chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eyelid disorder, Flushing, Headache
Clinical narrative: It started with my nerves being hyper sensitive, where anything brushed against my arm needle like pain would shoot through my arm.  Also whenever I turned my head I got dizzy. That lasted about an hour and half, then turned to full body aches and a slight headache. Over the next few hours the headache grew worse and worse. Then about noon I got the chills and my face became super flush and my eye lids felt like they were on fire.  When I arrived home from work at 1pm I took a warm/hot bath to try help with my body aches. Then I went to bed to help my body fight it. I was also drinking lots and lots of water and a few gatorades throughout the whole day. When I woke up at 11pm all of my symptoms were gone.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: It started with my nerves being hyper sensitive, where anything brushed against my arm needle like pain would shoot through my arm.  Also whenever I turned my head I got dizzy. That lasted about an hour and half, then turned to full body aches and a slight headache. Over the next few hours the headache grew worse and worse. Then about noon I got the chills and my face became super flush and my eye lids felt like they were on fire.  When I arrived home from work at 1pm I took a warm/hot bath to try help with my body aches. Then I went to bed to help my body fight it. I was also drinking lots and lots of water and a few gatorades throughout the whole day. When I woke up at 11pm all of my symptoms were gone.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Slight fever, soreness at injection site
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second vaccine was given 15 days after the first.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder, Arthralgia, Fatigue, Feeling abnormal, Headache
Clinical narrative: First day and first night extreme Sore arm- no sleep Second day - fatigue,  foggy head,  nausea , moodiness, extreme finger joint pain Third  day (today)  - Headache , ears ringing, low fever, joint pain,  sensitive skin, exhaustion,
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Sensitive skin, Tinnitus
Clinical narrative: First day and first night extreme Sore arm- no sleep Second day - fatigue,  foggy head,  nausea , moodiness, extreme finger joint pain Third  day (today)  - Headache , ears ringing, low fever, joint pain,  sensitive skin, exhaustion,
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Moderate joint pain, especially in shoulders, elbows, low back and hips. The next day very early in the morning lasting for 2-3 days
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Sever chills and body aches as well as fever reaching 101.8.  Profuse sweating.  Symptoms persisted for 24 hours and began to dissipate. Lingering less sever symptoms lasted beyond 24 hours (fatigue, chills)
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Pruritus, Skin lesion
Clinical narrative: Itchy, redness, 2inch by 1 inch red lesion. Firm to touch, hot
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given early, 15 days after 1st dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: -headache starting evening of the injection (1/28/21) -fatigue and headache throughout the following 2 days so through 1/30/21 -chills briefly the morning of 1/29/21 -sweats the evening of 1/29/21 -no fever measured
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: 3/23 developed chest tightness with shortness of breath 3/26 dry cough 3/30 +D-Dimer 14,103. CT showing pulmonary emboli right main pulmonary artery and left lower lobar artery.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Initially after first dose I had only sore arm, two days later I was awaken with loud ringing in my ears.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Haemoptysis
Clinical narrative: i got the vaccine on the tweleve of march twenty twenty one. and on the fourthteen of march around ten pm. i woke up from a nap with a nasty coughing fit. i couldnt breath,i started to cough up blood. it lasted for 5 minutes at least. then again two hours later i woke up coughing and with a extremly painfull chest pain. my chest felt like it was being compressed. after that i was fine. except for the occasional pain on my arm from the vaccine shot.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: i got the vaccine on the tweleve of march twenty twenty one. and on the fourthteen of march around ten pm. i woke up from a nap with a nasty coughing fit. i couldnt breath,i started to cough up blood. it lasted for 5 minutes at least. then again two hours later i woke up coughing and with a extremly painfull chest pain. my chest felt like it was being compressed. after that i was fine. except for the occasional pain on my arm from the vaccine shot.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: moderate swelling noted to patients hands. Benadryl givien
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This patient received her second shot too soon.  Her first shot was given on 03/20/2021 and her second shot was given on 03/31/2021. No adverse reaction noted at this time.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Lethargy, Pain
Clinical narrative: Sore arm within a few hours of injection. Fever, chills, chest pain, shortness of breath, body aches, and lethargy around 24 hours after injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm within a few hours of injection. Fever, chills, chest pain, shortness of breath, body aches, and lethargy around 24 hours after injection.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: At around 12 pm the day after my immunization, I felt very tired, a little chilled, achy, mild head ache, and had very little appetite.  This lasted throughout the rest of the day.  I woke up the following morning feeling fine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy liver, Blood bilirubin increased, Blood test, Computerised tomogram normal, Jaundice
Clinical narrative: Day after vaccine I developed sever jaundice including yellowing eyes.  One week after vaccine I had blood work done and my liver enzymes and bilirubin levels were.  On 3/23 I admitted myself to ER with jaundice and vomiting.  My liver levels were normal but bilirubin was still high.  At this point I had lost 30 pounds since my shot.   I was in the hospital for 5 days where the ran UT, CT, and MRI on my abdomen with none showing issues.   Jaundice and itchiness/jaundice got progressively worse.   The hospital ran multitude of blood tests to pin point the issue and even did a liver biopsy.  No tests showed anything abnormal but biopsy isn?t back yet.  At this point 4/1/21, I am still jaundiced, extremely itchiness, lethargy and a total of 33 pounds weigh loss.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Pruritus, Ultrasound scan normal, Vomiting, Weight decreased
Clinical narrative: Day after vaccine I developed sever jaundice including yellowing eyes.  One week after vaccine I had blood work done and my liver enzymes and bilirubin levels were.  On 3/23 I admitted myself to ER with jaundice and vomiting.  My liver levels were normal but bilirubin was still high.  At this point I had lost 30 pounds since my shot.   I was in the hospital for 5 days where the ran UT, CT, and MRI on my abdomen with none showing issues.   Jaundice and itchiness/jaundice got progressively worse.   The hospital ran multitude of blood tests to pin point the issue and even did a liver biopsy.  No tests showed anything abnormal but biopsy isn?t back yet.  At this point 4/1/21, I am still jaundiced, extremely itchiness, lethargy and a total of 33 pounds weigh loss.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Chills, fever, vomiting, body ache
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal pain, Rash, Rash erythematous, Urticaria
Clinical narrative: I waited to be monitored for 15 mins and left immediately after. On my car ride away I started noticing small bumps and a red rash on my chest and neck that looked like hives.   My throat felt very, very sore and turned bright red. It was difficult to swallow.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Dysstasia
Clinical narrative: Overall weakness and dizziness within minutes of the shot, had to sit down for a while/close eyes, legs tingling, hands shaking, had almost no energy in limbs or to stand, etc extreme sweating/hot then chills later, nausea, muscle pain upper neck/back/shoulders, and some symptoms continued an hour later including diarrhea. Some symptoms were better in 30 minutes or so as I stayed at Walgreens until I felt better, and hours later much better but still mild symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Mobility decreased, Myalgia, Nausea
Clinical narrative: Overall weakness and dizziness within minutes of the shot, had to sit down for a while/close eyes, legs tingling, hands shaking, had almost no energy in limbs or to stand, etc extreme sweating/hot then chills later, nausea, muscle pain upper neck/back/shoulders, and some symptoms continued an hour later including diarrhea. Some symptoms were better in 30 minutes or so as I stayed at Walgreens until I felt better, and hours later much better but still mild symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Overall weakness and dizziness within minutes of the shot, had to sit down for a while/close eyes, legs tingling, hands shaking, had almost no energy in limbs or to stand, etc extreme sweating/hot then chills later, nausea, muscle pain upper neck/back/shoulders, and some symptoms continued an hour later including diarrhea. Some symptoms were better in 30 minutes or so as I stayed at Walgreens until I felt better, and hours later much better but still mild symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Arm tingling to 3rd finger. Reassurance provided tingling resolved after 20 min.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches, chills and fatigue.  12-18 hours in duration.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error- Moderna Vaccine given to Age 16 year old. 16 year old presented with physician instruction to administer the vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: I felt normal; however, I believe it caused my blood pressure to increase.  My husband received his , also, and monitors his BP multiple times daily.  His BP continued to rise a little each day and thought our machine was off,  Then I took mine about 3 days later and my BP was 158/83- higher than I ever remember it.  Usually it is about 118 over seventy something.    It was back to about 108 over seventy something 5 days after the vaccine.  I wasn't going to report it, but thought someone might want to know.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: During the night after I received the injection, I suffered chills. Felt tired and lack of energy the following day.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysphagia
Clinical narrative: VR  received first dose and was observed for 15 minutes and departed the vaccination site. Approx. 5 minutes after departing she returned saying she was having difficulty swallowing. No other symptoms reported but did indicate she had some anxiety.  EMS was called to the site and was transported to the nearest facility.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given early, 15 days after the 1st
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Palpitations
Clinical narrative: At night I had a temperature of 101 and my heart was racing so fast it felt like it was going to beat out of my chest. I laid my phone on my chest and it was moving up and down and was visible to my wife. I did not seek medical care. My second shot is scheduled for 4/7 @ 9:45 AM.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Soreness of the injection site: Started about 6 hours after injection and lasted for about 1.5 day. Chills and fatigue, feeling like starting a cold or flu: Started about one day after the injection. Lasted for one night.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Following administration of dose 2 of moderna covid vaccine. pt has syncope episode and fell landing on butt and hitting head on floor. LOC elapsed 30 seconds. No seizures. Pt evaluated by onsite MD and placed on gurney to be evaluated at triage bay area. 1020am: BP 220/126 P120.  No meds and no previous allergies. 1050am: BP 176/104 P=85 . Pt was monitored and symptoms improved. Pt ambulated and was stable prior to d/c from vaccination site. onsite MD recommended for patient to follow-up with outside PCP if persistent elevated BP or symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Patient reports a rash at the injection site and rash on her upper back
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Ocular hyperaemia, Swelling of eyelid, Vision blurred
Clinical narrative: Moderna COVID-19 Vaccine EUA  Patient presented with swollen eye lids, painful eyes, itchy eyes morning after vaccine administration.  2 days later patient complained of redness(blood shot) eyes.  3 days after vaccine administration patient called pharmacy complaining of blurred vision.  Patient was instructed to seek medical care.  Patient was seen by ophthalmologist who prescribed prednisolone and cyclopentolate eye drops and will continue to follow until improved.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were available; shipment of GARDASIL 9 late/ the vaccine was in transit for too long; shipment of GARDASIL 9 late/ the vaccine was in transit for too long; This spontaneous report as received from a medical assistant referring to 12-year-old male patient. The patient's pertinent medical history, concurrent condition, and concomitant medication were not reported.    It was reported that there was a shipment of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) late. It was tried to deliver the vaccines on 26-FEB-2021, but it was unable to and actually delivered in shipping container on 01-MAR-2021 at 09:38 am. On that day, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (lot# T008151 has been verified to be a valid lot number, expiration date 21-JUN-2022) intramuscularly for prophylaxis at the private doctor's office/hospital  by trained healthcare professional (product distribution issue and circumstance or information capable of leading to medication error). The reporter reported the events to doctor and manufacturer previously. As a result of a reading from a digital data logger, there was no temperature excursion. The vaccine was available for return/evaluation. No additional adverse event was reported (no adverse event) and no drug treatment was prescribed for the experience. It was also reported that when reporter received an email regarding the vaccines were in transit for too long, they immediately stopped administering vaccines.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008151; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513- 2103USA001248:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Patient was administered improperly stored PROQUAD; This spontaneous report has been received from a nurse  concerning a 4 years old patient of unknown gender.The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 11-MAR-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) Lot # T025221, expiration date 19-JAN-2022 for prophylaxis (dosage regimen and anatomical location were not reported). No additional adverse events were repored.  The temperature was reported to had been at -12°Celsius (C) for 6 hours and 30 minutes. There was digital data logger involved and  no previous temperature excursion was reported.
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: a patient age 32 received her 1st shot in 1/2020 and her 2nd shot yesterday; This spontaneous report has been received from a health professional referring to a 32 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unspecified date in January 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 16-MAR-2021, the patient was vaccinated with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, frequency, anatomical location, lot # and expiration date were not provided) lot number T008151 with expiration date of 21-JUN-2022 for prophylaxis (inappropriate schedule of product administration).
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: The patinet had titer done and she is still low immunity to chicken pox.; This spontaneous report was received from a physician and refers to a 35-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 08-DEC-2020, the patient finished her series with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously (lot #, expiration date, dose and site of administration were not reported), for immunity to chicken pox, (it was not reported when she started the vaccination series and how many doses she received) however it was reported that the patient had a titer done and she was still low immunity to chicken pox (antibody test negative). It was reported that no treatment was given. The outcome of the event was unknown.  The causality assessment between the aforementioned event and the suspect vaccine was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no adverse reaction was noted; patient was given expired PNEUMOVAX 23; underwent a previous temperature excursion; This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 09-MAR-2021 the patient was vaccinated with an expired vaccine of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), prefilled syringe, dose:0 .5 milliliter,  lot # S013490,expiration date: 06-MAR-2021, for prophylaxis (dose number and anatomical location was not reported).  It was stated that the vaccine had also underwent a previous temperature excursion. She reported that the patient was monitored for 15 minutes and no adverse reaction was noted and no reports of an adverse reaction have been reported since administration. No product quality complaint. No additional information. No additional adverse events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S013490; expirationdate: 06-MAR-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: RV5
Symptoms: Expired product administered
Clinical narrative: No other AE.; received a dose of ROTATEQ on 3/29/2021. After administration, the customer noticed the expiration date was 2/14/2021.; This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 29-MAR-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (exact dose, injection site and lot number were not provided; lot # s013890 has been verified to be a valid lot number with expiration date 14-FEB-2021) for prophylaxis. The product did not have any prior temperature excursions. The patient did not experience any other adverse events.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported.; the administration of PROQUAD to a 17 year old patient; This spontaneous report as received from a nurse refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.     On 11-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, albumin status rHA (PROQUAD) lot # S031704 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 06-APR-2021 (exact dose, route of administration, anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other AE/PQC reported; temperature excursion on ROT ATEQ and states one dose has been administered; This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAR-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1742458, expiration date 22-JAN-2022 (strength, formulation, route of administration and dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 34.2 Fahrenheit degrees (F) for 8 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Troponin
Clinical narrative: Chest pain; A regulatory authority report was received from a healthcare provider concerning a 49 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain.  The patient's medical history included allergies to tetracyclines and Wellbutrin, bipolar disorder, and hypothyroidism. Products known to have been used by the patient, within two weeks prior to the event, included trazodone, lamotrigine, celecoxib, buspirone hydrochloride, levothyroxine, and cariprazine hydrochloride.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient developed chest pain 5-10 minutes after the first dose. The patient was hospitalized. Lab data included chest X-ray, electrocardiogram and troponin- all normal. No treatment information was provided.  Action taken with the drug in response to the event was not provided.  The outcome of the event, chest pain, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Mentioned by reporter / pandemic / prevented several patients to come back for their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, several patients could not return for their 2nd dose of Shingrix due to the pandemic situation. This case had been linked with the case- US2020236562, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236562:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Facial pain, Joint stiffness, Lymphadenopathy, Pain in jaw
Clinical narrative: very stiff jaws; my glands and/or lymph nodes were swollen; very severe pain in both jaws; pain also going up the side of my face on both sides; This case was reported by a consumer and described the occurrence of jaw pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than an hour after receiving Shingrix, the patient experienced jaw pain and facial pain. On an unknown date, the patient experienced jaw stiffness and enlargement of lymph nodes. Shingrix was discontinued. In September 2019, the outcome of the jaw pain and facial pain were recovered/resolved. On an unknown date, the outcome of the jaw stiffness was unknown and the outcome of the enlargement of lymph nodes was recovered/resolved.   It was unknown if the reporter considered the jaw pain, facial pain, jaw stiffness and enlargement of lymph nodes to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Within one hour of receiving Shingrix, the patient had very severe pain in both jaws, pain went to both sides of face. This pain lasted for approximately 3 hours. For the next month, the patient was left with very stiff jaws and glands or lymph nodes were swollen for about a week. The patient reported this to the physician and he said he had no other patients reporting such reactions and not to get the 2nd dose of Shingrix. As well as because of reaction to Shingrix, the physician said he was very concerned about this reaction and advised the patient not to get the COVID vaccinations. The patient asked about further information that might help the patient make a decision about getting or not getting the COVID vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: info on dosing interval (beyond 6 months between the first and second dose); This case was reported by a other health professional and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The dosing interval between the first and second dose beyond 6 months. The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. It was stated need more information on dosing interval.
Sex: U
Vaccine: HEP, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Refrigerator was left open / temperature / over 46 F since 10:30pm / to 10am; This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Boostrix, Engerix B and Shingrix. On an unknown date, unknown after receiving Boostrix, Engerix B and Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. On 26th March 2021, the refrigerator was left open and so the temperature was over 46 degree fahrenheit since 10:30pm all the way upto 10am on 27th March 2021, which led to incorrect storage of drug. The reporter wanted to know if the vaccines were still viable or not. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Unevaluable event
Clinical narrative: already had shingles when she got the vaccination; This case was reported by a consumer via interactive digital media (Shingrix GSK) and described the occurrence of off label use in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (already had a shingles at the time of vaccination.).   On 26th March 2021, the patient received Shingrix. On 26th March 2021, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The case was reported by the husband of the patient. The age at vaccination was not reported. The patient received the Shingrix vaccine but the patient did not know at the time of vaccination that the symptoms she experienced within the last 2 weeks now made it appear that she already had shingles, which led to off label use. No further information reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: rash on chest and back; rash on chest and back that is tender when wearing clothes; very sensitive of clothes; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than 2 weeks after receiving Shingrix, the patient experienced rash, tenderness and increased skin sensitivity. On an unknown date, the outcome of the rash, tenderness and increased skin sensitivity were unknown.   It was unknown if the reporter considered the rash, tenderness and increased skin sensitivity to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient has had rash on chest and back for 5 days that was tender when wearing clothes and was very sensitive of clothes. The reporter would write back after physician's diagnoses.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: both past due for dose 2 of Shingrix./ Patient 2 dose 1 : 15months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 15 months before the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as an adult as per vaccine indication. The patient was past due for 2nd dose of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No other details were reported. The reporter did not feel comfortable providing patient information. The reporter consented to follow up. This case is linked to the case US2021071588, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021071588:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance
Clinical narrative: In 2020 / received an influenza vaccine / again he lost his ability to walk; This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 71-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of gait disturbance (received 1st dose in 2019 along with pneumococcal vaccine and an influenza vaccine, refer case US2021071621), Pneumococcal vaccine with an associated reaction of gait disturbance and Influenza vaccine with an associated reaction of gait disturbance.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced walking difficulty. Rechallenge with Influenza vaccine Quadrivalent 2020-2021 season was positive. On an unknown date, the outcome of the walking difficulty was recovered/resolved.   It was unknown if the reporter considered the walking difficulty to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported but it could be 70 years or 71 years. In 2020, the patient received an Influenza vaccine (name unknown) and again he lost his ability to walk and slowly the ability to walk returned and resolved in about a week. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021071621:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I have had this two dose vaccine but am having an outbreak; This case was reported by a consumer via Shingrix Chatbot and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was reporting for him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. After receiving 2 doses of Shingrix, the patient had shingels outbreak. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation were not provided.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Full blood count, Influenza virus test negative, Pain, Pain in extremity
Clinical narrative: temp 101.5 following day following day 99.; Body aches; soreness of arm; This case was reported by a nurse via sales rep and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced fever. In October 2020, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the fever, pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received her first dose of Shingrix and on the following day experienced fever. The Patient also developed soreness of arm for 5 days. On the same day of vaccination the patient experienced body aches. Due to this the patient underwent Flu and covid-19 tests which were negative. The Full blood count was also reported to be normal. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 antibody test negative
Clinical narrative: temp 101.5 following day following day 99.; Body aches; soreness of arm; This case was reported by a nurse via sales rep and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced fever. In October 2020, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the fever, pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received her first dose of Shingrix and on the following day experienced fever. The Patient also developed soreness of arm for 5 days. On the same day of vaccination the patient experienced body aches. Due to this the patient underwent Flu and covid-19 tests which were negative. The Full blood count was also reported to be normal. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood triglycerides increased, Hypertriglyceridaemia, Pain, Pain in extremity, Tenderness
Clinical narrative: experienced a sore arm; Hypertriglyceridaemia Diagnosed about 2 years ago; This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in arm in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and hypertriglyceridemia. The patient was treated with fenofibrate. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the hypertriglyceridemia was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and hypertriglyceridemia to be related to Shingrix.  Additional details were provided as follows: Two years before the reporting date, the patient was vaccinated with Shingrix at 50.2 years of age. The patient had sore arm. The patient was diagnosed with Hypertriglyceridemia about 2 years ago. The patient was receiving Fenofibrate to treat hypertriglyceridemia. On 26th February 2021, the patient was vaccinated with Pfizer BioNTech Covid vaccine and experienced pain or tenderness. The reporter consented to follow up.  Note- Hypertriglyceridemia was reported as current condition and Fenofibrate as concomitant but since the patient also received Shingrix vaccine around the same time, Hypertriglyceridemia considered as adverse event and Fenofibrate as treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Vaccination failure
Clinical narrative: I got shingles from the vaccine/ suspected vaccination failure; I got shingles from the vaccine; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient got shingles from Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had the first shot. I can't get the second due to a severe reaction; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose and developed severe reaction. Due to this tilll the time of reporting, the patient did not receive second dose which led to incomplete course of vaccination.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 9 year old child was administered an adult dose (1 mL) of Havrix (hep A); 9 year old child was administered an adult dose (1 mL) of Havrix (hep A); after the dose was administered, it was discovered that the dose was expired; This case was reported by a nurse via sales rep and described the occurrence of overdose in a 9-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 30th March 2021, the patient received Havrix adult 1 ml. On 30th March 2021, unknown after receiving Havrix adult, the patient experienced overdose, adult product administered to child and expired vaccine used. On an unknown date, the outcome of the overdose, adult product administered to child and expired vaccine used were unknown.  Additional details were provided as follows: The patient who was approximately 9 years old, received an adult dose of Havrix, which led to overdose and adult product administered to child. After the dose was administered, it was discovered that the dose was already expired.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: GOT BOTH SHOT ONLY HAD A SLIGHT RASH ON ARM; GOT BOTH SHOT ONLY HAD / SORE AREM; This case was reported by a consumer via interactive digital media and described the occurrence of localized rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced localized rash and pain in arm. On an unknown date, the outcome of the localized rash and pain in arm were recovered/resolved.   It was unknown if the reporter considered the localized rash and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingles vaccine last year and had a slight rash on arm and sore arm, that went away, and the patient been fine. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2021AMR072688.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072688:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Vaccine positive rechallenge
Clinical narrative: GOT BOTH SHOT ONLY HAD A SLIGHT RASH ON ARM; GOT BOTH SHOT ONLY HAD / SORE AREM; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of rash (1st dose received on unknown date, patient experienced rash on arm refer case US2021AMR072676).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced rash and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the rash and pain in arm were recovered/resolved.   It was unknown if the reporter considered the rash and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got 2nd shot of Shingles vaccine in last year and had a slight rash on arm and sore arm, that went away and been fine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072676:Same reporter.