chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Rash, Scan with contrast, Vitamin D decreased
Clinical narrative: Initial symptoms in the first 24 hours matched with prior exposures to the vaccine. Significant arm swelling, a small rash, and muscle aches. The trend changed after 24 hours. In prior exposures, influenza-like/COVID-19-like symptoms lasted for up to 12 days. In this exposure, none of these symptoms was present. Instead, muscle aches worsened significantly, Vitamin D levels dropped to dangerously low levels, heart rate became increased, and chest pain was present upon exerted movements such as getting out of a chair. The chest pain resolved after 4-5 days but breathless has remained to the present day that impacts day to day exertions.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast normal, General physical health deterioration, Headache, Hypertension, Hypotension
Clinical narrative: After vaccination everything seemd okay. I had sever arm pain for 2 days that I have to keep my arm in sling after the first dose. Second dose of covid vaccine caused just fever and malaise for a day and severe headache plus a little arm pain. My blood pressure started rising after a few weeks (3 or 4 weeks after). I had a visit with my pcp because of severe muscle cramp on right side neck in February, 2021 and somewhere in March or April, 2021 had an office visit. My BP was high (in previous visits with other PCP my BP is always normal. I use to work as research coordinator so to check the machine I would check my BP and it was on lower side just 6 months before this incidence). My PCP casually asked me to follow my BP. I started checking and my BP was in range of 140-150 systtolic/100-110 diastolic. On next visit in May or June 2021 she started me on lisinopril 10 mg OD. Meanwhile on a routine mammogram I was diagnosed with suspicion of cancer and was advised biopsy. I had my biopsy in September, 2021 and that came out normal. This incident was also suspected to be due to covid vaccine as I took both injections on left arm and had biopsy of same breast with suspicious mammogram.  I stopped lisinopril in December, 2021 as my BP was 100/50 to 100/40 with lisinopril. I kept a track and my BP was low consistently without Lisinopril. My employer implemented booster mandate and I have to take booster on 1/8/2022. My BP started rising up again and I am back on Lisinopril. My BP is not even controlled with Lisinopril. It's again in range of 140-150/105-110.  My health is deteriorated after covid vaccination and I regret my decision of taking this vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Malaise, Mammogram abnormal, Mammogram normal, Muscle spasms
Clinical narrative: After vaccination everything seemd okay. I had sever arm pain for 2 days that I have to keep my arm in sling after the first dose. Second dose of covid vaccine caused just fever and malaise for a day and severe headache plus a little arm pain. My blood pressure started rising after a few weeks (3 or 4 weeks after). I had a visit with my pcp because of severe muscle cramp on right side neck in February, 2021 and somewhere in March or April, 2021 had an office visit. My BP was high (in previous visits with other PCP my BP is always normal. I use to work as research coordinator so to check the machine I would check my BP and it was on lower side just 6 months before this incidence). My PCP casually asked me to follow my BP. I started checking and my BP was in range of 140-150 systtolic/100-110 diastolic. On next visit in May or June 2021 she started me on lisinopril 10 mg OD. Meanwhile on a routine mammogram I was diagnosed with suspicion of cancer and was advised biopsy. I had my biopsy in September, 2021 and that came out normal. This incident was also suspected to be due to covid vaccine as I took both injections on left arm and had biopsy of same breast with suspicious mammogram.  I stopped lisinopril in December, 2021 as my BP was 100/50 to 100/40 with lisinopril. I kept a track and my BP was low consistently without Lisinopril. My employer implemented booster mandate and I have to take booster on 1/8/2022. My BP started rising up again and I am back on Lisinopril. My BP is not even controlled with Lisinopril. It's again in range of 140-150/105-110.  My health is deteriorated after covid vaccination and I regret my decision of taking this vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Thyroid function test abnormal
Clinical narrative: After vaccination everything seemd okay. I had sever arm pain for 2 days that I have to keep my arm in sling after the first dose. Second dose of covid vaccine caused just fever and malaise for a day and severe headache plus a little arm pain. My blood pressure started rising after a few weeks (3 or 4 weeks after). I had a visit with my pcp because of severe muscle cramp on right side neck in February, 2021 and somewhere in March or April, 2021 had an office visit. My BP was high (in previous visits with other PCP my BP is always normal. I use to work as research coordinator so to check the machine I would check my BP and it was on lower side just 6 months before this incidence). My PCP casually asked me to follow my BP. I started checking and my BP was in range of 140-150 systtolic/100-110 diastolic. On next visit in May or June 2021 she started me on lisinopril 10 mg OD. Meanwhile on a routine mammogram I was diagnosed with suspicion of cancer and was advised biopsy. I had my biopsy in September, 2021 and that came out normal. This incident was also suspected to be due to covid vaccine as I took both injections on left arm and had biopsy of same breast with suspicious mammogram.  I stopped lisinopril in December, 2021 as my BP was 100/50 to 100/40 with lisinopril. I kept a track and my BP was low consistently without Lisinopril. My employer implemented booster mandate and I have to take booster on 1/8/2022. My BP started rising up again and I am back on Lisinopril. My BP is not even controlled with Lisinopril. It's again in range of 140-150/105-110.  My health is deteriorated after covid vaccination and I regret my decision of taking this vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: liquid from the vaccine running down arm / liquid leaked from vaccine needle; She stuck the needle in; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (She stuck the needle in) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (She stuck the needle in). At the time of the report, ACCIDENTAL UNDERDOSE (liquid from the vaccine running down arm / liquid leaked from vaccine needle) and DEVICE CONNECTION ISSUE (She stuck the needle in) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Pharmacist took the needle out of the patient's arm and said the liquid from the vaccine came running down out of the arm down the chair. Also, pharmacist stuck the needle in, and its like it dripped all the way down the patient's elbow and down to the chair. Pharmacist was not sure how much came out, but said it seems like a lot came out. The patient had not experienced any symptoms. No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 0.25 ml received as first dose/Patient received half dose of Moderna COVID-19 vaccine instead of a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25 ml received as first dose/Patient received half dose of Moderna COVID-19 vaccine instead of a full dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.25 ml received as first dose/Patient received half dose of Moderna COVID-19 vaccine instead of a full dose). At the time of the report, ACCIDENTAL UNDERDOSE (0.25 ml received as first dose/Patient received half dose of Moderna COVID-19 vaccine instead of a full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Chills, Epistaxis, Fatigue, Haemoptysis
Clinical narrative: I started to bleed from the nose; Spit blood; Chest pain; Fatigue; Fever; Chills; Horrible headache; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "Horrible headache"; MYALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "Muscle pain"; EPISTAXIS (non-serious) with onset 10Sep2021, outcome "unknown", described as "I started to bleed from the nose"; HAEMOPTYSIS (non-serious) with onset 10Sep2021, outcome "unknown", described as "Spit blood"; CHEST PAIN (non-serious) with onset 10Sep2021, outcome "unknown", described as "Chest pain"; FATIGUE (non-serious) with onset 10Sep2021, outcome "unknown", described as "Fatigue".  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: I started to bleed from the nose; Spit blood; Chest pain; Fatigue; Fever; Chills; Horrible headache; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "Horrible headache"; MYALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "Muscle pain"; EPISTAXIS (non-serious) with onset 10Sep2021, outcome "unknown", described as "I started to bleed from the nose"; HAEMOPTYSIS (non-serious) with onset 10Sep2021, outcome "unknown", described as "Spit blood"; CHEST PAIN (non-serious) with onset 10Sep2021, outcome "unknown", described as "Chest pain"; FATIGUE (non-serious) with onset 10Sep2021, outcome "unknown", described as "Fatigue".  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event; an improperly dose of RECOMBIVAX HB was administered to a newborn; This spontaneous report as received from a healthcare professional refers to a "newborn" 1 day old female patient. On 19-JAN-2022, the patient was vaccinated with a 0.5 mL improperly dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # T021327 exp date 14-NOV-2022) (dose and route not reported). The temperature of excursion was 49.9 F for a time frame of 2 hours 30 minutes. There was no previous temperature excursion or data logger issue.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient had no known side effects.; Vaccine Coordinator reported a temperature excursion for ROT ATEQ which was supported. Caller reported that 1 dose of ROT ATEQ was administered to a patient.; This spontaneous report was received from a vaccine coordinator, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-JAN-2022, the patient was vaccinated with a 1 dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (lot # reported as: 174228, expiration date reported as: 01-SEP-2022; strength was not provided) for prophylaxis (product storage error). Temperature excursion for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was supported. Patient had no known side effects (no adverse event).  This is one of several reports received from the same reporter.  Lot number 174228 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Lot number 174228 does not match any Company product as confirmed by Lot Verification team.; Sender's Comments:  US-009507513-2201USA006297:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Expired Varivax administered; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 26-JAN-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T000340, expiration date) 0.5 milliliter (route of administration not provided) for prophylaxis (expired product administered). Caller stated the vaccine did not experience any temperature excursions. No additional adverse events reported.
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AEs reported; The patient was intended to be administered MMR II however PROQUAD was accidently administered; This spontaneous report was received from a nurse concerning a 15-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, current conditions and medical history was not provided.   On 03-DEC-2021, the patient received varicella zoster vaccine live (OKA/MERCK) (VARIVAX).  On 28-JAN-2022, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter lot number T028137 (rHA) and expiration date 15-FEB-2022 (route of administration was not provided) as prophylaxis, instead of receiving Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Extra dose administered).  No additional adverse events were reported.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue, onset 4 hours. Myalgia, onset 6 hours. Fever & chills onset 7 hours.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE; an expired dose of ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a 7-week-old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-JAN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #U007860, expiration date 14-JAN-2022; dose and route of administration were not provided) for prophylaxis (expired product administered). No additional adverse event. The outcome of expired product administered was unknown.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE; an expired dose of ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a 6-month-old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-JAN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #U007860, expiration date 14-JAN-2022; dose and route of administration were not provided) for prophylaxis (expired product administered). No additional adverse event. The outcome of expired product administered was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Neuropathy peripheral, Post herpetic neuralgia
Clinical narrative: herpes zoster, postherpetic neuralgia, peripheral neuropathy and balance issues; herpes zoster, postherpetic neuralgia, peripheral neuropathy and balance issues; herpes zoster, postherpetic neuralgia, peripheral neuropathy and balance issues; herpes zoster, postherpetic neuralgia, peripheral neuropathy and balance issues; Information has been received on 07-FEB-2022 from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's concurrent conditions, medical history and concomitant medications are not reported. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported)  for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered herpes zoster, postherpetic neuralgia, peripheral neuropathy and balance issues. As a result of these symptoms, the pt was seen and treated by medical providers in and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt condition, the pt sustained severe, serious, progressive, permanent personal permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 13-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 13-DEC-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot number U024221, expiration date 04-OCT-2023 (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported. The vaccine underwent a temperature excursion of 39.55 degrees Fahrenheit for 10 hours with no previous excursions reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; expired dose of M-M-R II was administered to patient; This spontaneous report was received from registered nurse referring to a patient of unreported age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 31-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II)  (expired product administered) 0.5 ml (lot number T001214, expiry date 12-JAN-2022 ; vaccination scheme, route of administration, and anatomical location of vaccination were not provided) for prophylaxis. Nurse confirmed that expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) did not experience a temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Sex: M
Vaccine: RV5
Symptoms: Intentional product misuse
Clinical narrative: 2nd dose would need to be administered by this Sunday (13Feb2022) but it is unknown if the patient will be able to receive dose before then; No additional AE; 2nd dose would need to be administered by this Sunday (13Feb2022) but it is unknown if the patient will be able to receive dose before then; This spontaneous report was received from physician referring to approximately 4-month-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On an unknown date, the patient vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at age 9-weeks-old (orally, vaccination scheme, and anatomical location of vaccination, lot number and expiry date were not provided) for prophylaxis. Physician stated that a child will receive second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Second dose would need to be administered by this Sunday (13-FEB-2022) but it was unknown if the patient will be able to receive dose before then (Intentional product misuse and circumstance or information capable of leading to medication error).  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: side effects experienced: none; inappropriate schedule of vaccine administration; This spontaneous report has been received from a lawyer via a Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS #1807USA004932), concerning a 66 year-old female patient. Before vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient received zoster vaccine live (ZOSTAVAX) (with experienced side effects of redness, hot to touch skin, swelling) and unspecified influenza (flu) vaccine. The patient's medical history included chicken pox (never received a chicken pox vaccine). The patient had never in the past smoked or used tobacco products. On 12-MAR-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine; dose, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. Another doses of suspect vaccine were administered to the patient on 18-APR-2018 and 29-SEP-2018 (inappropriate schedule of vaccine administration). None (also reported as not applicable, n/a) side effects experienced. The pt's other reported vaccinations included: unspecified tetanus vaccine, in 2018 (reporter did not recall specific dates), unspecified influenza vaccine in 2020, and unspecified Coronavirus disease (COVID) vaccine in 2021.  This is one of three reports regarding the same patient.; Sender's Comments:  US-009507513-2202USA003492: US-009507513-1807USA004932:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No further AE's were reported; An expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a nurse concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On 28-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml one time, lot #S010729, expiration date 01-DEC-2021; strength and route were not reported) for prophylaxis (expired product administered). Vaccine had not undergone a temperature excursion. No further adverse events were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2202USA003627: US-009507513-2202USA003751: US-009507513-2202USA003516: US-009507513-2202USA003778: US-009507513-2202USA003414: US-009507513-2202USA003522: US-009507513-2202USA003543: US-009507513-2202USA003651: US-009507513-2202USA003569: US-009507513-2202USA003660:
Sex: F
Vaccine: BCG
Symptoms: Acid fast bacilli infection, Antinuclear antibody positive, Biopsy skin abnormal, Chronic papillomatous dermatitis, Culture negative
Clinical narrative: chancre-variant cutaneous tuberculosis (TB) developed in response to the vaccination; BCG vaccine in an attempt to manage chronic migraines secondary to fibromyalgia; Information has been received from the authors of a literature, titled as stated above, referring to a 73-year-old female with a history of fibromyalgia. The patient had no history of immunosuppression and was not receiving immunomodulating therapy. Concomitant medication was not reported.  On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (reported as BCG vaccine) (route, dose detail, lot number and expiration date were not reported) in the right arm as off-label therapy in an attempt to manage chronic migraines secondary to fibromyalgia (off label use).   On an unknown date, the patient presented with an ulcer of the right upper extremity that had been present for 3 months. The patient reported that the ulcer directly overlaid the BCG vaccination site. Skin biopsy from an outside clinic showed granulomatous dermatitis and positive staining for Mycobacterium bovis (M bovis); a culture had failed to grow any organism. On physical examination, the patient was well appearing and afebrile. A large, nontender, full-thickness ulcer with a hypertrophic base was present on the proximal right arm. Initial biopsy at the authors' institution revealed pseudoepitheliomatous epidermal and follicular infundibular hyperplasia with inflamed granulation tissue and confluent granulomatous infiltrates. Ziehl-Neelsen staining demonstrated numerous acid-fast bacilli (AFB) scattered throughout the granulomatous dermal infiltrate. The hypertrophic wound base was subsequently debulked, and a fluorescent smear of the tissue showed AFB. Tissue culture showed AFB after 3 weeks of growth. Tissue smear demonstrated 2 AFB to 18 AFB per 50 fields, and 12 colonies with a rough and buff appearance were recovered from Lowenstein-Jensen slant in week 6 of incubation. A nucleic acid amplification test detected ribosomal ribonucleic acid (RNA) of mycobacterium tuberculosis complex. This constellation of findings was consistent with localized M bovis infection. The patient was diagnosed with cutaneous tuberculosis, specifically tuberculous chancre (chancre-variant cutaneous tuberculosis), secondary to receiving the BCG vaccine. After surgical debulking, the patient was instructed to clean the wound base with saline every other day, pat it dry, and cover the area with an adhesive foam dressing. The patient was also started on isoniazid monotherapy 300 mg twice weekly. After 6 months of treatment, the wound was nearly healed (recovering). The reporter considered the event to be a vaccine side effect, which was related to the BCG vaccine.  Upon internal review, the event of chancre-variant cutaneous tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Sex: F
Vaccine: BCG
Symptoms: Culture tissue specimen positive, Cutaneous tuberculosis, Granuloma, Granulomatous dermatitis, Hyperplasia
Clinical narrative: chancre-variant cutaneous tuberculosis (TB) developed in response to the vaccination; BCG vaccine in an attempt to manage chronic migraines secondary to fibromyalgia; Information has been received from the authors of a literature, titled as stated above, referring to a 73-year-old female with a history of fibromyalgia. The patient had no history of immunosuppression and was not receiving immunomodulating therapy. Concomitant medication was not reported.  On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (reported as BCG vaccine) (route, dose detail, lot number and expiration date were not reported) in the right arm as off-label therapy in an attempt to manage chronic migraines secondary to fibromyalgia (off label use).   On an unknown date, the patient presented with an ulcer of the right upper extremity that had been present for 3 months. The patient reported that the ulcer directly overlaid the BCG vaccination site. Skin biopsy from an outside clinic showed granulomatous dermatitis and positive staining for Mycobacterium bovis (M bovis); a culture had failed to grow any organism. On physical examination, the patient was well appearing and afebrile. A large, nontender, full-thickness ulcer with a hypertrophic base was present on the proximal right arm. Initial biopsy at the authors' institution revealed pseudoepitheliomatous epidermal and follicular infundibular hyperplasia with inflamed granulation tissue and confluent granulomatous infiltrates. Ziehl-Neelsen staining demonstrated numerous acid-fast bacilli (AFB) scattered throughout the granulomatous dermal infiltrate. The hypertrophic wound base was subsequently debulked, and a fluorescent smear of the tissue showed AFB. Tissue culture showed AFB after 3 weeks of growth. Tissue smear demonstrated 2 AFB to 18 AFB per 50 fields, and 12 colonies with a rough and buff appearance were recovered from Lowenstein-Jensen slant in week 6 of incubation. A nucleic acid amplification test detected ribosomal ribonucleic acid (RNA) of mycobacterium tuberculosis complex. This constellation of findings was consistent with localized M bovis infection. The patient was diagnosed with cutaneous tuberculosis, specifically tuberculous chancre (chancre-variant cutaneous tuberculosis), secondary to receiving the BCG vaccine. After surgical debulking, the patient was instructed to clean the wound base with saline every other day, pat it dry, and cover the area with an adhesive foam dressing. The patient was also started on isoniazid monotherapy 300 mg twice weekly. After 6 months of treatment, the wound was nearly healed (recovering). The reporter considered the event to be a vaccine side effect, which was related to the BCG vaccine.  Upon internal review, the event of chancre-variant cutaneous tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Sex: F
Vaccine: BCG
Symptoms: Inflammation, Mycobacterial infection, Mycobacterium tuberculosis complex test positive, Nucleic acid test, Off label use
Clinical narrative: chancre-variant cutaneous tuberculosis (TB) developed in response to the vaccination; BCG vaccine in an attempt to manage chronic migraines secondary to fibromyalgia; Information has been received from the authors of a literature, titled as stated above, referring to a 73-year-old female with a history of fibromyalgia. The patient had no history of immunosuppression and was not receiving immunomodulating therapy. Concomitant medication was not reported.  On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (reported as BCG vaccine) (route, dose detail, lot number and expiration date were not reported) in the right arm as off-label therapy in an attempt to manage chronic migraines secondary to fibromyalgia (off label use).   On an unknown date, the patient presented with an ulcer of the right upper extremity that had been present for 3 months. The patient reported that the ulcer directly overlaid the BCG vaccination site. Skin biopsy from an outside clinic showed granulomatous dermatitis and positive staining for Mycobacterium bovis (M bovis); a culture had failed to grow any organism. On physical examination, the patient was well appearing and afebrile. A large, nontender, full-thickness ulcer with a hypertrophic base was present on the proximal right arm. Initial biopsy at the authors' institution revealed pseudoepitheliomatous epidermal and follicular infundibular hyperplasia with inflamed granulation tissue and confluent granulomatous infiltrates. Ziehl-Neelsen staining demonstrated numerous acid-fast bacilli (AFB) scattered throughout the granulomatous dermal infiltrate. The hypertrophic wound base was subsequently debulked, and a fluorescent smear of the tissue showed AFB. Tissue culture showed AFB after 3 weeks of growth. Tissue smear demonstrated 2 AFB to 18 AFB per 50 fields, and 12 colonies with a rough and buff appearance were recovered from Lowenstein-Jensen slant in week 6 of incubation. A nucleic acid amplification test detected ribosomal ribonucleic acid (RNA) of mycobacterium tuberculosis complex. This constellation of findings was consistent with localized M bovis infection. The patient was diagnosed with cutaneous tuberculosis, specifically tuberculous chancre (chancre-variant cutaneous tuberculosis), secondary to receiving the BCG vaccine. After surgical debulking, the patient was instructed to clean the wound base with saline every other day, pat it dry, and cover the area with an adhesive foam dressing. The patient was also started on isoniazid monotherapy 300 mg twice weekly. After 6 months of treatment, the wound was nearly healed (recovering). The reporter considered the event to be a vaccine side effect, which was related to the BCG vaccine.  Upon internal review, the event of chancre-variant cutaneous tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Sex: F
Vaccine: BCG
Symptoms: Smear test, Syphilis, Vaccination site ulcer, Wound
Clinical narrative: chancre-variant cutaneous tuberculosis (TB) developed in response to the vaccination; BCG vaccine in an attempt to manage chronic migraines secondary to fibromyalgia; Information has been received from the authors of a literature, titled as stated above, referring to a 73-year-old female with a history of fibromyalgia. The patient had no history of immunosuppression and was not receiving immunomodulating therapy. Concomitant medication was not reported.  On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (reported as BCG vaccine) (route, dose detail, lot number and expiration date were not reported) in the right arm as off-label therapy in an attempt to manage chronic migraines secondary to fibromyalgia (off label use).   On an unknown date, the patient presented with an ulcer of the right upper extremity that had been present for 3 months. The patient reported that the ulcer directly overlaid the BCG vaccination site. Skin biopsy from an outside clinic showed granulomatous dermatitis and positive staining for Mycobacterium bovis (M bovis); a culture had failed to grow any organism. On physical examination, the patient was well appearing and afebrile. A large, nontender, full-thickness ulcer with a hypertrophic base was present on the proximal right arm. Initial biopsy at the authors' institution revealed pseudoepitheliomatous epidermal and follicular infundibular hyperplasia with inflamed granulation tissue and confluent granulomatous infiltrates. Ziehl-Neelsen staining demonstrated numerous acid-fast bacilli (AFB) scattered throughout the granulomatous dermal infiltrate. The hypertrophic wound base was subsequently debulked, and a fluorescent smear of the tissue showed AFB. Tissue culture showed AFB after 3 weeks of growth. Tissue smear demonstrated 2 AFB to 18 AFB per 50 fields, and 12 colonies with a rough and buff appearance were recovered from Lowenstein-Jensen slant in week 6 of incubation. A nucleic acid amplification test detected ribosomal ribonucleic acid (RNA) of mycobacterium tuberculosis complex. This constellation of findings was consistent with localized M bovis infection. The patient was diagnosed with cutaneous tuberculosis, specifically tuberculous chancre (chancre-variant cutaneous tuberculosis), secondary to receiving the BCG vaccine. After surgical debulking, the patient was instructed to clean the wound base with saline every other day, pat it dry, and cover the area with an adhesive foam dressing. The patient was also started on isoniazid monotherapy 300 mg twice weekly. After 6 months of treatment, the wound was nearly healed (recovering). The reporter considered the event to be a vaccine side effect, which was related to the BCG vaccine.  Upon internal review, the event of chancre-variant cutaneous tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Pyrexia
Clinical narrative: 2 shots, got shingles/suspected vaccination failure; shingles; Stinging, pain, body aches; itching/fire ants turned loose in affected areas; burning; lo-grade temp; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, stinging, pruritus, burning sensation and slight temperature. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and burning sensation were unknown and the outcome of the stinging and slight temperature were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, stinging, pruritus, burning sensation and slight temperature to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, stinging, pruritus and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got 2 Shingle shots and stated did pay it again to avoid shingles, which were a nightmare. The patient got shingles in 2020 in left side face into scalp. The patient stated imagined fire ants turned loose in affected area and had stinging, itching, burning and pain. The 2nd shot gave him/her a low-grade temperature and body aches and that lasted a couple of days. The patient reported that aftereffects of shingles were close to 2 years and counting. The patient told his/her friends to run and not to walk and get the 2 shots vaccine.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: 2 shots, got shingles/suspected vaccination failure; shingles; Stinging, pain, body aches; itching/fire ants turned loose in affected areas; burning; lo-grade temp; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, stinging, pruritus, burning sensation and slight temperature. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and burning sensation were unknown and the outcome of the stinging and slight temperature were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, stinging, pruritus, burning sensation and slight temperature to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, stinging, pruritus and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got 2 Shingle shots and stated did pay it again to avoid shingles, which were a nightmare. The patient got shingles in 2020 in left side face into scalp. The patient stated imagined fire ants turned loose in affected area and had stinging, itching, burning and pain. The 2nd shot gave him/her a low-grade temperature and body aches and that lasted a couple of days. The patient reported that aftereffects of shingles were close to 2 years and counting. The patient told his/her friends to run and not to walk and get the 2 shots vaccine.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had all shingles vaccinations, still got it./suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had all of the Shingles vaccinations and he/she still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling at the site; redness at the site; pain at the site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2022, the patient received the 1st dose of Shingrix. In February 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows:  The patient self-reported this case.                                        The patient got first shot of Shingrix last Sunday and still had swelling, redness and pain at the site. The patient enquired how long do the side effects last.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Vomiting
Clinical narrative: not feeling well; throwing up; arm was a little sore; This case was reported by a consumer via ((Shingrix GSK Chatbot))interactive digital media and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th February 2022, the patient received the 1st dose of Shingles vaccine. On 11th February 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling unwell and vomiting. In February 2022, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, feeling unwell and vomiting were recovering/resolving.   It was unknown if the reporter considered the pain in arm, feeling unwell and vomiting to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first shot of Shingrix vaccine on Thursday evening and less than a day after vaccination, on Friday morning the patient woke up with little sore arm but that was okay. The patient then started not feeling well. The patient spends half of Friday throwing up. On the day of reporting, the patient was doing better.  The follow-up could not be possible as no contact details were available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022025624  Additional details were provided as follows: The patient-self reported this case. The patient received dose of Shingrix vaccine and experienced arm soreness. No Lot number or Expiration date for the vaccine was known. The reporter gave permission to contact HCP. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022025624:Same patient, different dose