chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Paraesthesia
Clinical narrative: Patient indicated on 1-31-13, that she had this reaction and would stop by to discuss. On 2-4-13, we called her and she said she felt tingling and numbness in her right arm shortly after she received the shot. She said she had limited degree of motion and still has this. Her family MD told her not much they could do, and she said she is getting better.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Mobility decreased, Nausea, Neck pain
Clinical narrative: Nausea, arm, neck, wrist, leg pain, fever, chills, decreased limb mobility.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Nausea, arm, neck, wrist, leg pain, fever, chills, decreased limb mobility.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Headache, Injection site induration, Pruritus
Clinical narrative: Headache, local redness, itchy. Induration (warmth, redness, tenderness, swelling) at left arm injection site.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Dizziness, Feeling abnormal
Clinical narrative: Pt received vaccine at 830am. Within 1 hr started feeling bad. That evening pt had dizziness, chills, lethargy, joint pain, fever, & nausea. Lasted for 72 hours. Visited PCP & missed 3 days of work.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Lethargy, Nausea, Pyrexia
Clinical narrative: Pt received vaccine at 830am. Within 1 hr started feeling bad. That evening pt had dizziness, chills, lethargy, joint pain, fever, & nausea. Lasted for 72 hours. Visited PCP & missed 3 days of work.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool 1/28/13 (guaiac positive for stool).
Age: 77.0
Sex: F
Vaccine: TYP, YF
Symptoms: Chest discomfort, Erythema, Paraesthesia
Clinical narrative: Tightness in chest on 1/20/2013 along with paresthesia in hands and feet bilateral. Redness in hands, particularly around old hand fracture. Steroids and BENADRYL given at onset of symptoms; continued 2 steroid taper dose packs. No symptoms reported on 1/28/2013 - finished steroids.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received a FLUVIRIN shot on 1/7/2013. Today (2/4/13) she said her arm has been sore since she got the shot to the point she has trouble lifting it.
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Injection site pain
Clinical narrative: Awakened from sleep while trying to stretch, noticed pain in left shoulder when lifting arm above head. No self-treatment of shoulder pain at time. Decribes pain as intermittent and improves w/ activity; worsens when sedentary or extending arm posteriorly or when lifting arm above head. Examined on 1/29/2013 by primary care provider; pt declined pain meds. No other diagnostics done.
Age: 57.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Asthenia, Dyspnoea, Feeling cold, Headache, Hypersomnia
Clinical narrative: It started with being very cold and could not warm up.  Then during the night I got a fever but could not get up to check it and when I was able to check it it was 103.  I was having trouble breathing and was paranoid.  I thought I was hallucinating and was thinking who is the president and what year is it and did my temperature really say 103.  Plus I was thinking my husband was wanting me to die and I was afraid to tell him I wanted to go to the hospital.  We do Not have that kind of relationship.  Then I got a headache. By morning I was feeling better but was very weak all day and a little weak on Saturday.  Friday I pretty much slept all day.  I did better on Saturday and by Sunday I felt normal again.
Age: 57.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Mobility decreased, Paranoia, Pyrexia
Clinical narrative: It started with being very cold and could not warm up.  Then during the night I got a fever but could not get up to check it and when I was able to check it it was 103.  I was having trouble breathing and was paranoid.  I thought I was hallucinating and was thinking who is the president and what year is it and did my temperature really say 103.  Plus I was thinking my husband was wanting me to die and I was afraid to tell him I wanted to go to the hospital.  We do Not have that kind of relationship.  Then I got a headache. By morning I was feeling better but was very weak all day and a little weak on Saturday.  Friday I pretty much slept all day.  I did better on Saturday and by Sunday I felt normal again.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Right ankle was itchy and round, red patch and grew larger. In the following week a second patch appeared with the same itchy feeling.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported by patient that they were diagnosed with Guillain-Barre' syndrome approximately 1 month after receiving influenza vaccination.
Age: 10.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse events reported. Patient given extra dose HIB vaccine. Parent called next day to report error.  Mom stated patient well with no issues.
Age: 1.05
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Blood test, Body temperature increased, Convulsion, Listless, Lumbar puncture
Clinical narrative: 1 hr post vaccination became listless. On 2/3/2013 ran temp of 100 degrees in AM per father. In PM had a seizure was taken by ambulance to hospital and subsequently airlifted to another hospital. Spiked temp of 106 degrees.
Age: 42.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Full blood count, Injection site erythema, Injection site oedema, Oedema
Clinical narrative: +erythema and edema after vaccination that progressively worsened extending to below L. elbow.  Started receding after 4 days.  On 2/1/13, when I saw her in clinic, erythema and edema were mild over posterior lateral aspect of upper arm and above elbow.
Age: 42.0
Sex: F
Vaccine: MNQ
Symptoms: Red blood cell sedimentation rate increased, White blood cell count normal
Clinical narrative: +erythema and edema after vaccination that progressively worsened extending to below L. elbow.  Started receding after 4 days.  On 2/1/13, when I saw her in clinic, erythema and edema were mild over posterior lateral aspect of upper arm and above elbow.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain in extremity, Pruritus
Clinical narrative: Patient was vaccined on 01/25/13, monitored for 15 mins at the clinic before being released. Patient stated she noticed erythema to left arm that night, and on 01/26/13 she noticed a lump and continued erythema  (5in x 2ins per patient report) which continued for 2 days, 02/03 patient reports some redness and itching while lifting boxes on 02/03/13. Denies any itching today (02/04/13) states some achiness to arm otherwise she report feeling okay. Patient came by clinic and reported this to the pharmacist on 02/04/13, and I called her after returning to the clinic at 2:48pm to inquire about what happened and type of reaction.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Muscular weakness
Clinical narrative: Immediate onset bilateral leg weakness x ~ 4 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Cough, Oropharyngeal pain, Pain, Purulent discharge
Clinical narrative: Pt noticed while heading home that there was a bump on her arm where the flu shot was given the day before.  She never presented to the Dr. until today. She stated it continued to break out into blisers and as they all broke open the skin all became a big open area.  All that is left today is a small slightly purulent sore that looks as if it would scab over and heal if she would let it get some air.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling of arm at DTAP injection site, resolved on its own after 48 hrs. No s/s of infection per mom.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Joint range of motion decreased, X-ray limb normal
Clinical narrative: Pain to injection site and radiate to shoulder. Very limited range of motion to shoulder  - unable to take shirt off herself, and increased pain. 2.4.12 - getting better slowly.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging normal, Pain in extremity, X-ray normal
Clinical narrative: Pain to injection site and radiate to shoulder. Very limited range of motion to shoulder  - unable to take shirt off herself, and increased pain. 2.4.12 - getting better slowly.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal, Nuclear magnetic resonance imaging
Clinical narrative: Woke up and was barely able to walk.  Legs felt like they had wieghts on them - like gravity was heavy. Any walking caused pain.   Called doctor on 12/24/12 who suggested going to emergency room.  Received MRI at hospital and was recommended to see neurogist, and pain specialist.  Went to both and then saw neurosurgeon who sent me back to neurologist for lumbar puncture.  Results of lumbar puncture came back on 1/7 diagnosing Guillain-Barre and was admitted to hospital for 6 days and given IVIG treatment for 5 days.  Still unable to walk for more than a few feet unassisted.  Pain persists.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Sensation of heaviness
Clinical narrative: Woke up and was barely able to walk.  Legs felt like they had wieghts on them - like gravity was heavy. Any walking caused pain.   Called doctor on 12/24/12 who suggested going to emergency room.  Received MRI at hospital and was recommended to see neurogist, and pain specialist.  Went to both and then saw neurosurgeon who sent me back to neurologist for lumbar puncture.  Results of lumbar puncture came back on 1/7 diagnosing Guillain-Barre and was admitted to hospital for 6 days and given IVIG treatment for 5 days.  Still unable to walk for more than a few feet unassisted.  Pain persists.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye swelling, Fatigue, Lip swelling, Swelling face
Clinical narrative: Cough, exhaustion, swollen face, eyes, lips and tongue.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Cough, exhaustion, swollen face, eyes, lips and tongue.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous
Clinical narrative: Red bump rash covering body.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in right deltoid. Per dad in phone call on 1-18-2013 she is doing fine with no reactions.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Injection was in right deltoid.  Per parent, patient had no reactions and is doing fine.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in left deltoid.  Per parent, patient did fine with no reactions.
Sex: F
Vaccine: FLUX
Symptoms: Lung infection
Clinical narrative: This case was reported by a consumer and described the occurrence of lung infection in an adult female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified) and ADVAIR for unknown drug indication. A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR multi dose powder inhaler and Albuterol. On an unspecified date the subject received unspecified dose of Influenza vaccine unspecified (unknown). The subject started ADVAIR and Albuterol on unspecified dates. On an unknown date, less than one year after vaccination with Influenza vaccine unspecified, and an unspecified time after starting, Fluticasone proprionate+salmeterol xinafonate (inhaled) and Albuterol, the Albuterol, the subject experienced lung infection. The subject reported "I had a flu shot but I still ended up with a lung infection. It took longer than usually to get over it. I probably don't know much, but I just know I usually don't get the flu when I get the shots. This year I had a lung infection but I don't think it was due to the flu. I didn't have any other symptoms." This case was assessed as medically serious by GSK. At the time of reporting, the event was resolved.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Hypoaesthesia, Neuropathy peripheral, Oral pain, Teething
Clinical narrative: Pt starting feeling adverse reaction on 1/28 (7 days after vaccine) numbness on chin & pt went to clinic that evening. Found nothing wrong. Prior to that patient's teeth were bothering her (left side). Had pain in mouth while sleeping. Dentist seen 1/29 & no problems evident. Same day saw Dr 1/29 & she diagnosed neuropathy (trigeminal neuralgia).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Trigeminal neuralgia
Clinical narrative: Pt starting feeling adverse reaction on 1/28 (7 days after vaccine) numbness on chin & pt went to clinic that evening. Found nothing wrong. Prior to that patient's teeth were bothering her (left side). Had pain in mouth while sleeping. Dentist seen 1/29 & no problems evident. Same day saw Dr 1/29 & she diagnosed neuropathy (trigeminal neuralgia).
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Nausea
Clinical narrative: Pain in joint bilat, wrist, ankle, elbow occurred approx 24 hr., nausea, and redness at the site. Nausea. (2-1-13) inj, symptom 2-2-13.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness & itching at injection site. Relieved with BENADRYL. No further action necessary.
Age: 1.44
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt's mother brought in the patient, c/o redness and swelling to left thigh, warm to touch. Afebrile. Was seen by provider, prescribed cephalexin for 7 days and BENADRYL PRN.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Redness, swelling to entire left upper arm from deltoid to elbow. Quickly started to resolve within 24-48 hrs. Also patient reported pain to left arm which resolved within 48 hrs.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling to entire left upper arm from deltoid to elbow. Quickly started to resolve within 24-48 hrs. Also patient reported pain to left arm which resolved within 48 hrs.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: One month after vaccination patient has been experiencing cold sores on a monthly basis.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Extrapyramidal disorder
Clinical narrative: With 48 hrs of vaccine, developed a frequent "shuddering movement" (? tic). Lasted few days with decreasing frequency.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site nodule
Clinical narrative: Mom described a "knot" under the skin where shot was given almost 2 wks after shot was given. No "redness" or "red streaks" from site reported. "Feels like scar-tissue" No infection reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Injection 1/17. Elbow, wrist, and shoulder joint pain severe to moderate ever since injection till today 2/4.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash erythematous, Sleep disorder
Clinical narrative: This spontaneous report as received from 73 year old male (72 was also reported) with thyroid disease reporting on himself who 2-3 years ago on approximately 30-JAN-2010 was vaccinated with dose 1 live ZOSTAVAX (dose, route and lot # not provided). No other co-suspects were reported. Concomitant medications included acyclovir and gabapentin. The consumer stated that on 24-JAN-2013; he noticed red spots on his chest and left abdominal area that in a band that went around to his back in a horizontal type pattern. They did not itch, burn, or were painful initially but now he says they are very painful causing him to not sleep. He went to doctor today and was diagnosed with shingles. There was prescribed pain medicine and an antiviral pill acyclovir and gabapentin were given as a treatment. Labs were performed no results provided. The outcome of shingles was unknown. The relatedness for shingles was unknown for live ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical student concerning a patient of unknown age and gender who on 18-JAN-2013 was vaccinated with a dose of live ZOSTAVAX (lot number H011331 ,expiration date 08-SEP-2013) (route not provided) that was exposed to 20F for 360 hours. No adverse event reported. This is one of several reports received from the same source (Other MAARS number 1302USA001216, 1302USA000400, 1302USA001214). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical student concerning a patient of unknown age and gender who on 25-JAN-2013 was vaccinated with a dose of ZOSTAVAX (lot number H011331, expiration date 08-SEP-2013) (route not provided) that was exposed to 20F for 552 hours. NO adverse event reported. This is one of several reports received from the same source (Other MAARS number 1302USA001215, 1302USA000400, 1302USA001214). Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist regarding a 69 years old male patient. The patient's medical history included previous history of recurrent shingles at the time of vaccination. On 24-SEP-2012, the patient was vaccinated with 0.65 ml dose of live ZOSTAVAX subcutaneous, (Lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. About the first week of January 2013, the patient stated to developed shingles lesions. The patient had not been to see his health care provider about the case of shingles and was currently not on treatment for them. Laboratory test was not performed. At the time fo the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical student concerning a patient of unknown age and gender who on 14-JAN-2013 was vaccinated with a dose of ZOSTAVAX (lot number H011331, expiration date 08-SEP-2013) that was exposed to 20F for 264 hours. No adverse event reported. This is one of several reports received from the same source (Other MAARS number 1302USA001216, 1302USA001214, 1302USA001215). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical student concerning a patient of unknown age and gender who on 17-JAN-2013 was vaccinated with a dose of ZOSTAVAX (lot number H011331, expiration date 08-SEP-2013) (route not provided) that was exposed to 20F for 336 hours. No adverse event reported. This is one of several reports received from the same source (Other MAARS number 1302uSA001216, 1302USA000400, 1302USA001215). Additional information has been requested.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Band neutrophil percentage increased, Blood culture, CSF culture negative, CSF glucose normal, CSF protein increased
Clinical narrative: This male subject was enrolled in a study. On 24 January 2013, he received the 1st dose of either the new candidate pneumococcal protein vaccine (dPly/PhtD, 10 mcg) or vaccine placebo (ALPO4) co-administered with Pfizer's PREVENAR 13 and Merck's PEDVAXHIB. On 25 January 2013, one days after the 1st dose of Blinded vaccine, one day after the 1st dose of PREVNAR 13, one day after the 1st dose of PEDVAXHIB and one day after receiving a dose of the concomitant vaccine PEDIARIX, this one-month-old subject developed fever. The subject was hospitalised. The subject was treated with ampicillin trihydrate, cefotaxime and paracetamol. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the fever may have been caused by investigational product, PREVNAR 13 and PEDVAXHIB and that the event was possibly due to the concomitant vaccine PEDIARIX (GlaxoSmithKline) and to a viral infection. Investigator Comments: INITIAL CLINICAL SUMMARY 6 week old boy who had cough for 3 days, received vaccines at 14:15 on 24 Jan 2013. No congestion or rhinorrhea. Sick contacts include three cousins with cough, rhinorrhea, all of whom live in subject's home. At midnight on 25 Jan 2013, baby noted to feel warm and was irritable. Baby brought to ED, Temp documented at 101.2 Rectal and septic work-up initiated, including CBC, blood culture, urinalysis, urine culture, lumbar puncture, Influenza swab, and RSV swab. CBC, U/A and LP were reassuring. Influenza and RSV swabs were negative. Cultures are pending. Unfortunately, due to difficulty obtaining lab studies, baby was started on Cefotaxime prior to obtaining blood culture. Baby was to be admitted to the hospital for observation and antibiotics, but there were no more beds available. Baby was transferred to another facility where the baby was admitted for observation and antibiotics (Ampicillin and Cefotaxime). On admission, the baby was afebrile and appeared well. 29JAN2013 Addendum to Clinical Summary: The infant had temp elevation to 101.9F the first night of hospitalization. The next day the infant was noted to have some cough and RN but no further fever. At 48 hours the cultures were neg (noted antibiotics may cloud the blood culture results). UA and CSF findings did not support either as source of fever. Antibiotics were discontinued after 48 hrs. and the infant was discharged to home on 27Jan2013. Discharge DX: Fever, (Provider's narrative indicates Viral Infection as be most likely cause). Discharge Follow-Up: 29Jan2013 Discharge Meds: None.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: CSF white blood cell count, Cough, Culture urine, Eosinophil percentage, Feeling hot
Clinical narrative: This male subject was enrolled in a study. On 24 January 2013, he received the 1st dose of either the new candidate pneumococcal protein vaccine (dPly/PhtD, 10 mcg) or vaccine placebo (ALPO4) co-administered with Pfizer's PREVENAR 13 and Merck's PEDVAXHIB. On 25 January 2013, one days after the 1st dose of Blinded vaccine, one day after the 1st dose of PREVNAR 13, one day after the 1st dose of PEDVAXHIB and one day after receiving a dose of the concomitant vaccine PEDIARIX, this one-month-old subject developed fever. The subject was hospitalised. The subject was treated with ampicillin trihydrate, cefotaxime and paracetamol. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the fever may have been caused by investigational product, PREVNAR 13 and PEDVAXHIB and that the event was possibly due to the concomitant vaccine PEDIARIX (GlaxoSmithKline) and to a viral infection. Investigator Comments: INITIAL CLINICAL SUMMARY 6 week old boy who had cough for 3 days, received vaccines at 14:15 on 24 Jan 2013. No congestion or rhinorrhea. Sick contacts include three cousins with cough, rhinorrhea, all of whom live in subject's home. At midnight on 25 Jan 2013, baby noted to feel warm and was irritable. Baby brought to ED, Temp documented at 101.2 Rectal and septic work-up initiated, including CBC, blood culture, urinalysis, urine culture, lumbar puncture, Influenza swab, and RSV swab. CBC, U/A and LP were reassuring. Influenza and RSV swabs were negative. Cultures are pending. Unfortunately, due to difficulty obtaining lab studies, baby was started on Cefotaxime prior to obtaining blood culture. Baby was to be admitted to the hospital for observation and antibiotics, but there were no more beds available. Baby was transferred to another facility where the baby was admitted for observation and antibiotics (Ampicillin and Cefotaxime). On admission, the baby was afebrile and appeared well. 29JAN2013 Addendum to Clinical Summary: The infant had temp elevation to 101.9F the first night of hospitalization. The next day the infant was noted to have some cough and RN but no further fever. At 48 hours the cultures were neg (noted antibiotics may cloud the blood culture results). UA and CSF findings did not support either as source of fever. Antibiotics were discontinued after 48 hrs. and the infant was discharged to home on 27Jan2013. Discharge DX: Fever, (Provider's narrative indicates Viral Infection as be most likely cause). Discharge Follow-Up: 29Jan2013 Discharge Meds: None.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Full blood count normal, Influenza virus test negative, Irritability, Lumbar puncture normal, Lymphocyte percentage decreased
Clinical narrative: This male subject was enrolled in a study. On 24 January 2013, he received the 1st dose of either the new candidate pneumococcal protein vaccine (dPly/PhtD, 10 mcg) or vaccine placebo (ALPO4) co-administered with Pfizer's PREVENAR 13 and Merck's PEDVAXHIB. On 25 January 2013, one days after the 1st dose of Blinded vaccine, one day after the 1st dose of PREVNAR 13, one day after the 1st dose of PEDVAXHIB and one day after receiving a dose of the concomitant vaccine PEDIARIX, this one-month-old subject developed fever. The subject was hospitalised. The subject was treated with ampicillin trihydrate, cefotaxime and paracetamol. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the fever may have been caused by investigational product, PREVNAR 13 and PEDVAXHIB and that the event was possibly due to the concomitant vaccine PEDIARIX (GlaxoSmithKline) and to a viral infection. Investigator Comments: INITIAL CLINICAL SUMMARY 6 week old boy who had cough for 3 days, received vaccines at 14:15 on 24 Jan 2013. No congestion or rhinorrhea. Sick contacts include three cousins with cough, rhinorrhea, all of whom live in subject's home. At midnight on 25 Jan 2013, baby noted to feel warm and was irritable. Baby brought to ED, Temp documented at 101.2 Rectal and septic work-up initiated, including CBC, blood culture, urinalysis, urine culture, lumbar puncture, Influenza swab, and RSV swab. CBC, U/A and LP were reassuring. Influenza and RSV swabs were negative. Cultures are pending. Unfortunately, due to difficulty obtaining lab studies, baby was started on Cefotaxime prior to obtaining blood culture. Baby was to be admitted to the hospital for observation and antibiotics, but there were no more beds available. Baby was transferred to another facility where the baby was admitted for observation and antibiotics (Ampicillin and Cefotaxime). On admission, the baby was afebrile and appeared well. 29JAN2013 Addendum to Clinical Summary: The infant had temp elevation to 101.9F the first night of hospitalization. The next day the infant was noted to have some cough and RN but no further fever. At 48 hours the cultures were neg (noted antibiotics may cloud the blood culture results). UA and CSF findings did not support either as source of fever. Antibiotics were discontinued after 48 hrs. and the infant was discharged to home on 27Jan2013. Discharge DX: Fever, (Provider's narrative indicates Viral Infection as be most likely cause). Discharge Follow-Up: 29Jan2013 Discharge Meds: None.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Monocyte percentage, Neutrophil percentage, Nitrite urine absent, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: This male subject was enrolled in a study. On 24 January 2013, he received the 1st dose of either the new candidate pneumococcal protein vaccine (dPly/PhtD, 10 mcg) or vaccine placebo (ALPO4) co-administered with Pfizer's PREVENAR 13 and Merck's PEDVAXHIB. On 25 January 2013, one days after the 1st dose of Blinded vaccine, one day after the 1st dose of PREVNAR 13, one day after the 1st dose of PEDVAXHIB and one day after receiving a dose of the concomitant vaccine PEDIARIX, this one-month-old subject developed fever. The subject was hospitalised. The subject was treated with ampicillin trihydrate, cefotaxime and paracetamol. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the fever may have been caused by investigational product, PREVNAR 13 and PEDVAXHIB and that the event was possibly due to the concomitant vaccine PEDIARIX (GlaxoSmithKline) and to a viral infection. Investigator Comments: INITIAL CLINICAL SUMMARY 6 week old boy who had cough for 3 days, received vaccines at 14:15 on 24 Jan 2013. No congestion or rhinorrhea. Sick contacts include three cousins with cough, rhinorrhea, all of whom live in subject's home. At midnight on 25 Jan 2013, baby noted to feel warm and was irritable. Baby brought to ED, Temp documented at 101.2 Rectal and septic work-up initiated, including CBC, blood culture, urinalysis, urine culture, lumbar puncture, Influenza swab, and RSV swab. CBC, U/A and LP were reassuring. Influenza and RSV swabs were negative. Cultures are pending. Unfortunately, due to difficulty obtaining lab studies, baby was started on Cefotaxime prior to obtaining blood culture. Baby was to be admitted to the hospital for observation and antibiotics, but there were no more beds available. Baby was transferred to another facility where the baby was admitted for observation and antibiotics (Ampicillin and Cefotaxime). On admission, the baby was afebrile and appeared well. 29JAN2013 Addendum to Clinical Summary: The infant had temp elevation to 101.9F the first night of hospitalization. The next day the infant was noted to have some cough and RN but no further fever. At 48 hours the cultures were neg (noted antibiotics may cloud the blood culture results). UA and CSF findings did not support either as source of fever. Antibiotics were discontinued after 48 hrs. and the infant was discharged to home on 27Jan2013. Discharge DX: Fever, (Provider's narrative indicates Viral Infection as be most likely cause). Discharge Follow-Up: 29Jan2013 Discharge Meds: None.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Urine analysis normal, Viral infection, White blood cell count normal, White blood cells urine negative
Clinical narrative: This male subject was enrolled in a study. On 24 January 2013, he received the 1st dose of either the new candidate pneumococcal protein vaccine (dPly/PhtD, 10 mcg) or vaccine placebo (ALPO4) co-administered with Pfizer's PREVENAR 13 and Merck's PEDVAXHIB. On 25 January 2013, one days after the 1st dose of Blinded vaccine, one day after the 1st dose of PREVNAR 13, one day after the 1st dose of PEDVAXHIB and one day after receiving a dose of the concomitant vaccine PEDIARIX, this one-month-old subject developed fever. The subject was hospitalised. The subject was treated with ampicillin trihydrate, cefotaxime and paracetamol. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the fever may have been caused by investigational product, PREVNAR 13 and PEDVAXHIB and that the event was possibly due to the concomitant vaccine PEDIARIX (GlaxoSmithKline) and to a viral infection. Investigator Comments: INITIAL CLINICAL SUMMARY 6 week old boy who had cough for 3 days, received vaccines at 14:15 on 24 Jan 2013. No congestion or rhinorrhea. Sick contacts include three cousins with cough, rhinorrhea, all of whom live in subject's home. At midnight on 25 Jan 2013, baby noted to feel warm and was irritable. Baby brought to ED, Temp documented at 101.2 Rectal and septic work-up initiated, including CBC, blood culture, urinalysis, urine culture, lumbar puncture, Influenza swab, and RSV swab. CBC, U/A and LP were reassuring. Influenza and RSV swabs were negative. Cultures are pending. Unfortunately, due to difficulty obtaining lab studies, baby was started on Cefotaxime prior to obtaining blood culture. Baby was to be admitted to the hospital for observation and antibiotics, but there were no more beds available. Baby was transferred to another facility where the baby was admitted for observation and antibiotics (Ampicillin and Cefotaxime). On admission, the baby was afebrile and appeared well. 29JAN2013 Addendum to Clinical Summary: The infant had temp elevation to 101.9F the first night of hospitalization. The next day the infant was noted to have some cough and RN but no further fever. At 48 hours the cultures were neg (noted antibiotics may cloud the blood culture results). UA and CSF findings did not support either as source of fever. Antibiotics were discontinued after 48 hrs. and the infant was discharged to home on 27Jan2013. Discharge DX: Fever, (Provider's narrative indicates Viral Infection as be most likely cause). Discharge Follow-Up: 29Jan2013 Discharge Meds: None.
Age: 7.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, White blood cell count normal
Clinical narrative: Case number PHHY2013US000553 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 469635) on 02 Jan 2013 with follow-up received from Quality assurance department (reference number: 202587) on 01 Feb 2013. This report refers to 07-year-old male patient. His medical history included orthotropic heart transplant, chronic immunosuppression, Barth syndrome, cyclical neutropenia, cytomegalovirus infection, short stature disorder and constipation. Concomitant medications included amlodipine, atenolol and tacrolimus. The patient was vaccinated with FLUVIRIN (batch number: 1204301) intramuscularly in left arm and PNEUMOVAX (batch number: H012650) intramuscularly in left arm on 11 Oct 2012. On 11 Oct 2012, after the vaccination, he experienced progressive swelling, erythema, and tenderness of his left upper arm and left elbow. He was admitted to hospital for left arm cellulitis and was treated with IV antibiotics. On 12 Oct 2012, the white blood cell count was 10.7 (units and reference range not reported). The outcome of events was reported as complete recovery as of 15 Oct 2012. The seriousness and causality of the events was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1204301) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No further information was available. Follow-up received from Quality assurance department on 01 Feb 2013: Updated batch review report.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Emotional distress, Oedema peripheral, Pain in extremity, Skin irritation
Clinical narrative: Case number PHHY2013US000591 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470116) on 02 Jan 2013 with non-significant follow up received from Quality Assurance Department (reference number: 202596) on 07 Jan 2013, with a follow-up received from a quality assurance department on 01 Feb 2013. This report refers to 66-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: U4490AA) intramuscularly in arm and PNEUMOVAX (batch number: 1502AA) intramuscularly in arm on 29 Sep 2012. On an unspecified date, one or two days after the vaccination, she experienced painful, swollen arm. She stated that the area irritated was the back of her arm and not the area where the shots were given. She had to visit the ER and the physician determined it was cellulitis and prescribed cefadrone for her. She had high risk of C. difficile and was concerned about having to take antibiotic. She was very upset about reaction she had experienced. The outcome of events was reported as condition unchanged as of an unspecified date. The seriousness and causality of the events was not reported. Based on the document review, it was stated that the batch number (U4490AA) was not a FLUVIRIN batch number, so batch review was performed as an unknown batch number. It was reported that without the batch number, a batch specific review could not be carried out. Therefore, this review was based on general review of the quality requirements for FLUVIRIN. The stability data for the multi-dose presentation indicated that the batch would have complied with the product specification at the time of vaccination. Non-significant follow up received from Quality Assurance Department on 07 Jan 2013: Updated QA reference number only. Follow-up was received from quality assurance department on 01 Feb 2013: A batch review report was updated.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2013US000528 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470137) on 02 Jan 2013 also a quality complaint (no: 202365). This report refers to a 73-year-old male patient. His medical history included Crohn's disease. Concomitant medications included ASACOL, atenolol, AMBIEN, DYTRA-K and XANAX. He was vaccinated with FLUVIRIN (batch number: 1205801) intramuscularly in the left arm and PNEUMOVAX (batch number: H011780) intramuscularly in right arm on 08 Oct 2012. On 08 Oct 2012, after the vaccination, his arm was red and hurt about one inch below the injection site. The patient went to emergency room and was diagnosed with cellulitis. He was treated with BACTRIM for cellulitis. The outcome of events was reported as complete recovery as of 17 Oct 2012. The seriousness and causality of the events was not reported. Batch review report (reference number 202365) received from quality assurance department on 30 Jan 2013: Based on the document review, it was stated that the concerned FLUVIRIN batch number 1205801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from QA department received on 30 Jan 2013: Updated the batch review report.
Age: 56.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pain of skin, Pyrexia, Skin infection
Clinical narrative: Case number PHHY2013US000812 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 470398) on 02 Jan 2013 with a non-significant follow up received from Quality Assurance Department (reference number: 202786) on 07 Jan 2013, and with a follow up received from QA department on 04 Feb 2013: This report refers to a 56-year-old patient of an unknown gender. The patient was vaccinated with FLUVIRIN (batch number: 1206701) and PNEUMOVAX (batch number: H009826) both on the same (right arm) on 07 Oct 2012. "Flu shot was administered on front and the PNEUMOVAX was given 2 inches behind". On 09 Oct 2012, the patient felt feverish and arm tenderness for 2 days after vaccination. The patient had taken TYLENOL, MOTRIN and had applied ice on the arm. The fever had improved but redness on flu site lingered. The physician prescribed BACTRIM and informed that the patient had a skin infection. The patient had a visit to emergency room. Outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported. The quality assurance department stated that based on the batch review report it was concluded that the concerned FLUVIRIN batch 1206701 was manufactured in accordance with the approved internal procedures and it is in compliance with cGMP requirements. Non-significant follow up received from Quality Assurance Department on 07 Jan 2013: Updated QA reference number (202786) only. Follow up received from QA department on 04 Feb 2013. Batch review report updated.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Myalgia, Nausea, Pain in extremity
Clinical narrative: I began to feel pain in my thighs from the groin to the knee which got steadily worse.  After a few weeks, the pain moved to my upper arms back.  My doctor diagnosed it as polymyalgia.  The pain is consistent with what other sufferers have experienced after the high dose flu shot.  I have had this pain now for over 2 months and can find no relief. From what I understand, this flu shot has not been tested and proven safe. When I first received the shot on Oct. 16th, after about 3 hours I experienced extreme nausea and chills.  I reported this to VAERS at that time.  But this condition which has affected me and many others according to the internet is much worse. Chills.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2013US000860 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471231) website on 02 Jan 2013 with non-significant follow up received from Quality Assurance Department (reference number: 202609) on 07 Jan 2013, with a follow-up received from a Quality Assurance department (QA no: 202609) on 01 Feb 2013. This report refers to a 68-year-old female patient. Her medical history included lung disease. She was vaccinated with FLUVIRIN (batch number: 1205301) intramuscularly in the right arm on 19 Oct 2012. She was also vaccinated with PNEUMOVAX (manufacturer: Merck and co, batch number: H009826) intramuscularly in the right arm on the same date. On 20 Oct 2012, after vaccination the patient stated that her arm was very sore. On 21 Oct 2012, the patient complained of swollen arm, which was red and warm to touch. The patient went to ER and physician diagnosed it as cellulitis and the patient was given antibiotic (unspecified) as a treatment. The outcome of the events was reported as recovered. The seriousness and causality of the events were not reported. Based on the document review, it was stated that the concerned FLUVIRIN (batch number: 1205301) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from Quality Assurance Department on 07 Jan 2013: Updated QA reference number only. Follow-up was received from quality assurance department on 01 Feb 2013: Batch review report was updated.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Induration, Mass, Oedema peripheral
Clinical narrative: Case number PHHY2013US000869 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 471254) received on 02 Jan 2013 with follow-up received from Quality assurance department (reference number: 202321) on 30 Jan 2013. This report refers to a 70-year-old male patient. Concomitant medications included trimethoprim-sulfamethoxazole, doxycycline and tramadol. He was vaccinated with FLUVIRIN (batch number 1204601) intramuscularly and PNEUMOVAX (other manufacturer, batch number H010515) intramuscularly both in his right arm on 30 Aug 2012. On 30 Aug 2012, after the vaccination he had high fever. He also had redness, hot to touch, swelling from top of shoulder to the elbow, a hard mass in the middle. The patient visited emergency room and was diagnosed with cellulitis. The outcome of the events was reported as recovered as of 24 Oct 2012. The seriousness and causality assessment of the events was unknown. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1204601) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No further information was available. Follow-up received from Quality assurance department on 30 Jan 2013: Updated batch review report.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Case number PHHY2013US000869 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 471254) received on 02 Jan 2013 with follow-up received from Quality assurance department (reference number: 202321) on 30 Jan 2013. This report refers to a 70-year-old male patient. Concomitant medications included trimethoprim-sulfamethoxazole, doxycycline and tramadol. He was vaccinated with FLUVIRIN (batch number 1204601) intramuscularly and PNEUMOVAX (other manufacturer, batch number H010515) intramuscularly both in his right arm on 30 Aug 2012. On 30 Aug 2012, after the vaccination he had high fever. He also had redness, hot to touch, swelling from top of shoulder to the elbow, a hard mass in the middle. The patient visited emergency room and was diagnosed with cellulitis. The outcome of the events was reported as recovered as of 24 Oct 2012. The seriousness and causality assessment of the events was unknown. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1204601) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No further information was available. Follow-up received from Quality assurance department on 30 Jan 2013: Updated batch review report.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test abnormal, Cellulitis, Chills, Erythema, Pyrexia
Clinical narrative: Case number PHHY2013US000694, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471560) website (QA report no: 202323) on 02 Jan 2013. This report refers to a 47-year-old female patient. Her medical history included high blood pressure (BP), hyperthyroidism and allergy to sulfa antibiotics. Her concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 122102) and PNEUMOVAX (other manufacturer, batch number: 0813AA) on 19 Sep 2012. Both the vaccines were given intramuscularly. On 20 Sep 2012 (at 7 PM), she started developing chills and fever. On the same day (at 9.20 PM), the area (undetermined) was swollen, red and felt hot/warm to touch. On 21 Sep 2012, she had consulted the physician (emergency visit) and blood test was done for infection. The blood test result was abnormal and she was diagnosed with cellulitis. The outcome of the events was reported as recovered. The causality and seriousness of the events were not reported. Batch review report (reference number 202323) received from quality assurance department on 30 Jan 2013: Based on the document review, it was stated that the concerned FLUVIRIN, batch number 122102 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from QA department received on 30 Jan 2013: Updated the batch review report.