chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Discomfort, Dizziness, Fatigue, Immediate post-injection reaction
Clinical narrative: Within seconds of receiving vaccine RN asked client if she was feeling fine as she appeared pale. Client stated "I feel lightheaded". RN signaled lead PHN  assistance. RN set up anti-gravity chair and client was able to transfer self without assistance. Client reported medical history of acute psychosis and schizophrenia, no current medication and allergies to Cipro. PHN  took first set of vitals at 1402: blood pressure 104/70, pulse 65, oxygen sat 99%. PHN observed client start coughing to clear throat and asked client to elaborate new onset. Per client no shortness of breath, denied throat closing, but felt "heaviness over throat, like when you eat popcorn". PHN did not note any swelling or redness on face or neck area, no tongue swelling and client able to speak in full sentences. Client declined blurry vision, headache, or chest pain. PHN offered client Benadryl and client declined due to not having a ride and taking public transportation, per client would wait a few more minutes for symptoms to improve. At 1405 client reported throat feeling not improving and wanted Benadryl, per client "does not like shots and wants oral". At 1406 PHN  gave client Benadryl 50mg PO. Vitals at 1407: blood pressure 100/60, pulse 50, oxygen sat 99%. Per client dizziness same and "throat itch improved". Per client swallowing saliva just fine. Per client had no breakfast this morning, RN brought client juice and client begin to take small sips. At 1410 PHN took pulse manually, 53. Per client is aware pulse and blood pressure run low, and has not followed up with primary provider, but has been seen at ER when she felt chest pain 2 weeks ago. PHN advised client to make appointment with provider. Vitals at 1413: blood pressure 97/73, pulse 54, oxygen sat 99%. Per client dizziness and throat discomfort resolved and stated "I feel tired". PHN Ivonne gave client ER precautions and advised client to follow up with provider. At 1415 PHN reminded client of possible side effect of drowsiness with Benadryl, client verbalized understanding and stated "I live close, bus stop is right in front of my house." Vitals at 1419: blood pressure 110/69, manual pulse 48, oxygen sat 99%. Per client "feeling fine". Denied lightheadedness, headache, blurry vision, shortness of breath or chest pain. Per client wanted to leave. Client left facility with steady gait against medical advice at 1424.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pallor, Throat clearing, Throat irritation
Clinical narrative: Within seconds of receiving vaccine RN asked client if she was feeling fine as she appeared pale. Client stated "I feel lightheaded". RN signaled lead PHN  assistance. RN set up anti-gravity chair and client was able to transfer self without assistance. Client reported medical history of acute psychosis and schizophrenia, no current medication and allergies to Cipro. PHN  took first set of vitals at 1402: blood pressure 104/70, pulse 65, oxygen sat 99%. PHN observed client start coughing to clear throat and asked client to elaborate new onset. Per client no shortness of breath, denied throat closing, but felt "heaviness over throat, like when you eat popcorn". PHN did not note any swelling or redness on face or neck area, no tongue swelling and client able to speak in full sentences. Client declined blurry vision, headache, or chest pain. PHN offered client Benadryl and client declined due to not having a ride and taking public transportation, per client would wait a few more minutes for symptoms to improve. At 1405 client reported throat feeling not improving and wanted Benadryl, per client "does not like shots and wants oral". At 1406 PHN  gave client Benadryl 50mg PO. Vitals at 1407: blood pressure 100/60, pulse 50, oxygen sat 99%. Per client dizziness same and "throat itch improved". Per client swallowing saliva just fine. Per client had no breakfast this morning, RN brought client juice and client begin to take small sips. At 1410 PHN took pulse manually, 53. Per client is aware pulse and blood pressure run low, and has not followed up with primary provider, but has been seen at ER when she felt chest pain 2 weeks ago. PHN advised client to make appointment with provider. Vitals at 1413: blood pressure 97/73, pulse 54, oxygen sat 99%. Per client dizziness and throat discomfort resolved and stated "I feel tired". PHN Ivonne gave client ER precautions and advised client to follow up with provider. At 1415 PHN reminded client of possible side effect of drowsiness with Benadryl, client verbalized understanding and stated "I live close, bus stop is right in front of my house." Vitals at 1419: blood pressure 110/69, manual pulse 48, oxygen sat 99%. Per client "feeling fine". Denied lightheadedness, headache, blurry vision, shortness of breath or chest pain. Per client wanted to leave. Client left facility with steady gait against medical advice at 1424.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual bleeding occurred 1 day after each of my COVID vaccines.  Light spotting and only lasted 1 day.  But occurred after each of the covid vaccine and was approximately 8 days after my menstrual cycle had ended.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: My ovaries felt like they were going to fall out of my body. Not only that but the same thing happened to my friend.  It lasted about an hour and I could hardly stand straight.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Nausea
Clinical narrative: About 30-45 minutes after the vaccine. I had to lay down and I couldn?t move. And my arms went numb. Called my husband to come home from work. Almost called 911.  I started feeling like I was gonna faint. I had  Difficulty breathing and speaking. I was having Short breaths. Severe nausea . Thought I was gonna have Diarrhea but didn?t.  Laid down for almost an hour before I finally felt I could move.  And started feeling better.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: 10 days of fatigue, headache, body aches
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Metabolic function test, Pain, Troponin increased
Clinical narrative: 10 days of fatigue, headache, body aches
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Deep vein thrombosis, Pain in extremity, Peripheral swelling, Skin tightness
Clinical narrative: On 3 June my arm left forearm started to swell and there it was tight, I did hot and cold regiments thinking I injured it somehow, after the pain persisted I went to the my PCP and he ordered an ultrasound where it was discovered I had a DVT. This was 18 June. I received my second shot on 8 June. And last week I had the same symptoms, I contacted the hematologist and he ordered another ultra sound and now I have another DVT.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: On 3 June my arm left forearm started to swell and there it was tight, I did hot and cold regiments thinking I injured it somehow, after the pain persisted I went to the my PCP and he ordered an ultrasound where it was discovered I had a DVT. This was 18 June. I received my second shot on 8 June. And last week I had the same symptoms, I contacted the hematologist and he ordered another ultra sound and now I have another DVT.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Cramping in my left hand index finger. Becomes stiff and unable to move
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Reported with the first Pfizer COVID vaccine, he had dizziness the next day along with nausea and tiredness which lasted for two to three days. He reported he didn't eat with the first dose of Pfizer COVID vaccine. He denied other signs or symptoms of anaphylaxis. He stated he didn't have a follow-up with PCP and denied any known allergies or any chronic health conditions.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: Became ill with flu like symptoms for approximately 20+ hours.  Achy and very tired.  Stayed in bed most of the next day after 2nd dose.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Symptoms began morning after shot. Sore arm (left), headache, high fever, facial swelling, left axillary lymph node inflammation, general discomfort and pain. Lasted approximately 2-3 days.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face
Clinical narrative: Symptoms began morning after shot. Sore arm (left), headache, high fever, facial swelling, left axillary lymph node inflammation, general discomfort and pain. Lasted approximately 2-3 days.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: severe nausea May 8 @ 10 PM - May 10 @ 1 PM severe chills/insomnia May 8 @ 10 PM - May 9 @ 6 AM 103.6 fever May 9 @ 6 AM- May 11 @ 10 PM body pain, sweating, shaking, dizziness for the duration dizziness, confusion, shortness of breath on and off to present
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: severe nausea May 8 @ 10 PM - May 10 @ 1 PM severe chills/insomnia May 8 @ 10 PM - May 9 @ 6 AM 103.6 fever May 9 @ 6 AM- May 11 @ 10 PM body pain, sweating, shaking, dizziness for the duration dizziness, confusion, shortness of breath on and off to present
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hyperhidrosis, Hypoaesthesia, Pallor, Syncope
Clinical narrative: PATIENT FAINTED SHORTLY AFTER RECEIVING THE VACCINE. HE LOOKED PALE AND SWEATY. COMPLAINED FROM NUMBNESS OF HIS CHIN, AND HIS EXTREMITIES. FELT SICK TO HIS STOMACH TOO.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Feeling hot, Nausea, Pallor, Tremor
Clinical narrative: 15 without Preexisting Conditions, conveys feeling Nausea, hot, shakiness. Noted to be pale.  Laid down to cot, cold pack to forehead. VS taken within acceptable limits but for temperature  starting at 91.5F from the neck. Monitored without ALOC, self resolved symptoms. Temp improved to 93.5F. Able to ambulate out without assistance with mother.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Arteritis, Carditis
Clinical narrative: Patient's Mom Reported on 7/19/2021 Heart/Artery inflammation
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: About 3-4 weeks after the second Moderna vaccine, I developed shingles on my right torso. It was a fairly mild- moderate rash with a lot of pain in the area. The rash itself lasted about 2 weeks.  The pain and itching lasted longer.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Neuralgia, Palpitations, Rash
Clinical narrative: Nerve pain, armpit rash, shortness of breath, heavy heart beat.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Feeling abnormal, Paraesthesia
Clinical narrative: Before the shot I was fine. Once taken, a month later i began feelkng worse and needed to go the the hospital. Some of the symptoms are, Pins and needles feeling in face hands and feet, bloated stomach.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Thyroid function test
Clinical narrative: Hashimotos diagnosis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety, Autonomic nervous system imbalance, Chronic fatigue syndrome, Cognitive disorder
Clinical narrative: Symptoms consistent with MCAS, ME/CFS, neuropathy, anxiety, panic attacks, anaphylaxis, swelling of throat and tongue, dysautonomia, heart palpitations, widespread inflammation and neuropathy especially at sites of old or previous injury. Cognitive issues consistent with brain fog and extreme confusion.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal, Inflammation, Mast cell activation syndrome, Neuropathy peripheral
Clinical narrative: Symptoms consistent with MCAS, ME/CFS, neuropathy, anxiety, panic attacks, anaphylaxis, swelling of throat and tongue, dysautonomia, heart palpitations, widespread inflammation and neuropathy especially at sites of old or previous injury. Cognitive issues consistent with brain fog and extreme confusion.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack, Pharyngeal swelling, Post viral fatigue syndrome, Swollen tongue
Clinical narrative: Symptoms consistent with MCAS, ME/CFS, neuropathy, anxiety, panic attacks, anaphylaxis, swelling of throat and tongue, dysautonomia, heart palpitations, widespread inflammation and neuropathy especially at sites of old or previous injury. Cognitive issues consistent with brain fog and extreme confusion.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Urticaria
Clinical narrative: Rash/Hives within 2 hours of vaccine administration.  Rash/Hives reappeared the next day.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination complication
Clinical narrative: pt said she got covid arm 1 week after dose administered and now has tingling and numbness in her arms and legs
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Headache
Clinical narrative: Chest pain dizziness shortness of breath headache
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Body temperature, Chest pain, Cough, Diarrhoea
Clinical narrative: Chest pain dizziness shortness of breath headache
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Intentional dose omission, Loss of personal independence in daily activities, Migraine
Clinical narrative: Chest pain dizziness shortness of breath headache
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Throat tightness, Vomiting, Wheezing
Clinical narrative: Chest pain dizziness shortness of breath headache
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Seizure, Syncope
Clinical narrative: Patient had an syncope episode following a pfizer covid 19 shot. She had shortness of breath and appear to have a seizure afterwards. Gave 1 dose of an epipen and patient vitals was stable.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient reported via consent form that she was due for the 2nd COVID vaccine.  She stated on the consent form that she had received Pfizer as the 1st dose.  Pharmacist doubled checked that she had received 1st dose Pfizer at intake window and she confirmed.  Pharmacist also checked again prior to vaccination that she needed a 2nd dose Pfizer and patient confirmed.  Patient did not come in with vaccine card for 1st dose.  Several hours later patient returned stating that she had checked with the 1st pharmacy where she had received the 1st dose and they stated that she had been given a Moderna vaccine, not a Pfizer vaccine.  Patient also stated at time of return that she had not been given a vaccine card showing proof of vaccination from first pharmacy where she received the first dose.   Patient did not report any adverse events other than that stated above.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: On the consent form, mother wrote that patient is 12 years old so pharmacist quickly assumed that it was good to go without double checking the birthdate which was 2 days away from patient turning 12 years old. Today's date: 7/19/2021.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive covid test 7/7/2021. Pt did report of a negative covid test done outside of clinic after this positive.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Nausea, Vertigo
Clinical narrative: Severe vertigo and nausea with any movement , but most severe when putting  head down. Symptoms started 3 days after the first vaccine , lasted 2 weeks . Vertigo and nausea returned much worse the morning  after getting the second vaccine and symptoms continued for 3 weeks. Currently still has slight vertigo and imbalance intermittently.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell Palsy
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient presented to pharmacy complaining of welts that look like burns on back of shoulder, deltoid and chest on side where second Pfizer Covid dose was given almost one month prior. Patient states he did see a physician but was unclear (unable to explain or evasive) about treatment he received. He stated that the welts are not itchy, swollen or hot.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: SHORTLY AFTER RECEIVING HER SECOND COVID SHOT, PATIENT STATED THAT SHE WAS FEELING ITCHY.  PATIENT TOOK 25MG OF DIPHENHYDRAMINE.  PATIENT CONTINUED TO HAVE ITCHING FOR THE FOLLOWING 15 MINUTES, BUT NO WORSENING OF THE SYMPTOMS.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: No additional AE's reported; She states that a patient had already received 2 doses of MMRlI, 1 at 15 months and 1 at 4 years old but she was given a 3rd dose of MMRlI instead of the required VARIVAX/Misuse of MMRlI; was given MMRII insted of the requiered VARIVAX/Misuse MMRII; was given MMRII insted of the requiered VARIVAX/Missed dose of VARIVAX; This spontaneous report was received from an office manager, concerning an 18-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  The patient was vaccinated on an approximately unspecified date in 2004 (reported as at 15-month-old) and in 2007 (reported as at 4-year-old) with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Then, on 23-JUN-2021, the patient was vaccinated with a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, recombinant human albumin (rHA) (M-M-R II) (extra dose administered) lot number S039310 (which had been verified to be a valid lot number, upon internal validation) and expiration date 04-DEC-2021 as prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported), instead of a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (interchange of vaccine products and product dose omission issue). No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other adverse events reported; improperly stored dose of proquad was administered.; This spontaneous report was received from a medical assistance concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 21-JUN-2021, the patient was vaccinated with an improperly stored dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live ( recombinant human albumin (rHA) PROQUAD) 1 injection subcutaneously (lot number T034824 which was determined to be valid upon internal review with expiration date 11-APR-2022 but reported as 23-FEB-2022) (vaccination scheme frequency, route and anatomical location of administration were not reported) as prophylaxis (product storage error). The administered vaccine experienced a temperature excursion of 28 grades Fahrenheit (F) during a time frame of 4 hours, as recorded by data logger. There was not a previous temperature excursion. No other adverse events were reported.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Exposure during pregnancy, Pregnancy
Clinical narrative: receiving HPV vaccination before delivery; This literature market report has been received from authors of a published article, referring to a 26 years old female patient. The patient's medical history and concomitant medication were not provided. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date was not reported.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (vaccine exposure during pregnancy).    On an unknown date, the patient delivered an infant of unknown gender. The pregnancy outcome was live birth. The fetal outcome was unknown. The outcome of vaccine exposure during pregnancy was considered as recovered.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports regarding the same literature (linked case# 2107USA005600).; Sender's Comments:  US-009507513-2107USA005600:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; ROTATEQ that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 05-JUL-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1707446, expiration date was reported as 19-FEB-2022, but upon internal review was established as 09-FEB-2022 (exact dose was not reported) for prophylaxis. The administered dose was stored in a temperature of 48.0 degrees Fahrenheit (F) for 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient that received the first and second dose of GARDASIL 9 in 2017. The patient did not get the third dose and wants to know if GARDASIL 9 should be restarted.; No additional Adverse effects reported; This spontaneous report was received from a pharmacist referring to a currently 23 years old (also reported as 24 years old) male patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  In 2017, the patient received the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, batch/lot# and expiration date were unknown) for prophylaxis.  The patient did not get the third dose and wants to know if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) should be restarted. No additional Adverse effects reported.
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia, Scleroderma
Clinical narrative: fever; chills; scleroderma; This spontaneous report was received from a currently 66-year-old female patient referring to a herself via Pfizer. Her historical vaccine included Moderna Covid-19 vaccine. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On 10-MAY-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis.  On approximately 20-MAY-2021 (reported as 1.5 weeks or 10 days after the vaccination), she had a delayed reaction of fever and chills to the vaccine. On an unknown date in 2021, the patient experienced scleroderma. The outcome of fever and chills was reported as recovered on an unknown date in 2021. The outcome of scleroderma was not provided, however the patient stated, she was supposed to be starting an immunosuppressant therapy called mycophenolate mofetil (CELLCEPT) soon.  The reporter considered fever and chills to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The relatedness between scleroderma and the suspect vaccine was not provided.  Upon internal review, the event of scleroderma was considered to be medically significant.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; other zoster-related conditions; Information has been received regarding a case in litigation from a lawyer referring to a currently 71 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-MAY-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a health department for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: postherpetic neuralgia and other zoster-related conditions. The outcome of the events was unknown.
Age: 9.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from an office manager (described also as an healthcare professional (HCP)) and refers to a 9-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 07-JUL-2021, the patient was vaccinated with an improperly stored dose of hepatitis B vaccine (recombinant) thimerosal free (RECOMBIVAX HB) lot # T004378, expiration date 01-NOV-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a following temperatures: 49.7 degrees Fahrenheit (F) for 1 hour, 33.9 F for 15 hours, 35.1 F for 30 minutes, 47 F for 20 minutes, 35.5 F for 1 hour and 35 F for 1 hour. No previous temperature excursion occurred. Digital data logger was not involved. No adverse event (AE) was reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2107USA004929:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Achy; Chills; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure, celiac disease, psoriasis (the patient had on and off for 10-15 years), vitamin d low and thyroid disorder. Concomitant products included bisoprolol + hydrochlorothiazide, colecalciferol (Vitamin D3) and levothyroxine.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, pain and chills. On an unknown date, the outcome of the fever, pain and chills were unknown.   It was unknown if the reporter considered the fever, pain and chills to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reported did not have further details.
Sex: F
Vaccine: MENB
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient was twin. The patient was given a dose of Bexsero that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms were reported. This is one of the several cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:same reporter US-GLAXOSMITHKLINE-US2021142813:same reporter US-GLAXOSMITHKLINE-US2021142815:same reporter US-GLAXOSMITHKLINE-US2021142816:same reporter US-GLAXOSMITHKLINE-US2021142817:same reporter US-GLAXOSMITHKLINE-US2021142818:same reporter US-GLAXOSMITHKLINE-US2021AMR151443:same reporter US-GLAXOSMITHKLINE-US2021AMR151436:same reporter US-GLAXOSMITHKLINE-US2021AMR151444:same reporter US-GLAXOSMITHKLINE-US2021142817:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose/ The 1 ml vial was administered/ instead of the 0.5/ Havrix wrong dose administration; This case was reported by a other health professional via media and described the occurrence of overdose in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix 1 ml. On an unknown date, unknown after receiving Havrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter wanted information on providing the wrong dose of Havrix to the patient, as the 1 ml vial was administered to the patient instead of the 0.5 ml vial, which led to overdose. The follow-up would not be possible as no contact details were available.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Fatigue, Headache, Nausea, Social problem
Clinical narrative: had aches; was vomitting; headache that lasted lasted more than 2 days; fatigue for about a day and a half; first/ on November 3, 2020/ second dose was on July 9, 2021 / more than 6 months after the first due to receiving her COVID vaccine/nine months after the first dose; pain in bones; nauseas the day after vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on 3rd November 2020 and also experienced pain, pain in arm and feeling unwell, refer case US2021151044). Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 9th July 2021, the patient received the 2nd dose of Shingrix. On 9th July 2021, less than a day after receiving Shingrix, the patient experienced pain, vomiting, headache, bone pain, nausea, fatigue and social problem. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, vomiting, headache, bone pain, nausea and fatigue were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the pain, vomiting, headache, bone pain, nausea and fatigue to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient herself. The patient had received 2nd dose of Shingrix and experienced vomiting, had aches, headache that lasted more than 2 days, pain in bones, nauseas the day after vaccine, and fatigue for about a day and a half. The patient reported that she got her 2nd dose not within the 2 to 6 months recommended period, but 9 months after the 1st dose due to receiving her COVID vaccine around the time when she was supposed to get her 2nd dose of Shingrix, which led to social problem. The patient wanted to know whether there was any information about, how that would impact the effectiveness. The reporter consented to follow up via email only.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151044:same patient, same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: had aches; was vomitting; headache that lasted lasted more than 2 days; fatigue for about a day and a half; first/ on November 3, 2020/ second dose was on July 9, 2021 / more than 6 months after the first due to receiving her COVID vaccine/nine months after the first dose; pain in bones; nauseas the day after vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on 3rd November 2020 and also experienced pain, pain in arm and feeling unwell, refer case US2021151044). Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 9th July 2021, the patient received the 2nd dose of Shingrix. On 9th July 2021, less than a day after receiving Shingrix, the patient experienced pain, vomiting, headache, bone pain, nausea, fatigue and social problem. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, vomiting, headache, bone pain, nausea and fatigue were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the pain, vomiting, headache, bone pain, nausea and fatigue to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient herself. The patient had received 2nd dose of Shingrix and experienced vomiting, had aches, headache that lasted more than 2 days, pain in bones, nauseas the day after vaccine, and fatigue for about a day and a half. The patient reported that she got her 2nd dose not within the 2 to 6 months recommended period, but 9 months after the 1st dose due to receiving her COVID vaccine around the time when she was supposed to get her 2nd dose of Shingrix, which led to social problem. The patient wanted to know whether there was any information about, how that would impact the effectiveness. The reporter consented to follow up via email only.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151044:same patient, same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scar, Vaccination failure
Clinical narrative: suspected vaccination failure / I GOT THE SHOT IN OCT AND IN FEB I GOT SHINGLES / Shots Does Not Work.; have got shingle scars to prove it.; SHINGLES. all down my neck dwn to my breast accross my shoulder; They are extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received Shingles vaccine. In February 2021, between 3 and 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and scar. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and scar to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for herself. The age at vaccination was not reported. The patient got the Shingles shot in October and in February she got the shingles. The patient got shingles all down her neck, down to her breast and across her shoulder and she got shingles scars to prove it. The reporter mentioned that shingles were extremely painful and lasted for 3 weeks. The reporter stated that, shots did not work. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; PT CAME IN TODAY WITH SHINGLES; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a male 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 12th July 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received series of Shingrix in 2018. After receiving Shingrix, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: My brother delayed his second dose of Shingrix for 19.5 months after the first dose, due to the pandemic.; This case was reported by a consumer via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 19.5 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient was the reporter's brother. The age at vaccination was not applicable for this report. The patient delayed his 2nd dose of Shingrix for 19.5 months after the first dose, due to the pandemic. The reporter asked if the patient needs additional dose. No further information was reported. The follow up was not possible as no contact details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: mild flu after the shingles vaccine; This case was reported by a consumer via licensee and described the occurrence of influenza like illness in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included thyroidectomy (Thyroid removed from nodules and a goiter). Concomitant products included levothyroxine sodium (Synthroid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was unknown.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine a year ago of reporting date and experienced mild flu. This case has been linked to USCH2021AMR045885, reported by same reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Formication, Paraesthesia, Pruritus
Clinical narrative: itchy,crawly, nerve tingling sensation under the skin on her face and areas she had previously had shingles; itchy / under the skin on her face and areas she had previously had shingles; crawly, nerve tingling sensation under the skin on her face and areas she had previously had shingles; metallic taste; injections were slightly painful; This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for eosinophilic granulomatosis with polyangiitis.   The patient's past medical history included shingles. Concomitant products included prednisone.   On 22nd June 2021, the patient received Shingrix. On 25th June 2021, the patient started Nucala (subcutaneous) 300 mg cyclically (300 mg daily). On 25th June 2021, not applicable after receiving Shingrix and less than a day after starting Nucala, the patient experienced pain. On an unknown date, the patient experienced tingling sensation, itchy skin, crawling sensation of skin and taste metallic. Nucala was continued with no change. On an unknown date, the outcome of the tingling sensation, itchy skin and crawling sensation of skin were unknown and the outcome of the taste metallic was not recovered/not resolved and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the tingling sensation, itchy skin, crawling sensation of skin and taste metallic to be related to Shingrix and Nucala. It was unknown if the reporter considered the pain to be related to Nucala.  Additional details were reported as follows: The case was reported by patient herself. The patient received one dose of Nucala, she took 3 injections for a total of 300mg, dosing in both thighs and her stomach.  The patient noted that the injections were slightly painful and noted she might try to leave it out longer before injecting with her next dose. She added she left it out for 30 minutes. The patient also noted that since receiving the product she has experienced a metallic taste that lingers still.  She also noted that she had a history of shingles and 2 to 3 days prior to the first dose of Nucala, she received Shingrix. The patient stated that she experienced an itchy, crawly, nerve tingling sensation under the skin on her face and areas she had previously had shingles. She was unsure what might have caused these issues, but also noted she takes other medications and was taking 50mg of prednisone also that the pharmacist mentioned might decrease the effects of Shingrix.  The patient was encouraged to discuss these with her physician and offered to review the safety statement. She told her physician did, but only after she had received the first dose and found out she did not have an Epi-Pen.   The patient was prescribed an Epi-Pen. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Macule, Pain in extremity, Rash macular
Clinical narrative: big red blotch just below the injection site; Macule; experienced arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2021, the patient received the 1st dose of Shingrix. On 9th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 11th July 2021, the patient experienced red blotches and macule. On an unknown date, the outcome of the pain in arm, red blotches and macule were unknown.   It was unknown if the reporter considered the pain in arm, red blotches and macule to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient reported that, after receiving 1st dose of Shingrix vaccine he experienced arm pain.  Upon examination at 21:00 on 11th July 2021, the patient noted a big red blotch just below the injection site from which he was experiencing the pain and experienced macule. No further information was reported. The reporter consented to follow up.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose of Engerix-B to an adult patient; pediatric dose of Engerix-B to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 35-year-old female patient who received HBV (Engerix B pediatric) (batch number k329e, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received the 3rd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that adult patient was administered with Engerix B pediatric, which led to adult use of a child product and underdose. No further events were reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: pain in his arm at the injection site (not resolved)..; pain in his side (not resolved); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple myeloma. Concomitant products included Herpes zoster (Shingrix) and valaciclovir (Valacyclovir).   On 11th July 2021, the patient received the 2nd dose of Shingrix. On 12th July 2021, 1 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain and pain localized. On an unknown date, the outcome of the injection site pain and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain localized to be related to Shingrix.  On 11th July 2021, the patient received the 2nd dose of Shingrix.  On 12th July 2021, 1 days after receiving Shingrix, the patient experienced injection site pain and pain localized.  On an unknown date, the outcome of the injection site pain and pain localized were not recovered/not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: received 0.6 mL of Shingrix instead of 0.5 mL; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .6 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were reported as follows: The patient received 0.6 mL of Shingrix instead of 0.5 mL, which led to overdose. No more information available since reporter was not at work. Due to communication issues, a lot of information was not requested or tried to be confirmed after reporter mentioned the limited data available due to them not being at work. The reporter consented to follow up. This case has been linked with case ID US2021151034, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151034:Same reporter