chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, swelling arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a quick question about how the SHINGRIX vaccine was given. The patient received her 1st dose of SHINGRIX as a subcutaneous, which led to wrong route of vaccination. The patient even asked to be sure if it was to be given this way. Turned out, it was supposed to be given intramuscularly. The patient had a rather bad reaction to the SHINGRIX vaccine, her arm was red and swollen and very sore for 1 week. The patient's actual question was how would this affect the vaccine's effectiveness. The patient got the 2nd dose of SHINGRIX intramuscularly on the date of reporting. The patient wanted to know whether she need another 3rd dose or should she be okay.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient had been healthy prior to getting the vaccination. A day after vaccination, the patient got sick. The reporter wondered if it helped or caused illness.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of discomfort in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (vaccine for the shingles virus a few years ago). On 29th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received 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 discomfort and product supply issue. On an unknown date, the outcome of the discomfort was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was counseled that it was a two part process that required a follow up vaccine within a certain time window within six months from part 1 to ensure effectiveness. After 1st dose the patient caused, local discomfort for several days and have stayed in touch with Pharmacy ever since only to be told literally each month to check back because no additional supplies have been available. It was six months later and the patient was annoyed. The patient asked, what's the matter and when would be able to secure a follow up shot? Would have to start over if this didn't happen soon.
Sex: M
Vaccine: DTAP
Symptoms: Intensive care, Pertussis, Pyrexia, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 4-month-old male patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and fever (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, whooping cough and fever were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough and fever to be related to DTPa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was 28 years of age at the time of reporting. At 4 months, the patient ended up in neonatal intensive care unit (NICU) with a 106 degree F temperature after receiving DPT vaccine. Thereafter, his vaccines were given to him one at a time with 3 week intervals. He had the same reaction after the pertussis vaccine. It leads to another trip to emergency room with very high fever. The patient's immunologist said no more vaccinations would be given until the age of 5 years. The reporter was pro vaccination, but after the patient's kindergarten vaccinations, he had no negative reactions but got a horrible case of whooping cough a year later. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for pertussis, time to onset for event and laboratory confirmation for pertussis were not provided. Lab Comments: On an unknown date, lab test was performed.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that this case confirmed with cellulitis, but the events were resolved spontaneously. The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. This is one of the 13 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that this case confirmed with cellulitis, but the events were resolved spontaneously.The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. This is one of the 13 cases reported by same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Rash, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 58-year-old female patient who received SHINGRIX (batch number K2ZY4, expiry date 3rd April 2021) for prophylaxis. On 11th December 2018, the patient received SHINGRIX. In December 2018, 2 days after receiving SHINGRIX, the patient experienced rash, pain localized and skin warm. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the pain localized and skin warm were unknown. It was unknown if the reporter considered the rash, pain localized and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash 2 inches below the injection site. The rash was 1.5 inches in diameter, slightly painful, and slightly warm to the touch. The pharmacist consented to follow-up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster oticus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster oticus in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced herpes zoster oticus (serious criteria GSK medically significant). On an unknown date, the outcome of the herpes zoster oticus was recovered/resolved. It was unknown if the reporter considered the herpes zoster oticus to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient developed shingles in his ear approximately 2 months after receiving the 1st dose of SHINGRIX that lasted approximately 3 months. The pharmacist was unable to provide the lot number and expiration date of the SHINGRIX. The reported timing was as per the patient and was approximate. No further details were provided. The pharmacist consented to be followed up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th August 2018, 1 days after receiving SHINGRIX, the patient experienced itchy rash. The patient was treated with non-drug therapy (Cold Compresses) and diphenhydramine hydrochloride (Benadryl). On an unknown date, the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she started having the symptoms the day after the SHINGRIX vaccine. She had an itchy rash that covered her all upper arm on the same arm where she had the SHINGRIX vaccine. The patient had to use cold compresses and take Benadryl to treat it. The rash was 4 by 4 inches, just to the right of her injection site and it lasted about 5 days. The patient provided contact details of her physician and consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: 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 an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The pharmacist reported that patients just usually report that their arm hurts after receiving SHINGRIX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th December 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and general body pain. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and general body pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient experienced mild body aches which went away. The patient also experienced injection site soreness and redness which was still persisted 10 days later. The reporter consented to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 21st November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced itchy rash and pruritus. On an unknown date, the outcome of the itchy rash and pruritus were recovered/resolved. It was unknown if the reporter considered the itchy rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient developed a slightly itchy purpuric rash a few days after receiving SHINGRIX. The patient was seen in the office 8 days after vaccination for another reason and informed the physician about the rash on the vaccinated arm. Nothing was prescribed. This dose of SHINGRIX was not administered at the reporter's office and further details were not available. The reporter gave consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, 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 63-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and bone pain. On an unknown date, the outcome of the pain in arm and bone pain were recovered/resolved. It was unknown if the reporter considered the pain in arm and bone pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was a pharmacist and she was also the patient. She received the 1st dose of SHINGRIX in the beginning of August 2018 in the left arm. She had intense pain in her left arm that last for a few weeks. The patient stated that her entire left forearm was in pain and it almost felt like the pain was in the bone as well. The reporter did not gave consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Paraesthesia, Skin tightness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a 69-year-old male patient who received SHINGRIX (batch number E927Z, expiry date 27th February 2021) for prophylaxis. On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, tiredness, pins and needles and skin tightness. On an unknown date, the outcome of the general body pain, tiredness, pins and needles and skin tightness were not recovered/not resolved. It was unknown if the reporter considered the general body pain, tiredness, pins and needles and skin tightness to be related to SHINGRIX. Additional details were reported as follows: One day after vaccination, the patient developed diffuse body pain, feeling tired, feeling of pins and needles, and skin feels tight and stretched. The patient stated the symptoms were worse in the afternoon and were ongoing since 12th September 2018. The healthcare professional not convinced this was at all related to SHINGRIX, but patient requested the call. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's wife. The reporter stated that in the past the patient had received the flu vaccine from unknown manufacturer and then gotten the flu after receiving the vaccine. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure cases as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's wife. The reporter stated that in the past the patient had received the flu vaccine from unknown manufacturer and then gotten the flu after receiving the vaccine. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure cases as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 19-year-old female patient who received MENVEO (batch number AMVA036A, expiry date 1st October 2019) for prophylaxis. On 11th December 2018, the patient received the 1st dose of MENVEO (intramuscular). In December 2018, less than a week after receiving MENVEO, the patient experienced injection site cellulitis. The patient was treated with doxycycline. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to MENVEO. Additional details were reported as follows: This case was reported by the risk Manager of University. The patient received MENVEO on the left deltoid. On 17th December 2018, the patient was seen by a physician due to cellulitis in the deltoid. The physician had prescribed doxycycline 100mg twice daily for 10 days. On Thursday, the patient was called back with an update. The patient required an emergency room visit. The contact details of the physician was provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malignant melanoma
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX  for prophylaxis. Concurrent medical conditions included lymphoma. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced melanoma (serious criteria GSK medically significant and clinically significant/intervention required). On 26th September 2018, the patient experienced shingles (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the melanoma was unknown. It was unknown if the reporter considered the shingles and melanoma to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Fifteen days after vaccination, the patient experienced shingles. The patient was diagnosed with melanoma around that same time. The reporter consented to follow up.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial unsolicited valid non-serious report received from a Pharmacist on 02-Oct-2018. This case involves a 15-years-old (unknown gender) patient who was vaccinated with a dose of FLUBLOK QIV (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (15 year old patient received the FLUBLOK QUADRIVALENT vaccine). It was unknown whether patient experienced any adverse event following vaccination. 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 2001/83/EC 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. Follow up report received on 18-Dec-2018 from a Pharmacist. No new information received. List of documents held by sender: none.
Sex: U
Vaccine: FLU3, TD, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 67 years old patient who experienced two vaccines were administered at the same time, while he/she received vaccines ADACEL and TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE HIGH DOSE for Immunisation. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6128AA via intramuscular route in the arm nos. On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6014AB via intramuscular route in the arm nos. It was a case of actual medication error due to extra dose administered. The patient outcome is reported as Not Applicable for two vaccines were administered at the same time. 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 2001/83/EC 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.
Sex: F
Vaccine: DTAP, HIBV, MNQ, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who experienced expired DAPTACEL was administered to a patient, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Immunisation; ACTHIB for Immunisation; and MENACTRA for Immunisation. On 03-Dec-2018, the patient received a first dose 0.5 ml dose of suspect DAPTACEL lot C5101AA, expiry date- 26-Nov-2018 via unknown route. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for expired DAPTACEL was administered to a patient. 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 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.
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves female patient who was exposed to vaccine FLUBLOK QIV in context of administered the FLUBLOK to a pregnant patient. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. 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 INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route while she was pregnant. The patient outcome is reported as Not Applicable for administered the FLUBLOK to a pregnant patient. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 18 months old male patient who was vaccinated with 0.5 ml one time dose of ADACEL (Batch number U5702AA, expiry date 20 June 2019, dose in series, route and site of administration were not reported) on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. 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 2001/83/EC 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. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Pruritus, Urticaria
Clinical narrative: Patient described full body hives which were very itchy and painful. I asked further questions about size and shape to try and determine if they were more blister-like and electrical-pain or circular and itchy pain (to determine shingles outbreak vs hives). I referred the patient to speak with her general practitioner or an urgent care personnel ASAP. She called her PCP and spoke with a triage nurse and a PA, who determined that she was likely experiencing an allergic reaction to the SHINGRIX vaccine. They told her at that time to start taking Benadryl around the clock. She was vaccinated on Monday, started noticing hives Tuesday/Wednesday, called and spoke with me Thursday, and spoke with her office Thursday. I called her again on Saturday the 22nd to follow up with her.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Product supply issue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old 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 influenza-like symptoms, chills, fever and product supply issue. On an unknown date, the outcome of the influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the influenza-like symptoms, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 61 or 62 years. After receiving 1st dose of SHINGRIX, the patient experienced flu-like symptoms, chills and fever which lasted for 2 to 3 days. The patient was concerned about not being able to find a second dose of SHINGRIX as he had called numerous pharmacies in his area but SHINGRIX was not available (product supply issue). This was all the information provided as patient wanted to discuss SHINGRIX availability. The patient asked the call center representative if he could help to locate someone with SHINGRIX vaccine available. The call center representative replied that since SHINGRIX has been approved, there has been an extraordinary amount of demand from patients and healthcare professionals. Due to the remarkably high demand, you may find that your healthcare provider or local pharmacy was temporarily out of stock. To address the current high demand, GlaxoSmithKline had significantly increased deliveries and accelerated shipments of doses of vaccine for this year, and SHINGRIX was expected to be available throughout 2018 and shipped on a regular basis. As you may know the FDA approved dosing schedule for SHINGRIX was the first dose at month 0, followed by a second dose 2 to 6 month after the first dose. The centers for disease control and prevention (CDC) has provided guidance that if it's been more than 6 months since you got the first dose, you should get the second dose a soon as possible and you do not need to restart the vaccine series. The patient was advised to talk with his doctor or pharmacist about this guidance and individual situation. We did not have the information as to what pharmacies or locations would be receiving the vaccine.
Age: 1.0
Sex: U
Vaccine: MENB
Symptoms: Exposure via skin contact, Injection site erythema, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 1-year-old patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, injection site erythema, inadvertent exposure to vaccine, exposure via skin contact and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever, injection site erythema, inadvertent exposure to vaccine, exposure via skin contact and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. One year patient received a dose of BEXSERO, which led to inappropriate age at vaccination. During the first injection some of the vaccine liquid got out on the child's forearm and was wiped off by the nurse (not much though, a few drops), which led to inadvertent exposure to vaccine and exposure via skin contact. The nurse and the doctor reassured me that the vaccine would be effective and nothing to worry about. The patient had a mild fever for about 24 hours following the job and the injection area was red. The reporter was asking that the immunization was effective or should repeat the vaccine (if so, how much time should pass), or was there any treshhold for antibodies detectable in blood that could tell whether it was effective or not.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were reported as follows: The age at vaccination was not reported. The received flu when the flu shots first came out. The patient never want flu shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation for flu was not provided at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, 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. Previously administered products included ZOSTAVAX (received on an unknown date). On 13th December 2018, the patient received the 1st dose of SHINGRIX. On 13th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, upset stomach and tiredness. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the upset stomach and tiredness were unknown. It was unknown if the reporter considered the injection site pain, upset stomach and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. The age of patient was reported as 70 plus. A day before reporting, the patient received SHINGRIX on an unknown arm and experienced sore arm at injection site, some stomach upset and general tiredness which does not required medical attention. This case has been linked with case US2018GSK227321 (patient's husband).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the vaccine did not stop the shingles and made it much worse and more frequent. It was reported that, it was a disaster. The reporter disconnected the call while on hold and about to transferred the call to Regulatory Authority. The reporter provided the external phone number to the inquired for future reference. This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset were unknown. This case has been linked with case US2018GSK227345, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the vaccine did not stop the shingles and made it much worse and more frequent. The reporter disconnected the call while on hold and about to transferred the call to Regulatory Authority. The reporter provided the external phone number to the inquired for future reference. This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset were unknown. This case has been linked with case US2018GSK227344, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on a unknown date, had no appreciable reactions to the first shot). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. About a day after vaccination the patient developed a severe rash in my groin, down the insides of his thighs and all over his hands. The reporter reported is this typical and wanted to know can you have a first shot with no reaction and a second shot causing a severe reaction. The reporter wanted to know was the first shot not administered correctly or does this occasionally happen.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling, injection site pain and rash were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and rash to be related to SHINGRIX. Additional details were reported as follows: The lot number and expiration date and administration site unknown. The reporter spoke to HCP this morning and the physician later in the day. The reporter learned the patient was a female but no other patient information provided. The adverse event reported was minor injection site swelling and pain. Following administration the patient had a rash on the upper torso which appeared 2 days following administration. According to the physician, patient was not concerned about the swelling or pain, these resolved without additional treatment.  For the rash, the patient took Benadryl that evening and the rash resolved. The patient called the physician on the following day. The physician wanted to make sure the patient was ok to receive the second vaccine. The physician stated it was office policy not to share patient information with reporter to complete this adverse event report. The physician had a copy of a VAERS report that she would complete herself. Health care professional declined further follow up on this incident.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, 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 BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician mentioned generally that, the only adverse event she had really observed with BEXSERO was injection site pain.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Pyrexia, Rash generalised
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 10 years ago). 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, malaise and generalized rash. On an unknown date, the outcome of the fever, malaise and generalized rash were unknown. It was unknown if the reporter considered the fever, malaise and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient refused to receive the 2nd dose of SHINGRIX. Then she received her 1st dose of SHINGRIX six months ago. She developed fever, malaise and generalized rash that has persisted since that time.
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Blood pressure increased, Impaired work ability, Loss of consciousness, Meningitis, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of meningitis in a female patient who received SHINGRIX (batch number ZG47A, expiry date unknown) for prophylaxis. Co-suspect products included TETANUS TOXOID (TETANUS VACCINE) for prophylaxis. Concurrent medical conditions included tooth infection (treating with antibiotics). On 19th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient received TETANUS VACCINE at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced meningitis (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), rash, increased blood pressure and inability to work. On an unknown date, the outcome of the meningitis, passed out, rash, increased blood pressure and inability to work were unknown. It was unknown if the reporter considered the meningitis, passed out, rash, increased blood pressure and inability to work to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. Allegedly the patient was reach by the staff pharmacist for her 2nd dose for the Shingles vaccination. She informed the staff pharmacist that she had a reaction to the injection. After receiving SHINGRIX, in 2018, the patient experienced elevated blood pressure and a rash and she passed out at work. She had to have medical treatment due to her side effects from the vaccination. She missed 6 weeks off work and she was diagnosed with meningitis, she also confirmed that she had a Tetanus shot. It was unknown if the reporter considered the meningitis, passed out, rash, increased blood pressure and inability to work to be related to Tetanus shot.
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer and described the occurrence of meningitis in a female patient who received SHINGRIX (batch number ZG47A, expiry date unknown) for prophylaxis. Co-suspect products included TETANUS TOXOID (TETANUS VACCINE) for prophylaxis. Concurrent medical conditions included tooth infection (treating with antibiotics). On 19th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient received TETANUS VACCINE at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced meningitis (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), rash, increased blood pressure and inability to work. On an unknown date, the outcome of the meningitis, passed out, rash, increased blood pressure and inability to work were unknown. It was unknown if the reporter considered the meningitis, passed out, rash, increased blood pressure and inability to work to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. Allegedly the patient was reach by the staff pharmacist for her 2nd dose for the Shingles vaccination. She informed the staff pharmacist that she had a reaction to the injection. After receiving SHINGRIX, in 2018, the patient experienced elevated blood pressure and a rash and she passed out at work. She had to have medical treatment due to her side effects from the vaccination. She missed 6 weeks off work and she was diagnosed with meningitis, she also confirmed that she had a Tetanus shot. It was unknown if the reporter considered the meningitis, passed out, rash, increased blood pressure and inability to work to be related to Tetanus shot.