chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Ear infection, Pyrexia, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse concerning a 10 month old female patient with no pertinent medical history and no drug reactions or allergies who on 23-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot number 669829/0076AA, Expiry: 30-OCT-2012) 2ml oral. On 23-AUG-2011, the patient was vaccinated with the second dose of ROTATEQ (lot number 668818/1559Z was an invalid lot number for ROTATEQ, Expiry: 30-SEP-2012) 2ml oral. On 24-OCT-2011, the patient was vaccinated with the third dose of ROTATEQ (lot number not reported) 2ml oral. On 21-MAR-2012, the patient was seen in the doctor's office for an ear infection. She was treated with OMNICEF. On 22-MAR-2012 the patient experienced vomiting, diarrhea, dehydration with fever and stool positive for rotavirus. Subsequently, the patient recovered from vomiting and stool positive for rotavirus. On 22-MAR-2012, the patient was seen in the emergency room with vomiting, diarrhea, dehydration with fever. It was reported that OMNICEF was discontinued when vomiting started. The patient was treated with unnamed intravenous fluids and ZOFRAN. Stool was positive for rotavirus. She was released to her home. The patient returned to the emergency room on 23-MAR-2012. Hospital staff was unable to establish an intravenous line but repeated ZOFRAN. The vomiting stopped, not taking fluids but having diarrhea. The patient was sent home and was seen in the doctor's office on 25-MAR-2012 and on 26-MAR-2012 and doing better. It was reported that today, 27-MAR-2012, the patient had a normal stool. At the time of this report, the patient was recovering from ear infection, diarrhea and dehydration with fever. The events were considered to be an other important medical events by the reporter since they required intervention to prevent serious criteria. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Stool analysis normal, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 10 month old female patient with no pertinent medical history and no drug reactions or allergies who on 23-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot number 669829/0076AA, Expiry: 30-OCT-2012) 2ml oral. On 23-AUG-2011, the patient was vaccinated with the second dose of ROTATEQ (lot number 668818/1559Z was an invalid lot number for ROTATEQ, Expiry: 30-SEP-2012) 2ml oral. On 24-OCT-2011, the patient was vaccinated with the third dose of ROTATEQ (lot number not reported) 2ml oral. On 21-MAR-2012, the patient was seen in the doctor's office for an ear infection. She was treated with OMNICEF. On 22-MAR-2012 the patient experienced vomiting, diarrhea, dehydration with fever and stool positive for rotavirus. Subsequently, the patient recovered from vomiting and stool positive for rotavirus. On 22-MAR-2012, the patient was seen in the emergency room with vomiting, diarrhea, dehydration with fever. It was reported that OMNICEF was discontinued when vomiting started. The patient was treated with unnamed intravenous fluids and ZOFRAN. Stool was positive for rotavirus. She was released to her home. The patient returned to the emergency room on 23-MAR-2012. Hospital staff was unable to establish an intravenous line but repeated ZOFRAN. The vomiting stopped, not taking fluids but having diarrhea. The patient was sent home and was seen in the doctor's office on 25-MAR-2012 and on 26-MAR-2012 and doing better. It was reported that today, 27-MAR-2012, the patient had a normal stool. At the time of this report, the patient was recovering from ear infection, diarrhea and dehydration with fever. The events were considered to be an other important medical events by the reporter since they required intervention to prevent serious criteria. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Angioedema, Cough, Eyelid oedema, Immediate post-injection reaction, Rash pruritic
Clinical narrative: Hives urticaria angioedema - persistent cough immediately after - 5 minutes of varicella vaccine # 2 Pt started having pruritic rash - hives - urticaria on face & neck - swelling of eyelids, tachycardia - Pt was coughing - immediately - after giving - varicella - Pt was given Albuterol neb treatment, Oral steroids - sent to ER was given BENADRYL.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Tachycardia, Urticaria
Clinical narrative: Hives urticaria angioedema - persistent cough immediately after - 5 minutes of varicella vaccine # 2 Pt started having pruritic rash - hives - urticaria on face & neck - swelling of eyelids, tachycardia - Pt was coughing - immediately - after giving - varicella - Pt was given Albuterol neb treatment, Oral steroids - sent to ER was given BENADRYL.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: About 10 hr after receiving vaccine, developed alternating sensation of fever & chills, some leg aching, & all "hair follicles hurt". No rash. 24-28 hr after vaccine feeling much better.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness, Upper respiratory tract infection
Clinical narrative: Pt complaining of upper respiratory infection since shot was admin. Also c/o (L) arm "heaviness" since shot was admin. Pt requested form be filled out.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL
Symptoms: Epistaxis, Nasal cavity packing
Clinical narrative: After leaving office pt. had nose bleed that would not stop. Taken to convenient care where they packed it. They told grandmother to let Health Dept. know about problem. Said they thought it might have been "coincidence." No further problem.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, Blood disorder, Bone disorder, Electromyogram, Laboratory test
Clinical narrative: Crashed 15 days to the hour of receiving shot - All systems crashed - Blood, organs, bones, brain skin - finally diagnosed SLE-CNS.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Multi-organ disorder, Nervous system disorder, Scan, Skin disorder
Clinical narrative: Crashed 15 days to the hour of receiving shot - All systems crashed - Blood, organs, bones, brain skin - finally diagnosed SLE-CNS.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Systemic lupus erythematosus
Clinical narrative: Crashed 15 days to the hour of receiving shot - All systems crashed - Blood, organs, bones, brain skin - finally diagnosed SLE-CNS.
Age: 0.17
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Blood test, Haematochezia, Occult blood
Clinical narrative: Blood in stool for about 1 week after ROTATEQ given. Now resolved.
Age: 58.0
Sex: M
Vaccine: MEN, YF
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: A small blister appeared approximately two inches from the injection site.  At the time of the injection, I felt a sharp pain (similar to a scratch) and mentioned this to the nurse at the time.  The blister itself has not changed except to get a bit smaller in size as of today, 04/05/2012.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Pain, Pyrexia, Swelling face
Clinical narrative: As per parent, pt. with fever, swelling to his face and complaining about pain.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No physical symptoms.  Pediatric HBV dose inadvertently given to adult patient wanting adult HBV.
Age: 39.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, entire right tricep, bicep area.  Warm to touch.
Age: 39.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Rash pruritic
Clinical narrative: Swelling, redness, entire right tricep, bicep area.  Warm to touch.
Sex: U
Vaccine: RV1
Symptoms: Dehydration, Diarrhoea, Pyrexia, Rotavirus infection, Rotavirus test positive
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of rotavirus in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 16 March 2012 the subject received 1st dose of ROTARIX at 1 ml, oral. On 19 March 2012, 3 days after vaccination with ROTARIX, the subject experienced fever, diarrhea, vomiting and dehydration. On that same day, 19 March 2012, the subject tested positive for rotavirus vaccine. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of rotavirus in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 16 March 2012 the subject received 1st dose of ROTARIX at 1 ml, oral. On 19 March 2012, 3 days after vaccination with ROTARIX, the subject experienced fever, diarrhea, vomiting and dehydration. On that same day, 19 March 2012, the subject tested positive for rotavirus vaccine. At the time of reporting the outcome of the events was unspecified.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Asthenia, Crying, Feeding disorder of infancy or early childhood, Hypotonia, Intensive care
Clinical narrative: This case was reported by a physician and described the occurrence of poor oral feeding in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ (non-gsk). There were no concurrent medications. On 30 March 2012 the subject received 2nd dose of PEDIARIX in the left thigh and unspecified dose of ROTATEQ. On 31 March 2012, 1 day after vaccination with PEDIARIX and ROTATEQ, the subject experienced poor oral feeding, severe hypotonia (weakness) and weak crying. The physician reported that these symptoms appeared to be severe and the child's decreased tone was to the point that intubation was being considered to protect the child's airway. Tests and work-up for possible metabolic and neurological causes were being performed (results pending). It was reported that the subject was hospitalized in the intensive care unit. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Laboratory test, Metabolic function test, Neurological examination
Clinical narrative: This case was reported by a physician and described the occurrence of poor oral feeding in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ (non-gsk). There were no concurrent medications. On 30 March 2012 the subject received 2nd dose of PEDIARIX in the left thigh and unspecified dose of ROTATEQ. On 31 March 2012, 1 day after vaccination with PEDIARIX and ROTATEQ, the subject experienced poor oral feeding, severe hypotonia (weakness) and weak crying. The physician reported that these symptoms appeared to be severe and the child's decreased tone was to the point that intubation was being considered to protect the child's airway. Tests and work-up for possible metabolic and neurological causes were being performed (results pending). It was reported that the subject was hospitalized in the intensive care unit. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection, swollen, red and warm to touch, minimally tender RIGHT UPPER ARM.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Maternal exposure during pregnancy, Premature delivery
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included sub total thyroidectomy. The subject past medical history included two normal births, one spontaneous abortion and one elective abortion. On an unspecified date the subject received unspecified dose of BOOSTRIX (intramuscular, unknown). Her last menstrual period was on 22 April 2011 and estimated date of delivery was 12 December 2011. The subject was exposed to BOOSTRIX during unknown trimester. On an unspecified date, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy. The pregnancy was by normal conception. At the time of the report, there was no evidence of a defect from prenatal testing. The outcome of the pregnancy was unknown. Follow-up information was received on 03 April 2012. It was reported that the subject was 28 years old. Conception was reported to be normal. BOOSTRIX was administered to the subject intramuscularly, at 0.5 ml on 29 September 2011 (29 weeks, plus 3 days gestation). The mother prematurely delivered a live neonate of unspecified gender in October 2011. No defects were noted at birth. No further details were provided.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 6 x 4.5 cm tender, red, warm induration on (L) upper arm.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Asthenia, Blood test abnormal, Febrile convulsion, Hypotonia, Laboratory test normal
Clinical narrative: Began to throw up, looked like he was having a febrile seizure. Very weak like a rag doll flopping around in your arms. Lethargic, unresponsive loss of color to face. Took to Urgent care right away, then to ER.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Lethargy, Pallor, Unresponsive to stimuli, Vomiting, White blood cell count increased
Clinical narrative: Began to throw up, looked like he was having a febrile seizure. Very weak like a rag doll flopping around in your arms. Lethargic, unresponsive loss of color to face. Took to Urgent care right away, then to ER.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Cough, Lip swelling, Oedema peripheral
Clinical narrative: Patient complained of dry cough, swelling of hands, lips, some chest tightness. Pt. given O2 at 2 L /min. VSS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Rt thigh swollen.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: AFTER HEP A AND HPV WERE GIVEN, CLIENT BEGAN TO SHAKE, EYES ROLLED TO THE BACK OF HIS HEAD, HIS BODY STIFFEND AND LEGS CONTRACTED. HE COULD NOT HEAR FOR A BRIEF TIME, HIS SKIN BECAME COOL AND CLAMMY AND THEN WARM. HE BECAME DIZZY AT THE ONSET AND TOLD US SOMETHING WAS WRONG. WE LOWERED HIM TO THE FLOOR, SUPPORTING HIS HEAD. APPLIED A COOL TOWEL TO HIS FOREHEAD, TOLD HIM TO BREATHE AND RELAX, STARTING TAKING VITALS. THE INCIDENT TOOK ONLY A FEW MOMENTS, BUT WE PLACED HIM ON OUR TABLE AT A 45 DEGREE ANGLE AS HE STILLED COMPLAINED OF DIZZINESS, NAUSEA AND FEELING 'WEIRD' WE OBSERVED HIM FOR ONE HOUR RECORDING BP AND PULSE LOWEST BP WAS 90/50 AND PULSE RAN IN THE UPPER 60'S.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Nausea, Skin warm, Tremor
Clinical narrative: AFTER HEP A AND HPV WERE GIVEN, CLIENT BEGAN TO SHAKE, EYES ROLLED TO THE BACK OF HIS HEAD, HIS BODY STIFFEND AND LEGS CONTRACTED. HE COULD NOT HEAR FOR A BRIEF TIME, HIS SKIN BECAME COOL AND CLAMMY AND THEN WARM. HE BECAME DIZZY AT THE ONSET AND TOLD US SOMETHING WAS WRONG. WE LOWERED HIM TO THE FLOOR, SUPPORTING HIS HEAD. APPLIED A COOL TOWEL TO HIS FOREHEAD, TOLD HIM TO BREATHE AND RELAX, STARTING TAKING VITALS. THE INCIDENT TOOK ONLY A FEW MOMENTS, BUT WE PLACED HIM ON OUR TABLE AT A 45 DEGREE ANGLE AS HE STILLED COMPLAINED OF DIZZINESS, NAUSEA AND FEELING 'WEIRD' WE OBSERVED HIM FOR ONE HOUR RECORDING BP AND PULSE LOWEST BP WAS 90/50 AND PULSE RAN IN THE UPPER 60'S.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cold sweat, Dizziness, Extremity contracture, Feeling abnormal, Gaze palsy
Clinical narrative: AFTER HEP A AND HPV WERE GIVEN, CLIENT BEGAN TO SHAKE, EYES ROLLED TO THE BACK OF HIS HEAD, HIS BODY STIFFEND AND LEGS CONTRACTED. HE COULD NOT HEAR FOR A BRIEF TIME, HIS SKIN BECAME COOL AND CLAMMY AND THEN WARM. HE BECAME DIZZY AT THE ONSET AND TOLD US SOMETHING WAS WRONG. WE LOWERED HIM TO THE FLOOR, SUPPORTING HIS HEAD. APPLIED A COOL TOWEL TO HIS FOREHEAD, TOLD HIM TO BREATHE AND RELAX, STARTING TAKING VITALS. THE INCIDENT TOOK ONLY A FEW MOMENTS, BUT WE PLACED HIM ON OUR TABLE AT A 45 DEGREE ANGLE AS HE STILLED COMPLAINED OF DIZZINESS, NAUSEA AND FEELING 'WEIRD' WE OBSERVED HIM FOR ONE HOUR RECORDING BP AND PULSE LOWEST BP WAS 90/50 AND PULSE RAN IN THE UPPER 60'S.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Hypoacusis, Hypotension, Musculoskeletal stiffness, Nausea, Skin warm
Clinical narrative: AFTER HEP A AND HPV WERE GIVEN, CLIENT BEGAN TO SHAKE, EYES ROLLED TO THE BACK OF HIS HEAD, HIS BODY STIFFEND AND LEGS CONTRACTED. HE COULD NOT HEAR FOR A BRIEF TIME, HIS SKIN BECAME COOL AND CLAMMY AND THEN WARM. HE BECAME DIZZY AT THE ONSET AND TOLD US SOMETHING WAS WRONG. WE LOWERED HIM TO THE FLOOR, SUPPORTING HIS HEAD. APPLIED A COOL TOWEL TO HIS FOREHEAD, TOLD HIM TO BREATHE AND RELAX, STARTING TAKING VITALS. THE INCIDENT TOOK ONLY A FEW MOMENTS, BUT WE PLACED HIM ON OUR TABLE AT A 45 DEGREE ANGLE AS HE STILLED COMPLAINED OF DIZZINESS, NAUSEA AND FEELING 'WEIRD' WE OBSERVED HIM FOR ONE HOUR RECORDING BP AND PULSE LOWEST BP WAS 90/50 AND PULSE RAN IN THE UPPER 60'S.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Tremor
Clinical narrative: AFTER HEP A AND HPV WERE GIVEN, CLIENT BEGAN TO SHAKE, EYES ROLLED TO THE BACK OF HIS HEAD, HIS BODY STIFFEND AND LEGS CONTRACTED. HE COULD NOT HEAR FOR A BRIEF TIME, HIS SKIN BECAME COOL AND CLAMMY AND THEN WARM. HE BECAME DIZZY AT THE ONSET AND TOLD US SOMETHING WAS WRONG. WE LOWERED HIM TO THE FLOOR, SUPPORTING HIS HEAD. APPLIED A COOL TOWEL TO HIS FOREHEAD, TOLD HIM TO BREATHE AND RELAX, STARTING TAKING VITALS. THE INCIDENT TOOK ONLY A FEW MOMENTS, BUT WE PLACED HIM ON OUR TABLE AT A 45 DEGREE ANGLE AS HE STILLED COMPLAINED OF DIZZINESS, NAUSEA AND FEELING 'WEIRD' WE OBSERVED HIM FOR ONE HOUR RECORDING BP AND PULSE LOWEST BP WAS 90/50 AND PULSE RAN IN THE UPPER 60'S.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Mother reports had small, red, warm area at back of right arm that client reported as "itchy", has progressed to 10cm in diameter and remains red in color and warm to touch.  Client reports remains "itchy" as well but this has been alleviated with use of Benadryl given to client by parent. Medical director in house when client returned for report, prescription for Cephalexin 500mg (#21) 1 tab po three times daily for 7 days provided also to prevent possible infection.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling at both injection sites on anterolateral aspect of thighs.
Age: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Drug hypersensitivity, Dyspnoea, Erythema, Hypoaesthesia, Mobility decreased
Clinical narrative: Client c/o's of pain and numbness in left shoulder radiating down arm; pain continued throughout the week, client reported some redness and swelling but not severe; took 1200 mg ibuprofen on 3/22/12 and then had problems breathing/mouth swelling.  Seen by MD for allergic rx to ibuprofen and for shoulder/arm pain.  Pain continued on Friday at which time see contacted an orthopedic MD who gave her a cortisone injection.  Denies any relief from pain.  Prescribed Lortabs which have not decreased pain effectively. Came to health dept on 4/5/12 to report continued pain, numbness and limited movement.  Recommended to contact MD again for further evaluation.
Age: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Musculoskeletal pain, Oedema mouth, Pain in extremity, Swelling
Clinical narrative: Client c/o's of pain and numbness in left shoulder radiating down arm; pain continued throughout the week, client reported some redness and swelling but not severe; took 1200 mg ibuprofen on 3/22/12 and then had problems breathing/mouth swelling.  Seen by MD for allergic rx to ibuprofen and for shoulder/arm pain.  Pain continued on Friday at which time see contacted an orthopedic MD who gave her a cortisone injection.  Denies any relief from pain.  Prescribed Lortabs which have not decreased pain effectively. Came to health dept on 4/5/12 to report continued pain, numbness and limited movement.  Recommended to contact MD again for further evaluation.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dyspnoea
Clinical narrative: Mom called patient having respiratory difficulty. Went to ED by ambulance, questionable seizure activities, admitted to hospital for work up.
Age: 1.13
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever with seizure several hours after receiving vaccine. Family did not seek medical attention at an ER, they did call helpline told to give BENADRYL.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Nasopharyngitis, Rash generalised, Varicella post vaccine
Clinical narrative: Cold, rash on body - 'pox'.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Convulsion, Dizziness, Drooling, Urinary incontinence
Clinical narrative: Dizziness, seizure, spill saliva & urine --> gave EPIPEN 0.3 mg injection.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Chills, Dizziness, Headache, Influenza A virus test negative, Influenza B virus test
Clinical narrative: 4/4/12 4:00 PM BP 90/68 99.4 Pulse 132 c/o HA, dizziness, nauseated, body aches, vomiting, chills, myalgias. Given ZOFRAN 8mg SL 4:20. Given TYLENOL 650mg PO 4:45. IV fluids NS 1 Liter. 5:00 PM feeling better no N/V, HA improved, IV Dc'd. 4/4/12 BP 98/68 99.8 Pulse 100 5:30PM
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Laboratory test normal, Myalgia, Nausea, Pain, Vomiting
Clinical narrative: 4/4/12 4:00 PM BP 90/68 99.4 Pulse 132 c/o HA, dizziness, nauseated, body aches, vomiting, chills, myalgias. Given ZOFRAN 8mg SL 4:20. Given TYLENOL 650mg PO 4:45. IV fluids NS 1 Liter. 5:00 PM feeling better no N/V, HA improved, IV Dc'd. 4/4/12 BP 98/68 99.8 Pulse 100 5:30PM
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: High fevers up to 106.7 rectal.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall
Clinical narrative: Pt Rc'd Tdap (BOOSTRIX), HPV in (R) arm when he became dizzy and fell face first to the floor. He was checked by our PA and left in stable condition.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Face injury, Fall
Clinical narrative: Pt Rc'd Tdap (BOOSTRIX), HPV in (R) arm when he became dizzy and fell face first to the floor. He was checked by our PA and left in stable condition.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Crying, Irritability
Clinical narrative: Fussiness, smiling less per mom (although smiling on exam) crying intermittently.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swollen area on upper arm around injection area (about 4 inches in diameter) pt said it is very painful.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling (L) thigh - 3 cms. Redness & swelling (R) thigh - 1 cm.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Ataxia, Bladder catheterisation, Central nervous system inflammation, Convulsion, Influenza A virus test
Clinical narrative: Case number PHHY2010US093018 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 406223) website on 31 Dec 2010 and a follow up received from the quality assurance department on 05 Mar 2012 with a follow up information received on 26 Mar 2012. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 111797P1) through unspecified route and site on 15 Oct 2010. On the same day, he developed urinary retention which led to catheterization. He also had seizure, altered mental status and ataxia. He was hospitalized for 7 days. On 16 Oct 2010, elevated influenza A and B IgM and IgG was found. Spine and brain MRI on 17 Oct 2010 revealed extensive cord gray matter inflammation and leptomeningeal enhancement. The final outcome was reported as condition unchanged on 22 Oct 2010. A quality assurance investigation had been requested with reference number 149016. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 111797P1 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department (reference number: 149016) on 05 Mar 2012: Updated only the quality reference number. Follow up received from the quality assurance department (reference number: 149016) on 26 Mar 2012. Batch review report updated.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza B virus test, Laboratory test abnormal, Mental status changes, Metastases to meninges, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Case number PHHY2010US093018 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 406223) website on 31 Dec 2010 and a follow up received from the quality assurance department on 05 Mar 2012 with a follow up information received on 26 Mar 2012. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 111797P1) through unspecified route and site on 15 Oct 2010. On the same day, he developed urinary retention which led to catheterization. He also had seizure, altered mental status and ataxia. He was hospitalized for 7 days. On 16 Oct 2010, elevated influenza A and B IgM and IgG was found. Spine and brain MRI on 17 Oct 2010 revealed extensive cord gray matter inflammation and leptomeningeal enhancement. The final outcome was reported as condition unchanged on 22 Oct 2010. A quality assurance investigation had been requested with reference number 149016. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 111797P1 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department (reference number: 149016) on 05 Mar 2012: Updated only the quality reference number. Follow up received from the quality assurance department (reference number: 149016) on 26 Mar 2012. Batch review report updated.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal cord abnormal, Urinary retention
Clinical narrative: Case number PHHY2010US093018 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 406223) website on 31 Dec 2010 and a follow up received from the quality assurance department on 05 Mar 2012 with a follow up information received on 26 Mar 2012. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 111797P1) through unspecified route and site on 15 Oct 2010. On the same day, he developed urinary retention which led to catheterization. He also had seizure, altered mental status and ataxia. He was hospitalized for 7 days. On 16 Oct 2010, elevated influenza A and B IgM and IgG was found. Spine and brain MRI on 17 Oct 2010 revealed extensive cord gray matter inflammation and leptomeningeal enhancement. The final outcome was reported as condition unchanged on 22 Oct 2010. A quality assurance investigation had been requested with reference number 149016. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 111797P1 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department (reference number: 149016) on 05 Mar 2012: Updated only the quality reference number. Follow up received from the quality assurance department (reference number: 149016) on 26 Mar 2012. Batch review report updated.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site irritation, Pain in extremity
Clinical narrative: Case number PHHY2010US093265 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 408205) website on 31 Dec 2010 and a follow up received from the quality assurance department on 05 Mar 2012, with a follow up batch review report received from quality assurance department on 26 Mar 2012. This report refers to a 49-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 111822P1) intramuscularly on to right arm and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 0933Z) intramuscularly on to left arm on 18 Oct 2010. On 19 Oct 2010 he reported sore arm. He also reported that injection site irritation got worse and went to emergency room on 21 Oct 2010. Antibiotics and pain medication were prescribed and he was diagnosed with possible cellulitis. The final outcome was reported as complete recovery as of 01 Nov 2010. A quality assurance investigation had been requested with reference number 148857. The quality assurance department reported that based on the document review, it was stated that the FLUVIRIN (batch number: 1116933P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 05 Mar 2012: Updated only the quality reference number. Follow up batch review report received from quality assurance department on 26 Mar 2012: Updated batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: Case number PHHY2010US093402 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 409337) on 31 Dec 2010 with the follow-up received from the Quality assurance department (sentry reference number: 148848) on 02 Mar 2012, with a follow up batch review report received from quality assurance department on 26 Mar 2012. This case refers to a female patient. She was vaccinated with FLUVIRIN (batch number: unknown) on an unspecified date. It was reported that the FLUVIRIN vaccination at pharmacy failed to immunize and the patient had illness with flu from 26 Oct 2010. At the time of this report (on 05 Nov 2010), the patient was still having flu. It was reported that the previous annual injection of dead viruses have not resulted in illness. It was suspected that the virus type or the amount of vaccine was in error. The outcome was reported as condition unchanged. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN. From this conclusion there was no reason or explanation to account for the reported adverse event. Non significant follow-up received from the Quality assurance department on 02 Mar 2012: Updated sentry reference number. Follow up batch review report received from quality assurance department on 26 Mar 2012: Updated batch review report.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2011US113921, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS ref: 435616) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140854) on 10 Jan 2012 and a follow up report received on 26 Mar 2012. This report refers to a 90-year-old female patient. Her medical history included penicillin allergy. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1100501), into left arm, intramuscularly on 23 Sep 2011. On 24 Sep 2011, she awoke with vaccinated arm cellulitis. On the same day she was treated in emergency room and still recovering. The causality of the events was not reported. A quality investigation had been registered with reference number 140854. Based on the documents review, it was stated that the concerning FLUVIRIN batch number 1100501 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Updated Quality complaint number. Follow up received from the quality assurance department (reference number: 140854) on 26 Mar 2012. Batch review report updated.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Case number PHHY2011US113914 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 438188) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140862) on 10 Jan 2012, with a follow up batch review report received from quality assurance department on 26 Mar 2012. This report refers to a 68 year old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1102501) intramuscularly in the left arm and PNEUMOVAX 23 (batch number: 09332, manufactured by Merck & CO) intramuscularly in the left arm on 26 Sep 2011. The patient developed redness, tenderness and warmth to the 1/3 upper arm area on 27 Sep 2011, which was spreading down arm. She went to urgent care facility, who diagnosed cellulitis and prescribed two antibiotics. The patient returned on 28 Sep 2011, for urgent care because of redness which was moving down the arm towards the hands. The patient first developed symptoms approximately 24 hours after injections. The outcome of events was reported as complete recovery. The quality assurance department reported that based on the document review, it was stated that the FLUVIRIN (batch number: 1102501) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Quality complaint number was updated. Follow up batch review report received from quality assurance department on 26 Mar 2012: Updated batch review report.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Case number PHHY2011US113945 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 438513) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140856) on 10 Jan 2012 and a follow up information received on 26 Mar 2012. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1102501) through unspecified route on to left arm and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 0614AA) through unspecified route on to right arm on 11 Oct 2011. On 12 Oct 2011, she experienced inflammation, redness, soreness from bicep to wrist, possible cellulitis and mild fever of 100 degrees. She was advised to ice, BENADRYL and ibuprofen. Patient did ice, but did not use ibuprofen or BENADRYL. She visited doctor. The final outcome was reported as condition unchanged on the day of reporting, 14 Oct 2011. The PTC department opened a complaint for this case with the reference number 140856. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1102501 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Updated Quality complaint number. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Updated Quality complaint number. Follow up received from the quality assurance department (reference number: 140856) on 26 Mar 2012. Batch review report updated.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2011US113945 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 438513) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140856) on 10 Jan 2012 and a follow up information received on 26 Mar 2012. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1102501) through unspecified route on to left arm and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 0614AA) through unspecified route on to right arm on 11 Oct 2011. On 12 Oct 2011, she experienced inflammation, redness, soreness from bicep to wrist, possible cellulitis and mild fever of 100 degrees. She was advised to ice, BENADRYL and ibuprofen. Patient did ice, but did not use ibuprofen or BENADRYL. She visited doctor. The final outcome was reported as condition unchanged on the day of reporting, 14 Oct 2011. The PTC department opened a complaint for this case with the reference number 140856. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1102501 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Updated Quality complaint number. Non-significant follow-up received from Quality assurance department on 10 Jan 2012: Updated Quality complaint number. Follow up received from the quality assurance department (reference number: 140856) on 26 Mar 2012. Batch review report updated.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chromaturia, Death, Dyspnoea, Haemolytic anaemia, Myocardial infarction
Clinical narrative: Case number PHHY2011US113812 is a spontaneous report initially received from Vaccine Adverse Event Reporting System (VAERS ref: 441707) website on 30 Dec 2011 with a follow up received on 26 Mar 2012. This report refers to a 62 year old female patient. She was in normal health and was not using any concomitant medications. She was vaccinated with FLUVIRIN (batch number: 102136P1A) intramuscularly in the left arm on 22 Dec 2009. She noticed red color in urine on 18 Jan 2010, and she was out of breath on 23 Jan 2010. She was diagnosed with hemolytic anemia on 24 Jan 2010. Her condition worsened on 25 Jan 2010 and she was hospitalized to remove the spleen. Her kidneys failed on 26 Jan 2010. She experienced heart attack twice on 01 Feb 2010 and died during the second heart attack. The quality assurance department opened a complaint for this case with reference number 140109. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 102136P1A was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the quality assurance department (reference number: 140109) on 26 mar 2012. QA reference no and batch review report updated.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Renal failure, Splenectomy
Clinical narrative: Case number PHHY2011US113812 is a spontaneous report initially received from Vaccine Adverse Event Reporting System (VAERS ref: 441707) website on 30 Dec 2011 with a follow up received on 26 Mar 2012. This report refers to a 62 year old female patient. She was in normal health and was not using any concomitant medications. She was vaccinated with FLUVIRIN (batch number: 102136P1A) intramuscularly in the left arm on 22 Dec 2009. She noticed red color in urine on 18 Jan 2010, and she was out of breath on 23 Jan 2010. She was diagnosed with hemolytic anemia on 24 Jan 2010. Her condition worsened on 25 Jan 2010 and she was hospitalized to remove the spleen. Her kidneys failed on 26 Jan 2010. She experienced heart attack twice on 01 Feb 2010 and died during the second heart attack. The quality assurance department opened a complaint for this case with reference number 140109. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 102136P1A was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the quality assurance department (reference number: 140109) on 26 mar 2012. QA reference no and batch review report updated.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Arrested labour, Caesarean section, Laboratory test normal, Maternal exposure during pregnancy, Neonatal disorder
Clinical narrative: 17 yo female, who initially denied sexual activity was given HPV, 2nd dose, at approx 26 wks gestational age. Patient then presented later on 10/26/11 after positive home pregnancy test. Pt did not present for prenatal care until 33 6/7 weeks. Pt delivered NB female on 12/31/11 with phocomelia -absent right hand.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: 17 yo female, who initially denied sexual activity was given HPV, 2nd dose, at approx 26 wks gestational age. Patient then presented later on 10/26/11 after positive home pregnancy test. Pt did not present for prenatal care until 33 6/7 weeks. Pt delivered NB female on 12/31/11 with phocomelia -absent right hand.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Foetal disorder, Maternal exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: 17 yo female, who initially denied sexual activity was given HPV, 2nd dose, at approx 26 wks gestational age. Patient then presented later on 10/26/11 after positive home pregnancy test. Pt did not present for prenatal care until 33 6/7 weeks. Pt delivered NB female on 12/31/11 with phocomelia -absent right hand.
Age: 17.0
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Foetal exposure during pregnancy, Limb reduction defect
Clinical narrative: 17 yo female, who initially denied sexual activity was given HPV, 2nd dose, at approx 26 wks gestational age. Patient then presented later on 10/26/11 after positive home pregnancy test. Pt did not present for prenatal care until 33 6/7 weeks. Pt delivered NB female on 12/31/11 with phocomelia -absent right hand.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Red blood cells CSF positive, Venogram normal
Clinical narrative: Information has been received from a physician concerning a 13 years old female patient, one of 28 week preemie twins with asthma and a history of bilateral sinus surgery in December 2011 and no drug reactions/allergies who on 02-NOV-2011, was vaccinated with the first dose of GARDASIL (lot 668261/1397AA) 0.5 ml IM. On 16-JAN-2012, the patient received the second dose of GARDASIL (lot # not reported). Secondary suspect vaccinations included the second dose of VARIVAX (Merck) (lot #, dose and route not reported) given on 16-Jan-2012. Concomitant medications included FLOVENT, ZYRTEC and montelukast sodium (MSD). Physician reported that the patient experienced a 5 inch in diameter injection site reaction in the same arm where the patient had received GARDASIL on 16-JAN-2012. The injection site reaction began the evening of 16-JAN-2012. Physician described the injection site reaction as: red, hot and tender. The patient was treated with clindamycin (manufacturer and dose unspecified) and BENADRYL (dose unspecified), but the injection site reaction did not resolve until 2 weeks after 16-JAN-2012. It was reported that beginning on 16-JAN-2012 in the evening, the patient had experienced persistent headaches which woke her at night. The patient had not had a "headache-free" day since the patient had received GARDASIL on 16-JAN-2012. The patient had not attended school since 16-JAN-2012 (also reported as 18-JAN-2012) and was admitted to the hospital from 05-FEB-2012 to 09-FEB-2012 for a DHE 45 (manufacturer and dose unspecified) trial to treat the patient's headaches. The DHE 45 trial did not effectively treat the patient's headaches. The patient was admitted to the pediatric intensive care unit (ICU) on 27-MAR-2012, so that a "spinal tap" could be completed. The patient was diagnosed with "pseudo tumor" due to elevated intracranial pressure, which was "30". 10 ml of spinal fluid was removed, and the patient's intracranial pressure came down to "17". Spinal tap and serology were negative. The patient was receiving acetazolamide (MSD) and had experienced some relief headache. Physician reported that the patient had been treated by neurologist. Physician also reported that she suspected that the patient might have lyme disease. Magnetic resonance imaging (MRI) and blood work were performed (result not provided). Physician also mentioned that the patient has a twin who received the second dose of GARDASIL on 16-JAN-2012 (WAES # 1203USA04648). At the time of the report, the patient's outcome for headaches, "pseudo tumor" and lyme disease was unknown. Follow up information has been received from the physician who reported that patient had been sent home from the hospital and the lyme test was negative. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. The patient was admitted to hospital.