chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site pain in an unspecified number of patients who received FLUARIX QUADRIVALENT. On an unknown date, the patients received FLUARIX QUADRIVALENT, the patients 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 FLUARIX QUADRIVALENT. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated she had administered over 500 shots of FLUARIX and experienced soreness at injection site. This case is one of the 4 cases, reported by the same reporter.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a 6-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9PX3H, expiry date 30th June 2017). On 14th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site itching, injection site redness and injection site pain. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site itching, injection site redness and injection site pain were unknown. It was unknown if the reporter considered the injection site itching, injection site redness and injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: After receiving FLUARIX QUADRIVALENT in left deltoid, the patient experienced redness, itching, and pain at the injection site. The redness, pain, and itching had spread past the injection site to underneath the affected arm. The reporter did not have an exact date, and assumed it was bout 2 weeks ago reporting date. The reporter stated that they did not know that the events were began relating to receiving the vaccination. The reporter's call was transferred from vaccine service center. This case has been linked with US2016159820 by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm tender to touch. The sales representative did not have patient or product information. He had very limited details of adverse event. The sales representative stated that the healthcare professional might have called in to report the adverse event prior but was not absolutely sure. However, no duplicate case was found.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Flu Seasonal TIV Dresden. Previously administered products included meningococcal vaccine (unknown manufacturer and was well tolerated). On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On and unknown date, and unknown time after receiving Seasonal Influenza vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to Seasonal Influenza vaccine. Additional details were reported as follows: This case was previously reported to a doctor. This case was reported by the patient's mother. The age at vaccination was not reported. The patient did not have any issues with her previous vaccination except this flu vaccination. The manufacturer of the flu vaccine was unknown. For tolerance to MENVEO vaccination, see case US2016159873.
Age: 21.0
Sex: F
Vaccine: FLU4, HEP, MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Very red itchy swollen, large area about 8 x 4 cm.
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site haemorrhage, Injection site swelling, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site bleeding in a female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less that a year after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site bleeding, injection site swelling, difficulty breathing and hives. On an unknown date, the outcome of the injection site bleeding, injection site swelling, difficulty breathing and hives were unknown. It was unknown if the reporter considered the injection site bleeding, injection site swelling, difficulty breathing and hives to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported the patient's mother. The age at vaccination was not reported. The patient experienced hives up and down shoulder after receiving vaccination. The patient would require an emergency room visit for the reported events. The reporter declined to answer questions for safety report.
Sex: U
Vaccine: FLU3
Symptoms: Influenza like illness, Respiratory symptom
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of flu like symptoms in a patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced flu like symptoms and respiratory symptom. On and unknown date, the outcome of the flu like symptoms and respiratory symptom were unknown. It was unknown if the reporter considered the flu like symptoms and respiratory symptom to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that 2 to 3 patients who have presented to her clinic experienced flu like symptoms after receiving the flu shot. The symptoms were described as respiratory in nature. The patient required emergency room visit. This case was one of the 3 cases, reported by the same reporter.
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Respiratory symptom
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adolescent female patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced influenza-like symptoms and respiratory symptom. On and unknown date, the outcome of the influenza-like symptoms and respiratory symptom to be related to Seasonal Influenza vaccine. It was unknown if the reporter considered the influenza-like symptoms and respiratory symptom to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient who presented to her clinic experienced flu like symptoms after receiving the flu shot. The symptoms were described as respiratory in nature. The patient required emergency room visit. This case was one of the 3 cases, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscle spasms, Muscle tightness
Clinical narrative: Patient went walking at local gym after receiving flu vaccine and felt a sudden spasm and trouble turning neck B/C of tightness at SCM muscle. Was treated with stretches/muscle relaxer.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and describe the occurrence of injection site redness in a 16-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9J4B7, expiry date 30th June 2017). In November 2016, the patient received FLUARIX QUADRIVALENT. In November 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of injection site redness, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site redness, injection site swelling and injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received a dose of FLUARIX QUADRIVALENT and experienced an injection site reaction, described as redness, swelling, and pain. The reporter has given the permission to contact again. This case has been linked with case US2016GSK162604 for the same patient for event experienced after receiving BEXSERO vaccine. This is one of the 5 cases reported by the same reporter.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Eye oedema, Face oedema, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalize urticaria in a 31-year-old female patient who received FLUARIX QUADRIVALENT (batch number BS79K, expiry date 30th June 2016) for an unknown indication. Concomitant products included contraceptive nos (Birth Control). On 16th October 2015, the patient received FLUARIX QUADRIVALENT. On 17th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced generalized urticaria, face edema and eye edema. The patient was treated with BENADRYL and prednisone. On an unknown date, the outcome of the generalize urticaria, face edema and eye edema were recovered/resolved. The reporter considered the generalized urticaria, face edema and eye edema to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on left arm at the hospital last year 2015. The patient experienced hives all over her body, facial edema and eye edema. It was now flu season and trying o determine what part of the shot caused the reaction. The reporter stated that there are 2 manufacturers written on my paperwork. If so I would like as much information as I can get of the ingredients in that vaccine so that I can determine what the allergen would have been. The patient went to urgent care due to issues. The patient received an automated reply confirming receipt of information.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Drug interaction, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 46-year-old female patient who received RABAVERT. Co-suspect products included immunoglobulin human anti-rabies (HRIG) and prednisone for an unknown indication. The patient's past medical history included cat bite. Previously administered products included HRIG (received approximately 20 years ago) and Rabies vaccine (received approximately 20 years ago). Concurrent medical conditions included animal bite and asthma. Concomitant products included Influenza vaccine unspecified. On 27th October 2016, the patient received the 1st dose of RABAVERT (intramuscular) 1 ml and HRIG. In September 2016, the patient started prednisone at an unknown dose and frequency. On 27th October 2016, less than a day after receiving RABAVERT and an unknown time after starting prednisone, the patient experienced muscle soreness. On an unknown date, the patient experienced drug interaction. On an unknown date, the outcome of the muscle soreness was recovering/resolving and the outcome of the drug interaction was unknown. It was unknown if the reporter considered the muscle soreness and drug interaction to be related to RABAVERT. Additional details were provided as follows: The patient recently started a 4 dose series of RABAVERT after she thought had a bat bite, but never saw it so was not sure and received 1st dose of RABAVERT on Left deltoid. She explained that they injected medicine into the wound as well as injections in the deltoid so she assumed that she received HRIG as well as all 4 injections of the vaccine. She read that the immunoglobulin received this last time can make the vaccine ineffective. The patient had massive anxiety because thought that the recent HRIG injection was preventing the protection against rabies. On an unknown date, less than a week after receiving all vaccination, the patient experienced drug interaction. This case has been linked with case US2016GSK161876 as reported by same reporter.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown date. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced incorrect storage of drug and vaccination error. On an unknown date, the outcome of the incorrect storage of drug and vaccination error were unknown. It was unknown if the reporter considered the incorrect storage of drug and vaccination error to be related to FLUARIX. Additional details were provided as follows: The reporter stated that there university had a temperature excursion of FLUARIX vaccine that was administered to a number of patients, which led to vaccination error. They were wondering as what was the protocol as far as revaccinating the impacted patients, and any possible effects of revaccinating those patients.
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haematoma, Injection site swelling
Clinical narrative: This case was reported by a other professional via call center representative and described the occurrence of injection site hematoma in a 70-year-old female patient who received FLUARIX QUADRIVALENT (batch number 74Y32, expiry date 7th June 2017). On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hematoma, injection site swelling and injection site bruising. The patient was treated with medication unknown, medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site injection site hematoma, injection site swelling were recovered/resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the injection site hematoma, injection site swelling and injection site bruising to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient developed hematoma and swelling at the injection site (unknown arm) after receiving FLUARIX QUADRIVALENT. The ice was immediately applied and 3 days later the swelling had resolved and the patient's arm was bruised. No further information was reported regarding the event.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 37-year-old female patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). On 28th September 2016, the patient received FLULAVAL QUADRIVALENT. On 28th September 2016, immediately after received FLULAVAL QUADRIVALENT, the patient experienced injection site muscle pain and fever. On an unknown date, the outcome of the injection site muscle pain and fever were unknown. It was unknown if the reporter considered the injection site muscle pain and fever to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: As soon the patient received the shot she felt like she got punched very hard in the arm and it hurt really bad for few days. The patient could not move her arm without hurting and it hurt in the muscle not on the skin. The patient also had a high temperature for about 24 to 48 hours after the injection as well. She said the pain was getting better but it was about 6 weeks and still hurts.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of infection site pain in a 80-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3CG9P, expiry date 22nd June 2017). On 1st November 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 1st November 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site warmth and injection site redness. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site redness were recovering/resolving. The reporter considered the injection site pain, injection site warmth and injection site redness to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: At night of the vaccination day, the patient experienced injection site reaction, specifically injection site was sore, red and hot to touch. The redness was described as starting at injection site and moving down arm towards the crux of her elbow measuring 4 inches by 5 inches.
Sex: U
Vaccine: FLU4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a patient who received BEXSERO. Co-suspect products included FLUARIX QUADRIVALENT. On an unknown date, the patient received BEXSERO at an unknown dose and FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving BEXSERO and FLUARIX QUADRIVALENT, the patient experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site redness, injection site swelling and injection site pain to be related to BEXSERO and FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination of the patients was not reported. It was reported that the practice had multiple reports from 10 to 15 patients, who had experienced redness, swelling, and pain at the injection site, which lasted about 2 to 3 days, after receiving FLUARIX QUADRIVALENT and BEXSERO vaccine. At the time of reporting, both product and patients information were not available, but might be available upon follow up. The reporter has given the permission to contact again. This was one of the 5 cases reported by the same reporter.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received FLULAVAL QUADRIVALENT (batch number Y9H77, expiry date 30th April 2017). On 4th October 2016, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced pain in arm and skin warm. On an unknown date, the outcome of the pain in arm and skin were recovering/resolving. It was unknown if the reporter considered the pain in arm and skin warm to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT in unknown arm. The patient experienced lingering soreness at the injection site, which had subsided slightly. The reporter explained that the local newspaper in his town had recently ran an article that explained that if a person experiences pain after receiving the flu shot it was because the shot was given incorrectly? This patient stated that, his arm was painful, hot, but it was subsided a bit since the date of the injection.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pt. had severe pain after administration that became worse over the course of several days. Pt has had an MRI and prednisone course with no resolve. Pt. is going to see orthopedist.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Redness and warmth at injection site (approx. 8"x6" area). Fever and ill feeling for about 24 hours. Only right arm affected.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (Rt) arm pain redness and swelling.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: Patient vaccinated on 11/1/2016-experienced weakness in right upper arm on 11/3/16-extended to right shoulder on 11/10/2016-referred to MD.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Cough, Wheezing
Clinical narrative: Pt began to wheeze O2 98 pulse 111. Gave 1 treatment of Albuterol A/Ox3. Pt coughing after treatment, checked by NP.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The patient developed a rash on her face and other areas approx 3 days after shot. She took BENADRYL per her doctors instructions, but the rash continued until 11/3-11/4. She saw her doctor at this time and they referred her to allergist.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Neck pain
Clinical narrative: 11/11/16-Patient reports arm soreness from elbow to shoulder and neck. Reports treatment at home with ibuprofen. Reported in left arm only.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient is continuing to have muscle soreness at the injection site after more than 3 months after the vaccine.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient had pain and some swelling at injection site and could not lift arm up all the way without pain-Discontinue of arm movement has continued for 3 weeks and has very slowly been improving.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis, Paraesthesia, Swelling face
Clinical narrative: Patient began to notice swelling and tingling sensation to right side of face later in the day after getting the vaccine, 11/1/16. On 11/8/16 patient made an appt. to see Dr. who diagnosed him w/Bells Palsy r/t vaccine.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information had been received on 19-OCT-2016 from a nurse who reported that a 10 year old female received four doses of "HPV vaccine". The first two doses of "HPV vaccine" were administered in another country on 13-APR-2015 and 13-OCT-2015 and the nurse was uncertain which HPV vaccine the patient received. The nurse assumed that the HPV vaccine the patient received was GARDASIL and she did not have access to the lot numbers and expiration dates of those doses administered on 13-APR-2015 and 13-OCT-2015. The patient then received the following doses on the following dates: GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017) on 12-AUG-2016 and GARDASIL 9 (lot# M011117, expiration date 07-DEC-2017) on 13-OCT-2016. The patient had not experienced any adverse effects. No additional information was provided. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Cough, Drug interaction, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 46-year-old female patient who received RABAVERT. Co-suspect products included immunoglobulin human anti-rabies (HRIG) and prednisone for an unknown indication. The patient's past medical history included cat bite. Previously administered products included Rabies vaccine (received approximately 20 years ago), HRIG (received approximately 20 years ago) and RABAVERT with an associated reaction of adverse reaction (1st dose received on 27th October 2016). Concurrent medical conditions included asthma and animal bite. On 30th October 2016, the patient received the 2nd dose of RABAVERT and the 2nd dose of HRIG. In September 2016, the patient started prednisone at an unknown dose and frequency. On 30th October 2016, less than a day after receiving RABAVERT and not applicable after starting prednisone, the patient experienced headache, fatigue, cough, chest tightness and influenza-like symptoms. On 2nd November 2016, the patient experienced itchy legs. On an unknown date, the patient experienced drug interaction. On an unknown date, the outcome of the headache, fatigue, cough, chest tightness and itchy legs were recovering/resolving and the outcome of the influenza-like symptoms and drug interaction were unknown. The reporter considered the headache and fatigue to be related to RABAVERT. It was unknown if the reporter considered the cough, chest tightness, influenza-like symptoms and drug interaction to be related to RABAVERT. The reporter considered the itchy legs to be possibly related to RABAVERT. Additional details were provided as follows: The patient received the 2nd dose of RABAVERT on right deltoid. On 2nd November 2016 in the morning, 3 days after receiving RABAVERT, the patient experienced itching. The patient was underlying Asthma so was basically thinking the cough and chest tightness were related Asthma. The patient also noted flu like symptoms of headache and fatigue. The patient had itching of her thighs, as she had the HRIG shots in both thighs. On an unknown date, less than a week after receiving all vaccination, the patient experienced drug interaction. The patient recently experienced 2 puncture wounds on her left arm which was 2 and half inches up from her wrist. This case has been linked with case US2016GSK166662 as reported by same reporter.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Influenza like illness, Injection site pruritus, Pruritus, Wound
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 46-year-old female patient who received RABAVERT. Co-suspect products included immunoglobulin human anti-rabies (HRIG) and prednisone for an unknown indication. The patient's past medical history included cat bite. Previously administered products included Rabies vaccine (received approximately 20 years ago), HRIG (received approximately 20 years ago) and RABAVERT with an associated reaction of adverse reaction (1st dose received on 27th October 2016). Concurrent medical conditions included asthma and animal bite. On 30th October 2016, the patient received the 2nd dose of RABAVERT and the 2nd dose of HRIG. In September 2016, the patient started prednisone at an unknown dose and frequency. On 30th October 2016, less than a day after receiving RABAVERT and not applicable after starting prednisone, the patient experienced headache, fatigue, cough, chest tightness and influenza-like symptoms. On 2nd November 2016, the patient experienced itchy legs. On an unknown date, the patient experienced drug interaction. On an unknown date, the outcome of the headache, fatigue, cough, chest tightness and itchy legs were recovering/resolving and the outcome of the influenza-like symptoms and drug interaction were unknown. The reporter considered the headache and fatigue to be related to RABAVERT. It was unknown if the reporter considered the cough, chest tightness, influenza-like symptoms and drug interaction to be related to RABAVERT. The reporter considered the itchy legs to be possibly related to RABAVERT. Additional details were provided as follows: The patient received the 2nd dose of RABAVERT on right deltoid. On 2nd November 2016 in the morning, 3 days after receiving RABAVERT, the patient experienced itching. The patient was underlying Asthma so was basically thinking the cough and chest tightness were related Asthma. The patient also noted flu like symptoms of headache and fatigue. The patient had itching of her thighs, as she had the HRIG shots in both thighs. On an unknown date, less than a week after receiving all vaccination, the patient experienced drug interaction. The patient recently experienced 2 puncture wounds on her left arm which was 2 and half inches up from her wrist. This case has been linked with case US2016GSK166662 as reported by same reporter.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 16-year-old male patient who received BEXSERO (batch number 158701, expiry date 30th September 2017). On 2nd November 2016, the patient received BEXSERO. On 2nd November 2016, less than a day after receiving BEXSERO, the patient experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered injection site redness, injection site swelling and pain to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO and within 24 hours the patient experienced and injection site reaction, described as redness, swelling, and pain. The reporter has given the permission to contact again. This case has been linked with case US2016GSK165443, for the same patient for event experienced after receiving FLUARIX QIV.  This is one of the 5 cases reported by the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a radiology technician/vaccine coordinator referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the patients were vaccinated with an improperly stored doses of VAQTA lot # M011116 with an expiration date 17-JUN-2017 and lot # M002268 with an expiration date 20-SEP-2017 (dose, route and anatomical location were not reported). No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. With a data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 17-year-old female patient who received BEXSERO (batch number 158701, expiry date 30th September 2017. On 2nd November 2016, the patient received BEXSERO. On 2nd November 2016, less than a day after receiving BEXSERO, the patient experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered injection site redness, injection site swelling and pain to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO and within 24 hours the patient experienced an injection site reaction, described as redness, swelling, and pain. The reporter has given the permission to contact again. It was reported that there was no seriousness criteria associated with event (hospitalisation and death). This is one of the 5 cases reported by the same reporter.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 23-year-old female patient who received BEXSERO (batch number 158701, expiry date 30th September 2017. On 31st October 2016, the patient received BEXSERO. On 31st October 2016, less than a day after receiving BEXSERO, the patient experienced injection site redness, injection site swelling, headache and general body pain. On an unknown date, the outcome of the injection site redness, injection site swelling, headache and general body pain were recovering/resolving. It was unknown if the reporter considered injection site redness, injection site swelling, headache and general body pain to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO in her left deltoid and within 24 hours the patient began to experience redness and swelling at the injection site, headache, and body ache. The reporter has given the permission to contact again. It was reported that there was no seriousness criteria associated with event (hospitalisation and death). This is one of the 5 cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (incorrect product storage) (lot number: M000760, expiry date: 06-JAN-2018; lot number: L013064, expiry date: 14-APR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 9 degree Celsius (C) for 1 hour and 1 minute. No previous temperature excursion was reported. It was also reported that this case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA004873 and 1611USA004874 via same reporter link. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Expired product administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received on 20-OCT-2016 from a medical assistant who was reporting on a female patient who received the following vaccines: On 30-AUG-2011, the patient was 11 years old and received a dose of an unspecified "HPV" vaccine (manufacturer unknown). Lot number and expiration date were unspecified. On 29-OCT-2012, the patient received a dose of GARDASIL lot H009746, expired 11-JAN-2015. On 16-JAN-2015, the patient received a dose of either GARDASIL or GARDASIL 9. The reporter did not know which of the two vaccines were given. Lot reported K005881, exp. 14-JAN-2017 which is a valid lot for GARDASIL. On 20-OCT-2016 the patient received a dose of GARDASIL 9, lot M023169, exp. 13-JUN-2018. The patient did not report an adverse experience. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adolescent patients who received BEXSERO. On an unknown date, the patient received BEXSERO  (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be probably related to BEXSERO. Additional details were provided as follows: In 2016, several patients received BEXSERO and experienced flu-like symptoms. It was reported that even some other kids also experienced the symptoms. But no details were provided for the specific number of patients.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Neck pain, Pain in jaw
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neck pain in a female patient who received Meningococcal ACWY vaccine (potential MENVEO). Co-suspect products included Meningococcal B vaccine. Previously administered products included Meningitis vaccine (received a shot few years ago). On an unknown date, the patient received Meningococcal ACWY Vaccine (potential MENVEO) at an unknown dose and Meningococcal B vaccine at an unknown dose. On an unknown date, less than a month after receiving Meningococcal ACWY vaccine (potential MENVEO) and Meningococcal B vaccine, the patient experienced neck pain, jaw pain and headache. On an unknown date, the outcome of the neck pain, jaw pain and headache were unknown. It was unknown if the reporter considered the neck pain, jaw pain and headache to be related to Meningococcal ACWY Vaccine (potential MENVEO) and Meningococcal B vaccine. Additional details were provided as follows: The patient received meningitis shot a few years ago and was told that she needed to get her another one before she graduates. She just went to the doctors and she got a shot, plus the Meningitis B shot and had pain in her neck, jaw all day today and headache. The reporter was asking if the patient supposed to get both of them. She thought they set up another appointment in a month for another meningitis shot. The office was closed.
Age: 31.0
Sex: F
Vaccine: FLUX, HEP, TDAP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 31-year-old female patient who received TWINRIX adult. Co-suspect products included ENGERIX B adult (batch number F2LR7, expiry date 9th October 2016, and Hepatitis A vaccine. On an unknown date, the patient received TWINRIX adult, ENGERIX B adult and Hepatitis A vaccine at an unknown dose. On an unknown date, an unknown time after receiving TWINRIX adult and not applicable after receiving ENGERIX B adult and Hepatitis A vaccine, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient started TWINRIX schedule and then for the second dose in the series received ENGERIX B and Hepatitis A (unsure if it was HAVRIX), which led to inappropriate schedule of vaccine administered and wrong vaccine administered. It was not sure if it was accidental or intentional.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Hypoaesthesia, Impaired driving ability, Injected limb mobility decreased, Mobility decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 28-year-old male patient who received BOOSTRIX (batch number K2D2T, expiry date 8th December 2018). Concurrent medical conditions included asthma (has had since childhood). Concomitant products included vitamins NOS (Multivitamin). On 26th October 2016, the patient received BOOSTRIX (intramuscular) 0.5 ml. In October 2016, less than a week after receiving BOOSTRIX, the patient experienced injected limb mobility decreased, wheezing, movement disorder, numbness of limbs, tingling and muscle weakness. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the injected limb mobility decreased, movement disorder, numbness of limbs, tingling and muscle weakness were unknown and the outcome of the wheezing was recovering/resolving and the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, wheezing, movement disorder, numbness of limbs and tingling to be related to BOOSTRIX. The reporter considered the muscle weakness and fatigue to be related to BOOSTRIX. Additional details were provided as follows: Initially it was reported that, approximately within a day of getting the vaccination, the patient began to experience wheezing, and numbness and tingling in both arms and legs, which was almost to the point of feeling like pins and needles. The patient experienced difficulty in shifting the gears in his car due to the numbness and tingling. Also, the patient experienced difficulty during raising both of his arms. The reporter stated that the patient went to physician and was told that the wheezing was not related to the BOOSTRIX. The reporter was going to have the consumer contact to response center to provide further details. On 1st November 2016, the consumer was contacted and stated that, he did not talk initially about the numbness and tingling in his arms and legs, and the muscle weakness and only discussed wheezing and was told it was probably related to allergies. The patient stated that the symptoms of wheezing, muscle weakness, and numbness and tingling in his arms and legs started within 72 hours of receiving the vaccination. The patient went to the emergency room visit on 31st October 2016, because of the numbness and tingling, and muscle weakness. They were unable to find anything wrong with patient. It was reported that patient felt extremely fatigued after receiving the vaccination. The numbness and tingling in his arms was not constant but rather "on and off", and numbness in his legs was extremely pronounced when he was driving. He initially went to get the vaccination because he cut his pinky on a rusty plate that hold the battery in a car.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Movement disorder, Muscular weakness, Paraesthesia, Wheezing
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 28-year-old male patient who received BOOSTRIX (batch number K2D2T, expiry date 8th December 2018). Concurrent medical conditions included asthma (has had since childhood). Concomitant products included vitamins NOS (Multivitamin). On 26th October 2016, the patient received BOOSTRIX (intramuscular) 0.5 ml. In October 2016, less than a week after receiving BOOSTRIX, the patient experienced injected limb mobility decreased, wheezing, movement disorder, numbness of limbs, tingling and muscle weakness. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the injected limb mobility decreased, movement disorder, numbness of limbs, tingling and muscle weakness were unknown and the outcome of the wheezing was recovering/resolving and the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, wheezing, movement disorder, numbness of limbs and tingling to be related to BOOSTRIX. The reporter considered the muscle weakness and fatigue to be related to BOOSTRIX. Additional details were provided as follows: Initially it was reported that, approximately within a day of getting the vaccination, the patient began to experience wheezing, and numbness and tingling in both arms and legs, which was almost to the point of feeling like pins and needles. The patient experienced difficulty in shifting the gears in his car due to the numbness and tingling. Also, the patient experienced difficulty during raising both of his arms. The reporter stated that the patient went to physician and was told that the wheezing was not related to the BOOSTRIX. The reporter was going to have the consumer contact to response center to provide further details. On 1st November 2016, the consumer was contacted and stated that, he did not talk initially about the numbness and tingling in his arms and legs, and the muscle weakness and only discussed wheezing and was told it was probably related to allergies. The patient stated that the symptoms of wheezing, muscle weakness, and numbness and tingling in his arms and legs started within 72 hours of receiving the vaccination. The patient went to the emergency room visit on 31st October 2016, because of the numbness and tingling, and muscle weakness. They were unable to find anything wrong with patient. It was reported that patient felt extremely fatigued after receiving the vaccination. The numbness and tingling in his arms was not constant but rather "on and off", and numbness in his legs was extremely pronounced when he was driving. He initially went to get the vaccination because he cut his pinky on a rusty plate that hold the battery in a car.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 01-NOV-2016, the patients were vaccinated with improperly stored ROTATEQ orally, lot # M006111 with expiration date 18-NOV-2017, (dosage was not reported), which was exposed to temperature excursion (temperature: 51.3 degrees F, time frame: 1 hour) because of data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 01-NOV-0216, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M022077 with expiration date 10-MAR-2019, dosage and route of administration were not reported, which was exposed to temperature excursion (temperature: 51.3 degrees F, time frame: 1 hour) because of data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information was received from a female consumer of unknown age. On an unknown date the patient was vaccinated with GARDASIL. The patient reported she was vaccinated in her 27th week of pregnancy. She did not specify which dose this was. She reported that she experienced no adverse events. No other information was provided. Additional information is not expected.