chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: 2 days after injection Dizzy, heart palpitations, weakness, muscle loss, low Sodium, neck issues, don't recall all of them.  Ongoing
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pt was given dose number 3, covid-19 bivalent booster Pfizer 5-11. Dosage was 0.2ml but vial was not diluted first with 1.3 of diluent prior to withdraw of 0.2 dosage. Patients mom was notified via phone by RN of potential adverse events such as local reactions due to higher dose, no repeat booster dose needed.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: No adverse event
Clinical narrative: talked to mom and at this time no adverse event  has occurred
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Patient presented to pharmacy today and complained that her arm has been hurting since the vaccine was administered. Patient  verbalized that the pain was 8 to 9 out of 10. she also verbalized that her doctor had advised that she take Tylenol but it has not been effective. Patient advised to consult her doctor
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No symptoms or reactions
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Cough, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: I had my vaccination on 09/03/2022. I started to experience a lot of congestion coughing and chest pain in 10/2022. I tested COVID-19 negative 10/2022. I was informed to take cough medicine and FLONASE.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy lymph gland abnormal, Chest X-ray abnormal, Chills, Computerised tomogram thorax abnormal, Fatigue
Clinical narrative: HAD SOME TEMPORARY  ARM SORENESS TO VACCINE  SYMPTOMS OF ADVERSE EVENT BEGAN ON 10-31-22, AND LASTED AROUND THREE WEEKS BEFORE GOING TO URGENT CARE.  SYMPTOMS:  HARD CHILLS, INTERMITTENT FEVER, EXTREME FATIGUE, - AT URGENT CARE, LUNG XRAY AND THEN CT SCAN SHOWED LUNG NODULES & ENLARGED LYMPH NODE.  SENT TO PULMONOLOGY, BIOPSY SHOWED HISTOPLASMOSIS INFECTION, SENT TO INFECTIOUS DISEASE DOCTOR WHO STARTED ME ON ITRACONAZOLE (ANTI-FUNGAL MEDICATION)
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Histoplasmosis, Laboratory test, Lymphadenopathy, Pain in extremity, Pulmonary mass
Clinical narrative: HAD SOME TEMPORARY  ARM SORENESS TO VACCINE  SYMPTOMS OF ADVERSE EVENT BEGAN ON 10-31-22, AND LASTED AROUND THREE WEEKS BEFORE GOING TO URGENT CARE.  SYMPTOMS:  HARD CHILLS, INTERMITTENT FEVER, EXTREME FATIGUE, - AT URGENT CARE, LUNG XRAY AND THEN CT SCAN SHOWED LUNG NODULES & ENLARGED LYMPH NODE.  SENT TO PULMONOLOGY, BIOPSY SHOWED HISTOPLASMOSIS INFECTION, SENT TO INFECTIOUS DISEASE DOCTOR WHO STARTED ME ON ITRACONAZOLE (ANTI-FUNGAL MEDICATION)
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: HAD SOME TEMPORARY  ARM SORENESS TO VACCINE  SYMPTOMS OF ADVERSE EVENT BEGAN ON 10-31-22, AND LASTED AROUND THREE WEEKS BEFORE GOING TO URGENT CARE.  SYMPTOMS:  HARD CHILLS, INTERMITTENT FEVER, EXTREME FATIGUE, - AT URGENT CARE, LUNG XRAY AND THEN CT SCAN SHOWED LUNG NODULES & ENLARGED LYMPH NODE.  SENT TO PULMONOLOGY, BIOPSY SHOWED HISTOPLASMOSIS INFECTION, SENT TO INFECTIOUS DISEASE DOCTOR WHO STARTED ME ON ITRACONAZOLE (ANTI-FUNGAL MEDICATION)
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cholelithiasis, Cough, Illness, Infection, Influenza
Clinical narrative: suspected flu symptoms such as cough, congestion, nausea. nausea has continued for 3 months since sickness has gone away.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Respiratory tract congestion, Ultrasound abdomen abnormal, White blood cell count increased
Clinical narrative: suspected flu symptoms such as cough, congestion, nausea. nausea has continued for 3 months since sickness has gone away.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy lung abnormal, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Dyspnoea, Laboratory test
Clinical narrative: Patient presented to urgent care 9/20/2022 with SOB for a week.  Patient had chest xray and chest CT, revealing a mass in his left lung.  Biopsy on 10/7/22 positive for invasive squamous cell carcinoma.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pulmonary mass, Squamous cell carcinoma of lung
Clinical narrative: Patient presented to urgent care 9/20/2022 with SOB for a week.  Patient had chest xray and chest CT, revealing a mass in his left lung.  Biopsy on 10/7/22 positive for invasive squamous cell carcinoma.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypertension
Clinical narrative: I went to the doctor for a physical. They checked my blood pressure and it was high. I was prescribed amlodipine. I never had high blood pressure before.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Left arm hurts back and forth
Age: 0.42
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event occurred. Vaccine was administered one day before the patient turned 6 months old.
Age: 28.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Incorrect product formulation administered
Clinical narrative: Client seen for routine visit and public health department 03/06/2023. Requested covid bivalent booster. Client incorrectly received covid primary booster 0.3ml IM right deltoid at 02:10pm instead. Client made aware of error immediately upon discovery on 03/06/2023 at 04:00pm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Injections given on 3/3/23.  In the evening of 3/5/23 parents noted redness around deltoid injection site.  Redness still present on the morning of 3/6/23 and had spread down the upper arm.  Mom reports that the skin was red, but no noticeable swelling .  Skin warm to touch.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccine.
Age: 1.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker referring to a 21-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-FEB-2023, the patient was vaccinated with 1 dose (dosage form) of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #w020525, expiration date: 14-DEC-2023 for prophylaxis (strength and route of administration were not provided) (product storage error). The vaccine was exposed to 30 degrees Fahrenheit for 3 hours 15 minutes. There was no previous excursion. No additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not reported. On 02-FEB-2023, the patient was vaccinated with PROQUAD subcutaneous injection (0.5 ml, lot #W019626, expiration date: 19-DEC-2023, therapy type: rHA) administered for prophylaxis (strength and route of administration were not provided) after a temperature excursion (product storage error). The vaccine was exposed to minus 11.9 degrees Celsius for an unknown time frame. There was also previous excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of RECOMBIVAX was administered; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-DEC-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #U019135, expiration date: 22-NOV-2022, administered intramuscularly for prophylaxis (strength was not provided) (expired product administered). There was no adverse event reported.  This is one of the several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA008524:Same Reporter US-009507513-2302USA008289:Same Reporter
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE.; the third dose was received at the office but was not documented in the system so a fourth dose was administered to the patient at a pharmacy.; This spontaneous report was received from a advanced practice registered nurse (A.P.R.N.) and refers to a 23 year old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  The patient was already on the three dose series (not specific information provided). It was reported that the third dose was received at the office but was not documented in the vaccination system so, on 26-FEB-2023, a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis was administered to the patient at a pharmacy (route of administration, frequency, lot/batch # and expiration date were not reported) (extra dose administered). The reporter did not have lot/expiration as the dose was not given at his facility. No additional event was reported.   No further clarify.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; GARDASIL 9 was administered to a patient on 2/22/2023 after possibly being stored outside of it's recommended storage range. HCP reports that there were 16 days of no recorded temperature readings; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 22-FEB-2023, the patient was vaccinated with an improper stored (after possibly being stored outside of it's recommended storage range) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1775827 with expiration date of 27-JUN-2024, for prophylaxis (route of administration and frequency were not reported) (product storage error).    It was reported that there were 16 days of no recorded temperature readings and it was unknown if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was out of range.  No additional events reported.  No further information was provided to further clarify any details.
Age: 41.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; 41 year old patient was accidently administered two doses of PROQUAD; patient was accidently administered two doses of PROQUAD instead of two doses of MMR II; 41 year old patient was accidently administered two doses of PROQUAD; patient was accidently administered two doses of PROQUAD instead of two doses of MMR II; This spontaneous report was received from a medical assistant and refers to a 41-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.   On 27-JAN-2023, the patient was accidently vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot# W01273, expiration date 16-OCT-2023 (exact dose and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (product administered to patient of inappropriate age, wrong product administered). On 27-FEB-2023, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis lot# W012731 and expiration date 16-OCT-2023  (dose and route of administration were not provided)  (inappropriate schedule of product administration, wrong product administered). Both doses were supposed to be measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), but instead the patient was accidently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) both times. No additional adverse events were reported.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: The HCP states that the patient had already received all doses of RECOMBIVAX HB in the 3 dose series and reports that the patient had been vaccinated with RECOMBIVAX HB at 2, 4, and 6 months of age; no additional AE's; patient was supposed to receive a dose of Havrix and was inadvertently administered RECOMBIVAX HB instead; patient (...) was inadvertently administered RECOMBIVAX HB instead/the patient had already received all doses of RECOMBIVAX HB in the 3 dose series; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, patient had been vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided) at 2, 4, and 6 months of age (inappropriate schedule of product administration).  The Health Care Professional (HCP) reported that the patient was supposed to receive a dose of hepatitis a vaccine inact (HAVRIX) and was inadvertently administered hepatitis b vaccine (recombinant) (RECOMBIVAX HB) instead - on 08-FEB-2023, intramuscular injection, 0.5 milliliter, lot #W002452, expiration date: 26-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (Wrong product administered). The reporter stated that the patient had already received all doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) in the 3 dose series (Extra dose administered).  There were no adverse events reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported ROTATEQ was administered after a temperature excursion to a patient on Feb 23, 2023. No further information provided. No additional AE reported. No PQC reported.  Name of vaccine involved (including lot/exp): ROTATEQ (W029695 1/29/2024; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (formulation defaulted to oral liquid, route of administration defaulted to oral, exact dose was not reported) lot #W029695 was valid, expiration date 29-JAN-2024, for prophylaxis. The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered after temperature excursion. The vaccine was storage in temperature reported as 18 degrees Celsius for 3 hours 50 minutes. The vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had not previous temperature excursion, no additional adverse events were reported (product storage error) (no adverse event).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Accidental overdose, Regurgitation
Clinical narrative: Regurgitation of medication; A nurse reported that an infant regurgitated ROTATEQ on unspecific date.; This spontaneous information was received from a nurse concerning an infant patient of unknown age and gender. Patient's pertinent medical history, current condition and concomitant medications were not provided.  On an unknown date, the patient received a rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength, dose, frequency, lot number and expiration date was not provided).  On an unspecified date, the patient regurgitated the whole rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (accidental underdose/ regurgitation). The outcome of the event was not provided.  The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the events was not provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had 3 vaccines for shingles, had shingles 3 times/Suspected vaccination failure; Shingles 3 times; Excruciatingly painful condition; had 3 shingles vaccines; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received three doses of Shingles vaccine. The patient stated that in last year he/she experienced shingles three times. The condition was excruciatingly painful. The patient reported that he/she was told that if he/she did not had the vaccines he/she would had it far worse. The patient can not even imagine worse than his/her shingles experience thus far. The patient stated it may never come back again. The patient reported that get the vaccine and do favor on yourself. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingles in error, which led to extra dose administered. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Ophthalmic herpes zoster, Pain, Paraesthesia
Clinical narrative: still wakes up, it was in my eye; 3 times 1st time was hell it took over 2vyrs heal up it still wakes up in me; painful and aggravating I couldn't wear clothing/still have pins, needles pain; I couldn't wear clothing for a year; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, pain and activities of daily living impaired. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown and the outcome of the pain was not recovered/not resolved and the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, pain and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-FEB-2023 Reporter Comment: This case was reported by a patient via interactive digital media. The reporter reported that, he/ she got 3 times 1st time was hell it took over 2 years heal up it (shingles) still wakes up in her/him last time 5 months ago from reporting it was in his/her eye. The patient got 1st part vaccine it almost killed her/him. The doctor said not to get the 2nd part. The patient pray he/she got enough vaccine to fight it off the rest his/her life remainder.  The patient stated that good luck to all it was painful and aggravating. The patient could not wear clothing for a year and he /she still had pins needles pain comes and goes. Additional Supportive Information: As it was not clear if the event Shingles and ophthalmic herpes zoster were experienced before or after vaccination hence conservatively captured as event. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got it twice despite being vaccinated/suspected vaccination failure; got it twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comment:This case was reported by a consumer via interactive digital media The reporter got it 2 years prior to the reporting. It was mild case, 4 spots right hand and not vaccinated. The reporters husband got it twice despite being vaccinated. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain in extremity, Palpitations, Vaccination failure
Clinical narrative: Shingrix caused me to get shingles/Suspected vaccination failure; I have shingles in my eyes; Experiencing pain on leg; Experienced heart palpitations; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), leg pain and palpitation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, leg pain and palpitation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, leg pain and palpitation to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comment: The patient received the Shingrix vaccine on 6th December 2022.  The Shingrix vaccine caused me to get shingles. The patient has shingles in my eyes and experiencing pain on my rower part of my left leg.  Recently patient have experienced heart palpitations. I have reported this to the where I had received the vaccine. I have been to my nurse practitioner twice. I have also communicated with them on. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Anaphylactic shock, Illness
Clinical narrative: Anaphylactic shock; sick; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylactic shock in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's 2 older sisters had shingles and were in pain and discomfort for weeks).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the anaphylactic shock and sickness were unknown.   The reporter considered the anaphylactic shock to be possibly related to Shingrix. It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient reported that he/she had anaphylactic shock from the Shingrix vaccine and recommend people to get a blood test first to see what their immunity levels were. The patient reported that he/she had natural immunity and by getting the shot made sick. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Nausea, Pyrexia, Urinary incontinence
Clinical narrative: Nausea; Vomit; Fever temp greater 101; Weakness; Urinary incontinence; Weight loss 11 lbs; Fatigue; This case was reported by a physician via sales rep and described the occurrence of nausea in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   On 10th January 2023, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, vomiting, fever, weakness, urinary incontinence, weight loss and fatigue. On an unknown date, the outcome of the nausea, vomiting, fever, weakness, urinary incontinence and weight loss were unknown and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the nausea, vomiting, fever, weakness, urinary incontinence, weight loss and fatigue to be related to Shingrix.     Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: The patient received a dose of Shingrix and had nausea, vomit, fever (temperature greater than 101), weakness urinary incontinence, weight loss 11 lbs.  The patient stated symptoms lasted greater than 2 weakness.  The patient was still complains of fatigue. The patient had the followed up visit on 17th January 2023, 27th January 2023, 9th February 2023 and 14th February 2023. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting, Weight decreased
Clinical narrative: Nausea; Vomit; Fever temp greater 101; Weakness; Urinary incontinence; Weight loss 11 lbs; Fatigue; This case was reported by a physician via sales rep and described the occurrence of nausea in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   On 10th January 2023, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, vomiting, fever, weakness, urinary incontinence, weight loss and fatigue. On an unknown date, the outcome of the nausea, vomiting, fever, weakness, urinary incontinence and weight loss were unknown and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the nausea, vomiting, fever, weakness, urinary incontinence, weight loss and fatigue to be related to Shingrix.     Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: The patient received a dose of Shingrix and had nausea, vomit, fever (temperature greater than 101), weakness urinary incontinence, weight loss 11 lbs.  The patient stated symptoms lasted greater than 2 weakness.  The patient was still complains of fatigue. The patient had the followed up visit on 17th January 2023, 27th January 2023, 9th February 2023 and 14th February 2023. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Paraesthesia, Post herpetic neuralgia, Pruritus, Tenderness
Clinical narrative: pain under skin above muscle on left side of lower back reach towards the front of the torso; PHN type pain in thigh radiating to the leg; Tender to touch,; itchy; tingly; This case was reported by a pharmacist via sales rep and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 weeks after receiving Shingrix, the patient experienced back pain, post herpetic neuralgia, tenderness, pruritus and tingling. On an unknown date, the outcome of the back pain, tenderness, pruritus and tingling were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the back pain, post herpetic neuralgia, tenderness, pruritus and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date- 25-FEB-2023  Reporter's Comments- The reporter reported that 4 weeks post 2nd dose had pain under skin above muscle on left side of lower back reach towards the front of the torso. The patient had tender to touch, itchy, tingly. The reporter stated that lasted one month then transitioned to post herpetic neuralgia type pain in left thigh radiating down the leg, could still feel it 1 year later. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Flu symptoms; Arm hurts more; This case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2023AMR031872).   In February 2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced flu symptoms and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the flu symptoms and pain in arm were unknown.   It was unknown if the reporter considered the flu symptoms and pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR031872   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient just finished the 2nd shingle shot last week and the 2nd one gave a bit of flu symptoms and the arm was hurting a good bit more but that was about it. Additional Supportive Information: The follow-up could not be possible as no contact details were available. This case had been linked with US2023AMR031872, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR031872:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR031863   Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received 2nd dose of Shingles vaccine and the  arm  hurts a good bit more but that's about it. Additional Supportive Information: The follow-up could not be possible as no contact details were available. This case had been linked with US2023AMR031863, reported by the same reporter. This case was conservatively kept valid, as per narrative.; Sender's Comments:  US-GSK-US2023AMR031863:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Rash
Clinical narrative: Shingles after 1st shot; Rash; Pain; Discomfort; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2023, the patient received the 1st dose of Shingles vaccine. In February 2023, 5 days after receiving Shingles vaccine, the patient experienced shingles, rash, pain and discomfort. The patient was treated with emollients and protectives (Moisturizing Cream). On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the pain and discomfort were recovering/resolving.   It was unknown if the reporter considered the shingles, rash, pain and discomfort to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023032782   Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient stated that he/she got shingles outbreak after the 1st shot.  The patient asked his/her primary care physician that if 1st shot triggered the outbreak, as physician confirmed that he/she had Shingles 5 days after the shot. The physician replied that it was not a big deal and prescribed acyclovir and gabapentin, and recommended applying a moisturizing cream  to the rash.  The patient was in second week of the outbreak and he/she said that the pain and discomfort were manageable.  The patient was not discouraging anyone from getting vaccinated, but was just telling everyone what they need to know. Additional Supportive Information: The follow-up could not be possible as no contact details were available. As acyclovir and gabapentin were prescribed to the patient but was not whether the patient had started the prescribed drugs or not.; Sender's Comments:  US-GSK-US2023032782:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Muscle injury, Nerve injury
Clinical narrative: muscle damage; nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of muscle damage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 years ago).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle damage and nerve damage. On an unknown date, the outcome of the muscle damage and nerve damage were not recovered/not resolved.   It was unknown if the reporter considered the muscle damage and nerve damage to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-FEB-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles 4 years ago, a band from the center of chest around left side to the center of back and this unpleasant experience lasted nearly 3 months The patient got the Shingrix vaccinations about 18 months later.  The was still feeling the effects of muscles and nerve damage.  The reporter stated that get vaccinated if you were over 50.  No guarantee you would not get shingles but it would reduce the chances of getting it. Additional supportive information: This case was found as duplicate of case US2023AMR031915 All the information from the case US2023AMR031915 was merged into this case. The case US2023AMR031915 was deleted and this case stand as case of record for this patient.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite, Feeling abnormal, Malaise, Respiratory syncytial virus infection, Retching
Clinical narrative: RSV; Nauseous; Dry heaves caused by mucus; Lost 10 lbs in 15 days; Feel bad all over; No apetite; Malaise, feeling ill; This case was reported by a consumer via interactive digital media and described the occurrence of respiratory syncytial virus infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2023, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the patient experienced respiratory syncytial virus infection, nausea, dry heaves, weight loss, feeling bad and appetite absent. On an unknown date, the outcome of the respiratory syncytial virus infection, nausea, dry heaves, weight loss, malaise, feeling bad and appetite absent were unknown.   It was unknown if the reporter considered the respiratory syncytial virus infection, nausea, dry heaves, weight loss, malaise, feeling bad and appetite absent to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Feb-2023 Reporter's comments: The case was received from the patient via interactive digital media. The patient did not know if he/she had respiratory syncytial virus infection (RSV) but he/she was nauseous, dry heaves caused by mucus, had lost 10 lbs in 15 days, his/her body had malaise (felt bad all over), no appetite.  The patient need to get some help to determine what he/she had and find a treatment.  The patient started feeling ill after Shingle vaccination, 15 days ago. Additional supportive information: The follow-up could not be possible as no contact details were available. All the reported adverse events were coded as events considering that the patient had experienced all after vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: RSV; Nauseous; Dry heaves caused by mucus; Lost 10 lbs in 15 days; Feel bad all over; No apetite; Malaise, feeling ill; This case was reported by a consumer via interactive digital media and described the occurrence of respiratory syncytial virus infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2023, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the patient experienced respiratory syncytial virus infection, nausea, dry heaves, weight loss, feeling bad and appetite absent. On an unknown date, the outcome of the respiratory syncytial virus infection, nausea, dry heaves, weight loss, malaise, feeling bad and appetite absent were unknown.   It was unknown if the reporter considered the respiratory syncytial virus infection, nausea, dry heaves, weight loss, malaise, feeling bad and appetite absent to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Feb-2023 Reporter's comments: The case was received from the patient via interactive digital media. The patient did not know if he/she had respiratory syncytial virus infection (RSV) but he/she was nauseous, dry heaves caused by mucus, had lost 10 lbs in 15 days, his/her body had malaise (felt bad all over), no appetite.  The patient need to get some help to determine what he/she had and find a treatment.  The patient started feeling ill after Shingle vaccination, 15 days ago. Additional supportive information: The follow-up could not be possible as no contact details were available. All the reported adverse events were coded as events considering that the patient had experienced all after vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Fatigue, Headache, Injection site pain
Clinical narrative: Bones of the extremities hurt; Shoulder hurts; Vertigo; Headache; Tiredness; Vaccine is very painful/which is where the vaccine is applied; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had beginning of shingles), burning skin (felt a lot of burning where the leg started under the buttock), pruritus (felt a lot of itching where the leg started under the buttock), blister (patient's wife saw that they were little balls filled with liquid, an area about half an inch in diameter) and pimples (since previously legs had been filled from the waist down with some red-tipped pimples and they burned like acid, as he work cutting weeds and thought it was the effect of a poison ivy weed).   On 21st February 2023, the patient received Shingles vaccine. In February 2023, less than a week after receiving Shingles vaccine, the patient experienced injection site pain, vertigo, headache and tiredness. On 21st February 2023, the patient experienced shoulder pain. On 22nd February 2023, the patient experienced bone pain. On an unknown date, the outcome of the injection site pain, shoulder pain and bone pain were not recovered/not resolved and the outcome of the vertigo, headache and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, shoulder pain, vertigo, headache, tiredness and bone pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Feb-2023 Reporter's comments: The case was received from the patient via interactive digital media. The patient received the Shingles vaccine last Tuesday four days ago and warn that, the vaccine was very painful, after thirty minutes the shoulder starts to hurt, which was where the vaccine was applied. Less than a week after vaccination, the vaccine gave vertigo, headache, tiredness and the next day the bones of the extremities hurt. Until the day of reporting, the pain continues. The patient keep working because expenses and bills did not pay themselves.  The patient stated blessings for all. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Bones of the extremities hurt; Shoulder hurts; Vertigo; Headache; Tiredness; Vaccine is very painful/which is where the vaccine is applied; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had beginning of shingles), burning skin (felt a lot of burning where the leg started under the buttock), pruritus (felt a lot of itching where the leg started under the buttock), blister (patient's wife saw that they were little balls filled with liquid, an area about half an inch in diameter) and pimples (since previously legs had been filled from the waist down with some red-tipped pimples and they burned like acid, as he work cutting weeds and thought it was the effect of a poison ivy weed).   On 21st February 2023, the patient received Shingles vaccine. In February 2023, less than a week after receiving Shingles vaccine, the patient experienced injection site pain, vertigo, headache and tiredness. On 21st February 2023, the patient experienced shoulder pain. On 22nd February 2023, the patient experienced bone pain. On an unknown date, the outcome of the injection site pain, shoulder pain and bone pain were not recovered/not resolved and the outcome of the vertigo, headache and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, shoulder pain, vertigo, headache, tiredness and bone pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Feb-2023 Reporter's comments: The case was received from the patient via interactive digital media. The patient received the Shingles vaccine last Tuesday four days ago and warn that, the vaccine was very painful, after thirty minutes the shoulder starts to hurt, which was where the vaccine was applied. Less than a week after vaccination, the vaccine gave vertigo, headache, tiredness and the next day the bones of the extremities hurt. Until the day of reporting, the pain continues. The patient keep working because expenses and bills did not pay themselves.  The patient stated blessings for all. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle injury, Nerve injury
Clinical narrative: muscle damage; nerve damage; This case will be deleted because as per narrative patient got Shingrix vaccine and experienced muscle damage, nerve injury and it was not mentioned after which vaccine dose the patient experienced AE, we will keep 1 valid US2023AMR031879 with blank dose number.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Painful where they put it, hurts for days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-FEB-2023  Reporter's comment: The case  was received from the patient via interactive digital media. The reporter reported that he/she got the Shingles vaccine for prevention and arm was painful where they put the vaccine. The reporter reported that pain hurted for several days. The reporter said that there were two injections and the second was six months later. The reporter stated that he/she hoped that you were better. As per reported verbatim, outcome was captured conservatively.