chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Broke out in rashes all over body.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient has lingering pain in arm 2 months after vaccination
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain. Went to MD on 11/01/2019 and treated for cellulitis with medrol and cefprozil.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Myalgia, Pain in extremity
Clinical narrative: Pain in arm muscle immediately after immunization. Calling a month later and still experiencing pain in arm. No medical follow up.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperaesthesia, Injection site mass, Injection site pain, Pain, Pain in extremity
Clinical narrative: Within a few days of the vaccine, the patient developed an unusual pain syndrome in the upper and lower parts of the left arm.  There was a mass in the distal tricep (remote from the injection site) with intense pain with any flexion or extension of the elbow, hyperalgesia noted in the skin of the left arm, no visible sweating, redness or swelling of the arm.  strength was  normal.  There were no signs of systemic infection such as fevers or chills. The rest of the body  was normal. There was no fall or trauma to incite the injury.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Loss of consciousness, Nausea
Clinical narrative: Starting Saturday evening at 8 pm the pt started having a fever of about 101.5 degrees F, felt nauseous, got a headache, felt achy with widespread joint pain. The next day the fever increased to about 103 degrees F, was still achy and nauseous, developed erythema at injections site, and reported passing out at night on Sunday 11/3/19. On Monday evening the fever broke but pt still achy with widespread joint pain and nauseous. Tuesday 11-5-2019 patient reports feeling a bit better, still has erythema at injection site, achyness and a little nausea but states that she "feels like she is getting better". Pt initially reported the adverse event the morning of 11-5-19. She says she feels like she is getting better. Pt was advised to follow up with primary care provider if she felt she needed treatment. She states she doesn't think she needs any additional treatment and feels like it is improving.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Starting Saturday evening at 8 pm the pt started having a fever of about 101.5 degrees F, felt nauseous, got a headache, felt achy with widespread joint pain. The next day the fever increased to about 103 degrees F, was still achy and nauseous, developed erythema at injections site, and reported passing out at night on Sunday 11/3/19. On Monday evening the fever broke but pt still achy with widespread joint pain and nauseous. Tuesday 11-5-2019 patient reports feeling a bit better, still has erythema at injection site, achyness and a little nausea but states that she "feels like she is getting better". Pt initially reported the adverse event the morning of 11-5-19. She says she feels like she is getting better. Pt was advised to follow up with primary care provider if she felt she needed treatment. She states she doesn't think she needs any additional treatment and feels like it is improving.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient experienced itching, swelling, redness, and hot to touch on the area where she has received the vaccine.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chills, Dizziness, Dyspnoea, Ear discomfort
Clinical narrative: Fever, chills, vomiting, eyes feel like they are swimming in lava, ears also feel like they are swimming in lava, upset stomach, burping, severe aches and pains in entire body, dizzy, listless, shortness of breath, itchy skin everywhere, and really red skin.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Eructation, Erythema, Listless, Ocular discomfort, Pain
Clinical narrative: Fever, chills, vomiting, eyes feel like they are swimming in lava, ears also feel like they are swimming in lava, upset stomach, burping, severe aches and pains in entire body, dizzy, listless, shortness of breath, itchy skin everywhere, and really red skin.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Vomiting
Clinical narrative: Fever, chills, vomiting, eyes feel like they are swimming in lava, ears also feel like they are swimming in lava, upset stomach, burping, severe aches and pains in entire body, dizzy, listless, shortness of breath, itchy skin everywhere, and really red skin.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Injection site cellulitis
Clinical narrative: Cellulitis of left upper extremity Hematoma of left arm Given cephalexin 500 mg, 1 capsule by mouth three times daily for 7 days
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, RV1
Symptoms: Autopsy, Cerebral disorder, Death, Hypersomnia, Pyrexia
Clinical narrative: He got air bubbles on the brain ... he had a high fever slept all day long minus 3 hours a day
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, RV1
Symptoms: Sudden infant death syndrome
Clinical narrative: He got air bubbles on the brain ... he had a high fever slept all day long minus 3 hours a day
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: 3 minutes post immunization and after talking with pharmacist the patient fainted.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient had a rash on her arm
Age: 18.0
Sex: M
Vaccine: FLUR4
Symptoms: Pallor, Seizure, Syncope
Clinical narrative: Patient fainted about 15 seconds after receiving Flublok vaccine, then he had a seizure. Patient's mother was with him at the time and stated he had fainted once before, but no history of seizures. He was out for about 30 seconds, awakened, but was very white/pale. EMS was dispatched to check him out. He was okay and refused hospital transfer.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Dizziness, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: PATIENT COMPLAINED ABOUT THE ARM PAIN AFTER TAKING THE IMMUNIZATION. PHARMACIST ASKED THE PATIENT TO STAY SEATED AND WATCHED HER. AFTER A MINUTE PATIENT COMPLAINED ABOUT BEING LIGHTHEADED AND KEPT SAYING THAT IT'S GETTING WORSE. IN A MINUTE OR LESS PATIENT STARTED SHAKING AND PASSED OUT. HER EYES WAS OPEN AND SHE WAS SNORING. PHARMACIST ASKED THE PHARMACY TEAM TO CALL 911 AND PATIENT WAS CONSCIOUS IN 20-30 SECONDS. PARAMEDICS SHOWED UP IN 10 MINUTES AND MEANWHILE PATIENT WAS LAID DOWN. PATIENT VITALS WERE NORMAL BUT SHE COMPLAINED ABOUT NAUSEA  AND SHE ALSO HAD DIARRHEA. PATIENT WAS TAKEN TO ER FOR FURTHER EXAMINATION.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Snoring, Tremor
Clinical narrative: PATIENT COMPLAINED ABOUT THE ARM PAIN AFTER TAKING THE IMMUNIZATION. PHARMACIST ASKED THE PATIENT TO STAY SEATED AND WATCHED HER. AFTER A MINUTE PATIENT COMPLAINED ABOUT BEING LIGHTHEADED AND KEPT SAYING THAT IT'S GETTING WORSE. IN A MINUTE OR LESS PATIENT STARTED SHAKING AND PASSED OUT. HER EYES WAS OPEN AND SHE WAS SNORING. PHARMACIST ASKED THE PHARMACY TEAM TO CALL 911 AND PATIENT WAS CONSCIOUS IN 20-30 SECONDS. PARAMEDICS SHOWED UP IN 10 MINUTES AND MEANWHILE PATIENT WAS LAID DOWN. PATIENT VITALS WERE NORMAL BUT SHE COMPLAINED ABOUT NAUSEA  AND SHE ALSO HAD DIARRHEA. PATIENT WAS TAKEN TO ER FOR FURTHER EXAMINATION.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Affect lability, Crying, Ear pain, Headache, Mobility decreased
Clinical narrative: Pt experienced extreme body pain (feet and spine). Her fingers aren't working well. Sound hurts, painful hearing along with a headache. She also experienced emotional lability and crying. this lasted for about 24 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pt experienced extreme body pain (feet and spine). Her fingers aren't working well. Sound hurts, painful hearing along with a headache. She also experienced emotional lability and crying. this lasted for about 24 hours.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Electrocardiogram, Fatigue, Hyperhidrosis, Laboratory test
Clinical narrative: Patient was given TDAP vaccine per Nurse. Approximately 2-3 minutes later, patient became unresponsive for approximately 10 seconds, when he became cognitive of situation, he described symptoms of fatigue and visual disturbance. Pt became diaphoretic and ambulance was called to transfer to ER. State lasted approx. 4-5 min.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Unresponsive to stimuli, Visual impairment
Clinical narrative: Patient was given TDAP vaccine per Nurse. Approximately 2-3 minutes later, patient became unresponsive for approximately 10 seconds, when he became cognitive of situation, he described symptoms of fatigue and visual disturbance. Pt became diaphoretic and ambulance was called to transfer to ER. State lasted approx. 4-5 min.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Pt presented to office on 10/31/19 with Zoster Rash on same arm as receiving Varivax Immunization.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: injection site raised, red, irritated, warm to touch. LT Thigh: 11/2cm x 1cm Rt thigh: 2cm x 2cm
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3cm area of swelling & redness on left thigh
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria less than 24 hours after vaccine administration.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Rash erythematous
Clinical narrative: Patient stated The day after receiving the vaccine she felt dizzy and nausea. She tried to let it pass but it only became worse. On 11/04/209, she then developed a red rash on The same arm as the vaccine.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on anterior right lower arm proximal to wrist. Transient-improved.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Pruritus
Clinical narrative: Patient reported having redness, tenderness  and some itch at injection site the next day after vaccination was given. Then yesterday, patient noticed rash, itchiness and redness all over body.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reported having redness, tenderness  and some itch at injection site the next day after vaccination was given. Then yesterday, patient noticed rash, itchiness and redness all over body.
Age: 10.0
Sex: M
Vaccine: IPV, TDAP, IPV, TDAP
Symptoms: Blindness, Cyanosis, Loss of consciousness, Pallor, Vomiting
Clinical narrative: Patient came to office for vaccines, Tdap and IPV administered. Prior to administration of vaccines, Mom inquired about the possibility of special ordering vaccines that do not have any kind of preservative in them. Advised mother that that is not an option for us. Mother also requested that some of the vaccine be removed from the syringe prior to administration, creating a lesser dose of vaccine. Advised that this nurse would not do that. After vaccines were administered mother gave patient homeopathic thuja oral or sublingual, patient passed out minutes later. Father laid patient on exam table, patient came back to, pulse was weak, gave a cup of water, patient vomited, applied ice pack to back of neck, patient sat down. States is feeling better. 20 minutes after vaccines, patient is talking and joking with family. Mother stated repeatedly that the homeopathic herbal supplement could not have caused the syncope episode because it is all natural. Mother requested to see a doctor. Appointment changed from nursing appointment to Provider appointment.
Age: 10.0
Sex: M
Vaccine: IPV, TDAP, IPV, TDAP
Symptoms: Loss of consciousness, Pulse abnormal, Vomiting
Clinical narrative: Patient came to office for vaccines, Tdap and IPV administered. Prior to administration of vaccines, Mom inquired about the possibility of special ordering vaccines that do not have any kind of preservative in them. Advised mother that that is not an option for us. Mother also requested that some of the vaccine be removed from the syringe prior to administration, creating a lesser dose of vaccine. Advised that this nurse would not do that. After vaccines were administered mother gave patient homeopathic thuja oral or sublingual, patient passed out minutes later. Father laid patient on exam table, patient came back to, pulse was weak, gave a cup of water, patient vomited, applied ice pack to back of neck, patient sat down. States is feeling better. 20 minutes after vaccines, patient is talking and joking with family. Mother stated repeatedly that the homeopathic herbal supplement could not have caused the syncope episode because it is all natural. Mother requested to see a doctor. Appointment changed from nursing appointment to Provider appointment.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Pain in arm / Feeling there is a piece of needle in arm when moves it in certain directions; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 9235B, expiry date unknown) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient experienced pain in his arm. It has a feeling there was a piece of needle in his arm when he moved it in certain directions. He did not feel the pain all the time.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Sensation of foreign body
Clinical narrative: Pain in arm / Feeling there is a piece of needle in arm when moves it in certain directions; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 9235B, expiry date unknown) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient experienced pain in his arm. It has a feeling there was a piece of needle in his arm when he moved it in certain directions. He did not feel the pain all the time.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Hives around my daughter arm where the vaccine was administered.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave patient the Peds Hep B verses the Adult Hep B
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Client was not aware of her pregnancy status and had denied any possibility of her being pregnant at the time of immunization with VZV on 10/15/19. Client discovered her positive pregnancy status on 10/23/19. Merck was informed and Merck adverse event report number is 01392136.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Chest X-ray, Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen
Clinical narrative: Client was not aware of her pregnancy status and had denied any possibility of her being pregnant at the time of immunization with VZV on 10/15/19. Client discovered her positive pregnancy status on 10/23/19. Merck was informed and Merck adverse event report number is 01392136.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Impaired driving ability, Muscle spasms, Muscle tightness, Myalgia
Clinical narrative: I woke up the next morning with aches/chills/fever like symptoms which I knew was probably a side effect of the flu vaccine. Throughout the day my symptoms got worse, specifically muscle soreness and aches, until I could not drive myself to an after school event and had to have a friend drive me because the muscles in my legs were so tight. I  had severe cramps and muscle pains all up and down my legs. I did not go back to my doctor because I knew it was an adverse reaction to the vaccine and would pass, especially because this was the first time I have had the flu vaccine since I was a child.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: I woke up the next morning with aches/chills/fever like symptoms which I knew was probably a side effect of the flu vaccine. Throughout the day my symptoms got worse, specifically muscle soreness and aches, until I could not drive myself to an after school event and had to have a friend drive me because the muscles in my legs were so tight. I  had severe cramps and muscle pains all up and down my legs. I did not go back to my doctor because I knew it was an adverse reaction to the vaccine and would pass, especially because this was the first time I have had the flu vaccine since I was a child.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Injection site pain, Myalgia, Neck pain
Clinical narrative: Extreme generalized constant pain in upper right arm from elbow, up arm, up neck to base of skull. Not localized (like at injection site), more muscular in nature. I have never had a reaction to a flu shot before. I will be going to an urgent care later. I had to call off work as I am a nurse and cannot lift anything due to the pain.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event.; a patient was administered improperly stored PROQUAD; This spontaneous report has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information about medical history, concurrent conditions and drug allergies was not provided.      On 18-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: S013715, expiration date: 01-NOV-2020, therapy type: recombinant Human albumin (rHA); dose, frequency and route were unknown) for prophylaxis (product storage error). The sterile diluent was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.   The vaccine was stored between 5 degrees Fahrenheit to 46 degrees Fahrenheit (17.6 degrees Fahrenheit) for 6 hours and 15 minutes. There were no previous temperature excursions. The digital data logger was not involved. No adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received improperly stored Varivax; No adverse effect; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 26-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection for prophylaxis (lot number: S005078, expiration date: 19-FEB-2019 or lot number: R019237, expiration date: 04-JUL-2020) (exact dose and route of administration were not provided). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted in properly stored sterile diluent. No adverse effect was reported.  The vaccine experienced temperature excursion from -14 degree Celsius to -10 degree Celsius (-9.74 degree Celsius). Previous temperature excursion was not reported. The digital data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was administered an improperly stored dose of  PEDVAXHIB; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 10-OCT-2019, the patient received improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot # R036178, expiration date reported as 19-OCT-2021, but upon internal validation established as 09-OCT-2021, strength, dose and route were unknown) for prophylaxis. The vaccine was exposed to 46.5 degrees Fahrenheit for 15 minutes. No previous excursion was reported. The data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received an improperly stored dose ofROTATEQ on 09/26/2019.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not provided.  On 26-SEP-2019 the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose was not provided, lot # R026391, expiration date 09-JUL-2020, oral) for prophylaxis. The temperature excursion was 32.9 fahrenheit degree for 3 hours 40 minutes. There was no previous temperature excursion. There was a data logger involved. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received an improperly stored dose of ROTATEQ on 07/09/2019.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not provided.  On 09-JUL-2019 the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose was not provided, lot # R026391, expiration date 09-JUL-2020, oral) for prophylaxis. The temperature excursion was 32.9 fahrenheit degree for 3 hours 40 minutes. There was no previous temperature excursion. There was a data logger involved. No adverse effects were reported.
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Febrile convulsion, Vaccination complication
Clinical narrative: no one could be sure the child had a febrile seizure; many years ago an unspecified child had a reaction to the VARIVAX vaccine; This spontaneous report was received from a physician referring on a child, male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On an unknown date (reported as many ages ago), the patient was vaccinated with with varicella virus vaccine live (oka/merck) (VARIVAX) and (MERCK STERILE DILUENT) (strength, dose, route of administration, lot number, expiration date and indication were not reported).  On an unknown date, the patient had a reaction to the vaccine (vaccination complication) but no one could be sure if the child had a febrile seizure (febrile convulsion).  The outcome of vaccination complication and febrile convulsion was not reported. The relatedness between varicella virus vaccine live (oka/merck) (VARIVAX) and the aforementioned events, was related and for the febrile convulsion was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received a dose of MMR II 6 days before the patient's first birthday; No adverse effects were reported; This spontaneous report was received from a physician referring to a 11 months old patient of unknown gender. The patient's concomitant therapy, pertinent medical history and concurrent conditions were not provided.   On an unknown date (6 days before the patient's first birthday), the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose number, frequency, route of administration, anatomical location, lot number and expiration date were unknown by the reporter) for prophylaxis (product administered to patient of inappropriate age).  No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a patient was administered a properly stored but expired dose of VAQTA.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concomitant medication, concurrent condition, pertinent medical history and drug reactions/allergies were unknown.  On 28-OCT-2019, the patient was vaccinated with a properly stored but expired dose of hepatitis A vaccine, inactivated (VAQTA) (lot#: R018775, expiration date: 09-AUG-2019, dose, frequency and strength were unknown) for prophylaxis. There was no adverse event.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: soreness in both of her arms and at the injection site; soreness in both of her arms and at the injection site; This spontaneous report as received from a nurse via a company representative refers to a 12-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.     On 15-OCT-2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date in October 2019 (reported as after injection), the patient experienced soreness in both arms and at the injection site. The patient's father called into office. No treatment was given to the patient and no laboratory tests were performed. The outcome of the events was unknown.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: M
Vaccine: PPV
Symptoms: Concussion
Clinical narrative: he was admitted to the hospital 2 years ago for a concussion; Information has been received from a male physician (podiatrist) of unknown age, referring to himself. The patient's concomitant medication, concurrent condition, pertinent medical history and drug reactions/allergies were unknown.  On 05-NOV-2007, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (not valid lot# was reported as 0964V, dose, frequency, route, expiration date unknown) for prophylaxis.         In October 2017 (reported as 2 years ago), the patient was admitted to the hospital for a concussion. The outcome of concussion was unknown. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and concussion was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored V AQTA had been administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/ allergies were not provided.          On 28-OCT-2019, the patient was vaccinated with one dose hepatitis a vaccine, inactivated (VAQTA) (lot number S002506 and expiration date 04-APR-2020; dose number, frequency, anatomical location and route of administration were unknown) for prophylaxis (product storage error). No adverse events were reported. No product quality complaint (PQC) was involved. Temperature and time frame were 46.7 degrees Fahrenheit  for 15 minutes.The call was because of a "data logger''. There was no previous temperature excursion.
Sex: M
Vaccine: MMR
Symptoms: Malaise, Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: titer test shows the patient has titers for measles and rubella but not for mumps; got very ill; This spontaneous report was received from the patient's mother referring to a male patient of unknown age. Information on concomitant medication, pertinent medical history and drug reaction/allergies was not provided.      On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not reported)for prophylaxis. On an unknown date the patient got very ill after having measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). On an unknown date, an unknown titer test was performed and results showed the patient had titers for measles and rubella but not for mumps.  The outcome of the events was unknown. The causality assessment was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report has been received from a nurse via a company representative referring to a male patient of unknown age. Concomitant therapy included influenza virus vaccine (unspecified). The patient didn't have pertinent medical history, drug reactions or allergies.     On an unknown date, the patient was vaccinated with dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, batch/lot# and expiration date were unknown) intramuscularly for human papillomavirus (HPV) prevention.      On an unknown date (after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient fainted. No treatment was given for the event. No lab diagnostic/study was performed. The patient didn't seek medical attention. The outcome of the event was reported as recovered on an unknown date. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. No product quality complaint presented.    Upon internal review, the event of fainted was considered to be medically significant.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: started to faint; Information has been received from a nurse via the company representative referring to a 16 years old male patient. The patient had no concomitant medication, pertinent medical history, drug reactions or allergies.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (intramuscular; strength, dose, frequency, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient started to faint. The outcome of the event was reported as recovered. No treatment was given to the patient. No lab diagnostics or studies performed. The patient sought medical attention in office.The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Upon internal review, started to faint was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patient received a vaccine following a temperature excursion; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 25-OCT-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date and dose were not provided) orally for prophylaxis, following the vaccine temperature excursion. The vaccine underwent the excursion with the lowest temperature below 36 Fahrenheit degrees/ 2 Celsius degrees (35F) in a time frame of 430 minutes. There was no previous excursion and data logger was not involved. No adverse effects were reported.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: the patient cannot lift her arm above her shoulder; the patient experienced a nodule at the injection site; the patient experienced redness at the injection site; the patient experienced swelling at the injection site; the patient experienced muscle pain at the injection site; This spontaneous report was received from a pharmacist referring to a 26-years-old female patient. The patient had no pertinent medical history or previous drug reactions or allergies.  On 22-OCT-2019, the patient was vaccinated with one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular (dose, schedule and anatomical site of vaccination were not reported; lot number reported as R002344, expiration date reported as 16-NOV-2020, and upon internal validation stablished as the same) for human papilloma virus (HPV) (prophylaxis). Concomitantly, the patient was also taking famotidine (manufacturer unknown).  On 29-OCT-2019, the patient experienced redness (vaccination site erythema), swelling (vaccination site swelling), muscle pain (vaccination site pain) and a nodule at the injection site (vaccination site nodule). The patient could not lift her arm above her shoulder (injected limb mobility decreased). The patient had no laboratories/ studies performed; she sought medical attention, however she did not receive treatment for the events.  The outcome of injected limb mobility decreased, vaccination site pain, vaccination site swelling, vaccination site erythema and vaccination site nodule was reported as not recovered/not resolved. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned events was not reported.  The reporter considered the event injected limb mobility decreased to be serious due to disability/ incapacity.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; Expired dose of M-M-R II given today; This spontaneous information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 04-NOV-2019, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human Albumin (rhA)(M-M-R II) as prophylaxis (lot number: N024703 expiration date: 08-AUG-2019) (strength, route of administration and anatomical location were not reported). The nurse did not know if the patient should be revaccinated. She was also not aware if the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) underwent a temperature excursion. The stability of the dose could not be evaluated.  No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Severe rash/ diagnosed with shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt.) of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 03-MAR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for its intended purpose: the prevention of shingles. Shortly thereafter, the pt suffered a severe rash. Later, the pt presented on a medical center for this injury and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The pt sustained severe and permanent personal injuries. The reporter considered the herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain in extremity, Pyrexia
Clinical narrative: Shingles; Arm pain; Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) 50 mcg/mg. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, pain in arm, fever and chills. On an unknown date, the outcome of the shingles, pain in arm, fever and chills were unknown.   It was unknown if the reporter considered the shingles, pain in arm, fever and chills to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient was a kidney transplant patient. The patient after vaccination experienced arm pain, fever, chills and developed shingles. The patient was on immunosuppression drugs. The reporter asked whether patient should get the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Severe vertigo; Dizziness; This case was reported by a consumer and described the occurrence of vertigo in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vertigo and dizziness. On an unknown date, the outcome of the vertigo and dizziness were unknown.   It was unknown if the reporter considered the vertigo and dizziness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter for an unspecified number of patients. The age at vaccination was not applicable for this report. The reporter saw a new ENT specialist, who stated her that he had seen a couple of patients with severe vertigo and dizziness after Shingrix which is similar to her experience. This case linked with US2019AMR176889 and US2019AMR176896, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccination failure; shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 30th November 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 30th November 2021) for prophylaxis.   On 26th February 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th October 2019, 243 days after receiving Shingrix and 76 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the pharmacy intern. The patient received both doses of Shingrix on left deltoid. The reporter consented for follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Influenza like illness
Clinical narrative: flu-like symptoms; fatigue; lay around for 2 days; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue and bedridden. On an unknown date, the outcome of the influenza-like symptoms, fatigue and bedridden were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fatigue and bedridden to be related to Shingrix.  Additional details were received as follows: The patient received vaccine in left arm. The patient experienced flu-like symptoms, fatigued, could only "lay around" for 2 days then she recovered. The reporter consented to follow up. For tolerance for 2nd dose, please refer case US2019197560.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain
Clinical narrative: pain in the arm pit; This case was reported by a nurse via call center representative and described the occurrence of axillary pain in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number HY2XM, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, unknown after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the axillary pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The patient complained of pain in the arm pit area on the side of injection after receiving Fluarix. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: swelling; pain; tender; welt at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site tenderness and injection site wheal. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site tenderness and injection site wheal were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site tenderness and injection site wheal to be related to Shingrix.  Additional details were received as follows: The age group adult selected as per vaccine specification. The patient experienced a big welt at injection site, tender to touch, painful.  Took 3 weeks to go away. The reporter did not consented to follow up.  No additional information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Influenza like illness
Clinical narrative: Flu like symptoms; Difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number GL2HR, expiry date 31st May 2021) for prophylaxis.   Concurrent medical conditions included attention deficit/hyperactivity disorder.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and difficulty breathing. On an unknown date, the outcome of the influenza-like symptoms and difficulty breathing were unknown.   It was unknown if the reporter considered the influenza-like symptoms and difficulty breathing to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 70 or 71 years. The patient reported having flulike symptoms after first dose, as well as difficulty breathing. The reporter consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Tired; Headache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date 8th March 2022) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, 2 days after receiving Shingrix, the patient experienced tiredness and headache. On an unknown date, the outcome of the tiredness and headache were recovering/resolving.   It was unknown if the reporter considered the tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient experienced tiredness and headache. The patient planned to contact her physician on an unknown date. The patient consented to follow up. This case has been linked with case US2019199352, reported by the same reporter.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 years old received Flublok during a Flu fair/no ae; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked with 2019SA307219  This case involves a 9 years old patient who recieved INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] during a flu fair.  On 22-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1930, expiration date: 30-Jun-2020 via intramuscular route in the left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.