chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Pt fainted shortly after receiving vaccine, 911 called immediately, BP fluctuating rapidly, pt was mostly awake but not alert.  Paramedics took out in ambulance with Dad
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Headache, Joint swelling, Nausea
Clinical narrative: Her shot was yesterday at 10 am. She was fine while waiting her 15 minutes. She started getting a headache that turned severe and got nauseated on way home. Last evening noticed ankles swollen. All these symptoms are gone this am. She states her Blood Sugar was up this am- 174. It usually runs 110-130
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2 cases of breakthrough HZ / were vaccinated with Shingrix in the past / fully vaccinated/suspected vaccination failure; 2 cases of breakthrough HZ; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient was fully vaccinated with Shingrix and during the pandemic, the patient breakthrough herpes zoster. The physician attributed that the breakthrough herpes zoster case was due to stress of the pandemic. The case resolved without issue. The reporter could not recall patient's initials, age, date of birth and when they were vaccinated. This case was considered as suspected vaccination failure as details regarding laboratory confirmation of herpes zoster and exact time to onset were unknown at the time of reporting. The reporter consented to follow up. This case has been linked with the case US2021AMR102475, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102475:same reporter, different patient (2nd patient case)
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Possible Mondor's disease. Left side chest to mid abdominal thrombophlebitis.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Syncope
Clinical narrative: Patient experienced Syncopal episode and fell to floor,  laid patient on back and elevated feet,  with time and hydration fully recovered within 30 minutes
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain of skin, Pyrexia
Clinical narrative: Fever of 102.4 for 2 days, extremely achy skin from head to toe, teeth hurt, very weak, headache, chills
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Fever of 102.4 for 2 days, extremely achy skin from head to toe, teeth hurt, very weak, headache, chills
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Muscular weakness, Musculoskeletal stiffness, Swelling face
Clinical narrative: patient has severe headaches, stiff neck, insomnia, swollen face, and lazy leg
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash at sight of injection 7 days after vaccination with hard swelling and itching .
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Muscle spasms, Pain
Clinical narrative: Severe intestinal pain, cramping, stabbing pain, diarrhea
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Dizziness, Gait inability, Headache
Clinical narrative: leg pain for 2days.stomach pain for 10 days..sudden head pain followed by right side numbness. blurred vision dizzy unable to walk or talk for a hour or so first episode. 2ond felt like i was being flipped back wards..3rd. In bath tub. Head pain and fell to the left side.4th early in morning head pain and felt numbness on the left side again..
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging normal, Pain in extremity, Phlebotomy, Speech disorder
Clinical narrative: leg pain for 2days.stomach pain for 10 days..sudden head pain followed by right side numbness. blurred vision dizzy unable to walk or talk for a hour or so first episode. 2ond felt like i was being flipped back wards..3rd. In bath tub. Head pain and fell to the left side.4th early in morning head pain and felt numbness on the left side again..
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: leg pain for 2days.stomach pain for 10 days..sudden head pain followed by right side numbness. blurred vision dizzy unable to walk or talk for a hour or so first episode. 2ond felt like i was being flipped back wards..3rd. In bath tub. Head pain and fell to the left side.4th early in morning head pain and felt numbness on the left side again..
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Angiogram, Blood pressure measurement, Cerebrovascular accident, Computerised tomogram
Clinical narrative: leg pain for 2days.stomach pain for 10 days..sudden head pain followed by right side numbness. blurred vision dizzy unable to walk or talk for a hour or so first episode. 2ond felt like i was being flipped back wards..3rd. In bath tub. Head pain and fell to the left side.4th early in morning head pain and felt numbness on the left side again..
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypertension, Magnetic resonance imaging, Pain in extremity, Phlebotomy
Clinical narrative: leg pain for 2days.stomach pain for 10 days..sudden head pain followed by right side numbness. blurred vision dizzy unable to walk or talk for a hour or so first episode. 2ond felt like i was being flipped back wards..3rd. In bath tub. Head pain and fell to the left side.4th early in morning head pain and felt numbness on the left side again..
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: leg pain for 2days.stomach pain for 10 days..sudden head pain followed by right side numbness. blurred vision dizzy unable to walk or talk for a hour or so first episode. 2ond felt like i was being flipped back wards..3rd. In bath tub. Head pain and fell to the left side.4th early in morning head pain and felt numbness on the left side again..
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Case of breakthrough herpes zoster / was fully vaccinated with Shingrix in the past; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure and herpes zoster were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient was fully vaccinated with Shingrix and during the pandemic, the patient had breakthrough of herpes zoster. The reporter attributed the breakthrough herpes zoster case to the stress of the pandemic. The case had resolved without issue. The reporter could not recall patient's initials, age, date of birth and when they were vaccinated. The health care professional consented to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset  and laboratory confirmation were unknown at the time of reporting. This case has been linked with the case US2021AMR102457, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102457:same reporter ,same suspect(1st patient case)
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Eye movement disorder, Mobility decreased
Clinical narrative: Dizziness to the point I can?t keep my balance. I get so dizzy I can feel my eyes rolling back. It goes on all day. Has been going on for the past 4 days. Can?t make sudden quick movement or I loose my balance or eyes start rolling back.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Pain in right arm at injection spot, more than just feeling of soreness, 3 hours after injection.  Nausea 12 hours after shot, vomiting 15 hours after shot, headache started at 6 am day after shot (or 17 hours after shot). Headache continued for 29 hours - advil and tylenol not effective at getting rid of pain.  Nausea still continuing 48 hours after shot.  Sweating 14 hours after shot and continuing for 12 hours - could be due to fever (was not able to check temperature but was feeling warm)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pain in right arm at injection spot, more than just feeling of soreness, 3 hours after injection.  Nausea 12 hours after shot, vomiting 15 hours after shot, headache started at 6 am day after shot (or 17 hours after shot). Headache continued for 29 hours - advil and tylenol not effective at getting rid of pain.  Nausea still continuing 48 hours after shot.  Sweating 14 hours after shot and continuing for 12 hours - could be due to fever (was not able to check temperature but was feeling warm)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I received the vaccination on Tuesday and on Thursday morning. I started having this fluttering noise in my left ear. It lasts about a minute then stops then starts again.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Nausea
Clinical narrative: Tiredness, nausea and spiked blood sugar levels that are lowering slowly.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fibromyalgia, Rheumatoid arthritis
Clinical narrative: severe flare of RA and fibromyalgia
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shot and still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient had the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Rash papular
Clinical narrative: Patient reports getting a rash after their first dose of Moderna 8 days after injection. Patient reports redness at site of injection, warm, raised, no itching, but lasted for 1 week then resolved. Patient self treated at home and took ibuprofen and zyrtec.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Electrocardiogram, Loss of consciousness
Clinical narrative: -Patient received vaccine -Sat in observation area -Passed out and slumped over, was prevented from falling by wife and pharmacist. -Patient appeared to be sleeping but was roused after a minute or 2. -Paramedics were called and examined the patient, gave fluids and took to hospital -Patient called back and said they were released shortly after (low glucose and BP)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Tinnitus
Clinical narrative: Left ear: Ringing in ear, hearing loss, tinnitus Steroid shot injection in eardrum Not resolved
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage urinary tract, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Heavy menstrual clotting and menstrual cycle going on for 12 days.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Get the shot shingles/suspected vaccination failure; shingles; most painful thing ever; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles, the most painful thing ever after vaccination . This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Visual impairment
Clinical narrative: 5 minutes after the vaccine, patient started  feeling dizzy, change in vision and sweating. Taken the the patient to the exam room, and made him lie down with elevated legs. Given some water to drink. Checked BP -110/68 , HR-51, and O2 stats-96%, never loss consciousness, alert oriented during the time of incident. Skin looks pale  with profuse sweating. Denies any shortness of breath. Watched the patient for another 30 minutes and send home with after all the symptoms completely resolved/
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Ear pain, Injection site pain, Injection site pruritus
Clinical narrative: Dose 1: 4 days after vaccine until present (6 weeks), I have experienced dizziness and right knee pain. 7 days after vaccine until around day 28 (3 weeks), I had stabbing pain in right ear when swallowing. Dose 2: 1 day after vaccine until day 3, I had moderate swelling in left ankle. 1 day after vaccine until day 7, I experienced left ankle pain and right arm pain at injection site along with bullseye rash, swelling, warmth, itching and tenderness.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: Dose 1: 4 days after vaccine until present (6 weeks), I have experienced dizziness and right knee pain. 7 days after vaccine until around day 28 (3 weeks), I had stabbing pain in right ear when swallowing. Dose 2: 1 day after vaccine until day 3, I had moderate swelling in left ankle. 1 day after vaccine until day 7, I experienced left ankle pain and right arm pain at injection site along with bullseye rash, swelling, warmth, itching and tenderness.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Fatigue, Nausea, Neck pain
Clinical narrative: 103.1 fever, nausea, vomiting, total body ache/pain, fatigue lasting multiple days,   Fever broke with chills and cold sweat but then returned later. Neck has been sore and is still sore three days later. No stamina three days later.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: 103.1 fever, nausea, vomiting, total body ache/pain, fatigue lasting multiple days,   Fever broke with chills and cold sweat but then returned later. Neck has been sore and is still sore three days later. No stamina three days later.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Feeling abnormal, Hepatic pain, Influenza like illness
Clinical narrative: NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HIVE LIKE BUMPS ON BOTH ARMS SMALL BUMPS ON FOREHEAD, LOSS OF APPETITE, KIDNEY, LIVER PAIN, BACK ACNE. COGNITIVE CLARITY LOSS.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Renal pain, Urticaria
Clinical narrative: NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HIVE LIKE BUMPS ON BOTH ARMS SMALL BUMPS ON FOREHEAD, LOSS OF APPETITE, KIDNEY, LIVER PAIN, BACK ACNE. COGNITIVE CLARITY LOSS.
Age: 16.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: SHINGRIX given to 16 year old patient by accident instead of Menveo.; SHINGRIX given to 16 year old patient by accident; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2021, the patient received Shingrix. On 11th May 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The Nurse reported that Shingrix was given to 16 year old patient by accident instead of Menveo, which led to  wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Syncope, Tremor
Clinical narrative: Severe syncope, shaking, low blood pressure
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Skin burning sensation
Clinical narrative: About 4-5 days after my vaccine, I woke up with excruciating burning pain under my skin in my knee that felt like my leg was on fire. It lessened, but a faint pain remained and came and went for the following 24 hours. It went away for about a week, then came back. It is no longer excruciating pain like the first event which I haven?t felt since then, but it comes as a small burning sensation that occurs at random times at completely random parts of my body. It feels almost like a precise, burning nerve pain, but not pins and needles. I have felt it nearly everywhere on my body from literally my head to my toes, and almost everywhere in between. It lasts for no longer than a minute, and it only shows up in one or two areas of my body at once. It comes and goes often, so some days it?s constant and appears nearly all day, but some days I don?t feel it at all or only a small amount.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted approx 12 hours after dose 2
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact
Clinical narrative: pinched my arm hard and had to wipe my arm (vaccine spilled); Inadvertent exposure to vaccine; This case was reported by a consumer via call center representative and described the occurrence of exposure via skin contact in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Shingrix. On 10th May 2021, unknown after receiving Shingrix, the patient experienced exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient was vaccinated with dose of Shingrix yesterday from the date of reporting and reported that the health care professional pinched the arm had and had to wipe the arm, which led to exposure via skin contact and accidental exposure to product. The vaccine spilled. The consent to follow up was denied.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was given adjuvant only / vaccine was not mixed with antigen; was given adjuvant only / vaccine was not mixed with antigen; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The patient was given adjuvant only vaccine was not mixed with antigen prior to administering which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administrated / an expired dose of Menveo on April 30 2021 /expired on March 31 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA268A, expiry date 31st March 2021) for prophylaxis.   On 30th April 2021, the patient received Menveo. On 30th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided follows:  The age at vaccination was not reported. On 30th April 2021, the  patient received Menveo which was expired on 31st March 2021, which led to expired vaccine used. No adverse events reported. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was frozen while kept on the refrigerator that went too cold and reached 11°F; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number Z22C5, expiry date unknown) for prophylaxis.   Additional patient notes included Race: Indigenous.   On 5th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follow: The reporter informed Shingrix vaccine was stored in pharmacy refrigerator which went out of temperature range down to a minimum of 11 degree F for up to 12 hours which led to incorrect storage of drug. Shingrix was moved to a second fridge and marked do not use but pharmacist did not see the sign. The pharmacist injected one dose to the patient before discovering the vaccine was exposed to the temperature excursion. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: had received it and she does NOT think it was refrigerated prior to administration; This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional information was provided as follows:  The reporter was the patient. The age at vaccination was not reported. The patient received Shingrix, which was stored out of refrigerator, which led to incorrect storage of drug. The reporter stated that, she received the vaccine and does not think if it was refrigerated prior to administration. The reporter stated that, She saw them taking out of the box off the shelf and later when I went to look up the side effects and that needs to be refrigerated. The reporter mentioned that, she was pretty sure that it was not refrigerated.  She did not want to answer any further questions further.  She said she wanted to call the facility (right away) to find out if it was refrigerated or not.  She said she would call back and ended the call abruptly.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: never received a second dose during the 6 month window; patient developed shingles afterhis first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 7th April 2021, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix and experienced shingles.  Till the time of reporting, patient did not received 2nd dose which led to incomplete course of vaccination. The patient received 1st dose at a different pharmacy so no lot or expiry date was available. The reporter consented to follow up via postal.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received / 1st dose of Shingrix / 22nd October, 2020 /  received the COVID vaccine / second dose was delayed; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd October 2020, batch number-33TL7 expiration date-30th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient received the Covid vaccine and so the 2nd dose of shingrix was delayed. No further details were provided at the time of call. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had her first Shingrix dose in 2019 and second dose last week (May 2021); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In May 2021, the patient received the 2nd dose of Shingrix. In May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows:  The age at vaccination was not reported. Last week before date of reporting, the patient received 2nd dose of Shingrix, which led to lenghtening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: red ring appeared around the injection site that measured 2-3 inches around; sore arm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema 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 2 months after receiving Shingrix, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of Shingrix 6 to 8 weeks ago of the reporting date and experienced a sore arm and a red ring appeared around the injection site that measured 2 to 3 inches around. The soreness and redness had resolved. She had not received her 2nd dose yet.  No other information was provided. The reporter did not consent to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix with another diluent than ASO1B provided by GSK / administered with an incorrect adjuvant; Shingrix with another diluent than ASO1B provided by GSK / administered with an incorrect adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number LL2G7, expiry date 6th November 2022) for prophylaxis.   On 4th May 2021, the patient received Shingrix. On 4th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The Patient had received a dose of Shingrix with another diluent than ASO1B provided by GSK. HCP enquired information about how to proceed in the case that a Shingrix vaccine was administered with an incorrect adjuvant. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: gave her/adjuvant suspension/did not reconstitute the vial of lyophilized gE antigen; gave her/adjuvant suspension/did not reconstitute the vial of lyophilized gE antigen; This case was reported by a consumer via call center representative and described the occurrence of inappropriate reconstitution technique in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The case was reported by the husband of the patient. The age at vaccination was not reported. The husband reported that they only gave her a single-dose vial of adjuvant suspension component and did not reconstitute the vial of lyophilized gE antigen component, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. No further information was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/ on 8th September 2020./second dose/not given at the time of the call.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. Till the time of reporting patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The second dose was not given at the time of the call. No further details were reported. The HCP did not consent nor declined follow-up. No further details on the vaccine or patient were available at the time of the call.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received 1st dose / between September and October, 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose between September and October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable. The reporter stated the patient was 65 years and older but did not specify. Till the time of reporting the patient didn't receive the 2nd dose which led to incomplete course of vaccination. No further details of patient or vaccine were provided. No further details were reported. The reporter did not consent to follow up. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102194:Same reporter US-GLAXOSMITHKLINE-US2021102195:Same reporter US-GLAXOSMITHKLINE-US2021102197:Same reporter US-GLAXOSMITHKLINE-US2021102198:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Platelet count
Clinical narrative: NUMBNESS ON FOOT; LEG PAIN; This spontaneous report received from a consumer concerned a female of unspecified age (race and ethnicity not reported). The patient's height, and weight were not reported. The patient's concurrent conditions included low platelet count.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, ) dose, 1 total, administered ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter mentioned of blood clots in the news and was concerned due to having leg pain and numbness on her foot with history of low platelet count.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events leg pain and numbness on foot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: The case concerned a female patient of unspecified age (race and ethnicity not reported) who developed important medical events of a leg pain and numbness of foot unspecified time after receiving the Janssen Covid-19 vaccine, for prophylaxis of symptomatic SARS.COV2 S infection. The patient's height, and weight were not reported. The patient's concurrent condition included low platelet count. The outcome of the events leg pain and numbness on foot was not reported. Additional information (e.g. height, weight, full medical history, social history, family history, concomitant medications, specific platelet levels, peripheral smear, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, radiologic diagnostic test results such as ultrasound, CT, MRI, angiogram, or venogram) was not provided. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the relationship of leg pain and numbness of foot to vaccination is considered unclassifiable (BC Criteria level 5) due to insufficient information. Additional information has been requested for further assessment.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; the vaccine was administered after expiration; This spontaneous report was received from Healthcare Business Professional (HBP) (also reported as office manager), referring to a patient of  unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 04-MAY-2021,  a patient was vaccinated with a expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rha)(M-M-R II) 0.5 milliliter, lot number S013536, expiration date 02-MAY-2021 (dose, strength, scheme of vaccination, route of administration were not reported), as prophylaxis (Expired product administered).   No additional adverse event was reported.
Age: 42.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No other AE.; Patient received their first dose of GARDASIL 9 two years ago and has not received any additional doses since they received the first dose; This spontaneous report was received from a pharmacist referring to an adult patient of unknown gender. The patient's pertinent concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date in 2019 (reported as two years ago), at age of 42-year-old, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dosage form as prophylaxis (concentration, route of administration, anatomical location, lot number and expiration date were not reported) however, did not received any additional doses since they received the first dose (inappropriate schedule of product administration). No adverse event was not reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Injection site swelling, Laboratory test, Thrombosis
Clinical narrative: BLOOD CLOTS BOTH LEGS; POSSIBLE HEARTBURN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old male. The patients weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 16-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced swelling at injection site. On 19-APR-2021, patient had blood clots (1 in each leg), Hematologist put him on xarelto 10mg, in hospital for few days for blood clots. Patient initially went to hospital ER on 19-APR-2021 because he thought having chest pains or heartburn. Emergency Room ran tests and heart was normal, but found blood clots in his both legs. Lab test (NR: not provided) Heart normal. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought having chest pains/heartburn on 22-APR-2021, had not recovered from blood clots both legs, and the outcome of swelling at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504455-COVID-19 VACCINE AD26.COV2.S-Blood clot both legs. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: FELT LIKE TRUCK HIT ME; FLU- LIKE SYMPTOMS; EXTREME MUSCLE DISCOMFORT AND SENSITIVE HIPS AND IN LOWER BACK TO SIDE; SORE ARM; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced felt like truck hit me. On 02-MAY-2021, the subject experienced flu- like symptoms. On 02-MAY-2021, the subject experienced extreme muscle discomfort and sensitive hips and in lower back to side. On 02-MAY-2021, the subject experienced sore arm. On 02-MAY-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu- like symptoms, and fever on 03-MAY-2021, was recovering from felt like truck hit me, and had not recovered from extreme muscle discomfort and sensitive hips and in lower back to side, sore arm, and fatigue. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensory disturbance
Clinical narrative: FELT LIKE TRUCK HIT ME; FLU- LIKE SYMPTOMS; EXTREME MUSCLE DISCOMFORT AND SENSITIVE HIPS AND IN LOWER BACK TO SIDE; SORE ARM; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced felt like truck hit me. On 02-MAY-2021, the subject experienced flu- like symptoms. On 02-MAY-2021, the subject experienced extreme muscle discomfort and sensitive hips and in lower back to side. On 02-MAY-2021, the subject experienced sore arm. On 02-MAY-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu- like symptoms, and fever on 03-MAY-2021, was recovering from felt like truck hit me, and had not recovered from extreme muscle discomfort and sensitive hips and in lower back to side, sore arm, and fatigue. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Feeling abnormal, Genital hypoaesthesia, Headache
Clinical narrative: SWEATING; LIPS TURNED INTO PALE; VISION BLURRED; NO ENERGY; STRESSFUL HEADACHE; NUMBNESS IN THE GROIN AREA AND LEFT TESTICLES; SWOLLEN LEFT TESTICLE; FEEL EXTREME PAIN; FEELING SENSATION IN DEEP INSIDE BODY AND WAS NOT SUPERFICIAL/FEELING WAS GOING TOWARD LEFT SIDE OF PELVIS/FEELING BLOOD BEATS IN LOWER PART AREA; LEFT SIDE OF LOWER ABDOMEN AROUND THE WAISTLINE SWOLLEN; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery, and concurrent conditions included non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness in the groin area and left testicles. On APR-2021, the subject experienced swollen left testicle. On APR-2021, the subject experienced feel extreme pain. On APR-2021, the subject experienced feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area. On APR-2021, the subject experienced left side of lower abdomen around the waistline swollen. On APR-2021, the subject experienced stressful headache. Treatment medications included: morphine, and oxycodone hydrochloride. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced lips turned into pale. On 03-APR-2021, the subject experienced vision blurred. On 03-APR-2021, the subject experienced no energy. On 30-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) no sign of infection, Physical examination (NR: not provided) no sign of infection, and Urine analysis (NR: not provided) no sign of infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision blurred, and the outcome of numbness in the groin area and left testicles, sweating, swollen left testicle, lips turned into pale, no energy, feel extreme pain, feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area, stressful headache and left side of lower abdomen around the waistline swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.