chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K026666, expiration date: 20-OCT-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. ON an unkown dates, the patients were vaccinated with improperly store doses of VAQTA (lot # L009445, expiration date: 01-JUN-2017 and lot # L002717, expiration date: 02-JUN-2017 (dose and route of administration were not reported). No adverse effects were 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: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # K014833, expiration date: 14-SEP-2016, (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, frequency and route were not reported). On an unknown date, blood work showed negative for hepatitis B antibodies and now on an unknown date, her blood work showed a "false positive" for hepatitis B antibodies the patient experienced hepatitis B surface antibody negative. The outcome of the event was unknown. The causality of the event was not reported. Additional information is not expected as contact details were not reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # K026247, expiration date: 29-JAN-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of COMVAX lot # J013884, expiration date: 19-AUG-2016 and lot # J009691, expiration date: 29-NOV-2015 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a 6 month old patient of unknown gender. The patient's pertinent medical history and drug reactions were not reported. On an unknown date, the patient was vaccinated with a first dose of ROTATEQ vial (lot # reported as K024700, expiration date 30-JUL-2016, route of administration default to oral, dose was not provided). The patient's concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a 7 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a first dose of ROTATEQ vial (lot # reported as K024700, expiration date 30-JUL-2016, route of administration default to oral, dose was not provided). The patient's concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that between 30-JUN-2015 and 18-AUG-2015, the patients were vaccinated with the improperly stored doses of GARDASIL (lot # K010215 with expiration date 06-MAY-2017; dose and route of administration were not reported). No adverse effects were reported. 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 and refers to a unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions and allergies. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot #'s, expiration dates, doses, frequency were not reported). No adverse effect were reported and no product quality complaints (PQC) were involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that between 30-JUN-2015 and 18-AUG-2015, the patients were vaccinated with the improperly stored doses of M-M-R II (lot # K024036 with expiration date 26-NOV-2016 and lot # K024824 with expiration date 02-DEC-2016; dose and route of administration 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 an office manager refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that between 30-JUN-2015 and 18-AUG-2015, the patients were vaccinated with the improperly stored does of ROTATEQ (lot # K016263 with expiration date 26-JUN-2016, orally; dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 20-MAY-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms 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: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored GARDASIL (lot number and expiration date were unspecified, dose, frequency and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 16-JUN-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. 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 healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with the doses of PEDVAXHIB (lot#, dose, strength and route were not reported) which were exposed to a temperature outside of the recommended range. No adverse experience was reported. This is one of several reports 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 as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 22-JUN-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 92 year old female patient. No concurrent condition or medical history was reported. On an unknown date in 2007, also reported as 8 years ago, the patient was vaccinated with ZOSTAVAX (standard dosage, dose and route of administration not provided). No concomitant therapy was reported. On an unknown date in 2015, also reported as this past summer, the patient developed a very mild rash and severe post herpetic neuralgia. The patient sought medical attention and saw physician. The patient was treated with 300 units of Neurontin 3 times daily. No lab diagnostics were performed. The outcome of the event was reported as recovering. The patient was doing better and the physician would be tapering her off of the Neuroontin shortly. No product quality issued was involved. Additional information is not expected as the reporter did not wish further contact.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 11 year old female patient. Patient did not specify specific medical history. No drug reactions/allergies were reported. On 12-AUG-2015 patient was vaccinated with GARDASIL 9 (strength, dose, route were unspecified by the reporter). Concomitant therapies included meningococcal vaccine (unspecified). On 12-AUG-2015, patient experienced syncope after receiving treatment with GARDASIL 9. Reporter stated that patient did not receive any treatment for the event syncope. On 12-AUG-2015 patient recovered during the office visit from syncope. There was no product quality complaint involved. Reporter's causality statement was not reported at the time of the report. This is one of the two reports received from the same reporter (MARRS # 1508USA006794). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Influenza
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient's medical history included seizures. Concomitant therapies included LEVAQUIN. None drug reactions/allergies were reported. On 01-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (o.65 ml, subcutaneously lot # K018173, expiration date 10-JAN-2016). On 02-JUL-2015, the patient developed bronchitis and the flu. The patient sought an unspecified type of medical attention and she received the treatment with M-CLEAR and Z-PAK. None lab diagnostics studies were performed. The outcome of bronchitis and flue was reported as recovered on an unknown date in 2015. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Fall, Lip injury, Syncope
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 11 year old female patient. Patient did not specify specific medical history. No drug reactions/allergies were reported. On 12-AUG-2015 patient was vaccinated with GARDASIL 9 (strength, dose, route were unspecified by the reporter). Concomitant therapies included meningococcal vaccine (unspecified). On 12-AUG-2015, patient experienced syncope after receiving treatment with GARDASIL 9. Also reported patient experienced fell and received a minor cut on her lip during her syncope experience. Reporter stated that patient did not receive any treatment for the events. On 12-AUG-2015 patient recovered during the office visit from lip injury and syncope. There was no product quality complaint involved. Reporter's causality statement was not reported at the time of the report. This is one of the two reports received from the same reporter (MARRS # 1508USA008232). Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 13 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in  June 2015 (reported as "two months ago"), the patient was vaccinated with the second dose of GARDASIL injection (dose, lot # and expiry date were not provided) intramuscularly. While receiving the second dose of GARDASIL, the patient broke out in hives on his face and arm. Therapy with GARDASIL was discontinued. The patient sought medical attention, by coming to the office for a scheduled office visit. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 25-JUN-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 28-JUN-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 02-JUL-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 27-JUL-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received via company representative from a physician, and refers to a 65 year old female patient. No patient's medical history, concurrent conditions or concomitant therapies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date not specified). On an unknown date the physician noticed that the patient had cellulitis, which started to expand and continued to expand at the time of the report. The patient sought medical attention. The outcome of cellulitis was unknown. The relatedness between PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Oedema peripheral, Pain
Clinical narrative: This spontaneous report was received via company representative from a physician, and refers to a 65 year old female patient. No patient's medical history, concurrent conditions or concomitant therapies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date not specified). On an unknown date the physician noticed that the patient had cellulitis, which started to expand and continued to expand at the time of the report. The patient sought medical attention. The outcome of cellulitis was unknown. The relatedness between PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received via company representative from a physician, and refers to a 65 year old female patient. No patient's medical history, concurrent conditions or concomitant therapies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date not specified). On an unknown date the physician noticed that the patient had cellulitis, which started to expand and continued to expand at the time of the report. The patient sought medical attention. The outcome of cellulitis was unknown. The relatedness between PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 29-JUL-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Age: 10.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: (R) (L) Deltoid 2 inch round, red, tender. Treat with BENADRYL/hydrocortisone.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, expiration date, dose and route were not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 11-JUN-1997, the patient was vaccinated with a first dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). On 23-JUL-1997, the patient was vaccinated with a second dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). On 27-SEP-1997, the patient was vaccinated with a third dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). On 17-APR-2000, the patient was vaccinated with a fourth dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). On 07-AUG-2015, the patient was vaccinated with a fifth dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: Pt developed large painful lump (approximately 2 in diameter) and bruising where flu shot given; took BENADRYL and acetaminophen to help with symptoms.
Age: 79.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Bronchitis, Chills, Pyrexia, Vomiting
Clinical narrative: Patient's daughter called and stated patient developed chills and vomiting after receiving 3 vaccinations. 104 degree fever. Came down with bronchitis.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Bruxism, Contusion, Eye movement disorder, Fall, Fatigue
Clinical narrative: 08/18/2015 at about 3:45 PM patient was seen at Dr's office for 13 yr old physical check up. Patient received Hepatitis A 2nd dose at Right arm and MENACTRA at left arm given by Dr. At about 6-7 pm patient was at home. While talking to mom and sister, he suddenly fell backward to wood cabinet countertop behind him. The cabinet was about 3 feet high. His whole body and all extremities became stiffed, stop talking, with eyes roll up, sweating, urinating. Face turned dark and lips pale and grinding teeth. Incidences last 1-2 min. Patient didn't have shaking of the body. Patient didn't collapse down to the floor. No vomiting, no fecal incontinence. Mom didn't recall pt stopped breathing. Patient denied being hit to head. Patient woke up by himself and mom and sister took him to the bed. As per patient, he can hear everything during the event. He can recall everything. But he can't see and move at that time. Mom didn't call 911 nor take him to ER. As per mom, she just hold and hug him and pray for him for his recovery. As per mom patient looks tired. Patient has headache after that at top of head, sharp pain grade 6-7/10 but no medicine taken. Patient also complaint of pain, bruise at the left arm but able to move and lift up the arm. 8/19/15 less pain at the top of the head. 8/20/15 at about 4:30 pm mom called to office and spoke to her. Mom reported to Dr the incidence which occurred in 8/18/15. As per patient feeling ok except still headache but less frequent. Pt was scheduled appointment to see Dr. on 8/21/15. 8/21/15 patient was seen at doctor's office. As per patient, still headache not all the time, just on - off.  But now no headache, pain level 4/10. No more sharp pain. He feels well. No nausea/vomiting/dizziness/vision changes/hearing loss. No changes in taste and smell. No numbness/weakness/no tiredness. Eat/sleep well. No abdominal pain/cough/RNO/diarrhea. Sleep well. Eat well. Still c/o pain over left arm but no redness. C/O tenderness less and able to move arm and also the head. On exam on 8/21/15 left arm mild swelling at injection site. No redness. 1 cm size bluish discoloration. Sl. tender.  No blister/vesicle/pustule. Treatment none. Referred to Peds Neurologist for rule out seizure disorder.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Headache, Hyperhidrosis, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: 08/18/2015 at about 3:45 PM patient was seen at Dr's office for 13 yr old physical check up. Patient received Hepatitis A 2nd dose at Right arm and MENACTRA at left arm given by Dr. At about 6-7 pm patient was at home. While talking to mom and sister, he suddenly fell backward to wood cabinet countertop behind him. The cabinet was about 3 feet high. His whole body and all extremities became stiffed, stop talking, with eyes roll up, sweating, urinating. Face turned dark and lips pale and grinding teeth. Incidences last 1-2 min. Patient didn't have shaking of the body. Patient didn't collapse down to the floor. No vomiting, no fecal incontinence. Mom didn't recall pt stopped breathing. Patient denied being hit to head. Patient woke up by himself and mom and sister took him to the bed. As per patient, he can hear everything during the event. He can recall everything. But he can't see and move at that time. Mom didn't call 911 nor take him to ER. As per mom, she just hold and hug him and pray for him for his recovery. As per mom patient looks tired. Patient has headache after that at top of head, sharp pain grade 6-7/10 but no medicine taken. Patient also complaint of pain, bruise at the left arm but able to move and lift up the arm. 8/19/15 less pain at the top of the head. 8/20/15 at about 4:30 pm mom called to office and spoke to her. Mom reported to Dr the incidence which occurred in 8/18/15. As per patient feeling ok except still headache but less frequent. Pt was scheduled appointment to see Dr. on 8/21/15. 8/21/15 patient was seen at doctor's office. As per patient, still headache not all the time, just on - off.  But now no headache, pain level 4/10. No more sharp pain. He feels well. No nausea/vomiting/dizziness/vision changes/hearing loss. No changes in taste and smell. No numbness/weakness/no tiredness. Eat/sleep well. No abdominal pain/cough/RNO/diarrhea. Sleep well. Eat well. Still c/o pain over left arm but no redness. C/O tenderness less and able to move arm and also the head. On exam on 8/21/15 left arm mild swelling at injection site. No redness. 1 cm size bluish discoloration. Sl. tender.  No blister/vesicle/pustule. Treatment none. Referred to Peds Neurologist for rule out seizure disorder.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pain in extremity, Pallor, Skin discolouration
Clinical narrative: 08/18/2015 at about 3:45 PM patient was seen at Dr's office for 13 yr old physical check up. Patient received Hepatitis A 2nd dose at Right arm and MENACTRA at left arm given by Dr. At about 6-7 pm patient was at home. While talking to mom and sister, he suddenly fell backward to wood cabinet countertop behind him. The cabinet was about 3 feet high. His whole body and all extremities became stiffed, stop talking, with eyes roll up, sweating, urinating. Face turned dark and lips pale and grinding teeth. Incidences last 1-2 min. Patient didn't have shaking of the body. Patient didn't collapse down to the floor. No vomiting, no fecal incontinence. Mom didn't recall pt stopped breathing. Patient denied being hit to head. Patient woke up by himself and mom and sister took him to the bed. As per patient, he can hear everything during the event. He can recall everything. But he can't see and move at that time. Mom didn't call 911 nor take him to ER. As per mom, she just hold and hug him and pray for him for his recovery. As per mom patient looks tired. Patient has headache after that at top of head, sharp pain grade 6-7/10 but no medicine taken. Patient also complaint of pain, bruise at the left arm but able to move and lift up the arm. 8/19/15 less pain at the top of the head. 8/20/15 at about 4:30 pm mom called to office and spoke to her. Mom reported to Dr the incidence which occurred in 8/18/15. As per patient feeling ok except still headache but less frequent. Pt was scheduled appointment to see Dr. on 8/21/15. 8/21/15 patient was seen at doctor's office. As per patient, still headache not all the time, just on - off.  But now no headache, pain level 4/10. No more sharp pain. He feels well. No nausea/vomiting/dizziness/vision changes/hearing loss. No changes in taste and smell. No numbness/weakness/no tiredness. Eat/sleep well. No abdominal pain/cough/RNO/diarrhea. Sleep well. Eat well. Still c/o pain over left arm but no redness. C/O tenderness less and able to move arm and also the head. On exam on 8/21/15 left arm mild swelling at injection site. No redness. 1 cm size bluish discoloration. Sl. tender.  No blister/vesicle/pustule. Treatment none. Referred to Peds Neurologist for rule out seizure disorder.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Speech disorder, Tenderness, Urinary incontinence
Clinical narrative: 08/18/2015 at about 3:45 PM patient was seen at Dr's office for 13 yr old physical check up. Patient received Hepatitis A 2nd dose at Right arm and MENACTRA at left arm given by Dr. At about 6-7 pm patient was at home. While talking to mom and sister, he suddenly fell backward to wood cabinet countertop behind him. The cabinet was about 3 feet high. His whole body and all extremities became stiffed, stop talking, with eyes roll up, sweating, urinating. Face turned dark and lips pale and grinding teeth. Incidences last 1-2 min. Patient didn't have shaking of the body. Patient didn't collapse down to the floor. No vomiting, no fecal incontinence. Mom didn't recall pt stopped breathing. Patient denied being hit to head. Patient woke up by himself and mom and sister took him to the bed. As per patient, he can hear everything during the event. He can recall everything. But he can't see and move at that time. Mom didn't call 911 nor take him to ER. As per mom, she just hold and hug him and pray for him for his recovery. As per mom patient looks tired. Patient has headache after that at top of head, sharp pain grade 6-7/10 but no medicine taken. Patient also complaint of pain, bruise at the left arm but able to move and lift up the arm. 8/19/15 less pain at the top of the head. 8/20/15 at about 4:30 pm mom called to office and spoke to her. Mom reported to Dr the incidence which occurred in 8/18/15. As per patient feeling ok except still headache but less frequent. Pt was scheduled appointment to see Dr. on 8/21/15. 8/21/15 patient was seen at doctor's office. As per patient, still headache not all the time, just on - off.  But now no headache, pain level 4/10. No more sharp pain. He feels well. No nausea/vomiting/dizziness/vision changes/hearing loss. No changes in taste and smell. No numbness/weakness/no tiredness. Eat/sleep well. No abdominal pain/cough/RNO/diarrhea. Sleep well. Eat well. Still c/o pain over left arm but no redness. C/O tenderness less and able to move arm and also the head. On exam on 8/21/15 left arm mild swelling at injection site. No redness. 1 cm size bluish discoloration. Sl. tender.  No blister/vesicle/pustule. Treatment none. Referred to Peds Neurologist for rule out seizure disorder.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Decreased appetite, Drooling, Pyrexia
Clinical narrative: High fever 102+ F. Fever has lasted 48 hrs. Drooling. Loss of appetite.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Chronic pain in left shoulder; unable to raise arm; pain when trying to remove a shirt; unable to sleep on left side.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: LMP 24Jul15, Urine Pregnancy Test done prior to vaccine administration on 22Aug15, result positive series discontinued at that time.
Age: 52.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Activities of daily living impaired, Disorientation, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Shoulder joints started aching. Felt sick to stomach. Went to bed. Woke up middle of the night. Very hot sweaty, disorieanted. Asked husband to get cold cloth. While husband was out of bedroom, unbeknown to me I called 911. Per husband: I was convulsing when medical personnel arrived. Taken to hospital by ambulance. I don't recall anything after my husband left the bedroom. I woke in the E.R. Hospital put me in hospital. Long term effects have been neck surgery do to convulsions, constant headaches, numerous time missed from work.
Age: 52.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Musculoskeletal pain, Neck surgery, Seizure
Clinical narrative: Shoulder joints started aching. Felt sick to stomach. Went to bed. Woke up middle of the night. Very hot sweaty, disorieanted. Asked husband to get cold cloth. While husband was out of bedroom, unbeknown to me I called 911. Per husband: I was convulsing when medical personnel arrived. Taken to hospital by ambulance. I don't recall anything after my husband left the bedroom. I woke in the E.R. Hospital put me in hospital. Long term effects have been neck surgery do to convulsions, constant headaches, numerous time missed from work.
Age: 52.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Arthralgia, Disorientation, Neck injury, Renal failure, Seizure
Clinical narrative: Shoulder joints started aching. Felt sick to stomach. Went to bed. Woke up middle of the night. Very hot sweaty, disorieanted. Asked husband to get cold cloth. While husband was out of bedroom, unbeknown to me I called 911. Per husband: I was convulsing when medical personnel arrived. Taken to hospital by ambulance. I don't recall anything after my husband left the bedroom. I woke in the E.R. Hospital put me in hospital. Long term effects have been neck surgery do to convulsions, constant headaches, numerous time missed from work.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Puncture site pain
Clinical narrative: Donor reported at center increasing pain and tenderness to left arm around puncture site 7 days after Tetanus vaccination.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Chest pain, Cough, Dyspnoea
Clinical narrative: Abdominal pain, arthralgia, myalgia, HA, fever, chest pain, SOB, cough, symptoms x 14 days, now hospitalized.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Laboratory test, Lumbar puncture, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Abdominal pain, arthralgia, myalgia, HA, fever, chest pain, SOB, cough, symptoms x 14 days, now hospitalized.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: Abdominal pain, arthralgia, myalgia, HA, fever, chest pain, SOB, cough, symptoms x 14 days, now hospitalized.
Age: 0.18
Sex: F
Vaccine: DTOX, HIBV, IPV, TTOX
Symptoms: Urticaria
Clinical narrative: My daughter broke out in hives all over her body, face, and head.  In the last week this has now happened 5 times.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Red rash, swelling and mild pain at point of SC shingles vaccination injection. 3 inches by 1.5 inches wide.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pyrexia, Tremor
Clinical narrative: Fever, severe shaking, nausea, headache.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (lot # J006236 with expiration date 25-FEB-2016, lot # J006850 with expiration date 31-MAR-2016, lot # k006124 with expiration date 02-FEB-2017, lot# K007264 with expiration date 02-MAR-2017; dose, dose number and route were not reported), which were exposed to temperatures outside the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with GARDASIL 9 (lot# reported as L004014 with expiration date 04-MAR-2017; dose, dose number and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with RECOMBIVAX HB (lot # J006365 with expiration date 05-DEC-2015 and lot # L004754 with expiration date 10-NOV-2016; dose and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of PEDVAXHIB (lot # J016186 with expiration date 24-OCT-2016, K008874 with expiration date 23-FEB-2017, K011077 with expiration date 30-MAR-2017, and K025005 expiration date 21-JUL-2017; dose and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-AUG-2015 the patient received an expired dose of M-M-R II (lot # J008728 with expiration date of 26-JUL-2015; strength, dosage, frequency and route unspecified). No adverse effect was reported. 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 medical assistant refers to multiple unspecified patients of unknown age and unknown gender. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored GARDASIL (dose, frequency and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and unknown gender. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored M-M-R II (dose, frequency and route were not reported). No adverse effects were reported. 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: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of ROTATEQ (lot # K001198 with expiration date 25-OCT-2015, lot # L004453 with expiration date 27-MAY-2016, K022990 with expiration date 26-JUN-2016; dose and dose numbers were not reported) orally, which were exposed to temperatures outside of the recommended range. No adverse effects were reported. Thi sis one of several cases from the same reporter. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a 56 year old male patient. Patient's concurrent conditions included blood pressure and cholesterol (unspecified). On 10-AUG-2015 the patient was vaccinated with ZOSTAVAX, (strength and lot # were not reported with an expiry date of October 2015) 1 single shot, subcutaneous. Concomitant medications included unspecified blood pressure and cholesterol medicines. On 15-AUG-2015, 6 days after vaccination patient experienced rash on top left shoulder with pustules. The reporter stated patient did not receive treatment for the event rash pustular. The outcome of rash pustular was reported as recovering. There was no product quality complaint involved. Reporter's causality statement was not reported at the time of the report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to  unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # J012376 with expiration date 03-OCT-2015, K0110582 with expiration date 08-AUG-2016, L003775 with expiration date 04-FEB-2017, and L007225 with expiration date 03-MAR-2017; dose, route and dose number were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to 4 unspecified patients of unknown demographics. No concurrent condition, concomitant therapy or medical history were reported. On unspecified dates, these patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (dose and route of administration were unknown, lot # K010338, expiration date: 22-JUL-2016). No adverse effects were reported. This is one of the several reports received from the same reporter. 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 unspecified patients of unknown age and gender. On unspecified dates, the patients received improperly stored doses of RECOMBIVAX HB (route, strength, lot # expiration dates and dose were unknown) (incorrect product storage). No adverse effect was 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 unspecified patients of unknown age and gender. On unspecified dates, the patients received improperly stored doses of GARDASIL (route, strength, lot#, expiration dates and dose were unknown) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of VAQTA (lot # J005010 with expiration date 23-OCT-2015 and lot # L004743 with expiration date 01-JUN-2017; dose, route and dose number were not reported) which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. 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 unspecified patients of unknown age and gender. On unspecified dates, the patients received improperly stored doses of ROTATEQ (oral, strength, lot #, expiration dates and dose were unknown) (incorrect product storage). No adverse effect was 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: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of PRIQUAD (Merck) (lot # L009209 with expiration date 17-SEP-2016; dose, route and dose number were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unspecified dates, the patients received improperly stored doses of VAQTA (route, strength, lot#, expiration dates and doses were unknown) (incorrect product storage). No adverse effect was 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 certified medical assistant referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and concurrent condition were not reported. ON an unknown date the unspecified number of patients received improperly stored GARDASIL (dose, frequency and route were unknown, lot # K011562, expiration date 8-APR-2017). No concomitant medication was reported. No adverse effects reported. There was no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.