chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report was received from an approximately 66 year old female consumer with diabetes refers to herself. The patient reported she could not take "SSRI drugs" because they caused her to have a stroke years ago. On an unspecified date in March 2014 (reported as the end of March 2014) the patient was vaccinated with "one shot" ZOSTAVAX (lot # not provided)  route reported as injection. Other suspect therapies included MYRBETRIQ. Concomitant therapies included atenolol, metoprolol, LEVIMIR, NOVOLOG and other unspecified medications. She reported that, on an unspecified date around the time that she received ZOSTAVAX, she "switched from metoprolol to atenolol in order to be able to start MYRBETIQ. She had since switched back to metoprolol instead of atenolol and also stopping taking MYRBETRIQ. On an unspecified date in April 2014 (reported as a few days after receiving ZOSTAVAX, the patient experienced injection site reaction of "swelling, hardness, warmth, and redness" which "lasted 2 weeks". She reported that she had been and was still experiencing other reactions which began after the injection site reaction appeared (onset dates unspecified). These other reactions include "extreme itching" which was "everywhere" on he body but which was most pronounced and persistent on her upper body and especially in the areas of her chest, arms, and stomach. She also reported "redness" or "flushing" in her neck and face which was accompanied by itching and which "happened toward the end of the day". Since having had ZOSTAVAX she was also "sensitive to the sun" and experiencing aching and pain in her joints and fingers. She stated that the adverse effects she was till experiencing "seems to be getting better" slowly. She sought medical attention by calling her physician only about the flushing and itching of her face and neck. She did not mention her other adverse effects to her physician. The flushing and itching of her face and neck was originally suspected to be a reaction to MYRBETRIQ, which she began taking on an unspecified date after receiving ZOSTAVAX. None treatment was given for the adverse effects. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Headache, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: The injection site began to hurt like there was a knife in the arm and I started running a fever. This was followed with extreme fatigue and muscle pain. Headaches began the night of the 2nd. On the 3rd and 4th I could hardly move my arm. Pain was excruciating.
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: The injection site began to hurt like there was a knife in the arm and I started running a fever. This was followed with extreme fatigue and muscle pain. Headaches began the night of the 2nd. On the 3rd and 4th I could hardly move my arm. Pain was excruciating.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TD
Symptoms: Parotitis, Pyrexia, Salivary gland enlargement
Clinical narrative: Submandibular swelling on right side. Diagnosed as parotitis. Later had a high fever and started on antibiotic. On 7/6/14 swelling was found on left side. Not clear if this is a reaction or another sequelae.
Age: 1.1
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling and warmth at injection site of Menveo and swelling at injection site of Tdap the next day after receiving the injections. Cold compress to area was recommended and to call back pcp if any further problems.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity, Somnolence
Clinical narrative: With the exception of a sudden onset of sleepiness in the early afternoon (very rare for me), all went well until about 5:30 that afternoon when I noticed twinges when I raised my arm.  By 7 PM I was in severe pain with sharp pains radiating down my arm, not being able to raise my arm, and having much difficulty completing tasks requiring both arms.  The pain was reminiscent of tendinitis in the shoulder.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Electrocardiogram, Fatigue, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Reactions on the arm at injection site: Tenderness, Redness, Warmth, Itching, Hard Nodular Lump, Muscle aches and temporary limitation of arm movement; Headaches; Fatigue; Heart Palpitations.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site induration, Injection site mass, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Reactions on the arm at injection site: Tenderness, Redness, Warmth, Itching, Hard Nodular Lump, Muscle aches and temporary limitation of arm movement; Headaches; Fatigue; Heart Palpitations.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth, Myalgia, Palpitations
Clinical narrative: Reactions on the arm at injection site: Tenderness, Redness, Warmth, Itching, Hard Nodular Lump, Muscle aches and temporary limitation of arm movement; Headaches; Fatigue; Heart Palpitations.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: Mom states she broke out in rash all over body.Mom took her to Urgent care and stated that it was allergic reaction.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Acne, Injection site reaction, Skin exfoliation
Clinical narrative: Pt received 2 scaly, circular areas near injection site (one above bandaid and one to side of bandaid.  Both were dime to nickel's in size.  "Pimple's" appears on forehead and on both cheeks. Not itching/no fever.  Pt still has area
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Aphasia, Dyspnoea, Expired drug administered, Nasopharyngitis
Clinical narrative: This case was reported by a consumer and described the occurrence of cold virus in a 71-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included thyroid resection. Concurrent medical conditions included asthma, chronic obstructive pulmonary disease and menopausal. Concurrent medications included MICARDIS. The subject has been on ADVAIR for 10 to 15 years now. Over the years, her blood pressure had steadily gotten higher without medication to control it. She thought the high blood pressure was also tied in with menopause. On an unspecified date, the subject received 1st dose of Influenza vaccine (unspecified) (intramuscular, administration site unknown, batch number not provided). 1 week after vaccination with Influenza vaccine (unspecified), the subject experienced cold virus. She took 1/2 of an ALKA SELTZER PLUS tablet and then could not breathe and could not talk. Moreover, the ALKA SELTZER was expired. The subject was hospitalised for 2 days. At the time of reporting, the events were resolved.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood glucose increased, Body temperature increased, Computerised tomogram, Crying, Lethargy
Clinical narrative: Mother called EMS and they arrived at the home. Infant was lethargic.  Mother stated prior to calling baby was shaking all over and staring into space and lasted about 4 minutes.  No recent trauma.  Told EMS pt had immunizations this morning and last had dose of Tylenol at 1300.  Patient's lungs were clear, 100% SPO2 on RA, 99.4 tympanic temp.  Patient transported to EC, arriving at about 1900.  Vital signs on arrival were HR 150, RR 32, SPO2 97%, temp 100.9.  Patient given 80 mg Acetaminophen at 1915.  Patient had observed seizure activity 5 - 10 min, respirations dropped to less than 10/min. Began respirations by bag valve mask, pt began crying and O2 sats improved.  Placed on NC 2L.  Labs drawn at 2000 and pt sent to CT at 2100.  LP done to draw CSF at 2110. Meds given include Ativan 0.6 mg IV x1 at 2022, Vancomycin 120 mg IV x1, and Rocephin 300 mg IV x1 at 2130.  Patient transferred to Hospital via ambulance.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lumbar puncture, Respiratory rate decreased, Seizure like phenomena, Staring, Tremor
Clinical narrative: Mother called EMS and they arrived at the home. Infant was lethargic.  Mother stated prior to calling baby was shaking all over and staring into space and lasted about 4 minutes.  No recent trauma.  Told EMS pt had immunizations this morning and last had dose of Tylenol at 1300.  Patient's lungs were clear, 100% SPO2 on RA, 99.4 tympanic temp.  Patient transported to EC, arriving at about 1900.  Vital signs on arrival were HR 150, RR 32, SPO2 97%, temp 100.9.  Patient given 80 mg Acetaminophen at 1915.  Patient had observed seizure activity 5 - 10 min, respirations dropped to less than 10/min. Began respirations by bag valve mask, pt began crying and O2 sats improved.  Placed on NC 2L.  Labs drawn at 2000 and pt sent to CT at 2100.  LP done to draw CSF at 2110. Meds given include Ativan 0.6 mg IV x1 at 2022, Vancomycin 120 mg IV x1, and Rocephin 300 mg IV x1 at 2130.  Patient transferred to Hospital via ambulance.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cell count normal
Clinical narrative: Mother called EMS and they arrived at the home. Infant was lethargic.  Mother stated prior to calling baby was shaking all over and staring into space and lasted about 4 minutes.  No recent trauma.  Told EMS pt had immunizations this morning and last had dose of Tylenol at 1300.  Patient's lungs were clear, 100% SPO2 on RA, 99.4 tympanic temp.  Patient transported to EC, arriving at about 1900.  Vital signs on arrival were HR 150, RR 32, SPO2 97%, temp 100.9.  Patient given 80 mg Acetaminophen at 1915.  Patient had observed seizure activity 5 - 10 min, respirations dropped to less than 10/min. Began respirations by bag valve mask, pt began crying and O2 sats improved.  Placed on NC 2L.  Labs drawn at 2000 and pt sent to CT at 2100.  LP done to draw CSF at 2110. Meds given include Ativan 0.6 mg IV x1 at 2022, Vancomycin 120 mg IV x1, and Rocephin 300 mg IV x1 at 2130.  Patient transferred to Hospital via ambulance.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pustular
Clinical narrative: Rash with pustules all down the opposite arm that the vaccine was given. Patient reports it started getting better after a few days.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm (site of injection), red and swollen.  No fever or pain. Area not measured.
Age: 0.83
Sex: M
Vaccine: DTP
Symptoms: Cyanosis, Electroencephalogram abnormal, Grand mal convulsion, Hypotonia, Resuscitation
Clinical narrative: Within 2 days of DPT vaccination, 3 grand mal (tonic clonic) seizures. Patient was resuscitated by paramedics after third grand mal seizure.  Cyanosis. 6-7 minutes, lifeless. Transported to hospital.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 2 days later noticed red and swollen. Resolved some then on days 4-5 was in the sun all day. Increased red flare, swollen, and itchy.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fall
Clinical narrative: Child received MCV vaccine @ approximately 03:20 PM.  Child remained seated for approximately 7 minutes following injection.  Got-up from chair & proceeded out of room down the hall.  Child fell against the wall about 3 feet from the room & onto the floor face down.  Father immediately rolled child over & asked what was wrong, "are you alright"?  Child was conscious & alert when rolled over by father.  Child stated she felt extremely dizzy & does not remember anything after that.  Child remained on the floor & conscious.  We elevated her legs & applied ice to her head (small abrasion on left upper forehead @ base of hairline, approximately 11/2-2cm in length).  We gave her a lollipop to suck on since she had not eaten since breakfast earlier that morning.  We moved her to an upright position in a chair after about 10 minutes of being on the floor.  Child walked out without difficulty 10 minutes after being in the chair.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pain, Pain in extremity, Skin discolouration
Clinical narrative: On 6/18/14 around 2 PM client received Ped/Adoles Hepatitis A vaccine in her left deltoid and HPV vaccine in her right deltoid. Around 7 pm she developed pain with approx. 1/4 inch long fine line of pink discoloration. Denies any swelling. The pain continued to increase for the next couple of days and is slowly resolving. Denies any previous injuries to the deltoid area or limited range of her left arm. States it hurts when stretching out her arm rapidly to her side. On a scale of 1 to 10 a 3 when stretching out her arm. No redness or swelling noted in the deltoid area. The client was advised to see a healthcare provider especially if the pain got worse or didn't resolve or developed any other symptoms, i.e., fever, swelling, decreased ROM, or numbness or tingeling.   Denies any problem with the injection site in her right deltoid.
Age: 50.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TDAP
Symptoms: Hypoaesthesia, Injection site pruritus, Injection site rash, Injection site swelling, Rash
Clinical narrative: I noticed my arms where the shots were given was itching, and swelling. When I woke up on 07/04/2014 both arms had a rash in the area of the shot. The rash spread down my arms, and 3 of my fingertips felt numb.
Age: 50.0
Sex: F
Vaccine: HEPAB, TDAP, HEPAB, TDAP
Symptoms: Erythema, Rash, Rash pustular, Swelling, Tenderness
Clinical narrative: I noticed my arms where the shots were given was itching, and swelling. When I woke up on 07/04/2014 both arms had a rash in the area of the shot. The rash spread down my arms, and 3 of my fingertips felt numb.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Hot, red, burning, itchy rash spread from vaccination site over shoulder and onto neck and face. Not relieved by topical Benadryl.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Rash pruritic, Vaccination site rash
Clinical narrative: Hot, red, burning, itchy rash spread from vaccination site over shoulder and onto neck and face. Not relieved by topical Benadryl.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: Redness, swelling, lump, hot to touch.
Age: 1.09
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Autopsy, Cyanosis, Malaise, Nasopharyngitis, Sudden death
Clinical narrative: Pt was vaccinated 01/08/2014.  Died 01/19/2014.  Was active police investigation but autopsy was negative. No signs of trauma on body, tox screen normal.  Appears may have been Sudden unexplainable death of an infant.  Infant was found blue and unresponsive in corner of playpen w 2 blankets over him.  Detective said VAERS should be done, unable to know if vaccines played a role in death.  Pt was ill with a cold at time of death.
Age: 1.09
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Toxicologic test normal, Unresponsive to stimuli
Clinical narrative: Pt was vaccinated 01/08/2014.  Died 01/19/2014.  Was active police investigation but autopsy was negative. No signs of trauma on body, tox screen normal.  Appears may have been Sudden unexplainable death of an infant.  Infant was found blue and unresponsive in corner of playpen w 2 blankets over him.  Detective said VAERS should be done, unable to know if vaccines played a role in death.  Pt was ill with a cold at time of death.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chest pain, Headache, Hypertension, Local swelling
Clinical narrative: Body aches, swollen arm, swollen legs, high fever, headache, red eyes with blood, body weakness, high blood pressure, pain in the chest and stabbing pain in the chest.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Body aches, swollen arm, swollen legs, high fever, headache, red eyes with blood, body weakness, high blood pressure, pain in the chest and stabbing pain in the chest.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Dyspnoea, Myalgia, Pruritus, Urticaria
Clinical narrative: Myalgia, Urticaria, Pruritus and chills, shortness of breath.
Age: 1.61
Sex: M
Vaccine: HEPA
Symptoms: Ear infection
Clinical narrative: None stated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of RECOMBIVAX HB (lot#/batch# unspecified) dose, location, frequency and route unspecified, which was improperly stored, exposed to 1C for 24 hours. No known adverse effects. Additional information is not expected because the reporter would not be contacted.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dysuria, Muscle spasms, Pregnancy
Clinical narrative: This prospective pregnancy report as received from a physician refers to a 15 year old female patient with no pertinent medical history and drug reactions / allergies. First dose of VARIVAX was administered in 1999. On 19-MAY-2014, the patient was vaccinated with the first dose of GARDASIL lot#H020901, expiration date: 05-JUL-2015, dose 0.5 ml, intramuscular. On the same day (1-MAY-2014) the patient was also vaccinated with second dose of VARIVAX lot#J007019, expiration date: 05-JUL-2015, dose 0.5ml, subcutaneous. There was no concomitant medications. The physician stated that at the time of the patient's office visit, patient was unable to produce a urine sample and was not tested for pregnancy. The physician reported that she has discovered that the patient was approximately 18-20 weeks pregnant at this time, and would have been pregnant at the time of vaccination. The reporter stated that "the patient has been unable to undergo ultrasound as of yet to determine more specific gestation, but stated patient had planned to determine pregnancy but may be too far along with her pregnancy to do so. The patient became pregnant with LMP of approximately January 2014 and EDD of approximately October 2014. On 11-JUN-2014 the patient was seen in Emergency Room (ER) with complained of cramping, no specific treatment provided other than recommendation for follow up appointment at her Obstetrician/Gynecologist OB/GYN. The patient was seen at OB/GYN office on 12-JUN-2014, treatment unspecified. Cramping had ceased as of the 12-JUN-2014 OB/GYN appointment. The relatedness between cramping and vaccination with GARDASIL and VARIVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old male patient. The reporter stated that the patient was administered with 3 doses of GARDASIL (all were 0.5 ml, and all via intramuscular route) on dates (17-FEB-14, 29-APR-14, 02-JUL-14) that were outside the product insert recommends. Pertinent medical history and concomitant medications were not reported. No adverse effects reported. The outcome of the events was unknown. No further AE information was available. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as medical assistant) via a company representative referring to a patient of unknown age and gender (demographics unspecified). Pertinent medical history and concurrent conditions were unspecified. On an unknown date the patient fainted after getting vaccinated with second shot of GARDASIL (dose 2) (dose not reported). No other concomitant therapies reported. The outcome of the event was reported as recovering/resolving. The causality of the event was unspecified. No PQC reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # was not reported) for prevent shingles. On an unknown date, 18 months after being vaccinated with ZOSTAVAX. The patient developed shingles on her face and contacted pharmacist. She was treated with an unspecified antiviral medication. The outcome of shingles on her face was reported as recovering/resolving. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a currently 6 years old male patient (reporter's son). On an unknown dates the patient was vaccinated with two doses (Oka/Merck) VARIVAX; exact dates of each vaccination, anatomical location and dosage were not provided. It was reported that on an unknown date the patient still developed chickenpox even though they received both doses in the series of (Oka/Merck) VARIVAX. The outcome of events was unknown. Relatedness between events and vaccination was not reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 78 year old female patient with diabetes and hypertension. The physician described the patient as "relative health". Drug allergies/reaction and concomitant medication were unspecified. "2 years ago", in approximately June 2012 the patient was vaccinated with ZOSTAVAX (strength and lot # no reported), single standard dose. "1-2 week" ago, On approximately 04-JUN-2014, the patient developed shingles. The shingles rash presented on her lower right trunk and extended to her back. The rash was mild to moderate. The patient sought medical attention by urgent care visit/follow up office visit. The patient was treated with VICODIN and VALTREX. The outcome of adverse event was reported as recovering/resolving. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse refers to a 26 year old female patient. On 30-JUN-2014 the patient was vaccinated with her first dose of (Oka/Merck) VARIVAX (Lot# unspecified) dose, frequency and location unspecified for prevention of varicella. On an unspecified date in 2014, the patient took a pregnancy test and was found to be pregnant. The patient's estimated due date (EDD) was 03-MAR-2015. LMP (Last Menstrual Period) was 28-MAY-2014 (estimated date) and Date of Conception was 11-JUN-2014 (estimated date). Trimester (s) of exposure were the first. No adverse effects reported. No treatment was given for the event. At the time of this report, the pregnancy outcome was unknown. The reporting nurse did not assessed the seriousness. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 70 year old female patient (reported as in 70's now). Pharmacist stated that patient also reported that she had multiple cases of shingles prior to vaccination. No information about drug reactions and allergies was specified. No concomitant medications were reported. On an unknown date, more than five years ago, the patient was vaccinated with ZOSTAVAX (lot #, dose, route not reported) and immediately post vaccination she developed a mild case of shingles. No VZVIP packet sent as reported case of shingles was more than 5 years ago. The pharmacist asked whether a booster was recommended. There was no product quality complaint with ZOSTAVAX. The outcome of mild case of shingles is unknown. The causality of the event was not specified by the reporter. {Additional information has been requested./Additional information is not expected.}
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. On 02-JUL-2014 the patients were vaccinated with improperly stored PROQUAD (dose unknown). Pertinent medical history and concomitant medications were unknown. No adverse symptoms reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 29 year old male patient. The reporter stated that on an unspecified date in February 2014 the patient was vaccinated with second dose of GARDASIL. Pertinent medical history and concomitant medications were unknown. The reporter did not know when the patient received his first dose of GARDASIL. No adverse effects reported. The outcome of the events was unknown. No additional information provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Local swelling
Clinical narrative: Left arm swelling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fungal infection, Local swelling
Clinical narrative: Severe swelling under arm not at site - Pain in elbow 3 wks. 6-23 yeast infection doctor visit.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Child was given ROTATEQ #1 at age 17 weeks. Had vomiting < 2 x 1 day for 3 days and diarrhea < 4 x / day for 3 days after vaccine given. Also taking propanolol 4 mg TID. No episodes hypoglycemia. No dehydration. No ER visits.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: Large inflamed area around injection site approximately 4 inches.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 2 days after varicella injection, client presented with (R) tricep swelling 65 mm in diameter, erythema 27 mm in diameter, warm to the touch, Client had fever per report, but not on day of repeat visit.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Antinuclear antibody positive, Arthralgia, Blood uric acid normal, Borrelia test negative, C-reactive protein increased
Clinical narrative: Administered tetanus diphtheria toxoid vaccine 6/18/14. Developed pruritis and rash about 24 hrs later. Also (L) and (R) knee pain. Seen in urgent care 6/23/14. Rash better, but still itchy with some spots on hands. Knee pain improving. In progress of recovering.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash, Red blood cell sedimentation rate normal, Rheumatoid factor negative, X-ray limb normal
Clinical narrative: Administered tetanus diphtheria toxoid vaccine 6/18/14. Developed pruritis and rash about 24 hrs later. Also (L) and (R) knee pain. Seen in urgent care 6/23/14. Rash better, but still itchy with some spots on hands. Knee pain improving. In progress of recovering.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Started running a fever that night that got up to 103.1 on the third day took him to ER. When fever left he broke out in a rash took to dr and they thought mumps/measles. Rash got really bad and went back to doctors used cream on rash.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Eye swelling, Lip swelling, Pain, Swelling face
Clinical narrative: About 20 hrs after vaccination, patient began to experience facial swelling about lips and eyes. Difficulty with swallowing and generalize body aches. Patient placed on prednisone taper and prescribed epi-pen for future allergic reactions. Symptoms still present 6/27.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site infection
Clinical narrative: This spontaneous report as received from an administrator refers to a female non pregnant patient of unknown age. No pertinent medical history was reported. No drug reactions or allergies were reported. On 23-JUN-2014, the patient was vaccinated with a dose of PNEUMOVAX23 lot # J011799, exp 09-FEB-2015, subcutaneous injection (dose and dose number not reported). On an unspecified date, approximately in June 2014, the patient experienced skin surface infection below the injection site after receiving PNEUMOVAX23. The event was treated with cephalexin (unspecified dose and frequency). No lab diagnostics studies were performed. The outcome of event was reported as not recovered/not resolved. The patient sought medical attention by visiting the office on 25-JUN-2014. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Dermatitis allergic, Feeling cold, Hyperhidrosis, Pain
Clinical narrative: Diaphoresis. Sensation of cold. Generalized aches and pains. Cutaneous hypersensitivity. Increased body temperature.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of right upper leg.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Increased upper airway secretion, Nervousness
Clinical narrative: After vaccine administration (10-15 mins later) patient complained about mucus in her throat and started coughing and getting nervous.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a patient's mother refers to her son of 6 year old. The reporter stated that her son received first dose of VARIVAX (Merck) (dose and route of administration unknown) on 28-DEC-2013 without any adverse effects. On 30-JUN-2014 the patient was vaccinated with second dose of VARIVAX (Merck) (lot # J013907, expiry date: unspecified, dose unknown) in the left arm. Pertinent medical history and concomitant medications were unknown. Within hours of the administration the patient developed a 2 inch red, raised circle that was warm to touch. On an unspecified date the reporter called the physician's office. Treatment was not given for the event. The outcome of the events was reported as recovering/resolving. The causality was unknown. No further AE information was provided. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a male patient of approximately 15 years of age. The patient's concurrent medical condition included allergy to wasp venom and allergy to EPIPEN. On 08-FEB-2014, the patient was vaccinated with GARDASIL dose 1 (strength, route of administration and lot number were not reported). There was no concomitant medication. On an unknown date in 2014 the patient got sick and the patient canceled his appointment to receive his second dose of GARDASIL. The patient experienced fever and sore throat and was treated with penicillin on 17-APR-2014. The reporter was unsure when exactly the symptoms of the patient had started. There were no lab diagnostic studies performed. The patient had sought medical attention. There was no product quality complaint (PQC) involved. It was reported that the patient had recovered from the event on an unknown date in 2014. The causality of the events was not provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: One hour after receiving vaccine patient began vomiting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Lethargy, Pain, Pruritus
Clinical narrative: 5" x 5" - red area sore/hot - headache, itching, lethargy x 2 days with fever 99 - 100 degrees. TYLENOL and ice, sleep.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: 5" x 5" - red area sore/hot - headache, itching, lethargy x 2 days with fever 99 - 100 degrees. TYLENOL and ice, sleep.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report as received from an nurse practitioner via a company representative refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ROTATEQ. Dose, route and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse practitioner reported that the patient experienced diarrhea after both the first and the second dose (exact dates administered not indicated) of ROTATEQ. Consideration of whether the third dose should be administered was being assessed. The outcome of diarrhea was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt got shot on 6/21/14 - came back on 7/4 with rash on arm at injection site, patient states he doesn't have any other new symptoms. He will follow up with primary care.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Back pain, Painful respiration
Clinical narrative: Pt called at about 12:10pm today stating he has mid-back pain. He denied any SOB or any other problems at this time. Pt stated he had this pain when inhaling. Pt states he didn't have this with 1st Hep B.
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh w/ oval shaped area of warmth and erythema, mildly swollen and tender where he received imms (PENTACEL/Hep A).
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Generalised erythema, Local swelling, Rash, Rash erythematous
Clinical narrative: Broke out red all over, Sunday night 6-29-14 legs swelled up, 6-30-14 her left leg is more swollen and has red rash, no pain or itching.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular, Viral rash
Clinical narrative: Erythematous. Macular and papular rash at abdomen, neck and back started on 7/5/14. (about 9-10 days after vaccination). Associate symptoms includes fever (last night at maximun 99 degrees F). Negative for lymphadenopathy, painful rash, vomiting and wheezing.
Age: 4.0
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 4 year old patient of unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On 19-APR-2014, the 4 year old patient was vaccinated with ROTATEQ dose 1, 2ml, oral (strength and lot number were not reported). The reporter also stated that the second dose of ROTATEQ was administered in approximately June 2014 (reported as about 8-9 weeks later after the first dose). Concomitant therapies were unspecified. No adverse effect reported.  The outcome of the 4 year old patient receiving the first dose of ROTATEQ was unknown. The action taken with ROTATEQ was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local swelling, Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX in the arm (dose, dose number, route, strength ans lot number were unspecified). Concomitant therapies were unspecified. On an unknown date, one week after receiving ZOSTAVAX, the patient experienced an injection site reaction of a red swollen arm which resolved and then flared back up a few days later with a dark mark, in center of the redness and swelling; but a offset from the injection site. Performed laboratory diagnostics studies and treatment given were unspecified. The outcome of dark mark, in center of the redness and swelling was unknown. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The information on pertinent medical history and drug reactions or allergies was unknown. On 26-JUN-2014, the patient was vaccinated with M-M-R II (dose, frequency, route unknown), lot # H009784, Expiry date: 15-MAY-2014. The reporter stated that patient received an expired dose of M-M-R II on 26-JUN-2014. No adverse symptoms reported. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse to a 68 year old female patient with anxiety, irritable bowel, osteoporosis and allergic rhinitis. The patient's drug reactions included codeine allergy, penicillin allergy and sulfa allergy. On 02-JUN-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # j005011, expiration date 04-DEC-2014, 0.5 ml, intramuscular). Concomitant therapies included Estradiol (manufacturer unknown), Hydrochlorothiazide (manufacturer unknown), Levothyroxine sodium (manufacturer unknown), Neurontin, Aspirin, Omega-3 marine triglycerides (reported as fish oil), Alprazolam and Vitamins (unspecified) (reported as multivitamin). The "next day" after receiving PNEUMOVAX23), on 03-JUN-2014, the patient developed arm swelling, pain, and redness from the "shoulder area to the mid forearm". The nurse stated that the patient went to an unspecified emergency room on 03-JUN-2014 and was given an injection of Dexamethasone. She also stated that the patient was sent from the emergency room with prescriptions for Prednisone and Keflex and was told to also take over the counter Benadryl. The nurse reported that the patient was seen by the nurse practitioner on 04-JUN-2014. No lab diagnostics studies were performed. Outcome of the events was reported as recovered on 07-JUN-2014. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with doses of ROTATEQ suspension, oral (lot/batch number, expiration date, dose, dose number and indication not provided) that were improperly stored. No adverse effects were reported. This case is one of several reports from the same reporter. Additional information has been reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients with no demographic details. Medical history was not reported. Since an unknown date, an unknown number of patients were vaccinated with a VAQTA, (25/0.5 U/ml, 0.5 ml, intramuscular, lot #, expiration date and anatomical location not reported, frequency unspecified), which was not stored properly. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a female patient of unknown age, with no pertinent medical history. The patient was not pregnant. On an unknown date the patient was vaccinated with GARDASIL dose 2, intramuscular (strength, anatomical location, lot # and expiration date not reported). There were no concomitant medications. The reporter stated that the patient received the second dose of GARDASIL but it was not within the recommended dosing schedule. The reporter did not confirm how much time lapsed between doses 1 and 2 of GARDASIL. The patient did not seek medical attention and no treatment was given. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to multiple unspecified patients of unknown age and gender. On unspecified dates, the patient was vaccine with a dose of M-M-R- II (lot#, dose, route, indication no reported). The physician reported that "in the past" these patients had " low titers for 1 of the 3 M-M-R II , after receiving M-M-R II.  The physician stated that he had been "re-administering M-M-R II" to those unspecified patients. Concomitant medications were not supported. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Eye disorder, Immune system disorder, Musculoskeletal disorder, Nervous system disorder
Clinical narrative: So many hard to tell immune system, lungs hard to get air, legs, arms, shoulders, brain, eyes gave me trouble from 1976 to 1992. This was sure hell the pain.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: So many hard to tell immune system, lungs hard to get air, legs, arms, shoulders, brain, eyes gave me trouble from 1976 to 1992. This was sure hell the pain.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Disturbance in attention, Dizziness, Headache, Laboratory test
Clinical narrative: Case number PHHY2013US069531 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 479312) web site on 03 Jul 2013. This report refers to a 66-years-old female patient. Her medical history was not reported and concomitant medications included omeprazole 20 mg at a dose of 1 tablet once daily. She was vaccinated with FLUVIRIN (batch number: 122105) intramuscularly in the left arm on 18 Oct 2012. On the same date, she experienced extreme headache, fever, chills and muscle pain that lasted approximately 24 to 36 hours. It was followed by neck pain, nausea, dizziness, blurry eyes and inability to concentrate. Her primary care doctor thought that it was a virus with vertigo. She was treated by physical therapist for vertigo, but without any improvement. Diagnostic lab tests were performed and she had a magnetic resonance imaging (MRI) and it was sent for follow up studies which were ongoing at present. The outcome of the event was reported as condition unchanged as of 26 Dec 2012. Following an internal review received on 12 Jul 2013 of the information received on 03 Jul 2013, it was identified that the event vertigo was erroneously kept as non-serious and hence the event was now upgraded to medically significant.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Neck pain, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Case number PHHY2013US069531 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 479312) web site on 03 Jul 2013. This report refers to a 66-years-old female patient. Her medical history was not reported and concomitant medications included omeprazole 20 mg at a dose of 1 tablet once daily. She was vaccinated with FLUVIRIN (batch number: 122105) intramuscularly in the left arm on 18 Oct 2012. On the same date, she experienced extreme headache, fever, chills and muscle pain that lasted approximately 24 to 36 hours. It was followed by neck pain, nausea, dizziness, blurry eyes and inability to concentrate. Her primary care doctor thought that it was a virus with vertigo. She was treated by physical therapist for vertigo, but without any improvement. Diagnostic lab tests were performed and she had a magnetic resonance imaging (MRI) and it was sent for follow up studies which were ongoing at present. The outcome of the event was reported as condition unchanged as of 26 Dec 2012. Following an internal review received on 12 Jul 2013 of the information received on 03 Jul 2013, it was identified that the event vertigo was erroneously kept as non-serious and hence the event was now upgraded to medically significant.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo, Viral infection, Vision blurred
Clinical narrative: Case number PHHY2013US069531 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 479312) web site on 03 Jul 2013. This report refers to a 66-years-old female patient. Her medical history was not reported and concomitant medications included omeprazole 20 mg at a dose of 1 tablet once daily. She was vaccinated with FLUVIRIN (batch number: 122105) intramuscularly in the left arm on 18 Oct 2012. On the same date, she experienced extreme headache, fever, chills and muscle pain that lasted approximately 24 to 36 hours. It was followed by neck pain, nausea, dizziness, blurry eyes and inability to concentrate. Her primary care doctor thought that it was a virus with vertigo. She was treated by physical therapist for vertigo, but without any improvement. Diagnostic lab tests were performed and she had a magnetic resonance imaging (MRI) and it was sent for follow up studies which were ongoing at present. The outcome of the event was reported as condition unchanged as of 26 Dec 2012. Following an internal review received on 12 Jul 2013 of the information received on 03 Jul 2013, it was identified that the event vertigo was erroneously kept as non-serious and hence the event was now upgraded to medically significant.
Age: 27.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Erythema, Loss of consciousness, Muscle rigidity, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2013US020841, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480371) on 04 Mar 2013 with a follow up report received from the Quality Assurance Department (QA reference number: 227390) on 01 Jul 2014. This report refers to 27 year old male patient. His current condition included runny nose and cough and his concomitant medication was not reported. His vaccination history included an unspecified vaccine long time ago with which he experienced fainting. He was vaccinated with FLUVIRIN (batch number: 1205601) and ADACEL (other manufacturer, batch number: C4332AA) into left arm on 29 Dec 2012. On the same day post vaccination, when he tried to get up, he sat down and passed out. His head rolled back and he became red and rigid. He was stiff for approximately 30 seconds and then he slowly started labored breathing. Emergency medical team came and took blood pressure multiple times and stayed with him for 20 to 30 minutes then released him home with the father. He was not given any drugs like epinephrine. The outcome of the events was complete recovery. The seriousness and causality of the events was not reported. Based on the batch review performed, it was concluded that the FLUVIRIN batch number 1205601 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from the QA department on 01 Jul 2014: Updated batch review report.