chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 22-JUL-2016 the patient was vaccinated with an improperly stored dose of PROQUAD with lot # M001152 Expiration date: 05-JUL-2017 (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature was -14 C for 4 days. No data logger and no previous excursions were involved. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L048237, expiry date: 08-MAY-2017). Pharmacy technician stated that the vaccine underwent temperature excursion at 30.1 F for a duration of 13 hours 50 minutes. No data logger was involved and there was no previous temperature excursion. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 19-JUL-2016 the patient was vaccinated with an improperly stored dose of PROQUAD with lot # M001152 Expiration date: 05-JUL-2017 (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature was -14 C for 4 days. No data logger and no previous excursions were involved. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patient were vaccinated with improperly stored ROTATEQ (dose, lot# and expiration date were not reported; oral; therapy type; digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions and medical history included Shingles over 1 years ago and she got cold sores frequently. On 09-SEP-2016, the patient was vaccinated with ZOSTAVAX (Lot # M024700, expiration 18-JUL-2017) dose and route were not provided for shingles prevention. There was no concomitant medication reported. On an unspecified date in September 2016, the patient called to report that she was beginning to experience a cold sore on her lip. At the time of the report, the outcome of oral herpes was reported as not recovered/not resolved. The reporting pharmacist did not assess the causal relationship between the adverse events and the vaccination with ZOSTAVAX. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 3 months old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 04-AUG-2016 at 16:44, the patient was vaccinated with an improperly stored first dose of ROTATEQ lot # L039141 and expiration date 16-AUG-2017, (Strength and dose were not reported), via oral. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 24-AUG-2016, the patient received a dose of improperly stored VARIVAX (lot # L025207, expiration date: 07-JUL-2016) (dose and route of administration were not provided). There were no adverse effects reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 30-AUG-2016, the patient was vaccinated with improperly stored dose of VAQTA lot number reported as: LN749, expiry date: 26-AUG-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot # M020103 and expiry date 15-FEB-2016). These vaccines were exposed to 46.8 F for 78 minutes. No adverse effects were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Influenza like illness, Nausea
Clinical narrative: Child had received #3 HPV on 08-04-2016 at clinic. She stated she felt dizzy and nauseated about 20 minutes after getting home and this feeling continued for at least a week. Child said felt almost like having the flu.
Sex: U
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 13-SEP-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # J013394, expiration date 25-AUG-2016, dose was not reported) intramuscularly. On the same day, the patient was revaccinated with ENGERIX-B as recommended by the center for disease control (CDC). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Severe pain, fever.  Patient went to emergency room. Was seen by primary care 3 days later, still has pain. Was told that the needle may have entered the bursa in her shoulder.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Severe pain, fever.  Patient went to emergency room. Was seen by primary care 3 days later, still has pain. Was told that the needle may have entered the bursa in her shoulder.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: Patient had soreness in the arm for several days and felt nausea.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Mild Fever sore throat coughing from flu shot.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Lymphadenopathy, Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: About 2 hours after vaccine, had sever shoulder pain. Felt similar to a rotator cuff problem. Could not sleep all night. The day after glands or lymph nodes in neck felt swollen, which was noticeable when he tries to open his mouth. Also having calf pain in both legs when using them, which also started the day after and cannot be explained by physical activity.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: UPPER ARM SLOWLY BEGAN TO HURT MORE AND MORE AFTER INJECTION.  BY NIGHTTIME, I WAS UNABLE TO SLEEP DUE TO PAIN AND SWELLING IN ARM. THE BOX BELOW MAY NOT REFLECT ACCURATE OUTCOME DUE TO LESS THAN 24 HRS SINCE VACCINATION.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Injection site movement impairment, Injection site pain, Myalgia, Pain
Clinical narrative: Upset stomach, fever of about 101, aches, pains in muscles. Injection area sore to touch and move.  Took tylenol. Fever gone by morning. Aches gone by noon on next day.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Upset stomach, fever of about 101, aches, pains in muscles. Injection area sore to touch and move.  Took tylenol. Fever gone by morning. Aches gone by noon on next day.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, hot, swollen, upper 2/3 of right arm.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient reported redness in area that was becoming somewhat larger and warm.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Injected limb mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient is complaining of shoulder soreness and shooting pain in arm. Pt also stated weakness and inability to lift heavy objects above shoulder.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Patients right red, hot, swollen, sore.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site rash
Clinical narrative: Flat, painless rash on vaccinated arm (left arm).
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Hypertension, Wheezing
Clinical narrative: Severe Wheezing and High blood pressure. Called 911. Went to Emergency room but symptoms stopped after about an hour.
Age: 50.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Fatigue, Influenza like illness, Nausea, Neck pain, Pain in extremity
Clinical narrative: Patient says she experienced nausea, an episode of vomiting, soreness in her arm, "flu-like" symptoms, tired, sore neck.
Age: 50.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Vomiting
Clinical narrative: Patient says she experienced nausea, an episode of vomiting, soreness in her arm, "flu-like" symptoms, tired, sore neck.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Patient experiencing pain and redness that is warm to the touch.  The patient is also experiencing pain more than is normal for a vaccine. The patient was advised to go to hospital to get treatment in case signs are of cellulitis.  She is using Benadryl cream to treat but will go to the hospital.  Cellulitis has not been diagnosed and severity of reaction is unknown until she is admitted to hospital.
Age: 0.0
Sex: F
Vaccine: FLUX
Symptoms: Addison's disease, Adhesion, Arthropod bite, Autoimmune thyroiditis, Bladder cancer
Clinical narrative: I have Hashimoto's thyroiditis, Huntington's disease, Addison's disease, Epstein Barr, adhesive disorder, regenerative disorder, bladder cancer, hyperthyroidism, an 8.6cm tumor in liver, blood clots and tumors in my brain lungs and spine, scoliosis, kyphosis, spinal stenosis, spinal bone spurs, spinal degeneration, internal bleeding untreated due to medical office then telling another medical office I'm a drug addict who then told medical center who involved the law officials all the way up to the government slandering my name and destroying my reputation and family relationships and more importantly causing me to be at the center of psychological warfare that is terrorizing the world which has resulted in my being given intentionally the bubonic plague, pneumonic plague, hantavirus, Ebola, smallpox, typhoid fever, etc after being bit over a hundred times by the brown recluse, black widow, Asian jumping spider, and Korean backwoods spider also centipede and millipede bites, biochemical warfare! I still have not received any help and my life expectancy is hours not days at this point please send help.
Age: 0.0
Sex: F
Vaccine: FLUX
Symptoms: Brain neoplasm, Drug dependence, Ebola disease, Epstein-Barr virus infection, Exostosis
Clinical narrative: I have Hashimoto's thyroiditis, Huntington's disease, Addison's disease, Epstein Barr, adhesive disorder, regenerative disorder, bladder cancer, hyperthyroidism, an 8.6cm tumor in liver, blood clots and tumors in my brain lungs and spine, scoliosis, kyphosis, spinal stenosis, spinal bone spurs, spinal degeneration, internal bleeding untreated due to medical office then telling another medical office I'm a drug addict who then told medical center who involved the law officials all the way up to the government slandering my name and destroying my reputation and family relationships and more importantly causing me to be at the center of psychological warfare that is terrorizing the world which has resulted in my being given intentionally the bubonic plague, pneumonic plague, hantavirus, Ebola, smallpox, typhoid fever, etc after being bit over a hundred times by the brown recluse, black widow, Asian jumping spider, and Korean backwoods spider also centipede and millipede bites, biochemical warfare! I still have not received any help and my life expectancy is hours not days at this point please send help.
Age: 0.0
Sex: F
Vaccine: FLUX
Symptoms: Hepatic neoplasm, Huntington's disease, Hyperthyroidism, Internal haemorrhage, Kyphosis
Clinical narrative: I have Hashimoto's thyroiditis, Huntington's disease, Addison's disease, Epstein Barr, adhesive disorder, regenerative disorder, bladder cancer, hyperthyroidism, an 8.6cm tumor in liver, blood clots and tumors in my brain lungs and spine, scoliosis, kyphosis, spinal stenosis, spinal bone spurs, spinal degeneration, internal bleeding untreated due to medical office then telling another medical office I'm a drug addict who then told medical center who involved the law officials all the way up to the government slandering my name and destroying my reputation and family relationships and more importantly causing me to be at the center of psychological warfare that is terrorizing the world which has resulted in my being given intentionally the bubonic plague, pneumonic plague, hantavirus, Ebola, smallpox, typhoid fever, etc after being bit over a hundred times by the brown recluse, black widow, Asian jumping spider, and Korean backwoods spider also centipede and millipede bites, biochemical warfare! I still have not received any help and my life expectancy is hours not days at this point please send help.
Age: 0.0
Sex: F
Vaccine: FLUX
Symptoms: Legal problem, Lung neoplasm, Myelopathy, Personal relationship issue, Pneumonic plague
Clinical narrative: I have Hashimoto's thyroiditis, Huntington's disease, Addison's disease, Epstein Barr, adhesive disorder, regenerative disorder, bladder cancer, hyperthyroidism, an 8.6cm tumor in liver, blood clots and tumors in my brain lungs and spine, scoliosis, kyphosis, spinal stenosis, spinal bone spurs, spinal degeneration, internal bleeding untreated due to medical office then telling another medical office I'm a drug addict who then told medical center who involved the law officials all the way up to the government slandering my name and destroying my reputation and family relationships and more importantly causing me to be at the center of psychological warfare that is terrorizing the world which has resulted in my being given intentionally the bubonic plague, pneumonic plague, hantavirus, Ebola, smallpox, typhoid fever, etc after being bit over a hundred times by the brown recluse, black widow, Asian jumping spider, and Korean backwoods spider also centipede and millipede bites, biochemical warfare! I still have not received any help and my life expectancy is hours not days at this point please send help.
Age: 0.0
Sex: F
Vaccine: FLUX
Symptoms: Scoliosis, Smallpox, Spinal column stenosis, Spinal cord neoplasm, Thrombosis
Clinical narrative: I have Hashimoto's thyroiditis, Huntington's disease, Addison's disease, Epstein Barr, adhesive disorder, regenerative disorder, bladder cancer, hyperthyroidism, an 8.6cm tumor in liver, blood clots and tumors in my brain lungs and spine, scoliosis, kyphosis, spinal stenosis, spinal bone spurs, spinal degeneration, internal bleeding untreated due to medical office then telling another medical office I'm a drug addict who then told medical center who involved the law officials all the way up to the government slandering my name and destroying my reputation and family relationships and more importantly causing me to be at the center of psychological warfare that is terrorizing the world which has resulted in my being given intentionally the bubonic plague, pneumonic plague, hantavirus, Ebola, smallpox, typhoid fever, etc after being bit over a hundred times by the brown recluse, black widow, Asian jumping spider, and Korean backwoods spider also centipede and millipede bites, biochemical warfare! I still have not received any help and my life expectancy is hours not days at this point please send help.
Age: 0.0
Sex: F
Vaccine: FLUX
Symptoms: Typhoid fever, Viral infection
Clinical narrative: I have Hashimoto's thyroiditis, Huntington's disease, Addison's disease, Epstein Barr, adhesive disorder, regenerative disorder, bladder cancer, hyperthyroidism, an 8.6cm tumor in liver, blood clots and tumors in my brain lungs and spine, scoliosis, kyphosis, spinal stenosis, spinal bone spurs, spinal degeneration, internal bleeding untreated due to medical office then telling another medical office I'm a drug addict who then told medical center who involved the law officials all the way up to the government slandering my name and destroying my reputation and family relationships and more importantly causing me to be at the center of psychological warfare that is terrorizing the world which has resulted in my being given intentionally the bubonic plague, pneumonic plague, hantavirus, Ebola, smallpox, typhoid fever, etc after being bit over a hundred times by the brown recluse, black widow, Asian jumping spider, and Korean backwoods spider also centipede and millipede bites, biochemical warfare! I still have not received any help and my life expectancy is hours not days at this point please send help.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Hypersomnia, Somnolence
Clinical narrative: Copious Watery diarrhea. Extreme drowsiness. Wake up have diarrhea, sleep, slept all day 8/27, all that night, most of 8/28. Had to replenish electrolytes 8/28/16.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Malaise, Oral pain, Swelling face
Clinical narrative: Swelling of left sinus escalating into full left side of face swelling with inability to put food on left side of mouth without pain. Malaise throughout body and inability to sleep for 20 hours. Swelling began dissipating after that and is still slight in left sinus at time of report.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, body aches, vomiting.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Herpes zoster, Pyrexia, Rash generalised, Rash pustular
Clinical narrative: Shingles outbreak on lower left back, with a few out outbreaks across abdomen, 3 days later 20 pox scattered all over body with fever.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: Shingles outbreak on lower left back, with a few out outbreaks across abdomen, 3 days later 20 pox scattered all over body with fever.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diagnostic aspiration, Fatigue, Headache, Laboratory test, Rash generalised
Clinical narrative: Shingles outbreak on lower left back, with a few out outbreaks across abdomen, 3 days later 20 pox scattered all over body with fever.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shingles outbreak on lower left back, with a few out outbreaks across abdomen, 3 days later 20 pox scattered all over body with fever.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Dizziness, Eye movement disorder, Fall, Fatigue, Grunting
Clinical narrative: 12 y/o female presenting today for her first HPV vaccine. Received seasonal flu shot earlier same day. No previous reaction to any vaccines, NKDA. Patient stated she does not have a history of fainting with vaccines. No history of seizures. Vaccine administered by NP. About 10 seconds after administration, patient stated she was feeling lightheaded. Father was present in the room and stated patient was passing out. Patient's eyes had rolled up and she was slumping sideways. NP caught patient and laid her down on exam table. Patient grunted and stiffened, seizing for about 5 seconds with hands fisted and toes pointed. Laid unconscious for about 10-15 seconds, before jerking awake. NP asked if she felt okay, patient stated she felt numb. NP asked patient if she could move her fingers, and patient shook her head no. NP tapped patient's left foot and patient was able to state where she was being touched. Patient regained movement of toes about 30 seconds after awakening, and fingers 30 seconds after that. Was able to sit up independently 2 minutes later. Patient stated she could feel the herself regain feeling starting at her toes and moving upwards. Alert and oriented x3, cranial nerves intact with full strength in all limbs. 10 minutes after seizure, patient stated she had a headache and felt tired. Recommended call to EMS for transport to ER; father declined and said he would drive her. Patient remained in clinic for 15 minutes after seizure. Seizure precautions provided, instructed to call with any questions or concerns. Patient and parent state understanding and agree to treatment plan. Patient left with father to go to ER.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Headache, Hypoaesthesia, Loss of consciousness, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: 12 y/o female presenting today for her first HPV vaccine. Received seasonal flu shot earlier same day. No previous reaction to any vaccines, NKDA. Patient stated she does not have a history of fainting with vaccines. No history of seizures. Vaccine administered by NP. About 10 seconds after administration, patient stated she was feeling lightheaded. Father was present in the room and stated patient was passing out. Patient's eyes had rolled up and she was slumping sideways. NP caught patient and laid her down on exam table. Patient grunted and stiffened, seizing for about 5 seconds with hands fisted and toes pointed. Laid unconscious for about 10-15 seconds, before jerking awake. NP asked if she felt okay, patient stated she felt numb. NP asked patient if she could move her fingers, and patient shook her head no. NP tapped patient's left foot and patient was able to state where she was being touched. Patient regained movement of toes about 30 seconds after awakening, and fingers 30 seconds after that. Was able to sit up independently 2 minutes later. Patient stated she could feel the herself regain feeling starting at her toes and moving upwards. Alert and oriented x3, cranial nerves intact with full strength in all limbs. 10 minutes after seizure, patient stated she had a headache and felt tired. Recommended call to EMS for transport to ER; father declined and said he would drive her. Patient remained in clinic for 15 minutes after seizure. Seizure precautions provided, instructed to call with any questions or concerns. Patient and parent state understanding and agree to treatment plan. Patient left with father to go to ER.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Seizure
Clinical narrative: 12 y/o female presenting today for her first HPV vaccine. Received seasonal flu shot earlier same day. No previous reaction to any vaccines, NKDA. Patient stated she does not have a history of fainting with vaccines. No history of seizures. Vaccine administered by NP. About 10 seconds after administration, patient stated she was feeling lightheaded. Father was present in the room and stated patient was passing out. Patient's eyes had rolled up and she was slumping sideways. NP caught patient and laid her down on exam table. Patient grunted and stiffened, seizing for about 5 seconds with hands fisted and toes pointed. Laid unconscious for about 10-15 seconds, before jerking awake. NP asked if she felt okay, patient stated she felt numb. NP asked patient if she could move her fingers, and patient shook her head no. NP tapped patient's left foot and patient was able to state where she was being touched. Patient regained movement of toes about 30 seconds after awakening, and fingers 30 seconds after that. Was able to sit up independently 2 minutes later. Patient stated she could feel the herself regain feeling starting at her toes and moving upwards. Alert and oriented x3, cranial nerves intact with full strength in all limbs. 10 minutes after seizure, patient stated she had a headache and felt tired. Recommended call to EMS for transport to ER; father declined and said he would drive her. Patient remained in clinic for 15 minutes after seizure. Seizure precautions provided, instructed to call with any questions or concerns. Patient and parent state understanding and agree to treatment plan. Patient left with father to go to ER.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain
Clinical narrative: Severe sore throat.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the injection site -- possible rash development.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: AT 2:00 TO 3:00AM, PATIENT DEVELOPED HEADACHE AND CHILLS.  LATER IN THE MORNING DEVELOPED FEVER <100F AND BODY ACHES.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient indicated that start noticing a rash that developed around the injections site. The size of the rash it was approximately 3 In x 4 In. Patient indicated that is as painful and itchy. This continued for the next couple of days and still itchy today 09/24/16. Patient has being taking Ibuprofen and dephenyldramine and applying ice.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Diarrhoea, Dizziness, Feeling cold, Injection site pain
Clinical narrative: At first the injection site started to be extremely painful. Then chills, fever, weakness and general malaise. Diarrhea and cramping along with light headedness followed.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Malaise, Muscle spasms, Pyrexia
Clinical narrative: At first the injection site started to be extremely painful. Then chills, fever, weakness and general malaise. Diarrhea and cramping along with light headedness followed.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: INJECTION SITE REACTION. REDNESS, SWELLING, SKIN FIRMNESS AROUND INJECTION SITE.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient reported nausea and fever upon awakening in the morning.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Intense itching of head and upper torso.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Blood test, Fatigue, Headache, Influenza like illness
Clinical narrative: Experienced flu-like symptoms for 3 days. A week later, developed painful muscle cramps in calf muscles and muscle twitches all around the body but mainly in my legs. I also developed an internal tremor, long-term fatigue, tightening of the left cheek muscle, bad headaches, sore skin patches, scalp pain & back pain. Two years later, I still have constant twitching in my legs and around my body and some muscle cramping, as well as fatigue, a sore scalp and a sore back.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Muscle tightness, Muscle twitching, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Experienced flu-like symptoms for 3 days. A week later, developed painful muscle cramps in calf muscles and muscle twitches all around the body but mainly in my legs. I also developed an internal tremor, long-term fatigue, tightening of the left cheek muscle, bad headaches, sore skin patches, scalp pain & back pain. Two years later, I still have constant twitching in my legs and around my body and some muscle cramping, as well as fatigue, a sore scalp and a sore back.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pain of skin, Tremor, Ultrasound scan
Clinical narrative: Experienced flu-like symptoms for 3 days. A week later, developed painful muscle cramps in calf muscles and muscle twitches all around the body but mainly in my legs. I also developed an internal tremor, long-term fatigue, tightening of the left cheek muscle, bad headaches, sore skin patches, scalp pain & back pain. Two years later, I still have constant twitching in my legs and around my body and some muscle cramping, as well as fatigue, a sore scalp and a sore back.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: A large red circle grew around the injection site, swelled, then became hot and itchy. Continued to grow over next days. Largest diameter so far is 4 inches. Treated with Benadryl at home because no access to weekend healthcare.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. There was no information about the patient's current condition, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of an improperly stored dose of VARIVAX subcutaneous injection (possible lots of dosed vaccine was reported as: lot# M022103 with an expiration date: 04-MAY-2018; lot# M019643 with an expiration date: 20-APR-2018, lot # M009766 with an expiration date: 23-FEB-2018, lot# M002061 with an expiration date: 12-JAN-2-2018) (dose, frequency and route of administration were not reported). The reporter was unable to determine from which lot of VARIVAX the administered dose came. Administered dose of VARIVAX experienced temperature excursion of -7.4 Celsius degree for 55 minutes, on an unknown date. No adverse effects were reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a 72 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-SEP-2016, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 (lot # reported as M007769 with expiration date 27-JUN-2017; dose and route were not reported). No adverse effects were reported. The reporter also stated that the office was alerted on 16-SEP-2016, from Sanofi that shipment including PNEUMOVAX 23 vials were in transit too long. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 21-SEP-2016, the patient was inadvertently vaccinated with an expired dose PNEUMOVAX 23 (lot # K010466, expiration date 23-MAR-2016, intramuscularly, dose not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from a certified medical assistant on 30-AUG-2016. The nurse reported that the specified lot numbers of improperly stored vaccines administered between 19-MAY-2016 to 01-JUL-2016 were not available. This report refers to a patient of unknown age and gender. On 26-MAY-2016, the patient was vaccinated with incorrectly stored dose of ROTATEQ orally, lot#L035511 or K022993 or L029618. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from a certified medical assistant on 30-AUG-2016. The nurse reported that the specified lot numbers of improperly stored vaccines administered between 19-MAY-2016 to 01-JUL-2016 were not available. This report refers to a patient of unknown age and gender. On 23-JUN-2016, the patient was vaccinated with incorrectly stored ROTATEQ orally, lot # L035511 or K022993 or L029618. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M019707, expiry date 25-OCT-2017, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unknown patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # reported as L000433 with expiration date 09-JUL-2016 and lot # L006181 with expiration date 13-DEC-2016, orally (dose not reported). The vaccine underwent a temperature excursions below 36 degrees Fahrenheit for unknown time (reported as "more than 25 times"). It was reported that Data logger was used. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L040458 and expiry date 04-FEB-2018) (lot # M000442 and expiry date 31-MAR-2018) (dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist, a female patient of unknown age, who was reporting on herself. The patient's medical history and concomitant conditions were not reported. On 06-NOV-2015, the patient, who was a healthy person and not on pre-dialysis, was accidentally vaccinated with a first dose of RECOMBIVAX HB (strength: 40 microgram, route of administration, lot number and expiry date were not reported). Subsequently, on 11-APR-2016, the patient was vaccinated with a second dose of RECOMBIVAX HB (strength: 40 microgram, route of administration, lot number and expiry date were not reported). No concomitant therapy was reported. No adverse effect was reported. Additional information is not expected, because there is no consent to contact the physician.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza virus test negative, Pyrexia, Rash papular
Clinical narrative: Receive flu vaccine Sunday, 09/11/16. Friday, 09/16/16, developed fever to 102 degrees F. Saturday, 09/17/16, developed papular rash on (R) calf and was seen in urgent care.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 12 month old patient. On 25-AUG-2016, the patient was vaccinated with fourth dose of ROTATEQ (lot # M025565, expiry: 06-NOV-2017) 2 ml, oral after 32 weeks. No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PNEUMOVAX 23 administered in (R) deltoid 9/23/16. Site on 9/24/16 red, warm to touch, tender and swollen. Instructed to go to urgent care clinic for evaluation.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Malaise
Clinical narrative: Patient received vaccine 9/20/16. She came to see me on 9/24 and mentioned she had a large red area around vaccine was administered. She noticed some malaise. Redness and malaise has since resolved. It lasted 203 days.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site pruritus, Muscular weakness
Clinical narrative: Numbness and weakness and itching in left arm where vaccine given - started 3-4 days after getting vaccinated.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site erythema, Vaccination site bruising, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 68 year old female patient with scoliosis and allergy to sulfa antibiotics. The patient's medical history included chest pain, diverticulitis, shingles and headaches. On 14-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 which had a lot number of M027552, intramuscular (expiration date was not reported). The patient was not taking any concomitant medications. On 14-SEP-2016, at the evening, the patient developed bruising at the site of vaccination, her lower arm 3-4 inches and her above arm was swollen, hot to touch and red. The patient received an unspecified treatment for the adverse events. There was no product quality issue involved. At the reporting time, the patient was recovering from the events. The reporter did not assess the relationship between the events and PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date(s), the patient were vaccinated with improperly stored doses (4 doses) of PROQUAD (dosing details not known) (lot # L019998 and expiry date: 02-DEC-2016). The administered doses experienced a temperature excursion of -6.1 degree Celsius for 5 hours. The vaccine underwent previous temperature excursion of -14.8 degree Celsius for 20 minutes and -12.7 degree Celsius for 8 hours 20 minutes. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist regarding multiple unspecified patients of unknown age and gender. On an unknown dates the multiple unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L006392, expiry: 25-MAY-2016 and Lot# L028279, expiry: 28-OCT-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses (incorrect product storage) of GARDASIL 9 (lot # M020103 and expiry date 15-FEB-2018) dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site pain, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not reported). The reporter stated the patient came back in to the pharmacy on the next day 09-SEP-2016, with complaint of injection site reaction, and stated the entire backside of her arm was red and painful (unspecified which arm). The reporter did not state that redness was a rash, therefore breakthrough varicella could not be ruled out and VZV packet was requested. No treatment was given to the patient for the adverse events. The outcomes of the events were unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013203 and expiry date 28-JAN-2017) (lot # M014318 and expiry date 30-SEP-2017) (dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. The patient's concurrent conditions and medical history were not provided. On 15-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L048459 (dose was not reported). The nurse was not sure if this injection with GARDASIL 9 was the first, second or third dose in series. On 16-SEP-2016, the patient called the nurse to report that she had experienced dizziness, lightheadedness and a facial rash (onset date in September 2016). The patient denied any injection site reaction on her arm or any additional symptoms. The patient's outcome was unknown. Causality assessment between events and GARDASIL 9 was not provided. Additional information is not expected there was no consent to contact physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical histories were not reported. In approximately 2016, the patient were vaccinated with doses of VARIVAX (lot #, dose, frequency, route and site of administration were not reported) that were exposed to episodes of defrost cycling over the last several months. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030871 and expiry date 10-JUN-2018) (dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.