chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Put on shirt after it arm hurt since arm hurts-achy from after got shot down arm to wrist.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder pain-intermittent pain to fingers. Patient reported that the pain started after her flu shot.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pain
Clinical narrative: Pt. said she knotted up right after the shot. Said it was never red or hot, just a knot. She said she still has a small knot, less than a nickel size. Said it feels a little achy.
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 3 days after receiving BEXSERO, the patient experienced pain in arm, injection site erythema, injected limb mobility decreased and injection site pain. On an unknown date, the outcome of the pain in arm, injection site erythema, injected limb mobility decreased and injection site pain were recovered/resolved. It was unknown if the reporter considered the pain in arm, injection site erythema, injected limb mobility decreased and injection site pain to be related to BEXSERO. This case was reported by a physician via sales rep and described the occurrence of pain in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 3 days after receiving BEXSERO, the patient experienced pain, injection site erythema, movement disorder and injection site pain. On an unknown date, the outcome of the pain, injection site erythema, movement disorder and injection site pain were recovered/resolved. It was unknown if the reporter considered the pain, injection site erythema, movement disorder and injection site pain to be related to BEXSERO. Additional details were provided as follow: The age at vaccination was not reported. The patient received BEXSERO in an unknown arm. The patient experienced shooting pain down to her arm and elbow, injection site redness, difficulty moving arm and achiness at injection site. Limited information was provided by the sale representative from the physician. This case has been lined with case US2017026064, US2017026065 and US2017026068 as reported by same reporter.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 35-year-old male patient who received ENGERIX B Adult (batch number Z25GH, expiry date 5th March 2019). On 20th February 2017 15:00, the patient received ENGERIX B Adult. On 21st February 2017, 1 days after receiving ENGERIX B Adult, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to ENGERIX B Adult. Additional details were provided as follows: The patient received ENGERIX B Adult in left deltoid. On next day at night, the patient developed a fever. On 21st February 2017, the patient treated with TYLENOL. On 22nd February 2017, the reporter reported that the patient's body temperature was 101.3 degree C and it was remained on-gong while taking TYLENOL. The reported lot number (225GH) for ENGERIX B Adult did not exist and was updated to (Z25GH) as per the sales database.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2014US170081, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546845) website on 29 Dec 2014 and with follow up information received from the quality assurance department (QA reference number: 345053) on 06 Jan 2015, with the follow-up information received from Quality Assurance Department (reference number: 345053) on 19 Jan 2015. This report refers to an 11 year old male patient. Current condition included allergic rhinitis and asthma. Historical drug included pseudoephedrine hydrochloride. On 30 Sep 2014, he was vaccinated with MENVEO (batch number: M14023 and expiry date Jul 2015) into right arm. On the same day he also received GARDASIL (batch number: J015378, other manufacturer) into left arm; BOOSTRIX (batch number: N3BE2, other manufacturer) into right arm and FLUARIX QUADRIVALENT (batch number: LZ4S2, other manufacturer) into left arm. On the same date post vaccination he developed cellulitis right deltoid at the site. He went to the emergency room. Outcome of the event was unknown. Causality assessment was not reported. Seriousness assessment of vaccination site cellulitis was upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M14023) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 345053) on 06 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345053) on 19 Jan 2015: Updated MENVEO batch review report. On 20th February 2017, after GSK internal review, the suspect vaccine FLUARIX was changed into FLUARIX QUADRIVALENT.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling, Interchange of vaccine products
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 10-OCT-2016, at 15:15, the patient was vaccinated in the left upper arm with the second dose of GARDASIL 9 injection (lot number M030380, expiry date, dose and route of administration were not reported), for prophylaxis, to continue or complete a Human Papillomavirus (HPV) vaccination series that were started with GARDASIL. On the same day, at 17:00, the patient experienced bump where the injection was given, swelling, redness, tingling at the injection site and it was hurting to touch. The bumps were measured 2x1.5cm at the position of arm up (reported as when lifts up arm). At the time of reporting, the patient's outcome was recovered. The causality assessment between GARDASIL 9 and the adverse events was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA012066.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site paraesthesia, Injection site swelling, Pain
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 10-OCT-2016, at 15:15, the patient was vaccinated in the left upper arm with the second dose of GARDASIL 9 injection (lot number M030380, expiry date, dose and route of administration were not reported), for prophylaxis, to continue or complete a Human Papillomavirus (HPV) vaccination series that were started with GARDASIL. On the same day, at 17:00, the patient experienced bump where the injection was given, swelling, redness, tingling at the injection site and it was hurting to touch. The bumps were measured 2x1.5cm at the position of arm up (reported as when lifts up arm). At the time of reporting, the patient's outcome was recovered. The causality assessment between GARDASIL 9 and the adverse events was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA012066.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Abdominal pain upper, Asthenia, Chest discomfort, Constipation, Cough
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 57-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT and RABAVERT. Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included vitamin E and fish oil. On 5th January 2016, the patient received the 1st dose of RABAVERT. On 12th January 2016, the patient received the 2nd dose of RABAVERT. On 2nd February 2016, the patient received the 3rd dose of RABAVERT. On an unknown date, 122 days after receiving RABAVERT, RABAVERT and RABAVERT, the patient experienced autoimmune disorder (serious criteria hospitalization and GSK medically significant), Guillain Barre syndrome (serious criteria GSK medically significant), movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty. The patient was treated with immunoglobulins nos (IVIG). On an unknown date, the outcome of the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty were unknown. It was unknown if the reporter considered the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty to be related to RABAVERT, RABAVERT and RABAVERT. Additional details were provided as follows: Concomitant medications included unspecified medications for high blood pressure and diabetes. Approximately four to five months after receiving the 1st, 2nd and 3rd dose of RABAVERT vaccine, the patient experienced auto-immune disease, Guillain Barre syndrome, difficulty with moving, shortness of breath, tightness in chest, limited mobility, fall, numbness, tingling and feet flaps. The side effect primarily started with hands. The patient had limited mobility in the hands, arms and legs. The patient also had issues with opening a door, going upstairs and he also falls down quite often. The patient had numbness and tingling from the tips of his fingers up his arms and his legs were also numb. The patient stated that when he walked his feet got flapped. The physician was talking about putting him on plasma pheresis treatments. The patient also mentioned, he may have to get a port put into his chest to get the treatment. The physician diagnosed the patient with an auto-immune disease and Guillain Barre syndrome. The patient was extremely concerned about the treatment and outcome of what was going on with him. The patient was admitted into the hospital three times regarding the symptoms he had. The patient did not agree with his physician, since he has all of the side effects of the RABAVERT vaccine. The consent to contact the physician was provided.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Diarrhoea, Dysphagia, Dyspnoea, Grip strength decreased, Hypoaesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 57-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT and RABAVERT. Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included vitamin E and fish oil. On 5th January 2016, the patient received the 1st dose of RABAVERT. On 12th January 2016, the patient received the 2nd dose of RABAVERT. On 2nd February 2016, the patient received the 3rd dose of RABAVERT. On an unknown date, 122 days after receiving RABAVERT, RABAVERT and RABAVERT, the patient experienced autoimmune disorder (serious criteria hospitalization and GSK medically significant), Guillain Barre syndrome (serious criteria GSK medically significant), movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty. The patient was treated with immunoglobulins nos (IVIG). On an unknown date, the outcome of the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty were unknown. It was unknown if the reporter considered the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty to be related to RABAVERT, RABAVERT and RABAVERT. Additional details were provided as follows: Concomitant medications included unspecified medications for high blood pressure and diabetes. Approximately four to five months after receiving the 1st, 2nd and 3rd dose of RABAVERT vaccine, the patient experienced auto-immune disease, Guillain Barre syndrome, difficulty with moving, shortness of breath, tightness in chest, limited mobility, fall, numbness, tingling and feet flaps. The side effect primarily started with hands. The patient had limited mobility in the hands, arms and legs. The patient also had issues with opening a door, going upstairs and he also falls down quite often. The patient had numbness and tingling from the tips of his fingers up his arms and his legs were also numb. The patient stated that when he walked his feet got flapped. The physician was talking about putting him on plasma pheresis treatments. The patient also mentioned, he may have to get a port put into his chest to get the treatment. The physician diagnosed the patient with an auto-immune disease and Guillain Barre syndrome. The patient was extremely concerned about the treatment and outcome of what was going on with him. The patient was admitted into the hospital three times regarding the symptoms he had. The patient did not agree with his physician, since he has all of the side effects of the RABAVERT vaccine. The consent to contact the physician was provided.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Loss of control of legs, Muscle tightness, Muscular weakness, Paraesthesia, Peroneal nerve palsy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 57-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT and RABAVERT. Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included vitamin E and fish oil. On 5th January 2016, the patient received the 1st dose of RABAVERT. On 12th January 2016, the patient received the 2nd dose of RABAVERT. On 2nd February 2016, the patient received the 3rd dose of RABAVERT. On an unknown date, 122 days after receiving RABAVERT, RABAVERT and RABAVERT, the patient experienced autoimmune disorder (serious criteria hospitalization and GSK medically significant), Guillain Barre syndrome (serious criteria GSK medically significant), movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty. The patient was treated with immunoglobulins nos (IVIG). On an unknown date, the outcome of the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty were unknown. It was unknown if the reporter considered the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty to be related to RABAVERT, RABAVERT and RABAVERT. Additional details were provided as follows: Concomitant medications included unspecified medications for high blood pressure and diabetes. Approximately four to five months after receiving the 1st, 2nd and 3rd dose of RABAVERT vaccine, the patient experienced auto-immune disease, Guillain Barre syndrome, difficulty with moving, shortness of breath, tightness in chest, limited mobility, fall, numbness, tingling and feet flaps. The side effect primarily started with hands. The patient had limited mobility in the hands, arms and legs. The patient also had issues with opening a door, going upstairs and he also falls down quite often. The patient had numbness and tingling from the tips of his fingers up his arms and his legs were also numb. The patient stated that when he walked his feet got flapped. The physician was talking about putting him on plasma pheresis treatments. The patient also mentioned, he may have to get a port put into his chest to get the treatment. The physician diagnosed the patient with an auto-immune disease and Guillain Barre syndrome. The patient was extremely concerned about the treatment and outcome of what was going on with him. The patient was admitted into the hospital three times regarding the symptoms he had. The patient did not agree with his physician, since he has all of the side effects of the RABAVERT vaccine. The consent to contact the physician was provided.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Autoimmune disorder, Chest discomfort, Dyspnoea, Fall, Gait disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 57-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT and RABAVERT. Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included vitamin E and fish oil. On 5th January 2016, the patient received the 1st dose of RABAVERT. On 12th January 2016, the patient received the 2nd dose of RABAVERT. On 2nd February 2016, the patient received the 3rd dose of RABAVERT. On an unknown date, 122 days after receiving RABAVERT, RABAVERT and RABAVERT, the patient experienced autoimmune disorder (serious criteria hospitalization and GSK medically significant), Guillain Barre syndrome (serious criteria GSK medically significant), movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty. The patient was treated with immunoglobulins nos (IVIG). On an unknown date, the outcome of the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty were unknown. It was unknown if the reporter considered the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty to be related to RABAVERT, RABAVERT and RABAVERT. Additional details were provided as follows: Concomitant medications included unspecified medications for high blood pressure and diabetes. Approximately four to five months after receiving the 1st, 2nd and 3rd dose of RABAVERT vaccine, the patient experienced auto-immune disease, Guillain Barre syndrome, difficulty with moving, shortness of breath, tightness in chest, limited mobility, fall, numbness, tingling and feet flaps. The side effect primarily started with hands. The patient had limited mobility in the hands, arms and legs. The patient also had issues with opening a door, going upstairs and he also falls down quite often. The patient had numbness and tingling from the tips of his fingers up his arms and his legs were also numb. The patient stated that when he walked his feet got flapped. The physician was talking about putting him on plasma pheresis treatments. The patient also mentioned, he may have to get a port put into his chest to get the treatment. The physician diagnosed the patient with an auto-immune disease and Guillain Barre syndrome. The patient was extremely concerned about the treatment and outcome of what was going on with him. The patient was admitted into the hospital three times regarding the symptoms he had. The patient did not agree with his physician, since he has all of the side effects of the RABAVERT vaccine. The consent to contact the physician was provided.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Mobility decreased, Movement disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 57-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT and RABAVERT. Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included vitamin E and fish oil. On 5th January 2016, the patient received the 1st dose of RABAVERT. On 12th January 2016, the patient received the 2nd dose of RABAVERT. On 2nd February 2016, the patient received the 3rd dose of RABAVERT. On an unknown date, 122 days after receiving RABAVERT, RABAVERT and RABAVERT, the patient experienced autoimmune disorder (serious criteria hospitalization and GSK medically significant), Guillain Barre syndrome (serious criteria GSK medically significant), movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty. The patient was treated with immunoglobulins nos (IVIG). On an unknown date, the outcome of the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty were unknown. It was unknown if the reporter considered the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty to be related to RABAVERT, RABAVERT and RABAVERT. Additional details were provided as follows: Concomitant medications included unspecified medications for high blood pressure and diabetes. Approximately four to five months after receiving the 1st, 2nd and 3rd dose of RABAVERT vaccine, the patient experienced auto-immune disease, Guillain Barre syndrome, difficulty with moving, shortness of breath, tightness in chest, limited mobility, fall, numbness, tingling and feet flaps. The side effect primarily started with hands. The patient had limited mobility in the hands, arms and legs. The patient also had issues with opening a door, going upstairs and he also falls down quite often. The patient had numbness and tingling from the tips of his fingers up his arms and his legs were also numb. The patient stated that when he walked his feet got flapped. The physician was talking about putting him on plasma pheresis treatments. The patient also mentioned, he may have to get a port put into his chest to get the treatment. The physician diagnosed the patient with an auto-immune disease and Guillain Barre syndrome. The patient was extremely concerned about the treatment and outcome of what was going on with him. The patient was admitted into the hospital three times regarding the symptoms he had. The patient did not agree with his physician, since he has all of the side effects of the RABAVERT vaccine. The consent to contact the physician was provided.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Paraesthesia, Peroneal nerve palsy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 57-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT and RABAVERT. Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included vitamin E and fish oil. On 5th January 2016, the patient received the 1st dose of RABAVERT. On 12th January 2016, the patient received the 2nd dose of RABAVERT. On 2nd February 2016, the patient received the 3rd dose of RABAVERT. On an unknown date, 122 days after receiving RABAVERT, RABAVERT and RABAVERT, the patient experienced autoimmune disorder (serious criteria hospitalization and GSK medically significant), Guillain Barre syndrome (serious criteria GSK medically significant), movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty. The patient was treated with immunoglobulins nos (IVIG). On an unknown date, the outcome of the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty were unknown. It was unknown if the reporter considered the autoimmune disorder, Guillain Barre syndrome, movement disorder, shortness of breath, chest tightness, mobility decreased, fall, numbness, tingling and walking difficulty to be related to RABAVERT, RABAVERT and RABAVERT. Additional details were provided as follows: Concomitant medications included unspecified medications for high blood pressure and diabetes. Approximately four to five months after receiving the 1st, 2nd and 3rd dose of RABAVERT vaccine, the patient experienced auto-immune disease, Guillain Barre syndrome, difficulty with moving, shortness of breath, tightness in chest, limited mobility, fall, numbness, tingling and feet flaps. The side effect primarily started with hands. The patient had limited mobility in the hands, arms and legs. The patient also had issues with opening a door, going upstairs and he also falls down quite often. The patient had numbness and tingling from the tips of his fingers up his arms and his legs were also numb. The patient stated that when he walked his feet got flapped. The physician was talking about putting him on plasma pheresis treatments. The patient also mentioned, he may have to get a port put into his chest to get the treatment. The physician diagnosed the patient with an auto-immune disease and Guillain Barre syndrome. The patient was extremely concerned about the treatment and outcome of what was going on with him. The patient was admitted into the hospital three times regarding the symptoms he had. The patient did not agree with his physician, since he has all of the side effects of the RABAVERT vaccine. The consent to contact the physician was provided.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blindness, Confusional state, Fatigue, Headache, Migraine
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of facial swelling in a 16-year-old female patient who received MENVEO (batch number M16014, expiry date unknown). On 21st February 2017, the patient received the 1st dose of MENVEO (intramuscular). On 21st February 2017, less than a day after receiving MENVEO, the patient experienced headache (serious criteria other: Medically Significant), incoherent (serious criteria other: Medically significant), mental concentration difficult (serious criteria other: Medically Significant), Fatigue and blurred vision. On 22nd February 2017, the patient experienced facial swelling (serious criteria other: Medically Significant). In February 2017, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the facial swelling, incoherent, mental concentration difficult and blurred vision were recovering/resolving and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the facial swelling, headache, incoherent, mental concentration difficult, fatigue and blurred vision to be related to MENVEO. Additional details were provided as follows: The patient had somewhat severe headaches, on and off for almost 3 days. When the patient got very tired she begins to be unable to focus her thoughts or speak coherently. The patient was extremely fatigued. The first night after the vaccination, the patient slept almost like she was in a coma of some sort. The patient's parent's tried to move her to cover her 7 almost could not move her. The patient also had on and off blurred vision. On the next day, the patient woke up with facial swelling. No treatment was needed. The consent to contact reporter was provided.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of facial swelling in a 16-year-old female patient who received MENVEO (batch number M16014, expiry date unknown). On 21st February 2017, the patient received the 1st dose of MENVEO (intramuscular). On 21st February 2017, less than a day after receiving MENVEO, the patient experienced headache (serious criteria other: Medically Significant), incoherent (serious criteria other: Medically significant), mental concentration difficult (serious criteria other: Medically Significant), Fatigue and blurred vision. On 22nd February 2017, the patient experienced facial swelling (serious criteria other: Medically Significant). In February 2017, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the facial swelling, incoherent, mental concentration difficult and blurred vision were recovering/resolving and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the facial swelling, headache, incoherent, mental concentration difficult, fatigue and blurred vision to be related to MENVEO. Additional details were provided as follows: The patient had somewhat severe headaches, on and off for almost 3 days. When the patient got very tired she begins to be unable to focus her thoughts or speak coherently. The patient was extremely fatigued. The first night after the vaccination, the patient slept almost like she was in a coma of some sort. The patient's parent's tried to move her to cover her 7 almost could not move her. The patient also had on and off blurred vision. On the next day, the patient woke up with facial swelling. No treatment was needed. The consent to contact reporter was provided.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Disturbance in attention, Fatigue, Headache, Incoherent, Swelling face
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of facial swelling in a 16-year-old female patient who received MENVEO (batch number M16014, expiry date unknown). On 21st February 2017, the patient received the 1st dose of MENVEO (intramuscular). On 21st February 2017, less than a day after receiving MENVEO, the patient experienced headache (serious criteria other: Medically Significant), incoherent (serious criteria other: Medically significant), mental concentration difficult (serious criteria other: Medically Significant), Fatigue and blurred vision. On 22nd February 2017, the patient experienced facial swelling (serious criteria other: Medically Significant). In February 2017, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the facial swelling, incoherent, mental concentration difficult and blurred vision were recovering/resolving and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the facial swelling, headache, incoherent, mental concentration difficult, fatigue and blurred vision to be related to MENVEO. Additional details were provided as follows: The patient had somewhat severe headaches, on and off for almost 3 days. When the patient got very tired she begins to be unable to focus her thoughts or speak coherently. The patient was extremely fatigued. The first night after the vaccination, the patient slept almost like she was in a coma of some sort. The patient's parent's tried to move her to cover her 7 almost could not move her. The patient also had on and off blurred vision. On the next day, the patient woke up with facial swelling. No treatment was needed. The consent to contact reporter was provided.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Unresponsive to stimuli, Vision blurred
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of facial swelling in a 16-year-old female patient who received MENVEO (batch number M16014, expiry date unknown). On 21st February 2017, the patient received the 1st dose of MENVEO (intramuscular). On 21st February 2017, less than a day after receiving MENVEO, the patient experienced headache (serious criteria other: Medically Significant), incoherent (serious criteria other: Medically significant), mental concentration difficult (serious criteria other: Medically Significant), Fatigue and blurred vision. On 22nd February 2017, the patient experienced facial swelling (serious criteria other: Medically Significant). In February 2017, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the facial swelling, incoherent, mental concentration difficult and blurred vision were recovering/resolving and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the facial swelling, headache, incoherent, mental concentration difficult, fatigue and blurred vision to be related to MENVEO. Additional details were provided as follows: The patient had somewhat severe headaches, on and off for almost 3 days. When the patient got very tired she begins to be unable to focus her thoughts or speak coherently. The patient was extremely fatigued. The first night after the vaccination, the patient slept almost like she was in a coma of some sort. The patient's parent's tried to move her to cover her 7 almost could not move her. The patient also had on and off blurred vision. On the next day, the patient woke up with facial swelling. No treatment was needed. The consent to contact reporter was provided.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Full blood count, Laboratory test
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hemolytic anemia in a 65-year-old male patient who received BOOSTRIX. Co-suspect products included PNEUMOVAX 23. On 14th February 2017, the patient received BOOSTRIX and PNEUMOVAX 23. On 14th February 2017, 3 hrs after receiving BOOSTRIX, the patient experienced shortness of breath (serious criteria hospitalization), weakness (serious criteria hospitalization) and fatigability generalized (serious criteria hospitalization). In February 2017, the patient experienced hemolytic anemia (serious criteria hospitalization and GSK medically significant). The patient was treated with Steroids and medication unknown (Transfusion). On an unknown date, the outcome of the hemolytic anemia, shortness of breath, weakness and fatigability generalized were unknown. The reporter considered the hemolytic anemia, shortness of breath, weakness and fatigability generalized to be possibly related to BOOSTRIX. Additional details were provided as follows: The case was reported to the manufacturer. The patient received BOOSTRIX on the left deltoid. After experiencing the events, the patient continued on, thinking he would get better. On 27th February 2017, the patient was seen by the practice. A routine complete blood count (CBC) and chemistry panel was done. The patient's hemoglobin was at 7.4. The patient was sent to the emergency department with possible admission. The patient was admitted that day. In less than a month, the patient was diagnosed with hemolytic anemia and at time of report still remains hospitalized. The transfusions were difficult because the patient possesses antibodies that are tough to match. The reporter reported the incident to VAERS and to Merck for the PNEUMOVAX 23.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Fatigue, Full blood count, Haemoglobin
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hemolytic anemia in a 65-year-old male patient who received BOOSTRIX. Co-suspect products included PNEUMOVAX 23. On 14th February 2017, the patient received BOOSTRIX and PNEUMOVAX 23. On 14th February 2017, 3 hrs after receiving BOOSTRIX, the patient experienced shortness of breath (serious criteria hospitalization), weakness (serious criteria hospitalization) and fatigability generalized (serious criteria hospitalization). In February 2017, the patient experienced hemolytic anemia (serious criteria hospitalization and GSK medically significant). The patient was treated with Steroids and medication unknown (Transfusion). On an unknown date, the outcome of the hemolytic anemia, shortness of breath, weakness and fatigability generalized were unknown. The reporter considered the hemolytic anemia, shortness of breath, weakness and fatigability generalized to be possibly related to BOOSTRIX. Additional details were provided as follows: The case was reported to the manufacturer. The patient received BOOSTRIX on the left deltoid. After experiencing the events, the patient continued on, thinking he would get better. On 27th February 2017, the patient was seen by the practice. A routine complete blood count (CBC) and chemistry panel was done. The patient's hemoglobin was at 7.4. The patient was sent to the emergency department with possible admission. The patient was admitted that day. In less than a month, the patient was diagnosed with hemolytic anemia and at time of report still remains hospitalized. The transfusions were difficult because the patient possesses antibodies that are tough to match. The reporter reported the incident to VAERS and to Merck for the PNEUMOVAX 23.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Haemoglobin decreased, Haemolytic anaemia, Laboratory test, Transfusion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hemolytic anemia in a 65-year-old male patient who received BOOSTRIX. Co-suspect products included PNEUMOVAX 23. On 14th February 2017, the patient received BOOSTRIX and PNEUMOVAX 23. On 14th February 2017, 3 hrs after receiving BOOSTRIX, the patient experienced shortness of breath (serious criteria hospitalization), weakness (serious criteria hospitalization) and fatigability generalized (serious criteria hospitalization). In February 2017, the patient experienced hemolytic anemia (serious criteria hospitalization and GSK medically significant). The patient was treated with Steroids and medication unknown (Transfusion). On an unknown date, the outcome of the hemolytic anemia, shortness of breath, weakness and fatigability generalized were unknown. The reporter considered the hemolytic anemia, shortness of breath, weakness and fatigability generalized to be possibly related to BOOSTRIX. Additional details were provided as follows: The case was reported to the manufacturer. The patient received BOOSTRIX on the left deltoid. After experiencing the events, the patient continued on, thinking he would get better. On 27th February 2017, the patient was seen by the practice. A routine complete blood count (CBC) and chemistry panel was done. The patient's hemoglobin was at 7.4. The patient was sent to the emergency department with possible admission. The patient was admitted that day. In less than a month, the patient was diagnosed with hemolytic anemia and at time of report still remains hospitalized. The transfusions were difficult because the patient possesses antibodies that are tough to match. The reporter reported the incident to VAERS and to Merck for the PNEUMOVAX 23.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Fatigue, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hemolytic anemia in a 65-year-old male patient who received BOOSTRIX. Co-suspect products included PNEUMOVAX 23. On 14th February 2017, the patient received BOOSTRIX and PNEUMOVAX 23. On 14th February 2017, 3 hrs after receiving BOOSTRIX, the patient experienced shortness of breath (serious criteria hospitalization), weakness (serious criteria hospitalization) and fatigability generalized (serious criteria hospitalization). In February 2017, the patient experienced hemolytic anemia (serious criteria hospitalization and GSK medically significant). The patient was treated with Steroids and medication unknown (Transfusion). On an unknown date, the outcome of the hemolytic anemia, shortness of breath, weakness and fatigability generalized were unknown. The reporter considered the hemolytic anemia, shortness of breath, weakness and fatigability generalized to be possibly related to BOOSTRIX. Additional details were provided as follows: The case was reported to the manufacturer. The patient received BOOSTRIX on the left deltoid. After experiencing the events, the patient continued on, thinking he would get better. On 27th February 2017, the patient was seen by the practice. A routine complete blood count (CBC) and chemistry panel was done. The patient's hemoglobin was at 7.4. The patient was sent to the emergency department with possible admission. The patient was admitted that day. In less than a month, the patient was diagnosed with hemolytic anemia and at time of report still remains hospitalized. The transfusions were difficult because the patient possesses antibodies that are tough to match. The reporter reported the incident to VAERS and to Merck for the PNEUMOVAX 23.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Hypotension, Transfusion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hemolytic anemia in a 65-year-old male patient who received BOOSTRIX. Co-suspect products included PNEUMOVAX 23. On 14th February 2017, the patient received BOOSTRIX and PNEUMOVAX 23. On 14th February 2017, 3 hrs after receiving BOOSTRIX, the patient experienced shortness of breath (serious criteria hospitalization), weakness (serious criteria hospitalization) and fatigability generalized (serious criteria hospitalization). In February 2017, the patient experienced hemolytic anemia (serious criteria hospitalization and GSK medically significant). The patient was treated with Steroids and medication unknown (Transfusion). On an unknown date, the outcome of the hemolytic anemia, shortness of breath, weakness and fatigability generalized were unknown. The reporter considered the hemolytic anemia, shortness of breath, weakness and fatigability generalized to be possibly related to BOOSTRIX. Additional details were provided as follows: The case was reported to the manufacturer. The patient received BOOSTRIX on the left deltoid. After experiencing the events, the patient continued on, thinking he would get better. On 27th February 2017, the patient was seen by the practice. A routine complete blood count (CBC) and chemistry panel was done. The patient's hemoglobin was at 7.4. The patient was sent to the emergency department with possible admission. The patient was admitted that day. In less than a month, the patient was diagnosed with hemolytic anemia and at time of report still remains hospitalized. The transfusions were difficult because the patient possesses antibodies that are tough to match. The reporter reported the incident to VAERS and to Merck for the PNEUMOVAX 23.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives. Started on lower limbs and spread to the rest of body. Started around 10AM. Prescribed prednisolone and loratadine.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. From 30-DEC-2016 to 02-FEB-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M033216, expiration date 09-JAN-2018 (strength, route of administration, dose, and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was more than -10 Celsius degrees but less than 8 Celsius degrees and the timeframe was 768 hours. Also, they stated that previous temperature excursion was not involved, and this information was no registered in a digital data logger. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000473:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from an registered nurse referring to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (strength, route of administration, dose, frequency, lot# and expiration date were unspecified by the reporter) for prophylaxis. The reporter stated that the administered vaccines experienced two temperature excursions: the first one between 32F and 36F for 57 hours, and the other one between 46F and 77F for 24 hours. No previous temperature excursions were reported and the reported information was not registered in a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000341: US-009507513-1703USA000340.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a unspecified patients of unknown ages and genders. Information regarding medical history, drug reactions, allergies, concomitant therapies and concurrent conditions was not provided. Since 03-JAN-2017, the unspecified patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # M031574 and expiration date 11-NOV-2018, lot# M032649 and expiration date 11-NOV-2018 (route of administration, strength, dose and frequency were unknown by the reporter), for prophylaxis. The reporter stated that the temperature excursion of the vaccine was 0 Celsius (C) to 2 Celsius (C) and the time frame was 10 hours, also she stated that a previous temperature excursion was not involved, this information was registered in a digital data logger. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA011537: US-009507513-1702USA011538.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a unspecified patients of unknown ages and genders. Information regarding medical history, drug reactions, allergies, concomitant therapies and concurrent conditions was not provided. Since 03-JAN-2017, the unspecified patients were vaccinated with improperly stored doses VAQTA lot# M033611 and expiration date 02-MAR-2018 (route of administration, strength, dose and frequency were unknown by the reporter), for prophylaxis. The reporter stated that the temperature excursion of the vaccine was 0 Celsius (C) to 2 Celsius (C) and the time frame was 10 hours, also she stated that a previous temperature excursion was not involved, this information was registered in a digital data logger. No adverse effect was reported. This is one of several cases received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA010881: US-009507513-1702USA011538: