outcome of the fever, chills, general body pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated and difficulty sleeping were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, general body pain, mobility decreased, muscle pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated, pain in thigh and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had fever, chills, body aches, flu like symptoms and could not move arm for 2 days and still muscles really hurt deep inside and injection site left arm still hurting, pain radiates to thumb.  The patient previous condition meralgia peristatic was flaring and right upper outer thigh was very painful and it hurts to walk.  The patient try and sleep the outer thighs of both legs are burning and itching.  The patient had hard to get to sleep but if lay on side and put pressure on it that helps. Pain in arm and legs went away but it's flaring up again. The caller wants to know if condition could be why she experienced these reactions and if she should stay away from the SHINGRIX vaccine. The caller did not know if should get the second dose because she thinks the first dose is what caused the flare up in her condition, Meralgia Paresthetica. The reporter did not consent to follow up.  The caller did report to HCP and HCP was insisting patient still receive the 2nd dose vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Myalgia, Nausea
Clinical narrative: fever; massive headache; body aches; nausea; chills; lack of appetite; desire to drink fluids; swelling in my underarm /  severe swelling in left underarm; muscle pain; This case was reported by a consumer and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 12th January 2021, the patient received Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain were unknown.   It was unknown if the reporter considered the fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had basically all of the usual symptoms fever, massive headache and body aches, nausea, chills, lack of appetite and desire to drink fluids. The reporter asked was this normal. The patient had severe swelling in left underarm, fever and muscle pain.  The patient spoken with healthcare professional and they recommended Tylenol.  The reporter did not consent to follow up.; Sender's Comments:  US-GSKCCFUS-Case-00946152_AE-56101:FU1
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Polydipsia, Pyrexia, Swelling
Clinical narrative: fever; massive headache; body aches; nausea; chills; lack of appetite; desire to drink fluids; swelling in my underarm /  severe swelling in left underarm; muscle pain; This case was reported by a consumer and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 12th January 2021, the patient received Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain were unknown.   It was unknown if the reporter considered the fever, headache, general body pain, nausea, chills, appetite absent, excessive drinking, local swelling and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had basically all of the usual symptoms fever, massive headache and body aches, nausea, chills, lack of appetite and desire to drink fluids. The reporter asked was this normal. The patient had severe swelling in left underarm, fever and muscle pain.  The patient spoken with healthcare professional and they recommended Tylenol.  The reporter did not consent to follow up.; Sender's Comments:  US-GSKCCFUS-Case-00946152_AE-56101:FU1
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: desire to drink fluids; fever; massive headache; body aches; nausea; chills; lack of appetite and  desire to drink fluids; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking. On an unknown date, the outcome of the fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking were unknown.   It was unknown if the reporter considered the fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had basically all the usual symptoms fever, massive headache and body aches, nausea, chills, lack of appetite and desire to drink fluids.
Sex: U
Vaccine: VARZOS
Symptoms: Polydipsia, Pyrexia
Clinical narrative: desire to drink fluids; fever; massive headache; body aches; nausea; chills; lack of appetite and  desire to drink fluids; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking. On an unknown date, the outcome of the fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking were unknown.   It was unknown if the reporter considered the fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had basically all the usual symptoms fever, massive headache and body aches, nausea, chills, lack of appetite and desire to drink fluids.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Feeling abnormal, Injection site erythema, Pain in extremity, Palpitations
Clinical narrative: For 3 weeks / Large red patch / on her upper arm where the injection was given; Had a poor reaction' / stabbing stomach pain; Had a poor reaction'  / shins ached; Had a poor reaction'  / Fever; Had a poor reaction'  / racing heart/palpitations; Felt so bad / sat on the sofa with her front door unlocked / called her neighbors / in case she needed help; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 59EA2, expiry date August 2020) for prophylaxis.   Previously administered products included PNEUMOCOCCAL VACCINE with an associated reaction of nonspecific reaction (had reaction in 2018) and Shingrix with an associated reaction of pyrexia (received 1st dose on 19th April 2019, refer case US2021009441). Concurrent medical conditions included low blood pressure and drug allergy (Allergic to thimerosal, cilantro and codeine). Concomitant products included medication unknown (Bioidentical Hormones (Generic Ingredient Unknown)).   On 29th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The patient was healthy, had no kidney problems, no heart issues and exercises daily. The concomitant medication included thyroid medication. The patient got both Shingrix shots at the same pharmacy.   The patient received Shingrix and stated the expiration date listed was August 2020 which did not match the expiration date in our system. The patient had a poor reaction to the second shot symptoms included stabbing stomach pain, shins ached, fever, and racing heart palpitations and stated that lives alone and she felt so bad that she sat on the sofa with her front door unlocked in case she had to call 911. The patient called neighbors to let them know what was going on in case she needed help and said for 3 weeks she had a large red patch, about the size of a dessert plate, on her upper arm where the injection was given. All these events resolved and stated she did try to call to report her experience but we were closed for holiday Labor Day weekend. The reporter did not consent to follow up and did not want to share her physician contact information because the Shingrix injections were given at the pharmacy not the physician's office.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021009441:Same reporter, Same patient. 1st dose