chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient was in for a 5 year old well child check. Nurse was supposed to give Infanrix(Dtap), IPV, varicella, MMR. The nurse ended up giving Pediarix (Dtap, IPV, Hep B), IPV, varicella, and MMR.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: Patient is one year old. Given adult dose FLUZONE QIV 0.5ml.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Lethargy, Ultrasound scan
Clinical narrative: Patient had ileocolic intussusception on 8/31. Presented with vomiting, lethargy, and bloody stool.  Successfully reduced nonsurgically with air enema. Patient recovered well.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting, X-ray
Clinical narrative: Patient had ileocolic intussusception on 8/31. Presented with vomiting, lethargy, and bloody stool.  Successfully reduced nonsurgically with air enema. Patient recovered well.
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site swelling
Clinical narrative: Not tender, swelling at injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Swelling
Clinical narrative: Local swelling and soreness - no redness. Fever to 103.3, chills, fatigue.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: Reported that injection site became red, itchy  hard and warm to touch with hives going down arm, neck and half of torso. Benadryl given with some relief.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a reaction to a vaccine where the injection site became red and swelled up. Patient stated that the redness became worse when she came in on 09/03/2018. Pharmacist on duty informed patient that if it spreads further to contact her primary care doctor. However, if the redness subside that she will be fine. Patient was taking hydroxyzine prescribed from her doctor which seem to help.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Formication, Malaise, Nausea, Sensory disturbance
Clinical narrative: Pings sensation in back on left side; crawling sensation is on the left leg; nausea; malaise; disoriented; overall feeling unwell.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PC from mom. Pt received KINRIX and PROQUAD on 8/29/18. Mom reports that 2 days ago she noticed a raised red spot at the site of injection on left leg (site where Proquad was administered) about the size of a silver dollar. Pt said it "kind of" itches when mom asked him about it. No visible bruising or insect bite mark. Site is still red today, but less so. No other symptoms.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Bone pain, Condition aggravated, Injected limb mobility decreased, Pain in extremity
Clinical narrative: I had an asthma attack about 2 hours after the injection of PNEUMOVAX 23 Syringe at Pharmacy and the about 11pm and number 10 pain in the site of the injection I felt the pain going to the bone in my arm, deep pain. I could not move my arm not even put it up. The pain continued and I went to Dr the next day in the afternoon, he said take Tylenol 500mg every 6 hours also take Medrol pack for asthma, and I also  massage  my arm with menthol, I could not sleep, I woke up constantly because of the pain. I had some fever three days after and these symptoms continued for 7 days .
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: I had an asthma attack about 2 hours after the injection of PNEUMOVAX 23 Syringe at Pharmacy and the about 11pm and number 10 pain in the site of the injection I felt the pain going to the bone in my arm, deep pain. I could not move my arm not even put it up. The pain continued and I went to Dr the next day in the afternoon, he said take Tylenol 500mg every 6 hours also take Medrol pack for asthma, and I also  massage  my arm with menthol, I could not sleep, I woke up constantly because of the pain. I had some fever three days after and these symptoms continued for 7 days .
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Headache, Pyrexia, Vomiting
Clinical narrative: Headache, thrown up, fever chills and cold sweats.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Papilloedema
Clinical narrative: Patient began feeling like there was a Vasoline like substance under her eyelid on the morning of 9/4/18. She went to the ophthalmologist and was told the optic nerve was swollen. The patient's husband reported the incident to me, to see if it might have been due to the vaccine (SHINGRIX) given on 8/18. I called GSK, spoke with employee, and reported the incident. He informed me that this side effect was not reported in any studies which included greater than 29,000 patients.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Urticaria no respiratory compromise.  Given Claritin at school health center.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Paraesthesia, Product administered at inappropriate site
Clinical narrative: As reported by patient "Had second Shingrix at 780 on 8/16 in her left arm.  First one at her usual facility but they were out.  When she go the injection she asked the pharmacist why it was so much higher than the previous injection.  She was told, "It is fine, just turn your head."  She said she told him that it was much higher than the previous injection and this hurts so much more than previous injection.  It feels like it is being injected into her shoulder muscle.  She didn't want to pull away since needle was already in her arm.  She even asked the pharmacist if he was certain it was the right injection he was giving her since the first didn?t hurt like this upon injection.  She had the usual feelings of illness the couple days after that she had with first shot and they went away.  She is still having pain.  She is having trouble lifting her arm.  She has tingling in her shoulder and down her arm.  It is still really achy.  The doctor is sending her to an orthopedist.  They will most likely send her for an MRI.  She got this injection and now has to put out this money for something that may possibly have been the pharmacist's fault.  She can't even touch the bones in her arm.  She is only 53 and needs use of her arm."
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 08-AUG-2018, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously (strength, dose and site of administration were not reported) (lot # N026075, expiration date: 20-SEP-2019) for prophylaxis. Sterile diluent used to reconstitute the vaccine was properly stored. Administered dose of vaccine was exposed to a temperature excursion between 6 and 14 degrees Fahrenheit (10.2 degrees Fahrenheit) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Alopecia, Biopsy, Injection site rash, Rash, Rash generalised
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 29Aug2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and a healthcare professional. A 72-year-old female patient received the first dose of PREVNAR 13, (Lot Number: T78676, expiration date: 01Feb2020), intramuscularly in the left deltoid on 15May2018 14:30 at 0.5 ml, single (one time dose) for routine vaccination/immunization in a physician's office. The patient had no medical history and no concomitant medications. The patient previously took zoster/shingles vaccine in Dec2014 and influenza vaccine in Feb2018, both for immunization with no adverse events associated. The day after getting pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) injection, on 16May2018, she developed a rash. The rash got worse and worse to the point that she went to the Emergency Room on 26May2018 where she was under observation, but not admitted related to this event. She visited the physician's office on 29May2018. The rash was a diffuse rash, at the site of injection and all over the body, extending to the scalp and resulting in and a lot of hair loss also. The adverse events were described to be severe and considered by the physician as medically significant. The patient was probably 90% improved at time of this report. She went to a Dermatologist and was on oral steroids, steroids, creams, and anti-histamines. She had a Biopsy done. The patient had no further details on testing, treatment, or further medical interventions to provide for this report. The outcome of the events of diffuse rash and hair loss was recovering. The physician considered the adverse events to be related to pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "diffuse rash, at the site of injection and all over the body, extending to the scalp and resulting in and a lot of hair loss" cannot be fully excluded considering the compatible time association and the known adverse event profile of the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a non-contactable Physician via Pfizer sales representative. A patient of unspecified age and  gender received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. Within several hours of receiving vaccine the patient experienced right upper arm pain, localized swelling and redness, fever and lassitude with tender erythematous rash for 2 days. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Rash erythematous, Tenderness
Clinical narrative: This is a spontaneous report received from a non-contactable Physician via Pfizer sales representative. A patient of unspecified age and  gender received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. Within several hours of receiving vaccine the patient experienced right upper arm pain, localized swelling and redness, fever and lassitude with tender erythematous rash for 2 days. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a four years old male patient who was vaccinated with 0.5 ml dose of QUADRACEL (lot no C5497AA and Exp. Date 17 Jul 2010) via intramuscular route in the right thigh on 23-Aug-2018. The patients medical history was not reported. Previously patient received QUADRAEL from a well-child visit in Feb 2018. Concomitant medications included PROQUAD for Immunization. It was an actual medication error due to drug administered to patient of inappropriate age. it was reported that quadracel was early to male patient due to missing immunization records. It was unknown whether the patient had any adverse event (No known reports of symptoms or need for treatment). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 29-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an adult patient who received an exposed vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via unknown route. This is a case of actual medication error due to product storage error due to a temperature excursion where Adacel was recommended to be discarded. No AE information was provided.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.17
Sex: F
Vaccine: HEP, MMR, PNC13
Symptoms: Body temperature increased, Hypotonia, Injection site reaction, Loss of consciousness, Mobility decreased
Clinical narrative: 8/4/2018 seizure - unable to lift Rt. arm for half an hour. Temp of 100.5 degree. (R) arm and leg were shaking, went limp and lost consciousness for about 2 minutes.
Age: 1.17
Sex: F
Vaccine: HEP, MMR, PNC13
Symptoms: Seizure, Tremor
Clinical narrative: 8/4/2018 seizure - unable to lift Rt. arm for half an hour. Temp of 100.5 degree. (R) arm and leg were shaking, went limp and lost consciousness for about 2 minutes.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Dizziness, Oxygen therapy, Syncope
Clinical narrative: Patient had lightheadedness within minutes of receiving the injections.  She was monitored for fifteen minutes and allowed to go to the waiting room when asymptomatic.  Several minutes later she had syncopal episode after standing up.  She was brought back to the exam room, given water and oxygen via NC.  Vitals were monitored and her mother accompanied her.  After one hour she was symptom free and discharged.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Electroencephalogram, Gaze palsy, Musculoskeletal stiffness, Seizure, Tremor
Clinical narrative: Pt had a seizure the following day after vaccines were given, last approx. 1-2 min, pt was afebrile on onset of seizure activity. She was evaled at Hospital ER. She became siff and starting shaking, eye directed upwards. Mother called 911 and pt was transported to ER.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Basedow's disease, Condition aggravated, Confusional state, Exophthalmos, Muscular weakness
Clinical narrative: Thyroid storm diagnosed as Graves Disease treated via nuclear ablilation in Dec 2003... Initial symptoms: muscle weakness, confusion, heat intolerance, tremors, heart palpitations, bulging eyes, extreme weight loss (+50Lbs).
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Palpitations, Temperature intolerance, Thyrotoxic crisis, Tremor, Weight decreased
Clinical narrative: Thyroid storm diagnosed as Graves Disease treated via nuclear ablilation in Dec 2003... Initial symptoms: muscle weakness, confusion, heat intolerance, tremors, heart palpitations, bulging eyes, extreme weight loss (+50Lbs).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Mast cell activation syndrome, Peripheral swelling
Clinical narrative: Swelling of the arm from elbow up and into the chest, Pt states urgent care Dr said it was a mast cell reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.  It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a rash on his upper arm after receiving a dose of SHINGRIX. The reporting pharmacist did not have any additional details at the moment. The call transferred to MI (medical information) to determine if the patient should get the second dose or not.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter declined to provide demographics or details for the report. The reporter was patient's wife. In 2018, after receiving 1st dose of SHINGRIX the patient experienced shingles outbreak. The reporter reported that the patient missed 6 months window for the second dose of SHINGRIX due to pharmacy not having in stock, which led product suplly issue. The patient had denied permission to contact their physician. No further details were provided.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pain in extremity, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 27th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced fever, weird feeling, tremor, chills and pain in arm. On an unknown date, the patient experienced pharmaceutical product complaint. On 31st May 2018, the outcome of the fever, weird feeling, tremor, chills and pain in arm were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the fever, weird feeling, tremor, chills and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient experienced side effects after receiving his first dose of SHINGRIX.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Dizziness, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 16-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included MENVEO for prophylaxis. Previously administered products included MENVEO (1st dose received on an unknown date without any adverse reaction). On 28th August 2018, the patient received the 1st dose of BEXSERO and the 2nd dose of MENVEO. On 28th August 2018, 2 hrs after receiving BEXSERO and MENVEO, the patient experienced joint pain, sweating, felt faint and headache. The patient was treated with sulfamethoxazole + trimethoprim (Mortin). On an unknown date, the outcome of the joint pain, sweating, felt faint and headache were not recovered/not resolved. It was unknown if the reporter considered the joint pain, sweating, felt faint and headache to be related to BEXSERO and MENVEO. Additional details were provided as follows: The healthcare professional reported that 2 hours after vaccination with BEXSERO and MENVEO, the patient started experiencing joint pain, severe headache, feeling sweaty and faint. The healthcare professional stated during the course of the call that the patient's mother would be taking him to the emergency room. The healthcare professional stated that she told the patient's mother to give him motrin for the pain and headache.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a severe reaction to the product which lasted daily for 5 weeks. The patient reported general body aches which lasted way too long. After speaking with his physician, he made the decision not to get the 2nd dose because of the side effect he experienced. He claimed that it was not worth it and his physician agreed. The patient refused to provide any details over the phone.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number M17095, expiry date 31st August 2019) for prophylaxis. On 27th August 2018, the patient received the 1st dose of MENVEO (intramuscular). On 27th August 2018, less than a day after receiving MENVEO, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to MENVEO. Additional details were reported as follows: The patient received SHINGRIX in right arm and experienced swelling in the same arm. The swelling started the evening of the injection and by the next day almost his entire arm was swollen. The physician stated that the swelling was 4 by 7 inches.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and joint pain. On an unknown date, the outcome of the fever and joint pain were unknown. It was unknown if the reporter considered the fever and joint pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. Caller heard from the physician that he had seen three patients who after receiving 1st dose of SHINGRIX, experienced low grade fever and joint aches. This case linked with cases US2018157973 and US2018157978, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, shivering and myalgia. On an unknown date, the outcome of the influenza-like symptoms, shivering and myalgia were unknown. It was unknown if the reporter considered the influenza-like symptoms, shivering and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, a few patients have experienced flu-like symptoms such as shivering, chills and myalgia following the vaccination with SHINGRIX. The healthcare professional asked a general question over chat and reported that, he heard things like this but did not recall any specific details on the patients affected or the number of patients affected. No patient details were provided. This case has been linked with case US2018GSK159917, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not provided, but was captured adult as per vaccine indication. The pharmacist said that they had been giving SHINGRIX vaccine and in general they had observed more soreness at the injection site than what they normally see with the flu shot (US2018GSK160732). No particular patient's information was associated with this report. This case has been linked with case US2018158125 and US2018GSK160732 reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site hives in a adult male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site hives and injection site erythema. The patient was treated with Steroids and BENADRYL. On an unknown date, the outcome of the injection site hives and injection site erythema were unknown. It was unknown if the reporter considered the injection site hives and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient was in his seventies when he received a dose of SHINGRIX. The physician gave injectable steroid and BENADRYL to the patient.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 21st August 2018 11:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and arm discomfort. In August 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the arm discomfort was unknown. It was unknown if the reporter considered the injection site pain and arm discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to any one. The patient received SHINGRIX in the left arm. The reporter had a consumer (patient) that reported experiencing soreness at the injection site after receiving the SHINGRIX vaccine that lasted for two days. Over the last two days by the time of reporting, the patient reported that his left arm felt different. The reporter was unable to provide any additional details.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, 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 SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The reporter experienced soreness for three days at the injection site after receiving the SHINGRIX vaccination. The reporter gave permission for his physician to be contacted. The reporter filed additional report for his wife (for tolerance see case US2018158150).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, 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 SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The reporter stated that the patient experienced soreness for three days at the injection site after receiving the SHINGRIX vaccination. The reporter (patient's husband) gave permission for physician to be contacted. The reporter filed additional report for himself (for tolerance see case US2018158148).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant (MA). The age at vaccination was not reported. The patient experienced redness and swelling at injection site for almost 1 month. The physician was unsure if this was an adverse reaction. The patient's initials and date of birth were unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in an unknown arm and developed localized pain in the arm where the vaccine was given. This case was linked with US2018155150, reported for same patient for 2nd dose of SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cramp in hand in a adult patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cramp in hand. On an unknown date, the outcome of the cramp in hand was unknown. It was unknown if the reporter considered the cramp in hand to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, a patient experienced cramping in one hand. The healthcare professional asked a general question over chat and reported that he heard things like this but did not recall any specific details on the patient affected. No patient details were provided. This case has been linked with case US2018158105, reported by same reporter.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Lip swelling, Swelling face, Urticaria
Clinical narrative: Swollen lips, difficulty breathing, swollen face, hives.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-AUG-2018 the patient was vaccinated with improperly stored dose of ROTATEQ lot # N010709 with expiration date: 05-DEC-2018 (strength, dosing details and route of administration were not reported) for prophylaxis (product storage error). No adverse effect was reported. The storage temperature was below 0 degrees centigrade (C) (-5.3 C) (1 cycle) and time frame was 40 hours. There was no previous temperature excursion. Digital data logger was involved.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Hypersensitivity, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 65-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included carcinoma brain (was diagnosed 12 years ago and he continues to suffer from it, completed 4 doses of chemotherapy). On 25th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hearing loss (serious criteria GSK medically significant), allergic reaction, shingles, fever and general body pain. SHINGRIX was discontinued. On an unknown date, the outcome of the hearing loss, allergic reaction, fever and general body pain were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the hearing loss, allergic reaction, shingles, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by wife of the patient. At 17:30 hours, the patient received SHINGRIX on right arm. The patient had an allergic reaction. Within a few days the patient experienced low grade fever and all over aches. The reporter stated that the patient experienced shingles and also experienced hearing loss. The patient was on medical leave for brain cancer that was diagnosed 12 years ago and he continued to suffer from it. The reporter disconnected from call when more specific questions about events was asked. The reporter was threatening law suit against GlaxoSmithKline. This case has been linked with US2018151991, reported by the same reporter.
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Asocial behaviour, Autism spectrum disorder, Hyperacusis, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autistic behavior in a male patient who received HAVRIX for prophylaxis. Previously administered products included Hepatitis A vaccine (received on 31st October 2012) and Hepatitis A vaccine (booster dose received on 24th July 2013). On 22nd August 2016, the patient received HAVRIX. On 22nd August 2016, less than a day after receiving HAVRIX, the patient experienced autistic behavior (serious criteria GSK medically significant), behavior abnormal, generalized rash and fever. On an unknown date, the patient experienced hyperacusis and asocial behavior. On an unknown date, the outcome of the autistic behavior, behavior abnormal, hyperacusis and asocial behavior were not recovered/not resolved and the outcome of the generalized rash and fever were recovered/resolved. It was unknown if the reporter considered the autistic behavior, behavior abnormal, hyperacusis, generalized rash, asocial behavior and fever to be related to HAVRIX. Additional details were provided as follows: The reporter (mother of the patient) was calling on behalf of her son (patient). The age at vaccination was not reported. The reporter stated that on the same day when the patient received the vaccine, the mother of the patient noticed some behavioral changes in the patient (stated that the patient would not look at her or her husband) and that same night he also had a high fever and a rash all over his body. The reporter stated that he was usually a very compassionate person but that he all of a sudden he was not (she observed on the same day). The reporter stated that they were so concerned that they took him back to the doctor the next day, and the doctor did not think his symptoms (behavioral) had anything to do with the vaccine. The reporter stated that at the time of reporting the patient was not better and that he basically exhibits autistic behaviors, as he continues to suffer socially. They were taking him to evaluate his behaviors. The reporter also stated that the patient did not like noise, at the time of reporting. The reporter mentioned that the patient received this vaccine after being informed by her doctor's office that he needed the vaccine but it was determined that he had already received another Hepatitis A vaccine (different manufacturer, she believed it was Merck) and the booster as well and wondered if this could be the reason why he was having problems. The mother of the patient was informed that GSK did not have any information on this inquiry and that also could not find any information in the PI (product information) that lists similar side effects. The reporter did not state if the patient received a booster dose of HAVRIX. Lab Comments: On an unknown date, the patient was took to evaluate his behavior.
Sex: M
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autistic behavior in a male patient who received HAVRIX for prophylaxis. Previously administered products included Hepatitis A vaccine (received on 31st October 2012) and Hepatitis A vaccine (booster dose received on 24th July 2013). On 22nd August 2016, the patient received HAVRIX. On 22nd August 2016, less than a day after receiving HAVRIX, the patient experienced autistic behavior (serious criteria GSK medically significant), behavior abnormal, generalized rash and fever. On an unknown date, the patient experienced hyperacusis and asocial behavior. On an unknown date, the outcome of the autistic behavior, behavior abnormal, hyperacusis and asocial behavior were not recovered/not resolved and the outcome of the generalized rash and fever were recovered/resolved. It was unknown if the reporter considered the autistic behavior, behavior abnormal, hyperacusis, generalized rash, asocial behavior and fever to be related to HAVRIX. Additional details were provided as follows: The reporter (mother of the patient) was calling on behalf of her son (patient). The age at vaccination was not reported. The reporter stated that on the same day when the patient received the vaccine, the mother of the patient noticed some behavioral changes in the patient (stated that the patient would not look at her or her husband) and that same night he also had a high fever and a rash all over his body. The reporter stated that he was usually a very compassionate person but that he all of a sudden he was not (she observed on the same day). The reporter stated that they were so concerned that they took him back to the doctor the next day, and the doctor did not think his symptoms (behavioral) had anything to do with the vaccine. The reporter stated that at the time of reporting the patient was not better and that he basically exhibits autistic behaviors, as he continues to suffer socially. They were taking him to evaluate his behaviors. The reporter also stated that the patient did not like noise, at the time of reporting. The reporter mentioned that the patient received this vaccine after being informed by her doctor's office that he needed the vaccine but it was determined that he had already received another Hepatitis A vaccine (different manufacturer, she believed it was Merck) and the booster as well and wondered if this could be the reason why he was having problems. The mother of the patient was informed that GSK did not have any information on this inquiry and that also could not find any information in the PI (product information) that lists similar side effects. The reporter did not state if the patient received a booster dose of HAVRIX. Lab Comments: On an unknown date, the patient was took to evaluate his behavior.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in an unknown arm. The healthcare professional (HCP) reported that the patient received the a dose of SHINGRIX 2 months before the time of reporting and stated that he was unable to lift his arm since getting the vaccine. The HCP was unable to provide any further specifics of the event.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional (HCP) did not provide lot number, expiration date, or any other information. The shivering was lasted for 6 hours. The healthcare professional called to find out if patient should still receive the 2nd dose.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 97-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced red rash 2 inches below the injection site. The rash was slowly lessening. On 25th August 2018, the patient came back with rash, it was not sure when exactly the rash started. This case has been linked with case US2018155212 reported by the same reporter.
Sex: M
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a 11-year-old male patient who received MENVEO for prophylaxis. In August 2018, the patient received MENVEO. In August 2018, less than a week after receiving MENVEO, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO about one week ago and experienced headache for about 4 to 5 days.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 47-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for himself. The patient received 1st dose of SHINGRIX on right deltoid. The patient described experiencing a lot of pain during administration of the first dose of SHINGRIX. He said that it "felt like a stabbing with a knife". After the injection he experienced severe pain in his arm that lasted for two days. For the tolerability of 2nd dose of SHINGRIX, refer linked case US2018GSK160777 reported by the same reporter for himself. The patient had denied permission to contact their physician.