chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 28-JUL-2015 the patient was vaccinated with improperly stored dose of GARDASIL, lot # K023432, expiration date: 18-JUN-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS number: 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005125). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. The reporting medical assistant reported that, since 02-JUL-2015, these patients were vaccinated with VAQTA (lot # L009445, expiration date 01-JUN-2017; lot # K019560, 02-JUN-2017; lot # L007559, expiration date 01-JUN-2017; dose and route not reported) which were exposed to temperatures outside of the recommended range on 02-JUL-2015. Among them, unspecified patients received VAQTA (lot # L007559, expiration date 01-JUN-2017) on 07-AUG-2015 (reported as 07-AUG-2016), 11-AUG-2015, 12-AUG-2015 and 13-AUG-2015. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 27-JUL-2015, the patient was vaccinated with ZOSTAVAX, (dose, route, lot number and expiration date were not reported). There was no concomitant medication reported. On an unspecified date in approximately July 2015, the patient experienced injection site reaction after receiving ZOSTAVAX. The reporting pharmacist stated that the patient had "red marks" right around injection site (injection site erythema) without other symptoms. The patient sought medical attention and spoke with pharmacist, but no treatment was given for the event. At the time of the report, the outcome of the injection site reaction and the erythema was reported as recovering. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist (the patient's father) and refers to a currently 19 year old female patient with none pertinent medical history, drug reactions or allergies. The patient's concurrent conditions were not reported. On 03-DEC-1996, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX and then, on 24-SEP-2007 (which was considered an inappropriate schedule of drug administration) the patient received a second dose of (Oka/Merck) VARIVAX, (dose, route, lot numbers and expiration dates were not reported for both vaccines). The patient's concomitant therapies included minocycline. On 08-AUG-2015, the result of a titer for immunity to varicella (IgG) was reported as negative 0.8 (units not provided), (antibody test negative). No treatment was given to the patient. At the time of the report, the outcome of the resantibody test negative was unknown. The relatedness between the event and therapy with (Oka/Merck) VARIVAX was not 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 certified medical assistant (CMA) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. The reporting medical assistant reported that, since 02-JUL-2015, these patients were vaccinated with doses of ROTATEQ (lot # K023537, expiration date 22-JUN-2016, oral; dose not reported) which were exposed to temperatures outside of the recommended range on 02-JUL-2015. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patients received either VARIVAX (Merck) (lot # K007781, expire date 28-MAY-2016; lot# K011800, expire date 21-AUG-2016; L009203, expire date 17-MAR-2017, dose, dose# and route not provided) or PROQUAD (Merck) (lot# K011967, 21-FEB-2016; L009209, 17-SEP-2016, dose, dose# and route not provided) that were improperly stored. No adverse effects reported. The outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a child patient between the age of 2 years and 5 years old (gender unknown). No relevant medical history or concurrent conditions were reported. On 26-MAY-2015, a single-dose vial of PROQUAD (Merck) underwent temperature excursions at 5.3 degrees Celsius for 2 hours and 8 minutes. On 30-JUN-2015 the patient was vaccinated with above mentioned PROQUAD (Merck) (lot # K014798, expiration date 12-MAR-2016, injection; dose not reported). Concomitant medications were unknown. The reporting nurse stated that the patient had not experienced any adverse events. This is one of several reports received 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 concerning a patient of unknown age and gender. There was no pertinent medical history or drug reactions/allergies reported. On 03-AUG-2015 the patient was vaccinated with an improperly stored ROTATEQ (lot number K008212 and expiration date: 30-SEP-2015). No adverse effect reported. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a 40 years old patient of unknown gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, frequency and route were  unknown) at 40 years old, Inappropriate schedule of drug administration). The patient's concomitant medication was not reported. No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. The reporting medical assistant reported that, since 02-JUL-2015, these patients were vaccinated with doses of RECOMBIVAX HB (lot # K021444, expiration date 17-SEP-2016; lot# K026666, expiration date 22-OCT-2016; dose and route not reported) which were exposed to temperatures outside of the recommended range on 02-JUL-2015. Among them, unspecified patients received RECOMBIVAX HB (lot# K021444, expiration date 17-SEP-2016) on 07-AUG-2015, 10-AUG-2015, 11-AUG-2015 and 13-AUG-2015. No adverse experience was 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: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# K005078 with expiration date of 01-APR-2016, lot# reported as "K020218" with expiration date 24-OCT-2016) (dose and route unknown). No adverse effects reported. No product quality complaints (PQC) involved. 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: Information has been received from a health worker (medical assistant) referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 06-AUG-2015 the patient received a dose of improperly stored PEDVAXHIB injection (strength, route, lot# and expired date were unknown). No adverse experience reported. There were no product quality complaints (PQC) involved. 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 healthcare worker refers to an unspecified number of patients of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L009203, expiry date 17-MAR-2017; lot # K018961, expiry date 15-OCT-2016; and lot # L011084, expiry date 01-APR-2017, (dose, frequency and route of administration not provided). No adverse effects reported. No product quality complaint (PQC) was involved. There was no additional information to report. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Gait disturbance, Limb discomfort
Clinical narrative: Information has been received via a field representative from a 70 year old male consumer concerning himself. The patient's right knee was previously severely damaged when he was younger. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, one injection (lot # and expiration date not reported), subcutaneously. Concomitant therapy were not reported. On an unknown date, two days after receiving ZOSTAVAX, the patient experienced "peripheral neuropathy localized in an injured area behind his right knee". ZOSTAVAX was not reintroduced. The outcome of the event was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Gait disturbance, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Information has been received via a field representative from a 70 year old male consumer concerning himself. The patient's right knee was previously severely damaged when he was younger. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, one injection (lot # and expiration date not reported), subcutaneously. Concomitant therapy were not reported. On an unknown date, two days after receiving ZOSTAVAX, the patient experienced "peripheral neuropathy localized in an injured area behind his right knee". ZOSTAVAX was not reintroduced. The outcome of the event was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Gait disturbance, Hypoaesthesia, Intermittent claudication, Limb discomfort
Clinical narrative: Information has been received via a field representative from a 70 year old male consumer concerning himself. The patient's right knee was previously severely damaged when he was younger. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, one injection (lot # and expiration date not reported), subcutaneously. Concomitant therapy were not reported. On an unknown date, two days after receiving ZOSTAVAX, the patient experienced "peripheral neuropathy localized in an injured area behind his right knee". ZOSTAVAX was not reintroduced. The outcome of the event was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal, Pain in extremity, Peripheral venous disease
Clinical narrative: Information has been received via a field representative from a 70 year old male consumer concerning himself. The patient's right knee was previously severely damaged when he was younger. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, one injection (lot # and expiration date not reported), subcutaneously. Concomitant therapy were not reported. On an unknown date, two days after receiving ZOSTAVAX, the patient experienced "peripheral neuropathy localized in an injured area behind his right knee". ZOSTAVAX was not reintroduced. The outcome of the event was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Information has been received via a field representative from a 70 year old male consumer concerning himself. The patient's right knee was previously severely damaged when he was younger. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, one injection (lot # and expiration date not reported), subcutaneously. Concomitant therapy were not reported. On an unknown date, two days after receiving ZOSTAVAX, the patient experienced "peripheral neuropathy localized in an injured area behind his right knee". ZOSTAVAX was not reintroduced. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since an unspecified date in May 2015 (exact date unspecified, approximately in 2015), the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006124, expiration date 01-FEB-2017, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effected reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since an unspecified date in May 2015 (exact date unspecified, approximately in 2015), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K010238 with expiration date 14-APR-2016, lot # K022265 with expiration date 22-OCT-2016, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effected reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Crying, Headache, Tremor, Vomiting
Clinical narrative: Some change in behavior was noted by parents, nothing dramatic, but was a little fussy and had decreased appetite.  The following day she went to swimming class, but didn't interact.  She refused to walk at times and acted as if she were having leg pain.  Then woke up at 01:30 AM on Tuesday 8/18 with a bad headache, so much so that she was hitting herself in the head.  Shortly after this she had 3 episodes of vomiting with some abdominal pain, but no fever.  Family almost took her to the ER but she got a little better.  She finally started feeling better by 02:00 PM that same day.  She was examined by me at 10:15 AM today (8/19/15).  At this time she had a normal exam except for a slightly red pharynx.  She was alert, answering questions appropriately, and her neurological exam was normal.  She had no rash.  A rapid strep test was done and was negative.  It was felt that this could represent an adverse reaction to MMR vaccine received on 08/14/15, or possibly a viral gastroenteritis.  She was sent home and told to follow up with any return of symptoms, especially seizures or encephalopathy.  She has no signs of encephalitis or encephalopathy presently, in my opinion.
Age: 6.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Abdominal pain, Abnormal behaviour, Decreased appetite, Gait disturbance, Headache
Clinical narrative: Some change in behavior was noted by parents, nothing dramatic, but was a little fussy and had decreased appetite.  The following day she went to swimming class, but didn't interact.  She refused to walk at times and acted as if she were having leg pain.  Then woke up at 01:30 AM on Tuesday 8/18 with a bad headache, so much so that she was hitting herself in the head.  Shortly after this she had 3 episodes of vomiting with some abdominal pain, but no fever.  Family almost took her to the ER but she got a little better.  She finally started feeling better by 02:00 PM that same day.  She was examined by me at 10:15 AM today (8/19/15).  At this time she had a normal exam except for a slightly red pharynx.  She was alert, answering questions appropriately, and her neurological exam was normal.  She had no rash.  A rapid strep test was done and was negative.  It was felt that this could represent an adverse reaction to MMR vaccine received on 08/14/15, or possibly a viral gastroenteritis.  She was sent home and told to follow up with any return of symptoms, especially seizures or encephalopathy.  She has no signs of encephalitis or encephalopathy presently, in my opinion.
Age: 6.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Irritability, Neurological examination normal, Pain in extremity, Pharyngeal erythema, Social avoidant behaviour
Clinical narrative: Some change in behavior was noted by parents, nothing dramatic, but was a little fussy and had decreased appetite.  The following day she went to swimming class, but didn't interact.  She refused to walk at times and acted as if she were having leg pain.  Then woke up at 01:30 AM on Tuesday 8/18 with a bad headache, so much so that she was hitting herself in the head.  Shortly after this she had 3 episodes of vomiting with some abdominal pain, but no fever.  Family almost took her to the ER but she got a little better.  She finally started feeling better by 02:00 PM that same day.  She was examined by me at 10:15 AM today (8/19/15).  At this time she had a normal exam except for a slightly red pharynx.  She was alert, answering questions appropriately, and her neurological exam was normal.  She had no rash.  A rapid strep test was done and was negative.  It was felt that this could represent an adverse reaction to MMR vaccine received on 08/14/15, or possibly a viral gastroenteritis.  She was sent home and told to follow up with any return of symptoms, especially seizures or encephalopathy.  She has no signs of encephalitis or encephalopathy presently, in my opinion.
Age: 6.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Some change in behavior was noted by parents, nothing dramatic, but was a little fussy and had decreased appetite.  The following day she went to swimming class, but didn't interact.  She refused to walk at times and acted as if she were having leg pain.  Then woke up at 01:30 AM on Tuesday 8/18 with a bad headache, so much so that she was hitting herself in the head.  Shortly after this she had 3 episodes of vomiting with some abdominal pain, but no fever.  Family almost took her to the ER but she got a little better.  She finally started feeling better by 02:00 PM that same day.  She was examined by me at 10:15 AM today (8/19/15).  At this time she had a normal exam except for a slightly red pharynx.  She was alert, answering questions appropriately, and her neurological exam was normal.  She had no rash.  A rapid strep test was done and was negative.  It was felt that this could represent an adverse reaction to MMR vaccine received on 08/14/15, or possibly a viral gastroenteritis.  She was sent home and told to follow up with any return of symptoms, especially seizures or encephalopathy.  She has no signs of encephalitis or encephalopathy presently, in my opinion.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Viral skin infection
Clinical narrative: Rash on legs, followed by fever. Rash appears on arms, and part of face. Some rashes on torso. Fever for two days (8/14 & 8/15). Treated with Tylenol. Rash darken and appear to be clearing on the third day. Signs of the rash still present as of today.
Age: 37.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Pyrexia, Tenderness
Clinical narrative: Fever, chills, tenderness that grew by the hour. This lasted until 8/16/15 PM.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac monitoring normal, Dizziness, Laboratory test normal, Nausea, Pain in extremity
Clinical narrative: severe arm pain, dizziness, nausea the first day, 2nd day syncope with seizure like activity, 3rd day syncope with seizure like activity, 4th day syncope with seizure like activity. continued syncope several times daily with seizure like activity since shot was administered.  Put on heart monitor, no issues, labs checked, no known cause, scheduled for EEG, still having multiple syncope daily with seizure like activity
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: severe arm pain, dizziness, nausea the first day, 2nd day syncope with seizure like activity, 3rd day syncope with seizure like activity, 4th day syncope with seizure like activity. continued syncope several times daily with seizure like activity since shot was administered.  Put on heart monitor, no issues, labs checked, no known cause, scheduled for EEG, still having multiple syncope daily with seizure like activity
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma
Clinical narrative: AFTER RECEIVING THE GARDASIL VACCINE MY DAUGHTER DEVELOPED ASTHMA...NO FAMILY HISTORY OF ASTHMA.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 102.5 orally. Rash started on trunks to lower legs. Mother pointed to the Measles poster and indicated that type of rash. No URI symptoms and no nausea and vomiting. Fever was treated for 2 days with Advil. After wards the rash is almost gone but has a few areas in back of legs and trunk.
Age: 11.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: R deltoid area swollen 4in X 3in, mild erythema, pruritis, no pain reported.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood cholesterol normal, Blood glucose normal, Blood test normal, Cold sweat, Decreased appetite
Clinical narrative: Started with a headache; thought she was having mouth/jaw issues.  Had teeth shaved, purchased a night guard, and wisdom teeth removed.  Headaches continued, over the years symptoms increased to include aches, extreme fatigue, dizzy upon standing, swollen lymph glands, nausea, no appetite and when hungry nauseous after eating, clammy, night sweats, freezing all the time.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness postural, Fatigue, Feeling cold, Haemoglobin normal, Headache
Clinical narrative: Started with a headache; thought she was having mouth/jaw issues.  Had teeth shaved, purchased a night guard, and wisdom teeth removed.  Headaches continued, over the years symptoms increased to include aches, extreme fatigue, dizzy upon standing, swollen lymph glands, nausea, no appetite and when hungry nauseous after eating, clammy, night sweats, freezing all the time.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased, Helicobacter test negative, Lymphadenopathy, Mononucleosis heterophile test negative, Nausea
Clinical narrative: Started with a headache; thought she was having mouth/jaw issues.  Had teeth shaved, purchased a night guard, and wisdom teeth removed.  Headaches continued, over the years symptoms increased to include aches, extreme fatigue, dizzy upon standing, swollen lymph glands, nausea, no appetite and when hungry nauseous after eating, clammy, night sweats, freezing all the time.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Night sweats, Pain, Streptococcus test negative, Thyroid function test normal, Wisdom teeth removal
Clinical narrative: Started with a headache; thought she was having mouth/jaw issues.  Had teeth shaved, purchased a night guard, and wisdom teeth removed.  Headaches continued, over the years symptoms increased to include aches, extreme fatigue, dizzy upon standing, swollen lymph glands, nausea, no appetite and when hungry nauseous after eating, clammy, night sweats, freezing all the time.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Asthenia, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Pt developed weakness, inability to ambulate, fever, nausea, vomiting x 1, diaphoresis. Pt went to ED on 8/6/15 and was admitted to hospital.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Pt developed weakness, inability to ambulate, fever, nausea, vomiting x 1, diaphoresis. Pt went to ED on 8/6/15 and was admitted to hospital.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hypersensitivity, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, dizzy, lightheaded, PCP determined to be an allergic reaction and added to allergy list.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose, Electrocardiogram, Pallor, Seizure like phenomena
Clinical narrative: Patient received MCV4, Tdap and HPV 9. Patient was standing by with window with by his father while I began to immunize patients brother. After I administered the first vaccine. Patient went pale and appeared to be having a seizure like event.  Dad grabbed him to stablize while I went to get Dr. for assistance. Had patient lie down on the exam table.  Vitals were performed as well as glucose and EKG. Got the patient some juice and crackers until stable and until Dr. okayed him to leave.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Photophobia
Clinical narrative: Severe frontal headache behind eyes with light sensitivity; no vomiting or nausea, not throbbing.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Rash at injection site which spread to generalized rash.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Laboratory test normal
Clinical narrative: Apnoea within hours of vaccine administration. Seen in ER and had severe apnoeic event during lab draw. Airlifted to medical center (referral center). Hospitalized x 2 days.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electrocardiogram normal, Hypotonia, Pallor
Clinical narrative: 8/11/15 6:20am seen in ED for pallor and limpness after 2 mo. vaccines given 8/10/15 at 3pm. RR 10 at hosp, EKG normal - admitted for observation. No clear etiology for symptoms.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from a contactable nurse. A 77-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot/Batch # L62074, Expiration Date Nov2016), intramuscular in the left deltoid on 03Jun2015 at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient experienced cellulitis like symptoms in left arm and redness after the vaccine was given, both on an unspecified date with outcome of unknown. The patient had no fever so she was told TYLENOL and ice.
Age: 0.38
Sex: M
Vaccine: PNC13
Symptoms: Acoustic stimulation tests abnormal, Death, Expired product administered
Clinical narrative: This is a spontaneous report from a contactable licensed practitioner nurse. A 4-month-old male patient received on 07Jul2015 at 09:50 am the second dose of PREVNAR 13 (Lot/batch number: H65078, expiry date 30Jun2015, NDC number: 00005-1971-02) intramuscular on the right thigh at 0.5 ml single. Medical history included failure to thrive on 21Apr2015 and ongoing. Concomitant medications given on an unspecified date in 2015 included: second dose of ROTATEQ (manufactured by Merck, lot number K001832) oral and second dose of PENTACEL (manufactured by Sanofi, lot number C4679AA) administered intramuscular in left thigh. The patient previously received on unknown date, the first dose of PREVNAR 13 and on 21Apr2015 ROTATEQ and PENTACEL. The patient had no illness at the time of vaccination. The patient underwent on unknown date a hearing test and it showed a bilateral abnormality. The patient was administered with a 7 days expired PREVNAR 13. The patient did not receive any treatment after the vaccine was administered and no emergency room or doctor visit was requested. The patient passed away. The cause of death was not reported. Follow up (07Jul2015): New information reported from a contactable nurse includes: patient's date of birth, date and time of vaccination, site of vaccination and dose, medical history, lab data, past vaccine history, causality assessment. Follow-up (12Aug2015): New information reported from a contactable nurse includes onset date of the medical history and siblings. Death added as event. Case upgraded to serious.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Exfoliative rash, Laboratory test, Pityriasis rubra pilaris, Rash erythematous
Clinical narrative: Initial unsolicited report received from a healthcare professional on 3 August 2015. A 59-year-old male patient had received a first dose of ADACEL (batch number, route of administration not reported) in right deltoid on 8 July 2015. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none and concomitant medication were reported as none. On 17 July 2015, nine days after vaccination, the patient developed a red scaling rash that had spread starting from his head progressing to his face and then full trunk. It both itches and burns. The patient was diagnosed with pityriasis rubra pilaris. Reporter consider it as a life-threatening illness. The patient required ER visit. The patient had tried triamcinolone cream without success as corrective treatment and was concerned that this may lead to more serious physical conditions such as liver and spleen enlargement. The patient's blood work is pending and he is being seen as a case at a symposium this week for evaluation and treatment. Laboratory investigations were reported as 'labs'. At the time of this report, the event outcome was not recovered. Documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Initial unsolicited report received from a healthcare professional on 3 August 2015. A 59-year-old male patient had received a first dose of ADACEL (batch number, route of administration not reported) in right deltoid on 8 July 2015. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none and concomitant medication were reported as none. On 17 July 2015, nine days after vaccination, the patient developed a red scaling rash that had spread starting from his head progressing to his face and then full trunk. It both itches and burns. The patient was diagnosed with pityriasis rubra pilaris. Reporter consider it as a life-threatening illness. The patient required ER visit. The patient had tried triamcinolone cream without success as corrective treatment and was concerned that this may lead to more serious physical conditions such as liver and spleen enlargement. The patient's blood work is pending and he is being seen as a case at a symposium this week for evaluation and treatment. Laboratory investigations were reported as 'labs'. At the time of this report, the event outcome was not recovered. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Epilepsy, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a consumer regarding his approximately 22 year old daughter. The patient had seasonal type allergies. On an unknown date in June 1993, the patient was vaccinated with first dose of RECOMBIVAX HB (lot number 1513V and expiry date unknown) (dose, frequency and route were not reported). The patient was vaccinated with second dose of RECOMBIVAX HB in August 1993 (lot number: 0841W and expiry date: unknown) and finally the third dose on an unspecified date with unspecified lot and expiration date on an unknown date in 1993. The patient had completed the entire three doses of RECOMBIVAX HB in 1993. Concomitant therapies included ZYRTEC and other vaccinations (product name unspecified) that she got at the same time. On an unknown date (reported as last few years), the patient was diagnosed with a type of epilepsy. The reporter stated that his daughter's vaccination with RECOMBIVAX HB proved ineffective. On an unknown date in August 2015 (reported as recently, beginning of August) the patient had some blood work done to test for titers for hepatitis B and it revealed that the patient had no antibodies or immunity developed even after completing all the three doses of the vaccination. The patient sought medical attention and the current physician of his daughter was revaccinating her because she did not seroconvert to the original vaccination. He was concerned for his daughter as she was working in a hospital during college and he hoped she was not exposed to the hepatitis B virus while working there. The outcome of the events was reported as recovering/resolving. Upon internal review, the epilepsy was considered as other medically significant event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dysphonia, Headache, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: 2mm by 2mm induration at injection site with pain in deltoid. Patient is having headaches and some horseness. No fever has been present.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever of 105.5, nausea.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Axillary pain, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling of axilla and entire arm (same side as vaccination).
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: FOR THREE DAYS FOLLOWING IMMUNIZATION, DONOR EXPERIENCED THE FOLLOWING SYMPTOMS: SORENESS, HEADACHE, DIAPHORESIS, FATIGUE.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test, Dizziness, Echocardiogram, Electroencephalogram, Headache
Clinical narrative: Pt has been having dizziness, headaches, and an episode of unconsciousness 1 day post vaccination. He has had possible absence seizures with it. Has continued to be dizzy and have headaches since then. We are investigating further with labs and imaging but at this time have not done any treatment.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate normal, West Nile virus test
Clinical narrative: Pt has been having dizziness, headaches, and an episode of unconsciousness 1 day post vaccination. He has had possible absence seizures with it. Has continued to be dizzy and have headaches since then. We are investigating further with labs and imaging but at this time have not done any treatment.
Age: 18.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Back pain, Chills, Dizziness, Headache, Pain in extremity
Clinical narrative: Excrutiating pain thoughout arms and into lower back, fever, chills, dizziness, headache, swelling by injection spot.
Age: 18.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia, Swelling
Clinical narrative: Excrutiating pain thoughout arms and into lower back, fever, chills, dizziness, headache, swelling by injection spot.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives for seven subsequent days.  Woke with hives and after taking Benadryl hives disappeared until next morning.
Age: 0.83
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Inadvertent Tdap was given to infant instead of DTaP. No adverse effects were reported. Patient's parent was notified and advised to return for DTaP booster.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Vision blurred, Visual impairment
Clinical narrative: Started with seeing black dots in vision. Vision is now blurred and dizzy.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope within two minutes after injection.
Age: 1.37
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site abscess, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left thigh redness, warmth - appears like cellulitis/abscess with some induration. Treat with Keflex and Clindamycin.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother called clinician 8/7 stating son's injection sites were reddened and swollen.  Denies fever.  Instructed mother to apply warm compresses to the site.  If swelling and redness increases to follow up with doctor.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Fever 103.8, headache, myalgia followed by resolution of fever and arthralgia in knees.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient's mother reported that her daughter's right upper arm was swollen and hot near the site of the SC ProQuad injection; redness was in the shape of a triangle. Left deltoid distal to injection sites of polio and DTaP injections also became red and swollen on morning of 8/14/15. Mother noted that child was "normal--she's herself." Mother mentioned the clinic the family attends so I called that clinic to ask if patient could come in; clinic encouraged patient to come in. Mother reported on 8/17/15 that she had taken her daughter to clinic on 8/14/15 where topical ointment and liquid antihistamine were prescribed. Mother reported on 8/17/15 that her daughter was "doing good" and "rashes are going away."
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Syncope, Tongue biting
Clinical narrative: Syncope fall from table bite to his tongue. Provider at patients side vitals taken cool compress provided and vitals stable at discharge 11:15Am.
Age: 15.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's arm where the shot was given started turning red and there is a huge bump.  The bump and redness is spreading over her left arm.  We believe it is from the Meningococcal Vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: A red, slightly swollen, red rash that patient had on the injection site. It feels a little warm to the touch and sore.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Vaccination complication
Clinical narrative: Raised and 3 inches long and warm to the touch.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Itchy, raised rash over body, started at Daycare after nap.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient came in on Monday (8/17/15) complaining of redness around the injection site.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Asthenia, Crying, Delusion, Dyskinesia, Dyspnoea
Clinical narrative: Mother Reports child had a fever 100.4 temp., 130 pulse in the ER.  She was very weak, delusional, pain in arms & legs, HA, breathing heavily, O2 sat down, crying, arms & legs jerking, couldn't see nurse & Mom very well in front of her - everybody was blurry.  After pain med given in IV, 20 to 35 minutes patient was back to her normal self.  Mom reported this 8/17/2015 & stated that her daughter was fine that day.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Headache, Oxygen saturation decreased, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: Mother Reports child had a fever 100.4 temp., 130 pulse in the ER.  She was very weak, delusional, pain in arms & legs, HA, breathing heavily, O2 sat down, crying, arms & legs jerking, couldn't see nurse & Mom very well in front of her - everybody was blurry.  After pain med given in IV, 20 to 35 minutes patient was back to her normal self.  Mom reported this 8/17/2015 & stated that her daughter was fine that day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: My arm began to swell and itch and hurt, a rash, and got worse for a few days. Now just a hard red area about the size of a half-dollar, but whole body feels like pins sticking me from the inside and itching in many places.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash
Clinical narrative: My arm began to swell and itch and hurt, a rash, and got worse for a few days. Now just a hard red area about the size of a half-dollar, but whole body feels like pins sticking me from the inside and itching in many places.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Patient was having soreness in the arm where the immunization was given.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram abnormal, Injected limb mobility decreased, Injection site joint effusion, Injection site pain
Clinical narrative: Patient came to primary care clinic and received a second pneumoccoccal 23 (PPSV23) immunization approximately 15 weeks after having the PCV13 vaccination per provider order due to immunosuppression (s/p kidney transplant). The PPSV23 was given IM in the left deltoid. Administering nurse reported that the patient's deltoid muscle did seem somewhat odd shaped. Appropriate landmarks were found and immunization was administered in left deltoid. When injecting the needle into the patient's deltoid, the nurse reported feeling the needle hit bone, so needle was pulled back slightly and injected vaccine in muscle. Patient did not report to the nurse any sudden or severe pain at the time of the injection. Patient left clinic and returned home, where he performed a rigorous workout which included exercising his shoulders and arms (per later Emergency Department consult report). Approximately 2 hours after the workout, the patient reported developing severe, sudden pain in the left shoulder, preventing him from doing any movement of the left shoulder. Patient presented to the Emergency Department where CT was performed and interpretation by radiologist of the CT left shoulder showed "Small glenohumeral joint effusion with a few locules of gas could relate to inadvertent intra-articular injection given recent history of vaccine administration."  After orthopedic consult, patient was discharged, accompanied by wife from ED to home with oxycodone oral pain management. Per follow-up phone calls on 8/18/15 by Emergency Department MD and primary care nurse, patient's wife reported that patient was feeling much better and having adequate pain control of left shoulder pain. Reviewed with patient's wife the plan for patient to have follow-up with Orthopedic doctor on 8/20/15 and plan to review incident. Primary care provider was notified of event and plan for review.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 62.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Glossodynia, Lymphadenopathy, Malaise, Muscular weakness
Clinical narrative: CHILLS, SORE THROAT, NIGHT SWEATS, MUSCLE WEAKNESS.
Age: 62.0
Sex: M
Vaccine: MNQ
Symptoms: Night sweats, Oropharyngeal pain, Pharyngitis streptococcal, Sinus disorder, Sinus headache
Clinical narrative: CHILLS, SORE THROAT, NIGHT SWEATS, MUSCLE WEAKNESS.
Age: 62.0
Sex: M
Vaccine: MNQ
Symptoms: Sputum discoloured
Clinical narrative: CHILLS, SORE THROAT, NIGHT SWEATS, MUSCLE WEAKNESS.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: Injection site reaction - bleeding and bruising within a few minutes of administration
Age: 20.0
Sex: M
Vaccine: ANTH, HEP, HEPAB
Symptoms: Wrong drug administered
Clinical narrative: Pt. given wrong immunization.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Inappropriate schedule of drug administration, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 47 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 27-SEP-2006, the patient was vaccinated with the first pediatric/adolescent dose of RECOMBIVAX HB, 0.5 ml, lot umber 652093/1099R, expiration date 31-MAR-2008 (route was not provided). ON 27-OCT-2006, the patient was vaccinated with the second pediatric/adolescent dose of RECOMBIVAX HB, 0.5 ml, lot number 652093/1099R, expiration date 31-MAR-2008 (route was not provided). Then, on 23-JUL-2007, the patient was vaccinated with the third pediatric/adolescent dose of RECOMBIVAX HB, 0.5 ml, lot number 653788/0610F, expiration date 14-NOV-2008 (route was not provided). Also on 23-JUL-2007, there was an inappropriate schedule of drug administration as the third dose was administered almost 10 months apart from the first dose. In 2011, the patient had titers drawn and the results were positive for Hepatitis B. No adverse event was reported. It was unkonwn if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) lot# L005297, expiration date: 17-AUG-2016, (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse, the dose was exposed to a temperature excursion from 12-AUG-2015 at 12:30 PM to 14-AUG-2015 at 5 PM, for a total of 53 hours at 13.1 C. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old patient (unspecified gender). On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.