chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Gait disturbance, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back pain in an unspecified number of adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced back pain, walking difficulty and muscle spasm. On an unknown date, the outcome of the back pain, walking difficulty and muscle spasm were unknown. It was unknown if the reporter considered the back pain, walking difficulty and muscle spasm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured adult as per vaccine indication. The patients had no history of back pain. During conversation with the reporter, the reporter mentioned that he and his wife talked to their physician and physician was concerned about the back pain, muscle spasms and difficulty walking after receiving the SHINGRIX. The physician said to the reporter that, he had seen similar symptoms in other people. The reporter did not have specific demographics of other patients to report. This is 1 of the 4 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in an unspecified numbers of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. During the conversation with the reporter, the reporter stated that, he had been talking with his friends and friends of friends, who said they had terrible symptoms with SHINGRIX. The reporter did not have specific demographics of the patients to report. The reporter did not have specific events reported on the other patients. This is 1 of 4 cases, reported by the same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th September 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In June 2018, less than a month after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On 4th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: Sometime in late June 2018, the patient received 1st dose of SHINGRIX. The patient experienced arm soreness and redness at the injection site. The patient received 2nd dose of SHINGRIX subcutaneously behind the right arm, which led to inappropriate route of vaccination. The physician's contact details was provided. This case has been linked with US2018163141, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site pain, Muscle spasms, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain. The patient was treated with ADVIL, TYLENOL and muscle relaxants. On an unknown date, the outcome of the injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient experienced redness and tenderness at the injection site. The patient's neck and back were aching, along with excruciating pain. The patient had muscle spasms all around the neck, back and her shoulder. She went back to the clinic on 18th August 2018 and she was prescribed muscle relaxant medication. The physician advised her to take ADVIL and TYLENOL every 6 hours. Later on the same day she also contacted her physician. It lasted for total of 14 days and then she recovered. The patient gave permission to contact her health care provider. No further details were provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain. The patient was treated with ADVIL, TYLENOL and muscle relaxants. On an unknown date, the outcome of the injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient experienced redness and tenderness at the injection site. The patient's neck and back were aching, along with excruciating pain. The patient had muscle spasms all around the neck, back and her shoulder. She went back to the clinic on 18th August 2018 and she was prescribed muscle relaxant medication. The physician advised her to take ADVIL and TYLENOL every 6 hours. Later on the same day she also contacted her physician. It lasted for total of 14 days and then she recovered. The patient gave permission to contact her health care provider. No further details were provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 56-year-old female patient who received Shingrix for prophylaxis. On 14th June 2018, the patient received the 1st dose of Shingrix. On 14th June 2018, less than a day after receiving Shingrix, the patient experienced hives (serious criteria other: As per reporter), painful rash (serious criteria other: As per reporter) and itchy rash (serious criteria other: As per reporter). The patient was treated with Benadryl. On an unknown date, the outcome of the hives, painful rash and itchy rash were recovered/resolved. It was unknown if the reporter considered the hives, painful rash and itchy rash to be related to Shingrix. Additional details were reported as follows: The health care professional (HCP) stated that, the patient reported a moderate to severe painful, itching rash with hives within an hours after vaccination with Shingrix. HCP stated patient was advised to take Benadryl for this reaction at that time. No further treatment was needed. Shingrix was administered at a local pharmacy, but did not have vaccine information for the adverse event.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 76-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 7th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 7th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 8th September 2018, the patient experienced injection site erythema. On 10th September 2018, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the cellulitis and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a nurse practitioner (NP). The patient received SHINGRIX vaccine in the left arm inadvertently administered in to the soft tissue above the elbow and not intramuscularly, which led to wrong route of vaccination. Two days after receiving SHINGRIX, the patient had a pink spot at the injection site and 3 days after receiving SHINGRIX, the patient developed cellulitis (not further specified). The reported batch number for SHINGRIX did not exist and was updated from M7784 to M77B4 as per sales database.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in an adult female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received SHINGRIX. On 17th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching. The patient was treated with ASPERCREME. On an unknown date, the outcome of the injection site itching was recovered/resolved. It was unknown if the reporter considered the injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had vaccination for shingles on 17th July 2018, since then where the shot was given the patient had severe itching on upper arm, it had just quit itching about a week ago on 1st September 2018. It was so bad the patient could not sleep without ASPERCREME on it. The patient questioned if it could be a reaction to the shot and at the time of reporting the patient was afraid to get the 2nd one which she knew she needed to be immune.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of hives in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced hives. The patient was treated with steroids nos. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by certified medical assistant (CMA). The age at the vaccination was not reported. The patient experienced hive like symptoms within the first 12 hours and worsened within the next 24 hours. The patient followed up the clinic on 9th August 2018, and that is when he received oral and intramuscular steroids. The reporter agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced flu like symptoms. This case has been linked with case US2018GSK164083, reported by the same reporter (patient's daughter). The reporter did not agree to be contacted for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable. The reporter stated that her sister in law told her that a lot of people had a lot of reactions. The lot of people were not feeling well. The reporter provided this information regarding that statement. The reporter had denied permission to contact their physician. This case was linked with case US2018162463, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Inappropriate schedule of product administration, Pain in extremity, Wrong product administered
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 4th August 2018, refer case US2018162430). Concurrent medical conditions included solitary kidney. On 5th September 2018, the patient received the 2nd dose of SHINGRIX. On 5th September 2018, unknown after receiving SHINGRIX, the patient experienced wrong vaccine administered and drug dose administration interval too short. In September 2018, the patient experienced pain in arm and bone pain. Rechallenge with SHINGRIX was positive. On 7th September 2018, the outcome of the pain in arm and bone pain were recovered/resolved. On an unknown date, the outcome of the wrong vaccine administered and drug dose administration interval too short were unknown. It was unknown if the reporter considered the pain in arm and bone pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient inadvertently received 2nd dose SHINGRIX earlier than recommended when he was supposed to receive Hepatitis B vaccine, which led to shortening of the vaccination schedule and wrong vaccine administered. The patient stated that his bones were hurting and arm was sore after receiving the dose of SHINGRIX. The patient was feeling better at the time of reporting. No further information was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination were not reported. The reporter (daughter of the patient) stated that the patient experienced pain at injection site and flu like symptoms after receiving the SHINGRIX. This case has been linked with case US2018GSK077003 and US2018GSK164087 reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Productive cough, Rash pruritic, Swelling
Clinical narrative: Patient states: itching/rash on left arm started 5-31-18 at night (estimated time reported as 10 PM). Self treated with BENADRYL. Patient comes to ER on 6-3-18 at 11:08 AM with complaint of cough with mucus and swelling which started that morning (on 6-3-18). Patient denies: swallowing difficulty, breathing, fevers, chills, palpitations or nausea and vomiting. Treatment: Methylprednisolone 125 mg once, diphenhydramine 25 mg once, famotidine 20 mg once.
Age: 1.33
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PT HAD REDNESS SWELLING AND ITCHING NEXT MORNING AT INJECTION SITE VISITED DR ON MONDAY 9/17 HE STARTED PT ON LEVAQUIN 500MG DAILY FOR 5 DAYS RECCOMMENDED 2ND SHOT BE GIVEN IN LEFT ARM.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient stated their arm was swollen, red, warm to the touch and itchy. When she came in on Sunday the arm was examined it looked fine. But she stated it was still warm to the touch.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Corneal scar, Eye discharge, Eye disorder, Iridocyclitis, Pupillary disorder
Clinical narrative: 4 days after the vaccination patient mentioned that she thought something was wrong with her right eye. She said it was felt funny and was kind of blurry. It looked ok so we thought it might be her contact. She mentioned it again a few days later (or I asked, can't remember). It was still bothering her. She said it was blurry and felt wet when she woke up. It didn't look red or irritated and didn't hurt or itch. I told her to take a break from contacts for a few days but there was no improvement or apparent increase in any obvious symptoms. She was seen by her optometrist on 6/27 who sent her to an ophthalmologist who diagnosed her with anterior uveitis in both eyes, even though patient had only complained about the right eye. She had scarring and sticking of the pupil to the cornea. She was on atropine drops and steroid drops all summer. It was quiet at the end of August but she went for a followup appointment on 9/14/18 with Dr. where she is a student and it was come back in the right eye. She is on drops again. She never had this problem until a few days after receiving the TRUMENBA vaccine.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vision blurred
Clinical narrative: 4 days after the vaccination patient mentioned that she thought something was wrong with her right eye. She said it was felt funny and was kind of blurry. It looked ok so we thought it might be her contact. She mentioned it again a few days later (or I asked, can't remember). It was still bothering her. She said it was blurry and felt wet when she woke up. It didn't look red or irritated and didn't hurt or itch. I told her to take a break from contacts for a few days but there was no improvement or apparent increase in any obvious symptoms. She was seen by her optometrist on 6/27 who sent her to an ophthalmologist who diagnosed her with anterior uveitis in both eyes, even though patient had only complained about the right eye. She had scarring and sticking of the pupil to the cornea. She was on atropine drops and steroid drops all summer. It was quiet at the end of August but she went for a followup appointment on 9/14/18 with Dr. where she is a student and it was come back in the right eye. She is on drops again. She never had this problem until a few days after receiving the TRUMENBA vaccine.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abnormal sensation in eye, Angiogram, Antinuclear antibody increased, Blood test, Borrelia test negative
Clinical narrative: 4 days after the vaccination patient mentioned that she thought something was wrong with her right eye. She said it was felt funny and was kind of blurry. It looked ok so we thought it might be her contact. She mentioned it again a few days later (or I asked, can't remember). It was still bothering her. She said it was blurry and felt wet when she woke up. It didn't look red or irritated and didn't hurt or itch. I told her to take a break from contacts for a few days but there was no improvement or apparent increase in any obvious symptoms. She was seen by her optometrist on 6/27 who sent her to an ophthalmologist who diagnosed her with anterior uveitis in both eyes, even though patient had only complained about the right eye. She had scarring and sticking of the pupil to the cornea. She was on atropine drops and steroid drops all summer. It was quiet at the end of August but she went for a followup appointment on 9/14/18 with Dr. where she is a student and it was come back in the right eye. She is on drops again. She never had this problem until a few days after receiving the TRUMENBA vaccine.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Corneal scar, Iridocyclitis, Iris adhesions, Keratitis, Lacrimation increased
Clinical narrative: 4 days after the vaccination patient mentioned that she thought something was wrong with her right eye. She said it was felt funny and was kind of blurry. It looked ok so we thought it might be her contact. She mentioned it again a few days later (or I asked, can't remember). It was still bothering her. She said it was blurry and felt wet when she woke up. It didn't look red or irritated and didn't hurt or itch. I told her to take a break from contacts for a few days but there was no improvement or apparent increase in any obvious symptoms. She was seen by her optometrist on 6/27 who sent her to an ophthalmologist who diagnosed her with anterior uveitis in both eyes, even though patient had only complained about the right eye. She had scarring and sticking of the pupil to the cornea. She was on atropine drops and steroid drops all summer. It was quiet at the end of August but she went for a followup appointment on 9/14/18 with Dr. where she is a student and it was come back in the right eye. She is on drops again. She never had this problem until a few days after receiving the TRUMENBA vaccine.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Loss of personal independence in daily activities, Mydriasis, Photophobia, Pupillary disorder, Syncope
Clinical narrative: 4 days after the vaccination patient mentioned that she thought something was wrong with her right eye. She said it was felt funny and was kind of blurry. It looked ok so we thought it might be her contact. She mentioned it again a few days later (or I asked, can't remember). It was still bothering her. She said it was blurry and felt wet when she woke up. It didn't look red or irritated and didn't hurt or itch. I told her to take a break from contacts for a few days but there was no improvement or apparent increase in any obvious symptoms. She was seen by her optometrist on 6/27 who sent her to an ophthalmologist who diagnosed her with anterior uveitis in both eyes, even though patient had only complained about the right eye. She had scarring and sticking of the pupil to the cornea. She was on atropine drops and steroid drops all summer. It was quiet at the end of August but she went for a followup appointment on 9/14/18 with Dr. where she is a student and it was come back in the right eye. She is on drops again. She never had this problem until a few days after receiving the TRUMENBA vaccine.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient presented to the pharmacy after having what started as itching which led to redness and swelling and heat in the rash area which started the day after the vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Headache, muscles hurt on most of the body, shivering, very very sick feeling and tired.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills, headache and nausea. Patient thought she was having an allergic reaction. Counseled on a true allergy. Told patient to contact pcp if symptoms continue.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Axillary pain
Clinical narrative: SEVERAL HOURS AFTER PT LEFT CLINC HE COMPLAINED ABOUT PAIN UNDER THE ARM THE NIGHT HE RECEIVED VACCINE. PARENT DIDNT NOT SEE REDNESS OR SWELLING IN THE AREA.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: 9/14/18--pt is experiencing hives, got shingles shot on Wednesday and came in today. I observed hives on her vaccinated arm (left) as well as right wrist. Pt was not having difficulty breathing and minor itching. Advised to take BENADRYL and sold her a tube of hydrocortisone. Told to go to ER if anything got worse as I have not seen the generalized hives with SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 20-JUL-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 27-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A 69-year-old female patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced breaking out in rashes all over her back, arms, legs and stomach on an unspecified date. Therapeutic measures were taken as a result of itching which included an unspecified cream but reported that it keeps coming back and the doctors can't seem to regulate it. Outcome of the events was unknown.
Age: 61.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Abdominal pain upper, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 61-year-old male patient received PREVNAR 13 (Lot number: 005197102, expiration date: Apr2019), and AFLURIA QUADRIVALENT, both via an unspecified route of administration on 07Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she had a patient come in and get vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine inact split virion 4v on Friday night, 07Sep2018. Within 10 minutes of getting the shots, he got some major cramping in stomach that went down to his leg at least 24 hours. He is doing better now. However, he wasn't sure if it was due to the vaccines and wanted to know if there was a correlation. The outcome of the event major cramping in stomach that went down to his leg was recovered on 08Sep2018.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from the patient's daughter referring to a 87 year old female patient. The patient's pertinent medical history included shortness of breath, slightly elevated temperature and symptoms of a cold. Additionally, the patient contracted the flu on an unreported date. Her historical drugs included acetaminophen (TYLENOL) that made her became pretty sick. The patient's concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one shot of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown), for prophylaxis (route of administration, lot # and expiration date were not reported). Concomitant medications included influenza virus vaccine (unspecified). On an unknown date, the patient experienced pneumonia described as nosocomial. It was stated that the patient had it four times and she was treated several times for that (no details provided). At the time of reporting, the outcome of the event was unknown. The causality assessment between the event and the suspect therapies was not provided. Upon internal review, pneumonia was determined to be a medically significant event.  This one of two reports received from the same reporter and referred to the same patient (1809USA004780).; Sender's Comments: US-009507513-1809USA004780:
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Clostridium difficile infection, Clostridium test positive, Drug ineffective
Clinical narrative: This spontaneous report was received from the patient's daughter referring to a 87 year old female patient. The patient's pertinent medical history included shortness of breath, slightly elevated temperature and symptoms of a cold. Additionally, the patient contracted the flu on an unreported date. Her historical drugs included acetaminophen (TYLENOL) that made her became pretty sick. The patient's concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one shot of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown), for prophylaxis (route of administration, lot # and expiration date were not reported). Concomitant medications included influenza virus vaccine (unspecified). On an unknown date, the patient experienced pneumonia described as nosocomial. It was stated that the patient had it four times and she was treated several times for that (no details provided). At the time of reporting, the outcome of the event was unknown. The causality assessment between the event and the suspect therapies was not provided. Upon internal review, pneumonia was determined to be a medically significant event.  This one of two reports received from the same reporter and referred to the same patient (1809USA004780).; Sender's Comments: US-009507513-1809USA004780:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21 -JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Sex: F
Vaccine: FLU4, IPV, MMRV, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years and two-month old female patient who was vaccinated with a 0.5 ml dose of ADACEL (lot number:U5770AA and Expiry date: 15-Sep-2019) via intramuscular route in the right arm instead of DAPTACEL on 03-Nov-2017. The patient was about to administer with fifth dose of DAPTACEL. The patient's medical history, previous medications and concomitant medications were not reported. The patient's concomitant medication included PROQUAD, IPOL and 0.5 ml dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose in series, route and site of administration was not reported) on the same visit (date not reported). It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up report received from a nurse on 05-Sep-2018. The patient's age was reported. The patient's concomitant medications were reported. The vaccination details were updated. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: 102 degree fever after both shots; chills, body aches... all lasting a day and a half.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Extra dose administered, Headache, Pain, Pain in extremity
Clinical narrative: The individual received 2 doses of PNEUMOVAX, 2.5 weeks apart in error - 8/20/2018 and 9/5/2018. Both vaccines were same lot number. The individual stated after 1st immunization, mild sore arm. After second immunization, he states that he had a "severe" sore arm, swelling, redness, headache, and body aches for 24/36hrs; resolved at 48hrs when notified patient of error.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: The individual received 2 doses of PNEUMOVAX, 2.5 weeks apart in error - 8/20/2018 and 9/5/2018. Both vaccines were same lot number. The individual stated after 1st immunization, mild sore arm. After second immunization, he states that he had a "severe" sore arm, swelling, redness, headache, and body aches for 24/36hrs; resolved at 48hrs when notified patient of error.