chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pyrexia, Ultrasound scan normal
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 April 2015. The case linked to 2015SA058850 (same event on same drug for two different patients). A 29-year-old female patient, whose concomitant medications were not reported, had received a first dose of ADACEL (batch number- C4888AA, route of administration was not reported) into left deltoid on 25 April 2015. Illness at time of vaccination was reported as none and patient did not have history of sepsis, obesity and renal issues. On 30 April 2015, 5 days after vaccination, the patient was admitted to the hospital with a diagnosis of cellulitis. Patient was being treated with vancomycin but, they were unsure of the plan of treatment as the site was only cultured on the day of report. The Vancomycin was being provided as MRSA (Methicillin-resistant Staphylococcus aureus cellulitis) was suspected. Patient was admitted to the hospital and required ER/doctor visit. Laboratory investigations included wound cultures. At the time of this report outcome of events were unknown. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: White blood cell count normal
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 April 2015. The case linked to 2015SA058850 (same event on same drug for two different patients). A 29-year-old female patient, whose concomitant medications were not reported, had received a first dose of ADACEL (batch number- C4888AA, route of administration was not reported) into left deltoid on 25 April 2015. Illness at time of vaccination was reported as none and patient did not have history of sepsis, obesity and renal issues. On 30 April 2015, 5 days after vaccination, the patient was admitted to the hospital with a diagnosis of cellulitis. Patient was being treated with vancomycin but, they were unsure of the plan of treatment as the site was only cultured on the day of report. The Vancomycin was being provided as MRSA (Methicillin-resistant Staphylococcus aureus cellulitis) was suspected. Patient was admitted to the hospital and required ER/doctor visit. Laboratory investigations included wound cultures. At the time of this report outcome of events were unknown. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Cellulitis staphylococcal, Culture wound
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 April 2015. The case linked to 2015SA058850 (same event on same drug for two different patients). A 29-year-old female patient, whose concomitant medications were not reported, had received a first dose of ADACEL (batch number- C4888AA, route of administration was not reported) into left deltoid on 25 April 2015. Illness at time of vaccination was reported as none and patient did not have history of sepsis, obesity and renal issues. On 30 April 2015, 5 days after vaccination, the patient was admitted to the hospital with a diagnosis of cellulitis. Patient was being treated with vancomycin but, they were unsure of the plan of treatment as the site was only cultured on the day of report. The Vancomycin was being provided as MRSA (Methicillin-resistant Staphylococcus aureus cellulitis) was suspected. Patient was admitted to the hospital and required ER/doctor visit. Laboratory investigations included wound cultures. At the time of this report outcome of events were unknown. Documents held by sender: none.
Age: 1.14
Sex: M
Vaccine: MEN, MMR
Symptoms: Abnormal behaviour, Pyrexia
Clinical narrative: High fever, change in behavior.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site became very red, painful, swollen. Had fever, chills. Duration 5 days. was 75% improved 5 days after injection.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Autonomic nervous system imbalance, Back pain, Chest pain, Dysarthria, Dyspepsia
Clinical narrative: On March 30, 2014 I was given a Tdap shot for a leash burn on the back of my legs. My VIS said I should get the booster Td only Tdap once in a lifetime but NP said that recommendations had changed so I received the shot. On June 13th, I had pain behind my right eye, paresthesias in my face which continued followed a few days later by pain in my toe and tingling/numbness extending up my leg, spine and back of head rendering me with blurred vision, difficulty turning my eye, weakness in both legs and arms, burning pain in legs & spine, slurred speech, & difficulty chewing. This lasted for at least 6 months or more. I was left with muscle twitching and sensory issues in my calves then experienced a relapse of the same symptoms as the original attack in February 2015. This time it resulted in further disabilities with autonomic problems with racing heart, chest pains, digestive problems, leg and arm numbness, back stiffness and pain and possibility of permanent disability given difficulty in standing and walking.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Echocardiogram, Electrocardiogram, Electromyogram, Eye movement disorder, Eye pain
Clinical narrative: On March 30, 2014 I was given a Tdap shot for a leash burn on the back of my legs. My VIS said I should get the booster Td only Tdap once in a lifetime but NP said that recommendations had changed so I received the shot. On June 13th, I had pain behind my right eye, paresthesias in my face which continued followed a few days later by pain in my toe and tingling/numbness extending up my leg, spine and back of head rendering me with blurred vision, difficulty turning my eye, weakness in both legs and arms, burning pain in legs & spine, slurred speech, & difficulty chewing. This lasted for at least 6 months or more. I was left with muscle twitching and sensory issues in my calves then experienced a relapse of the same symptoms as the original attack in February 2015. This time it resulted in further disabilities with autonomic problems with racing heart, chest pains, digestive problems, leg and arm numbness, back stiffness and pain and possibility of permanent disability given difficulty in standing and walking.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Laboratory test, Lumbar puncture, Mastication disorder, Muscle twitching
Clinical narrative: On March 30, 2014 I was given a Tdap shot for a leash burn on the back of my legs. My VIS said I should get the booster Td only Tdap once in a lifetime but NP said that recommendations had changed so I received the shot. On June 13th, I had pain behind my right eye, paresthesias in my face which continued followed a few days later by pain in my toe and tingling/numbness extending up my leg, spine and back of head rendering me with blurred vision, difficulty turning my eye, weakness in both legs and arms, burning pain in legs & spine, slurred speech, & difficulty chewing. This lasted for at least 6 months or more. I was left with muscle twitching and sensory issues in my calves then experienced a relapse of the same symptoms as the original attack in February 2015. This time it resulted in further disabilities with autonomic problems with racing heart, chest pains, digestive problems, leg and arm numbness, back stiffness and pain and possibility of permanent disability given difficulty in standing and walking.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: On March 30, 2014 I was given a Tdap shot for a leash burn on the back of my legs. My VIS said I should get the booster Td only Tdap once in a lifetime but NP said that recommendations had changed so I received the shot. On June 13th, I had pain behind my right eye, paresthesias in my face which continued followed a few days later by pain in my toe and tingling/numbness extending up my leg, spine and back of head rendering me with blurred vision, difficulty turning my eye, weakness in both legs and arms, burning pain in legs & spine, slurred speech, & difficulty chewing. This lasted for at least 6 months or more. I was left with muscle twitching and sensory issues in my calves then experienced a relapse of the same symptoms as the original attack in February 2015. This time it resulted in further disabilities with autonomic problems with racing heart, chest pains, digestive problems, leg and arm numbness, back stiffness and pain and possibility of permanent disability given difficulty in standing and walking.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Paraesthesia, Sensory disturbance, Vision blurred
Clinical narrative: On March 30, 2014 I was given a Tdap shot for a leash burn on the back of my legs. My VIS said I should get the booster Td only Tdap once in a lifetime but NP said that recommendations had changed so I received the shot. On June 13th, I had pain behind my right eye, paresthesias in my face which continued followed a few days later by pain in my toe and tingling/numbness extending up my leg, spine and back of head rendering me with blurred vision, difficulty turning my eye, weakness in both legs and arms, burning pain in legs & spine, slurred speech, & difficulty chewing. This lasted for at least 6 months or more. I was left with muscle twitching and sensory issues in my calves then experienced a relapse of the same symptoms as the original attack in February 2015. This time it resulted in further disabilities with autonomic problems with racing heart, chest pains, digestive problems, leg and arm numbness, back stiffness and pain and possibility of permanent disability given difficulty in standing and walking.
Age: 2.0
Sex: M
Vaccine: MMR, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Child patient was given Zostavax vaccine instead of Varivax Vaccine.
Age: 2.0
Sex: M
Vaccine: MMR, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Child patient was given Zostavax vaccine instead of Varivax Vaccine.
Sex: M
Vaccine: RV5
Symptoms: Ileus, Intestinal resection, Intussusception
Clinical narrative: Information has been received from a patient's grandmother via a company representative via email referring to the male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ROTATEQ (dose, frequency, dose# were not reported) orally. On an unknown date the patient experienced intussusception and ileus after receiving the ROTATEQ. The patient was hospitalized and had to have an unspecified surgery, on an unknown date, where part of the patient's intestines were removed after opening the patient's stomach. It was unknown the duration of stay. It was not specified by the reporter if the ROTATEQ was discontinued. The outcome of ileus and intussusception was unknown. The relationship between these events and ROTATEQ was not reported. Upon internal review, the events of intussusception and ileus was considered to be medically significant. Additional information is not expected as no contact information was provided by the reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Influenza like illness, Injection site mass, Oropharyngeal pain
Clinical narrative: To initial reaction, then on 4/10 had flu like symptoms and neck, shoulder, and hip joint pain but gone by 4/17.  Then started again on 4/22 through 4/27, but gone again then started again 5/1 to 5/3.  On 5/1 while rubbing shoulders noticed hard lump on left upper arm (where I was injected with shingles vaccine) then by 5/3 gone and the lump almost gone. On 5/7 started to get sore throat, had bubbles in throat and again infection, but then almost clear on morning of 5/8, but still flu symptoms and small lump.  On 5/8 the physician was able to feel the small lump where I was vaccinated and see throat infection.  Physician ordered antibiotics and currently running blood tests - based on above asked me to file report.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal disorder, Pharyngitis
Clinical narrative: To initial reaction, then on 4/10 had flu like symptoms and neck, shoulder, and hip joint pain but gone by 4/17.  Then started again on 4/22 through 4/27, but gone again then started again 5/1 to 5/3.  On 5/1 while rubbing shoulders noticed hard lump on left upper arm (where I was injected with shingles vaccine) then by 5/3 gone and the lump almost gone. On 5/7 started to get sore throat, had bubbles in throat and again infection, but then almost clear on morning of 5/8, but still flu symptoms and small lump.  On 5/8 the physician was able to feel the small lump where I was vaccinated and see throat infection.  Physician ordered antibiotics and currently running blood tests - based on above asked me to file report.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patients upper arm became swollen, red and warm to touch with pain.  Patients mother reached out for assistance the next day 7 May and referred to ER where child was treated for Cellulitis with antibiotics, and followed up with clinic 8 May.
Age: 12.0
Sex: F
Vaccine: TYP
Symptoms: Affect lability, Amnesia, Fatigue
Clinical narrative: Fatigue, emotional lability, transient problems with memory.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Pt given vaccine in the morning at 8:45 am. At 10:30 am mom called he was unsconsolable/crying. At 1:30 pm called fever 103.2. No redness at sight.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Fullness, hardness and redness of his left thigh injection site with pain and bruising.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Subsequent swelling and erythema on upper (L) thigh where vaccines were given.
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Hallucination, auditory
Clinical narrative: This spontaneous report as received from a licensed practical nurse via a company representative refers to a female patient of unknown age. The nurse heard of this adverse event from the patient's mother. In approximately May 2013 (reported as 2 years ago), the patient was vaccinated with a dose (reported as one dose) of GARDASIL (route of administration, lot # and expiration date unknown). Afterwards, on an unknown date, the patient experienced an inability to walk right and was hearing voices in her head. The patient's mother saw an article which discussed similar effects related to GARDASIL use (reported in MARRS # 1505USA003630) and correlated the symptoms discussed in that article to the patient's experience. The patient sought an unspecified medical attention. The outcome of the adverse events was unknown. The relatedness between the adverse events and the vaccination with GARDASIL was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient noted a silver dollar sized red, hot and rasied itchy area on the morning of 4/23/15. Patient took 1 BENADRYL at 10:45 am on 4/23/15.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Local erythema, warmth, tenderness worsening for 6 days when evaluated today.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Arm very red, swollen, warm to touch, painful.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Huge erythematous skin left thigh (warm and tender).
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Paralysis
Clinical narrative: Initial unsolicited report received from a non healthcare professional  (consumer) on 01-May-2015. A male patient (age not reported), whose medical history and concomitant medications were not provided had received a dose of influenza vaccine (dose details, batch number, route of administration and site of administration were not reported) on an unspecified date. On an unspecified date, few weeks post vaccination, the patient was not feeling well. He was also paralyzed from the waist down on an unspecified date however he was back on his feet. Laboratory investigations and corrective treatments were not provided. At the time of this report, the outcome was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: Paralysis. Documents held by sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to multiple unspecified patients. Patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (injection, lot#, dose, route and dose number were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Acute disseminated encephalomyelitis, Central nervous system lesion, Coma, Mobility decreased, Paralysis
Clinical narrative: Initial unsolicited report received from a consumer on 01 May 2015. A female patient (age at the time of event unspecified), whose concomitant medications were not reported, had received a dose of H1N1 flu shot (batch number, expiry date, dose and dose number, route and site of administration were not reported) on an unspecified date in 2010. The patient had medical history of asthma. On an unspecified date, after vaccination, the patient got paralyzed, and three months after vaccination, patient had coma for about three weeks. Patient also had an autoimmune disease called Acute Disseminated Encephalomyelitis (ADEM) with lesions on her brain and spinal cord, although doctors told that condition was a result of flu shot, but federal health officials said that's tough to prove. It was also reported that, five year later at the age of twenty two, patient was wheelchair-bound and can barely move the left side of her body. Laboratory investigations and corrective treatments were not reported. At the time of reporting, outcome of event for coma was recovered and unknown for Acute Disseminated Encephalomyelitis and paralyzed. Documents held by sender: none.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Wheelchair user
Clinical narrative: Initial unsolicited report received from a consumer on 01 May 2015. A female patient (age at the time of event unspecified), whose concomitant medications were not reported, had received a dose of H1N1 flu shot (batch number, expiry date, dose and dose number, route and site of administration were not reported) on an unspecified date in 2010. The patient had medical history of asthma. On an unspecified date, after vaccination, the patient got paralyzed, and three months after vaccination, patient had coma for about three weeks. Patient also had an autoimmune disease called Acute Disseminated Encephalomyelitis (ADEM) with lesions on her brain and spinal cord, although doctors told that condition was a result of flu shot, but federal health officials said that's tough to prove. It was also reported that, five year later at the age of twenty two, patient was wheelchair-bound and can barely move the left side of her body. Laboratory investigations and corrective treatments were not reported. At the time of reporting, outcome of event for coma was recovered and unknown for Acute Disseminated Encephalomyelitis and paralyzed. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to multiple unspecified patients. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAC (lot#, dose, route and dose number were not provided). No adverse effect was reported. This is one of several reports received from the same souce. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Asthenia, Axonal neuropathy
Clinical narrative: Developed debilitating arthralgia and questions if influenza---nasal caused it. She developed symptoms 8 months following each dose (in April of the next year). Seen by an allergist with no causal relationship found. Dx axonal neuropathy.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There were no medical history and concurrent condition reported. Over 2 years ago, in approximately 2013 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route and lot# not provided). There was no concomitant medication reported. At the time of reporting, the patient would like to receive the second dose. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients. Between 06-APR-2015 and 30-APR-2015, the unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, strength, lot# and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 year old patient of unknown gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 07-MAY-2015, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (dose, frequency and indication were not provided). No adverse symptoms reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding to a patient of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX, Lot number-K016128, expiration date-23-SEP-2016 which was stored incorrectly. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Right upper extremity diffuse, erythematous maculopapular rash. Right upper forearn also swollen. Amoxicillin/clavulanate 500 mg BID.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with no pertinent medical history and no drug reactions or allergies. On 06-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and anatomical location were not specified, subcutaneously) (lot # K023622, expiration date: 20-FEB-2016) for shingles. Concomitant medication was not reported. On 07-MAY-2015, the patient experienced "a red, raised hard lump at the injection site that was three inches in diameter and warm to the touch". The patient presented to the pharmacist on 08-MAY-2015 also reported as "today" and the pharmacist specifically noted that was not a varicella rash. No treatment was given for adverse event. No laboratory or diagnostic tests were performed. No product quality complaint (PQC) was involved. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. Reporter stated that on 01-MAY-2015, the patient may had been vaccinated with GARDASIL 9 (dose, frequency and indication were not reported), who was nursing. Reporter also stated that GARDASIL 9 had not been administered to the patient yet at the time of reporting. Patient sought medical attention due to the office visit. The outcome of event was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history or concurrent condition were not provided. On 23-APR-2015 the patient was vaccinated with the first dose of GARDASIL (injection, strength, lot#, dose were unspecified) intramuscularly. On 07-MAY-2015 the patient was inadvertently administered the second dose of GARDASIL (injection, strength, lot#, dose, were unspecified) intramuscularly (inappropriate schedule of vaccine administered). No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, "since 07-JAN-2015", the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # J000722, expired date as 17-SEP-2015; lot# reported as KJ008570, expired date as 05-FEB-2016) (therapy type, strength, dosage and route were not reported). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unspecified dates, the patient was vaccinated with PROQUAD (route, dose, Lot# and expiration date not reported), but the vaccines had been exposed to temperatures warmer than 5F, which was outside of the recommended range. No adverse effects have been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, "since 07-JAN-2015", the patients were vaccinated with improperly stored MMR II, lot # J006185, expired date as 24-MAY-2015: lot# J016234, expired date as 19-DEC-2015; lot# K003806, expired date as 13-MAR-2016; lot# K020188, expired date as 22-OCT-2016) (strengtth, dosage and route were not reported). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of an unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date in 2015, "since 07-JAN-2015", the patients were vaccinated with improperly stored GARDASIL injection (lot # H021861, expired date as 09-OCT-2015; lot# K023432, expired dates as 18-JUN-2016; lot# K003520, expired date as 20-NOV-2016; lot# K006124, expired date as 02-FEB-2017) (strength, dosage and route were not reported). No adverse effects were reported. This is one of several reports that 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 as received from a medical assistant refers to patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with ROTATEQ was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unspecified dates, the patient was vaccinated with (Oka/Merck) VARIVAX (route, dose, Lot# and expiration date not reported), but the vaccines had been exposed to temperatures warmer than 5F, which was outside of the recommended range. No adverse effects have been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, "since 07-JAN-2015", the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K006136, expired date as 29-APR-2016; lot# reported as K011799, expired ate as 21-AUG-2016) (strength, dosage and route were not reported). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse practitioner via a field representative and refers to a male patient of unknown age. patient had no pertinent medical history and no known drug reactions/allergies. On 07-OCT-2014, the patient was vaccinated with the second dose of GARDASIL intramuscularly. After the receipt of this dose, on 07-OCT-2014, the patient passed out (loss of consciousness), while in office. No laboratory studies were performed. Treatment included supportive measures. Patient recovered on an unspecified date in approximately October 2014, and was then sent home. Patient also received the third dose of GARDASIL on an unspecified date, without any complications. Causality assessment was not provided. additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 04-MAY-2015, the patient was vaccinated with second dose of improperly stored GARDASIL, lot # K008931, expiry date 02-NOV-2016, 0.5 milliliter (ml), intramuscularly, that was exposed to 31.1F for 30 hours. No adverse effect was reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated totally 9 doses of improperly stored RECOMBIVAX HB (lot number, dose and route were unknown). No adverse effects were reported. This is one of several 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 registered nurse regarding to a patient of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, the patient was vaccinated with PROQUAD lot # K020751, expiration date-30-APR-2016 which was stored incorrectly. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. On unspecified dates after 28-AUG-2014, the patients were vaccinated with improperly stored ZOSTAVAX (lot#, expiration date, dose and route were unknown). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 01-MAY-2015 the patient was inadvertently vaccinated with a dose of expired ZOSTAVAX (lot#, dose and route were unknown). The expiration date was 20-MAR-2015. No concomitant therapy was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were received totally 40 doses of improperly stored ROTATEQ orally (lot number and dose were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were received totally 8 doses of improperly stored GARDASIL (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age who was currently 7 weeks postpartum. No other relevant medical history or concurrent conditions were reported. On an unknown date in February 2014 the patient was vaccinated with the first dose of GARDASIL (0.5ml; lot# and expiration date unknown) intramuscularly. The patient became pregnant on an unspecified date after receiving the vaccine. On 5-MAY-2015, the patient who was currently nursing her 7 week old infant, was in the physician's office to receive the dose number two of GARDASIL (0.5ml: lot# and expiration date unknown). Other than pregnancy, no adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. There was no product quality issue reported. This is one of the many reports from the same source. 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 licensed practical nurse refers to an unspecified patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date, the patients were vaccinated with a doses of an improperly stored LIQUID PEDVAXHIB lot # K019701, expiration date 17-JUL-2017 (doses and routes were not provided). Secondary suspects and concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from the physician during a phone call referring to an 18 month oldl male patient. The patient's medical history and drug reactions/allergies were not reported. The patient was vaccinated with doses of ROTATEQ orally (dose and lot# were not reported) respectively in December 2013 (the first dose), in March 2014 (second dose) and in May 2014 (third dose). The patient probably went to the emergency room (ER) on 27-APR-2015 and was administered intravenous fluid (manufacturer and dosage information unavailable) and antiemetic treatment (manufacturer and dosage information unavailable), and was tested positive for rotavirus. On 30-APR-2015, the patient "look great" at the follow up appointment. The final outcome of the event and the causality were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The nurse reported that multiple unspecified patients received either MMR II (strength, dose and route were unknown) or VAQTA (strength, dose and route were unknown) that were improperly. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 04-MAY-2015 the patient was inadvertently vaccinated with a dose of GARDASIL 9, intramuscular after completing the GARDASIL (4) series on an unspecified date in 2011. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Not feeling well morning of 5/8/2015.  Had swelling, erythema, tenderness of right deltoid.  Later that day developed fever, that night had diarrhea. Continued to have fever the next day.  Is feeling better today 5/11/2015.  Still has erythema, edema and tenderness in the right deltoid but he says it is improving.
Age: 63.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Not feeling well morning of 5/8/2015.  Had swelling, erythema, tenderness of right deltoid.  Later that day developed fever, that night had diarrhea. Continued to have fever the next day.  Is feeling better today 5/11/2015.  Still has erythema, edema and tenderness in the right deltoid but he says it is improving.
Age: 1.15
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: PT has light red rash noted on arms, truck and legs.  No open wounds.  Not raised rash.  No fever or other illness noted.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Patient was fine after immunization until he stood, then he became dizzy.  We had his sit down on pharmacy bench.  His skin appeared sweaty, however it was warm in the store. He said he was hot before the shot, but was now hotter. He stated he had not eatten since last night.  He was going to eat after the shot, because it was his lunchbreak here (stockman).  BP was 93/57 mmhg 10 min post-shot. Gave him cold bottle of water and pk crackers.  BP 114/83 mmhg 25 min post-shot. Gave 2nd water which he drank.  Also drank can of soda.  BP 121/82mmhg 20 min post-shot.  Felt some better, so went to the breakroom to eat lunch. Observed walking to back with no staggering.  He did not know what his normal BP was because he does not have PCP.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients fo unknown age and gender. Since on an unknown date in March 2015, the unspecified patients were vaccinated with improperly stored VAQTA (lot# K012457 and expiry date: 04-JUN-2017) (dose and frequency were not reported) for an unknown indication. No adverse effects were reported. No product quality complaint was reported for VAQTA. This is one of the several reports 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 as received from a certified medical assistant (healthcare worker) refers to 7 unspecified patients of unknown age and gender. On unknown dates in 2015 (reported as since 11-MAR-2015), the patients were vaccinated with doses of improperly stored ROTATEQ, oral (dose and lot number were not reported). No adverse effects were 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 healthcare worker refers to an unspecified patients of unknown age and unknown gender. Since on an unknown date in March 2015, the unspecified patients were vaccinated with improperly stored doses of oral ROTATEQ (lot# K005396 and expiry date: 28-FEB-2016) (dose and frequency were not reported) for an unknown indication. No adverse effects were reported. No product quality complaint was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a other health professional refers to a 18 year old female patient. The patient had no medical history and drug reactions or allergies. On 14-OCT-1997, the patient was vaccinated with a first doses of MMR II (lot number and expiration date were not reported) 0.5 ml, subcutaneous. On 31-OCT-2000, the patient was vaccinated with a second dose of MMR II (lot number and expiration date were not reported) 0.5 ml, subcutaneous. Secondary suspects and concomitant therapies were not reported. On 09-JAN-2015, the patient had serologic tests done and the result was seronegative at 9.0 (units not provided). On 16-JAN-2015 the patient was vaccinated with a third dose of MMR II (lot number and expiration date were not reported), 0.5 ml, subcutanoeus. On 06-MAR-2015, the patient had serologic tests done and the result was seronegative at 10.6 (units not provided). On 18-APR-2015, the patient had serologic tests done and the result was still seronegative at 9 (units not provided). The outcome of antibody test negative was unknown. The relatedness between adverse event and MMR II was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to 5 unspecified patients. Information regarding concurrent conditions and medical history was not provided. On unspecified dates, the 5 patient was vaccinatted with doses of improperly stored PNEUMOVAX 23 lott # K004483, exp. date: 16-AUG-2015 (dose, dose number, route and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information is not expected because the reporter gave no consent to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date these patients were vaccinated with improperly stored (trade name reported as PEDVAXHIB) (dose, frequency, route, lot number and expiration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a male patient of unknown age. On an unknown date tthe patient was vaccinated with MMR II dose 1 (dose, route and lot # unspecified). On 21-APR-2015 the patient was again vaccinated with MMR II lot # J003623; expiry: 22-MAR-2015, dose 2, subcutaneous (dose unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered on 21-APR-2015 was an expired vaccine used in the series which was inadvertently administered to the patient. No adverse event was reported. The outcome of expired vaccine used and no adverse event is unknown. Additional informatino has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. Since on an unknown date in March 2015, the unspecified patients were vaccinated with improperly stored doses of ROTATEQ (lot# K010221 and expiry date: 12-MAY-2016) (dose and frequency were not reported) for an unknown indication. No adverse effects were reported. No product quality complaint was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.