chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018 13:30, the patient received the 2nd dose of SHINGRIX. On 17th July 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, fever, worn out and feeling cold. On an unknown date, the outcome of the shivering and feeling cold were recovered/resolved and the outcome of the fever and worn out were not recovered/not resolved. It was unknown if the reporter considered the shivering, fever, worn out and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter. The patient experienced could not get warm and a wiped out feeling the morning.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea 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 nausea, pain and fatigue. On an unknown date, the outcome of the nausea, pain and fatigue were unknown. It was unknown if the reporter considered the nausea, pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the adverse events. This reporter would not provide any additional information. The reporter was not their doctor. They were her friends and she would give them the agency phone to call themselves. This case has been linked with US2018GSK130861, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea 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 nausea, pain and fatigue. On an unknown date, the outcome of the nausea, pain and fatigue were unknown. It was unknown if the reporter considered the nausea, pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the adverse events. This reporter would not provide any additional information. She was not their doctor. They were her friends and she would give them the GRC phone to call themselves. This case has been linked with US2018128750, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not have time to provide further information during call. This is 1 of the 4 cases reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Irritability, Nausea, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician, received via a Pfizer Sales Representative. A female patient, age: 18, unit: unknown, receive TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, after vaccination, the patient experienced extreme redness, swelling, high fever at body temperature 103, nausea and extreme irritability. The outcome of the events was unknown. The information on the batch number has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC, RVX
Symptoms: Cough, Insomnia, Sneezing
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 4 months old male patient who experienced coughing alot, sneezing, he is waking up every one to two hours while he received vaccines PREVNAR, ROTAVIRUS VACCINE and PENTACEL. The patients past vaccination(s) included rotavirus on 07-MAY-2018 and PREVENAR and PENTACEL vaccine on 07-MAY-2018. The patients past medical history, medical treatment(s) and family history were not provided. On 09-Jul-2018, the patient received a Primary second dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur orally. On 11-Jul-2018, the patient received a Primary second dose of suspect PREVNAR not produced by Sanofi Pasteur lot number not reported. On 09-Jul-2018, the patient received 0.5 ml Primary second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: C5439AA, expiry date: 29 Oct 2018 in leg. On an unknown date he also received a Primary first dose of the same vaccine. On an unspecified date, the patient developed a non-serious coughing alot (cough), unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, Unknown latency following the administration of ROTAVIRUS VACCINE and Unknown latency following the administration of PREVNAR. On an unspecified date, the patient developed a non-serious sneezing Unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, Unknown latency following the administration of ROTAVIRUS VACCINE and Unknown latency following the administration of PREVNAR. On an unspecified date, the patient developed a non-serious he is waking up every one to two hours (sleep disorder) Unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, Unknown latency following the administration of ROTAVIRUS VACCINE and Unknown latency following the administration of PREVNAR. It was an actual medication error due to product preparation error as HIB part of Pentacel was only mixed with Sterile water. Final diagnosis was hib part of pentacel was only mixed with sterile water (product preparation error), he is waking up every one to two hours, sneezing and coughing alot. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for hib part of pentacel was only mixed with sterile water, as Unknown for coughing a lot, as Unknown for sneezing and as Unknown for he is waking up every one to two hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is related to case 2018SA200801 for patient and 2018SA200800 for patient, from the same reporter. This case involves a 4 years old male patient who experienced light headed, clammy and diaphoretic (sweaty), while he received vaccine QUADRACEL. The patients family history included Mom has a history of passing out with shots. The patients past medical history, medical treatment, vaccination was not provided. The patient did not receive any concomitant medication. On 19-Jul-2018, the patient received a first dose 0.5ml of suspect QUADRACEL lot C5497AA, expiry date 17 Jul 2020 via intramuscular route in unknown administration site. On 19-Jul-2018, the patient developed a non-serious light headed same day following the administration of QUADRACEL. On 19-Jul-2018, the patient developed a non-serious clammy (cold sweat) same day following the administration of QUADRACEL. On 19-Jul-2018, the patient developed a non-serious diaphoretic (sweaty) (hyperhidrosis) same day following the administration of QUADRACEL. Lab data was not provided. Final diagnosis was diaphoretic (sweaty), clammy and light headed. As a corrective treatment the patient was laying down. The patient outcome is reported as Unknown for light headed, as Unknown for clammy and as Unknown for diaphoretic (sweaty). List of documents held by sender- none.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, HIBV, MMR, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 7/19/18 RN accidently gave a single antigen HIB vaccine in addition to a PENTACEL vaccine today. TC to MOC and informed of vaccination error, to have MOC monitor child for any increased side effects, and call clinic if she has any concerns. RN to contact MOC next week to check on status of child. 7/24/18 TC to MOC. MOC stated child is "fine" and experienced no significant side effects from the vaccinations given on 7/19/18. Advised MOC to call clinic if child develops any concerning side effects. No further follow-up needed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient states experience low grade fever and feels achy.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Blister, Culture wound, Full blood count, Induration
Clinical narrative: Localized swelling and induration w/ multiple vesicles, and large bulla, fever and myalgias w/ nausea.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Metabolic function test, Myalgia, Nausea, Pyrexia, Swelling
Clinical narrative: Localized swelling and induration w/ multiple vesicles, and large bulla, fever and myalgias w/ nausea.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral test
Clinical narrative: Localized swelling and induration w/ multiple vesicles, and large bulla, fever and myalgias w/ nausea.
Age: 27.0
Sex: M
Vaccine: JEV1, YF
Symptoms: Dyspnoea, Pharyngeal oedema, Throat irritation
Clinical narrative: Patient experienced throat swelling, shortness of breath, and a rash on his throat. The PA administered epinephrine. The patient went to the Emergency room. The Emergency Room administered diphenhydramine, SOLUMEDROL, ranitidine, and albuterol. The patient's breathing improved and the rash disappeared. The patient was discharged home.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Patient fainted shortly after administering vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Client received a PROQUAD and a PEDIARIX on 07/23/18 at 09:40 am. Client needed 1 more Varicella, MMR, and 3 doses of Hep B for daycare requirements. Client received her 3rd dose of IPV in 2016 and her 4th dose of DTaP in 2016.  It was brought to my attention PEDIARIX is not recommended for the 4th and 5th dose of IPV and DTaP. However, these vaccines may be counted.  Father of patient was called and notified. Parents of client reported no adverse events or outcomes from this vaccine. No treatment was needed.
Age: 29.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Blister, Injection site rash, Injection site vesicles, Rash generalised
Clinical narrative: Patient received Tdap, MMR and varicella #1 vaccines on 7/10/18. Patient called clinic on 7/24/18 stating that he got blisters/rash on the injection sites and throughout the body. Patient was seen by PCP and PCP thought it was insect bites; pt was treated with oral and topical steroids; blisters/rash has not improved. Pt was instructed to follow up with PCP for further evaluation.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The patient was inadvertently given a PROQUAD instead of the MMR-II. Patient had no reaction to this event.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood test normal, Dehydration, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: My son became ill on 6/26/18. We were told it was strep throat. On 6/27/18, my son began to complain of his legs hurting and not wanting to walk. We took him back to the Dr. on 6/28/18. They sent us to ER. Where they did blood work and took a urine sample. They gave him a IV saying he was dehydrated. And sent us home saying it was the Strep making him not want to walk and his muscles hurt. Friday 6/29/2018, we took him back to his pediatrician who again said this is just Strep throat and it could get worse before it gets better. On Sunday 7/1/2018, my son was up all night screaming in pain. We took him back to the Dr. who finally said something neurological is going on take him to the ER. We decided to take him to Hospital, where they finally diagnosed my son with Guillain-Barre Syndrome; through a 2 1/2 hr long MRI and a spinal tap. He was admitted to the hospital on 7/2/2018. He received four IVIG treatments over the course of 4 days and is now in the recovery stage. We hope to be release on 7/31/2018, with continued Outpatient Physical Therapy which could last anywhere from 6 months to a year.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Lumbar puncture abnormal, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: My son became ill on 6/26/18. We were told it was strep throat. On 6/27/18, my son began to complain of his legs hurting and not wanting to walk. We took him back to the Dr. on 6/28/18. They sent us to ER. Where they did blood work and took a urine sample. They gave him a IV saying he was dehydrated. And sent us home saying it was the Strep making him not want to walk and his muscles hurt. Friday 6/29/2018, we took him back to his pediatrician who again said this is just Strep throat and it could get worse before it gets better. On Sunday 7/1/2018, my son was up all night screaming in pain. We took him back to the Dr. who finally said something neurological is going on take him to the ER. We decided to take him to Hospital, where they finally diagnosed my son with Guillain-Barre Syndrome; through a 2 1/2 hr long MRI and a spinal tap. He was admitted to the hospital on 7/2/2018. He received four IVIG treatments over the course of 4 days and is now in the recovery stage. We hope to be release on 7/31/2018, with continued Outpatient Physical Therapy which could last anywhere from 6 months to a year.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pharyngitis streptococcal, Screaming, Streptococcus test positive, Urine analysis normal
Clinical narrative: My son became ill on 6/26/18. We were told it was strep throat. On 6/27/18, my son began to complain of his legs hurting and not wanting to walk. We took him back to the Dr. on 6/28/18. They sent us to ER. Where they did blood work and took a urine sample. They gave him a IV saying he was dehydrated. And sent us home saying it was the Strep making him not want to walk and his muscles hurt. Friday 6/29/2018, we took him back to his pediatrician who again said this is just Strep throat and it could get worse before it gets better. On Sunday 7/1/2018, my son was up all night screaming in pain. We took him back to the Dr. who finally said something neurological is going on take him to the ER. We decided to take him to Hospital, where they finally diagnosed my son with Guillain-Barre Syndrome; through a 2 1/2 hr long MRI and a spinal tap. He was admitted to the hospital on 7/2/2018. He received four IVIG treatments over the course of 4 days and is now in the recovery stage. We hope to be release on 7/31/2018, with continued Outpatient Physical Therapy which could last anywhere from 6 months to a year.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Inflammation, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Patient developed round/oval raised inflammation rash on arm over deltoid. Also developed flu like symptoms, fever, sweats, and soreness in arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed round/oval raised inflammation rash on arm over deltoid. Also developed flu like symptoms, fever, sweats, and soreness in arm.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion, Injection site bruising, Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Patient came to pharmacy on 7/24/2018 reporting severe bruising in the right arm, no current pain, swelling, tingling or other sensation reported at this time. He stated that after 24 hours of receiving the vaccine he experienced pain and redness at the injection site. The redness then began to spread from the injection site and ran to the inner part of the arm, he reported to have swelling in the upper arm and there was a bruise that began to appear in the area where the redness was present. The bruise from observation was located on most of the upper inner arm and it had spread. I noticed the patient was on a blood thinner and this could have been a sign of his medication. I suggested he call and see his provider immediately to ensure there was not a blood clot present and to ensure that there was no excessive thinning of the blood due to the size of the bruise. The bruise did seem to be healing at the time patient presented his reaction to the pharmacy. However, the above was advised as a precaution.
Age: 64.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: It was brought to our attention that there was an immunization error made on a patient. The patient had an injury on Friday, July 20th and came to the walk-in clinic Saturday, July 21st to see about updating her tetanus status. The walk-in provider ordered a Td to be administer red. In error, a PENTACEL was given. This came to light during an audit that was being performed by one of the nurses. She did call the patient and informed her of the error. At that time, it was thought that the patient would need additional tetanus coverage since the patient was given a pediatric dose. The patient came in this morning and said she was having a reaction to the vaccination. In the meantime, agency contacted and asked about giving a Td for coverage. One of the nurses informed us that she does not need additional immunizations. She is covered with the Dtap. She also said the HIB and Polio in the PENTACEL would not cause the patient any problems. Two nurses went and visited with patient about her reaction at 9:30 this morning. She has not had any respiratory symptoms. She stated that her left arm (where she received the vaccination) was very sore and it also hurt up into her left shoulder and her neck. She did have a warm, red area from the injection site down to about 3 to 4 inches above her elbow and she said it itches. It is blotchy in nature and the patient said it is actually a little improved. We advised Tylenol and ice. It was explained to the patient that a Td was ordered for her and that she was given a pediatric vaccination that also contained Hib and Polio. I told her this was an error. She was given VIS sheets on these vaccinations for her information. We went over the information with her that we received from agency and explained that she is completely covered for tetanus with the vaccine she received. She said she was satisfied with the information she was given, and she was very understanding about the error. She was instructed to call us with any concerns she may have regarding this issue. An incident report was filed. We were also advised by agency that we will need to complete a VAERS form for the state, a Vaccine Adverse Event Reporting System. This will be completed as requested.
Age: 64.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth, Neck pain, Rash macular
Clinical narrative: It was brought to our attention that there was an immunization error made on a patient. The patient had an injury on Friday, July 20th and came to the walk-in clinic Saturday, July 21st to see about updating her tetanus status. The walk-in provider ordered a Td to be administer red. In error, a PENTACEL was given. This came to light during an audit that was being performed by one of the nurses. She did call the patient and informed her of the error. At that time, it was thought that the patient would need additional tetanus coverage since the patient was given a pediatric dose. The patient came in this morning and said she was having a reaction to the vaccination. In the meantime, agency contacted and asked about giving a Td for coverage. One of the nurses informed us that she does not need additional immunizations. She is covered with the Dtap. She also said the HIB and Polio in the PENTACEL would not cause the patient any problems. Two nurses went and visited with patient about her reaction at 9:30 this morning. She has not had any respiratory symptoms. She stated that her left arm (where she received the vaccination) was very sore and it also hurt up into her left shoulder and her neck. She did have a warm, red area from the injection site down to about 3 to 4 inches above her elbow and she said it itches. It is blotchy in nature and the patient said it is actually a little improved. We advised Tylenol and ice. It was explained to the patient that a Td was ordered for her and that she was given a pediatric vaccination that also contained Hib and Polio. I told her this was an error. She was given VIS sheets on these vaccinations for her information. We went over the information with her that we received from agency and explained that she is completely covered for tetanus with the vaccine she received. She said she was satisfied with the information she was given, and she was very understanding about the error. She was instructed to call us with any concerns she may have regarding this issue. An incident report was filed. We were also advised by agency that we will need to complete a VAERS form for the state, a Vaccine Adverse Event Reporting System. This will be completed as requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Joint swelling, Peripheral swelling, X-ray limb
Clinical narrative: About a week after receiving vaccination pt experienced joint pain in hands, feet and neck. Felt like getting arthritis. Waited a week and contacted doctor. MD wanted to see her. Symptoms started to go away after about 2 months. Symptoms started off worse in the beginning and slowly got better.  Had 2 joints (right index finger and left right toe) became swollen. Still has swelling in right finger.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Per mother developed tenderness and redness to right deltoid for 3 days. No fever per mom redness size of a tangelo.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-JAN-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 05-OCT-2015, the patient was treated by a physician for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-OCT-2011, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided) and on 26-APR-2012, was inoculated with the ZOSTAVAX vaccine for the second time (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-APR-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. On or about 23-JUN-2017, the patient sought subsequent treatment from a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and excruciating pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at a health center 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. In 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from another health professional and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally for prophylaxis, lot # N029870, and expiration date 03-FEB-2019 (dose, strength, and frequency were unknown). It was reported that the patients did not experience any adverse effects. The ROTATEQ were stored at a temperature of 32°F up to 35°F (34F) during 44 hours. No previous temperature excursions were reported. Data logger was involved.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a 75-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (around the age of six or seven years). On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 10 days after receiving SHINGRIX, the patient experienced blister and varicella-like rash. On an unknown date, the outcome of the blister was unchanged and the outcome of the varicella-like rash was not recovered/not resolved. The reporter considered the blister and varicella-like rash to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient remembered that in the year 1972 or 1973 that his kids had chickenpox and he developed similar blisters at that time. His children's pediatrician told him that he had the chickenpox, too. The patient received SHINGRIX on the left arm. Approximately 10 to 14 days after receiving the SHINGRIX vaccine, the patient noticed four blisters on the inside of his upper left calf, about an inch below his knee. The patient said they looked like the chickenpox. Three to four days later they appeared to be filled with water. Three to four days after days after that the blisters were almost gone. A day before reporting, on 10th July 2018, the patient noted that he had three to four blisters on the left side of his neck, one blister on his left cheek, one blister on his right cheek, and one in the inside of his left ear. All of these new blisters are filled with fluid. On the date of reporting, the patient noticed a fluid-filled blister on the top of his left thigh. The reporter gave permission to contact his physician.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site erythema and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she experienced soreness at the injection site after receiving the SHINGRIX vaccine. The soreness continued for about one week from her elbow and up and it was red and sore. The patient has denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of localized erythema 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 localized erythema, pain localized, local swelling and adverse reaction. On an unknown date, the outcome of the localized erythema, pain localized, local swelling and adverse reaction were unknown. It was unknown if the reporter considered the localized erythema, pain localized, local swelling and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced localized redness, swelling, pain, and general complaints. The reporter did not have any other information to report about the patient or vaccine. The reporter did not speak to the patient till the time of reporting.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received PNEUMOVAX 23 for immunisation. About one year before the patient experienced swelling on arm on an unspecified date with outcome of unknown. Information about batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Influenza like illness, Injection site cellulitis, Nausea
Clinical narrative: Started having flu like symptoms the next day, worsened over the next few days (fatigue, nauseous). Cellulitis started on right arm Sunday and extends from top of shoulder to elbow/antecubital area.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Patient was complaining about shoulder pain that has not gone away since receiving her 1st dose in April.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient reported arm swelling after shot. She iced it and took BENADRYL/APAP which didn't help much. I referred patient to doctor. Doctor prescribed MEDROL dose pack. Patient was counseled on use and ok.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Full body rash that itches.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Feeling abnormal, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Haven't felt right since this shot. Was ill with muscle pain and low fever for nearly a week after. It's now been nearly 2 months and I have had very strange nerve pain throughout my body. They are sharp, burning pain. They occur out of nowhere. They will follow a nerve wherever they occur: my scalp, arms, legs, across the trunk of my body, groin, hands, face, etc. VERY WEIRD and uncomfortable. They vary in intensity. And, I've never had anything like this before the SHINGRIX shot. Also, there was swelling and a rash at the injection site that lasted for 2 weeks. Much longer than any reaction I've had before (usually from a flu shot which can last 5-6 days). I am still experiencing sharp pain at the injection site ...nearly 2 months later. The fever varied but was not over 100. Fever was recurring over a full week after the injection. The reaction has been severe enough, and not getting any better, that I am now afraid of taking the 2nd shot - and I am not a person who is adverse to immunizations or queasy about shots.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia, Pain, Pyrexia
Clinical narrative: Haven't felt right since this shot. Was ill with muscle pain and low fever for nearly a week after. It's now been nearly 2 months and I have had very strange nerve pain throughout my body. They are sharp, burning pain. They occur out of nowhere. They will follow a nerve wherever they occur: my scalp, arms, legs, across the trunk of my body, groin, hands, face, etc. VERY WEIRD and uncomfortable. They vary in intensity. And, I've never had anything like this before the SHINGRIX shot. Also, there was swelling and a rash at the injection site that lasted for 2 weeks. Much longer than any reaction I've had before (usually from a flu shot which can last 5-6 days). I am still experiencing sharp pain at the injection site ...nearly 2 months later. The fever varied but was not over 100. Fever was recurring over a full week after the injection. The reaction has been severe enough, and not getting any better, that I am now afraid of taking the 2nd shot - and I am not a person who is adverse to immunizations or queasy about shots.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash that progressed from the neck down the whole body and fever with max temp 101 x2days.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: History of presenting illness: Reports they received MMR and Varicella vaccines 9 days back for thee 1 yr WCC and now has developed rash and fever. Rash started 07/18/2018, started from neck and then progressed down to involve the whole body. T-max of 101 F 2 days before the onset of rash.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient felt feverish during the night after receiving the shot. Fever had resolved by the morning.  Patient also complained of a sore hand for a couple of days after the immunization but has since felt better and resumed her exercise routine.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure decreased, Dizziness, Feeling cold, Gait disturbance, Nausea
Clinical narrative: Member reported to Staff Immunizations on 24Jul2018 requesting her second dose of Hepatitis A. After reviewing the member's file for immunizations and labs, member was given the Adult Vaccination Screening Form. Member answered "yes" to "Do you have allergies to any medications, food (especially eggs) or any vaccine?" Member's answer: "Ibuprofen". Member also answered "yes" to "Have you taken cortisone, prednisone, other steroids or anti-cancer drugs or had radiation in the past 3 months?" Member answered: "Prednisone, for some nerve issue concerning dental work". Member cleared to receive Hep A. Patient received vaccine without complaint, instructed to wait 15 minutes before leaving. After 15 minutes, member was checked on, who then stated that she was feeling "dizzy and lightheaded". Member attempted to stand, but had an unsteady gait and sat down. Member showed no signs of itching, hives, redness, raising of the site, shortness of breath, chest pain or any other allergic reaction symptoms. After consulting with Health Center nurses, patient was taken into Treatment Room for observation and vitals. Over the course of 3 hours, patient's blood pressure dropped from 109/68 to 99/67. Member stated she was cold, nauseous with sensitivity to light while still feeling lightheaded and dizzy. Patient slept, and noted she felt better afterwards. Vitals retaken to be 110/76. Member received ZOFRAN for nausea. Dr. was the overseeing provider for this encounter, and determined the patient fit to go home Sick in Quarters for the remainder of the day. Patient left with stable vitals.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Photophobia
Clinical narrative: Member reported to Staff Immunizations on 24Jul2018 requesting her second dose of Hepatitis A. After reviewing the member's file for immunizations and labs, member was given the Adult Vaccination Screening Form. Member answered "yes" to "Do you have allergies to any medications, food (especially eggs) or any vaccine?" Member's answer: "Ibuprofen". Member also answered "yes" to "Have you taken cortisone, prednisone, other steroids or anti-cancer drugs or had radiation in the past 3 months?" Member answered: "Prednisone, for some nerve issue concerning dental work". Member cleared to receive Hep A. Patient received vaccine without complaint, instructed to wait 15 minutes before leaving. After 15 minutes, member was checked on, who then stated that she was feeling "dizzy and lightheaded". Member attempted to stand, but had an unsteady gait and sat down. Member showed no signs of itching, hives, redness, raising of the site, shortness of breath, chest pain or any other allergic reaction symptoms. After consulting with Health Center nurses, patient was taken into Treatment Room for observation and vitals. Over the course of 3 hours, patient's blood pressure dropped from 109/68 to 99/67. Member stated she was cold, nauseous with sensitivity to light while still feeling lightheaded and dizzy. Patient slept, and noted she felt better afterwards. Vitals retaken to be 110/76. Member received ZOFRAN for nausea. Dr. was the overseeing provider for this encounter, and determined the patient fit to go home Sick in Quarters for the remainder of the day. Patient left with stable vitals.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient stopped by pharmacy 3 days after the injection a complained of intense pain on the injection site, and a lot of itching redness and swelling. Pharmacist advised using compresses BENADRYL capsules and cream. Patient called back Tuesday 7-24-2018 (4 days later and said that the compresses and BENADRYL cream were working and getting better. I advised patient to call me Friday 7-28-2018 to check in with symptoms.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: PATIENT COMPLAINED OF FEVER, BUT HAD NO WAY TO ACTUALLY MEASURE HER TEMPERATURE AND SWELLING IN THE ARM AT THE INJECTION SITE. PATIENT HAD USED IBUPROFEN AND ICE ON THE SITE. PATIENT WAS ADVISED TO CONTINUE TREATMENT AND SEEK MEDICAL ATTENTION IF SYMPTOMS CONTINUE. ALSO COUNSELED PATIENT TO TRY TO OBTAIN A THERMOMETER TO SEE IF PATIENT WAS RUNNING FEVER.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest discomfort, Fatigue, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms, All-over body aches, Stomach slightly upset, Tired, Short-term tightness in chest.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Attempted vaccine administration into left arm IM site, but accidentally hit bone. Pulled out syringe and inserted vaccination into proper IM site and administered vaccine. There was no bleeding or immediate swelling. Patient called pharmacy later that evening and mentioned his left arm was throbbing with no issues with breathing and no major rash or redness around injection site.  Pharmacist on duty told patient to take ibuprofen and BENADRYL and use ice. She instructed the patient to visit the doctor if his symptoms worsened and to inform the pharmacy and to visit the ER if having trouble with breathing. Patient followed up with the next day. He reports his arm still hurt but reports no warmth to the touch, no crustiness, no loss of feeling, and no other signs of infection. He reported his breathing as normal.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Balance disorder, Fall, Heart rate decreased, Muscle contractions involuntary, Musculoskeletal stiffness
Clinical narrative: Patient accompanied his brother to the brother's appointment today, he had not yet eaten today (morning appointment), while here, both brothers requested the meningococcal Group B vaccine. Patient was given the vaccine, he complimented the nurse who gave it, saying it barely hurt, but about 10-15 seconds after the injection (long enough to put the bandaid on the site), and patient stiffened his R arm involuntarily and lost his balance and awareness while sitting on the gurney thus falling backward. He was supported by the nurse and remained sitting. MD was called into room immediately. When MD arrived, patient appeared pale, was holding his R arm stiffly, was supported in a sitting position by the nurse, and was unresponsive to my questions for about 30 seconds, then he looked at me and asked 'What happened?", as his R arm started to relax. Radial pulse was slow, regular, not bounding, not particularly strong. Patient was moved by wheelchair to the treatment room where 10 L O2 were administered by mask, and patient was hooked up to a monitor which noted O2 sats at 100%, HR mid 40s, and adequate systolic BP. patient now fully alert, and lying on the gurney comfortably. Lungs clear to auscultation bilaterally and anteriorly, heart sinus tachycardia by auscultation and monitor, radial pulse regular, not thready or weak. Color was now returning to patient's face. Over the next 10 minutes, O2 was removed, O2 sats remained in the high 90s, and pulse came up to the 60s. Patient drinking water without difficulty. Patient gradually sitting on his own, dangled legs over gurney side, then was able to stand and walk without difficulty. MD discussed with patient and mother that it appears patient had a vasovagal reaction with seizure like activity (involuntary R arm tenseness). Before any further vaccines, patient should let the nurse know of this previous reaction, and he should be sure and eat before receiving vaccines.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pallor, Presyncope, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Patient accompanied his brother to the brother's appointment today, he had not yet eaten today (morning appointment), while here, both brothers requested the meningococcal Group B vaccine. Patient was given the vaccine, he complimented the nurse who gave it, saying it barely hurt, but about 10-15 seconds after the injection (long enough to put the bandaid on the site), and patient stiffened his R arm involuntarily and lost his balance and awareness while sitting on the gurney thus falling backward. He was supported by the nurse and remained sitting. MD was called into room immediately. When MD arrived, patient appeared pale, was holding his R arm stiffly, was supported in a sitting position by the nurse, and was unresponsive to my questions for about 30 seconds, then he looked at me and asked 'What happened?", as his R arm started to relax. Radial pulse was slow, regular, not bounding, not particularly strong. Patient was moved by wheelchair to the treatment room where 10 L O2 were administered by mask, and patient was hooked up to a monitor which noted O2 sats at 100%, HR mid 40s, and adequate systolic BP. patient now fully alert, and lying on the gurney comfortably. Lungs clear to auscultation bilaterally and anteriorly, heart sinus tachycardia by auscultation and monitor, radial pulse regular, not thready or weak. Color was now returning to patient's face. Over the next 10 minutes, O2 was removed, O2 sats remained in the high 90s, and pulse came up to the 60s. Patient drinking water without difficulty. Patient gradually sitting on his own, dangled legs over gurney side, then was able to stand and walk without difficulty. MD discussed with patient and mother that it appears patient had a vasovagal reaction with seizure like activity (involuntary R arm tenseness). Before any further vaccines, patient should let the nurse know of this previous reaction, and he should be sure and eat before receiving vaccines.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Fatigue, Headache, Pain
Clinical narrative: Swelling, burning, itching , Body aches, headache, fatigue, chills, poss fever.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling, burning, itching , Body aches, headache, fatigue, chills, poss fever.
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Bed rest, Chills, Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness, swelling, warm to touch - lasted from 19 Jul-24 Jul 18. Fever, chills, muscle/joint aching; could hardly lift right arm for 2 days. Interfered with normal activity; 3 days with bed rest and acetaminophen.
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Injection site redness, swelling, warm to touch - lasted from 19 Jul-24 Jul 18. Fever, chills, muscle/joint aching; could hardly lift right arm for 2 days. Interfered with normal activity; 3 days with bed rest and acetaminophen.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: Patient experienced swelling, heat, redness, and itching at the injection site. She had a faded handprint-sized area on the upper arm at the 7 day mark today. The heat and itching are not listed as common side effects in the literature, hence this report.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever, lethargic.