chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain lower, Back pain, Blood pressure increased, Groin pain, Headache
Clinical narrative: Case number PHEH2013US004809 is an initial spontaneous report received from a consumer on 25 Feb 2013. This case refers to a 42-year-old male patient. He was little overweight but otherwise he was healthy. He was vaccinated with the first dose of post exposure RABAVERT (batch number: 504011C, expiration date: Jan 2016) intramuscularly on 11 Feb 2013, and experienced events (see linked case: PHHY2013US020907). He received the second dose of IMOVAX (other manufacturer, batch number: EO801-H1180, expiration date: 28 Mar 2014) intramuscularly on 13 Feb 2013. After the second dose, he experienced pain below the kidney that radiated into groin, which persisted but was not really bad. This pain went into both sides after he received the third dose with RABAVERT (batch number: not reported) intramuscularly on 18 Feb 2013. On day seven, his blood pressure was elevated to 187/115. It was also reported that he had pressure in his head. The next day he had fever of 101 F and pain in lower back. As of 25 Feb 2013, he still had increased blood pressure, flu-like symptoms, fever and body aches. The patient has no history of high blood pressure. The increase in blood pressure ranged from 150-160s/90-125. He was vaccinated with the fourth dose of rabies vaccine with an unspecified rabies vaccine (manufacturer and batch number: not reported) on 25 Feb 2013. The final outcome of these events was not reported. The seriousness and causality were not reported. No other information was available.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Case number PHEH2013US004809 is an initial spontaneous report received from a consumer on 25 Feb 2013. This case refers to a 42-year-old male patient. He was little overweight but otherwise he was healthy. He was vaccinated with the first dose of post exposure RABAVERT (batch number: 504011C, expiration date: Jan 2016) intramuscularly on 11 Feb 2013, and experienced events (see linked case: PHHY2013US020907). He received the second dose of IMOVAX (other manufacturer, batch number: EO801-H1180, expiration date: 28 Mar 2014) intramuscularly on 13 Feb 2013. After the second dose, he experienced pain below the kidney that radiated into groin, which persisted but was not really bad. This pain went into both sides after he received the third dose with RABAVERT (batch number: not reported) intramuscularly on 18 Feb 2013. On day seven, his blood pressure was elevated to 187/115. It was also reported that he had pressure in his head. The next day he had fever of 101 F and pain in lower back. As of 25 Feb 2013, he still had increased blood pressure, flu-like symptoms, fever and body aches. The patient has no history of high blood pressure. The increase in blood pressure ranged from 150-160s/90-125. He was vaccinated with the fourth dose of rabies vaccine with an unspecified rabies vaccine (manufacturer and batch number: not reported) on 25 Feb 2013. The final outcome of these events was not reported. The seriousness and causality were not reported. No other information was available.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Vaccination complication
Clinical narrative: Redness over 1/2 arm, could not lift arm. Went to UC & was prescribed prednisone x 5 days. Dx: Vaccine reaction -(L) arm - resolved.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site pain, Injection site reaction, Melanocytic naevus
Clinical narrative: Have a grown mole like area where shot was administered and from time to time it throbs.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Hair growth abnormal, Injection site pain, Injection site reaction
Clinical narrative: Have a grown mole like area where shot was administered and from time to time it throbs.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Headache, Nausea, Tearfulness
Clinical narrative: Pt called 2/13/13 & said she developed HA shortly after receiving vaccine, now feeling nauseated, tired & tearful. Instructed to call her personal dr to inform & get further instructions.
Age: 63.0
Sex: F
Vaccine: YF
Symptoms: Headache, Hypoaesthesia oral, Sensation of heaviness, Somnolence, Stomatitis
Clinical narrative: C/O lips feeling numb, thick feeling roof of mouth - no swelling no SOB, vs stable 1108A BENADRYL 50 mg IM 1121 c/o HA & heaviness in arms & legs vs remained stable 1130 vs stable sleepy-released with husband ambulatory.
Age: 0.36
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt given KINRIX at 4 months of age. Parents did not report any signs and symptoms. MD called & requested return call - received none.
Age: 0.18
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt given KINRIX (DTAP/IPV) at 2 mo of age. Pt's mother reports no adverse effects.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt given KINRIX (DTAP/IPV) at 2 mo of age. Pt's mother reports no adverse events.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Ultrasound scan vagina
Clinical narrative: Information was received from an investigator on 21FEB2013. Adverse events: Drug exposure during pregnancy and spontaneous abortion. In DEC2012, a 26 year old female (gravida 1, para 0) received dose 1 and 2 of BIOTHRAX (lot FAV309). Based on the first day of her last menstrual period (FDLMP), the estimated gestational age (EGA) at dose 2 of BIOTHRAX was determined to be 1 day. In JAN2013, she received immunization with smallpox vaccination (EGA 2+6). Subsequently, in JAN2013 she found out that she was pregnant. She sought counsel with a physician because she was concerned about having received both anthrax and smallpox vaccines inadvertently during pregnancy. In FEB2013, she reported that she had spontaneously aborted at (approximate gestational age 6+6 weeks). At the time of report, her beta human chorionic gonadotropin levels continued to decrease (from 2227 to 685.3). Comment: Spontaneous abortion reported in a 26-year-old female following an inadvertent exposure to BIOTHRAX and Smallpox vaccination during early gestation period. Pregnancy was confirmed using transvaginal ultrasound. HCG data is in line with an early spontaneous abortion. The available data is inadequate for evaluating a causal relationship with either vaccine.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin decreased, Ultrasound scan vagina
Clinical narrative: Information was received from an Investigator on 21FEB2013. Adverse events: Drug exposure during pregnancy and spontaneous abortion. In Dec2012, a 26 year old female (gravida 1, para 0) received dose 1 and 2 of BIOTHRAX (lot FAV309). Based on the first day of her last menstrual period (FDLMP), the estimated gestational age (EGA) at dose 2 of BIOTHRAX was determined to be 1 day. In JAN2013, she received immunization with smallpox vaccine (EGA 2+6). Subsequently, in JAN2013 she found out that she was pregnant. She sought counsel with a physician because she was concerned about having received both anthrax and smallpox vaccines inadvertently during pregnancy. In FEB2013, she reported that she had spontaneously aborted at (approximate gestational age 6+6 weeks). At the time of report, her beta human chorionic gonadotropin levels continued to decrease (from 2227 to 685.3).
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Choroiditis
Clinical narrative: This literature case was forwarded by Novartis with the reference number: PHHY2013US017448. An initial report was received on 18.FEB.2013 and concerns a previously healthy 33-year-old male patient, who on an unspecified date received typhoid vaccine (manufacturer and batch number: not reported). On the same day, the patient also received inactivated hepatitis A and yellow fever vaccination (manufacturer and batch number: not reported).
Age: 0.53
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt given KINRIX (DTAP/IPV) at 6 mo of age. Pt's mother reports no adverse events.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Eyelid oedema, Swelling face, Urticaria
Clinical narrative: Face swelling, eyes swollen shut, urticaria on face/neck/arms.
Age: 1.05
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site nodule, Pain, X-ray
Clinical narrative: Nodule on (L) thigh, increased erythema 2-22-13, pain today 2 x 2 cm.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Lacrimation increased, Rash, Rash generalised, Rash macular
Clinical narrative: Pt at PCP for WCC 5yr. Pt was given MMR in right upper thigh & VARIVAX in left upper thigh. Shortly after pt developed sneezing and blotchy red spots on face and vomiting with watery eyes. Rash then spread across whole body. Pt did have episode of unresponsiveness that lasted 5-10 seconds. Vitals once checked were stable, oxygen 98% nml temp and BP. Pt transported to hosp for tx of allergic reaction.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Sneezing, Unresponsive to stimuli
Clinical narrative: Pt at PCP for WCC 5yr. Pt was given MMR in right upper thigh & VARIVAX in left upper thigh. Shortly after pt developed sneezing and blotchy red spots on face and vomiting with watery eyes. Rash then spread across whole body. Pt did have episode of unresponsiveness that lasted 5-10 seconds. Vitals once checked were stable, oxygen 98% nml temp and BP. Pt transported to hosp for tx of allergic reaction.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Severe pain in left arm starting about 1 1/2 hours after injection. Had to go to ER check on pain meds, pain was so severe. Unable to use (L) arm check on one week & had continuing pain for that time.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cough, Headache, Pyrexia
Clinical narrative: Joint ache, chills, running nose, coughing, slight feverish, headache.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Joint ache, chills, running nose, coughing, slight feverish, headache.
Age: 27.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Oedema peripheral, Paraesthesia
Clinical narrative: Left hand and finger edema with paresthesias dorsal hand & digits.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Chills, Eosinophil percentage decreased, Injection site erythema, Injection site pain
Clinical narrative: Fever, right upper arm pain & swelling & chills (10 cm x 13.2 redness & swelling). Dx Cellulitis, on cephalexin 500 mg QID x 10 days.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site swelling, Lymphocyte percentage decreased, Neutrophil percentage increased, Pyrexia, White blood cell count increased
Clinical narrative: Fever, right upper arm pain & swelling & chills (10 cm x 13.2 redness & swelling). Dx Cellulitis, on cephalexin 500 mg QID x 10 days.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Fever, right upper arm pain & swelling & chills (10 cm x 13.2 redness & swelling). Dx Cellulitis, on cephalexin 500 mg QID x 10 days.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Full blood count abnormal, Injection site induration, Injection site swelling, White blood cell count increased
Clinical narrative: Fever, right upper arm pain & swelling & chills (10 cm x 13.2 redness & swelling). Dx Cellulitis, on cephalexin 500 mg QID x 10 days.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Rash generalised, Tenderness
Clinical narrative: Pt received PNEUMOVAX23 - that evening he described severe tenderness of arm & progressed to involve aching pain of entire, not red or swelling. No respiratory symptoms next am generalized rash.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site urticaria
Clinical narrative: Pt developed a welt at site of injection within 24 hrs. Welt progressed so pt sought care from physician who diagnosed cellulitis & prescribed a course of antibiotics for patient.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The pharmacist reported that the patient called the pharmacy and stated she received ZOSTAVAX on 21-FEB-2013 and developed the shingles on 23-FEB-2013. Pharmacist was offered the VZVID packed and declined, stating he had never seen the patient and he had no idea if the patient would call again. He did not know anything about the patient. The outcome of shingles was unknown. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Injection site erythema, Injection site injury
Clinical narrative: Redness in the area where the vaccine was administered, upset stomach is upset. Appears to be injection mechanical type injury to left upper arm.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Lyme disease, Nervousness
Clinical narrative: This spontaneous report as received from a company representative refers to a 12 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, intramuscular. Dose and frequency were not provided. On an unknown date the patient experienced stomach pain, nervousness and symptoms similar to lyme disease. The outcome of symptoms similar to lyme disease, nervousness and stomach pain was unknown. The action taken regarding GARDASIL was reported as discontinued and not reintroduced. The reporter relatedness was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Local swelling, Pain
Clinical narrative: Localized redness/swelling/pain with/w localized allergic reaction (approx. 1 week of sxs). Rx: ZYRTEC 10 mg bid.
Age: 38.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Increased upper airway secretion
Clinical narrative: States that he was not sick prior to 1/8/13. Following day he started with thick mucus "lodging in his throat", clear in color, lasts throughout day. Has had persistently since 1/9/13. No other s/s. Reported at pt's request.
Age: 47.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP, TYP
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Red rash on torso - itching. Lasted 3-4 days - required no treatment.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Injection site reaction
Clinical narrative: 24 hrs after admin had 6x6cm red indurated area. Local rxn (R) arm site of MENVEO admin.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Laboratory test normal, Vomiting
Clinical narrative: Severe vomiting & diarrhea thru whole night following shot on 10/1/12.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Mom noticed redness to the area 2/23/13, improved 2/24/13 & appears worse today (2/25/13). No fever no firming, good level of activity. 2; 4 cm diameter areas of erythema on lateral aspect of (L) thigh & anterior thigh.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient who is less than a day. Pertinent medical history and past drug history was unknown. On 02-MAR-2013, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) which may be HEPATITIS B VACCINE (RECOMBINANT)(lot number was reported as 0737AE, expiry date was 18-APR-2014 and dose was not reported) that has been out of refrigerator for 2-4 hours. The outcome was unknown and it was unknown if the patient would continued to received hepatitis b vaccine (recombinant)(manufacturer unknown). Additonal information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a lawyer regarding a case in litigation. A male was vaccinated in a pharmacy on 10NOV12 with ZOSTAVAX and sustained an allergic reaction after receiving the vaccine. Upon internal review, allergic reaction was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syringe issue
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to a patient of unknown gender and age, who on an unknown date was vaccinated with GARDASIL (lot number H019495 expiration date 15-AUG-2015). The healthcare worker reported that a prefilled GARDASIL syringe leaked during administration, and that the patient needed to receive the dose of a second syringe. It was also reported that the syringe tip cap was attached properly prior to its use, the leaking occurred from the syringe when the plunger rod was being pushed forward and the needle used was able to be attached securely to the syringe. The reporter stated that the syringe carton tray was intact and undamaged on receipt, with its cellophane cover intact and completely sealed. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse symptoms, signs, events administered expired dose on 10/31/12. Re-vaccinated per CDC recommendation on 12/1/12.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a Doctor of pharmacist refers to a 72 year old male patient, with no pertinent medical history and no drug reactions/allergies. On 19-NOV-2012, the patient was vaccinated with ZOSTAVAX (lot # H013945, expired on 25-OCT-2013), subcutaneous. No concomitants medications were reported. The reported stated that on an unknown date after administration of ZOSTAVAX in 2013 or 2013, the patient began to experienced generalized pruritus. No rash was present. The patient sought medical attention by calling the pharmacy. The outcome of generalized pruritus was reported as not recovered. No treatment was given. The causality between ZOSTAVAX and generalized pruritis was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 55 year old female patient. On 14-JAN-2013 the patient was vaccinated with ZOSTAVAX lot # H019042, 0.65 ml once. On 16-JAN-2013, stated as about 2 days after she got the shot, the patient developed blisters and redness on the upper half of the arm she got the vaccine in. The patient sought medical attention and was treated with BENADRYL. The patient came back to the office on 25-JAN-2013 and there was "barely a red spot". The outcome of blisters and redness on the upper half of the arm she got the vaccine in was reported as recovered/resolving. No action was taken regarding the ZOSTAVAX. Relatedness for blisters and redness on the upper half of the arm she got the vaccine in and ZOSTAVAX was not provided by the reporter. The case was cross referenced with case 1303USA001535. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Pyrexia
Clinical narrative: Fever (103.5 degrees F) 12 hours after vaccination. It lasted over +- 12 hours.
Age: 8.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Eye swelling, Full blood count, Radioallergosorbent test, Swelling face
Clinical narrative: Swelling of eyes and face.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Headache, Vomiting
Clinical narrative: Epigastric pain, vomiting for 6 hrs, headache.  Treatment was only to restart liquids and get rest.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: I awoke in the middle of the night feeling extremely cold, as if I had the "chills".  I took two Ibuprofen and after 20 minutes, I was able to sleep again until 7:00AM.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient started to have slight pain about 10 minutes after the injection prior to leaving the pharmacy.  Daughter called on Monday saying that the Sunday after the injection, she had a large area (2x3 inches) come up at the site and it was very painful.  She said it was very warm to the touch and the area stayed that way for a few days before contacting the pharmacy.  The area had started to get smaller with yellowing around the base of the red perimeter.  Patient had been placing cold packs on the area to help with swelling and redness.  Daughter contacted pharmacy on Thursday and advised to take Tylenol for the pain and try Benadryl for a few doses to help with any allergic reaction symptoms.  She was advised to take her to the doctor if it didn't subside but that with the yellowing of the skin, it may be a bruising under the skin from the injection.  Patient was called on March 5 and area was no longer red and swollen and the size was down to a pinpoint area.  Patient voiced no other complaints.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient started to have slight pain about 10 minutes after the injection prior to leaving the pharmacy.  Daughter called on Monday saying that the Sunday after the injection, she had a large area (2x3 inches) come up at the site and it was very painful.  She said it was very warm to the touch and the area stayed that way for a few days before contacting the pharmacy.  The area had started to get smaller with yellowing around the base of the red perimeter.  Patient had been placing cold packs on the area to help with swelling and redness.  Daughter contacted pharmacy on Thursday and advised to take Tylenol for the pain and try Benadryl for a few doses to help with any allergic reaction symptoms.  She was advised to take her to the doctor if it didn't subside but that with the yellowing of the skin, it may be a bruising under the skin from the injection.  Patient was called on March 5 and area was no longer red and swollen and the size was down to a pinpoint area.  Patient voiced no other complaints.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Per mom patient had  large knot on left leg, red, hot to touch, size of baseball.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Drooling, Sensory loss, VIIth nerve paralysis
Clinical narrative: Onset of Bell's Palsy, with loss of sensation on left face and drooling. Admitted to ER on next day morning (01/11/2013).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cardiac function test normal, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Severe diarrhea and severe sweating.  One time diarrhea.  Very weak and tired.  Passed out.  Taken to ER.  Bp 61/55.  Heart attack R/O.  Possible flu but contacted Flu one month later.  Given 1L of NS and sent home.  Slept 36 hours.  No further complications.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypersomnia, Influenza, Loss of consciousness
Clinical narrative: Severe diarrhea and severe sweating.  One time diarrhea.  Very weak and tired.  Passed out.  Taken to ER.  Bp 61/55.  Heart attack R/O.  Possible flu but contacted Flu one month later.  Given 1L of NS and sent home.  Slept 36 hours.  No further complications.
Age: 1.25
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Endotracheal intubation, Febrile convulsion, Full blood count normal
Clinical narrative: Complex febrile seizure with status epilepticus requiring intubation.
Age: 1.25
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Metabolic function test normal, Status epilepticus, Urine analysis normal
Clinical narrative: Complex febrile seizure with status epilepticus requiring intubation.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Fatigue, Lymphadenopathy, Malaise, Mononucleosis heterophile test negative
Clinical narrative: Patient was given Gardasil vaccine this morning around 8:15 AM.  Around noon this day she to notice she was achy and having chills.  That evening she ran a fever over 100 degrees F orally taken by mother.  The next morning she was nauseated and threw up.  She continued to spike fevers in the evening/night time with generalized aches/chills, nausea, headaches through out the week.  On Friday March 1, 2013 patient was still febrile and noted to be itchy.  Her mother reported she had broken out into hives from her head, chest, trunk and decided to take her in the local emergency department.  Patient was febrile, tachycardic, noted to have swollen lymph nodes and was tested for MONO and German Measles (to my report).  She tested negative to both of these.  She also had labs drawn and was noted to have a low white blood cell count.  She was encouraged to take Benadryl for itchiness and started on an antibiotic with no sure cause of possible infection/hives rash.  I spoke with the mother today, March 5, 2013 and patient does not have any obvious hives but still itchy on her head.  She is still spiking fevers at night with malaise and fatigue.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pruritus, Pyrexia, Tachycardia
Clinical narrative: Patient was given Gardasil vaccine this morning around 8:15 AM.  Around noon this day she to notice she was achy and having chills.  That evening she ran a fever over 100 degrees F orally taken by mother.  The next morning she was nauseated and threw up.  She continued to spike fevers in the evening/night time with generalized aches/chills, nausea, headaches through out the week.  On Friday March 1, 2013 patient was still febrile and noted to be itchy.  Her mother reported she had broken out into hives from her head, chest, trunk and decided to take her in the local emergency department.  Patient was febrile, tachycardic, noted to have swollen lymph nodes and was tested for MONO and German Measles (to my report).  She tested negative to both of these.  She also had labs drawn and was noted to have a low white blood cell count.  She was encouraged to take Benadryl for itchiness and started on an antibiotic with no sure cause of possible infection/hives rash.  I spoke with the mother today, March 5, 2013 and patient does not have any obvious hives but still itchy on her head.  She is still spiking fevers at night with malaise and fatigue.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Viral test negative, Vomiting, White blood cell count decreased
Clinical narrative: Patient was given Gardasil vaccine this morning around 8:15 AM.  Around noon this day she to notice she was achy and having chills.  That evening she ran a fever over 100 degrees F orally taken by mother.  The next morning she was nauseated and threw up.  She continued to spike fevers in the evening/night time with generalized aches/chills, nausea, headaches through out the week.  On Friday March 1, 2013 patient was still febrile and noted to be itchy.  Her mother reported she had broken out into hives from her head, chest, trunk and decided to take her in the local emergency department.  Patient was febrile, tachycardic, noted to have swollen lymph nodes and was tested for MONO and German Measles (to my report).  She tested negative to both of these.  She also had labs drawn and was noted to have a low white blood cell count.  She was encouraged to take Benadryl for itchiness and started on an antibiotic with no sure cause of possible infection/hives rash.  I spoke with the mother today, March 5, 2013 and patient does not have any obvious hives but still itchy on her head.  She is still spiking fevers at night with malaise and fatigue.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Intradermal Flu Licensed for ages 18-64yrs given.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Diffuse rash that appears as small non-raised patches. Not pruritic.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Intradermal Flu Licensed for ages 18-64yrs given.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Intradermal Flu Licensed for ages 18-64yrs given.
Age: 24.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: N/V, RASH ON CHEST, PROGRESSED TO NECK AND LOWER JAW. DENIES ITCHING OR NO SWALLOWING DIFFICULTY.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 66 year old patient of unknown gender. On 11-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # H020000, subcutaneous. On 11-FEB-2013, 1,5 hours after onset of therapy the patient experienced severe back pain. He was evaluated at a local emergency room but a diagnosis was not available. The outcome of severe back pain was not provided. This case was cross referenced with case 1303USA001456. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Back pain, Spinal X-ray, X-ray abnormal
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 year old patient of unknown gender. On 13-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # H020000, subcutaneous. On 13-FEB-2013, 5 minutes after onset of therapy the patient experienced severe back pain. The nurse applied heat to the patient's back and the pain resolved within 30 minutes. The back pain recurred a few minutes later and the patient was sent for a lumbar spine x-ray, which revealed "mild arthritis". No further information provided. The outcome of severe back pain was not provided. This case was cross referenced with case 1302USA009575. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a male patient of unknown age. At an unknown date, the patient was vaccinated with ZOSTAVAX lot # H019042. At an unknown date, the patient developed blisters and redness on the upper half of the harm he got the vaccine in. The outcome of blisters and redness on the upper half of the arm he go the vaccine in was not reported. No action was taken regarding the ZOSTAVAX. Relatedness for blisters and redness on the upper half of the arm he got the vaccine in and ZOSTAVAX was not provided by the reporter. The case was cross referenced with case 1302USA009579. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender who on an unknown date may had received a dose of GARDASIL, in the gluteal muscle. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Malaise, Pallor, Syncope
Clinical narrative: 3/4/13 1610 Client received Gardasil, Varicella, & Menactra. At approx 1615 client was standing next to her mom & states "I don't feel well" RN & Mom took clients arm as syncope episode happened. Pale in color. Lowered client to floor and elevated her feet. Client aroused in less than a minute. BP 110/72. After approx 5 min assisted Client to standing and walked into exam room. 1625 patient reports feeling well, color pink, smiling walked out with Mom at side.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PT began to have redness, itching and swelling at the injection site. The symptoms worsened over the first 48 hours. The symptoms began to lessen on the 3rd day and at that time the site was slightly red with a distinct red dot at injection point and red circle around the area. Itching had subsided as well.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Feeling cold, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Freezing, chills, fever of 101.5, sweats, and whole body aches. Most of the symptoms lasted 24 hrs except the body aches which lasted for 48 hrs.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Pallor, Posture abnormal, Tremor
Clinical narrative: Gave HPV in left arm; within 10-15 (patient was sitting in an arm chair) seconds patient went blank, pale, starting shaking all over, head went back, I cradled back of head went to my knees to prevent him coming out of chair.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Blood test, Gait disturbance, Hepatic enzyme increased, Pain in extremity
Clinical narrative: Son started to experience pain and swelling in hands and feet. Started with finger swelling and rapidly spread all over body. My son is currently unable to attend school and barely can walk. Has elevated liver enzymes.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Son started to experience pain and swelling in hands and feet. Started with finger swelling and rapidly spread all over body. My son is currently unable to attend school and barely can walk. Has elevated liver enzymes.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Blood test, Gait disturbance, Hepatic enzyme increased, Oedema peripheral
Clinical narrative: Son started to experience pain and swelling in hands and feet. Started with finger swelling and rapidly spread all over body. My son is currently unable to attend school and barely can walk. Has elevated liver enzymes.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Pain in extremity, Swelling
Clinical narrative: Son started to experience pain and swelling in hands and feet. Started with finger swelling and rapidly spread all over body. My son is currently unable to attend school and barely can walk. Has elevated liver enzymes.
Age: 63.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Chills, Erythema, Fatigue, Full blood count abnormal, Henoch-Schonlein purpura
Clinical narrative: Fever to 102, shaking chills, fatigue lasted three days then red hot patch on arm six by eight inches. Then petechial rash and palpable purpura started on legs and progressed up to arms then truck and breasts started on 02/10/2013 and is still going on although starting to improve on March 4th. Biopsy done IGA found in vasculitis.
Age: 63.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Palpable purpura, Petechiae, Platelet count increased, Pyrexia, Skin warm
Clinical narrative: Fever to 102, shaking chills, fatigue lasted three days then red hot patch on arm six by eight inches. Then petechial rash and palpable purpura started on legs and progressed up to arms then truck and breasts started on 02/10/2013 and is still going on although starting to improve on March 4th. Biopsy done IGA found in vasculitis.
Age: 63.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Tremor, Vasculitis
Clinical narrative: Fever to 102, shaking chills, fatigue lasted three days then red hot patch on arm six by eight inches. Then petechial rash and palpable purpura started on legs and progressed up to arms then truck and breasts started on 02/10/2013 and is still going on although starting to improve on March 4th. Biopsy done IGA found in vasculitis.
Age: 0.59
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Around injection site develped a hard lump, about 2" in diameter.  The site was very hot and had redness and swelling that covered the entire top 1/2 of her thigh, probably about 5-6" in diameter.
Age: 5.0
Sex: M
Vaccine: 6VAX-F, MMRV
Symptoms: Lethargy, Speech disorder
Clinical narrative: Pallalia and lethargy gradually fading over the course of two years.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Haemorrhage, Pain, Skin mass
Clinical narrative: Pt was bleeding as the needle was pulled out, when I wiped her arm down we noticed the hard lump on her arm. The area was very red. As serum was being injected pt stated that it felt really thick. Pt complained of pain in the area. No other symptoms. Dr. evaluated pt and advised to take BENADRYL, ice for a couple of hours & then heat.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt had entire (R) leg swell circumferentially secondary to DaPT hot to touch evolved over 5 day period. Txed BENADRYL & KEFLEX. Father EPIPEN for fire auto.
Age: 61.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Rash pruritic, Rash pustular, Skin exfoliation
Clinical narrative: Per pt -> Travel shots 2/11/13 -> 2/12/13 Pimple eruptions", "looked like chicken pox pimples" over back, left shoulder & abd became scaly & dried up & disappeared left no marks. Pt states she stated oral typhoid 3/1/13 and developed same "pimple eruptions" itchy both times.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mother c/o fever - 101 degrees - 102 degrees profuse vomiting of all formula ingested beginning on 3/4/13. Late AM of 3/5/13 fever down to 99 degrees, pt still vomiting all formula. Symptoms did not begin until after pt. received immunizations.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Burning sensation, Chest X-ray, Cough, Dyspnoea, Erythema
Clinical narrative: A consumer report has been received concerning a 55 year old female patient. The patient's concurrent disease included Attention deficit/hyperactivity disorder, allergic to dust, pollen, and cat hair. The concomitant medications included Prednisone, cough medications, and antidepressants. The patient received nasal FLUMIST, a spray in each nostril on an unknown date for seasonal flu. The patient reported that she had shortness of breath, her body felt like it was on fire. She had breathing problems, her eyes swelled up, face swelled up, and she had a dry hacking cough on 11-Jan-2013. On 12-Jan and 13-Jan her airway closed for 35 sec. She also suffered from redness on her neck and upper chest. On 11-Feb, she went to a hospital emergency room. The doctor said it looked like Lupus and treated her with prednisone. She had hives all over her body. Doctor said she may have chlamydia. She had a chest X-ray. 30-Jan was the worst day for her red puffy face. She also had muscle weakness. She had a red infected pustule under her tongue. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. She was treated for Attention deficit/hyperactivity disorder in Nov 2012. At the time of reporting, the events of shortness of breath / breathing problems, red puffy face / faced swelled up, hives all over body / red sunburned like skin, closed airway for 35 sec, infected pustule under tongue, and muscle weakness were continuing, and the outcome of body felt like was on fire, dry hacking cough, swollen eyes, green mucus coming up, and redness of neck chest was unknown.. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. The company physician considered the events of closed airway for 35 sec, dry hacking cough, shortness of breath / breathing problems, red puffy face / face swellled up, body felt like it was on fire, swollen eyes, hives all over body / red sunburned like skin to be serious as Important medical events and the infected pustule under tongue, muscle weakness, green mucus coming up, and redness of neck & chest to be non serious. Laboratory values are available.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye swelling, Increased bronchial secretion, Lupus-like syndrome, Muscular weakness, Obstructive airways disorder
Clinical narrative: A consumer report has been received concerning a 55 year old female patient. The patient's concurrent disease included Attention deficit/hyperactivity disorder, allergic to dust, pollen, and cat hair. The concomitant medications included Prednisone, cough medications, and antidepressants. The patient received nasal FLUMIST, a spray in each nostril on an unknown date for seasonal flu. The patient reported that she had shortness of breath, her body felt like it was on fire. She had breathing problems, her eyes swelled up, face swelled up, and she had a dry hacking cough on 11-Jan-2013. On 12-Jan and 13-Jan her airway closed for 35 sec. She also suffered from redness on her neck and upper chest. On 11-Feb, she went to a hospital emergency room. The doctor said it looked like Lupus and treated her with prednisone. She had hives all over her body. Doctor said she may have chlamydia. She had a chest X-ray. 30-Jan was the worst day for her red puffy face. She also had muscle weakness. She had a red infected pustule under her tongue. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. She was treated for Attention deficit/hyperactivity disorder in Nov 2012. At the time of reporting, the events of shortness of breath / breathing problems, red puffy face / faced swelled up, hives all over body / red sunburned like skin, closed airway for 35 sec, infected pustule under tongue, and muscle weakness were continuing, and the outcome of body felt like was on fire, dry hacking cough, swollen eyes, green mucus coming up, and redness of neck chest was unknown.. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. The company physician considered the events of closed airway for 35 sec, dry hacking cough, shortness of breath / breathing problems, red puffy face / face swellled up, body felt like it was on fire, swollen eyes, hives all over body / red sunburned like skin to be serious as Important medical events and the infected pustule under tongue, muscle weakness, green mucus coming up, and redness of neck & chest to be non serious. Laboratory values are available.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Oral infection, Oral pustule, Productive cough, Rash erythematous, Skin exfoliation
Clinical narrative: A consumer report has been received concerning a 55 year old female patient. The patient's concurrent disease included Attention deficit/hyperactivity disorder, allergic to dust, pollen, and cat hair. The concomitant medications included Prednisone, cough medications, and antidepressants. The patient received nasal FLUMIST, a spray in each nostril on an unknown date for seasonal flu. The patient reported that she had shortness of breath, her body felt like it was on fire. She had breathing problems, her eyes swelled up, face swelled up, and she had a dry hacking cough on 11-Jan-2013. On 12-Jan and 13-Jan her airway closed for 35 sec. She also suffered from redness on her neck and upper chest. On 11-Feb, she went to a hospital emergency room. The doctor said it looked like Lupus and treated her with prednisone. She had hives all over her body. Doctor said she may have chlamydia. She had a chest X-ray. 30-Jan was the worst day for her red puffy face. She also had muscle weakness. She had a red infected pustule under her tongue. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. She was treated for Attention deficit/hyperactivity disorder in Nov 2012. At the time of reporting, the events of shortness of breath / breathing problems, red puffy face / faced swelled up, hives all over body / red sunburned like skin, closed airway for 35 sec, infected pustule under tongue, and muscle weakness were continuing, and the outcome of body felt like was on fire, dry hacking cough, swollen eyes, green mucus coming up, and redness of neck chest was unknown.. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. The company physician considered the events of closed airway for 35 sec, dry hacking cough, shortness of breath / breathing problems, red puffy face / face swellled up, body felt like it was on fire, swollen eyes, hives all over body / red sunburned like skin to be serious as Important medical events and the infected pustule under tongue, muscle weakness, green mucus coming up, and redness of neck & chest to be non serious. Laboratory values are available.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Swelling face, Urticaria
Clinical narrative: A consumer report has been received concerning a 55 year old female patient. The patient's concurrent disease included Attention deficit/hyperactivity disorder, allergic to dust, pollen, and cat hair. The concomitant medications included Prednisone, cough medications, and antidepressants. The patient received nasal FLUMIST, a spray in each nostril on an unknown date for seasonal flu. The patient reported that she had shortness of breath, her body felt like it was on fire. She had breathing problems, her eyes swelled up, face swelled up, and she had a dry hacking cough on 11-Jan-2013. On 12-Jan and 13-Jan her airway closed for 35 sec. She also suffered from redness on her neck and upper chest. On 11-Feb, she went to a hospital emergency room. The doctor said it looked like Lupus and treated her with prednisone. She had hives all over her body. Doctor said she may have chlamydia. She had a chest X-ray. 30-Jan was the worst day for her red puffy face. She also had muscle weakness. She had a red infected pustule under her tongue. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. She was treated for Attention deficit/hyperactivity disorder in Nov 2012. At the time of reporting, the events of shortness of breath / breathing problems, red puffy face / faced swelled up, hives all over body / red sunburned like skin, closed airway for 35 sec, infected pustule under tongue, and muscle weakness were continuing, and the outcome of body felt like was on fire, dry hacking cough, swollen eyes, green mucus coming up, and redness of neck chest was unknown.. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. The company physician considered the events of closed airway for 35 sec, dry hacking cough, shortness of breath / breathing problems, red puffy face / face swellled up, body felt like it was on fire, swollen eyes, hives all over body / red sunburned like skin to be serious as Important medical events and the infected pustule under tongue, muscle weakness, green mucus coming up, and redness of neck & chest to be non serious. Laboratory values are available.
Age: 0.76
Sex: M
Vaccine: FLU3, HEP, IPV
Symptoms: Clonus, Crying, Diet refusal, Eye movement disorder, Irritability
Clinical narrative: Fussy, refused a bottle. Noted clonic movements eyes rolled back not making noises - lasted 1.5 minutes. No post-ictal period just cried.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ectopic pregnancy, Ectopic pregnancy termination, Fallopian tube operation, Maternal exposure before pregnancy, Tubal rupture
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to her 25 years old daughter. On an unknown date the patient was vaccinated with dose 3 of GARDASIL (Lot# and route not reported). The consumer stated that the patient had suffered (2) ectopic pregnancies after receiving the GARDASIL dosages (3). The first ectopic pregnancy occurred approximately eight months ago (approximately in June 2012) where she stayed at hospital for two days and had had one of her fallopian tubes removed due to a rupture. The LMP and EDD were not known. The pregnancy outcomes were ectopic termination. At the time of reporting, the patient's outcome was unknown. Upon internal review, the second episode of ectopic pregnancy was considered to be an event of medically significant. Additional information has been requested. The patient was hospitalized.