chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Very sore arm several hours after the injection.  Next day had a terrible headache, general achiness, nausea, brain fog, and chills.  Did not feel better until the following day 11/7/2019.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea, Thirst
Clinical narrative: Patient came over to clinic to receive vaccination of HPV and Menactra.  Patient was given menecta injection in right deltoid and also given HPV in left deltoid in medication room.  She walked out to hallway in clinic to get a stuffed animal and patient c/o being dizzy per Dr. Dr. assisted her to a chair in the clinic.  Patient was mildly diaphoretic.  Nurse took her VS and she then said, she felt like she was going to throw up.  She closed her eyes briefly.  Nurse Gave her a few sternal rubs.  She responded  to the sternal rubs, she c/o being thirsting.  Epinephrine pen was given per Dr. Patient was able to answers question appropriately then she stated she felt better.   VS: pulse ox 96% to RA, pulse 84, temp 97.5, b/p 97/64. Staff called 911.  When ambulance arrived she was able to answer questions by emergency personnel.  Patient transported to ER per ambulance.  Patient returned from ER around 5:00 pm the same day.  Therapist checked in with patient.  She was monitored through out night and legal guardian was notified.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Fatigue, Myalgia, Pharyngeal swelling
Clinical narrative: Swelling of eyes, throat, sore muscles, tired,
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Arthralgia, Body temperature increased, Injection site erythema, Malaise
Clinical narrative: Pt started to feel unwell the morning after receiving the vaccines, but went to school any way.  Came home from school in the afternoon complaining of pain in all joints and had a temp of 100.2.  Had red area around site of injection on left arm "about the size of a quarter" per his grandmother.  Stayed home from school 11/7 and 11/8 and grandmother reports he is "starting to feel better today".  Redness at site of injection is gone and pt is afebrile.  Not seen in the office since the date of the injection.  I am answering "no" to question 20 below, because he is not fully recovered, yet.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Fatigue, Headache, Oral herpes, Pain
Clinical narrative: about 4 days after receiving the vaccine on 8/23/19 I began having sharp ear pain in L ear  accompanied by very sensitive skin/ear on L side.  I had also had a slight headache that did not go away and felt very tired. Upon going to urgent care for my ear, the PA asked questions that led her to believe that I was pre-shingles and put me on  valacyclovire. Upon taking it the pain was gone the next day.  Then, about  October 24, 2019 I started having sharp pain in my lower jaw and a tooth on my lower jaw and one on my upper jaw became very sensitive to cold and then heat.  I also developed a cold sore (first in 10+ years) about the same time. This continued for about a week (I was out of town at a conference) and upon going to my dentist on 10/31 he took x-rays and examined me and could find no sign of infection or problems.  I was using cold sore medication and as the sore diminished so did the pain.  At the time of both these episodes, my life had become very chaotic and stressful, and as the stress lessened so did the symptoms - particularly the second time since I did not go to urgent care, but was working on the stressors and feeling less stressed as the symptoms were going away.  I never had shingles symptoms before these episodes.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Sensitive skin, Stress, Temperature intolerance, Toothache
Clinical narrative: about 4 days after receiving the vaccine on 8/23/19 I began having sharp ear pain in L ear  accompanied by very sensitive skin/ear on L side.  I had also had a slight headache that did not go away and felt very tired. Upon going to urgent care for my ear, the PA asked questions that led her to believe that I was pre-shingles and put me on  valacyclovire. Upon taking it the pain was gone the next day.  Then, about  October 24, 2019 I started having sharp pain in my lower jaw and a tooth on my lower jaw and one on my upper jaw became very sensitive to cold and then heat.  I also developed a cold sore (first in 10+ years) about the same time. This continued for about a week (I was out of town at a conference) and upon going to my dentist on 10/31 he took x-rays and examined me and could find no sign of infection or problems.  I was using cold sore medication and as the sore diminished so did the pain.  At the time of both these episodes, my life had become very chaotic and stressful, and as the stress lessened so did the symptoms - particularly the second time since I did not go to urgent care, but was working on the stressors and feeling less stressed as the symptoms were going away.  I never had shingles symptoms before these episodes.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray dental normal
Clinical narrative: about 4 days after receiving the vaccine on 8/23/19 I began having sharp ear pain in L ear  accompanied by very sensitive skin/ear on L side.  I had also had a slight headache that did not go away and felt very tired. Upon going to urgent care for my ear, the PA asked questions that led her to believe that I was pre-shingles and put me on  valacyclovire. Upon taking it the pain was gone the next day.  Then, about  October 24, 2019 I started having sharp pain in my lower jaw and a tooth on my lower jaw and one on my upper jaw became very sensitive to cold and then heat.  I also developed a cold sore (first in 10+ years) about the same time. This continued for about a week (I was out of town at a conference) and upon going to my dentist on 10/31 he took x-rays and examined me and could find no sign of infection or problems.  I was using cold sore medication and as the sore diminished so did the pain.  At the time of both these episodes, my life had become very chaotic and stressful, and as the stress lessened so did the symptoms - particularly the second time since I did not go to urgent care, but was working on the stressors and feeling less stressed as the symptoms were going away.  I never had shingles symptoms before these episodes.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain, Pyrexia
Clinical narrative: By 6 pm on the 4th of November I had pain at the injection site, I couldn't lift my arm.  I had generalized aches, fever and shakes.  By the next morning I called in at work, I couldn't get out of bed I had a rash from under my arms to the top of my legs. Wednesday I relaxed all day drinking plenty of fluids.   I tried to work on Thursday but left early with a fever.  I'm still in bed, I missed 2 days of work and I work per diem as an RN.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Tremor
Clinical narrative: By 6 pm on the 4th of November I had pain at the injection site, I couldn't lift my arm.  I had generalized aches, fever and shakes.  By the next morning I called in at work, I couldn't get out of bed I had a rash from under my arms to the top of my legs. Wednesday I relaxed all day drinking plenty of fluids.   I tried to work on Thursday but left early with a fever.  I'm still in bed, I missed 2 days of work and I work per diem as an RN.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site pain, Loss of personal independence in daily activities, Pyrexia, Rash
Clinical narrative: By 6 pm on the 4th of November I had pain at the injection site, I couldn't lift my arm.  I had generalized aches, fever and shakes.  By the next morning I called in at work, I couldn't get out of bed I had a rash from under my arms to the top of my legs. Wednesday I relaxed all day drinking plenty of fluids.   I tried to work on Thursday but left early with a fever.  I'm still in bed, I missed 2 days of work and I work per diem as an RN.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: By 6 pm on the 4th of November I had pain at the injection site, I couldn't lift my arm.  I had generalized aches, fever and shakes.  By the next morning I called in at work, I couldn't get out of bed I had a rash from under my arms to the top of my legs. Wednesday I relaxed all day drinking plenty of fluids.   I tried to work on Thursday but left early with a fever.  I'm still in bed, I missed 2 days of work and I work per diem as an RN.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Product administered at inappropriate site
Clinical narrative: The injection was given very high in the shoulder. The usual tenderness from an injection was there but progressed into pain moving the arm in certain directions over time. Progressively getting worse in a few days to which ADL were compromised. Reported this to my employer and had a Physical therapist evaluate and give exercise to do. I am a Physician assistant and I am going to see a MD at another clinic 11/11 19 as the pain and limitation has continued .
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injected limb mobility decreased, Myalgia, Nausea
Clinical narrative: Extreme overall body aches (mainly muscles) began about 8 hours after injection followed by intense chills at 9 hours post injection. Low grade fever 99-100F from approx. 9 hours post injection to 18 hours post injection. Pain in right arm (couldn't raise arm beyond 90 degrees to floor) began with intensity about 8 hours post injection. Headache started about 18 hours post injection.  Slight nausea (dry heaves once) around 20 hours post injection.  I took 3  regular strength (325 mg) Tylenol pills over the course of 16 ours and drank 8 oz. of green tea about  24 hours post injection.  Symptoms had largely cleared up by 30 hours post injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Retching
Clinical narrative: Extreme overall body aches (mainly muscles) began about 8 hours after injection followed by intense chills at 9 hours post injection. Low grade fever 99-100F from approx. 9 hours post injection to 18 hours post injection. Pain in right arm (couldn't raise arm beyond 90 degrees to floor) began with intensity about 8 hours post injection. Headache started about 18 hours post injection.  Slight nausea (dry heaves once) around 20 hours post injection.  I took 3  regular strength (325 mg) Tylenol pills over the course of 16 ours and drank 8 oz. of green tea about  24 hours post injection.  Symptoms had largely cleared up by 30 hours post injection.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypersensitivity, Pain, Pruritus, Rash
Clinical narrative: Started to experience hives, rash, welts, itching, burning and stinging pain later while at home.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Started to experience hives, rash, welts, itching, burning and stinging pain later while at home.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swollen, itchy bicep where vaccines are given. Pt states it was the worst 11/7/19 and has since gotten a little better. Pt took diphenhydramine and it helped some symptoms.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Employee states that within four hours after receiving flu vaccine  four weeks ago she experienced acute right upper arm pain in the area of the injection site without swelling or redness. Describes her right upper pain as unresolved dull throbbing at rest and sharp pain when moving the arm in certain directions. Has modified her ADL's because of the pain. Taking two Tylenol at night with some benefit.  Advised by NP to continue periodically applying ice or heat to the right shoulder. Physical therapy ordered, employee states will go to PT at least 3 times prior to returning to office visit in 1-3 weeks. NP recommended a referral to orthopedic surgery for an examination and possible anti-inflammatory treatment. MD concurs with evaluation and treatment plan as presented by NP.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site warmth
Clinical narrative: Dose given left upper lateral thigh. Reaction notes a coupe hours later. Called office next day and provider said it was an infection, prescribed antibiotics. I was giving Tylenol, ibuprofen, Benadryl and icing area. Provider said to do warm compresses and antibiotics. Even after 2 doses of prescribed antibiotics the site is still red, warm, and firm. No fever present.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Swelling
Clinical narrative: Redness and swelling that extends past elbow and to the back shoulder blade
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Received Flu vaccine 9/30/19. Pain at site of injection (L) shoulder immediately. Pain (L) shoulder has continued since 9/30/19. Saw NP at Clinic for evaluation + treatment. Physical Therapy PT two times a week for 4 (four) weeks.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report as received from a pharmacist refers to a patient of unknown age. Information concerning his concurrent conditions, pertinent history, allergies and concomitant therapies were not provided.   On 28-SEP-2019, the patient was vaccinated with improperly  stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012246, expiration date: 10-FEB-2021, dose and route of administration were not provided) for prophylaxis. No adverse effect was reported.   The vaccine underwent temperature excursion: 68 Fahrenheit degrees for 8 hours. There was previous temperature excursion of 68 Fahrenheit degrees for 2 hours. Data logger involved.
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: pea size swelling at injection site; Wallnut size swelling at injection site; This spontaneous information has been received from a charge nurse via company representative, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the reporter.  On an unspecified date, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (reported as to prevent human papillomavirus (HPV)) (strength, route of administration, lot number and expiration date were unknown) and developed a pea size swelling at injection site (vaccination site swelling).  On an unspecified date in October 2019 (reported as this week), the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (reported as to prevent human papillomavirus (HPV)) (strength, route of administration, lot number and expiration date were unknown) and developed walnut sized swelling at injection site. The nurse reported that the swelling resolved within 48 hours. The patient did not seek for medical attention and no treatment was given for the vaccination site swellings. It was unknown if lab diagnostics or studies were performed.  The causal relationship between the vaccination site swelling and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Temp 100'F nausea, vomiting, uncontrollable shivering, diarrhea, severe malaise which lasted 12 hrs. (L) arm (upper) severe Raised & tender and Red lasting 3 days.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Temp 100'F nausea, vomiting, uncontrollable shivering, diarrhea, severe malaise which lasted 12 hrs. (L) arm (upper) severe Raised & tender and Red lasting 3 days.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpes zoster eye disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at Senior Center for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for herpes zoster eye disease. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Upon internal review, the event of herpes zoster eye disease was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Head banging, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Felt immediate Pain at the injection site his left arm when the vaccine was administered; Injection site swelling; Injection site redness; Headache; Shivering; Dry heaves; Achy all over; Could not sleep on left side due to the arm pain; Arm pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (injection site pain, after receiving 1st dose on 27th August 2019, see case US2019158372).   On 28th October 2019 11:00, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm. On 28th October 2019, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient felt pain at the injection site on his left arm when the vaccine was administered. The pain progressed and swelling and redness presented at the site. The patient also had a headache, shivering, dry heaves and achy all over body. The patient barely slept and had to take a hot shower to stop the shivering. The patient could not sleep on left side due to the arm pain. The patient received 1st dose and had adverse events, for tolerance refer case US2019158372.
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Retching
Clinical narrative: Felt immediate Pain at the injection site his left arm when the vaccine was administered; Injection site swelling; Injection site redness; Headache; Shivering; Dry heaves; Achy all over; Could not sleep on left side due to the arm pain; Arm pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (injection site pain, after receiving 1st dose on 27th August 2019, see case US2019158372).   On 28th October 2019 11:00, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm. On 28th October 2019, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient felt pain at the injection site on his left arm when the vaccine was administered. The pain progressed and swelling and redness presented at the site. The patient also had a headache, shivering, dry heaves and achy all over body. The patient barely slept and had to take a hot shower to stop the shivering. The patient could not sleep on left side due to the arm pain. The patient received 1st dose and had adverse events, for tolerance refer case US2019158372.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Shngrix injection really hurt; This case was reported by a pharmacist and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain 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 selected as adult as per vaccine indication. The patient complained that the Shingrix injection really hurt. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Urticaria
Clinical narrative: Hives; Headaches; This case was reported by a consumer and described the occurrence of hives in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced hives and headache. The patient was treated with cetirizine hydrochloride (Zyrtec), prednisone, famotidine (Pepcid) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives and headache were unknown.   It was unknown if the reporter considered the hives and headache to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was a reporter' sister. The patient was currently working and did not have the time right now. The reporter concerned because patient was highly reactive to new medications. The patient experienced hives and headaches. The physician prescribed the following 1 take prednisone as prescribed take 2 Zyrtec in the am, 1 pepcid in the afternoon, and 1 benadryl at night for about a month. The patient adviced to follow up if no resolution of symptoms or signs of bacterial infection warmth, redness, green discharge. The reporter enquired about what was the difference between this shingles vaccination and the other vaccines. The reporter consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Influenza like illness, Injection site rash
Clinical narrative: inappropriate schedule of; fever; shivering; headache; itchy bumps on stomach; rash at injection site; flu-like symptoms; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019, refer linked case US2019197555).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced itchy rash, injection site rash, papular rash and drug dose administration interval too long. On an unknown date, the patient experienced fever, shivering, headache and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash to be related to Shingrix.  Additional details were provided as follows: Less than 3 months after receiving Shingrix, the patient experienced flu-like symptoms, fever, shivering and headache. The patient experienced rash at injection site and  itchy bumps on stomach. These resolved after 5 days. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash papular, Rash pruritic
Clinical narrative: inappropriate schedule of; fever; shivering; headache; itchy bumps on stomach; rash at injection site; flu-like symptoms; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019, refer linked case US2019197555).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced itchy rash, injection site rash, papular rash and drug dose administration interval too long. On an unknown date, the patient experienced fever, shivering, headache and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash to be related to Shingrix.  Additional details were provided as follows: Less than 3 months after receiving Shingrix, the patient experienced flu-like symptoms, fever, shivering and headache. The patient experienced rash at injection site and  itchy bumps on stomach. These resolved after 5 days. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: inappropriate schedule of; fever; shivering; headache; itchy bumps on stomach; rash at injection site; flu-like symptoms; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019, refer linked case US2019197555).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced itchy rash, injection site rash, papular rash and drug dose administration interval too long. On an unknown date, the patient experienced fever, shivering, headache and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash to be related to Shingrix.  Additional details were provided as follows: Less than 3 months after receiving Shingrix, the patient experienced flu-like symptoms, fever, shivering and headache. The patient experienced rash at injection site and  itchy bumps on stomach. These resolved after 5 days. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pyrexia, Rash pruritic
Clinical narrative: inappropriate schedule of; fever; shivering; headache; itchy bumps on stomach; rash at injection site; flu-like symptoms; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019, refer linked case US2019197555).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced itchy rash, injection site rash, papular rash and drug dose administration interval too long. On an unknown date, the patient experienced fever, shivering, headache and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, shivering, headache, itchy rash, injection site rash, influenza-like symptoms and papular rash to be related to Shingrix.  Additional details were provided as follows: Less than 3 months after receiving Shingrix, the patient experienced flu-like symptoms, fever, shivering and headache. The patient experienced rash at injection site and  itchy bumps on stomach. These resolved after 5 days. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Influenza like illness, Injection site rash
Clinical narrative: fever; Drug dose administration interval too long; shivering; headache; flu-like symptoms; rash at injection site; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019 and experienced fatigue (refer case  US2019197555 )).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced influenza-like symptoms, injection site rash, itchy rash, fever, shivering and headache. On an unknown date, the outcome of the influenza-like symptoms, injection site rash, itchy rash, shivering and headache were recovered/resolved and the outcome of the fever and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site rash, itchy rash, fever, shivering and headache to be related to Shingrix.  Additional details were received as follows: The patient experienced flu-like symptoms, rash at injection site, itchy bumps on stomach, fever, shivering and headache. These resolved after 5 days. The patient was unable to get the second shot until 20th August 2019, which led to lengthening of vaccination schedule.   The reporter consented to follow up. This is 1 of 4 cases reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash papular, Rash pruritic
Clinical narrative: fever; Drug dose administration interval too long; shivering; headache; flu-like symptoms; rash at injection site; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019 and experienced fatigue (refer case  US2019197555 )).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced influenza-like symptoms, injection site rash, itchy rash, fever, shivering and headache. On an unknown date, the outcome of the influenza-like symptoms, injection site rash, itchy rash, shivering and headache were recovered/resolved and the outcome of the fever and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site rash, itchy rash, fever, shivering and headache to be related to Shingrix.  Additional details were received as follows: The patient experienced flu-like symptoms, rash at injection site, itchy bumps on stomach, fever, shivering and headache. These resolved after 5 days. The patient was unable to get the second shot until 20th August 2019, which led to lengthening of vaccination schedule.   The reporter consented to follow up. This is 1 of 4 cases reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: fever; Drug dose administration interval too long; shivering; headache; flu-like symptoms; rash at injection site; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019 and experienced fatigue (refer case  US2019197555 )).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced influenza-like symptoms, injection site rash, itchy rash, fever, shivering and headache. On an unknown date, the outcome of the influenza-like symptoms, injection site rash, itchy rash, shivering and headache were recovered/resolved and the outcome of the fever and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site rash, itchy rash, fever, shivering and headache to be related to Shingrix.  Additional details were received as follows: The patient experienced flu-like symptoms, rash at injection site, itchy bumps on stomach, fever, shivering and headache. These resolved after 5 days. The patient was unable to get the second shot until 20th August 2019, which led to lengthening of vaccination schedule.   The reporter consented to follow up. This is 1 of 4 cases reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pyrexia, Rash pruritic
Clinical narrative: fever; Drug dose administration interval too long; shivering; headache; flu-like symptoms; rash at injection site; itchy bumps on stomach; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 17th January 2019 and experienced fatigue (refer case  US2019197555 )).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced influenza-like symptoms, injection site rash, itchy rash, fever, shivering and headache. On an unknown date, the outcome of the influenza-like symptoms, injection site rash, itchy rash, shivering and headache were recovered/resolved and the outcome of the fever and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site rash, itchy rash, fever, shivering and headache to be related to Shingrix.  Additional details were received as follows: The patient experienced flu-like symptoms, rash at injection site, itchy bumps on stomach, fever, shivering and headache. These resolved after 5 days. The patient was unable to get the second shot until 20th August 2019, which led to lengthening of vaccination schedule.   The reporter consented to follow up. This is 1 of 4 cases reported by the same reporter.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Scab
Clinical narrative: Scab; This case was reported by a consumer and described the occurrence of scab in a 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 the 2nd dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced scab. On an unknown date, the outcome of the scab was recovering/resolving.   It was unknown if the reporter considered the scab to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient just received 2nd dose of Shingrix on an unknown arm and flu shot in another arm on the same day. The patient then ended up with a scab that was now about to come off. The patient did not see that as a side effect, just wanted to report it.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Having problems / People are suffering; This case was reported by a consumer and described the occurrence of adverse reaction in patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Many cases published on the internet about many other people having problems with Shingrix as well. The problems occurred due Shingrix need to fix, so that it would not happen to more people. The people were suffering and even dying from Shingrix. This case had been linked to the case US2019AMR196945, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Musculoskeletal pain
Clinical narrative: shoulder pain; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain 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, less than a day after receiving Shingrix, the patient experienced shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the shoulder pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient came in to the store to get the second Shingrix vaccine. In the evening after getting the first Shingrix vaccine, the patient experienced shoulder pain and flu like symptoms. The reporter consented to follow up. The pharmacist stated she was filling in at this store, and was not the regular pharmacist.  The reporter did not get patient's name at time of discussion with patient, and is unable to provide details, other than what is provided at time of initial report. The reporter was agreeable to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection Hurt; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain 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 selected as adult as per vaccine indication. The patient complained that the Shingrix injection really hurt. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Hot to Touch; Hives; Swelling/ bump; Redness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included food allergy and food allergy.   On 8th August 2019, the patient received the 1st dose of Shingrix. On 17th October 2019, 70 days after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced swelling arm, erythema of extremities and skin warm. The patient was treated with cortisone (non-proprietary) (Cortisone 10). Shingrix was discontinued. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the skin warm was unknown and the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on right arm. Less than 3 months after receiving Shingrix, the patient experienced had swollen and red arm for approximately 1.5 weeks. The caller reported that it went away and then she had hotness in her arm. The patient started to have hives and had no past medical history of hives.  The caller mentioned around that time, the patient ate a few things that she never had before.  The patient also mentioned she is allergic to different things like chocolate and cheese which causes migraines and she had avoided it for approximately 35 years. The caller reported hives went away in a few days after putting Cortisone 10 on it and bathing and showering as usual, but at the reporting date a bump appeared every few days in different places. The caller declined to provide further information for safety report.  The caller did not consent to follow-up and did not not want to receive any correspondence.  The caller mentioned she may call back later to provide information after speaking with her doctor.  The provided MI phone number for her doctor's reference.  The caller reported never smoking or drinking. She was considering not receiving 2nd dose even if her doctor approved it.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Diarrhoea, Injected limb mobility decreased, Mass, Musculoskeletal disorder
Clinical narrative: May 15th 2019 - Left Arm - Lump and so sore couldn't Lift Arm yet in Aug. Nausia and diarea off + on. Aug 5th 2019 - Right Arm After Several days and Month Couldn't Lift either Arm + Sore. Did ultra Sound + Bloodwork  Dr visit #2 Trying 3 days of steroid than Aleve for 10 days 2 x Day 11-1-19 Dr visit put Cortizone shot in left Arm. No Longer could lift Arm At All. Right Arm wanted to Also Do Cortizone shot As had 50% use of Arm. Refused that day, Possible When I go in for physical 11-11-19. Started physical therapy for both arms 11-4-19. Doing better since Cortizone Shot.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Ultrasound scan normal
Clinical narrative: May 15th 2019 - Left Arm - Lump and so sore couldn't Lift Arm yet in Aug. Nausia and diarea off + on. Aug 5th 2019 - Right Arm After Several days and Month Couldn't Lift either Arm + Sore. Did ultra Sound + Bloodwork  Dr visit #2 Trying 3 days of steroid than Aleve for 10 days 2 x Day 11-1-19 Dr visit put Cortizone shot in left Arm. No Longer could lift Arm At All. Right Arm wanted to Also Do Cortizone shot As had 50% use of Arm. Refused that day, Possible When I go in for physical 11-11-19. Started physical therapy for both arms 11-4-19. Doing better since Cortizone Shot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash - urticaria scalp + flank 5 days after vaccine (2nd). Still persisting after 5 weeks.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Employee evaluated at Occupational Medicine regarding ongoing right shoulder pain. RPA note states employee received flu shot 4 weeks ago and after 2 hours developed right shoulder pain which has continued. Employee states pain increases with activity, has been taking ibuprofen with some relief but not getting better. Reports dull ache in right shoulder at rest that becomes increased pain with certain movements. No redness, ecchymosis or swelling. ROM of right shoulder is full in all planes with pain to movement. Plan methylPREDNisone 4 mg oral tablet, referral to Physical therapy with follow up appointment in 1-2 weeks.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Insomnia, Pain, Skin warm
Clinical narrative: Extreme soreness, pain,  swelling, hot to touch, small red lump in area, difficulty sleeping, feeling weak.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Extreme soreness, pain,  swelling, hot to touch, small red lump in area, difficulty sleeping, feeling weak.