chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to three patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with VAQTA (dose, route and lot# were not reported), which were improperly stored. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to four patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with oral, ROTATEQ (dose, dose number and lot# were not reported), which were improperly stored. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Informatoin has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, dose number, lot# and route were not reported), which was improperly stored. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (LVN) referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 19-AUG-2015 the patient was vaccinated with a dose of expired M-M-R II (lot # J006140, expiry date 17-APR-2015)(dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (LVN) referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 19-AUG-2015 the patient was vaccinated with a dose of expired M-M- R II (lot # J006140, expiry date 17-APR-2015) (dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient reported minimal pain/swelling at the injection site and severe pain/inflammation at the elbow after received Pneumovax 23.
Age: 75.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Arthralgia, Arthritis, Injection site pain, Injection site swelling
Clinical narrative: Patient reported minimal pain/swelling at the injection site and severe pain/inflammation at the elbow after received Pneumovax 23.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy test, Dizziness, Ear pain, Flushing, Throat irritation
Clinical narrative: Flu shot given at 1:45 PM (8-23-15). Received call from mother at 4:30 PM same day said patient had red face & difficulty swallowing. Went to ER. Next day PCP-given BENADRYL-was not picked up.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Erythema
Clinical narrative: Flu shot given at 1:45 PM (8-23-15). Received call from mother at 4:30 PM same day said patient had red face & difficulty swallowing. Went to ER. Next day PCP-given BENADRYL-was not picked up.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Urticaria
Clinical narrative: Rash, swelled, painful, hives at the injection site of upper left arm. Hives on the left arm.
Age: 0.16
Sex: F
Vaccine: DTPPHIB, HEP, PPV, RVX
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Per mom had swelling, redness, and small bumps on thigh around injection sight for a week.
Age: 7.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Child was given the HPV vaccine when she was 7 yrs and 11 months old.  Father informed on 9/9/15 and father denied any side effects or adverse events following vaccination in February.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Muscle twitching, Tic
Clinical narrative: Twitching, tics motor and verbal.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body aches, headache, nausea, fever.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash on neck advised to use hydrocortisone. On 9/1/15 presents with Herpes zoster to right flank and right upper thigh. Treated with Zovirax  800mg 5X day for 7 days and medrol pack.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tinnitus
Clinical narrative: Awakened from sleep with a continuous ROARING tinnitus in left ear--(loud as an air-raid warning horn) that persisted for 1/2 hour and then recurred 12 hours later---lasting for 1 hour.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Approx 6 hours after vaccination pt experienced body aches and pains.  Approx 7 hours after vaccination pt experienced chills and 102 fever.  Fever stopped by the third day.
Sex: U
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and unknown gender. No concurrent condition or medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (dose and route of administration was not provided). No concomitant therapy was reported. On an unknown date, approximately 1 year after vaccination the patient experienced immune thrombocytopenic purpura. The outcome of immune thrombocytopenic purpura was unknown. The causality assessment was not reported. No product quality issue was involved. Upon internal review, the immune thrombocytopenic purpura was considered as serious due to medically significant event. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Electromyogram, Lumbar puncture, Nuclear magnetic resonance imaging, Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Pyrexia, Seizure, Seizure like phenomena, Tonic clonic movements
Clinical narrative: The patient presents for fever and seizure activity that occurred at 2 o'clock this afternoon.  The patient has had no previous history of seizures.  He started having a temperature yesterday while playing outside.  Had been doing well for the entire day, but developed a temperature of 103.9.  Mother had been giving Tylenol approximately every 4 hours.  Child was febrile today, had had Tylenol last at 10 o'clock and around 2 o'clock., when he would have had the opportunity to be re-dosed, he was about to take a nap and had tonic-clonic activities of his upper and lower extremities, extended his neck, and had blanching of his lips.  Seizure-like activity lasted 1 minute.  He was not incontinent of urine, did not bite his tongue.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urinary incontinence
Clinical narrative: The patient presents for fever and seizure activity that occurred at 2 o'clock this afternoon.  The patient has had no previous history of seizures.  He started having a temperature yesterday while playing outside.  Had been doing well for the entire day, but developed a temperature of 103.9.  Mother had been giving Tylenol approximately every 4 hours.  Child was febrile today, had had Tylenol last at 10 o'clock and around 2 o'clock., when he would have had the opportunity to be re-dosed, he was about to take a nap and had tonic-clonic activities of his upper and lower extremities, extended his neck, and had blanching of his lips.  Seizure-like activity lasted 1 minute.  He was not incontinent of urine, did not bite his tongue.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Itchy red patches on arm shoulder, neck and torso on same side as the injection site.  Red bumps on opposite arm.  Advised to report to after hours care.  Did not report to Dr.  Medicated with OTC drugs Benadryl 2 pills twice daily for 3 days.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood lactate dehydrogenase increased, Chest X-ray normal, Computerised tomogram head normal
Clinical narrative: Post vaccines mom reported lethargy and trouble breathing. Brought via ambulance mom stated patient stopped breathing x 2 mins. Pt admitted for 24 hour observation.  Dx possible febrile seizure with postictal state sec fever vs vaccines.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Dyspnoea, Laboratory test abnormal, Lethargy, Respiratory arrest
Clinical narrative: Post vaccines mom reported lethargy and trouble breathing. Brought via ambulance mom stated patient stopped breathing x 2 mins. Pt admitted for 24 hour observation.  Dx possible febrile seizure with postictal state sec fever vs vaccines.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain
Clinical narrative: Severe back ache, similar to the back aches I get when I have a fever.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Blood bilirubin increased, Blood ketone body present, Blood test abnormal, Chromaturia
Clinical narrative: On 4/21/15 he started having a loss of appetite. Within 48 hours he vomited. We assumed it was a virus. The vomiting 2-3 times per day continued for days. NO one else in the home became ill, so we suspected another cause. No fever. Each day he was getting worse and complaining of severe stomach pain. We took him to the Doc on 4/28 and they guessed a virus. On 4/29 his urine was brown and he was dehydrated. Returned to the doctor. Blood work and ultrasound were ordered. Ultrasound showed thickening of the pyloric sphincter and gastroparesis. Blood work and urine showed high levels of ketones and bilirubin and various abnormal blood results. He was found as having hypoglycemia ketosis.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Dehydration, Gastrointestinal disorder, Hypoglycaemia, Impaired gastric emptying
Clinical narrative: On 4/21/15 he started having a loss of appetite. Within 48 hours he vomited. We assumed it was a virus. The vomiting 2-3 times per day continued for days. NO one else in the home became ill, so we suspected another cause. No fever. Each day he was getting worse and complaining of severe stomach pain. We took him to the Doc on 4/28 and they guessed a virus. On 4/29 his urine was brown and he was dehydrated. Returned to the doctor. Blood work and ultrasound were ordered. Ultrasound showed thickening of the pyloric sphincter and gastroparesis. Blood work and urine showed high levels of ketones and bilirubin and various abnormal blood results. He was found as having hypoglycemia ketosis.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Ketosis, Urine bilirubin increased, Urine ketone body present, Vomiting
Clinical narrative: On 4/21/15 he started having a loss of appetite. Within 48 hours he vomited. We assumed it was a virus. The vomiting 2-3 times per day continued for days. NO one else in the home became ill, so we suspected another cause. No fever. Each day he was getting worse and complaining of severe stomach pain. We took him to the Doc on 4/28 and they guessed a virus. On 4/29 his urine was brown and he was dehydrated. Returned to the doctor. Blood work and ultrasound were ordered. Ultrasound showed thickening of the pyloric sphincter and gastroparesis. Blood work and urine showed high levels of ketones and bilirubin and various abnormal blood results. He was found as having hypoglycemia ketosis.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Welt started to develop at injection site.  Grew to size of baseball then today (09/10/2015) spread down to patients elbow.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, Swelling and pain on Right Deltoid.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Confusional state, Feeling abnormal, Flat affect, Headache
Clinical narrative: Mother called and reported he felt "off/different" the minute he received the vaccine.  States 9/2/15 he had sore are, he was "sluggish/didn't feel well/headache" and that he missed football practice that evening and slept from the moment he got home from getting this vaccine until the next morning.  His behavior was "off" over the next following days "erratic behavior/flat affect" and then on 9/7/15 he was acting "spacy and confused after school"; On 9/8/15 he developed a "soft ball sized blotch that was red and swollen".
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Pain, Rash macular, Sluggishness, Swelling
Clinical narrative: Mother called and reported he felt "off/different" the minute he received the vaccine.  States 9/2/15 he had sore are, he was "sluggish/didn't feel well/headache" and that he missed football practice that evening and slept from the moment he got home from getting this vaccine until the next morning.  His behavior was "off" over the next following days "erratic behavior/flat affect" and then on 9/7/15 he was acting "spacy and confused after school"; On 9/8/15 he developed a "soft ball sized blotch that was red and swollen".
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Vaccination site induration, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Quarter size red knot on left leg at vaccination site.  Swelling and firm lump under skin 8 days after receiving vaccination.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Soreness at injection site continues several weeks after receiving vaccine. Advil taken daily.  Hurts when pressure applied at injection site.  Ache in shoulder experienced when sleeping or waking feels dull.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Fever. Severe muscle and body aches and chills.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness around vaccination site.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 12 year old female patient. The patient's concurrent conditions included absent seizures. There was no history of drug allergies or reactions. On 26-NOV-2014, the patient was vaccinated with first dose of GARDASIL (unknown strength, route and lot#). The patient received the second dose of GARDASIL on 10-APR-2015 (inappropriate schedule of drug administration). On 27-AUG-2015, the patient was vaccinated with third dose of GARDASIL (unknown strength) lot # L004014 with expiration date of 04-MAR-2017 intramuscular. Concomitant therapies included ethosuximide (unknown manufacturer). Th patient became pregnant with approximated date of last month period in 2015. ON 27-AUG-2015, the patient was confirmed to be pregnant via a urine test after being vaccinated with GARDASIL. The patient sought medical attention and via palpation and measurement and they believed that the patient to be six months pregnant. The pregnancy outcome was pending. The patient has an appointment with an Obstetrics/gynecologist next week. There was no product quality complaint involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Burning sensation, Hyperaesthesia, Pain, Pruritus
Clinical narrative: Reported today 9-10-15 by Dr.-Pain Management clinic. Per Doctor patient noted a pimply area ? healed blisters, sensitive, itchy, painful burning- almost like a trigeminal neuralgia per doctor.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Swelling, redness, and mild tenderness to right deltoid.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness, SOB, "asthma" like symptoms.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Injection site pain, Neck pain
Clinical narrative: Unilateral neck pain, redness pain of left wrist then redness and pain changes to the right wrist and back to left again. No redness, pain at injection site.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, Swelling and Redness, warm to the touch, below the injection site at the Deltoid all the way down to elbow.
Age: 4.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Dyskinesia, Full blood count, Streptococcus test, Tic, Varicella virus test
Clinical narrative: MOM STATES PT CAME IN A WEEK OR SO AGO FOR SHOT ONLY VISIT TO START GETTING HER KINDERGARTEN SHOTS SO THAT WHEN SHE IS TO START SCHOOL NEXT YR SHE WILL BE READY.  PARENTS DO ALTERNATE VACCINE SCHEDULE. MOM REPORTS THAT PT HAS SINCE RECEIVING THE VACCINES (HEP B #2 & VVX #1) ON 8/25/15, DEVELOPED A FACIAL TIC.  MOM'S SISTER NOTICED THIS 1ST AS SHE KEEPS CHILD DURING THE DAY.  SX STARTED LAST WEEK.  MOM DESCRIBES THE SX AS PT'S LOWER JAW JUTS OUT (FORWARD) WHILE HER HEAD JERKS FORWARD.  BOTH OF THESE MOVEMENTS OCCUR SIMULTANEOUSLY & @ LEAST 50x/DAY AS COUNTED BY MOM, DAD, & MOM'S SISTER, PER MOM.  IT'S ALMOST LIKE SOMETHING W/ THE MUSCLES IN HER NECK ACCORDING TO MOM.  THERE HAS NOT BEEN ANY INJURY THAT SHOULD CAUSE THIS TO HAPPEN.  MOM SAYS SHE CANNOT LINK THIS TO ANYTHING ELSE OTHER THAN THE VARIVAX VACCINE B/C PT HAD NEVER HAD IT BEFORE.  MOM ALSO STATES THAT PT DOESN'T EVEN REALIZE THAT SHE IS DOING THESE MOVEMENTS B/C IT'S HAPPENING WHEN SHE IS COLORING, WATCHING T.V., TALKING, etc.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Haematoma, Hypoaesthesia, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Large amount of bruising, swelling, pain distal to injection site accompanied by numbness and tingling to left ring and small finger. Diagnosed as Hematoma secondary to MMR injection. Experiencing ulnar nerve irritation d/t swelling. Negative for compartment syndrome, abscess or cellulitis.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Radiculopathy, Swelling
Clinical narrative: Large amount of bruising, swelling, pain distal to injection site accompanied by numbness and tingling to left ring and small finger. Diagnosed as Hematoma secondary to MMR injection. Experiencing ulnar nerve irritation d/t swelling. Negative for compartment syndrome, abscess or cellulitis.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness, rash at the injection site.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Seizures.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever 102, pain in left arm, nausea, vomiting, diarrhea.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ataxia, Chest X-ray, Choking, Computerised tomogram head, Culture urine
Clinical narrative: Was taking a bottle, starting choking and started with seizure activity, parents called EMS. In ER Fever and seizure activity. CBC with diff, chem 14, UA with culture, head CT w/o contrast, chest x-ray done in ER. Seen Dr on 09/10/15 at 14:33 pm, for mild ataxia, rechecked PLT count.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count, Full blood count, Laboratory test, Platelet count, Seizure
Clinical narrative: Was taking a bottle, starting choking and started with seizure activity, parents called EMS. In ER Fever and seizure activity. CBC with diff, chem 14, UA with culture, head CT w/o contrast, chest x-ray done in ER. Seen Dr on 09/10/15 at 14:33 pm, for mild ataxia, rechecked PLT count.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urine analysis
Clinical narrative: Was taking a bottle, starting choking and started with seizure activity, parents called EMS. In ER Fever and seizure activity. CBC with diff, chem 14, UA with culture, head CT w/o contrast, chest x-ray done in ER. Seen Dr on 09/10/15 at 14:33 pm, for mild ataxia, rechecked PLT count.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Neck pain, Pain
Clinical narrative: SHOOTING PAIN UP R SIDE OF NECK.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash on left thigh.
Age: 23.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in lymph gland under left armpit.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had swelling & redness around the area of injection with no pain.
Age: 50.0
Sex: F
Vaccine: FLUC3
Symptoms: Headache, Malaise
Clinical narrative: Persistent headaches and malaise.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Large circular rash at site of injection which has worsened since time of injection. Shingles like rash on torso that developed in the 2 days after injection. Pt has not yet seeked treatment but will see PCP 9/11.
Age: 29.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red bump at injection 2 weeks after injection, then 3 other red bumps that itch.  Referred patient to Doctor.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchy, soft ball sized red spot on administration site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: NEXT DAY AFTER THE VACCINATION SHE HAD REDNESS AROUND THE INJECTION SITE (3 INCH DIAMETER), AND IT WAS ITCHY AT THE INJECTION SITE.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose decreased, Chills, Condition aggravated, Diabetes mellitus
Clinical narrative: Patient is a diabetic and states 20 minutes after injection his blood sugar was low and he was eating. Patient called back around 5pm having chills. Paramedic responded and he did not have a seizure only chills. Wife suspected a seizure. Patient did not go to the hospital.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: A third party reported that pt experienced vomiting and diarrhea after receiving vaccine.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Productive cough
Clinical narrative: "Super headache, coughing, throat phlegmy".
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Fatigue, Feeling cold, Nausea
Clinical narrative: She felt cold, pain in shoulder hip and knee joints and joints of hand, felt nauseous around 1 am. Felt tired. When she called around 9:30 am she was feeling better.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Third party reported that pt experienced vomiting and diarrhea after receiving the vaccine.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Prevnar 13 administered in right deltoid.  Red rectangular patch appeared at injection site approximately 5 day following injection. Fluzone HD administered in left deltoid.  Arm became swollen on inside of elbow which appeared day after injection.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Abdominal pain, Barium enema, Intussusception
Clinical narrative: Patient seen for well care 8/28/2015. Given MMR/Varicella/PREVNAR, presented to the office on 9/8/2015 with abdominal pain and dx and treated for intussusception.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's right arm, which is where PNEUMOVAX 23 was administered, swelled, turned red, and was hot to the touch. Pt also had difficulty moving this arm.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Patient's right arm, which is where PNEUMOVAX 23 was administered, swelled, turned red, and was hot to the touch. Pt also had difficulty moving this arm.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Product use issue
Clinical narrative: None noted.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dry throat, Headache, Heart rate increased, Ocular hyperaemia
Clinical narrative: Got on 9/9 dry throat, eyes bloodshot that night chills, headache, fast HR-started at 2pm-mild sx 2 yrs ago w/ flu shot. 9/10-still have sx but more mild.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Allergic reaction to vaccine. Erythema, tenderness, and swelling, itchiness at injection site. TX symptomatically with BENADRYL, ibuprofen, and ice packs.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Allergic reaction to vaccine. Erythema, tenderness, and swelling, itchiness at injection site. TX symptomatically with BENADRYL, ibuprofen, and ice packs.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Spotty on left front chest and back. Pt mentioned some pain as well as itch.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Chills, Myalgia, Neck pain, Ocular hyperaemia, Paraesthesia
Clinical narrative: Received flu shot and BEXSERO 9/3/2015. 9/7-9/8-generalized myalgias/chills-went away. 9/9-generalized body paresthesias, "prickliness" diminishing but not gone. 9/10-sore upper neck and red eye (L).
Age: 18.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Chest pain, Chills, Myalgia, Neck pain, Ocular hyperaemia
Clinical narrative: Received flu shot and BEXSERO 9/3/2015. 9/7-9/8-generalized myalgias/chills-went away. 9/9-generalized body paresthesias, "prickliness" diminishing but not gone. 9/10-sore upper neck and red eye (L).
Age: 18.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Received flu shot and BEXSERO 9/3/2015. 9/7-9/8-generalized myalgias/chills-went away. 9/9-generalized body paresthesias, "prickliness" diminishing but not gone. 9/10-sore upper neck and red eye (L).
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swollen, felt hot approx. 10-15 cms down the site of injection. pain on day of shot & next day in injection site.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling in arm administered (left).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Pt returned to pharmacy 2 days after administration, red, rash like area on arm below where shot administered, hot to touch. Visited urgent care.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX quadrivalent (batch number 7994K, expiry date 16th June 2016). On an unknown date, the patient received FLUARIX quadrivalent .5 ml. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details were provided as follows: This case was reported by a pharmacy intern. The healthcare professional reported that several patients were vaccinated with FLUARIX QIV and they experienced soreness (tenderness) in arm around injection site. The reporter reported that about 90% of patients had reported the pain around injection site, which was an increase from when they administered the product last year. No further information was reported regarding the event.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Fatigue, Headache, Skin warm
Clinical narrative: Large red area, swelling, hot to touch. Starting evening when shot was administered, cough, headache, very tired-referred to primary physician told her to apply ice pack.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Large red area, swelling, hot to touch. Starting evening when shot was administered, cough, headache, very tired-referred to primary physician told her to apply ice pack.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Pruritus
Clinical narrative: Local reaction with pruritus and erythema. Cool compresses, antihistamine, hydrocortisone cream.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Eye irritation, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Fever, nausea, headache, dizziness, sore throat, pale, eye bothering her, light rash within 48 hrs of vaccination per parent. Seizure noted on 9/9/15.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pallor, Pyrexia, Rash, Seizure
Clinical narrative: Fever, nausea, headache, dizziness, sore throat, pale, eye bothering her, light rash within 48 hrs of vaccination per parent. Seizure noted on 9/9/15.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. On 08-SEP-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K009809, expiry date 16-MAY-2015, 0.5 ml, intramuscular. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. Approximately in 2015, an unspecified number of patients were vaccinated with unspecified doses in series of GARDASIL 9 lot number L004014, expiration date 04-MAR-2017 (dose and route of administration were not reported). The vaccine was improperly stored between 26-AUG-2015 and 01-SEP-2015. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The pharmacist reported that a patient received the first dose of GARDASIL (dose, route of vaccination and lot# were not reported) in July 2013, the second dose in October 2014 and at the time of the report, was in the office to receive a third dose. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 01-AUG-2015, patients were vaccinated with RECOMBIVAX HB, (dose, frequency and route of administration were not provided), lot # K021444, expiration date 17-SEP-2016; lot # K026666, expiration date 22-OCT-2016 and lot # L004754, expiration date 10-NOV-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative referring to a 52 year old female patient with asthma. The patient had allergy to penicillin. On 11-JUN-2015 the patient was vaccinated with ZOSTAVAX (dose and route of vaccination were not reported, lot # L003216 with exp date: 30-APR-2016) for shingles prevention. Concomitant therapies included valacyclovir. On 12-JUN-2015 the patient experienced an "outbreak of hives throughout her body" while on therapy with ZOSTAVAX. The patient went to the physician's office on an unspecified date for medical attention. The patient was treated with BENADRYL and prednisone and was later seen by a dermatologist on an unspecified date. The outcome of the outbreak of hives throughout her body was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-DEC-2012, the patient was vaccinated with the first dose of VAQTA (dose, lot number, expiration date and route of administration were not reported). The patient was vaccinated with the second dose of VAQTA (dose, lot number, expiration date and route of administration were not reported), slightly before schedule on 13-MAY-2013. There was no adverse effects reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: Skin rash and swelling. Diphenhydramine.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Confusional state, Encephalopathy
Clinical narrative: Confusion & encephalopathy.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Nerve compression, Oedema peripheral, Paraesthesia
Clinical narrative: RN note 4/19/13. Patient came to the clinic today for the following: he states that he was here yesterday, and had a tetanus shot into his left deltoid. Was fine last night. This morning when he woke up, he found the following: left inner aspect of forearm is "tingly and numb" and states that it feels like it fell asleep. Inner aspect of lower left FA is edematous, no redness. Denies pain. VS 136/91 pulse 79 afebrile at 97.0. "Feels like it had NOVOCAINE injected into it". Bilateral hand grasp is strong. No weakness on left side noted. Reports that this started at 5am. Reports having hx of carpal tunnel and MI fairly recently. Is presently enrolled in cardiac rehab, but cancelled for the day. Denies any kind of CP, angina, arm pain. Suggested using ice prn to reduce the edema, that will in turn perhaps relieve pressure on nerve that is causing the numbness.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Peripheral swelling
Clinical narrative: Erythema Multiforme and swelling of arm. Diphenhydramine 25 mg PRN.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Interchange of vaccine products, No adverse event, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician assistant refers to a 19 year old female patient. No pertinent medical history was reported. On an unknown date in April 2015, the patient was vaccinated with GARDASIL (dose, route and lot# were not reported) followed by a dose of GARDASIL 9 (dose, route and lot# were not reported). Concomitant therapies included birth control pills. Later on an unknown date, the patient found out she was pregnant with last menstrual period of March 2015. It was unknown exactly when the patient became pregnant in regards to the timing of her being vaccinated with GARDASIL and GARDASIL 9. Patient sought medical attention by an office visit. No Product Quality Complaint (PQC) was involved. Lab tests included Ultrasound scan and results were unknown. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On unknown dates, the patients came down with a mild case of shingles. The outcome of herpes zoster was unknown. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB lot # K007258, expiration date- 04-MAR-2017. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a multiple unspecified patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # K010440, expiration date: 23-JUL-2016 (dose, dose number, route and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories and drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot# L015047, expiration date 29-APR-2017; lot# I003775, expiration date 04-FEB-2017; lot# k005425, expiration date 15-APR-2016; lot# I006385, expiration date 25-FEB-2017; lot# I012035, expiration date 07-APR-2017; lot# I013067, expiration date 14-APR-2017; lot# L017143, expiration date 13-MAY-2017; doses, site and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Information has been received from a pharmacist referring to a 65 year old female patient with allergy to Penicillin. The patient's concurrent conditions included hypertension and hypothyroidism. There was no medical history reported. On 20-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L006381, expiry date 25-MAY-2016) (dosage and strength were not reported) subcutaneously in the right arm, the patient was also administered with a dose of PREVNAR 13, in the left arm on the same day. Concomitant therapies also included amlodipine, atorvastatin and  levothyroxine sodium. The patient presented to the pharmacist on 24-AUG-2015 with the reactions: "a red, swollen area the size of a quarter at the ZOSTAVAX injection site: which started on an unspecified date in August 2015. The patient also had a rash on the back of her neck, and a faint rash on her right cheek just below her eye (started on an unspecified date in August 2015). The patient was going to see her physician on 24-AUG-2015. ON an unspecified date in August 2015, the patient was prescribed 800 mg of Acyclovir by an unspecified physician for the treatment of the rash. At the time of the report, the outcome of the events was reported as not recovered. This is one of the two reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown dates, the patients received improperly stored (Oka/Merck) VARIVAX (lot# L017145, expiration date: 13-MAY-2017; lot # K026387, expiration date: 15-DEC-2016; lot# L006383, expiration date: 25-FEB-2017), 0.5 ml subcutaneously. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer via social media refers to a baby patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL. Concomitant medications were unknown. On an unknown date, the patient experienced adverse event. The outcome and causality of adverse event was not reported. Additional information is not expected as the reporter contact details were not provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 24-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (0.5 ml, lot # L019996, expiration date 02-DEC-2016) subcutaneously. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or drug reaction reported. The reporter read an article on the Internet pertaining to the patient who was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expired date were unknown) on an unknown date. No concomitant therapy was reported. It was reported that the patient had a "tennis ball size lump" at the injection site when he/she woke up on the day after the vaccination. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, Herpes zoster
Clinical narrative: Information has been received from a medical assistant via a company representative referring to a patient of unknown age and gender with an unspecified cancer. Drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) (Medication error). Concomitant drug was not reported. On an unknown date the patient developed shingles. Outcome of shingles and the relatedness between shingles and ZOSTAVAX were unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 26-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), 0.5 ml, lot # L019996, expiration date 02-DEC-2016, subcutaneously. Concomitant drug was not reported. No adverse effects were reported. This was one of the two reports from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 4 month old patient of unknown gender. No concurrent condition or medical history was reported. On 20-JUL-2105, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration not provided). No concomitant therapy was reported. It was reported that the vaccination was outside of the recommendations in the PNEUMOVAX 23 prescribing information. The physician stated that the event may have been reported previously by an unspecified person. No adverse effects was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB Lot#J014855 and J009051 (dose was not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a mother refers to a female patient (her daughter) of unknown age. On 15-JUL-2015, the patient was supposed to receive second dose of GARDASIL 9 but was vaccinated with GARDASIL, 0.5 ml, intramuscular by mistake. No adverse effects were being reported. The outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 08-SEP-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, route, lot# L004005 and expiration date 05-AUG-2016). No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 08-SEP-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (strength, route, lot# L005298 and expiration date 17-FEB-2017). No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Concurrent conditions, medical history and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (lot # K015972, expiration date 23-SEP-2015, dose and route of administration were not specified). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.