chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from licensed vocational nurse, concerning a 2 year old twin patient of unknown gender (twin experience reported on 1403USA003554). The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient received an expired dose of vaccinated with M-M-R II, (dose and route not provided), Lot # 1732AA, expiry date on 04-NOV-2013. No adverse effects reported. This is one of several reports received from a same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Foetal exposure during pregnancy
Clinical narrative: This spontaneous report was received from a registered nurse refers to a male infant of 36 weeks gestational age. On unknown date in March 2011, the infant's mother was vaccinated with dose 1 of GARDASIL for prevention of HPV. On 28-SEP-2011, the infant's mother was vaccinated with dose 2 of GARDASIL. On 09-NOV-2011, infant's mother went to the office and had a positive pregnancy test. She was 5.5 weeks pregnant with an LMP of 03-OCT-2011. At 36 weeks the infant's mother was induced due to hypertension and anemia. On 14-JUN-2012 the infant boy was born with birth weight of 4 pounds and 10 ounces at 36 weeks. The infant had no congenital anomalies. There was no information regarding infant's pediatrician. The infant's mother had not received any further GARDASIL vaccines. This is one of 2 reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from licensed vocational nurse, concerning a 2 year old twin patient of unknown gender (twin experience reported on 1403USA003555). The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient received an expired dose of vaccinated with MMR II (dose and route not provided), Lot # 1732AA, expiry date on 04-NOV-2013. No adverse effects reported. This is one of several reports received from a same source. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema normal, Emotional distress, Haematochezia
Clinical narrative: Inconsolability, abdominal pain: bloody stools started 02/19/2014, admitted to hospital 02/27/2014 found to have small bowel/small bowel intussusception, twice visualized on ultrasound, self resolved. No lead points or polyps in bowel identified to cause this by diagnostic barium enema. Discharged from hospital in good condition 3/1/2014.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Inconsolability, abdominal pain: bloody stools started 02/19/2014, admitted to hospital 02/27/2014 found to have small bowel/small bowel intussusception, twice visualized on ultrasound, self resolved. No lead points or polyps in bowel identified to cause this by diagnostic barium enema. Discharged from hospital in good condition 3/1/2014.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity, Rash, Skin warm
Clinical narrative: Pt reports that arm became swollen, painful and hot after receiving vaccine. Later developed a rash that went down her arm.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. Pharmacy technician reported that the patient was administered a dose of VARIVAX (Merck) (0.5ml, lot# 1943AA, expiry date 12-DEC-2013, subcutaneous, indication not reported) on 24-FEB-2014 that was expired. No adverse events were reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 5 year old male patient. The patient's medical history and concurrent conditions were not provided. On 26-FEB-2014 the patient was vaccinated with a dose of PROQUAD, with an expiration date of 23-FEB-2014. Information regarding dose, route and lot number was not provided. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself via market research agency. No medical history was reported. On an unknown date in August 2012, the patient was vaccinated with a dose of ZOSTAVAX. No concomitant mediations were reported. On an unknown date in September 2012, the patient started to break out 1 week ago after vaccination with bumps on lower back which was confirmed by HCP as shingles. Patient took medications provided by the doctor plus BENADRYL cream. No diagnostic tests were performed. The outcome of shingles was reported as recovered on an unknown date October 2012(3 weeks duration). The causality was not reported. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 year old patient of unknown gender. The patient's medical history and concurrent conditions were not provided. It was reported that the patient was vaccinated with the first dose of GARDASIL 'when they were 16 years old". The patient was in the office on 16-FEB-2014, attempting to received the 2nd dose of GARDASIL and "they were now 21 years old". Information regarding dose, route and lot number were not provided. No adverse effects were reported. Additional information is not expected.
Age: 1.05
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a consumer refers to a 12 month old female patient concerning her daughter. Patient had no pertinent medical history and drug allergies. On 03-FEB-2014 the patient was vaccinated with VARIVAX (merck) (strength, dose number, dose unit, lot# and expiry date unknown), intramuscular. Concomitant therapies included M-M-R II,  TDAP (manufacture unknown) and hepatitis A vaccine (manufacture unknown) on the same day. Consumer reported that when the medical assistant, administered the VARIVAX (merck), it was done with a 1 inch needle and administered intramuscularly at a 90 degree angle. While the medical assistant was trying to administer the VARIVAX (merck) into her daughter's thigh, somehow the VARIVAX (merck) sprayed out from the syringe like a garden hose and shot into the consumer right eye. The patient did not get the full dose and another dose of VARIVAX (merck) was administered to the patient at this same visit. No treatment was given for the event and no laboratory tests were performed. Consumer also noted that another medical assistant administered PROQUAD and VARIVAX to an unspecified 12 month old patient on an unspecified date which was captured in case# 1403USA002425. No further information was provided. This case# 1402USA002360 has been linked to case #1402USA007700 via same reporter link. Follow up information was received from the consumer refers to her 1 year old (initial reported as 12 months old) daughter with one sibling. On 03-FEB-2014 5:00 pm, the patient was vaccinated with a dose of VARIVAX (merck) (lot # H017133, expiry date unspecified) intramuscular in the right thigh (dose not reported). Concomitant therapies included M-M-R II (lot # J006994, expiry date 14-JUN-2015) subcutaneous in the right thigh (dose not reported), DTAP (lot # AC14B177BA, expiry date unspecified) intramuscular in the left thigh (dose not reported) and VAQTA (lot # J003719, expiry date 27-SEP-2015) intramuscular in the left thigh (dose not reported) vaccinated at the same day. On 03-FEB-2014 5:00 pm, when the medical assistant, administered the VARIVAX (merck), it was done with a 1 inch needle and administered intramuscularly at a 90 degree angle. While the medical assistant was trying to administer the VARIVAX (merck) into her daughter's thigh, somehow the VARIVAX (merck) sprayed out from the syringe like a garden hose and shot into the consumer right eye (which was captured in case# 1402USA007700). This caused mild irritation. The mother proceeded to flush eye and had routine eye exam the following day. The exam was normal. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Dyspnoea, Head discomfort, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a 65 year old female patient with allergic to all sulfa drugs and rheumatoid arthritis refers to herself. On 03-FEB-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) (one single injection, injection). The patient's medical history included fibromyalgia. Concomitant therapies included LYRICA. On 03-FEB-2014 the patient experienced large mesquite like bite at the injection site 8 hours after receiving PNEUMOVAX 23. The patient then reported that the "bite" became tender and then it was more "red and rash like" and later spread to the under part of her arm. The patient also reported that on 06-FEB-2014, the physician treated this "red and rash like bite" with KEFLEX (dosage/frequency/manufacturer unspecified). The patient then stated that she was allergic to all "SULFA DRUGS" (names/dosages/frequencies/manufacturer unspecified). The patient explained that this "red rash like bite" had now turned into a "rock hard lump and has not yet resolved itself". The patient reported that this created a "flare up in her body, breathing problems, head, sinus and neck problems". "Blood work" was performed and no results were provided. The reporter did not provide the seriousness or causality of the event. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site rash, Musculoskeletal discomfort, Rash erythematous
Clinical narrative: This spontaneous report as received from a 65 year old female patient with allergic to all sulfa drugs and rheumatoid arthritis refers to herself. On 03-FEB-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) (one single injection, injection). The patient's medical history included fibromyalgia. Concomitant therapies included LYRICA. On 03-FEB-2014 the patient experienced large mesquite like bite at the injection site 8 hours after receiving PNEUMOVAX 23. The patient then reported that the "bite" became tender and then it was more "red and rash like" and later spread to the under part of her arm. The patient also reported that on 06-FEB-2014, the physician treated this "red and rash like bite" with KEFLEX (dosage/frequency/manufacturer unspecified). The patient then stated that she was allergic to all "SULFA DRUGS" (names/dosages/frequencies/manufacturer unspecified). The patient explained that this "red rash like bite" had now turned into a "rock hard lump and has not yet resolved itself". The patient reported that this created a "flare up in her body, breathing problems, head, sinus and neck problems". "Blood work" was performed and no results were provided. The reporter did not provide the seriousness or causality of the event. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Sinus disorder
Clinical narrative: This spontaneous report as received from a 65 year old female patient with allergic to all sulfa drugs and rheumatoid arthritis refers to herself. On 03-FEB-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) (one single injection, injection). The patient's medical history included fibromyalgia. Concomitant therapies included LYRICA. On 03-FEB-2014 the patient experienced large mesquite like bite at the injection site 8 hours after receiving PNEUMOVAX 23. The patient then reported that the "bite" became tender and then it was more "red and rash like" and later spread to the under part of her arm. The patient also reported that on 06-FEB-2014, the physician treated this "red and rash like bite" with KEFLEX (dosage/frequency/manufacturer unspecified). The patient then stated that she was allergic to all "SULFA DRUGS" (names/dosages/frequencies/manufacturer unspecified). The patient explained that this "red rash like bite" had now turned into a "rock hard lump and has not yet resolved itself". The patient reported that this created a "flare up in her body, breathing problems, head, sinus and neck problems". "Blood work" was performed and no results were provided. The reporter did not provide the seriousness or causality of the event. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from licensed vocational nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient received an expired dose of MMR II (dose and route not provided), Lot # 1732AA, expiry date on 04-NOV-2013. No adverse effects reported. This is one of several reports received from a same source. Additional information has been requested.
Sex: U
Vaccine: FLUC3
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: At 1-week post vaccination, patient reported symptoms of headache, nausea, and dizziness. The severity of symptoms has decreased in severity, but are still being experienced 3+ months later.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Incorrect dose administered, No adverse event
Clinical narrative: No adverse events. Client received FLUVIRIN at a health fair on 10-13-13. Also received another FLUVIRIN at Health Department on 10-21-13. Client was pregnant when she received both vaccines.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Appetite disorder, Crying, Speech disorder
Clinical narrative: 45 min after vaccine administration - high pitched cry extending off and on through night and next morning. Baby stopped trying to sit up and stopped verbalizing consonants. Also stopped eating solids. Identical twin sat up 9/21- pt sat up 11-27.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity, Rash, Rash erythematous
Clinical narrative: Pt developed allergic reaction within 1-2 m. after Hep A injection. (R) deltoid. Developed erythematous rash on both arms and anterior trunk. No resp. distress. 15ml Diphenhydramine.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity, Respiratory disorder
Clinical narrative: Arm pain, upper resp symptoms.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Cough, Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm and shoulder pain. H/A, stomach cramps, congestion, cough. Doesn't know if she has allergy to egg or not, but doesn't eat eggs. Didn't inform employer of reaction to eggs.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Arm and shoulder pain. H/A, stomach cramps, congestion, cough. Doesn't know if she has allergy to egg or not, but doesn't eat eggs. Didn't inform employer of reaction to eggs.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm pain reported 10/31/2013. Tx with steroids.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Respiratory disorder
Clinical narrative: Upper resp symptoms - 10/24/2013 hospitalized with pneumonia.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Left thigh red, swollen, itchy and painful at both immunization site. Fever of 104 documented.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHEH2014US004368 is an initial spontaneous report from a consumer received on 27 Feb 2014. This report refers to 31-year-old female patient. She had no existing condition before the vaccination. Concomitant medications were not reported. She was vaccinated with one single dose of FLUVIRIN (batch number: 13392P) intramuscular on 28 Oct 2013. On the same day, she went for a swim and every time she lifted her arm she experienced a sharp pain where she had received the injection. She never had pain in her left arm. It does not hurt to touch but to this day, she experienced the same level of pain whenever she lifts her arm. The reporter assessed the events as serious (significant disability). Outcome of the events was reported as condition unchanged. Causality of the events was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age who on 05-MAR-2014, was vaccinated subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 (lot number 0653AE) that was expired. The vaccine expired on 10-FEB-2014. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Patient states she felt tired on 3-3-14, but on 3-4-14 she had diarrhea, fatigue, nausea and headache. No swelling or soreness at site of injection or respiratory problems. Symptoms resolved on 3-5-14, no medical care was needed.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Developed hive-like rash to bl legs 5 days after administration of vaccine with clearing around site of immunization on left thigh. No other signs of illness. No other recent exposures.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Disorientation, Dizziness, Fatigue, Hypoaesthesia, Tremor
Clinical narrative: Numbness in right hand, right foot and right side of the face. Blurred vision, dizziness, disorientation, fatigue and tremors in the right hand.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Vision blurred
Clinical narrative: Numbness in right hand, right foot and right side of the face. Blurred vision, dizziness, disorientation, fatigue and tremors in the right hand.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test, Antinuclear antibody, Biopsy skin, Blood copper, Blood heavy metal test
Clinical narrative: Pt reported that she got Zostavax on 10/18/12 & Flu shot on 9/25/12. Reports burning sensation in arms and legs involving shoulder, forearm & thigh, this started 2 days after she got Zostavax vaccine. Improved in 2/13, but in 3/13 got worse. On a scale out of 10 her burning is rated a 5-6.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Electromyogram, Electrophoresis protein, Full blood count, Glycosylated haemoglobin
Clinical narrative: Pt reported that she got Zostavax on 10/18/12 & Flu shot on 9/25/12. Reports burning sensation in arms and legs involving shoulder, forearm & thigh, this started 2 days after she got Zostavax vaccine. Improved in 2/13, but in 3/13 got worse. On a scale out of 10 her burning is rated a 5-6.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hepatitis C, Immunology test, Nerve conduction studies, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Pt reported that she got Zostavax on 10/18/12 & Flu shot on 9/25/12. Reports burning sensation in arms and legs involving shoulder, forearm & thigh, this started 2 days after she got Zostavax vaccine. Improved in 2/13, but in 3/13 got worse. On a scale out of 10 her burning is rated a 5-6.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Vitamin B6
Clinical narrative: Pt reported that she got Zostavax on 10/18/12 & Flu shot on 9/25/12. Reports burning sensation in arms and legs involving shoulder, forearm & thigh, this started 2 days after she got Zostavax vaccine. Improved in 2/13, but in 3/13 got worse. On a scale out of 10 her burning is rated a 5-6.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Fatigue, Feeling cold, Hyperhidrosis, Pain
Clinical narrative: About 13 hours after receiving Tdap I had cold sweats.  Could not get warm and drenched in sweat. Also had severe body aches. Worse than any flu symptoms I have ever experienced. Extreme exhaustion. Could not get out of bed until 3:45 the day after receiving vaccination.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Pyrexia, Rash pruritic, Throat irritation
Clinical narrative: C/O fever - 99.7, itchy bumps on body and sore itchy throat. Rates pain in throat at 3.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Asthenia, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Client noted on (R) arm (where the injection was given) hot, swollen, painful (localized) and mild weakness started yesterday 3/6/14. Nurse noted on the injection site - mild soreness and swelling. No open area, warm to touch.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Diarrhoea, Urticaria
Clinical narrative: Patient developed hives on chest, arms, back and thighs at 1900 on 3-6-14. Given dose of BENADRYL and hives gone morning of 3-7-14. Hives started on forehead 3-7-14 at approximately 12 noon. Given dose BENADRYL - resolved by 1400 - will continue BENADRYL every 6 hours until hives gone x 24 hours.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Local swelling, Pain in extremity
Clinical narrative: Initial soreness of Lt arm.  7 PM 3/6/14 arm became extremely painful and swollen.  Pt used ibuprofen and Icy Hot on arm. Pt contacted PCP where shot given.  Arm circumference Rt wrist 8" and deltoid 16".  Lt wrist 9" and  deltoid 17".  Dr. notified and advised to go to ER.  Pt refused to go to ER due to child care.  Pt given Diphenhydramine 25 mg tablet po given at 3:00 PM.  Instructed to take Diphenhydramine 25 mg po TID.  Lt. radial pulse intact.  Neurosensory intact to Lt hand.  Decreased ROM of Lt fingers and arm. No shortness of breath, no wheezing, no stridor, no dizziness.  Pt instructed to go to ER if condition changes to develop numbness or loss of sensation in arm, decrease in temperature, or change in color of arm.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Injection site erythema, Skin warm
Clinical narrative: Circumferential erythema approx. 3 in above site of injection and approx. 6 in below site of injection.  Limited range of motion of injected arm and warm to touch.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Death, Hypophagia, Lethargy
Clinical narrative: Patient was a former 23 wk 6 day gestation premature infant who was discharged home from NICU on 2/27/14 into child protective services. She had her 2 mo immunizations in hospital and followed up with us on 3/3/14. She was given her 4 mo vaccines - which were the same as 2 mo shots. Became more lethargic on 3/3/14 and decreased PO intake. Died the following day.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash started in the vagina area and then spread to torso, legs, arms, and cheeks. No fever.
Age: 1.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Head banging, Screaming
Clinical narrative: Child started screaming and banging her head approx 2 hours after vaccination per mother. Child continues to exihibit this behaviour at least once daily per mother. Had never done this prior.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: MOTHER REPORTS WARMTH, REDNESS AND SWELLING TO SITE. PARENT ADVISED TO APPLY COLD COMPRESS/ICE TO SITE. ADMINISTER ACETAMINOPHEN OR IBUPROFEN, IF DESIRED.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Started with a headache followed by joint pain in shoulder, knee and hip. Next morning woke up with a headache and the injection area was sore, swollen and red.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus
Clinical narrative: At 11:00am started w/arm itching, then after one hour it began to hurt and swell.  The redness 10cmX8cm started this morning around 8am(03/07/2014).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Local swelling, Pruritus, Skin irritation
Clinical narrative: Within just a few minutes my arm began to itch, burn and turn red and immediately got hot.  A lump appeared.  Began to itch more as time went on.  The pharmacist gave me Benadryl liquid..it helped temporarily, but that night swelled around 1/2 my arm and this went on for at least 4 days. Called my Dr. and he said wait another day as it could be abscessed..however, it has subsided but not completely to this date, still some irritation.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Upper extremity mass
Clinical narrative: Within just a few minutes my arm began to itch, burn and turn red and immediately got hot.  A lump appeared.  Began to itch more as time went on.  The pharmacist gave me Benadryl liquid..it helped temporarily, but that night swelled around 1/2 my arm and this went on for at least 4 days. Called my Dr. and he said wait another day as it could be abscessed..however, it has subsided but not completely to this date, still some irritation.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Aphagia, Bedridden, Cough, Impaired work ability, Malaise
Clinical narrative: None. Until the next day starting with a dry cough, continued into throwing up & a fever. I thought it was the flu. I was bed ridden for a whole week; could not move or eat. It just hit me today what may be caused by this after reading the possible risks after this vaccine. I broke the fever last night but currently still have a very bad cough. Im not sure if my illness is from this but it is quite ironic and have never been so sick in my entire life.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Mobility decreased, Pyrexia, Vomiting
Clinical narrative: None. Until the next day starting with a dry cough, continued into throwing up & a fever. I thought it was the flu. I was bed ridden for a whole week; could not move or eat. It just hit me today what may be caused by this after reading the possible risks after this vaccine. I broke the fever last night but currently still have a very bad cough. Im not sure if my illness is from this but it is quite ironic and have never been so sick in my entire life.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: The patient was diagnosed with intussusception on 3/5/14.  Patient received Rotateq on 2/27/14.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Paraesthesia, Swelling
Clinical narrative: Initially painful and swollen, then noticed numbness and tingling.  States she feels like arm is weaker than the other.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Influenza like illness, Injection site pain, Joint range of motion decreased
Clinical narrative: I received the Tdap vaccine on 03/06/2014 as a requirement for work.  Within hours I had pain in the left shoulder where I received the vaccine.  I had anticipated being sore and thus requested that the shot be given on the left side in my non-dominant arm.  Tenderness was greater than anticipated but by the next morning had progressed to excruciating pain.  In addition, I had flu like symptoms with whole body aches and joint pain.  I took 400mg ibuprofen twice with only minimal improvement of symptoms.  I felt feverish and tympanic membrane temperature was 100.5 F.  This was after having taken Motrin about an hour prior so Tmax is unknown.  The alarming symptom was the excruciating 8/10 pain in left arm.  I have limited range of motion on that side d/t both pain and weakness.  I cannot raise the left arm greater than 30 degrees in any direction and if I try to I get pain that radiates up my neck and down the ulnar side of my arm.  I have pain from the slightest bump to my body which is nearly unbearable and I am completely unable to lay on that side, use it for support or pick my son up with the left arm.  This is both scary and concerning as I am an ICU nurse and will not be able to fulfill all the requirements of my job if this persists.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal disorder, Neck pain, Pain, Pain in extremity, Tenderness
Clinical narrative: I received the Tdap vaccine on 03/06/2014 as a requirement for work.  Within hours I had pain in the left shoulder where I received the vaccine.  I had anticipated being sore and thus requested that the shot be given on the left side in my non-dominant arm.  Tenderness was greater than anticipated but by the next morning had progressed to excruciating pain.  In addition, I had flu like symptoms with whole body aches and joint pain.  I took 400mg ibuprofen twice with only minimal improvement of symptoms.  I felt feverish and tympanic membrane temperature was 100.5 F.  This was after having taken Motrin about an hour prior so Tmax is unknown.  The alarming symptom was the excruciating 8/10 pain in left arm.  I have limited range of motion on that side d/t both pain and weakness.  I cannot raise the left arm greater than 30 degrees in any direction and if I try to I get pain that radiates up my neck and down the ulnar side of my arm.  I have pain from the slightest bump to my body which is nearly unbearable and I am completely unable to lay on that side, use it for support or pick my son up with the left arm.  This is both scary and concerning as I am an ICU nurse and will not be able to fulfill all the requirements of my job if this persists.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13, RV5
Symptoms: Cough, Retching, Vomiting
Clinical narrative: Intractable vomiting after Rotateq oral vaccine administration.  One hour after administration my daughter was breastfed and given avocado and put down for a nap.  She awoke out of sleep coughing and had a very large emesis.  She proceeded to vomit for the next four hours every 15-20 minutes, ending in dry heaves.  Returned to pediatrician's office for recheck and MD prescribed Zofran and Pedialyte.  After giving Zofran she was able to tolerate Pedialyte given from a syringe.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Inflammation, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt reports 2 days after vaccine given, she woke up with a very sore arm - painful and numb at the same time - she had a hard time moving her left arm - she knew something was wrong. The next week she began frequent visits to the chiropractor who said there was a lot of inflammation. Pt states she is feeling better but her arm still hurts.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, X-ray limb normal
Clinical narrative: Pt reports 2 days after vaccine given, she woke up with a very sore arm - painful and numb at the same time - she had a hard time moving her left arm - she knew something was wrong. The next week she began frequent visits to the chiropractor who said there was a lot of inflammation. Pt states she is feeling better but her arm still hurts.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus generalised, Throat tightness
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 48 year old female patient. Pertinent medical history and drug reactions/allergies were not reported. On 12-OCT-2012, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (Lot# was reported as H013847 and expiration date April /2014) (dose and route were not reported) and influenza virus vaccine (manufacturer unknown) (dose, lot number, expiration date and route were not reported), in separate arms. Concomitant therapy was not reported. The patient called in to the physician, office on 15-OCT-2012 stating that she "had been itchy all over her body for 2 days (13-OCT-2012) and felt like her throat was closing". The physician, instructed the patient to go to an unspecified Emergency Room. The field representative reported that the patient was admitted to an unspecified hospital on 15-OCT-2012. "While in the hospital they reported" the injection site where the pneumococcal vaccine (manufacturer unknown) was administered was red, swollen and hot to the touch. Lab diagnostics studies were not reported. The patient was discharged from the hospital on 17-OCT-2012. The field representative reported that the patient "had since recovered". Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Arrested labour, Caesarean section, Exposure during pregnancy, Ultrasound antenatal screen, Ultrasound scan abnormal
Clinical narrative: Information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product concerning a 24 year old female who was vaccinated with doses of GARDASIL (lot# 672232/1495AA, exp: 25-FEB-2013), 0.5ml, intramuscularly on 17-JUN-2011 and in approximately 2012, respectively. The nurse reported that the patient received a third dose of GARDASIL and found out a week day later that she was pregnant. No adverse effect known. The patient did not sought medical attention. The patient's LMP was 15-DEC-2011 and estimated delivery date 20-SEP-2012. Follow up information has been received from a physician concerning the patient with abnormal Papanicolaou smear (low-grade squamous intraepithelial lesion positive HPV), with no significant past medical history and with no previous pregnancies, full term deliveries, spontaneous abortions, fetal deaths or elective terminations who had received the first dose of GARDASIL (lot# 668260/1570Z, expiry date: 06-APR-2013) on 17-JUN-2011, the second dose of GARDASIL (lot# 669308/0636AA, expiry date: 11-AUG-2013) on 18-AUG-2011 and the third dose of GARDASIL (lot# 672232/1495AA, expiry date: 22-AUG-2014) on 13-JAN-2012. On 31-JAN-2012 the patient did ultrasound for dating and the result showed early gestational sac. Estimated conception date was 29-DEC-2011, date of last menstrual period was 15-DEC-2011 and estimated delivery date was 21-SEP-2012. Follow up information received with updates: On 25-FEB-2014 a phone call was placed to the physician/licensed practical nurse (LPN). The receptionist stated that the physician and L.P.N. were unavailable at that time. The receptionist also stated that their practice only does gynecology not obstetrics. The receptionist stated that the hospital where patient is being treated requested medical records from their practice. On 26-FEB-2014 a phone call was placed to institute. The receptionist stated someone will have to call back. A message was left requesting the pregnancy outcome for the patient. On 28-FEB-2014 a phone call was placed to institute. The receptionist stated the office has upgraded to a new computer system and she does not have access to the old system, however one of the providers can get access. The receptionist asked that someone call back on 04-MAR-2014 for additional information. On 05-MAR-2014, called and spoke to a Nurse Practitioner. The nurse reported that the baby was born via C-section for arrested labor and there were no problems. Baby was born normal and healthy with no congenital anomalies. Upon internal review, the event baby was born via C-section is considered to be an other medically important event. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever for several days including one day of 106.2.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: Immediate raised wheals with erythema around injection sites. Diphenhydramine HCl 12.5mg/5ml given orally.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling of (L) arm.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt was given Zostavax on 3/5/14. On 3/7/14 she returned and the site was somewhat swollen and red. Informed pt to call me or MD if it gets any worse or more painful. Also told her she could ice it if she wanted.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Injection site reaction, Local reaction, Rash maculo-papular, Skin lesion
Clinical narrative: 2 maculopapular lesions to the lateral aspect of left thigh without erythema or warmth. Slight induration. Non-infected localized reaction. Tx: warm compresses.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site discharge, Injection site swelling
Clinical narrative: 3/6/14 (L) upper arm swollen and draining clear fluid. Given BENADRYL and Rx for prednisone.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Diarrhoea, Occult blood negative, Vomiting, Weight decreased
Clinical narrative: Patient had vaccines 2/28/14 then 4 days later developed vomiting and diarrhea. Weight loss = 6 oz.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Immediate post-injection reaction, Swelling
Clinical narrative: Pt had a allergic reaction to the MMR lot # H018949. Just when I injected the MMR vaccine it started to swell up. I then told dr to inform her. Dr then informed me to give pt a cold patch to put on right leg. Pt then waited 15 mins. but it was still the same.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Infantile spitting up, Influenza virus test, Metabolic function test, Pyrexia
Clinical narrative: Excessive sleepiness, fever. Parents report they first noted fever at approx 2100, was 103.1 rectally; went to ER and there was 101.7 rectally no TYLENOL given prior to that visit; since the ER visit, no further fever whatsoever; nursed well while in ER; has continued to nurse well since then. Became sleepy yesterday during day; has continued to be sleepier than usual this AM-no prolonged wakeful periods although does wake up to nurse vigorously. Had forceful spitup at 1600 yesterday; had another at ER's brief series, no spitting  up this AM.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Somnolence, Urine analysis
Clinical narrative: Excessive sleepiness, fever. Parents report they first noted fever at approx 2100, was 103.1 rectally; went to ER and there was 101.7 rectally no TYLENOL given prior to that visit; since the ER visit, no further fever whatsoever; nursed well while in ER; has continued to nurse well since then. Became sleepy yesterday during day; has continued to be sleepier than usual this AM-no prolonged wakeful periods although does wake up to nurse vigorously. Had forceful spitup at 1600 yesterday; had another at ER's brief series, no spitting  up this AM.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Unusually red and swollen 3 days out. 10 inches in diameter. Given course of antibiotic by dr.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender (reported as a child). Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (dose, strength and route were not reported) lot # H012983 expiration date 28-FEB-2014. Co-suspect and concomitant therapies were not reported. On an unknown date, the patient was administered expired ROTATEQ vaccine. No adverse effects reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a physician referring to a 2 month old infant to an unknown gender who on 04-MAR-2014, was vaccinated with the first dose of LIQUID PEDVAXHIB (lot # not reported). The physician reported that the syringe broke during administration of a first dose of LIQUID PEDVAXHIB to a 2 month old infant. Physician stated he was not sure if the patient received any of the LIQUID PEDVAXHIB dose during administration. No adverse symptoms reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician via a Company Representative concerning a 61 year old male patient without pertinent medical history. Drug reactions/allergies were not reported. In June 2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot number and expiration date were not reported) as directed. Secondary therapies were not reported. Concomitant therapies included unspecified statin medication which was discontinued and the problem persisted. Reporter explained that in June 2012, the patient developed a localized pain bilaterally down his arm accompanied by numbness and tingling in his hands following administration with ZOSTAVAX. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 07-AUG-2013 the patient was vaccinated with a doe of PNEUMOVAX 23 (lot # H012650, expiration date: 27-FEB-2014) (dose, route unknown) which was improperly stored. No adverse event reported. This is one of several reports (1403USA000875; 1403USA001194; 1403USA001195) from the same reporter. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 01-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J001180, expiration date: 18-AUG-2014) (dose, route unknown) which was improperly stored. No adverse event reported. This is one of several reports (1403USA000875; 1403USA001193; 1403USA001195) from the same reporter. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 05-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H012650, expiration date: 27-FEB-2014) (dose, route unknown) which was improperly stored. No adverse event reported. This is one of several reports (1403USA001193; 1403USA001194; 1403USA001195) from the same reporter. Additonal information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 30-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # HJ001180, expiration date: 18-AUG-2014) (dose, route unknown) which was improperly stored. No adverse event reported. This is one of several reports (1403USA000875; 1403USA001193; 1403USA001194) from the same reporter. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Blood test, Computerised tomogram, Feeling of body temperature change, Lumbar puncture
Clinical narrative: Thighs felt achy and starting to have pain. Elevated feet. Hot and cold sensation through body. Legs started feeling shaky and unable to bear weight coming down stairs. By 12/15/13 pm could not walk.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: Thighs felt achy and starting to have pain. Elevated feet. Hot and cold sensation through body. Legs started feeling shaky and unable to bear weight coming down stairs. By 12/15/13 pm could not walk.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives broke out on both arms 15 mins after shot.
Age: 62.0
Sex: F
Vaccine: PPV, TD, VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Temp of 106.1 right arm at injection swollen, red, hard and hot to the touch applied warm compress to area, Tylenol 1000mg taken temp down to 101.2 the next day 3/7/2014 as of 3/8/2014 no temp area remain red, swollen and tender to the touch and swollen area approximately 4cmx8cm not as painful today.
Age: 62.0
Sex: F
Vaccine: PPV, TD, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Temp of 106.1 right arm at injection swollen, red, hard and hot to the touch applied warm compress to area, Tylenol 1000mg taken temp down to 101.2 the next day 3/7/2014 as of 3/8/2014 no temp area remain red, swollen and tender to the touch and swollen area approximately 4cmx8cm not as painful today.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Situation: On 25 Feb 2014, patient came to the facility and received Typhoid, TwinRix, and Anthrax. She came in again on 01 Mar 2014 to receive Smallpox but also received a second Anthrax. The person who administered the Anthrax vaccine is currently unknown at this time. There is currently an investigation to find out who that was. There is no record of who administered it in logbook or health record.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Blister, Erythema, Inappropriate schedule of drug administration, Rash pustular
Clinical narrative: Situation: On 25 Feb 2014, patient came to the facility and received Typhoid, TwinRix, and Anthrax. She came in again on 01 Mar 2014 to receive Smallpox but also received a second Anthrax. The person who administered the Anthrax vaccine is currently unknown at this time. There is currently an investigation to find out who that was. There is no record of who administered it in logbook or health record.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea started around 7pm on 03/07/2014. Vomiting started at 6:45am on 03/08/2014 which is when mild fever was discovered.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: OFF & ON RASH AT SITE OF INJECTION, REPORTED TO PHARMACY ON 2/22/2014.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Antinuclear antibody, Rash erythematous, Viral rash
Clinical narrative: By 6 PM had 2 red raised dots on neck area, by following AM 2 more spots flank and shoulder, day 3 entire buttocks broken out.  Saw Dr. who documented as exanthem viral. Started high dose vitamin C treatment and the spots resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Rash, Rash erythematous, Rash pruritic, Skin lesion
Clinical narrative: Following vaccination, patient experienced extreme fatigue and tiredness starting 2 days after vaccine. A couple days later, tiny pinpoint sized dark red spots appeared on torso, arms, upper legs, chest. Some spots itchy, not all. Lesions took about a week to clear up.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Dermatitis diaper, Injection site discolouration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extremely swollen, hot, discolored and painful arm at and surrounding injection site. Lethargy.  Rash around mouth and diaper area. Swelling, pain lasted more than a week. Discoloring lasted nearly 1 month, rashes continue 1 month plus.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Lethargy, Rash
Clinical narrative: Extremely swollen, hot, discolored and painful arm at and surrounding injection site. Lethargy.  Rash around mouth and diaper area. Swelling, pain lasted more than a week. Discoloring lasted nearly 1 month, rashes continue 1 month plus.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: INJECTION SITE BECAME RED AND SWOLLEN, WITH REDNESS EXTENDING FROM UPPER ARM AND DOWN PAST ELBOW.