chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left upper arm - 4/2/13 small red, swollen area and warm to touch appeared per Mother progressively got worse brought to HD on 4/3/13 area now 4"x9" red, swollen, very warm to touch with small blisters. Reports afebrile but medicated with TYLENOL, decreased appetite, and fatigue. Right upper arm - red, swollen, warm to touch circular 1"-1 1/2" diameter.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Discomfort, Faeces discoloured, Flatulence, Irritability
Clinical narrative: stringy yellow bowel movement. Whining and straining. Fever 101.4. Fussy and gassy.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: stringy yellow bowel movement. Whining and straining. Fever 101.4. Fussy and gassy.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Optic neuritis, Paraesthesia, White matter lesion
Clinical narrative: (R) neuroretinitis. (R) upper extremity paresthesia. Multiple white matter lesions on MRI.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Oedema peripheral, Pain, Rheumatoid arthritis
Clinical narrative: Initial report received from a healthcare professional on 12 November 2012. A 78-year-old female patient had no relevant medical history and no illness at the time of vaccination, received intramuscular dose of FLUZONE HD in left deltoid (Lot number U4537AA) on 21 October 2012. On 22 October 2012, the patient had presented bilateral ankle, figure and thumb swelling and painful to walk. Corrective medications were not reported and relevant Laboratory test were reported as none. The patient's outcome was not reported. Documents held by sender: None. Follow-up information was received from a healthcare professional on 01 April 2013. Based on the new information, this case has been upgraded to serious. The events were not related, the patient was diagnosed with rheumatoid arthritis. Outcome was recovered.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Oedema peripheral, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 15 November 2012. A adult female patient, whose age, concomitant medications and medical history were not reported; had received a dose of FLUZONE ID vaccine (lot number: UT4471AA, anatomical site of administration was not reported) on an unspecified date. On an unspecified date, the patient's entire upper arm was swollen and was warm to touch. Corrective treatment and laboratory details were not reported. The patient's outcome was not reported. Follow-up information was received from a healthcare professional on 01 April 2013. Based on the new information, this case has been upgraded to serious. The patient was 37-years-old who received the injection of FLUZONE Intradermal in the left deltoid area. The patient was diagnosed with cellulitis that resolved after treatment with KEFLEX. The patient had no past medical history and no illness at the time of vaccination. Outcome was reported as recovered. Documents held by sender: none.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Diarrhoea, Irritability, Lethargy, Urine analysis normal
Clinical narrative: Complaints of vomiting and diarrhea. Baby fussy, lethargic and drawing up his legs. Cath UA is normal. Advised to watch for dehydration and call if fever > 100.4.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Complaints of vomiting and diarrhea. Baby fussy, lethargic and drawing up his legs. Cath UA is normal. Advised to watch for dehydration and call if fever > 100.4.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Increased upper airway secretion, Influenza, Influenza A virus test positive, Pain
Clinical narrative: Initial report was received from a consumer on 18 January 2013. Case is invalid (no patient identifiers). Three unidentified patients had received an intramuscular injection of FLUZONE (lot number, site and exact date of administration not reported) in October of 2012. Two months later, in December of 2012, the patients came down with flu symptoms and tested positive for the A strain using the BD Veritor test. Symptoms included cough, fever for 2.5 days, chest congestion, runny nose with copious mucus and widespread body aches. The symptoms lasted about a week. The patient had no illness at the time of vaccination. Outcome was recovered. Follow-up information was received from a healthcare professional on 01 April 2013. The patient was a 35-year-old female who received FLUZONE, lot number UH713AB on 21 September 2012. Adverse event onset date was reported as 18 January 2013. Outcome remained recovered. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Initial report was received from a consumer on 18 January 2013. Case is invalid (no patient identifiers). Three unidentified patients had received an intramuscular injection of FLUZONE (lot number, site and exact date of administration not reported) in October of 2012. Two months later, in December of 2012, the patients came down with flu symptoms and tested positive for the A strain using the BD Veritor test. Symptoms included cough, fever for 2.5 days, chest congestion, runny nose with copious mucus and widespread body aches. The symptoms lasted about a week. The patient had no illness at the time of vaccination. Outcome was recovered. Follow-up information was received from a healthcare professional on 01 April 2013. The patient was a 35-year-old female who received FLUZONE, lot number UH713AB on 21 September 2012. Adverse event onset date was reported as 18 January 2013. Outcome remained recovered. Documents held by sender: None.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: High fever associated with seizure.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Autoimmune disorder, Bacterial test negative, Blood test normal, HIV test negative, Hepatitis viral test negative
Clinical narrative: Influenza shot provided by clinic on 1/10/2013. I am reporting an adverse reaction and potentially life changing health problem which I believe was caused by a recent influenza shot. I am a 51 year old male who was in excellent health until receiving a flu shot at a local pharmacy on January 10th 2013. I had never received a prior flu shot in my life before and because of all the media hype saying that this was going to a bad flu season decided to get one. Soon after I developed pain and swelling on my toes. My primary care doctor was unable to see me for several months so went to urgent care that day January 22nd. They took photos of my feet, blood work and sent me to hospital to have a blood bacterial culture done. Both the urgent care and hospital blood lab results came in normal. I was then recommended to see a dermatologist by my primary care doctor which I did and had 2 more sets of blood work done to rule out HIV, Diabetes, Hepatitis, and a anti - streptolysin test. Blood tests were taken 1/31 and 2/7 which both came back normal. The dermatologist diagnosed me with Vasculitis. I then was recommended by my primary care doctor to have an ultra sound done on my legs which was done in a hospital setting on March 4th. Results have come back normal. Something in my immune system changed after receiving the influenza vaccine on January 10th to cause vasculitis. After taking a course of Prednisone to reduce inflammation in March I thought the condition would subside but recently have had extreme swelling in my feet again along with evidence of vasculitis appearing in my finger tips as well. I don't know how someone with a healthy history comes down with disease all of a sudden but there is a strong correlation in my case between the flu shot and the sudden onset of Vasculitis. At this point I am waiting to see a Rheumatologist on April 18th to see if they can determine what has triggered this sudden auto immune disease.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Oedema peripheral, Pain in extremity, Streptococcus test negative, Ultrasound scan normal
Clinical narrative: Influenza shot provided by clinic on 1/10/2013. I am reporting an adverse reaction and potentially life changing health problem which I believe was caused by a recent influenza shot. I am a 51 year old male who was in excellent health until receiving a flu shot at a local pharmacy on January 10th 2013. I had never received a prior flu shot in my life before and because of all the media hype saying that this was going to a bad flu season decided to get one. Soon after I developed pain and swelling on my toes. My primary care doctor was unable to see me for several months so went to urgent care that day January 22nd. They took photos of my feet, blood work and sent me to hospital to have a blood bacterial culture done. Both the urgent care and hospital blood lab results came in normal. I was then recommended to see a dermatologist by my primary care doctor which I did and had 2 more sets of blood work done to rule out HIV, Diabetes, Hepatitis, and a anti - streptolysin test. Blood tests were taken 1/31 and 2/7 which both came back normal. The dermatologist diagnosed me with Vasculitis. I then was recommended by my primary care doctor to have an ultra sound done on my legs which was done in a hospital setting on March 4th. Results have come back normal. Something in my immune system changed after receiving the influenza vaccine on January 10th to cause vasculitis. After taking a course of Prednisone to reduce inflammation in March I thought the condition would subside but recently have had extreme swelling in my feet again along with evidence of vasculitis appearing in my finger tips as well. I don't know how someone with a healthy history comes down with disease all of a sudden but there is a strong correlation in my case between the flu shot and the sudden onset of Vasculitis. At this point I am waiting to see a Rheumatologist on April 18th to see if they can determine what has triggered this sudden auto immune disease.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Vasculitis
Clinical narrative: Influenza shot provided by clinic on 1/10/2013. I am reporting an adverse reaction and potentially life changing health problem which I believe was caused by a recent influenza shot. I am a 51 year old male who was in excellent health until receiving a flu shot at a local pharmacy on January 10th 2013. I had never received a prior flu shot in my life before and because of all the media hype saying that this was going to a bad flu season decided to get one. Soon after I developed pain and swelling on my toes. My primary care doctor was unable to see me for several months so went to urgent care that day January 22nd. They took photos of my feet, blood work and sent me to hospital to have a blood bacterial culture done. Both the urgent care and hospital blood lab results came in normal. I was then recommended to see a dermatologist by my primary care doctor which I did and had 2 more sets of blood work done to rule out HIV, Diabetes, Hepatitis, and a anti - streptolysin test. Blood tests were taken 1/31 and 2/7 which both came back normal. The dermatologist diagnosed me with Vasculitis. I then was recommended by my primary care doctor to have an ultra sound done on my legs which was done in a hospital setting on March 4th. Results have come back normal. Something in my immune system changed after receiving the influenza vaccine on January 10th to cause vasculitis. After taking a course of Prednisone to reduce inflammation in March I thought the condition would subside but recently have had extreme swelling in my feet again along with evidence of vasculitis appearing in my finger tips as well. I don't know how someone with a healthy history comes down with disease all of a sudden but there is a strong correlation in my case between the flu shot and the sudden onset of Vasculitis. At this point I am waiting to see a Rheumatologist on April 18th to see if they can determine what has triggered this sudden auto immune disease.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: None. Pt was given a ZOSTAVAX at Phy. on 4/16/12. Then she got a Rx for a ZOSTAVAX from the GYN to take to pharmacy and they gave her one on 3/7/13.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Sore arm which developed into adhesive capsulitis. Now undergoing physical therapy.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site on both injection sites.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Bacterial test negative, CSF culture negative, CSF glucose normal, CSF protein normal, CSF test abnormal
Clinical narrative: MMR and VARIVAX given 3/11/13 when well. 12 days later seen on 3/23/13 very fussy with fever. Fading rash with extreme irritability and fussiness evaluated by Neurology and Peds ID. Work up most consistent with viral encephalopathy.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Encephalopathy, Full blood count normal, Irritability, Lymphocyte percentage increased, Pyrexia
Clinical narrative: MMR and VARIVAX given 3/11/13 when well. 12 days later seen on 3/23/13 very fussy with fever. Fading rash with extreme irritability and fussiness evaluated by Neurology and Peds ID. Work up most consistent with viral encephalopathy.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: MMR and VARIVAX given 3/11/13 when well. 12 days later seen on 3/23/13 very fussy with fever. Fading rash with extreme irritability and fussiness evaluated by Neurology and Peds ID. Work up most consistent with viral encephalopathy.
Age: 0.79
Sex: M
Vaccine: HIBV, PNC
Symptoms: Crying, Enema administration, Intussusception, Pain, Surgery
Clinical narrative: 3/24 cried in pain off and on throughout the day. Periods of crying became more frequent and intense as day went on. No other symptoms. Urgent care X-ray wasn't normal so referred to hospital. Ultrasound revealed intussusception. Enema, then surgery, followed.
Age: 0.79
Sex: M
Vaccine: HIBV, PNC
Symptoms: Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: 3/24 cried in pain off and on throughout the day. Periods of crying became more frequent and intense as day went on. No other symptoms. Urgent care X-ray wasn't normal so referred to hospital. Ultrasound revealed intussusception. Enema, then surgery, followed.
Age: 0.84
Sex: F
Vaccine: HEP
Symptoms: Rash macular, Urticaria
Clinical narrative: Hives / blotchy rash to face and upper chest after Hep B given IM. BENADRYL 2.5cc given at 6:31pm decreased hives. D/C to home at 6:42pm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Redness to (L) upper thigh plus to 2.5 cm larger than Rt. Pt. was given MILLIPRED 10mg/5mL oral solution 10mL PO each day x 3 days #30.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site rash
Clinical narrative: This spontaneous report as received from a 50 year old male patient reporting on himself with none pertinent medical history and none reaction/allergies. On 27-MAR-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (Lot # and exp date not provided) intramuscularly in the tricep (dose not provided). No other co suspects were reported. No concomitant therapy was reported. On 28-MAR-2013, the patient did not seek medical attention. Lab diagnostics were not performed. The outcome of the patient developed joint pain and rash around the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Patient queried for Adult vaccine questionnaire patient answered no to question #8 (Are you currently pregnant or plan on becoming pregnant?) Immunization given.
Age: 43.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Chills, Erythema, Fatigue, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Patient had in 24 hrs pain in left arm, red, tender, swelling locally. Also had fevers to 102, chills, nausea, fatigue.
Age: 43.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Local swelling, Nausea, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Patient had in 24 hrs pain in left arm, red, tender, swelling locally. Also had fevers to 102, chills, nausea, fatigue.
Age: 43.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: White blood cell count increased
Clinical narrative: Patient had in 24 hrs pain in left arm, red, tender, swelling locally. Also had fevers to 102, chills, nausea, fatigue.
Age: 1.01
Sex: F
Vaccine: IPV, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives, 5 x 6cm. BENADRYL given.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt received PNEUMOVAX vaccine shot in his left arm. Pt received the shot in the left bicep instead of the deltoid. Pt left arm is swollen & red w/warm to touch.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist to a 26 year old female patient. On 24-AUG-2012 the patient was vaccinated with the first dose of GARDASIL 120 Y(Lot # and exp date not reported) (dose and route not reported). No other co suspects were reported. No concomitant therapy was reported. The pharmacist reported that the patient received the first dose of GARDASIL at 26 years and 2 months of age. No adverse symptoms reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a 15 year old female patient experienced inappropriate schedule of vaccine administration. On 21-AUG-2008 the patient was vaccinated with 1st dose GARDASIL. On 08-DEC-2011 the patient was vaccinated with 2nd dose GARDASIL. On 17-FEB-2012 the patient was vaccinated with 3rd dose GARDASIL. No adverse event reported. Additional information is not expected.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report as received from a LPN (licensed practical nurse) refers to a 24 year old male patient. The patient medical history was unknown. It was reported that on an unknown date, the patient may have received GARDASIL. No dosing information was provided. On an unspecified date, the patient presented with condyloma (genital warts). The patient received unspecified treatment for the condyloma. The reporting nurse could not verify whether or not the patient had really received any doses of GARDASIL. The outcome of the condyloma was unknown. The reporter provided no causality assessment for GARDASIL and the condyloma. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 79 year old female patient regarding herself. The patient had no pertinent medical history or drug allergies. On an unknown date in 2011, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported) in the arm. Concomitant therapies included (reported a atnolol) atenolol for mitral valve prolapse(reported as mitro valve) and LEVOXYL (reported as lavoxil) as thyroid medication. On an unknown date in DEC-2012, the patient stated that marks start out as red and as the months go by the patches that are 2 to 3 inches in diameter turn brown. Treatment rendered for the event was unknown. There was no laboratory tests performed. The outcome of the event was reported as unknown. The patient did not see medical attention. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: HERPES ZOSTER IN 2 DOSE VARICELLA VACCINE RECIPIENT.
Age: 1.54
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Diarrhoea, Injection site mass, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: Large red swollen golf ball sized lump on leg, followed by full body hives for 7+ days, vomiting, diarrhea. Hard pea sized lump under skin at injection site. Hives in circle also around injection site in addition to the full body hives.
Age: 1.54
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Urticaria, Vomiting
Clinical narrative: Large red swollen golf ball sized lump on leg, followed by full body hives for 7+ days, vomiting, diarrhea. Hard pea sized lump under skin at injection site. Hives in circle also around injection site in addition to the full body hives.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: HERPES ZOSTER IN 2 DOSE VARICELLA VACCINE RECIPIENT.
Age: 17.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster in varicella vaccine recipient (unclear if patient received one or two doses in the past).
Age: 1.04
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 102 temp the day following vaccine administration only; swelling at injection sites since the date of vaccine adminstration.  During nighttime bath on 3/30/13 mother noticed, blotchy spots on leg and torso.  Also noticed a half-dollar sized swollen area on right thigh which was red, hot and firm to the touch.  Phoned primary care provider on 4/1/13 to report the reaction.  Instructed by primary care provider to monitor site and use ice intermittently to area.  If no improvement by Wednesday 4/3/13, client was to be brought in to provider's office for examination.  As of 4/3/13 at 9:00 am, area was without redness and heat; no appointment made to see primary care provider.
Age: 1.04
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash macular
Clinical narrative: 102 temp the day following vaccine administration only; swelling at injection sites since the date of vaccine adminstration.  During nighttime bath on 3/30/13 mother noticed, blotchy spots on leg and torso.  Also noticed a half-dollar sized swollen area on right thigh which was red, hot and firm to the touch.  Phoned primary care provider on 4/1/13 to report the reaction.  Instructed by primary care provider to monitor site and use ice intermittently to area.  If no improvement by Wednesday 4/3/13, client was to be brought in to provider's office for examination.  As of 4/3/13 at 9:00 am, area was without redness and heat; no appointment made to see primary care provider.
Age: 0.91
Sex: F
Vaccine: DTAPIPV, HIBV, IPV, PNC13
Symptoms: Rhinorrhoea
Clinical narrative: SLIGHT RHINORRHEA.
Age: 1.56
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother reported that site looked like a mosquito bite and a little red the day before and by 7:00 PM it had swelled, it is size of baseball this AM and taking her to clinic, no temp reported.
Age: 23.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema
Clinical narrative: LOCAL REDNESS AROUND INJECTION SITE.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Seizure like phenomena, Tremor
Clinical narrative: Patient had a febrile seizure. Per dad he started with a low grade fever that day and developed seizure like activity (shaking uncontrolably for about 3-5 min) shortly after the fever started.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Chills, Dizziness, Myalgia, Nasal congestion
Clinical narrative: Severe myalgia and arthralgia (back, ribs), tactile temps, chills, nasal congestion, dizziness.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Skin warm
Clinical narrative: Severe myalgia and arthralgia (back, ribs), tactile temps, chills, nasal congestion, dizziness.
Age: 1.24
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia, Respiratory arrest, Unresponsive to stimuli, Vomiting
Clinical narrative: Spiked fever of 103.5, vomited, became unresponsive, had febrile seizure and stopped breathing for 30 seconds.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: 4 inch raised welt- burning sensation, itching.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Palpitations
Clinical narrative: Pt reported intermittent dizziness lasting 30 min - 1 hr reports symptoms reoccur q2-7d. Pt also reporting palpitations.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: Redness, warmth, circular rash.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Development of erythema, warmth, pain and swelling at right deltoid region where shot was administered.  9-cm diameter area of mild erythema at injection site, no purulent drainage noted, patient afebrile.  Cellulitus Dx, treated with Keflex 500mg every 6hrs for 10 days.  F/U scheduled for 04/04/2013.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: I was administered the wrong vaccination- was supposed to receive DTaP, was given HPV vaccine, which is not indicated in pregnancy.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Amylase normal, Blood glucose normal, Delivery, Episiotomy
Clinical narrative: I was administered the wrong vaccination- was supposed to receive DTaP, was given HPV vaccine, which is not indicated in pregnancy.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Live birth, Precipitate labour, Pregnancy test urine positive, Streptococcus test negative
Clinical narrative: I was administered the wrong vaccination- was supposed to receive DTaP, was given HPV vaccine, which is not indicated in pregnancy.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound scan normal, Wrong drug administered
Clinical narrative: I was administered the wrong vaccination- was supposed to receive DTaP, was given HPV vaccine, which is not indicated in pregnancy.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy on first day then a red streak down arm.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Temperature of 100 degrees, nausea, diarrhea, body and joint aches, headache, swelling and redness at site.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea, Pain
Clinical narrative: Temperature of 100 degrees, nausea, diarrhea, body and joint aches, headache, swelling and redness at site.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Middle insomnia, Mobility decreased, Pain
Clinical narrative: Pain so strong it woke me up.  I took 3 aspirin. I could not lift my arm from my side the pain was so severe.  Level 6-7.  It felt like someone had hit me with a stick very hard.  The pain kept me awake for several hours.  Now, 3 PM the following day, the pain is still bad (I've been taking aspirin and ibuprofen) but I can raise my arm a litle.  There is no swelling or redness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersensitivity, Injection site erythema, Pharyngeal oedema, Sensation of heaviness
Clinical narrative: PX HAD PAIN AT TIME OF IMMUNIZATION, THEN ABOUT 9PM ON 3.27.13, PX FELT AS IF AN ALLERGIC REACTION OF THROAT SWELLING, WAIST DOWN HEAVINESS, AND COLD CHILLS. THOSE SYMPTOMS LASTED ABOUT AN HOUR AND SHE USED ELECTRIC BLANKET FOR CHILLS. SHE ALSO HAD REDNESS AT THE INJECTION SITE 1"X4" THAT WENT AROUND TO THE BACK AND CURRENTLY STILL RED. ON 4.3.13 THE PX FELT THROAT SWELLING WAS AGAIN OCCURRING. SHE WAS INSTRUCTED TO VISIT MD WHICH SHE DID, AND HE FELT TO WAIT AND SEE AND THOUGHT SHE WOULD BE FINE.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Cognitive disorder, Computerised tomogram, Disturbance in attention
Clinical narrative: Initially I became very tired, but that was followed by day after day of lassitude, exploding headaches, daily heart palpitations, forgetfulness, difficulty spelling simple words, difficulty completing simple tasks like using my Ipad. Slurred speech, dizziness. Numbness in my hands and feet, shortness of breath. Noticable difficulty writing and swallowing. It all came to a climax 2/6/13 when I went to the doctor and I could not finish writing to fill out the paperwork, I was having trouble swallowing, trouble breathing and my legs became so weak, I could not walk. I had to have help just transferring. I was hospitalized from 2/6/13-2/8/13 supportive treatment with IV fluids and some therapy. I also had subsequent tests to rule out myasthenia gravis, MS, and ALS. These were ruled out and likewise TIA and CVA were both ruled out as well. I was just medically released to return to work 3/25/13 because I still had weakness, poor activity tolerance and intermittant dysarthria.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysarthria, Dysgraphia, Dysphagia, Dyspnoea
Clinical narrative: Initially I became very tired, but that was followed by day after day of lassitude, exploding headaches, daily heart palpitations, forgetfulness, difficulty spelling simple words, difficulty completing simple tasks like using my Ipad. Slurred speech, dizziness. Numbness in my hands and feet, shortness of breath. Noticable difficulty writing and swallowing. It all came to a climax 2/6/13 when I went to the doctor and I could not finish writing to fill out the paperwork, I was having trouble swallowing, trouble breathing and my legs became so weak, I could not walk. I had to have help just transferring. I was hospitalized from 2/6/13-2/8/13 supportive treatment with IV fluids and some therapy. I also had subsequent tests to rule out myasthenia gravis, MS, and ALS. These were ruled out and likewise TIA and CVA were both ruled out as well. I was just medically released to return to work 3/25/13 because I still had weakness, poor activity tolerance and intermittant dysarthria.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Fatigue, Headache, Hypoaesthesia, Memory impairment
Clinical narrative: Initially I became very tired, but that was followed by day after day of lassitude, exploding headaches, daily heart palpitations, forgetfulness, difficulty spelling simple words, difficulty completing simple tasks like using my Ipad. Slurred speech, dizziness. Numbness in my hands and feet, shortness of breath. Noticable difficulty writing and swallowing. It all came to a climax 2/6/13 when I went to the doctor and I could not finish writing to fill out the paperwork, I was having trouble swallowing, trouble breathing and my legs became so weak, I could not walk. I had to have help just transferring. I was hospitalized from 2/6/13-2/8/13 supportive treatment with IV fluids and some therapy. I also had subsequent tests to rule out myasthenia gravis, MS, and ALS. These were ruled out and likewise TIA and CVA were both ruled out as well. I was just medically released to return to work 3/25/13 because I still had weakness, poor activity tolerance and intermittant dysarthria.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Palpitations
Clinical narrative: Initially I became very tired, but that was followed by day after day of lassitude, exploding headaches, daily heart palpitations, forgetfulness, difficulty spelling simple words, difficulty completing simple tasks like using my Ipad. Slurred speech, dizziness. Numbness in my hands and feet, shortness of breath. Noticable difficulty writing and swallowing. It all came to a climax 2/6/13 when I went to the doctor and I could not finish writing to fill out the paperwork, I was having trouble swallowing, trouble breathing and my legs became so weak, I could not walk. I had to have help just transferring. I was hospitalized from 2/6/13-2/8/13 supportive treatment with IV fluids and some therapy. I also had subsequent tests to rule out myasthenia gravis, MS, and ALS. These were ruled out and likewise TIA and CVA were both ruled out as well. I was just medically released to return to work 3/25/13 because I still had weakness, poor activity tolerance and intermittant dysarthria.
Age: 0.51
Sex: M
Vaccine: DTAP, DTAPIPVHIB, RVX
Symptoms: Body temperature increased, Irritability, Skin warm, Vomiting
Clinical narrative: Vomiting.  He vomited a few times in a row, after he had been acting fussy for awhile.  His head also felt hot and his temperature was 100.8.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 years old female patient with no pertinent medical history reported and no drugs reactions or allergies. On 20-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot # H019996, expiration date 02-FEB-2013), 0.65 ml, subcutaneous. No other co-suspects or concomitant medications were reported. On an unknown date, shortly after being vaccinated, the patient developed an injection site reaction of redness and swelling. Her injection site reaction lasted for about 1 and 1/2 weeks. Approximately two weeks after her injection site reaction resolved, the patient began to experience chills, nausea, loss of appetite and headache. The patient developed 10 lesions on her back and she was recently diagnosed with chickenpox. The outcome for chills, nausea, loss of appetite, headache and chickenpox was reported as not recovered. No treatment information was reported. The patient sought medical attention by calling the pharmacist and an by an office visit. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Skin lesion, Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 years old female patient with no pertinent medical history reported and no drugs reactions or allergies. On 20-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot # H019996, expiration date 02-FEB-2013), 0.65 ml, subcutaneous. No other co-suspects or concomitant medications were reported. On an unknown date, shortly after being vaccinated, the patient developed an injection site reaction of redness and swelling. Her injection site reaction lasted for about 1 and 1/2 weeks. Approximately two weeks after her injection site reaction resolved, the patient began to experience chills, nausea, loss of appetite and headache. The patient developed 10 lesions on her back and she was recently diagnosed with chickenpox. The outcome for chills, nausea, loss of appetite, headache and chickenpox was reported as not recovered. No treatment information was reported. The patient sought medical attention by calling the pharmacist and an by an office visit. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a Nurse Practitioner refers to a approximately 16 year old female patient. No medical history was reported. On 08-AUG-2011, the patient received dose 1 GARDASIL (lot# 1511Z, expiry: 26-APR-2013) 0.5 ml intramuscularly and dose 2 of GARDASIL(lot# 1561AA, expiry: August 2014) 0.5 ml intramuscularly on 20-APR-2012. On 28-DEC-2012, the patient was vaccinated with dose 3 GARDASIL(Lot #, expiry: March 2015) 0.5 ml, intramuscularly. Concomitant therapies included prenatal vitamins (unspecified) and unspecified antibiotics (ANTIMICROBIAL (UNSPECIFIED)) prescribed for the patient 2 weeks ago. The patient became pregnant with LMP of 28-SEP-2012 and EDD of 05-JUL-2013. The pregnancy outcome was outcome pending. The Nurse Practitioner  reported that the pregnant patient received GARDASIL. Patient sought medical attention(office visit). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received form a physician refers to a patient of unknown age and gender. On 26-MAR-2013, the patient inadvertently received expired RECOMBIVAX HB (Lot number was reported as 0890Y, expiry date was 04-JUN-2012), 0.5 milliliter (ml), intramuscularly. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. On an unspecified date approximately on April 2011 (reported as approximately 2 years ago), the patient was vaccinated with dose 2 of GARDASIL (lot #, expiry not reported), 0.5 ml, intramuscularly. No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a patient of unknown age who on 29-MAR-2013 was vaccinated with a dose of PROQUAD that was exposed to unknown temperature conditions above 0 degrees C for 15 hours (Lot # H015789, Exp 24-FEB-2014) (dose and route not provided). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 28-MAR-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and lot # not reported) intramuscularly. The nurse reported that a patient was inadvertently given a dose of PNEUMOVAX 23 from an expired vial. No adverse effect was reported. PQC filed to document that the lot number from the carton did not match the lot number from the vial of PNEUMOVAX 23. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex serology, Injection site rash, Laboratory test, Rash
Clinical narrative: This spontaneous report as received from a medical assistant and a company representative, refers to a 55 year old female patient with hypertension and hyperlipidemia. No drug reactions/allergies were reported. On 27-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H022153 exp 18-MAR-2014), 0.65 ml, subcutaneous in the left arm. The patient developed a rash at the injection site on 29-MAR-2013. The patient came into the physician's office on 01-APR-2013 and had a rash on her left buttock. Treatment included unspecified antiviral medications. The physician took a sample of the rash and sent it to a local lab to be tested for herpes simplex and herpes zoster. Results currently not available. The outcome of rash at the injection site and rash on her left buttock was reported as not recovered. Additional information is not expected.
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient. On an unknown date the patient who is 40 years old was vaccinated with a dose of PROQUAD (dose, route and lot # not reported). No adverse effects reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Full blood count, Glycosylated haemoglobin, Joint range of motion decreased, Lipids
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 63 year old female patient with Graves disease, hypertension, hypothyroidism, postural hypotension, bone loss, eczema, insulin resistance, allergy to codeine, allergy to CECLOR, allergy to KEFLEX, allergy to penicillin and LEVOQUIN. On 06-DEC-2012 the patient was vaccinated with 0.5ml PNEUMOVAX 23 (lot # H012972, expiry date 09-MAR-2014) intramuscularly in the left arm. Concomitant therapies included lots of medications. The patient experienced pain and decreased range of motion of the left arm. The date of onset of the adverse symptoms was not known. The patient came to the office on 26-MAR-2013. No treatment was given for adverse event. Metabolic panel, complete blood count, lipid profile, HA1C, thyroid panel were performed and results were not provided. Blood work was drawn and results were pending. The outcome of adverse events was not recovered. The patient had sought medical attention via office visit. The patient had been referred to doctor for further evaluation. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Pain in extremity, Thyroid function test
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 63 year old female patient with Graves disease, hypertension, hypothyroidism, postural hypotension, bone loss, eczema, insulin resistance, allergy to codeine, allergy to CECLOR, allergy to KEFLEX, allergy to penicillin and LEVOQUIN. On 06-DEC-2012 the patient was vaccinated with 0.5ml PNEUMOVAX 23 (lot # H012972, expiry date 09-MAR-2014) intramuscularly in the left arm. Concomitant therapies included lots of medications. The patient experienced pain and decreased range of motion of the left arm. The date of onset of the adverse symptoms was not known. The patient came to the office on 26-MAR-2013. No treatment was given for adverse event. Metabolic panel, complete blood count, lipid profile, HA1C, thyroid panel were performed and results were not provided. Blood work was drawn and results were pending. The outcome of adverse events was not recovered. The patient had sought medical attention via office visit. The patient had been referred to doctor for further evaluation. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: Within 24 hours of vaccine, got severe (R) deltoid pain, temp to 103.5, redness overlying injection site.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Rash
Clinical narrative: Rash. Erythema. Shoulder pain (L) deltoid per NP school nurse.
Age: 21.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt received ADACEL vaccine in (L) deltoid on 3/29/13 presented to ER 3/31 with redness at site of injection 3 cm induration noted at PCP OV 4/1/13 swelling, warm - prescribed KEFLEX in ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Syringe issue
Clinical narrative: KINRIX was given into left arm and injecting the medicine seeped out around needle. Noticed defect in syringe after taken needle off.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Right arm became swollen, indurated, erythematous, and tender following immunization on 4/2/13. Area of swelling, induration, erythema and tenderness was 4 inches in size (approx) at time of follow up visit for adverse event on 4/3/13.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Generalized convulsions for one minute after administration of HPV (GARDASIL).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site redness, tenderness, and small amount of swelling... Currently reported at approx 76hrs post injection time.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever, seizure activity same day as vaccines given details vague - caregiver doesn't remember details.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on injection arm approximately 2 wks after.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Musculoskeletal stiffness, Staring
Clinical narrative: Pt. was stiff and staring for 5-10 seconds after about 4 hrs after izs. Was taken to ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Chills, Depressed level of consciousness, Nausea, Somnolence
Clinical narrative: Per mother, next day patient had T max 104.3 F with rigors/chills and extra sleepy/difficulty to arouse. Brought to ED. Later patient had nausea. Mother educated about fever management and when to go to ED. Patient came back to Peds clinic for evaluation 4/4/13. Reaction resolved.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Ear pain, Headache, Laboratory test abnormal, Lumbar puncture
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.