chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: swelling with red area extending to elbow; pain; redness; myalgia; fatigue; headache; shivering; fever; gastrointestinal upset; vomiting; bruising at injection site; This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 22nd April 2019, the patient received Shingrix (intramuscular) .5 ml. On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising were recovering/resolving.   The reporter considered the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The nurse used 25gauge needle. Within 12 hours of vaccine administration, the patient had pain, redness and swelling with red area extending to elbow, myalgia, fatigue, headache, shivering, fever of 103 degree F, Gastrointestinal upset with vomiting and bruising at injection site. The patient was still experiencing less severe symptoms at this time of reporting. The patient was recovering after missing day of work. The reporter thought that the event was related to the product and incident was directly related to vaccine. The reporter did not agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: swelling with red area extending to elbow; pain; redness; myalgia; fatigue; headache; shivering; fever; gastrointestinal upset; vomiting; bruising at injection site; This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 22nd April 2019, the patient received Shingrix (intramuscular) .5 ml. On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising were recovering/resolving.   The reporter considered the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, myalgia, fatigue, headache, shivering, fever, gastrointestinal upset, vomiting and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The nurse used 25gauge needle. Within 12 hours of vaccine administration, the patient had pain, redness and swelling with red area extending to elbow, myalgia, fatigue, headache, shivering, fever of 103 degree F, Gastrointestinal upset with vomiting and bruising at injection site. The patient was still experiencing less severe symptoms at this time of reporting. The patient was recovering after missing day of work. The reporter thought that the event was related to the product and incident was directly related to vaccine. The reporter did not agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection site pain; swelling at injection site; injection site redness; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   The reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The age at vaccination was not applicable for this report. The nurse ordered to administer a dose of Bexsero among other vaccines. She mentioned that she has had multiple adverse events regarding Bexsero with the classification of pain, redness and swelling to the injection site for about a week. The reporter mentioned that this reaction was more severe than other vaccines she administers. When asked about reporting, she stated that she has reported some cases and not reported some and did not have the paperwork anyway. The nurse had been made aware that the safety team would put this as a general adverse event in with her team and if needed they would reach out to her. The nurse had been informed to shake the syringe while use and referred the prescribing information regarding to the pain, redness, and swelling. The nurse agreed to be followed up.
Sex: U
Vaccine: HPVX, MEN, MENB
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt faint; This case was reported by a physician via sales rep and described the occurrence of faint in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis and MENINGOCOCCAL VACCINES (NOS) (MCV VACCINE) for prophylaxis.   On an unknown date, the patient received Bexsero, HPV vaccine and MCV VACCINE. On an unknown date, less than a day after receiving Bexsero and HPV vaccine, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Bexsero and HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter shared that, when she administered Bexsero at separate injection site on the same day as MCV and HPV, the patient felt faint. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue
Clinical narrative: fatigue; uncomfortable; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in an unspecified number of adult patient who received Herpes zoster (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 fatigue and discomfort. On an unknown date, the outcome of the fatigue and discomfort were unknown.   It was unknown if the reporter considered the fatigue and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's age was not reported but age group was captured as adult as per vaccine indication. The patients experienced crummy fatigue and felt uncomfortable.  The reporter was unable to quantify or provide details regarding these patients. The reporter consented to follow up.  This case has been linked to US2019104149, reported by the same reporter. No other details were obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: feeling tired; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2018, the patient received the 1st dose of Shingrix. On 3rd August 2018, 1 days after receiving Shingrix, the patient experienced tiredness and influenza-like symptoms. On an unknown date, the outcome of the tiredness and influenza-like symptoms were resolved with sequelae.   It was unknown if the reporter considered the tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced tiredness and influenza-like symptoms for just one day after receiving vaccine. This case has been linked with case US2019GSK109703, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue
Clinical narrative: fatigue; uncomfortable; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and discomfort. On an unknown date, the outcome of the fatigue and discomfort were unknown.   It was unknown if the reporter considered the fatigue and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced crummy fatigue and felt uncomfortable.  The reporter also stated, other patients have experienced this as well and was unable to quantify or provide details regarding other patients, refer case US2019GSK109123. The reporter consented to follow up and was ok to recontact.  No other details were obtained.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: joint aches; muscle aches; aches primarily in areas below the waist, in the hips, knees and lower legs.; This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th May 2019, 2 days after receiving Shingrix, the patient experienced joint pain, muscle pain and leg pain. On an unknown date, the outcome of the joint pain, muscle pain and leg pain were recovering/resolving.   It was unknown if the reporter considered the joint pain, muscle pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient experienced pain in areas below the waist, in the hips, knees and lower legs. The patient contineusly experienced the issues and for that seeing the nurse practitioner. Emergecy room visit was required.
Age: 37.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Sleep apnoea syndrome, Syncope, Vertigo
Clinical narrative: fainted; sleep apnea; vertigo; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 37-year-old female patient who received HAB (Twinrix) for prophylaxis.   On 16th May 2019, the patient received Twinrix 1 ml. In May 2019, less than a day after receiving Twinrix, the patient experienced fainting (serious criteria GSK medically significant), dizziness, sleep apnea and vertigo. On an unknown date, the outcome of the fainting, dizziness, sleep apnea and vertigo were recovered/resolved.   It was unknown if the reporter considered the fainting, dizziness, sleep apnea and vertigo to be related to Twinrix.  Additional details were provided as follows: Within 24 hours after vaccination the patient fainted and then experienced dizziness, sleep apnea and vertigo.  The dizzines and vertigo went away after 2 weeks. The sleep apnea went away after a couple of days. The reporter gave consented to follow up.
Age: 37.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Paraesthesia, Sleep apnoea syndrome, Vertigo
Clinical narrative: fainted; sleep apnea; vertigo; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 37-year-old female patient who received HAB (Twinrix) for prophylaxis.   On 16th May 2019, the patient received Twinrix 1 ml. In May 2019, less than a day after receiving Twinrix, the patient experienced fainting (serious criteria GSK medically significant), dizziness, sleep apnea and vertigo. On an unknown date, the outcome of the fainting, dizziness, sleep apnea and vertigo were recovered/resolved.   It was unknown if the reporter considered the fainting, dizziness, sleep apnea and vertigo to be related to Twinrix.  Additional details were provided as follows: Within 24 hours after vaccination the patient fainted and then experienced dizziness, sleep apnea and vertigo.  The dizzines and vertigo went away after 2 weeks. The sleep apnea went away after a couple of days. The reporter gave consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: Bleeding at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number GE9S7, expiry date 21st September 2021) for prophylaxis.   The patient's past medical history included injection site hemorrhage (due to some other injections).   On 12th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 12th June 2019, immediately after receiving Shingrix, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: Reported batch number GE9S7 pertains to Shingrix adjuvant. On the day of reporting, the patient experienced some bleeding after receiving 2nd dose and bandage was applied on it. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Diffuse joint aching, lasting 2 months
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Headache, Insomnia
Clinical narrative: Lt arm very sore two hours after the injection- then at 4 hours after started not feeling well achy and headache.  Went to bed woke up with sever pain in all joints. Tylenol taken when went to bed at 6 hours after injection.  Woke up after three hours of sleep with the severe pain in all the joints and sever headache.  Took another Tylenol. Up most of the night with severe headache, nausea, chills, severe pain in bones and joints. Took Tylenol and then waited three hours and took Ibuprofen.  Took both medications at three hour intervals through out the early morning and up until 28 hours after the injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: Lt arm very sore two hours after the injection- then at 4 hours after started not feeling well achy and headache.  Went to bed woke up with sever pain in all joints. Tylenol taken when went to bed at 6 hours after injection.  Woke up after three hours of sleep with the severe pain in all the joints and sever headache.  Took another Tylenol. Up most of the night with severe headache, nausea, chills, severe pain in bones and joints. Took Tylenol and then waited three hours and took Ibuprofen.  Took both medications at three hour intervals through out the early morning and up until 28 hours after the injection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Pain
Clinical narrative: Fever, diarrhea, body aches, fatigue,  stomach cramps, vomiting, loss of appetite
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, diarrhea, body aches, fatigue,  stomach cramps, vomiting, loss of appetite
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Flatulence, Injection site pain, Nausea
Clinical narrative: Fatigue, fever, nausea, dizziness, flatulence, pain at site of injection
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue, fever, nausea, dizziness, flatulence, pain at site of injection
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient  had outbreak of shingles in her right ear and right side of face.  Shingles started started on 6/15/19 after vaccination on 6/12/19.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient came in for R arm being completely swollen and warm to the touch.  Patient stated the swelling began the night of the administration and continued to swell. Patient was not complaining of any pain or loss of movement. No fever. He is otherwise well.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Facial paralysis
Clinical narrative: Bells palsy-Started with L sided facial weakness on 6/14.   Parents didn't notice anything until yesterday.   When she smiles she only feels the R side moving. No pain.   Can close eyes ok but smile and raising eyebrows is off.   breathing is fine.  walking is fine.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient received M-M-R II Intramuscularly instead of subcutaneosly; No adverse symptoms reported; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly instead of subcutaneously for prophylaxis (strength, dose number, anatomical location, lot number and expiration date were not reported).   There were no adverse symptoms reported.
Sex: F
Vaccine: HPV9
Symptoms: Aphasia, Neurological symptom
Clinical narrative: the patient developed a "neurological symptom", described as the patient "not being able to get her words out correctly"; This spontaneous report was received from a consumer via company representative, referring to her daughter, a 15-year-old female patient.  The patient's concurrent conditions included Attention deficit/hyperactivity disorder (ADHD). The patient medical history was not reported. Concomitant medications included lisdexamfetamine dimesylate (VYVANSE).  On an unspecified day in November 2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot# and expiration date not reported) for the prevention of HPV.  On an unknown date, the patient experienced a neurological symptom, described as the patient "not being able to get her words out correctly" (non-fluent aphasia). The patient's mother had not contacted a physician, the patient was not hospitalized, and the patient's mother said that the patient would not receive her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) due to the event. At the time of the report, the outcome of non-fluent aphasia was unknown.  The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and non-fluent aphasia was not reported.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Influenza like illness, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Product supply issue; Flu like symptoms; Body achiness/sore body; Low fever; Sore arm; Upset stomach; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 40 years ago).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. In April 2018, 4 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, fever, pain in arm and upset stomach. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, pain in arm and upset stomach were recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, pain in arm and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a history of shingles about 40 years ago. The patient reported that, in April 2018 or May 2018, received 1st dose of Shingrix in the right arm. Four hours after receiving the vaccination, the patient started to experience side effects including a bad case of flu symptoms, body achiness, low fever, sore body which included sore arm and an upset stomach.  All of his symptoms resolved after 3 days. The patient claimed that the vaccine was the worst compared to his other vaccines he had received in the past.  The serum was not available six months later for 2nd shot. The pharmacy said they had the serum. The patient asked what was their best course of action. From the reporter standpoint, not having another shot was a good choice since he had three uncomfortable days after the first one.  On the other hand, the patient had shingles and did not want to repeat that experience. However till the time of reporting, the patient did not receive the 2nd dose of Shingrix.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product supply issue, Pyrexia
Clinical narrative: Product supply issue; Flu like symptoms; Body achiness/sore body; Low fever; Sore arm; Upset stomach; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 40 years ago).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. In April 2018, 4 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, fever, pain in arm and upset stomach. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, pain in arm and upset stomach were recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, pain in arm and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a history of shingles about 40 years ago. The patient reported that, in April 2018 or May 2018, received 1st dose of Shingrix in the right arm. Four hours after receiving the vaccination, the patient started to experience side effects including a bad case of flu symptoms, body achiness, low fever, sore body which included sore arm and an upset stomach.  All of his symptoms resolved after 3 days. The patient claimed that the vaccine was the worst compared to his other vaccines he had received in the past.  The serum was not available six months later for 2nd shot. The pharmacy said they had the serum. The patient asked what was their best course of action. From the reporter standpoint, not having another shot was a good choice since he had three uncomfortable days after the first one.  On the other hand, the patient had shingles and did not want to repeat that experience. However till the time of reporting, the patient did not receive the 2nd dose of Shingrix.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Rash macular
Clinical narrative: big red warm spot/ red patch; redness at injection site; injection site warmth; This case was reported by a consumer via call center representative and described the occurrence of spot-like rash in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th May 2019, the patient received Shingrix. On 13th May 2019, 5 days after receiving Shingrix, the patient experienced spot-like rash, injection site erythema and injection site warmth. On an unknown date, the outcome of the spot-like rash, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the spot-like rash, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were reported as follows: At the time of this report, the patient was having a big red warm spot on her arm. The patient experienced red patch that was warm to the touch. The patient wanted to know how long it would last. The pharmacist reported that Individual responses could vary, but the majority of general adverse events seen with Shingrix had a median duration of 2 to 3 days. Solicited adverse reactions were collected for 7 days after each dose. Some patients may continue to experience reactions beyond 3 days. Unsolicited adverse events were collected for 30 days after each dose.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional information was provided as follows: This case was reported by the consumer for his/her father. Age at the time of vaccination was not reported. The patient received Shingrix dose 4 weeks ago from date of reporting and few days later he broke out in hives all over his arms and face. The reporter mentioned that they know that hives is a rare side effects but few weeks seems extreme. The reporter inquired, whether it was normal or not.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Injection site pain, Nausea, Pain
Clinical narrative: pain at injection site/tenderness at injection site; nausea; feeling cold; aches and pains/pain; feeling feverish; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th June 2019, immediately after receiving Shingrix, the patient experienced injection site pain, nausea, feeling cold, pain and feeling hot. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the nausea, feeling cold, pain and feeling hot were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nausea, feeling cold, pain and feeling hot to be related to Shingrix.  Additional details were provided as follows: The caller was a patient.  The patient received Shingrix and experienced pain during the injection and tenderness at the injection site following the injection.  The patient reported that she was feeling nauseous, cold and feeling like she had a fever.  The patient also reports that she developed aches and pains following the vaccine. Symptoms started the same day that she received the vaccine.  The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: red raised rash around the site; red raised rash around the site; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received Shingrix. In June 2019, several days after receiving Shingrix, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were unknown.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. The physician reported that had a patient who received  the vaccine and developed red raised rash around the site. The reporter did not consent to follow up. The reporter did not have additional information.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: soreness arm; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   On 3rd June 2019, the patient received Bexsero. In June 2019, less than a month after receiving Bexsero, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Bexsero 1 week ago and experiencing a sore arm. The soreness had not resolved. The reporter did not had any additional details.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Vaccination failure
Clinical narrative: vaccination failure; shingles; Injection site pain; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (over 20 year before). Previously administered products included Zostavax (received on an unknwon date).   On 1st December 2018, the patient received the 1st dose of Shingrix. On 4th February 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 122 days after receiving Shingrix and 60 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and injection site pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix and Shingrix.   Additional details were provided as follows: The patient received 1st dose on right deltoid and 2nd dose on right deltoid. The reporter stated that even after receiving two doses of Shingrix, the patient experienced shingles. The reporter stated that 2 to 3 months after receiving dose two, the patient broke out again, although he does note the area of flaring was much smaller and less painful than previous flares. The patient had injection site pain that felt like he had been hit with a baseball bat. The pain at the site lasted for about 7 days after both doses and resolved with over the counter pain medication (not otherwise specified). The batch number was not available at the time of reporting.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Malaise, Myalgia, Pyrexia
Clinical narrative: Headache, fever 100 F, sweating, muscle aches,  malaise ,
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: 3 cm by 4 cm hard area on left upper arm. Hot to touch, pain scale from 1-10 is a 7, no discharge, no open skin. MOD difficulty moving left arm sue to pain. Motrin, hydroxyzine and motrin given to patient for pain and itchiness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Flu like symptoms of chilling/sweating/muscle aches/headache/nausea/dry heaves. In bed for 24 hours. Today (6/19/2019) out of bed but eating toast and water. Weak and entire body sore
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Retching
Clinical narrative: Flu like symptoms of chilling/sweating/muscle aches/headache/nausea/dry heaves. In bed for 24 hours. Today (6/19/2019) out of bed but eating toast and water. Weak and entire body sore
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: Pt received the vaccine on May 9th 2019.  on May 13th pt presented to the facility complaining of back pain. Per note she developed right sided back pain on May 10th approximately on dermatome T9-T10. Pt rated it a 3/10 pain that is burning and aching. A rash started to develop on May 12th and spread overnight. She complained of itching and burning. There was one vesicle noted at her visit among the red rash.  Pt has never had shingles before. An order for Valacyclovir HCL 1g take one tablet 3 times  daily  for 7 days.  Pt has completed  the course of medication.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt received the vaccine on May 9th 2019.  on May 13th pt presented to the facility complaining of back pain. Per note she developed right sided back pain on May 10th approximately on dermatome T9-T10. Pt rated it a 3/10 pain that is burning and aching. A rash started to develop on May 12th and spread overnight. She complained of itching and burning. There was one vesicle noted at her visit among the red rash.  Pt has never had shingles before. An order for Valacyclovir HCL 1g take one tablet 3 times  daily  for 7 days.  Pt has completed  the course of medication.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction, Pain
Clinical narrative: LOCAL INJECTION SITE REDNESS AND BODY ACHES
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Musculoskeletal pain, Pain
Clinical narrative: Began to experience profound fatigue and severe musculoskeletal pain in the evening of the day I received the vaccine. This pain became generalized, and lasted for 5 days, with gradual improvement as time went on.  Two weeks after receiving the second dose of Shingrex vaccine, on May 31, I developed severe pain in my left upper back below the scapula.  This pain was the same severe pain that I've experienced in previous episodes of zoster sine herpete. I was seen by Dr.'s PA, and started on Famcyclovir 500 mg three times a day and Hydrocodone 5-325 prn.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site discomfort, Injection site pain, Nausea
Clinical narrative: Patient states she woke up feeling very nauseated and dizzy. The nausea has continued into late morning.  Her arm at the injection site feels tense and sore.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Immediate post-injection reaction, Myoclonus, Syncope
Clinical narrative: syncopal event, immediately after vaccine. fell forward and hit forehead on the ground, brief myoclonus and then took 30-45 minutes to recover and to be able to leave clinic. follow up by phone later in the day. patient was feeling better and was able to go to play practice. goose egg on forehead had gone down with ice. no concussion symptoms
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pt described arm pain as severe ache & had difficulty using to complete daily tasks
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Flatulence, Malaise, Muscle spasms
Clinical narrative: Nauseous, loose bowels, general malaise, gassy stomach, cramping, tiredness
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nauseous, loose bowels, general malaise, gassy stomach, cramping, tiredness
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pt. was advised not to get pregnant for 3 months following vaccination.  She reported Last Menstrual Period was 4-18-19 and was taking oral contraceptives.  I saw her today for New OB appointment and she is approximately 9 weeks pregnant (by her LMP).  Therefore, she would have conceived one week after receiving Varivax.  I'm waiting for ultrasound confirmation of the fetus' gestational age.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: The patient's mother called 6/19/19 to report that the patient had a palm-sized area of redness and swelling at the injection site of her meningococcal vaccine. The patient has been taking benadryl and ibuprofen and reports some itching and firmness of the skin at the site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Client received dose #2.  Client stated after about 1 hour after she started developing severe pain in her left arm.  Client did take some Tylenol but the pain continued to escalade.  Client went to walk-in clinic who sent her over to the ER.  The only thing the ER doctor could find is that the injection could have been given to high in the deltoid.  Client also believes that the vaccine was administered to high and into the shoulder instead of the muscle.  Client states that her pain has gotten better but hasn't completely resolved.  She continues to exercise it on her own and plans to see an orthopedic doctor if the pain doesn't go away.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Constipation, Flatulence, Headache, Nausea
Clinical narrative: Headache, body aches, nausea, chills, fever,constipation, Stomach gas
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, body aches, nausea, chills, fever,constipation, Stomach gas
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, Use of accessory respiratory muscles
Clinical narrative: Mother reports child had a fever as high as 102.5axillary starting on 2/14/2019 with wheezing and chest retractions. Child was seen in the urgent care clinic on 2/16/2019 was tested for RSV and Influenza which were both negative. His O2 stats were okay the mid-level practitioner questioned if the child had croupe. The child was sent home and given Tylenol as needed he was drinking okay but wouldn't eat for approximately 4 days. The mother reports that the child just wanted to be held. After the 4 days the child was fine and has had no further problems.
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Mother reports child had a fever as high as 102.5axillary starting on 2/14/2019 with wheezing and chest retractions. Child was seen in the urgent care clinic on 2/16/2019 was tested for RSV and Influenza which were both negative. His O2 stats were okay the mid-level practitioner questioned if the child had croupe. The child was sent home and given Tylenol as needed he was drinking okay but wouldn't eat for approximately 4 days. The mother reports that the child just wanted to be held. After the 4 days the child was fine and has had no further problems.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Lethargy, Rash, Rash erythematous, Somnolence
Clinical narrative: Monday 6/17 , Patient was lethargic and slept for a large portion of the day. Tuesday 6/18, Patient woke up with a low fever and felt lethargic all day.  He slept most of the day and ran a temperature between 100 and 101.5. Wednesday 6/19, Patient woke up with no fever (temperature a normal 98.2) and is feeling normal but has a red rash all over his torso.  This is on-going at this time.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Rash erythematous, Rash morbilliform, Rash papular
Clinical narrative: Abnormal behavior immediately after receiving the vaccine.  Rash that looks like measles, red, with bumps.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Pruritus
Clinical narrative: Within a few days after receiving the vaccine I (the patient) began experiencing severe nocturnal pruritus. This was severe enough to awaken me several times during the night. This is a new event for me - I have never experienced something like this before. The pruritus is localized to the anterior/lateral thigh on my left leg (L4 dermatome). There have been occasional itches elsewhere but this is the predominant one that awakens me on a nightly basis.I have ended up take Benadryl 25 mg on a regular basis to try to prevent a recurrence. Last night (on the advice of my non-medically-trained wife) I tried applying a topical Peppermint oil which did provide some relief. I am hoping that this is a self-limited relatively short-term adverse reaction!!! I have had no other exposures recently to account for symptoms similar to this.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Shivers, fever of 101 to 102 after Tylenol, headache, pain/soreness at injection site, redness and heat at injection site, tiredness, mild nausea.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: Shivers, fever of 101 to 102 after Tylenol, headache, pain/soreness at injection site, redness and heat at injection site, tiredness, mild nausea.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Shivers, fever of 101 to 102 after Tylenol, headache, pain/soreness at injection site, redness and heat at injection site, tiredness, mild nausea.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Shivers, fever of 101 to 102 after Tylenol, headache, pain/soreness at injection site, redness and heat at injection site, tiredness, mild nausea.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: Light headedness, dizzy. Resolved after 10-15 minutes
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Day 1:  by the time I was going to bed that night, started running a fever. Temperature was between 99.8 - 100.2.  Day 2:  woke up with a fever of 99.8. Felt like I had the flu. Body aches, shivers, nausea. Arm was sore.  Day 3:  arm began turning red at injection site and swelling. By the end of the day, red and swollen area was about 7 inches long by 4 inches wide, and the red area was hot to the touch.  Day 4:  redness and heat started to dissipate, but arm was still sore.  Day 5:  redness was significantly less prominent and it was no longer hot to the touch.  Day 8:  still a small patch of redness remains about 6 inches down from injection site, but no pain and no heat.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Day 1:  by the time I was going to bed that night, started running a fever. Temperature was between 99.8 - 100.2.  Day 2:  woke up with a fever of 99.8. Felt like I had the flu. Body aches, shivers, nausea. Arm was sore.  Day 3:  arm began turning red at injection site and swelling. By the end of the day, red and swollen area was about 7 inches long by 4 inches wide, and the red area was hot to the touch.  Day 4:  redness and heat started to dissipate, but arm was still sore.  Day 5:  redness was significantly less prominent and it was no longer hot to the touch.  Day 8:  still a small patch of redness remains about 6 inches down from injection site, but no pain and no heat.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Pt had no adverse symptoms upon injection or after the course .
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness, Blood glucose normal, Electroencephalogram, Loss of consciousness, Seizure
Clinical narrative: Vision loss, fainting, convulsing, loss of conscienceness
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Vision loss, fainting, convulsing, loss of conscienceness
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Rash, Skin warm
Clinical narrative: Day 1& 2 after - bad migraine-like headache Day 2-today horrible hot radiating rash
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: chills/ shivering; aches and pains; pain at injection site; headache; feeling feverish; This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th June 2019, less than a day after receiving Shingrix, the patient experienced chills, pain, injection site pain, headache and fever. On an unknown date, the outcome of the chills, pain, injection site pain, headache and fever were recovered/resolved.   It was unknown if the reporter considered the chills, pain, injection site pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient received Shingrix on left arm. On the same day of vaccination, the patient developed aches and pains, shivering, chills, headache, and pain at the injection site. The patient also felt feverish. The reporter did not give consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 15th April 2019, 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 shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The patient developed a mild case of Shingles sometime after receiving the Shingrix. Emergency room visit required.