chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, HIBV, DTPPVHBHPB, HIBV, RV5, DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a dose of Vaxelis and a dose of ActHIB on the same day which is equivalent to a double dose of HIB. Doctor informed, parents informed, state immunization system informed, and an internal event reporting system completed. Manufacturer of vaccinations was notified. Per CDC it is not harmful to get a double dose of HIB.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Cardiac assistance device user, Myocardial ischaemia
Clinical narrative: ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 5/2/2023 PRESENCE OF CARDIAC DEFIBRILLATOR
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Fatigue, Feeling abnormal, Full blood count normal, Headache
Clinical narrative: Menquadfi and Bexsero were administered in the office at 1200 on 7/28. Father was present at time of injections and offered consent.  Patient left the office and drove himself home shortly after the vaccines were given.  3:15pm: Pt. called his mom c/o feeling tired and not well, and was going to take a nap.  3:29pm: Pt. called his mom stating he had just passed out, felt strange and needed help.  ~3:40pm: Mom arrived home and found pt., breathing, but not responding normally to verbal commands.  Mom drove pt. to the nearest ER, about 10 minutes drive.  During the drive, pt. experienced extreme neck pain, chills, headache and began convulsing.  Upon arriving at ER, pt. was moved to trauma bay where he received Ativan, Bendaryl, and steroids.  A CBC was drawn and WNL.  Pt. remained in ER for 3 hours under observation and was discharged home that evening feeling well and 'normal."  Pt. has no recall of these events after calling his mom at 3:15pm.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Hyporesponsive to stimuli, Loss of consciousness, Neck pain, Seizure
Clinical narrative: Menquadfi and Bexsero were administered in the office at 1200 on 7/28. Father was present at time of injections and offered consent.  Patient left the office and drove himself home shortly after the vaccines were given.  3:15pm: Pt. called his mom c/o feeling tired and not well, and was going to take a nap.  3:29pm: Pt. called his mom stating he had just passed out, felt strange and needed help.  ~3:40pm: Mom arrived home and found pt., breathing, but not responding normally to verbal commands.  Mom drove pt. to the nearest ER, about 10 minutes drive.  During the drive, pt. experienced extreme neck pain, chills, headache and began convulsing.  Upon arriving at ER, pt. was moved to trauma bay where he received Ativan, Bendaryl, and steroids.  A CBC was drawn and WNL.  Pt. remained in ER for 3 hours under observation and was discharged home that evening feeling well and 'normal."  Pt. has no recall of these events after calling his mom at 3:15pm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, Headache, Vomiting (X4). Rash and swelling over left thigh on 07/26/23, PM, with pain at site.  LAD left groin  14cm X 5.5cm redness at injection site.  Recommending applying cool/ice compress.  Prescribed Augmentin for Cellulitis
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Rash, Vomiting
Clinical narrative: Fever, Headache, Vomiting (X4). Rash and swelling over left thigh on 07/26/23, PM, with pain at site.  LAD left groin  14cm X 5.5cm redness at injection site.  Recommending applying cool/ice compress.  Prescribed Augmentin for Cellulitis
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Reactive site pain/redness, fever, chills, and swollen lumphnodes
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Deep vein thrombosis
Clinical narrative: ACUTE DVT OF LEFT TIBIAL VEIN ANGIOEDEMA, INIT
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE HYPOXIA
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Ill-defined disorder, Narcolepsy
Clinical narrative: NARCOLEPSY DUE TO ANOTHER MEDICAL CONDITION
Age: 1.33
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Erroneously administered 5th dose of PCV-13 series
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19
Clinical narrative: Hospitalization for Acute hypoxic respiratory failure due to COVID-19 on dates 7/15/2023-7/20/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol use, COVID-19, COVID-19 pneumonia, Hyponatraemia, Inadequate diet
Clinical narrative: Hospitalization for Neck malignancy, beer potomania, asymptomatic COVID-pneumonia  on dates 7/18/2023-7/20/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm
Clinical narrative: Hospitalization for Neck malignancy, beer potomania, asymptomatic COVID-pneumonia  on dates 7/18/2023-7/20/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site discharge, Injection site haemorrhage, Injection site rash, Rash erythematous
Clinical narrative: Staff gave the Pfizer bivalent vaccine to the patient in her right upper arm, and as soon as the needle was pulled out there was a gush of blood and vaccine that came out of her arm. She was cleaned up and a six-inch red rash formed around the injection site. She was given another dose on the left upper arm intramuscular and there was no adverse reaction. The facility director called Dr., and he prescribed Benadryl 25mg x1 right then and routinely after if needed.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dementia, Mental status changes, Pneumonia
Clinical narrative: Hospitalization for altered mental status/Dementia, pneumonia on dates 7/20/2023- 8/3/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Developed DVT right femoral, popliteal, calf veins, onset of symptoms 9/12/22, diagnosed 9/15/22 by ultrasound at a local hospital.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Cardiovascular symptom, Electrocardiogram normal, Full blood count normal, Hypoaesthesia
Clinical narrative: Right after injection I tried to get up. My vision became blurry. They laid me down, and then I began to have tremors, and when they assessed me my heart rate was at 145. I began to feel palpitations in my chest. EMS was then called and was taken to Hospital.  Currently my cardiovascular symptoms have subsided. But now my left arm feels numb, tingly, sometimes burns. My shoulder feels stiff and I am having spasms in other parts of my body when I sleep. My leg and my hand jerks at night when resting.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test normal, Musculoskeletal stiffness, Palpitations, Paraesthesia, Tremor
Clinical narrative: Right after injection I tried to get up. My vision became blurry. They laid me down, and then I began to have tremors, and when they assessed me my heart rate was at 145. I began to feel palpitations in my chest. EMS was then called and was taken to Hospital.  Currently my cardiovascular symptoms have subsided. But now my left arm feels numb, tingly, sometimes burns. My shoulder feels stiff and I am having spasms in other parts of my body when I sleep. My leg and my hand jerks at night when resting.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Right after injection I tried to get up. My vision became blurry. They laid me down, and then I began to have tremors, and when they assessed me my heart rate was at 145. I began to feel palpitations in my chest. EMS was then called and was taken to Hospital.  Currently my cardiovascular symptoms have subsided. But now my left arm feels numb, tingly, sometimes burns. My shoulder feels stiff and I am having spasms in other parts of my body when I sleep. My leg and my hand jerks at night when resting.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administration error-did not dilute the vial
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acute psychosis, Toxic encephalopathy
Clinical narrative: Hospitalization for acute psychosis/toxic metabolic encephalopathy on dates 7/22/2023-7/24/2023. Treated with no COVID-19 medications.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Ear pain, Headache, Injection site pain
Clinical narrative: PT states that she got the Shingrix vaccine on 07-18-2023 and she had chills, joint pain, headache, pain in ears, pain at injection site
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization for COVID-19 infection on dates 7/22/2023- 8/1/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Inflammation, Injection site rash, Rash, Rash pruritic
Clinical narrative: Patient started developing a rash on left shoulder and neck 3 days after vaccine administration. Reported rash was slightly itchy, only painful when she scratched it, not spreading. Advised my FNP to take Zyrtec 10 mg daily PO x2 weeks and hydrocortisone/Benadryl cream to inflamed areas on shoulder twice daily for 7-10 days.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Axillary pain, Hypersensitivity, Injected limb mobility decreased, Oedema peripheral, Peripheral swelling
Clinical narrative: Allergic type reaction. Had injection of Prevnar 20 in left arm and Shingrix in right arm. No reaction with shingles vaccine in right arm. Left arm severely swollen and very hot to touch. Could not raise arm and swollen and sore in armpit area. The pharmacy recommended to see Doctor to see if antibiotics needed. She visited an ER. The Doctor suspects allergic reaction, but is giving her cephalexin 500mg  every 6 hours for 5 days just in case.  We are following up with patient from the pharmacy in the next couple of days to review her status.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm
Clinical narrative: Allergic type reaction. Had injection of Prevnar 20 in left arm and Shingrix in right arm. No reaction with shingles vaccine in right arm. Left arm severely swollen and very hot to touch. Could not raise arm and swollen and sore in armpit area. The pharmacy recommended to see Doctor to see if antibiotics needed. She visited an ER. The Doctor suspects allergic reaction, but is giving her cephalexin 500mg  every 6 hours for 5 days just in case.  We are following up with patient from the pharmacy in the next couple of days to review her status.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: erythematous local reaction - approx 10cm diameter of swelling and erythema - this was improving within 5-6 days
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Open polio vial experienced two temperature excursions (warm temp) totaling 35 minutes. One on 6/27 for 26 minutes at 9.0 degrees C and one on 7/13 for 9 minutes at 8.9 degrees C. Polio deemed non viable per manufacturer immunization consultant. Dose given on 7/28, which was non viable at the time due to temperature excursions. Parent to be notified that child will need revaccinated. No adverse reactions have been noted at this time.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 47.0
Sex: M
Vaccine: VARCEL
Symptoms: Decreased appetite, Dizziness, Lip blister, Nausea, Rash
Clinical narrative: On July 22, I noticed a rash on my arm, my face and small spots on my body. On July 24, the rash on my arm went away, but my face continued to itch, so I saw my dermatologist and urgent care. I was given a topical cream for the face and an antihistamine for the itching.  On August 1, I started to feel nausea, dizziness and loss of appetite. On August  3 I took a COVID test and it was negative, so this is likely related to the vaccine. On August 3 I noticed more blisters forming (a total of 3-4 new ones, one of which was on my lip)
Age: 47.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic, SARS-CoV-2 test negative
Clinical narrative: On July 22, I noticed a rash on my arm, my face and small spots on my body. On July 24, the rash on my arm went away, but my face continued to itch, so I saw my dermatologist and urgent care. I was given a topical cream for the face and an antihistamine for the itching.  On August 1, I started to feel nausea, dizziness and loss of appetite. On August  3 I took a COVID test and it was negative, so this is likely related to the vaccine. On August 3 I noticed more blisters forming (a total of 3-4 new ones, one of which was on my lip)
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Technician gave vaccine in left deltoid.  When patient stood up, they described feeling light-headed so she sat back down and then fainted for a brief moment.  Light-headedness persisted for about 15 minutes after regaining consciousness and then patient felt well enough to walk home with father.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Injection site bruising, Injection site reaction, Skin exfoliation
Clinical narrative: Patient said that she's having bruising in the vaccinated arm at the injection site and surrounding areas; and a little skin peeled off.  Patient said she will contact her doctor.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15
Symptoms: Febrile convulsion
Clinical narrative: Simple Febrile Seizure (10-15minutes)
Sex: U
Vaccine: PNC15
Symptoms: Product storage error
Clinical narrative: No further AE information available.; HCP called to report that 2 doses of VAXNEUVANCE were given after a TE.; This spontaneous report was received from a nurse referring to two patients of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) experienced temperature excursion with 46.67 Fahrenheit degrees for 3 Hours 0 Minutes 0 Seconds. There was no previous temperature excursion.    On an unknown date in 2023 (reported as at some point during the last 20 days), the patients were vaccinated with 2 doses of improperly stored r pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (lot # W036242, expiration date 01-OCT-2024; strength was not reported) for prophylaxis (product storage error). HCP reported no symptoms. No product quality complaint (PQC) was reported.  This case was considered non-valid due to lack of patients identifiers.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; Vaccine stored improperly and experience a supported temperature excursion; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 11-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), lot #W038813 verified ad valid after internal review, expiration date: 04-JUN-2024, administered for prophylaxis (anatomical location, strength, and route of administration were not provided). The vaccine was stored improperly and experienced a supported temperature excursion: temperature/ time frame: 12.43 F for 11 hours 30 minutes; 18.43 F for 2 hours 20 minutes. No patient side effects reported. No additional adverse event was provided.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Pharmacist confirms no symptomatic events or side effects reported. No additional AE/No PQC. / No adverse event known; VARIVAX Temperature Excursion. Improperly stored VARIVAX was administered; This spontaneous report was received from a pharmacist concerning a 32-year-old female patient.  The patient's concurrent conditions and concomitant therapies were not reported. Pre-existing physician-diagnosed allergies, birth defects or medical conditions were none known.  On 15-JUN-2023, the patient received the first dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) with lot #W012165 and expiration date on 12-APR-2024, administered subcutaneously (SC) in the left arm for prophylaxis. The vaccine was administered by the healthcare professional at a pharmacy, and it was purchased with private funds. It was unknown if there was illness at the time of vaccination.  On unspecified dates, three separate temperature excursions occurred: one up to 12.092 degrees Fahrenheit (F) for 6 hours and 15 minutes, the second up to 13.6 F for 2 hours and 30 minutes, and the third up to 12.1 F for 1 hour, 45 minutes and 5 seconds. The temperature excursions occurred as a result of a reading from a Digital Data logger.    No adverse events were known.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA011964: US-009507513-2307USA000909: US-009507513-2307USA011966:
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE/No PQC; HBP called to report a TE with PROQUAD from 8/19/2022.  Administered to this patient on 11/1/2022.; Inappropriate age at vaccine administration; This spontaneous report has been received from another reporter and refers to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 01-NOV-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (rha) (PROQUAD) subcutaneous injection, 0.5 milliliter (ml) (valid lot number U039261 [expiration date 09-JUN-2023]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion (product storage error). Additionally, the patient was also administered outside the indications, regarding administration between the ages of 12 months to 12 years (product administered to patient of inappropriate age).  No adverse effects reported.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No adverse effects reported; HBP called to report a TE with PROQUAD from 8/19/2022.  Administered to this patient on 12/20/2022.; patient was 15 at the time he was administered PROQUAD; This spontaneous report was received from a healthcare business professional (HBP) (also reported as office manager) referring to a 15 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On 20-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 ml, lot # U039261, expiration date 09-JUN-2023; strength and route were not reported) for prophylaxis, which was outside of labeling approved age, and the vaccine had temperature excursion (TE) (product storage error, product administered to patient of inappropriate age). No adverse effects were reported (no adverse event).  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2308USA000495: US-009507513-2308USA000450: US-009507513-2308USA000144: US-009507513-2308USA000469: US-009507513-2308USA000432: US-009507513-2308USA000669: US-009507513-2308USA000185:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms reported; Caller reported AE for improperly stored administered PROQUAD. No symptoms reported. Obtained consent to contact HCP. TE Filed (Case #02441023). AEs Filed (Cases #02441027, 02441050, 02441051, 02441052, 02441053). No additional AE/PQC.  Product Name:; This spontaneous report has been received from a nurse, regarding a 4-years-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 03-JUL-2023, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters prophylaxis (C6002BA, which was determined to be non-valid, and to not match any company lot by the validation lot team) (strength, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion between 0.6 and 10 degrees Celsius (C) and up to 8 degrees C for 6 hours and 15 minutes. There was a no previous temperature excursion reported.   No additional symptoms reported.  This is one of several cases form the same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Mobility decreased
Clinical narrative: 4 joints of my fingers that are inflamed; not being able to move; This serious case was reported by a consumer and described the occurrence of joint inflammation in a 56-year-old male patient who received Herpes zoster (Shingles vaccine) (batch number 2R375, expiry date 05-MAY-2024) for prophylaxis.   On 06-JUN-2023, the patient received Shingles vaccine. On 06-JUN-2023, less than a day after receiving Shingles vaccine, the patient experienced joint inflammation (Verbatim: 4 joints of my fingers that are inflamed) (serious criteria hospitalization and other: as per reporter) and mobility decreased (Verbatim: not being able to move) (serious criteria hospitalization and other: as per reporter). The patient was treated with famotidine. The outcome of the joint inflammation and mobility decreased were not resolved.   It was unknown if the reporter considered the joint inflammation and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the joint inflammation and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-JUL-2023 The reporter was a patient. The reporter reported that after taking Shingles vaccine he had serius problems, of not being able to move, where a had to be taken to the hospital by ambulance, he had 4 joints of his fingers that were inflamed, patient asked for help. The patient was in hospital for hours after taking the vaccine. The other product used IC famotidine for unknown indication. The patient need helped to find a medicine, he had been living this nightmare for 2 months after vaccine. The reporter reported that the physician said that they would never sow a case like this. The reporter requested to consent the follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Acne, Gait inability, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I got shingles a year ago; two pimples on my left buttock; unable to walk; pain was so bad; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria hospitalization and GSK medically significant), shingles (Verbatim: I got shingles a year ago) (serious criteria hospitalization), pimples (Verbatim: two pimples on my left buttock ) (serious criteria hospitalization), unable to walk (Verbatim: unable to walk) (serious criteria hospitalization) and pain (Verbatim: pain was so bad) (serious criteria hospitalization). The patient was treated with morphine. The outcome of the vaccination failure was unknown and the outcome of the shingles, pimples, unable to walk and pain were resolved (duration 5 months).   It was unknown if the reporter considered the vaccination failure, shingles, pimples, unable to walk and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pimples, unable to walk and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 30-JUL-2023 The case was received from the patient interactive digital media. The patient got shingles a year ago and it only took two pimples on his/her left buttock for him/her to be unable to walk for a couple of months.  The patient was in the hospital many times and the pain was so bad that he/she was put on morphine and his/her recovery took up to five months. The patient was already been vaccinated for shingles. 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. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got it from the shot/suspected vaccination failure; My mother who never had shingles got it from the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got it from the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My mother who never had shingles got it from the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 30-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that his or her mother who never had shingles, but got it from the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got after the vaccine; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got after the vaccine). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-JUL-2023 This case was reported by a patient via interactive digital media. The patient got it after the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had shingle shot but still got shingles / Suspected vaccination failure; Got shingles; painful; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingle shot but still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were resolved (duration 3 weeks).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-AUG-2023 This case was reported by a patient via interactive digital media. It was reported that the patient had the shingle shot but still got shingles. It was so painful but did not last but for about three weeks. 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: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Erythema greater than 100mm; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Erythema greater than 100mm). The outcome of the erythema was resolved (duration 3 days).   The reporter considered the erythema to be related to Shingrix.     The company considered the erythema to be related to Shingrix.   Additional Information: GSK receipt date: 31-Jul-2023 The patient was over the age of 60 years.  The patient received 1st dose of Shingrix and had erythema greater than 100 mm which got recovered after 3 days. Follow-up not possible as no contact details provided
Sex: U
Vaccine: VARZOS
Symptoms: Gait disturbance, Pain
Clinical narrative: I was walking sideways; very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17-JUL-2023, the patient received Shingles vaccine. On 17-JUL-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: very painful). On 18-JUL-2023, the patient experienced walking difficulty (Verbatim: I was walking sideways). The outcome of the pain and walking difficulty were not reported.   It was unknown if the reporter considered the pain and walking difficulty to be related to Shingles vaccine.     It was unknown if the company considered the pain and walking difficulty to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-Jul-2023 This case was reported the patient via interactive digital media The patient got vaccine on Monday, which was very painful and hurt all night and the next day the patient was walking sideways. Follow-up not possible as no contact details provided
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Lip swelling, Paraesthesia, Pharyngeal swelling, Swelling face
Clinical narrative: She had a severe allergic reaction; throat swelling; face tingling; face swelling; lips swelling; This non-serious case was reported by a consumer via sales rep and described the occurrence of allergic reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included immunocompromised and shingles (had an outbreak of shingles at 19 years old).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: She had a severe allergic reaction), throat swelling (Verbatim: throat swelling), tingling (Verbatim: face tingling), facial swelling (Verbatim: face swelling) and lip swelling (Verbatim: lips swelling). The outcome of the allergic reaction, throat swelling, tingling, facial swelling and lip swelling were not reported.   It was unknown if the reporter considered the allergic reaction, throat swelling, tingling, facial swelling and lip swelling to be related to Shingrix.     It was unknown if the company considered the allergic reaction, throat swelling, tingling, facial swelling and lip swelling to be related to Shingrix.   Additional Information: GSK Receipt date: 25-JUL-2023 The reporter reported that one of the staff members in his/her office where he/she had lunch received 1 dose of Shingrix at a local in late May early June 2023.  She had a severe allergic reaction as face, lips, throat swelling, face tingling. The pharmacist called and she went to the emergency room for treatment. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Pt reported fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included MODERNA COVID VACCINE with an associated reaction of fatigue.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Pt reported fatigue). The outcome of the fatigue was resolved (duration 24 hrs).   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUL-2023 The patient self-reported this case. She had fatigue similar to experience with Moderna Covid vaccine.  It was resolved within 24 hours. The reporter denied consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm is soar; This non-serious 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.   Family history included shingles (To mother).   On 27-JUL-2023, the patient received Shingles vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: My arm is soar). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date:28-JUL-2023 This case was reported by a patient via interactive digital media. The reporter had been wanting to get the shingles shot for several years.  The reporter's insurance did not cover it and it cost 750 dollars for the 2 shot series.  But at the time of reporting he/she had the hill and had medicare that will cover it. The reporter got the shot a day before reporting and his/her arm was soar but he/she was glad that she could get it. The reporter never want to experience the kind of pain her mother felt.  The reporter advised to get shot. The follow-up could not be possible as no contact details were available. This case has been linked with the case US2023AMR103739 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR103739:Mother case, same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Neck pain, Pain, Rash
Clinical narrative: shingles; neck pain; rash; I wasn't able to work for days; had pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Family history included shingles (mother had shingles.).   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles), neck pain (Verbatim: neck pain), rash (Verbatim: rash), impaired work ability (Verbatim: I wasn't able to work for days) and pain (Verbatim: had pain). The outcome of the shingles, neck pain, rash and impaired work ability were resolved and the outcome of the pain was resolved (duration 5 months).   It was unknown if the reporter considered the shingles, neck pain, rash, impaired work ability and pain to be related to Shingrix.     It was unknown if the company considered the shingles, neck pain, rash, impaired work ability and pain to be related to Shingrix.   Additional Information: GSK Receipt date: 28-JUL-2023 This case was reported by patient via interactive digital media. The reporter reported that her mother had shingles, but she was not afraid of getting it because of her active, healthy lifestyle. The reporter states that she got the shingles shot and shortly after got the shingles. The reporter states that she knows, shingles varies from person to person but for her, it started with four days of neck pain. The pain kept getting worse. Then a rash developed, and her doctor diagnosed with shingles.  The pain was so intense that she not able to work for days. Even after the rash went away, she had pain that lasted for five months. She wishes she would not have waited to learn more about shingles.  The reporter states that don't wait talk to a doctor or pharmacist today about shingles prevention for those over 50. Follow up was not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: pain swelling at injection site; pain swelling at injection site; fatigue; myalgia; headache; shivering; fever; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain swelling at injection site), injection site swelling (Verbatim: pain swelling at injection site), fatigue (Verbatim: fatigue), myalgia (Verbatim: myalgia), headache (Verbatim: headache), shivering (Verbatim: shivering) and fever (Verbatim: fever). The outcome of the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever were resolved (duration 36 hrs).   It was unknown if the reporter considered the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever to be related to Shingrix.   Additional Information: GSK receipt date: 31-JUL-2023 The patient self reported that pain and swelling at injection site, fatigue, myalgia, headache, shivering and fever post 2nd dose of Shingrix. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: pain swelling at injection site; pain swelling at injection site; fatigue; myalgia; headache; shivering; fever; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain swelling at injection site), injection site swelling (Verbatim: pain swelling at injection site), fatigue (Verbatim: fatigue), myalgia (Verbatim: myalgia), headache (Verbatim: headache), shivering (Verbatim: shivering) and fever (Verbatim: fever). The outcome of the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever were resolved (duration 36 hrs).   It was unknown if the reporter considered the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever to be related to Shingrix.   Additional Information: GSK receipt date: 31-JUL-2023 The patient self reported that pain and swelling at injection site, fatigue, myalgia, headache, shivering and fever post 2nd dose of Shingrix. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles; This non-serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-JUL-2023 This case was reported by a patient via interactive digital media. It was reported that the patient got the Shingles shot and 2 weeks later got shingles. The follow up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got deathly ill from the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced illness (Verbatim: got deathly ill from the shot). The outcome of the illness was not reported.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.     It was unknown if the company considered the illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUL-2023 This case was received from patient's family member via interactive digital media. The reporter's mother in-law got deathly ill from the shot.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Swelling left arm/left arm was swelling from the elbow all the way down to left hand; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-JUN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, several days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb (Verbatim: Swelling left arm/left arm was swelling from the elbow all the way down to left hand). The outcome of the extensive swelling of vaccinated limb was not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Shingrix.     It was unknown if the company considered the extensive swelling of vaccinated limb to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2023 The patient self-reported this case. The patient administered first dose of Shingrix and noticed days later that his arm was swelling from the elbow all the way down to his left hand. The swelling continued. Doctor was not aware. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Feeling abnormal, Heavy metal increased, Hypersensitivity
Clinical narrative: almost died; high level of nickel in blood; This serious case was reported by a consumer via call center representative and described the occurrence of near death experience in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included nickel allergy.   On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced near death experience (Verbatim: almost died) (serious criteria GSK medically significant) and blood heavy metal increased (Verbatim: high level of nickel in blood). The outcome of the near death experience was not reported and the outcome of the blood heavy metal increased was unknown.   The reporter considered the near death experience to be related to Influenza vaccine. It was unknown if the reporter considered the blood heavy metal increased to be related to Influenza vaccine.     The company considered the near death experience to be related to Influenza vaccine. It was unknown if the company considered the blood heavy metal increased to be related to Influenza vaccine.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter was the patient. She stated that in the past she almost died because of an unspecified influenza flu shot. She said that the flu shot used was a multi dose product which contained the metal nickel. She said that she had to get the nickel out of her brain and chest because it made her feel like she was dying. She said that blood work was drawn they ran a heavy metal test and her nickel blood level was higher than it should be higher than a factory worker, enough to kill her. It was unclear if she was hospitalized. No further details were reported.