chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 27-SEP-2013, the patient was vaccinated with the first dose of GARDASIL (0.5ml, intramuscularly, lot numbers not reported). On 03-DEC-2013, the patient was vaccinated with the second dose of GARDASIL (0.5ml, intramuscularly, lot numbers not reported). On 23-JAN-2014, the patient was vaccinated with the third dose of GARDASIL (0.5ml, intramuscularly, lot number not reported). No adverse event reported. Additional information has been requestes.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 40 year old male patient. On an unspecified date in 1978, the patient was vaccinated with the first and second doses of MMR II (dose, route and lot # not reported). The pharmacist reported that "now" in 2014, the patient had negative titers for MMR. The outcome of negative titers for MMR was unknown. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: DTPHEP, FLUX, HEPA
Symptoms: Attention deficit/hyperactivity disorder, Childhood disintegrative disorder, Decreased appetite, Injection site swelling, Injection site warmth
Clinical narrative: Started with swollen, hot areas of shots and fever. Baby Tylenol was administered for fever and pain. Very cranky, wouldn't sleep well. Over the next couple of months he went from speaking sentences to just "Mama", "Dada" and "uh-oh", quit potty training, quit sleeping well at night, quit eating most of the foods he ate normally. He would learn new words and then drop the other words he knew. We have done speech therapy.
Age: 1.58
Sex: M
Vaccine: DTPHEP, FLUX, HEPA
Symptoms: Irritability, Pain, Poor quality sleep, Pyrexia, Speech disorder developmental
Clinical narrative: Started with swollen, hot areas of shots and fever. Baby Tylenol was administered for fever and pain. Very cranky, wouldn't sleep well. Over the next couple of months he went from speaking sentences to just "Mama", "Dada" and "uh-oh", quit potty training, quit sleeping well at night, quit eating most of the foods he ate normally. He would learn new words and then drop the other words he knew. We have done speech therapy.
Age: 25.0
Sex: M
Vaccine: MMR, SMALL
Symptoms: Injection site cellulitis, Malaise, Pain, Pruritus, Rash
Clinical narrative: Seen on 3/30/14 for cellulitis of the arm around smallpox vaccine as well as body aches and general feeling of malaise. Was administered Motrin and follow-up in next couple of days if symptoms worsen. Pt f/u the next day with a rash covering upper torso and few spots on thighs. Was given Benadryl to help with the itching. Pt returned to clinic the following day with symptoms not resolving. Discussed with pt the possibility of the rash being fungal or folliculitis and either course of treatment would require medication that is DNIFing. Pt decline medication at the time due to flying schedule. Pt instructed to return if symptoms worsened.
Age: 44.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Grip strength decreased, Paraesthesia
Clinical narrative: Severe grip weakness in bilat arms/hands.  Some paresthesias in upper extremities.  Slowly resolving w/ Naproxen 500 mg bid and time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Apparent life threatening event, Endotracheal intubation, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 65 year old female patient with none pertinent medical history. On an unspecified date in 2009, the patient was vaccinated with a dose of ZOSTAVAX, single shot, subcutaneous (lot# and expiry not reported). On an unknown date, the patient developed "a severe case of shingles on the right side of her face down to her neck." "This patient was hospitalized and had to be intubated." The physician noted "this was a life threatening event." The outcome of the events was now recovered on an unspecified date. The patient sought medical attention. Therapy with ZOSTAVAX was also reported as continued. Upon internal review, "had to be intubated" was considered as medically significant. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Visual acuity reduced
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. On an unknown date in 1992, the patient received vaccination with M-M-R II, subcutaneous injection. No other concomitant therapies reported. On an unknown date in 1992 the patient suffered from limited vision (disability) and was discharged due to limited vision. The action taken of the event with the suspect product was assessed as not applicable. The patient sought medical attention by contacting the physician. It was unspecified whether the event was life-threatening, and also unspecified whether hospitalization occurred. Intervention to prevent the seriousness criteria was unspecified. There was no overdose, no cancer and no PQC involved. The outcome of limited vision was unknown. The causality of the event was unspecified. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a healthcare worker who received the information from a physician refers to a patient (referred as third unspecified child) of unknown age. About a year ago approximately in 2013 the patient was vaccinated with VARIVAX (Merck) (lot information, dose strength and dose number was not reported), via subcutaneous route. No concomitant medication was reported. About a year ago approximately in 2013 the patient developed cellulitis (hospitalization). Patient's parents sought medical attention. The patient was admitted over night to an unspecified hospital. The outcome of cellulitis was reported as recovered/resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Cold sweat, Dizziness, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced swelling and redness at injection site and after a few minutes of counseling passed out for 10-15 seconds. Patient broke out in cold sweats and reported feeling warm and lightheaded.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Loss of consciousness
Clinical narrative: Patient experienced swelling and redness at injection site and after a few minutes of counseling passed out for 10-15 seconds. Patient broke out in cold sweats and reported feeling warm and lightheaded.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Chest X-ray normal, Febrile convulsion, Full blood count, Metabolic function test
Clinical narrative: Febrile seizure, lasting less than 5 minutes, transported to local ER by ambulance, seen and observed, lac normal, CXR normal sent home with fever control measures.
Age: 1.34
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Convulsion, Death
Clinical narrative: Seizure resulting in death.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Intussusception, Irritability, Ultrasound abdomen
Clinical narrative: On 4/6/14 vomiting and diarrhea noted blood in stool and very fussy. Sent to ED. Diag. Intussusception.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: On 4/6/14 vomiting and diarrhea noted blood in stool and very fussy. Sent to ED. Diag. Intussusception.
Age: 57.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Back pain, Injection site pain
Clinical narrative: Pain in back (deltoid, etc) and shoulder muscles on the left side (side of immunization).  Pain has persisted and impacts me daily.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Soreness and weakness in arm that received flu and pneumonia shots for next twelve months.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unknown amount of patients with unknown demography. The Nurse reported that on 07-APR-2014 (also reported as yesterday morning), unknown amount of patients were vaccinated with ROTATEQ (dose, route and frequency were not reported) which was exposed to 19C for 1.5 hours. No adverse effect reported. No further information was provided. This case is linked to the case 1404USA005550 and 1404USA008613 (same reporter link). Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Lymphadenopathy
Clinical narrative: Patient received ZOSTAVAX subcutaneously in left arm on Wednesday 4/9/14. She returned on Sunday 4/13/14 to report she had local rash at injection site and swollen lymph nodes under left arm.
Age: 1.12
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Dry skin, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Rash beginning at injection site. Upon examination on 04/07/2014: rash is noted that is diffuse in location; the color is mainly red; it is best characterized as lacy or reticular and raised, rough. Site of her MMR is especially concerning because it is still warm, with induration, and tender to touch despite the fact that it has been nearly 2 weeks since pt had the vaccination administered.
Age: 1.12
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Injection site warmth, Streptococcus test negative
Clinical narrative: Rash beginning at injection site. Upon examination on 04/07/2014: rash is noted that is diffuse in location; the color is mainly red; it is best characterized as lacy or reticular and raised, rough. Site of her MMR is especially concerning because it is still warm, with induration, and tender to touch despite the fact that it has been nearly 2 weeks since pt had the vaccination administered.
Age: 1.16
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Apnoea, Asthenia, Blood culture negative, Blood test, CSF culture
Clinical narrative: Mother states that patient was in her USOH up until two days PTA when she developed mild cough and rhinorrhea. 1 day PTA patient developed fever to 103, treated with anti-pyretics. On the day of admission patients was slightly low energy and with slightly decreased appetite but was overall playful with normal mental status and adequate PO/UOP. While in her dad's arms at a cousin's birthday party this evening patient suddenly began to stare slightly upward, looking past her dad, and her body became stiff. Father laid her on the ground and she bagan to have a generalized tonic clonic seizure with symmetric involvement and progression. Parents report a subtle blue appearance to patient at that time and concerns for whether or not she was breathing- GM gave a few rescue breaths with unclear effect. EMS arrived within 5 minutes and initially felt patient's respirations were sufficient, however they report apnea en route and subsequently intubated her with a 3.0 ETT. Patient continued seizing en route and was given ativan x1 with no apparent effect. In the ED patient received an addtional dose of Ativan. She had a CSR which showed ETT at the thoraci inlet and was subsequently reintubated with a 4.5 ETT. Sedation maintained with propofol drip. Blood culture, CBC, BMP were obtained and was WNL. PICU transport team was called but was out on transport; patient was transferred to pediatric ICU via lifestar.
Age: 1.16
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest X-ray, Computerised tomogram head, Cough, Culture urine, Cyanosis
Clinical narrative: Mother states that patient was in her USOH up until two days PTA when she developed mild cough and rhinorrhea. 1 day PTA patient developed fever to 103, treated with anti-pyretics. On the day of admission patients was slightly low energy and with slightly decreased appetite but was overall playful with normal mental status and adequate PO/UOP. While in her dad's arms at a cousin's birthday party this evening patient suddenly began to stare slightly upward, looking past her dad, and her body became stiff. Father laid her on the ground and she bagan to have a generalized tonic clonic seizure with symmetric involvement and progression. Parents report a subtle blue appearance to patient at that time and concerns for whether or not she was breathing- GM gave a few rescue breaths with unclear effect. EMS arrived within 5 minutes and initially felt patient's respirations were sufficient, however they report apnea en route and subsequently intubated her with a 3.0 ETT. Patient continued seizing en route and was given ativan x1 with no apparent effect. In the ED patient received an addtional dose of Ativan. She had a CSR which showed ETT at the thoraci inlet and was subsequently reintubated with a 4.5 ETT. Sedation maintained with propofol drip. Blood culture, CBC, BMP were obtained and was WNL. PICU transport team was called but was out on transport; patient was transferred to pediatric ICU via lifestar.
Age: 1.16
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Endotracheal intubation, Full blood count normal, Grand mal convulsion, Intensive care
Clinical narrative: Mother states that patient was in her USOH up until two days PTA when she developed mild cough and rhinorrhea. 1 day PTA patient developed fever to 103, treated with anti-pyretics. On the day of admission patients was slightly low energy and with slightly decreased appetite but was overall playful with normal mental status and adequate PO/UOP. While in her dad's arms at a cousin's birthday party this evening patient suddenly began to stare slightly upward, looking past her dad, and her body became stiff. Father laid her on the ground and she bagan to have a generalized tonic clonic seizure with symmetric involvement and progression. Parents report a subtle blue appearance to patient at that time and concerns for whether or not she was breathing- GM gave a few rescue breaths with unclear effect. EMS arrived within 5 minutes and initially felt patient's respirations were sufficient, however they report apnea en route and subsequently intubated her with a 3.0 ETT. Patient continued seizing en route and was given ativan x1 with no apparent effect. In the ED patient received an addtional dose of Ativan. She had a CSR which showed ETT at the thoraci inlet and was subsequently reintubated with a 4.5 ETT. Sedation maintained with propofol drip. Blood culture, CBC, BMP were obtained and was WNL. PICU transport team was called but was out on transport; patient was transferred to pediatric ICU via lifestar.
Age: 1.16
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lumbar puncture, Metabolic function test normal, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Mother states that patient was in her USOH up until two days PTA when she developed mild cough and rhinorrhea. 1 day PTA patient developed fever to 103, treated with anti-pyretics. On the day of admission patients was slightly low energy and with slightly decreased appetite but was overall playful with normal mental status and adequate PO/UOP. While in her dad's arms at a cousin's birthday party this evening patient suddenly began to stare slightly upward, looking past her dad, and her body became stiff. Father laid her on the ground and she bagan to have a generalized tonic clonic seizure with symmetric involvement and progression. Parents report a subtle blue appearance to patient at that time and concerns for whether or not she was breathing- GM gave a few rescue breaths with unclear effect. EMS arrived within 5 minutes and initially felt patient's respirations were sufficient, however they report apnea en route and subsequently intubated her with a 3.0 ETT. Patient continued seizing en route and was given ativan x1 with no apparent effect. In the ED patient received an addtional dose of Ativan. She had a CSR which showed ETT at the thoraci inlet and was subsequently reintubated with a 4.5 ETT. Sedation maintained with propofol drip. Blood culture, CBC, BMP were obtained and was WNL. PICU transport team was called but was out on transport; patient was transferred to pediatric ICU via lifestar.
Age: 1.16
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Respiratory arrest, Rhinorrhoea, Staring, Viral test
Clinical narrative: Mother states that patient was in her USOH up until two days PTA when she developed mild cough and rhinorrhea. 1 day PTA patient developed fever to 103, treated with anti-pyretics. On the day of admission patients was slightly low energy and with slightly decreased appetite but was overall playful with normal mental status and adequate PO/UOP. While in her dad's arms at a cousin's birthday party this evening patient suddenly began to stare slightly upward, looking past her dad, and her body became stiff. Father laid her on the ground and she bagan to have a generalized tonic clonic seizure with symmetric involvement and progression. Parents report a subtle blue appearance to patient at that time and concerns for whether or not she was breathing- GM gave a few rescue breaths with unclear effect. EMS arrived within 5 minutes and initially felt patient's respirations were sufficient, however they report apnea en route and subsequently intubated her with a 3.0 ETT. Patient continued seizing en route and was given ativan x1 with no apparent effect. In the ED patient received an addtional dose of Ativan. She had a CSR which showed ETT at the thoraci inlet and was subsequently reintubated with a 4.5 ETT. Sedation maintained with propofol drip. Blood culture, CBC, BMP were obtained and was WNL. PICU transport team was called but was out on transport; patient was transferred to pediatric ICU via lifestar.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site pain, Injection site pruritus, Middle insomnia
Clinical narrative: Dull pain, itching, prickly burning sensation at inj site. Wakes me in my sleep to scratch, and sometimes wakes me w/ stabbing pain, so I rub the area. I was given the TDAP vaccine (0.5ml, Lot # U4329AA) on 5/30/2012 for having a metal wire pierce my foot. To this day I am experiencing a dull pain, itching, prickly burning sensation in the ara at the injection site. There is nothing visually seen in the area on the surface of the Lt deltoid where the vaccine was administered (no swelling, not hot with fever, and not red). There is just an uncomfortable feeling in the area of the dose administration constantly.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (medical assistant) refers to a patient of unknown age and gender. On 13-DEC-2013 the patient was vaccinated with the third dose of ROTATEQ. The ROTATEQ was improperly stored. It was exposed to temperatures of 32F for 32 minutes on 02-DEC-2013, then 32F for 24 minutes on 03-DEC-2013, then on the same day 03-DEC-2013 at 31F for 8 minutes, then 33 F for 19 minutes on 04-DEC-2013. No adverse effects reported. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: TDAP
Symptoms: Chest discomfort, Dizziness, Dysstasia, Injection site discomfort, Injection site warmth
Clinical narrative: Uncomfortable creeping warmth from (hip) injection site, when reached upper chest discomfort and extreme dizziness, unable to stand or sit stable chest discomf, it lasted 8 days - slight residual remains, dizziness residual also (2 days intense).
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Fever to 103.9.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Areflexia, Balance disorder, Dysstasia, Guillain-Barre syndrome
Clinical narrative: Loss of balance, loss of use of lower body, weakness in arms, no reflexes in lower body, inability to walk, stand or sit unassisted.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Posture abnormal
Clinical narrative: Loss of balance, loss of use of lower body, weakness in arms, no reflexes in lower body, inability to walk, stand or sit unassisted.
Age: 37.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal, Surgery
Clinical narrative: Flu and Tdap 12-7-12. Surgery 12-13-12. Admitted Guillain Barre 12-22-12.
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Cardiovascular evaluation, Chest pain, Hyperhidrosis, Laboratory test normal, Local swelling
Clinical narrative: Two hours post typhoid administration, patient developed chest pain, (L) arm pain, swollen hands and diaphoresis. BP 240/110. R 76 P Ox 96%. Eval in local ER determined reaction to the typhoid injection. F/U with PCP/rheumatologist suggested.
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Two hours post typhoid administration, patient developed chest pain, (L) arm pain, swollen hands and diaphoresis. BP 240/110. R 76 P Ox 96%. Eval in local ER determined reaction to the typhoid injection. F/U with PCP/rheumatologist suggested.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Rash started on 4/12/14, vaccine administered (MMR) on 4/4/14, no fever, rash started on the trunk, then spread to the face, neck, back and lower extremity, no itching. No treatment given.
Age: 51.0
Sex: F
Vaccine: TYP, YF
Symptoms: Eye swelling, Periorbital oedema, Throat irritation
Clinical narrative: As per client a few hours after vaccination she developed (R) eye swelling and itchy throat. Went to ER. Treated for periorbital edema with BENADRYL 50mg PO and d/c'd.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Patient nauseated and vomited x 1 approx 8 min after vaccines. Felt better within 20 mins.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm with diffuse erythema and warmth of upper arm centered about a left deltoid injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pruritus, Skin warm
Clinical narrative: Itchy, hot, swollen arm. Resolved on its own after 7 days.
Age: 51.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema
Clinical narrative: Received yellow fever vaccine on back right arm, subq, on 3/17/2014.  On Tuesday and Wednesday (3/18 and 3/19) developed a red rectangle, shaped area on R upper arm (back).  Area was approximately 4" x 3".  Went to pharmacy on 3/19, was directed to ice area which patient did. The ice improved the situation.  Much smaller area by 3/21 but called Health Department to report it.
Age: 1.26
Sex: F
Vaccine: MMR
Symptoms: Childhood disintegrative disorder, Electroencephalogram, Gaze palsy, Staring
Clinical narrative: Crawling then stopped, staring into space with right eye turned in and upward for 15 seconds, then seemed fine.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Pyrexia
Clinical narrative: Patient c/o fever, light-headedness, and fatigue. Recommended TYLENOL for fever and encouraged plenty of fluids.
Age: 19.0
Sex: M
Vaccine: MNQ, TD, TYP, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash developed approx. 13 days after getting shots. Client states rash is on arms, knees, and lower back and is red and raised. Denies other symptoms.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Muscular weakness, Pyrexia
Clinical narrative: Fever, bil leg weakness, decreased strength legs.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Crying
Clinical narrative: Patient was inconsolable after 2 mo. shots. Went to ER after hours of crying.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Area swollen, red, tender to touch.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, PPV, TDAP
Symptoms: Erythema, Local swelling, Pruritus, Rash
Clinical narrative: REDNESS, SWELLING, PRURITUS AND RASH OVER ARM/FOREARM.  HE WAS TREATED WITH BENADRYL.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased activity, Decreased appetite, Dizziness, Dyskinesia, Fatigue
Clinical narrative: Immediately following shots patient became  tired and her fever started within 3 hours. Her fevers over the last week have gone as high as 102.9, restless sleeping, vomiting, she hasn't ate in 5 days but is drinking fluids and keeping them down. Dizziness,red throat, not active at all, purple lips at times, shaking, jerking, fussy.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Irritability, Lip discolouration, Pharyngeal erythema, Poor quality sleep
Clinical narrative: Immediately following shots patient became  tired and her fever started within 3 hours. Her fevers over the last week have gone as high as 102.9, restless sleeping, vomiting, she hasn't ate in 5 days but is drinking fluids and keeping them down. Dizziness,red throat, not active at all, purple lips at times, shaking, jerking, fussy.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Tremor, Vomiting, White blood cell count increased
Clinical narrative: Immediately following shots patient became  tired and her fever started within 3 hours. Her fevers over the last week have gone as high as 102.9, restless sleeping, vomiting, she hasn't ate in 5 days but is drinking fluids and keeping them down. Dizziness,red throat, not active at all, purple lips at times, shaking, jerking, fussy.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Gait disturbance, Pyrexia, Somnolence, Vomiting
Clinical narrative: Immediately following shots patient became  tired and her fever started within 3 hours. Her fevers over the last week have gone as high as 102.9, restless sleeping, vomiting, she hasn't ate in 5 days but is drinking fluids and keeping them down. Dizziness,red throat, not active at all, purple lips at times, shaking, jerking, fussy.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Immediately following shots patient became  tired and her fever started within 3 hours. Her fevers over the last week have gone as high as 102.9, restless sleeping, vomiting, she hasn't ate in 5 days but is drinking fluids and keeping them down. Dizziness,red throat, not active at all, purple lips at times, shaking, jerking, fussy.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Nausea
Clinical narrative: Nausea, weakness, fatigue, headache, stomach pain.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenitis, Swelling, Tenderness
Clinical narrative: Swollen, tender axillary and cervical lymphadenitis.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Burning sensation, Confusional state, Crying, Headache
Clinical narrative: At around 11:00 pm, almost exactly 12 hours after the vaccines (Dtap & Polio) were administered, my daughter woke up in the middle of the night crying - she was running a fever of 100 degrees and drenched in sweat, she complained of a headache, a stomachache, and was inconsolable. She vomited 3 times - mostly stomach bile. She was restless, could not sleep, and her body felt like it was on fire. She was also acting confused and not making a lot of sense, but that may have been from the fever. It did eventually go down with Motrin, but she continued to run a fever on and off throughout the day, as well as complained of a headache and overall pain. By the end of the day, 4/15/14, she seems to be back to normal, but this "reaction" did NOT seem to be normal to me.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Hyperhidrosis, Insomnia, Irritability, Pain, Pyrexia
Clinical narrative: At around 11:00 pm, almost exactly 12 hours after the vaccines (Dtap & Polio) were administered, my daughter woke up in the middle of the night crying - she was running a fever of 100 degrees and drenched in sweat, she complained of a headache, a stomachache, and was inconsolable. She vomited 3 times - mostly stomach bile. She was restless, could not sleep, and her body felt like it was on fire. She was also acting confused and not making a lot of sense, but that may have been from the fever. It did eventually go down with Motrin, but she continued to run a fever on and off throughout the day, as well as complained of a headache and overall pain. By the end of the day, 4/15/14, she seems to be back to normal, but this "reaction" did NOT seem to be normal to me.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Restlessness, Vomiting
Clinical narrative: At around 11:00 pm, almost exactly 12 hours after the vaccines (Dtap & Polio) were administered, my daughter woke up in the middle of the night crying - she was running a fever of 100 degrees and drenched in sweat, she complained of a headache, a stomachache, and was inconsolable. She vomited 3 times - mostly stomach bile. She was restless, could not sleep, and her body felt like it was on fire. She was also acting confused and not making a lot of sense, but that may have been from the fever. It did eventually go down with Motrin, but she continued to run a fever on and off throughout the day, as well as complained of a headache and overall pain. By the end of the day, 4/15/14, she seems to be back to normal, but this "reaction" did NOT seem to be normal to me.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt given immunization in Left Deltoid.  When he came to our clinic for evaluation two days later, there was redness, swelling, and skin was warm to touch surrounding injection site and extending almost entirely around his upper arm to the elbow.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Regurgitation, Swelling face, Urticaria, Wheezing
Clinical narrative: Hives, wheezing, facial swelling, stomach regurgitation on the way home from clinic within 30-40 minutes, then to ER via ambulance - got IM BENADRYL, IM epinephrine, albuterol nebs, eventually steroids, ranitidine in ER.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Cellulitis, Culture urine, Full blood count, Injection site erythema
Clinical narrative: Left arm swelling and erythema at pneumococcal injection. Cellulitis, fever, leukocytosis.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Leukocytosis, Pyrexia
Clinical narrative: Left arm swelling and erythema at pneumococcal injection. Cellulitis, fever, leukocytosis.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Cough, Nasal congestion, Rash
Clinical narrative: Rash onset Sunday April 6, 2014, afebrile. appetite good, rash increasing in quantity fast since onset. Constant cough one day (sunday), nasal congestion since date of immunization.
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On 10-FEB-2014 the patient was vaccinated with 1 vial of MMR II (lot # J006954, expiration date: 07-JUN-2015, route and anatomical location of administration not reported). According to reporting physician on 25-FEB-2014, the patient developed "measles like rash" after receiving MMR II. There was no treatment given for the event. The outcome of measles like rash was reported as recovered/resolved on an unspecified date in 2014. The patient sought medical attention by consulting the physician. The relatedness between reported event MMR II administration, was not reported. This case is linked to MARRS # 1403USA010834 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. No medical history of concurrent conditions reported. On 11-APR-2014, the patient was inadvertently vaccinated with ROTATEQ (dose, strength and lot number not provided). No co-suspect or concomitant therapies were reported. The reporter stated that ROTATEQ vaccine had been improperly stored. At the time of the report, the outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 38 year old male patient. On 04-APR-2014 (reported as today), the patient was vaccinated with the first dose of expired VARIVAX, lot # 0471AE, expiration date 02-APR-2014, 0.5 ml, subcutaneous. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever; swelling of right arm; pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash over side and back of body.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Skin papilloma
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with an unspecified dose of GARDASIL (lot number, dose and route not reported). The nurse reported that an unspecified patient received an unspecified dose in the GARDASIL series on an unspecified date. The patient had a preexisting wart on her finger which became "worse and bigger" following the GARDASIL administration. The patient sought unspecified medical attention. At the time of reporting, the outcome of event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. The patients pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 31-MAR-2014 the patient was vaccinated with GARDASIL lot # J013324, expire date 12-FEB-2016, intramuscular. No concomitant medications were reported. On 31-MAR-2014, few minutes after the therapy the patient fainted. The sought medical attention was not reported. After few minutes (31-MAR-2014) the patient recovered from the adverse event fainted. It was reported that the lot check was requested. This is one of the two report received from the same reporter link (1404USA004213). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Blindness transient, Hypotension, Nausea, Pallor, Staring
Clinical narrative: Pt was observed for 15 min and during the 15 min observation she reported being nauseous. While speaking to her she started looking pale and staring into space. She startd to faint but we caught her before she fell to the ground avoiding head injury. She reported lack of vision for 1 minute but recovered. EMT was called and they advised pt to go to ER with them b/c pt's hypotension. BP at first check was 78/62. Second check 103/70.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Pt was observed for 15 min and during the 15 min observation she reported being nauseous. While speaking to her she started looking pale and staring into space. She startd to faint but we caught her before she fell to the ground avoiding head injury. She reported lack of vision for 1 minute but recovered. EMT was called and they advised pt to go to ER with them b/c pt's hypotension. BP at first check was 78/62. Second check 103/70.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (medical assistant) refers to unknown number of patients. On unknown dates the patients might have received improperly stored GARDASIL. The vaccine was exposed to temperatures of 32F for 32 minutes on 02-DEC-2013, then 32F for 24 minutes on 03-DEC-2013, then on the same day 03-DEC-2013 at 31F for 8 minutes, then 33F for 19 minutes on 04-DEC-2013, then 33F for 34 minutes on 17-DEC-2013. No adverse effects reported. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On 11-APR-2014 the patient was inadvertently administered a dose of PROQUAD (dose strength, route, indication was not reported) and VARIVAX instead of a dose of MMR and VARIVAX. No adverse effects reported. The outcome of the event reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen at site of injection. Area became red, itchy bump. Resolved on its own.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever, seizure approx 7-8 hours after vaccine administered.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Muscle twitching, Syncope
Clinical narrative: This spontaneous report as received from the patients mother via company representative referring to a 15 year old female patient with not known drug reactions or allergies. On 17-MAR-2014 the patient was vaccinated with GARDASIL first dose, 0.5 ml, intramuscular (site, lot number and expiration date not provided) at the nurse's office. It was also reported that on 17-MAR-2014 the patient received VAQTA (dosage, formulation site, lot number, expiration date and indication not provided). On 17-MAR-2014 the patient fainted 5-10 minutes after administration of GARDASIL. The patient also experienced generalized muscle twitching for less than 1 minute. The patient subsequently recovered completely while in the nurse's office (on 17-MAR-2014) without requiring medical treatment. None laboratories were performed. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: High fever (104 degrees), swelling of left thigh (injection site).
Sex: U
Vaccine: HPV4, MMR, RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. The following vaccines were improperly stored and it was unknown if they were administered or not, to unspecified patients on unspecified dates. ROTATEQ lot # H011443 expiration date 15-NOV-2013, GARDASIL lot 1495AA with expiration date 22-AUG-2014 and MMR II lot number H020255 was expiration date 08-NOV-2014 and H012142 with expiration date 29-JUN-2014. Additional information has been requested. In the report received on 17-SEP-2013 the nurse reported that also VARIVAX has unspecified temperature excursions over the last year and it was administered to an unspecified number of unspecified patients on unspecified dates. As per correspondence from 31-MAR-2014 lot number H020255 for MMR II has been found to be as a batch number and it was valid with lot number 1500AA. The albumin status RHA (recombinant human albumin) for that lot. As regards MMR II with lot number H012142 the albumin status was HSA (human serum albumin) for that lot.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unknown amount of patients with unknown demography. The Nurse reported that on 07-APR-2014 (also reported as yesterday morning), unknown amount of patients were vaccinated with VAQTA (dose, route and frequency were not reported) which was exposed to 19C for 1.5 hours. No adverse effect reported. No further information was provided. This case is linked to the case 1404USA008612 and 1404USA008613 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unknown amount of patients with unknown demography. The Nurse reported that on 07-APR-2014 (also reported as yesterday morning), unknown amount of patients were vaccinated with LIQUID PEDVAXHIB (dose, route and frequency were not reported) which was exposed to 19C for 1.5 hours. No adverse effect reported. No further information was provided. This case is linked to the case 1404USA005550 and 1404USA008612 (same reporter link). Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: High fever (104 degrees), swelling of thigh (injection site).
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions reported. On 11-APR-2014, the patient was inadvertently vaccinated with RECOMBIVAX HB (dose, strength and lot number not provided). No co-suspect or concomitant therapies were reported. The reporter stated that RECOMBIVAX HB vaccine had been improperly stored. At the time of the report, the outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Occult blood negative
Clinical narrative: Severe diarrheal reaction 2 days after vaccines given. Had 12-15 diarrhea stools/day x 5 days. Almost needed ER for dehydration. Took a long time to recover. Seen in offcie 2/4/14 and 2/10/14 with diarrhea.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 47 or 48 year old male patient. The patient current conditions included HIV positive. The reporter stated that on an unknown date, the patient who was 47 or 48 years old was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). No adverse events were reported. No further information was provided. Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 months (recently 9 months) patient of unknown gender. On 06-SEP-2013 the patient was vaccinated with the first dose of ROTATEQ (lot# unspecified) (dose and strength unspecified). On 14-JAN-2015 the patient was vaccinated with the second dose of ROTATEQ (lot# unspecified) (dose and strength unspecified). On 08-APR-2014 the patient was vaccinated with the third dose of ROTATEQ (lot# unspecified) (dose and strength unspecified). No adverse symptoms reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Tinnitus
Clinical narrative: This spontaneous report as received from an office manager via a company representative refers to a 24 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot # not provided) (dose and route not reported). Concomitant therapy was not reported. On an unknown date after receiving GARDASIL the patient complained of tinnitus. The outcome of tinnitus was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 3 or 4 unspecified patients of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date about 3 or 4 patients received their second dose of GARDASIL, 0.5 ml, route intramuscular, within the past six months, off-schedule from their first dose of GARDASIL and no adverse effects reported. The outcome of event reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Headache, Nausea
Clinical narrative: This spontaneous report as received from the mother of a consumer refers to a 17 year old female patient. The patient's medical history included heart defect at birth and heart surgery at 1 years old. On 31-JUL-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular in the left arm. The second dose of GARDASIL was received on an unspecified date in October 2013. Five days later on an unspecified date in 2013 the patient experienced frequent headaches for a few weeks, which eventually dissipated. The patient received the third dose of GARDASIL on 17-FEB-2014. The patient did not use any concomitant medication and no known previous drug reactions/allergies. As of approximately 20-FEB-2014 the patient maintained a constant headache sometimes accompanied by nausea. The patient returned to the physician's office on an unknown date and was prescribed steroids (brand and manufacturer not specified). Unspecified blood work was performed on an unknown date. It was reported that the patient was still experiencing the headaches. The outcome of the nausea was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (medical assistant) refers to unknown number of patients. On unknown dates the patient might have received improperly stored RECOMBIVAX HB. The vaccine was exposed to temperature of 32F for 32 minutes on 02-DEC-2013, then 32F for 24 minutes on 03-DEC-2013, then on the same day 03-DEC-2013 at 31F for 8 minutes, then 33F for 19 minutes on 04-DEC-2013, then 33F for 34 minutes on 17-DEC-2013. No adverse effects reported. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Rash
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to a male patient of unknown age. On 12-DEC-2013, the patient was vaccinated with ZOSTAVAX lot # J006827 (dose, route and frequency were not reported). Concomitant therapies included PROVENTIL. On an unknown date, the patient experienced a rather large rash after receiving ZOSTAVAX. The reporter stated that the rash was below chest on left side and extended around to flank area. The physician was interested in collecting specimen from rash. The patient sought medical attention and saw the physician in office. On an unknown date, isolate collected from the patient. The patient was treated with ZOVIRAX tablets and ointment. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.