chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: Approx 30 hours pot inj. I started shivering uncontrollably, went to bed for the majority of 18 hours. Alternating between shivers and sweating. Vertigo and dizziness made getting to the bathroom extremely difficult. Headache and body aches too. Woke up at 4pm on Sat. 2/27.  The headache may also have been a caffeine withdrawal effect since I slept through all day Saturday without having any coffee.  I was not warned not to overexert myself but 7 hours before I fell sick I was pushing a 8hp. Snowblower through heavy melting snow. I tired quickly so i stopped after ~ 30 minutes.  Felt much better Sunday morning
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pain, Vertigo
Clinical narrative: Approx 30 hours pot inj. I started shivering uncontrollably, went to bed for the majority of 18 hours. Alternating between shivers and sweating. Vertigo and dizziness made getting to the bathroom extremely difficult. Headache and body aches too. Woke up at 4pm on Sat. 2/27.  The headache may also have been a caffeine withdrawal effect since I slept through all day Saturday without having any coffee.  I was not warned not to overexert myself but 7 hours before I fell sick I was pushing a 8hp. Snowblower through heavy melting snow. I tired quickly so i stopped after ~ 30 minutes.  Felt much better Sunday morning
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Chest X-ray, Chills, Computerised tomogram, Dizziness, Dysarthria
Clinical narrative: Felt lightheaded. Began having trouble forming words around 3:15-3:30 close to 24 hrs after injection. Words began to slur and I got the chills and then my ears felt like they were on fire. I could feel the blood pumping in my head and I got a headache.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Skin warm
Clinical narrative: Felt lightheaded. Began having trouble forming words around 3:15-3:30 close to 24 hrs after injection. Words began to slur and I got the chills and then my ears felt like they were on fire. I could feel the blood pumping in my head and I got a headache.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Caesarean section, Haemorrhage in pregnancy, Injection site pain, Premature separation of placenta
Clinical narrative: I have a complicated pregnancy. I was hospitalized on 01-19-2021 at about 10pm.  I had repeated bleeding episodes. At the hospital they diagnosed me with chronic placental abruption.  I delivered my baby by emergency C-section.   I also had left arm soreness  at the injection site.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus, Rash
Clinical narrative: My only side effects at the time were a sore arm and fatigue lasting a few days.  However, after a week, my upper arm developed a rash and itch. It's still itchy a week later. I apply a generic hydrocortisone cream (1%) to relieve the itch. I looked up this symptom and found this article about what they call Covid Arm. https://www.health.com/condition/infectious-diseases/coronavirus/covid-arm-rash-moderna
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Had very mild Tinnitus prior to vaccine after second vaccine Tinnitus got significantly worse and has not gotten any better.  I also had vertigo after vaccine for three weeks which I had never had before.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: Chills, body aches, nausea, headache, stomache
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Hypotensive, bradycardia, dizziness, sweating. Patient recovered quickly after approximately 20 minutes, no transport or medications needed.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Constipation, Flushing, Headache
Clinical narrative: Immediately felt sensation of medication moving throughout my body.  Full body flush, racing heart, Chills and nausea. Loss of balance upon walking. Slept for 11 hours following vaccination.  Pain in injection site and painful lump appeared next to it. Headaches, body aches constantly, as well as constipation. It?s been 11 days since the shot and I still have a headache a small lump. The lump is slowly receding and no longer painful.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Immediate post-injection reaction, Injection site mass, Injection site pain, Nausea
Clinical narrative: Immediately felt sensation of medication moving throughout my body.  Full body flush, racing heart, Chills and nausea. Loss of balance upon walking. Slept for 11 hours following vaccination.  Pain in injection site and painful lump appeared next to it. Headaches, body aches constantly, as well as constipation. It?s been 11 days since the shot and I still have a headache a small lump. The lump is slowly receding and no longer painful.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Sensation of foreign body
Clinical narrative: Immediately felt sensation of medication moving throughout my body.  Full body flush, racing heart, Chills and nausea. Loss of balance upon walking. Slept for 11 hours following vaccination.  Pain in injection site and painful lump appeared next to it. Headaches, body aches constantly, as well as constipation. It?s been 11 days since the shot and I still have a headache a small lump. The lump is slowly receding and no longer painful.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: 34 year old female complained of shortness of breath. Onsite EMS responded. Vitals BP 138/89 HR 104 100% O2. Refused care, released against medical care.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: The soreness in my arm, whole arm the same day I received the vaccine. I took some Tylenol. On 01/18/2021, my arm was very itching at the injection site. The 01/19/2021  I developed a red circle around the injection site. It was warm and puffy. I showed one of the doctors I work with and she said it as long as it was hot there was no need to worry, as she had the same thing happen. This lasted for about 3 days, then started to fade to a pink color and it went away.  On 01/23/2021, I developed a red dots, all under my bra line and it spread to my stomach. It looked like measles, I started putting Hydrocortisone cream on and started using Sensitive soap. It is still there as of today, it is starting to go away.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: The soreness in my arm, whole arm the same day I received the vaccine. I took some Tylenol. On 01/18/2021, my arm was very itching at the injection site. The 01/19/2021  I developed a red circle around the injection site. It was warm and puffy. I showed one of the doctors I work with and she said it as long as it was hot there was no need to worry, as she had the same thing happen. This lasted for about 3 days, then started to fade to a pink color and it went away.  On 01/23/2021, I developed a red dots, all under my bra line and it spread to my stomach. It looked like measles, I started putting Hydrocortisone cream on and started using Sensitive soap. It is still there as of today, it is starting to go away.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: SEVERE FACIAL SWELLING, PATIENT WENT TO ANOTHER FACILITY 24 HOURS AFTER VACCINE ADMINISTERED AND WAS TREATED WITH AN INJECTION AND A STEROID DOSE PACK PER HER REPORT.  SHE PRESENTED TO OUR VACCINE CLINIC FOR HER SECOND INJECTION AND REPORTED THE REACTION.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Erythema, Feeling hot, Swelling face
Clinical narrative: SEVERE FACIAL SWELLING, PATIENT WENT TO ANOTHER FACILITY 24 HOURS AFTER VACCINE ADMINISTERED AND WAS TREATED WITH AN INJECTION AND A STEROID DOSE PACK PER HER REPORT.  SHE PRESENTED TO OUR VACCINE CLINIC FOR HER SECOND INJECTION AND REPORTED THE REACTION.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Oedema peripheral, Sleep disorder
Clinical narrative: Severe pain and swelling of lymph nodes under the right armpit and right side of breast.  Pain level was a 9 on a scale of 10.  Feels like a golf ball is there but not to the touch.  I barely slept the first night.  I thought I was imagining the swelling but took pictures to compare left and right arm.  Swelling is definitely noticeable.  I didn't have Tylenol in the house so I used a wet wash cloth underneath my right arm pit to ease the pain.   Helped a little bit but not much.  The next night I used a refrigerated Gatorade bottle underneath my arm which worked much better.   3rd night I finally was able to get Tylenol and that seemed to help more so but I am still swollen and painful but now more tolerable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: L facial droop, DX= Bells Palsy
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Skin warm
Clinical narrative: 1/22/21 1300;  2/23/21 1300; Moderna 029L20A(#1), 13M20A(#2) redness and itching at injection site; warm to touch
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Tiredness, fever, chills.  My fever was approx 100 but I felt as if I were freezing.  I was fully dressed and under covers but was still unable to get warm.  Nausea, no appetite, headaches, and mental fog.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Tiredness, fever, chills.  My fever was approx 100 but I felt as if I were freezing.  I was fully dressed and under covers but was still unable to get warm.  Nausea, no appetite, headaches, and mental fog.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received Phizer Covid Vaccine in replace of Moderna .  No adverse reactions. CDC notified and no further actions required.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever, Body Aches, Headache, Tired - General flu like symptoms Treatment - ibuprofen for body aches, bed rest Symptoms appeared within 12 hours, 40 hours later - I am feeling a little better and expect to progress through the day and tomorrow.  I do not have concerns for long-term effects based on how I feel so far.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: On the evening of February 25, 2021, the injection site began to itch intensely and a rash developed. From that evening through today, March 1, 2021, the itching has diminished though it does still itch somewhat. The rash continues, expanding out from the injection site. I have experienced no pain nor fever associated with the rash.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Myalgia, Nausea
Clinical narrative: 1/8 vaccination 12:30  2 hours later,  I got really fatigued; couldn't walk. Quads locked up. Nausea. I couldn't even it hurt. Nausea and vomiting for 7 days. Fever, shivers, chills. That Monday after vaccine, I couldn't even care for patient due to fatigue and nausea.  1/11 urgent care. Covid; negative. Prescribed Ibuprofen and Zofran *quad still hurts.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: 1/8 vaccination 12:30  2 hours later,  I got really fatigued; couldn't walk. Quads locked up. Nausea. I couldn't even it hurt. Nausea and vomiting for 7 days. Fever, shivers, chills. That Monday after vaccine, I couldn't even care for patient due to fatigue and nausea.  1/11 urgent care. Covid; negative. Prescribed Ibuprofen and Zofran *quad still hurts.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: I woke up this morning with my hands swollen and bumpy with a red, rough rash. They do not itch.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: wednesday 2/24/2021 around 1am, pt woke with fever, sweat, nausea, vomiting, exterme weaknes, fatigue, dizziness and a headache, these symptoms continued until friday 2/26/2021 1 pm,  then resolved, pt felt fine that day.pt treated with tylenol, fluids..
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: wednesday 2/24/2021 around 1am, pt woke with fever, sweat, nausea, vomiting, exterme weaknes, fatigue, dizziness and a headache, these symptoms continued until friday 2/26/2021 1 pm,  then resolved, pt felt fine that day.pt treated with tylenol, fluids..
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Bell's palsy, Blood pressure increased, Chest discomfort, Facial paralysis
Clinical narrative: Patient is a 49 y.o. female hx of asthma, GERD p/w L sided lower and upper facial droop in the context of receiving Moderna vaccine 2 days ago. Reports she noticed the facial droop a few hours after receiving the vaccine. Also has had generalized myalgias, denies f/c. Denies camping trips/going in the woods, never been diagnosed with lyme disease. Denies rash, hearing changes, vision changes, CP, SOB, abd pain, n/v/d/c, f/c, dysuria pain/weakness/numbness of the extremities,   Pt received first dose of Covid vaccine on 2/20/2021. A few hours later noted mild facial droop, started to note numbness getting worse over 2 day period and presented to ED. Had labs, lyme negative. Diagnosed with bells palsy and discharged on prednisone, has 2 days left. The following day symptoms started to improve and she feels they fully resolved at this point. BP was elevated in ED, she reports she doesn't have a BP cuff at home but will get one. Feeling well overall but does occasionally experiencing symptoms of heart racing and chest tightness. Attributes this to anxiety and stress, mother just passed away. Denies CP, syncope.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Family stress, Hypoaesthesia, Laboratory test normal, Myalgia, Palpitations
Clinical narrative: Patient is a 49 y.o. female hx of asthma, GERD p/w L sided lower and upper facial droop in the context of receiving Moderna vaccine 2 days ago. Reports she noticed the facial droop a few hours after receiving the vaccine. Also has had generalized myalgias, denies f/c. Denies camping trips/going in the woods, never been diagnosed with lyme disease. Denies rash, hearing changes, vision changes, CP, SOB, abd pain, n/v/d/c, f/c, dysuria pain/weakness/numbness of the extremities,   Pt received first dose of Covid vaccine on 2/20/2021. A few hours later noted mild facial droop, started to note numbness getting worse over 2 day period and presented to ED. Had labs, lyme negative. Diagnosed with bells palsy and discharged on prednisone, has 2 days left. The following day symptoms started to improve and she feels they fully resolved at this point. BP was elevated in ED, she reports she doesn't have a BP cuff at home but will get one. Feeling well overall but does occasionally experiencing symptoms of heart racing and chest tightness. Attributes this to anxiety and stress, mother just passed away. Denies CP, syncope.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Patient is a 49 y.o. female hx of asthma, GERD p/w L sided lower and upper facial droop in the context of receiving Moderna vaccine 2 days ago. Reports she noticed the facial droop a few hours after receiving the vaccine. Also has had generalized myalgias, denies f/c. Denies camping trips/going in the woods, never been diagnosed with lyme disease. Denies rash, hearing changes, vision changes, CP, SOB, abd pain, n/v/d/c, f/c, dysuria pain/weakness/numbness of the extremities,   Pt received first dose of Covid vaccine on 2/20/2021. A few hours later noted mild facial droop, started to note numbness getting worse over 2 day period and presented to ED. Had labs, lyme negative. Diagnosed with bells palsy and discharged on prednisone, has 2 days left. The following day symptoms started to improve and she feels they fully resolved at this point. BP was elevated in ED, she reports she doesn't have a BP cuff at home but will get one. Feeling well overall but does occasionally experiencing symptoms of heart racing and chest tightness. Attributes this to anxiety and stress, mother just passed away. Denies CP, syncope.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Pyrexia
Clinical narrative: Serve Stomach pain, very week, and a fever
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dystonia, Headache, Vomiting
Clinical narrative: first vaccine 2/4/21 el9265 first vaccine  , second was 2/25/21 en6200 - second vaccine headache, vomited  ice to headache and arm, food and fluids very difficult to understand caller , shaky voice ( dystonia)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Affect lability, Aphasia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. Nausea and fatigue persisted, along with the loss of appetite (as of this date, still no appetite...only being able to handle orange juice and saltine crackers); emotions are still a wreck; concentration level is still small; multi tasking is not doable; seem to lose words along the way in conversation.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. Nausea and fatigue persisted, along with the loss of appetite (as of this date, still no appetite...only being able to handle orange juice and saltine crackers); emotions are still a wreck; concentration level is still small; multi tasking is not doable; seem to lose words along the way in conversation.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Dyspnoea, Limb discomfort, Pain in extremity
Clinical narrative: 1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face and head - 3 -4 days after shot - did not recognize it as a reaction - no treatment given 3rd - difficulty breathing, asthma attack, full body covered with hives - 5 days after shot - took Benadryl for 24 hours -  went to urgent care the next morning and was given steroid medication to take each day for a week,  directed to continued to take Benadryl until steroids stop the hives 4th - second respiratory reaction with coughing and difficulty breathing - took an extra Benadryl.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face and head - 3 -4 days after shot - did not recognize it as a reaction - no treatment given 3rd - difficulty breathing, asthma attack, full body covered with hives - 5 days after shot - took Benadryl for 24 hours -  went to urgent care the next morning and was given steroid medication to take each day for a week,  directed to continued to take Benadryl until steroids stop the hives 4th - second respiratory reaction with coughing and difficulty breathing - took an extra Benadryl.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored dose administered; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.  On 22-FEB-2021, the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, lot # T025367 with expiration date 18-NOV-2022, (route of administration and frequency were unknown) was administered to the patient (product storage error). The vaccine was stored at 47.6 degrees Fahrenheit for 24 hours. Digital data logger was not involved. It was unknown if there was a previous temperature excursion. No additional adverse events were reported. 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; devicelotnumber: T025367; expirationdate: 18-NOV-2022; 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: Chills, Nausea
Clinical narrative: shivering; nauseous; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 9th January 2021, the patient received the 2nd dose of Shingrix. On 10th January 2021, 1 days after receiving Shingrix, the patient experienced shivering and nausea. On an unknown date, the outcome of the shivering and nausea were unknown.   It was unknown if the reporter considered the shivering and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient 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. The patient received 2nd dose of Shingrix and on the next day, the patient was shivering and nauseous. The patient wanted to know that do he/she needed to contact physician or wait it out and how long would these symptoms continue.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder
Clinical narrative: Effecting my eyes; This case was reported by a other health professional and described the occurrence of eye disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eye disorder. On an unknown date, the outcome of the eye disorder was unknown.   It was unknown if the reporter considered the eye disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported , however captured as adult as per vaccine indication The patient received shingles shot and it was effecting the patient's eyes. The patient was very concerned and asked to get help.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Pyrexia
Clinical narrative: How high a fever could someone expect after vaccination / Side effect fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient experienced side effect of shingrix a fever. The patient wanted to that how high a fever could someone expect after the Shingrix vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Taking them a long time to get over it / knocked for a loop / not expecting / pain, to last for so long; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   The reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. Age at vaccination was not reported, the patient was in her late 70's. The patient had the Shingrix shot and told her that it was taking them a long time to get over it.  They were knocked for a loop and not expecting the side effects, such as pain, to last for so long. The reporter provided limited information. This is 1 of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021017003: US-GLAXOSMITHKLINE-US2021017036:Same reporter US-GLAXOSMITHKLINE-US2021017037:Same reporter. Case for friend 1 of 2. US-GLAXOSMITHKLINE-US2021017003: US-GLAXOSMITHKLINE-US2021017036:Same reporter. Case for friend 2 of 2.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Pain in extremity
Clinical narrative: My temperature is 99.1°F; Shivering; Arm is fairly sore; This case was reported by a consumer via interactive digital media and described the occurrence of body temperature increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2021 11:45, the patient received the 2nd dose of Shingrix .5 ml. On 27th January 2021, less than a day after receiving Shingrix, the patient experienced body temperature increased, shivering and pain in arm. On an unknown date, the outcome of the body temperature increased, shivering and pain in arm were unknown.   It was unknown if the reporter considered the body temperature increased, shivering and pain in arm 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 the temperature was 99.1 The patient experienced shivering and arm was sore. The reporter asked might take acetaminophen to reduce the temperature.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Couldn't lay on her left side / arm was so sore; Couldn't get out of bed for 2 days/Couldn't lay on her left side; This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had pain in arm and could not lay on left side. The patient said when she had vaccine, she could not get out of bed for 2days. This case linked with US2021AMR020911, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR020911:Same reporter.
Age: 6.0
Sex: U
Vaccine: FLU4
Symptoms: Gastrointestinal disorder, Vasculitis
Clinical narrative: vasculitis; twin also experienced similar symptoms of GI; This case was reported by a physician via sales rep and described the occurrence of gastrointestinal disorder in a 6-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included premature birth (patient was born 6 weeks premature).   On 16th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2020, 10 days after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced gastrointestinal disorder. On 29th October 2020, the patient experienced vasculitis. On an unknown date, the outcome of the gastrointestinal disorder and vasculitis were unknown.   It was unknown if the reporter considered the gastrointestinal disorder and vasculitis to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient developed gastrointestinal symptoms and vasculitis but did not seen by the doctor as the mother did brought only twin to the doctor's office. The patient's twin also experienced similar symptoms of gastrointestinal symptoms and vasculitis (refer case US2021AMR022024). The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR047386:same reporter US-GLAXOSMITHKLINE-US2021AMR022024:twin´s case
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm 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 was captured as adult as per the vaccine indication. After receiving Shingrix, the patient had sore arm. For the tolerance of 2nd dose, refer linked case US2021AMR024485.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024485:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin induration
Clinical narrative: my arm had a huge knot the size of an egg; it hurt so bad; my arm had a huge knot the size of an egg; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, refer case US2021AMR024462).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, pain in arm and skin induration. On an unknown date, the outcome of the swelling arm, pain in arm and skin induration were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm and skin induration to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, after vaccination with Shingrix, had huge knot the size of an egg in the arm and was hurting. The reporter stated that, the side effect lated for 2 weeks and then recovered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024462:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt both times; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain (1st dose received on nknown date in 2019 which hurts refer case US2021AMR024825).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was reported. The age group at vaccination was not reported was captured as an adult as per vaccination. The patient stated, the shot hurt. The reporter did consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024825:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: sounds just like angioedema after first dose of shingrix; This case was reported by a pharmacist via sales rep and described the occurrence of angioedema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was unknown.   It was unknown if the reporter considered the angioedema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient was over 50 years. The patient was now just reporting she experienced what sounds like angioedema after first dose of shingrix this past fall. The reporter was agreed to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Anger, Malaise
Clinical narrative: sick as a dog; This case was reported by a other health professional via call center representative and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were reported as follows: The patient was a medical assistant. 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 received a dose of Shingrix and was sick as a dog afterward. On 31st December 2020, the patient received 2nd  dose of shingrix and did not had any symptoms afterwards. The patient was angry throughout call and declined to provide any contact details, wishing to remain anonymous. No further information provided. The reporter did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Mobility decreased, Myalgia
Clinical narrative: Fatigue; Myalgia; Achiness; difficulty getting out of bed; Swelling at the injection site; Pain  at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 11th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 11th January 2021, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On 12th January 2021, the patient experienced fatigue, myalgia, pain and mobility decreased. On an unknown date, the outcome of the injection site swelling, injection site pain, fatigue, myalgia, pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fatigue, myalgia, pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received the 2nd dose of Shingrix and on the same day, she had pain and swelling at the injection site and on the next day, she had difficulty getting out of bed due to myalgia, fatigue, and achiness. Till the time of reporting, the patient continued to have these symptoms. The reporter did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Fatigue; Myalgia; Achiness; difficulty getting out of bed; Swelling at the injection site; Pain  at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 11th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 11th January 2021, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On 12th January 2021, the patient experienced fatigue, myalgia, pain and mobility decreased. On an unknown date, the outcome of the injection site swelling, injection site pain, fatigue, myalgia, pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fatigue, myalgia, pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received the 2nd dose of Shingrix and on the same day, she had pain and swelling at the injection site and on the next day, she had difficulty getting out of bed due to myalgia, fatigue, and achiness. Till the time of reporting, the patient continued to have these symptoms. The reporter did not consent to follow-up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: sharp Pain and is traveling up to the left shoulder; Soreness at the injection site /the sensation is now a sharp Pain and is traveling up to the left shoulder; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received Shingrix (intramuscular). On 6th January 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 12th January 2021, the patient experienced shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's daughter. The patient received Shingrix and on the same day, had soreness at the injection site and now that sensation was a sharp pain and 6 days  after receiving Shingrix, was traveling up to the left shoulder. The reporter did not consent to follow-up.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: pain in her arm; fever of 101-102; chills; This case was reported by a consumer and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA QUAD) for prophylaxis and PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of no adverse event (previously received on an unknown date). Concomitant products included ibuprofen and cough cold preparations nos (Daytime Cold And Flu (Ingredients Unknown)).   On 12th January 2021, the patient received the 1st dose of Shingrix (intramuscular), AFLURIA QUAD and PNEUMOVAX. On 12th January 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, fever and chills. On an unknown date, the outcome of the pain in arm, fever and chills were unknown.   It was unknown if the reporter considered the pain in arm, fever and chills to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient had participated in the COVID vaccine trial and she had a similar reaction with pain, headache, fever and she felt crummy for 24 hours. The patient received Shingrix, Afluria Quad 2021 and Pneumovax and she started to had pain in her arm with chills and a fever of 101 to 102 degree F all night long that day. The patient stated that the following day she still had a fever of 102 degree F. It was unknown if the reporter considered the pain in arm, fever and chills to be related to Afluria Quad 2021 and Pneumovax. The reporter consented to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: painful shingles rash; painful shingles rash; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 22nd November 2020, 2 days after receiving Shingrix, the patient experienced shingles and painful rash. On 6th December 2020, the outcome of the shingles and painful rash were recovered/resolved.   It was unknown if the reporter considered the shingles and painful rash to be related to Shingrix.  Additional details were reported as follows: The patient developed a painful shingles rash on her right abdomen which lasted for 14 days. No other information was reported.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Itchy rash on her arm; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 18th January 2021, 7 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   The reporter considered the itchy rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and about one week later developed an itchy rash on his arm.   No lot number or expiration date was known for this vaccine.   No HCP information was provided The reporter did not consent to follow up. This case linked with US2021022952 and US2021022953, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021022952:same reporter US-GLAXOSMITHKLINE-US2021022953:same reporter
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular, Urticaria
Clinical narrative: hives /  little red itchy spots; hives /  little red itchy spots; hives /  little red itchy spots; This case was reported by a consumer and described the occurrence of hives in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included heart disorder.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 5 months after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced hives, pruritus and red rash. Shingrix was discontinued. On an unknown date, the outcome of the hives, pruritus and red rash were not recovered/not resolved.   It was unknown if the reporter considered the hives, pruritus and red rash to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient himself. Age at vaccination was not reported. The patient did not have lot number.  The patient received shingles shot in September or October of 2020, along with a flu shot.  The patient had hives. They break out with little red itchy spots it was ok during the day but at night he must get up and put gel on the spots to stop the itching. The patient got a shot for itching but they were still itching.  The patient spots moved to his legs and arms, the patient did not plan on getting the second shot. The reporter did not consent to follow-up. This case was linked with US2021025209 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025209:same reporter
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: hives / red itchy spots; hives / red itchy spots; hives / red itchy spots; This case was reported by a consumer and described the occurrence of hives in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 5 months after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced hives, pruritus and red rash. On an unknown date, the outcome of the hives, pruritus and red rash were not recovered/not resolved.   It was unknown if the reporter considered the hives, pruritus and red rash to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient's husband. Age at vaccination was not reported. The patient received shingles shot in September or October of 2020, along with a flu shot. The reporter did not have lot number.  The patient had hives. They break out with little red itchy spots it was ok during the day but at night he must get up and put gel on the spots to stop the itching.  The patient got a shot for itching but they were still itching.  The patient spots moved to his legs and arms, the patient did not plan on getting the second shot. The reporter did not consent to follow-up. This case was linked with the case US2021025208, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025208:same reporter
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Pharyngeal swelling, Stomatitis
Clinical narrative: mouth irritation; difficulty swallowing; throat swelling; This case was reported by a consumer via call center representative and described the occurrence of mouth irritation in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 20th November 2020, 5 min after receiving Shingrix, the patient experienced mouth irritation, swallowing difficult and throat swelling. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the mouth irritation, swallowing difficult and throat swelling were recovered/resolved.   It was unknown if the reporter considered the mouth irritation, swallowing difficult and throat swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in a pharmacy and it was unknown if patient received a vial or a prefilled syringe.  The patient reports that after about 5 minutes got into car and started to feel throat swelling, mouth irritation and difficulty swallowing.   The patient drove to an urgent care facility and was given antihistamines and monitored and then released.   All symptoms resolved in about two weeks after injection. The reporter did not consent to followup. Emergency room visit required.