chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid - location of IM injection - pain, swelling, pruritus (itching) - severe extending to elbow. Exam approx 12 hours after admin.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site rash
Clinical narrative: Red, raised rash from elbow to shoulder that started at injection site and spread. Rash resolved slowly over 5 days and is now the size of a quarter. No treatment administered. Patient has felt very "run down."
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Pt felt dizzy/nauseous after 1st dose of HPV. Pt given ice pack to back of neck, had him lie down. Given juice and crackers. BP and HR taken MD assessed patient before leaving office.
Age: 1.06
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pyrexia, Rash, Skin lesion
Clinical narrative: Rash onset following immunizations at 8/4/14 appointment - was 8/6/14. Lesions on abdomen, legs, arms, and face. Patient had low-grade fever, but resolved. Will use calamine lotion.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Irritability, Pyrexia, Scab
Clinical narrative: Fever, vesicles appeared 3 weeks/1 day after immunization, fever up to 103; vesicles broke, scabbed over, child irritable.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Child presented to clinic day following immunizations. Both administered to (R) deltoid. (R) upper arm has 12 x 12 cm warm, red and indurated area around the site. Advised ice, BENADRYL and 2.5% hydrocortisone ointment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: Growing hot knot at the injection site on her left arm.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash and erythema multiforme.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 64 year old female patient with unspecified allergies. On 05-APR-2014 the patient was vaccinated with 1 shot of ZOSTAVAX (dosage, route and lot# not reported) at a retail pharmacy. On 05-APR-2014, almost immediately after vaccination, the patient had allergic reaction with a significant rash and swelling at injection site. On 07-APR-2014 patient sought medical attention and an unspecified provider, and she was given amoxicillin (for 7 days) and fluconazole, but on 08-APR-2014, her symptoms didn't improve, and patient was prescribed prednisone. No lab test was performed. The outcome of events were not reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old patient (gender was unknown). On 04-AUG-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dosage, route and lot# not reported), right after being administered VARIVAX (dosage, route and lot# not reported) on the same day. No adverse effects reported. The outcome of event was unknown. No Product Quality Complaint (PQC) filed. Additional information has been requested.
Age: 1.29
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 month old patient. On 01-MAY-2014 the patient was vaccinated with VARIVAX (lot # J009164, EXP 24-JUL-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). Physician reported that after administering ZOSTAVAX an anonymous patient developed a "chicken pox rash after 3 to 4 weeks." The physician also reported a second reaction on patient's leg that happened later. It was not sure what second reaction entailed. The outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with VARIVAX (Merck) (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with VARIVAX (Merck) that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from a healthcare professional refers to a 5 year old patient. On 05-JUN-2014 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with VARIVAX (merck) (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with VARIVAX (merck) that was stored improperly on unknown date. There were no adverse effects reported. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from a healthcare professional refers to a 5 years old patient. On 04-JUN-2014 the patient was vaccinated with a dose of improperly stored VARIVAX (merck) (lot # J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a female patient who was "either in seventh or eleventh grade". On 14-AUG-2014 the patient received her first dose of GARDASIL (lot# not reported, dose 0.5 ml, intramuscularly) in the morning. Concomitant therapies included TDAP and meningococcal vaccine (unspecified). The nurse reported that on 14-AUG-2014 the patient had a "full blown seizure" after administration. The nurse stated that the patient did not have a history of seizures but once "fell down so hard that she blacked out from crying". The nurse reported that the patient walked out of the facility unaided and went home with her mother, but that they later decided to go to unspecified hospital. It was not clear whether or not the patient had been admitted to the hospital. No treatment was given for the adverse event. The outcome of the event was not reported. Upon internal review, "full blown seizure" was determined to be medically significant. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Acute disseminated encephalomyelitis, Dizziness, Headache, Vertigo
Clinical narrative: Case number PHHY2014US065828 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 526586) web site on 28 May 2014, with the follow-up information received from the Quality Assurance Department on 05 Aug 2014: This report refers to a 52-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) into left arm on 08 Jan 2014. On the same day, post vaccination, he experienced bad headache. On 09 Jan 2014, he experienced vomiting and dizziness. He was taken to doctor where it was told that it was vertigo. On an unknown date, he was hospitalized and weeks later it was found that he couldn't walk. On an unknown date, the neurologist confirmed that it was an acute disseminated encephalomyelitis (ADEM). The events were reported as serious (permanent disability and hospitalization). Outcome of the events was unknown and causality of the events was not reported. Upon the follow-up QA department stated that, the reported FLUVIRIN batch number: 13455P is a Novartis batch number however the batch was rejected and was not released to the market, hence investigation will be performed with unknown batch. Follow-up information received from the Quality Assurance Department on 05 Aug 2014: Updated QA comments.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2014US065828 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 526586) web site on 28 May 2014, with the follow-up information received from the Quality Assurance Department on 05 Aug 2014: This report refers to a 52-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) into left arm on 08 Jan 2014. On the same day, post vaccination, he experienced bad headache. On 09 Jan 2014, he experienced vomiting and dizziness. He was taken to doctor where it was told that it was vertigo. On an unknown date, he was hospitalized and weeks later it was found that he couldn't walk. On an unknown date, the neurologist confirmed that it was an acute disseminated encephalomyelitis (ADEM). The events were reported as serious (permanent disability and hospitalization). Outcome of the events was unknown and causality of the events was not reported. Upon the follow-up QA department stated that, the reported FLUVIRIN batch number: 13455P is a Novartis batch number however the batch was rejected and was not released to the market, hence investigation will be performed with unknown batch. Follow-up information received from the Quality Assurance Department on 05 Aug 2014: Updated QA comments.
Age: 0.99
Sex: M
Vaccine: HIBV, PPV, HIBV, PNC13
Symptoms: Diet refusal, Dyspnoea, Hypotonia, Injection site pain, Irritability
Clinical narrative: Given HIB and PREVNAR vaccine. About 6 hours later - letharigc, not responding to mom, refusing to nurse.
Age: 0.99
Sex: M
Vaccine: HIBV, PPV, HIBV, PNC13
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: Given HIB and PREVNAR vaccine. About 6 hours later - letharigc, not responding to mom, refusing to nurse.
Age: 0.99
Sex: M
Vaccine: HIBV, PPV, HIBV, PNC13
Symptoms: Diet refusal, Lethargy, Unresponsive to stimuli
Clinical narrative: Given HIB and PREVNAR vaccine. About 6 hours later - letharigc, not responding to mom, refusing to nurse.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Abdominal X-ray, Culture stool, Diarrhoea, Diarrhoea haemorrhagic, Full blood count
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old female patient with no drug allergies. The patient's pertinent medical history ws none. On 10-JUN-2014 the patient ws vaccinated with first dose of ROTATEQ (Dose/Frequency: 2 ml, Therapy Route: Oral). Concomitant therapies included Vitamin D drops (unspecified). On 12-AUG-2014, the patient was vaccinated with second dose of ROTATEQ. On 12-AUG-2014, the patient experienced diarrhea, blood in stool and fever of 102.8F. Lab diagnostics studies performed included complete blood count (CBC), Stool culture, X-ray of abdomen and hemoccult on an unknown date and the results were not provided. The patient sought medical attention but the events were not treated. The outcome of diarrhea, blood in stool and fever of 102.8 F was unknown. The causality of diarrhea, blood in stool and fever of 102.8 F was not reported. No product quality complaint (PQC) was reported for ROTATEQ. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Haematochezia, Occult blood, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old female patient with no drug allergies. The patient's pertinent medical history ws none. On 10-JUN-2014 the patient ws vaccinated with first dose of ROTATEQ (Dose/Frequency: 2 ml, Therapy Route: Oral). Concomitant therapies included Vitamin D drops (unspecified). On 12-AUG-2014, the patient was vaccinated with second dose of ROTATEQ. On 12-AUG-2014, the patient experienced diarrhea, blood in stool and fever of 102.8F. Lab diagnostics studies performed included complete blood count (CBC), Stool culture, X-ray of abdomen and hemoccult on an unknown date and the results were not provided. The patient sought medical attention but the events were not treated. The outcome of diarrhea, blood in stool and fever of 102.8 F was unknown. The causality of diarrhea, blood in stool and fever of 102.8 F was not reported. No product quality complaint (PQC) was reported for ROTATEQ. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Abdominal X-ray, Culture stool, Diarrhoea, Full blood count, Haematochezia
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old female patient with no drug allergies. The patient's pertinent medical history ws none. On 10-JUN-2014 the patient ws vaccinated with first dose of ROTATEQ (Dose/Frequency: 2 ml, Therapy Route: Oral). Concomitant therapies included Vitamin D drops (unspecified). On 12-AUG-2014, the patient was vaccinated with second dose of ROTATEQ. On 12-AUG-2014, the patient experienced diarrhea, blood in stool and fever of 102.8F. Lab diagnostics studies performed included complete blood count (CBC), Stool culture, X-ray of abdomen and hemoccult on an unknown date and the results were not provided. The patient sought medical attention but the events were not treated. The outcome of diarrhea, blood in stool and fever of 102.8 F was unknown. The causality of diarrhea, blood in stool and fever of 102.8 F was not reported. No product quality complaint (PQC) was reported for ROTATEQ. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Occult blood, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 month old female patient with no drug allergies. The patient's pertinent medical history ws none. On 10-JUN-2014 the patient ws vaccinated with first dose of ROTATEQ (Dose/Frequency: 2 ml, Therapy Route: Oral). Concomitant therapies included Vitamin D drops (unspecified). On 12-AUG-2014, the patient was vaccinated with second dose of ROTATEQ. On 12-AUG-2014, the patient experienced diarrhea, blood in stool and fever of 102.8F. Lab diagnostics studies performed included complete blood count (CBC), Stool culture, X-ray of abdomen and hemoccult on an unknown date and the results were not provided. The patient sought medical attention but the events were not treated. The outcome of diarrhea, blood in stool and fever of 102.8 F was unknown. The causality of diarrhea, blood in stool and fever of 102.8 F was not reported. No product quality complaint (PQC) was reported for ROTATEQ. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTIPV
Symptoms: Injection site bruising, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Bruise at the injection site and a large red rash that covered most of her arm, the spot was raised and hot to touch.
Age: 0.83
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash consistent with Erythema Multiforme.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Hypertension, Pharyngeal oedema, Swelling, Swelling face
Clinical narrative: Swelling of forehead, tongue, throat.  911 administered Benadryl by IV then took me to the Emergency Room.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: Swelling of forehead, tongue, throat.  911 administered Benadryl by IV then took me to the Emergency Room.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anti-neuronal antibody, Antinuclear antibody positive, Areflexia, CSF protein increased, Dyskinesia
Clinical narrative: This medically confirmed literature report (initial receipt 12-Aug-2014) concerns a 50 year-old female patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date seven days following the influenza vaccine, the patient was presented with symmetric sensory paresthesia. On examination, she had areflexia, marked loss of joint position sense in both proximal and distal arms and legs, and involuntary limb movements characterised as pseudochoreoathetosis. The movements were present at rest, but when her eyes were closed, she was unaware of the movements and they were exacerbated. There was cerebrospinal fluid albuminocytological dissociation with protein 196 mg/dl and a white blood count of 1. Electrodiagnostic studies on two occasions demonstrated progressive sensory nerve action potential loss with preserved compound muscle action potentials. Anti-Hu antibodies were negative, anti-nuclear antibodies were abnormal at a titer of 1:40 with a diffuse pattern, and serum protein electrophoresis was normal. She was diagnosed with a sensory ataxic variant of GBS. Outcome was reported as unknown.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electrophoresis protein, Electrophoresis protein normal, Guillain-Barre syndrome, Paraesthesia, Sensory loss
Clinical narrative: This medically confirmed literature report (initial receipt 12-Aug-2014) concerns a 50 year-old female patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date seven days following the influenza vaccine, the patient was presented with symmetric sensory paresthesia. On examination, she had areflexia, marked loss of joint position sense in both proximal and distal arms and legs, and involuntary limb movements characterised as pseudochoreoathetosis. The movements were present at rest, but when her eyes were closed, she was unaware of the movements and they were exacerbated. There was cerebrospinal fluid albuminocytological dissociation with protein 196 mg/dl and a white blood count of 1. Electrodiagnostic studies on two occasions demonstrated progressive sensory nerve action potential loss with preserved compound muscle action potentials. Anti-Hu antibodies were negative, anti-nuclear antibodies were abnormal at a titer of 1:40 with a diffuse pattern, and serum protein electrophoresis was normal. She was diagnosed with a sensory ataxic variant of GBS. Outcome was reported as unknown.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: White blood cell count
Clinical narrative: This medically confirmed literature report (initial receipt 12-Aug-2014) concerns a 50 year-old female patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date seven days following the influenza vaccine, the patient was presented with symmetric sensory paresthesia. On examination, she had areflexia, marked loss of joint position sense in both proximal and distal arms and legs, and involuntary limb movements characterised as pseudochoreoathetosis. The movements were present at rest, but when her eyes were closed, she was unaware of the movements and they were exacerbated. There was cerebrospinal fluid albuminocytological dissociation with protein 196 mg/dl and a white blood count of 1. Electrodiagnostic studies on two occasions demonstrated progressive sensory nerve action potential loss with preserved compound muscle action potentials. Anti-Hu antibodies were negative, anti-nuclear antibodies were abnormal at a titer of 1:40 with a diffuse pattern, and serum protein electrophoresis was normal. She was diagnosed with a sensory ataxic variant of GBS. Outcome was reported as unknown.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anti-neuronal antibody, Antinuclear antibody, Areflexia, Ataxia, CSF protein
Clinical narrative: This medically confirmed literature report (initial receipt 12-Aug-2014) concerns a 50 year-old female patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date seven days following the influenza vaccine, the patient was presented with symmetric sensory paresthesia. On examination, she had areflexia, marked loss of joint position sense in both proximal and distal arms and legs, and involuntary limb movements characterised as pseudochoreoathetosis. The movements were present at rest, but when her eyes were closed, she was unaware of the movements and they were exacerbated. There was cerebrospinal fluid albuminocytological dissociation with protein 196 mg/dl and a white blood count of 1. Electrodiagnostic studies on two occasions demonstrated progressive sensory nerve action potential loss with preserved compound muscle action potentials. Anti-Hu antibodies were negative, anti-nuclear antibodies were abnormal at a titer of 1:40 with a diffuse pattern, and serum protein electrophoresis was normal. She was diagnosed with a sensory ataxic variant of GBS. Outcome was reported as unknown.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: CSF test abnormal, CSF white blood cell count, Dyskinesia, Electrophoresis protein, Loss of proprioception
Clinical narrative: This medically confirmed literature report (initial receipt 12-Aug-2014) concerns a 50 year-old female patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date seven days following the influenza vaccine, the patient was presented with symmetric sensory paresthesia. On examination, she had areflexia, marked loss of joint position sense in both proximal and distal arms and legs, and involuntary limb movements characterised as pseudochoreoathetosis. The movements were present at rest, but when her eyes were closed, she was unaware of the movements and they were exacerbated. There was cerebrospinal fluid albuminocytological dissociation with protein 196 mg/dl and a white blood count of 1. Electrodiagnostic studies on two occasions demonstrated progressive sensory nerve action potential loss with preserved compound muscle action potentials. Anti-Hu antibodies were negative, anti-nuclear antibodies were abnormal at a titer of 1:40 with a diffuse pattern, and serum protein electrophoresis was normal. She was diagnosed with a sensory ataxic variant of GBS. Outcome was reported as unknown.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Paraesthesia, Peripheral sensory neuropathy, Sensory loss
Clinical narrative: This medically confirmed literature report (initial receipt 12-Aug-2014) concerns a 50 year-old female patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date seven days following the influenza vaccine, the patient was presented with symmetric sensory paresthesia. On examination, she had areflexia, marked loss of joint position sense in both proximal and distal arms and legs, and involuntary limb movements characterised as pseudochoreoathetosis. The movements were present at rest, but when her eyes were closed, she was unaware of the movements and they were exacerbated. There was cerebrospinal fluid albuminocytological dissociation with protein 196 mg/dl and a white blood count of 1. Electrodiagnostic studies on two occasions demonstrated progressive sensory nerve action potential loss with preserved compound muscle action potentials. Anti-Hu antibodies were negative, anti-nuclear antibodies were abnormal at a titer of 1:40 with a diffuse pattern, and serum protein electrophoresis was normal. She was diagnosed with a sensory ataxic variant of GBS. Outcome was reported as unknown.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Death
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 12 year old female patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported). Concomitant medications were not provided. The physician reported that she read a report, possibly online, about the patient who had a seizure on an unknown date after administration of GARDASIL and died on 31-JUL-2014. The cause of death was unspecified. The patient had sought unspecified medical attention. Outcome of seizure was unknown. Causality was not provided. Upon internal review, seizure was determined to be medically significant. Additional information is not expected because the reporter did not want to be contacted.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site cellulitis, Skin warm, Swelling
Clinical narrative: Person developed cellulitis in upper arm where PPSV 23 was given.  Person was seen the next afternoon by her PCP's office and began Cipro 500 mg po bid x 7 days. Swelling redness and warmth resolved by 08/18.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Person developed cellulitis in upper arm where PPSV 23 was given.  Person was seen the next afternoon by her PCP's office and began Cipro 500 mg po bid x 7 days. Swelling redness and warmth resolved by 08/18.
Age: 51.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: Pt has a very large reddened swollen area on (L) arm. Area is warm to touch. Pt was given Ceftriaxone 1 gram IM. She also started oral antibiotic for cellulitis.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Headache, Lethargy
Clinical narrative: On going complaints of headache, lethargic, dizziness, vision problems, stomach ache, joint pain, neck ache.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Visual impairment
Clinical narrative: On going complaints of headache, lethargic, dizziness, vision problems, stomach ache, joint pain, neck ache.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 3 patients of unknown age. On 05-AUG-2014 the patients was vaccinated with GARDASIL (lot# was not reported). The reporter reported that GARDASIL were improperly stored. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients. The patients medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Convulsion, Gene mutation identification test positive, Grand mal convulsion
Clinical narrative: Presented to the ED in full body tonic clonic seizure activity. Convulsions noted to cease at 2225 IV administration of midazolam. Then transferred to another hospital.
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Bacterial test, CSF test, Computerised tomogram, Convulsion, Cytogenetic analysis
Clinical narrative: Presented to the ED in full body tonic clonic seizure activity. Convulsions noted to cease at 2225 IV administration of midazolam. Then transferred to another hospital.
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Electroencephalogram, Endotracheal intubation, Metabolic function test, Nuclear magnetic resonance imaging, Status epilepticus
Clinical narrative: Presented to the ED in full body tonic clonic seizure activity. Convulsions noted to cease at 2225 IV administration of midazolam. Then transferred to another hospital.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Induration, Local swelling, Pruritus
Clinical narrative: She had redness/swelling and warmth to localized area after receiving vaccine.  She states after a number of days it then turned hard and itchy.  She states area is still bruised but has gotten better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: She had redness/swelling and warmth to localized area after receiving vaccine.  She states after a number of days it then turned hard and itchy.  She states area is still bruised but has gotten better.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date (also reported that a few days after) the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). No concomitant medications reported. On an unknown date the patient developed swelling and erythema at the injection site. The patient told this to pharmacist and pharmacist to company representative. The outcome of swelling and erythema at the injection site were unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Feeling cold, Loss of consciousness, Pallor
Clinical narrative: Received HPV dose #3 at 3:15pm. Patient had loss of consciousness, pale and cold for about 1 minute.  Awoke and alert after.  Given apple juice and reported feeling improved.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a nurse practitioner refers to a number of unspecified patients. Nurse practitioner reported that unspecified number of improperly stored VARIVAX (Merck) (dose, route, lot# not reported) and PROQUAD (merck) (dose, route, lot# not reported) doses had been administered to unspecified patients. No adverse effects reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 3 year old patient. On 08-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J012377, expiration date 03-OCT-2015, dose and route not reported)   which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.37
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 16 month  old patient. On 21-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J012377, expiration date 03-OCT-2015, dose and route not reported)   which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It ws reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was unspecified whether the patient had sought any medical attention. There was  no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also , reported that M-M-R II was not mentioned int he original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from office manager refers to a 5 years old patient. On 05-JUN-2014 the patient was vaccinated with a dose of improperly   stored M-M-R II (lot # J013315, expiration date 18-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 years old patient. On 15-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (0.5 ml, subcutaneous, lot # not reported) which was improperly stored dose exposed to a maximum of -9C for total 2.5 hours. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient ws unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever - pt did not call this pharmacy with details, so information is limited.
Age: 1.31
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 month old patient. On 27-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J012377, expiration date 13-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.26
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It ws reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was unspecified whether the patient had sought any medical attention. There was  no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also , reported that M-M-R II was not mentioned int he original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from office manager refers to a 15 months  old patient. On 09-JUN-2014 the patient was vaccinated with a dose of improperly   stored M-M-R II (lot # J012818, expiration date 18-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient. On 04-AUG-2014 the patient ws vaccinated with M-M-R II (0.5 ml, subcutaneous, lot # was not reported, exp 03-AUG-2014). The vaccine was expired. No adverse effect reported. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It ws reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was unspecified whether the patient had sought any medical attention. There was  no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also , reported that M-M-R II was not mentioned int he original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from office manager refers to a 17 monrhs old patient. On 03-JUN-2014 the patient was vaccinated with a dose of improperly   stored M-M-R II (lot # J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (primary contact also reported as physician), refers to a 17 year old female patient. No concurrent conditions or medical history were provided. The nurse reported that, in 2011, the patient was vaccinated with the first dose of GARDASIL and, in June 2014, got the second dose of GARDASIL injection (doses, route of administration, indication, lot# and expiry dates unspecified for both). Third dose was not administered. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as there is no consent to contact with the physician.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Flushing
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old female patient with no drug reactions or allergies. On 12-AUG-2014 the patient was vaccinated with PNEUMOVAX23 lot # K005797, 0.5 ml, intramuscular. On 12-AUG-2014, patient experienced immediate flushing of her face and arms after administration of PNEUMOVAX23. Patient sought medical attention in pharmacy. None lab diagnostics studies were performed. At the time of the report the outcome of the event was recovered., reported as the symptoms resolved quickly without requiring medical treatment. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 14-AUG-2014 the patient was vaccinated with one dose of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous (lot number not reported) that was stored improperly. No adverse effects were reported. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different date: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot number, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 6 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot# J011344, expiration date 10-MAY-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 0.09
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patients identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 4 week old patient who on 10-JUN-2014 was vaccinated with improperly stored dose of RECOMBIVAX HB Lot# J012567, expiration date 30-JAN-2016 (dose and route of administration not reported). This is one of several reports received from the same reporter. Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and rug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 11 year old patient who on 10-JUN-2014 was vaccinated with improperly stored dose of RECOMBIVAX HB lot# J006365, expiration date 05-DEC-2015 (dose and route of administration not reported). This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old patient. On 15-AUG-2014 the patient ws vaccinated with (Oka/Merck) VARIVAX (0.5ml, subcutaneous, lot # not provided) which was improperly stored dose exposed to a maximum of 9-C for total 2.5 hours. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. thi sis one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 4 year old patient. On 23-MAY-2014 the patient ws vaccinated with (Oka/Merck) VARIVAX (lot # J012377, expiration date 13-OCT-2014, dose and route not reported which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Ophthalmic herpes simplex
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included ophthalmic herpes. No drug allergy and no concomitant medication. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, lot # and indication were not reported). The patient was diagnosed with a recurrence of ophthalmic herpes simplex 2-3 days after administration of ZOSTAVAX. The patient, who had a pre-existing history of ophthalmic herpes, was administered ZOSTAVAX 2-3 days ago at another facility. She was evaluated by an unspecified ophthalmologist and was prescribed VALTREX. The patient sought medical attention. The outcome of event was reported as not recovered/not resolved. Additional information is not expected.
Age: 1.2
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a 14 months old patient. On 04-AUG-2014 the patient was vaccinated with MMR II (0.5 ml, subcutaneous, lot# was not reported, exp 03-AUG-2014). The vaccine was expired. No adverse effect reported. This is one of two reports from same source. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 month old patient. On 16-MAY-2014 the patient was vaccinated with VARIVAX (Merck) (lot # J012377, expiration date 03-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.