chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: The shot was given into the left deltoid within the safe zone (triangle). Patient reported that the pain in the arm did not subside after the shot and continued to bother her with a 7/10 pain. There was tingling down in the fingers, general arm weakness, and limited mobility of the left arm. Patient was consulted and told to follow up with her primary care provider.
Sex: M
Vaccine: HEP
Symptoms: Mental status changes, Myoclonus, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myoclonic jerks in a male patient who received ENGERIX B (batch number 2KJ42, expiry date unknown). On an unknown date, the patient received ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, the patient experienced myoclonic jerks, mental status changes and fever. On an unknown date, the outcome of the myoclonic jerks, mental status changes and fever were unknown. It was unknown if the reporter considered the myoclonic jerks, mental status changes and fever to be related to ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The hepatitis B vaccine was administered to a healthy patient other than having pacemaker. The patient experienced myoclonic jerks, altered mental status and high fever.
Sex: U
Vaccine: DTAPIPV
Symptoms: Erythema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of redness of legs in a patient who received KINRIX (batch number 7559R, expiry date unknown). On 29th December 2017, the patient received KINRIX. On an unknown date, less than a month after receiving KINRIX, the patient experienced redness of legs and pharmaceutical product complaint. On an unknown date, the outcome of the redness of legs and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the redness of legs to be related to KINRIX. Additional details were provided as follows: The Patient experienced baseball size redness on thigh then the redness got bigger and was now covering the entire thigh. This case has been linked to the case US2018005860 and US2018005861 reported by the same reporter.
Sex: M
Vaccine: HEPAB
Symptoms: Bronchitis, Condition aggravated, Cough, Malaise, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a male patient who received TWINRIX. Concurrent medical conditions included bronchitis. On an unknown date, the patient received the 1st dose of TWINRIX. On an unknown date, less than a month after receiving TWINRIX, the patient experienced limbs stiffness, cough and sickness. On an unknown date, the outcome of the limbs stiffness and cough were recovered/resolved and the outcome of the sickness was unknown. The reporter considered the limbs stiffness to be related to TWINRIX. The reporter considered the cough to be unrelated to TWINRIX. It was unknown if the reporter considered the sickness to be related to TWINRIX. The reporter considered the cough to be unrelated to TWINRIX. It was unknown if the reporter considered the sickness to be related to TWINRIX. Additional information was provided as follows: This case was reported by a patient himself. The age at vaccination was not reported. After the shot the patient had some stiffness in the arm where it was received. The patient was due for his 2nd dose on 3rd January 2018, but 3 weeks after the first dose he had walked his dog in very cold temperatures and it irritated his pre-existing bronchitis causing him to have a lot of coughing. His physician decided not to administer the vaccine on 3rd January 2018 due to him being too sick, but he did get an inhaler and the coughing resolved shortly after starting the inhaler. The patient had still not received his 2nd dose at the time of this report, but he might receive it later on the reporting day. The reporter declined to provide any additional information.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted.
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a week after receiving dTpa vaccine, the patient experienced generalized urticaria. The patient was treated with prednisone. On an unknown date, the outcome of the generalized urticaria was recovering/resolving. It was unknown if the reporter considered the generalized urticaria to be related to dTpa vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient was given TDAP about 7 weeks before the reporting date in 2017 and within 2 days she experienced hives all over the body. The patient tried to get rid of it herself and then she went to her doctor and got prednisone. After that the hives came back. They are somewhat better now. The side effects made it very miserable for her to take. The patient provided name of her physician's office. The patient was looking forward to hear from GlaxoSmithKline.
Age: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 5-year-old patient who received KINRIX (batch number 75F53, expiry date unknown). Concomitant products included TYLENOL. On 12th January 2018, the patient received KINRIX. In January, 2018, less than a week after receiving KINRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: In January 2018, the patient's body temperature was recorded as 102.8 and 103.6 degree Fahrenheit. The batch number reported for KINRIX (75S53) did not exist and was updated to 75F53 as per sales database.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling face
Clinical narrative: Case number PHHY2016US176626 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 650723) on 21 Dec 2016. This report refers to a 30 year old female patient. The patient had no medical history or current conditions. Her concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185284) into left arm on 25 Aug 2016. Within one hour of vaccination, the patient started to itch and developed facial swelling. Following the events the patient visited emergency room. She was treated with prednisone 20 mg taper and diphenhydramine 25 mg (100 mg dose) with no relief. The patient finally recovered from the events in approximately 2 days. The events were reported as non-serious, but the event facial swelling was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 32.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood glucose normal, Cooling therapy, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Case number PHHY2016US178035 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 653179) on 21 Dec 2016. This report refers to a 32 year old male patient. His medical history was not reported. He had no current conditions. His concomitant medications were not reported. He was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168705) intramuscularly in the left arm on 13 Sep 2016. On the same day about 15 minutes after vaccination, the patient experienced dizziness/lightheadedness. Cold compress was applied and his blood pressure was taken by the pharmacist and it was 154/92 (units and normal values were not reported). The emergency number 911 was called after the onset of heavy breathing. His blood pressure was again measured by the emergency medical technician (EMT) and it was 132/84. His glucose was 87 (units and normal values were not reported) and portable electrocardiogram (EKG) results were unremarkable. The events outcome was unknown. The events were reported as non-serious, but the event heavy breathing was upgraded as medically significant as per the information available in the source documents. The causality of the events was not reported.
Age: 41.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Fall, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal
Clinical narrative: Case number PHHY2016US175495, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 653269) website on 21 Dec 2016. This case also contains QA reference number: 1018729. This report refers to a 41 years old male patient. Past medical history was not reported. Current conditions included as septicemia and diabetes. Procedure included as toe amputation. Concomitant medications was not reported. The patient was vaccinated with FLULCELVAX (batch number: 174275 and expiry date: 30 Jun 2016) and PREVNAR (other manufacturer, batch number: L019306), both intramuscularly on 29 Feb 2016. On 23 Mar 2016, the patient experienced unsteady gait, numbness in feet and legs, falling and shaking. On 04 May 2016, a spinal tap was performed which revealed Guillain-Barre Syndrome (GBS). The patient was hospitalized due to the events on an unknown date for 13 days. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious. The causality of the events was not reported. The quality assurance department reported that, batch review report (reference number: 1018729) received from quality assurance department on 24 Jan 2017: Based on the document review, it was stated that the concerned FLUCELVAX, batch number: 174275, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1018729) on 28 Dec 2016 and 24 Jan 2017 (Combined report): Updated QA reference number and added suspect drug information (expiry date). Non significant follow up report received from a Quality Assurance Department (QA reference number: 1018729) on 24 Jan 2017: Updated batch review report (Conclusion added).
Age: 41.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Tremor
Clinical narrative: Case number PHHY2016US175495, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 653269) website on 21 Dec 2016. This case also contains QA reference number: 1018729. This report refers to a 41 years old male patient. Past medical history was not reported. Current conditions included as septicemia and diabetes. Procedure included as toe amputation. Concomitant medications was not reported. The patient was vaccinated with FLULCELVAX (batch number: 174275 and expiry date: 30 Jun 2016) and PREVNAR (other manufacturer, batch number: L019306), both intramuscularly on 29 Feb 2016. On 23 Mar 2016, the patient experienced unsteady gait, numbness in feet and legs, falling and shaking. On 04 May 2016, a spinal tap was performed which revealed Guillain-Barre Syndrome (GBS). The patient was hospitalized due to the events on an unknown date for 13 days. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious. The causality of the events was not reported. The quality assurance department reported that, batch review report (reference number: 1018729) received from quality assurance department on 24 Jan 2017: Based on the document review, it was stated that the concerned FLUCELVAX, batch number: 174275, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1018729) on 28 Dec 2016 and 24 Jan 2017 (Combined report): Updated QA reference number and added suspect drug information (expiry date). Non significant follow up report received from a Quality Assurance Department (QA reference number: 1018729) on 24 Jan 2017: Updated batch review report (Conclusion added).
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US179448, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 656706) website on 21 Dec 2016. This report refers to a 26-years-old female patient. Past medical history was not reported. Current condition included allergy to mango oil. The patient's vaccination history included that she had been receiving seasonal flu shots for as long as she could remember. Concomitant medications included over the counter drugs Vitamin B12, Vitamin B6, folic acid, magnesium calcium and zinc. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618501) intramuscularly in left arm on 29 Sep 2016. On 30 Sep 2016 (Friday) after vaccination, the patient experienced that her legs became itchy in the morning and that eventually the itch spread to her arms and torso. In the evening she started developing hives. On the next day morning (Saturday) the hives were covering the majority of her body. She was given a prescription (unspecified details) by her physician. On the next day morning (Sunday) she woke up even worse with severe itching, pain or sensitivity so her physician instructed her go to urgent care where she was given an IV (unspecified details) which helped to clear it up however next day (Monday) morning she woke up with hives starting to develop again. She took the medication that was prescribed (unspecified details) and it helped calm it down. The outcome of events was reported as condition unchanged. The seriousness was not reported. The seriousness assessment of the events pain, pruritus and urticaria was upgraded (medically significant) based on the information available in the source document.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2016US178433, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 658048) website on 21 Dec 2016. This report refers to a 40 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618701) intramuscularly into the left arm on 31 Aug 2016. On 20 Sep 2016, the patient experienced rash on entire body. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious. The causality of the event was not reported. The seriousness assessment of the events was upgraded (medically significant) based on the information available in the source document.
Sex: U
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2017US010787 is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 659535) on 23 Jan 2017. This report refers to a patient of unknown demographics. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown start date. Two weeks after vaccination, the patient experienced Bell's palsy. Lab data and corrective treatment were not reported. The outcome of the event was not reported. The event was reported as non-serious but was upgraded as medically significant based on NVS-IME list. The causality of the event was not reported.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US178987, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 659617) website on 21 Dec 2016. This report refers to a 30 years old male patient. Past medical history and concomitant medications  were not reported. Current condition included sulpha allergy. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185325A) in left arm on 26 Sep 2016. On 27 Sep 2016 (reported as approximately 30 hrs after vaccination), the patient reported broke out with hives all over body. The patient was treated with 6 BENADRYL Liqui Gels (25 mg) over next 24 hrs. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious. The causality of the event was not reported. The seriousness assessment of the event was upgraded to medically significant based on the information available in the source document.
Age: 68.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2017US028848 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660481) website on 21 Feb 2017. This report refers to a 68 years old male patient. It was reported that patient had no medical history and current illness. Concomitant medications were not reported. The patient was vaccinated with first dose of FLUCELVAX QUADRIVALENT (batch number: 165703) intramuscularly into the right arm on 15 Oct 2016. It was reported that, the patient received the vaccination after confirming that he never had any severe reactions previously. On the same day after vaccination, the patient ended up fainting minutes, but became conscious soon after. It was reported that the patient afterwards stated that he had this happened before some years back (details unspecified). The final outcome of the event was reported as complete recovery on 15 Oct 2016. The event was assessed as non serious by the reporter and causality was not reported. Seriousness assessment for the event syncope was upgraded (medically significant) based on the information available in the source document.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Laboratory test normal, Lethargy, Myalgia
Clinical narrative: Case number PHHY2017US029849 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661937) website on 21 Feb 2017. This report refers to a 52 year old male patient. Medical history was reported as none. Concomitant medications included ASA, fish oil and Vit C supplements. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185327) intramuscularly into right arm on 04 Oct 2016. After vaccination on 06 Oct 2016, patient woke up with lethargy, progressive muscle/joint aches and uncontrolled chills. It was reported that the patient did not check body temperature. Patient also experienced rash, small pinhead size red flat dots all over body except on face and no itching. The lab tests were performed on 06 Oct 2016 and the results were within normal limits (results unspecified). It was reported that chills and aches were resolved in 24 hours and rash resolved in 7 days. The outcome of the events chills, muscle and joint aches were reported as complete recovery on an unknown date (reported as within 24 hours), for the events rash generalized and rash erythematous was reported as complete recovery on an unknown date (reported as resolved in 24 hours) and for the other event was not reported. Seriousness of the events were reported as non-serious and causality was not reported. Seriousness assessment of the event rash generalized was upgraded to (medically significant) based on the information available in the source document.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Case number PHHY2017US029849 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661937) website on 21 Feb 2017. This report refers to a 52 year old male patient. Medical history was reported as none. Concomitant medications included ASA, fish oil and Vit C supplements. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185327) intramuscularly into right arm on 04 Oct 2016. After vaccination on 06 Oct 2016, patient woke up with lethargy, progressive muscle/joint aches and uncontrolled chills. It was reported that the patient did not check body temperature. Patient also experienced rash, small pinhead size red flat dots all over body except on face and no itching. The lab tests were performed on 06 Oct 2016 and the results were within normal limits (results unspecified). It was reported that chills and aches were resolved in 24 hours and rash resolved in 7 days. The outcome of the events chills, muscle and joint aches were reported as complete recovery on an unknown date (reported as within 24 hours), for the events rash generalized and rash erythematous was reported as complete recovery on an unknown date (reported as resolved in 24 hours) and for the other event was not reported. Seriousness of the events were reported as non-serious and causality was not reported. Seriousness assessment of the event rash generalized was upgraded to (medically significant) based on the information available in the source document.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Urticaria
Clinical narrative: Case number PHHY2017US015089, is an initial spontaneous report received Vaccine Adverse Events Reporting System (VAERS reference number: 665139) on 23 Jan 2017. This report refers to a 09 years old male patient. Historical condition was not reported. Current condition included allergies to different things but never to flu vaccines. Concomitant medication was not reported. The patient was vaccinated at school with FLUCELVAX QUADRIVALENT (batch number: 186111) intramuscularly into left arm on 02 Nov 2016. On same day (20 minutes after vaccination), the patient started having hives/rash breaking out all over arms/backs/chest/neck. The patient was treated with BENADRYL 75 mg. Hives/rash faded when the parent picked up the patient and was going to doctor. On 10 Nov 2016 the school nurse stated that, the patient's mother did not picked up the child and did not go to doctor. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events urticaria and rash was upgraded to medically significant based on the information available in the source document.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Case number PHHY2017US015259, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 667318) website on 23 Jan 2017. This report refers to a 04 years old male patient. Past medical history was not reported. Current condition included as craniosynostosis and otitis media on 19 Oct 2016. Concomitant medication included as Acetaminophen cherry flavor. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185886) into the left leg, intramuscularly on 14 Nov 2016 at 11:55 am. The patient also vaccinated with KINRIX (other manufacture, batch number: JD797) into the right leg intramuscularly and first dose of PROQUAD (other manufacture, batch number: M014304) into the left leg subcutaneously on 14 Nov 2016 at 11:55 am. The patient also received TYLENOL on 14 Nov 2016 at 11:55 am. On the same day after vaccination at 12:10 pm, the patient experienced itching and was covered in hives head to toe, swelling in face and bottom lip. The patient was treated with BENADRYL on 14 Nov 2016 at 12:20 hours. Patient monitored for 01 hour. Patient vitals were taken every 15 minutes and were found to be stable. No respiratory distress was observed. Swelling and hives decreased at discontinuation of product (unspecified name). Patient was instructed to monitor for increased symptoms and BENADRYL was required for every 6 hours. The outcome of the events was reported as complete recovery as of 15 Nov 2016 at 08:38 hours upon a follow up call. The seriousness and causality of the events were not reported. The seriousness assessment of the events swelling face, lip swelling, pruritus and urticarial was upgraded to serious (medically significant) based on the information available in the source document.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Redness, skin rash, itching.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 49-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 26th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 16th January 2018, the patient experienced contusion and pain. On an unknown date, the outcome of the contusion, pain and inappropriate age at vaccine administration were unknown. The reporter considered the contusion to be probably related to SHINGRIX. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in right deltoid. A 48 years old patient received SHINGRIX, which led to inappropriate age at vaccine administration. The patient visited the Clinic at some point and reported that 21 days after receiving SHINGRIX, she experienced bruising and pain behind her arm. The reporting pharmacist did not administer the vaccine and she did not have any additional details regarding the event at this time.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 49-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 26th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 16th January 2018, the patient experienced contusion and pain. On an unknown date, the outcome of the contusion, pain and inappropriate age at vaccine administration were unknown. The reporter considered the contusion to be probably related to SHINGRIX. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in right deltoid. A 48 years old patient received SHINGRIX, which led to inappropriate age at vaccine administration. The patient visited the Clinic at some point and reported that 21 days after receiving SHINGRIX, she experienced bruising and pain behind her arm. The reporting pharmacist did not administer the vaccine and she did not have any additional details regarding the event at this time.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Drug administered to patient of inappropriate age, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 49-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 26th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 16th January 2018, the patient experienced contusion and pain. On an unknown date, the outcome of the contusion, pain and inappropriate age at vaccine administration were unknown. The reporter considered the contusion to be probably related to SHINGRIX. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in right deltoid. A 48 years old patient received SHINGRIX, which led to inappropriate age at vaccine administration. The patient visited the Clinic at some point and reported that 21 days after receiving SHINGRIX, she experienced bruising and pain behind her arm. The reporting pharmacist did not administer the vaccine and she did not have any additional details regarding the event at this time.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Pain, Product administered at inappropriate site, Pruritus
Clinical narrative: Patient was given injection in the forearm which resulted in a 2 1/2 inch diameter local reaction requiring hydrocortisone and antibiotics including two extra office visits to manage.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin discolouration, Skin warm, Swelling, Tenderness, Wound secretion
Clinical narrative: Patient was given injection in the forearm which resulted in a 2 1/2 inch diameter local reaction requiring hydrocortisone and antibiotics including two extra office visits to manage.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Local reaction
Clinical narrative: Patient was given injection in the forearm which resulted in a 2 1/2 inch diameter local reaction requiring hydrocortisone and antibiotics including two extra office visits to manage.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin discolouration, Skin disorder
Clinical narrative: Patient was given injection in the forearm which resulted in a 2 1/2 inch diameter local reaction requiring hydrocortisone and antibiotics including two extra office visits to manage.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Patient was given injection in the forearm which resulted in a 2 1/2 inch diameter local reaction requiring hydrocortisone and antibiotics including two extra office visits to manage.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site reaction, Muscle spasms, Pain
Clinical narrative: Severe muscle cramping throughout arm where injection was given, as well as in the pinky of that hand and extending up the shoulder and into the left side of my neck. Pain within the range of normal was felt immediately after the vaccine, but the pain began to get worse at around 9 PM (3 hours post-vaccination). Since, the pain has developed into a cramping feeling, has gotten worse, and spread.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: After receiving the PPV23 shot I have symptoms of Left arm pain around the Left shoulder joint. Limited range of motion in left shoulder. Constant shooting pain up left arm. Tingling sensation in the fingers of the left hand.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Wrong technique in device usage process
Clinical narrative: This spontaneous report was received from a nurse via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (dose, frequency were not provided) lot# N021092 and expiration date 11-MAR-2019, for prophylaxis. On an unknown date, the nurse had difficulty opening ROTATEQ tubes and she was using a sterile needle to puncture the dosing tubes, open and administer doses. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JAN-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB one time dose (lot # M001579, Expiry date: M001579) intramuscular for prophylaxis, which experienced a temperature excursion. It was unknown if there were previous temperature excursions. It was unknown if data logger was involved. There was no product quality complaint reported. As of 20-JAN-2018, the patient did not report an adverse reaction.
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Headache, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a 14-year-old female patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, 12 hrs after receiving BEXSERO, the patient experienced headache, nausea and feels awful. On an unknown date, the outcome of the headache, nausea and feels awful were unknown. It was unknown if the reporter considered the headache, nausea and feels awful to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. In the morning at 9:00, the patient received 2nd dose of BEXSERO and in the evening at 9:00 pm, the patient experienced feels terrible, headache, nausea, just gross. The reporter looked on web site and saw the patient experienced common side effects but the web site did not say how long she would experience them.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Patient developed LEFT shoulder pain within 2 hours, which was progressively worse over several weeks and had continued for several months. She treated with NSAIDS 2-3 times per day, heat and stretching. She denies weakness, numbness or tingling, other than a little tingling to her arm immediately after receipt. She was sitting, vaccinator was standing. The description of the site placement describes appropriate placement. She has no history of adverse reactions with immunizations. No history of injury to the shoulder, which is her nondominant arm. She denies any local site reaction such as erythema, edema. MRI was unremarkable; she was sent for PT. At follow-up 22 JAN 2018 symptoms nearly resolved.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Antinuclear antibody negative, Asthenia, Blood thyroid stimulating hormone normal, Discomfort, Full blood count normal
Clinical narrative: Pt states Tdap given on 12/27/17, couple hours later felt tingling/numbness to (L) arm. Worsened one day later radiating to Bilateral arms and has now worsened to whole body. Pt sates onset of itch discomfort for the past week, chest palpitations for the past 3 days with no improvement. OTC AA, ADVIL, BENADRYL with no help. Symptoms progressed to fluctuating tingling of multiple parts of body, then in second week shooting pains, by third week fluctuating weakness and tingling.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain, Palpitations, Paraesthesia, Pruritus
Clinical narrative: Pt states Tdap given on 12/27/17, couple hours later felt tingling/numbness to (L) arm. Worsened one day later radiating to Bilateral arms and has now worsened to whole body. Pt sates onset of itch discomfort for the past week, chest palpitations for the past 3 days with no improvement. OTC AA, ADVIL, BENADRYL with no help. Symptoms progressed to fluctuating tingling of multiple parts of body, then in second week shooting pains, by third week fluctuating weakness and tingling.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Thyroxine free normal, Vitamin B12 normal
Clinical narrative: Pt states Tdap given on 12/27/17, couple hours later felt tingling/numbness to (L) arm. Worsened one day later radiating to Bilateral arms and has now worsened to whole body. Pt sates onset of itch discomfort for the past week, chest palpitations for the past 3 days with no improvement. OTC AA, ADVIL, BENADRYL with no help. Symptoms progressed to fluctuating tingling of multiple parts of body, then in second week shooting pains, by third week fluctuating weakness and tingling.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Heart rate increased, Lethargy
Clinical narrative: Felt rapid heart rate, headache and dizziness a few hours after the shot. Went to doctor the next day and the nurse took my blood pressure which was normal. Also no fever at the time. Nurse told me to monitor. Still feel lethargic.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Dry eye, Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 28-FEB-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-MAR-2013, the patient was treated at an Eye Center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and herpes zoster ophthalmicus, a damaging eye condition of zoster infections of the eye. The patient was prescribed prednisone, famciclovir, and cyclosporine ophthalmic emulsion (RESTASIS EYEDROPPERETTE) for management of her painful condition. On or about 13-MAY-2013, she sought subsequent treatment at an Eye Center for ongoing and worsening symptoms, which was then diagnosed as keratoconjunctivitis sicca, a chronic condition that damages the eye and can also lead to blindness. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 28-FEB-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-MAR-2013, the patient was treated at an Eye Center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and herpes zoster ophthalmicus, a damaging eye condition of zoster infections of the eye. The patient was prescribed prednisone, famciclovir, and cyclosporine ophthalmic emulsion (RESTASIS EYEDROPPERETTE) for management of her painful condition. On or about 13-MAY-2013, she sought subsequent treatment at an Eye Center for ongoing and worsening symptoms, which was then diagnosed as keratoconjunctivitis sicca, a chronic condition that damages the eye and can also lead to blindness. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-JUN-2014, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-JAN-2016, the patient was treated at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed VALTREX, and PERCOCET for management of her painful and persistent symptoms. On or about 05-APR-2016, the patient sought subsequent treatment for ongoing and worsening symptoms, which was then diagnosed as herpes zoster dermatitis. The patient was prescribed VALTREX, and PERCOCET and LOTRISONE for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 12-Feb-2016 the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-Oct-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Acne, Amnesia, Asthenia, Back pain, Burning sensation
Clinical narrative: Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Cognitive disorder, Confusional state, Depression, Dizziness, Fatigue
Clinical narrative: Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Hypersensitivity, Hypoaesthesia, Inappropriate affect, Migraine, Muscular weakness
Clinical narrative: Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Myalgia, Paraesthesia, Rash, Skin discolouration, Syncope
Clinical narrative: Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Tinnitus
Clinical narrative: Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Antinuclear antibody negative, Borrelia test negative, C-reactive protein normal, Confusional state, Disturbance in attention
Clinical narrative: Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Dizziness, Full blood count normal, Headache, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, HPV9
Symptoms: Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Raynaud's phenomenon, Red blood cell sedimentation rate normal
Clinical narrative: Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.