chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Bacterial infection, Chest X-ray abnormal, Decreased appetite, Epstein-Barr virus test, Eyelid margin crusting
Clinical narrative: My daughter came down with a fever for 5 days starting on Feb 19 which was 6 days after her MMR and Varicella vaccines.  According to multiple sources online her reaction was consistent to a reaction to the Measles portion of the vaccine.  She did have a minor rash. She continued with fever and not wanting to eat anything and her illness and fever progressed from there to a possible diagnosis of Mono about a week later which was based on a monospot test which according to the CDC is not very reliable in children and her Epstein Barr results were not returned or shipped to facility because of inclement weather (that's where they send bloodwork for Epstein Barr.) She got worse after the "diagnosis". She developed a terrible crust over her eyes that kept coming throughout the day for over about a week and her nose was terribly full of snot.  She was not eating still and I was having to give her Ensure everyday along with her fluids for 7 weeks to keep her "fed."  Her white count at the time of the Mono diagnosis was 23,000.  She was still not eating on her own much by the first week in April (only a bite here and there) I was continuing to talk with nurse periodically about her condition on the phone and I was continuing to keep her hydrated and give her Ensure at home. On April 9th she came down with 104 fever and we tried to treat her at home for a couple of days but there was no change so on April 11 we took her to the ER and I spent 5 hours there with her as they ran tests for everything imaginable.  Her white count was still very high (22,000) and according to the ER doc nothing was showing us the cause of the fever but he decided to treat her symptom (fever) as a bacterial infection. Later on her doctor told me that the xray report showed a tiny sign of something that could have been early Pneumonia.  I have obtained copies of most of her records related to this situation.  Nothing ever cultured out bacterially speaking but the antibiotic that she was given has seemed to help and so far as of April 20th she has been better.  This has been a Very difficult time for our family as we have tried to figure out what could be wrong with our child.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Laboratory test, Mononucleosis heterophile test, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: My daughter came down with a fever for 5 days starting on Feb 19 which was 6 days after her MMR and Varicella vaccines.  According to multiple sources online her reaction was consistent to a reaction to the Measles portion of the vaccine.  She did have a minor rash. She continued with fever and not wanting to eat anything and her illness and fever progressed from there to a possible diagnosis of Mono about a week later which was based on a monospot test which according to the CDC is not very reliable in children and her Epstein Barr results were not returned or shipped to facility because of inclement weather (that's where they send bloodwork for Epstein Barr.) She got worse after the "diagnosis". She developed a terrible crust over her eyes that kept coming throughout the day for over about a week and her nose was terribly full of snot.  She was not eating still and I was having to give her Ensure everyday along with her fluids for 7 weeks to keep her "fed."  Her white count at the time of the Mono diagnosis was 23,000.  She was still not eating on her own much by the first week in April (only a bite here and there) I was continuing to talk with nurse periodically about her condition on the phone and I was continuing to keep her hydrated and give her Ensure at home. On April 9th she came down with 104 fever and we tried to treat her at home for a couple of days but there was no change so on April 11 we took her to the ER and I spent 5 hours there with her as they ran tests for everything imaginable.  Her white count was still very high (22,000) and according to the ER doc nothing was showing us the cause of the fever but he decided to treat her symptom (fever) as a bacterial infection. Later on her doctor told me that the xray report showed a tiny sign of something that could have been early Pneumonia.  I have obtained copies of most of her records related to this situation.  Nothing ever cultured out bacterially speaking but the antibiotic that she was given has seemed to help and so far as of April 20th she has been better.  This has been a Very difficult time for our family as we have tried to figure out what could be wrong with our child.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: My daughter came down with a fever for 5 days starting on Feb 19 which was 6 days after her MMR and Varicella vaccines.  According to multiple sources online her reaction was consistent to a reaction to the Measles portion of the vaccine.  She did have a minor rash. She continued with fever and not wanting to eat anything and her illness and fever progressed from there to a possible diagnosis of Mono about a week later which was based on a monospot test which according to the CDC is not very reliable in children and her Epstein Barr results were not returned or shipped to facility because of inclement weather (that's where they send bloodwork for Epstein Barr.) She got worse after the "diagnosis". She developed a terrible crust over her eyes that kept coming throughout the day for over about a week and her nose was terribly full of snot.  She was not eating still and I was having to give her Ensure everyday along with her fluids for 7 weeks to keep her "fed."  Her white count at the time of the Mono diagnosis was 23,000.  She was still not eating on her own much by the first week in April (only a bite here and there) I was continuing to talk with nurse periodically about her condition on the phone and I was continuing to keep her hydrated and give her Ensure at home. On April 9th she came down with 104 fever and we tried to treat her at home for a couple of days but there was no change so on April 11 we took her to the ER and I spent 5 hours there with her as they ran tests for everything imaginable.  Her white count was still very high (22,000) and according to the ER doc nothing was showing us the cause of the fever but he decided to treat her symptom (fever) as a bacterial infection. Later on her doctor told me that the xray report showed a tiny sign of something that could have been early Pneumonia.  I have obtained copies of most of her records related to this situation.  Nothing ever cultured out bacterially speaking but the antibiotic that she was given has seemed to help and so far as of April 20th she has been better.  This has been a Very difficult time for our family as we have tried to figure out what could be wrong with our child.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion, Rash
Clinical narrative: FEBRILE SEIZURE; RASH.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour
Clinical narrative: Patient lost his smile and talking that had been very well developed by 4 mos old. This lasted 3 weeks. These returned fairly quickly again at 3 weeks after the vaccines. He has been developing at his normal rate thereafter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: 2-3 inch circle of redness around injection site on right arm. Went to little clinic on 4/23/15 and was treated with Bactrim ds for cellulitis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: Rash, spots, burning on hip/stomach, side, took place 3 days after she got Zostavax shot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, severe chills and body ache lasted approximately 12 hours, chills disappeared moderate headache and severe body ache continued off and on for the next 2 days.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Musculoskeletal stiffness, Pallor, Posturing
Clinical narrative: Patient was administered Hep A and Gardasil (HPV) vaccines. She immediately became light-headed, dizzy and went from sitting position to lying on exam table. The office CMA in the room described a few seconds of stiffening/posturing. She never lost consciousness but was pale and somnolent. Within 20-30 seconds she was conversant, feeling better. After 5-10 minutes she was completely back to baseline.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Somnolence
Clinical narrative: Patient was administered Hep A and Gardasil (HPV) vaccines. She immediately became light-headed, dizzy and went from sitting position to lying on exam table. The office CMA in the room described a few seconds of stiffening/posturing. She never lost consciousness but was pale and somnolent. Within 20-30 seconds she was conversant, feeling better. After 5-10 minutes she was completely back to baseline.
Age: 68.0
Sex: F
Vaccine: IPV
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain level at 8-9 on a scale of 1-10  at injection site. Unable to use arm for 4-5 days, significant pain for another 3 weeks.  Pain level at 2-3 continues - to this day.  4/25/2015.  Some days up to
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient developed body aches, chills, and a severe headache about 12 hours after receiving vaccine. Severe headache accompanied by blurred vision lasted until late night of 4-22-15. Patient states symptoms resolved, though still very red and sore at injection site.
Sex: F
Vaccine: PPV
Symptoms: Vision blurred
Clinical narrative: Patient developed body aches, chills, and a severe headache about 12 hours after receiving vaccine. Severe headache accompanied by blurred vision lasted until late night of 4-22-15. Patient states symptoms resolved, though still very red and sore at injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The patient returned to the pharmacy after one week and the site of injection was red, hot and itching.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red, raised, circular rash behind each knee appearing within 14 days of immunization; resolved slowly over 2 weeks.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: RA-> LA, (R) groin-> (L) groin, (R) ankle-> (L) ankle. Rash developed at sites in order listed above over 2-3 day period-took approximately 2 weeks ro resolve.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Dizziness, Nausea
Clinical narrative: Nausea and dizziness about 5 hours post receiving vaccine. At time of report patient is still symptomatic. At the ER he was prescribed meclizine and ZOFRAN. ER doctor attributed his symptoms to vaccine.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age referring himself. The patient's pertinent medical history was not reported. On an unknown dates, the patient was vaccinated with first two shots of GARDASIL, five weeks apart. No adverse effect was reported. No product quality complaint (PQC) was reporred for GARDASIL. Additional information is not expected as the contact details were not reported.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown demographics. No medical history or concurrent conditions were reported. On an unknown date in May 2013, the patient was vaccinated with first dose of GARDASIL, the patient was vaccinated with the second dose on an unknown date in August 2013 and the third dose on an unknown date in May 2014 (inappropriate schedule of drug administration). On 01-APR-2015, the patient was vaccinated with a fourth dose of GARDASIL. No adverse events were reported. The outcome of the event was unknown. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was unspecified. On an unknown date, the unspecified number of patients were vaccinated with MMR II (dose, frequency and route were unspecified). On an unknown date, the patients experienced arthritis pain. The pharmacist reported that she does not know if this was an exacerbation of pre-existing arthritis or a new diagnosis of arthritis. It was also reported that these cases were so many years ago. The outcome of arthritis pain was unknown. The relatedness of arthritis pain with MMR II, live was not reported. No product quality complaint (PQC) was reported for MMR II. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with LIQUID PEDVAXHIB (dose strength, route unspecified) lot # K002746, expiration date 09-DEC-2016 that were improperly stored. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with expired dose of PNEUMOVAX 23 (strength and route unspecified) lot # J010396, expiration date 16-FEB-2016. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. 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 two unspecified patients of unknown age and unknown gender. The two unspecified patients pertinent medical history was not reported. Since 02-MAR-2015, the two unspecified patients were vaccinated with (Oka/Merck) VARIVAX which underwent supported temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Incomplete course of vaccination, Viral titre decreased
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. The patient's medical history and drug reactions were not reported. "30 years ago" (approximately in 1985) when the patient was in her childhood, the patient was vaccinated with only one dose in the series of MMR II injection (therapy type: HSA, dose, route, lot number and expire date not reported) and the patient had severe anaphylactic reactions with clindamycin, penicillin (unspecified) (unknown formulation), "the sulfas", erythromycin, and KEFLEX (anaphylactic reaction to drug). A recent (approximately in 2015) unspecified titer level was low. The outcome of anaphylactic reaction to drugs and viral titer decreased was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 4 year old male patient. On 13-APR-2015 the patient was vaccinated with a dose of PROQUAD (lot # K022444, expiration date 13-MAY-2016, strength, dose and route were unknown) which was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Autism, Pyrexia, Roseola
Clinical narrative: Information has been received from a mother referring to her daughter of unknown age. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with M-M-R II (strength, dose, route, lot# and expiration unknown). On an unknown date, the patient developed a high fever and roseola after receiving M-M-R II. The patient was also reported with autism, but it was not specified if she was diagnosed before or after receiving M-M-R II. The outcome of events was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling at vaccine site, erythema.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein, Differential white blood cell count, Full blood count, Liver function test, Lymphadenitis
Clinical narrative: Acute lymphadenitis- supraclavicular lymph nodes on left side (same side where vaccine was injected) and a 4cm welt on chest was noted with itching.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Acute lymphadenitis- supraclavicular lymph nodes on left side (same side where vaccine was injected) and a 4cm welt on chest was noted with itching.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Asthenia, Hypoaesthesia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain, tingling, numbness in opposite arm from vaccination. Persistent pain and weakness for over a week (still there).  Unable to do some normal things with my arm and hand. Lifting and range of motion is suddenly difficult. I had injured this arm and hand some years ago, but it had recovered and been fine for over four years.  This came on quite suddenly for no apparent reason (no abnormal use of arm or strain).  The only thing I can think that happened around the same time was the vaccination.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Paraesthesia, Weight bearing difficulty
Clinical narrative: Pain, tingling, numbness in opposite arm from vaccination. Persistent pain and weakness for over a week (still there).  Unable to do some normal things with my arm and hand. Lifting and range of motion is suddenly difficult. I had injured this arm and hand some years ago, but it had recovered and been fine for over four years.  This came on quite suddenly for no apparent reason (no abnormal use of arm or strain).  The only thing I can think that happened around the same time was the vaccination.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient states redness, soreness, and swollen arm from Prevnar still one week post vaccination. Low grade fever went away. Patient states this happened with previous pneumonia vaccine as well.
Age: 23.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, FLUX, HEPA, HPV4
Symptoms: Arthralgia, Pain in extremity, Paraesthesia
Clinical narrative: Tingling pain all the way down my arm, and into my hand starting a couple of days after my vaccine. Gardasil was the only vaccine in that arm. It got a little bit better; I was doing heavy lifting this weekend (4/25), and now my wrist and hand have the same tingling pain all over again. It's a distinct feeling, and my left side does not have it.
Age: 23.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, FLUX, HEPA, HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling pain all the way down my arm, and into my hand starting a couple of days after my vaccine. Gardasil was the only vaccine in that arm. It got a little bit better; I was doing heavy lifting this weekend (4/25), and now my wrist and hand have the same tingling pain all over again. It's a distinct feeling, and my left side does not have it.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Adverse event following immunisation
Clinical narrative: Information has been received from a dentist concerning a 14 year old male patient (the dentist's grandson). The patient's medical history and concurrent condition were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (lot#, expiration date, dose and route not provided). It was unspecified if patient received GARDASIL or GARDASIL 9. Concomitant therapy was not provided. On 16-APR-2015 the patient experienced an unspecified reaction after receiving GARDASIL, resulting in the patient being hospitalized at an unspecified hospital. The outcome of the adverse event was unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Two days after the injection was given a large red, no pain, itchy rash appeared on the upper arm. 6-8 inches long, 2 1/2 inches wide wrapping around and down the arm. Rash faded after 1 week on ZYRTEC and hydrocortisone cream. 4/18 rash appeared; 4/24 clear.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Hives/hive-like rash on thighs/groin/waist area that occurred in patches overnight the day of injection. Saw PCP and started on a MEDROL dose pack. Rash continue to spread to back the day after.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to the pharmacy around 4 pm on 4/25. His left upper arm was red, swollen, and hot to the touch above the elbow. He stated that this started in the evening of 4/23 after his vaccination. I suggested he go to urgent care. He came back around 5:30 with scripts for an antibiotic and steroid. He was diagnosed with cellulitis and told to go to the ER if no improvement.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Patient received ZOSTAVAX on 4/15/15. On 4/19/15-pt reported a raised rash near injection site. Went to emergency room on 4/20/15 for treatment-rash began to blister.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare workers refers to a 3 month old patient. The patient's medical history and concurrent conditions were not reported. On 16-APR-2015, the patient was vaccinated with VAQTA (strength: 25/0.5 (units not provided), lot # K012457, expiration date: 04-JUN-2017, route of administration, dose and frequency was unknown) inadvertently. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a consumer referring to her 17 year old daughter. Concurrent condition and medical history were not reported. On unknown dates, the patient was vaccinated with 2 doses of GARDASIL (lot number, dose and route were unknown). On 09-DEC-2010 the patient was vaccinated with the third dose of GARDASIL (lot number, dose and route were unknown). Concomitant therapies were not reported. On an unknown date, after completing her series of the GARDASIL vaccine, the patient had contracted an unspecified strain of Human papilloma virus (HPV). The outcome and causality of the event was unknown. Additional information is not expected because there's no contact information provided.
Age: 1.13
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Passed away approx 11:30 PM from receiving flu vaccine that morning.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Amylase normal, Asthenia, Blood HIV RNA, Cytomegalovirus test negative, Differential white blood cell count normal
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old male patient. No concurrent or historical conditions were reported. On 05-SEP-2013 the patient was vaccinated with the first dose of GARDASIL and on 23-FEB-3015, the patient was vaccinated with the second dose of GARDASIL which was reported as inappropriate schedule of drug administration. On 05-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K023435, Expiration date 5-NOV-2015) 0.5 ml, intramuscular in the left deltoid. The nurse confirmed that product was not GARDASIL 9. No concomitant medication was reported. On 25-MAR-2015, 567 days after onset of third dose of GARDASIL therapy the patient experienced pyrexia reported as "fevers up to 103F", fatigue, malaise and parotid gland enlargement reported as "bilateral swelling of parotid glands". The nurse stated that no adverse effect were experienced by the patient post administration of first and second dose of GARDASIL. On an unspecified date, the patient call to the physician office to seek for medical attention. Treatment suggested was rest and unspecified fever management. In 2015, laboratory diagnostics studies were performed: Full blood count (CBC): Normal (reported as Negative), Cytomegalovirus test (CMV): Negative, Mumps antibody test (Mumps Virus Antibody): Negative, Blood immunoglobulin M (IgM): Negative, Blood Immunoglobulin G (IgG): Negative, Serum: Negative. Serum Epstein Barr virus: HIV: Negative, Amylase: Normal (reported as Negative). Units were not provided for any of the tests. Treatment suggested was rest and unspecified fever management. The nurse stated that in 2015, the parotid gland enlargement, malaise, pyrexia and fatigue had fully resolved. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Epstein-Barr virus antibody negative, Full blood count normal, HIV test, HIV test negative, Lymph node pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old male patient. No concurrent or historical conditions were reported. On 05-SEP-2013 the patient was vaccinated with the first dose of GARDASIL and on 23-FEB-3015, the patient was vaccinated with the second dose of GARDASIL which was reported as inappropriate schedule of drug administration. On 05-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K023435, Expiration date 5-NOV-2015) 0.5 ml, intramuscular in the left deltoid. The nurse confirmed that product was not GARDASIL 9. No concomitant medication was reported. On 25-MAR-2015, 567 days after onset of third dose of GARDASIL therapy the patient experienced pyrexia reported as "fevers up to 103F", fatigue, malaise and parotid gland enlargement reported as "bilateral swelling of parotid glands". The nurse stated that no adverse effect were experienced by the patient post administration of first and second dose of GARDASIL. On an unspecified date, the patient call to the physician office to seek for medical attention. Treatment suggested was rest and unspecified fever management. In 2015, laboratory diagnostics studies were performed: Full blood count (CBC): Normal (reported as Negative), Cytomegalovirus test (CMV): Negative, Mumps antibody test (Mumps Virus Antibody): Negative, Blood immunoglobulin M (IgM): Negative, Blood Immunoglobulin G (IgG): Negative, Serum: Negative. Serum Epstein Barr virus: HIV: Negative, Amylase: Normal (reported as Negative). Units were not provided for any of the tests. Treatment suggested was rest and unspecified fever management. The nurse stated that in 2015, the parotid gland enlargement, malaise, pyrexia and fatigue had fully resolved. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Mumps antibody test negative, Myalgia, Night sweats, Oral discomfort, Parotid gland enlargement
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old male patient. No concurrent or historical conditions were reported. On 05-SEP-2013 the patient was vaccinated with the first dose of GARDASIL and on 23-FEB-3015, the patient was vaccinated with the second dose of GARDASIL which was reported as inappropriate schedule of drug administration. On 05-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K023435, Expiration date 5-NOV-2015) 0.5 ml, intramuscular in the left deltoid. The nurse confirmed that product was not GARDASIL 9. No concomitant medication was reported. On 25-MAR-2015, 567 days after onset of third dose of GARDASIL therapy the patient experienced pyrexia reported as "fevers up to 103F", fatigue, malaise and parotid gland enlargement reported as "bilateral swelling of parotid glands". The nurse stated that no adverse effect were experienced by the patient post administration of first and second dose of GARDASIL. On an unspecified date, the patient call to the physician office to seek for medical attention. Treatment suggested was rest and unspecified fever management. In 2015, laboratory diagnostics studies were performed: Full blood count (CBC): Normal (reported as Negative), Cytomegalovirus test (CMV): Negative, Mumps antibody test (Mumps Virus Antibody): Negative, Blood immunoglobulin M (IgM): Negative, Blood Immunoglobulin G (IgG): Negative, Serum: Negative. Serum Epstein Barr virus: HIV: Negative, Amylase: Normal (reported as Negative). Units were not provided for any of the tests. Treatment suggested was rest and unspecified fever management. The nurse stated that in 2015, the parotid gland enlargement, malaise, pyrexia and fatigue had fully resolved. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Polymerase chain reaction, Pyrexia, Swelling face
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old male patient. No concurrent or historical conditions were reported. On 05-SEP-2013 the patient was vaccinated with the first dose of GARDASIL and on 23-FEB-3015, the patient was vaccinated with the second dose of GARDASIL which was reported as inappropriate schedule of drug administration. On 05-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K023435, Expiration date 5-NOV-2015) 0.5 ml, intramuscular in the left deltoid. The nurse confirmed that product was not GARDASIL 9. No concomitant medication was reported. On 25-MAR-2015, 567 days after onset of third dose of GARDASIL therapy the patient experienced pyrexia reported as "fevers up to 103F", fatigue, malaise and parotid gland enlargement reported as "bilateral swelling of parotid glands". The nurse stated that no adverse effect were experienced by the patient post administration of first and second dose of GARDASIL. On an unspecified date, the patient call to the physician office to seek for medical attention. Treatment suggested was rest and unspecified fever management. In 2015, laboratory diagnostics studies were performed: Full blood count (CBC): Normal (reported as Negative), Cytomegalovirus test (CMV): Negative, Mumps antibody test (Mumps Virus Antibody): Negative, Blood immunoglobulin M (IgM): Negative, Blood Immunoglobulin G (IgG): Negative, Serum: Negative. Serum Epstein Barr virus: HIV: Negative, Amylase: Normal (reported as Negative). Units were not provided for any of the tests. Treatment suggested was rest and unspecified fever management. The nurse stated that in 2015, the parotid gland enlargement, malaise, pyrexia and fatigue had fully resolved. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Amylase normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Cytomegalovirus test negative, Epstein-Barr virus test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old male patient. No concurrent or historical conditions were reported. On 05-SEP-2013 the patient was vaccinated with the first dose of GARDASIL and on 23-FEB-3015, the patient was vaccinated with the second dose of GARDASIL which was reported as inappropriate schedule of drug administration. On 05-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K023435, Expiration date 5-NOV-2015) 0.5 ml, intramuscular in the left deltoid. The nurse confirmed that product was not GARDASIL 9. No concomitant medication was reported. On 25-MAR-2015, 567 days after onset of third dose of GARDASIL therapy the patient experienced pyrexia reported as "fevers up to 103F", fatigue, malaise and parotid gland enlargement reported as "bilateral swelling of parotid glands". The nurse stated that no adverse effect were experienced by the patient post administration of first and second dose of GARDASIL. On an unspecified date, the patient call to the physician office to seek for medical attention. Treatment suggested was rest and unspecified fever management. In 2015, laboratory diagnostics studies were performed: Full blood count (CBC): Normal (reported as Negative), Cytomegalovirus test (CMV): Negative, Mumps antibody test (Mumps Virus Antibody): Negative, Blood immunoglobulin M (IgM): Negative, Blood Immunoglobulin G (IgG): Negative, Serum: Negative. Serum Epstein Barr virus: HIV: Negative, Amylase: Normal (reported as Negative). Units were not provided for any of the tests. Treatment suggested was rest and unspecified fever management. The nurse stated that in 2015, the parotid gland enlargement, malaise, pyrexia and fatigue had fully resolved. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Full blood count normal, HIV test negative, Inappropriate schedule of drug administration, Malaise
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old male patient. No concurrent or historical conditions were reported. On 05-SEP-2013 the patient was vaccinated with the first dose of GARDASIL and on 23-FEB-3015, the patient was vaccinated with the second dose of GARDASIL which was reported as inappropriate schedule of drug administration. On 05-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K023435, Expiration date 5-NOV-2015) 0.5 ml, intramuscular in the left deltoid. The nurse confirmed that product was not GARDASIL 9. No concomitant medication was reported. On 25-MAR-2015, 567 days after onset of third dose of GARDASIL therapy the patient experienced pyrexia reported as "fevers up to 103F", fatigue, malaise and parotid gland enlargement reported as "bilateral swelling of parotid glands". The nurse stated that no adverse effect were experienced by the patient post administration of first and second dose of GARDASIL. On an unspecified date, the patient call to the physician office to seek for medical attention. Treatment suggested was rest and unspecified fever management. In 2015, laboratory diagnostics studies were performed: Full blood count (CBC): Normal (reported as Negative), Cytomegalovirus test (CMV): Negative, Mumps antibody test (Mumps Virus Antibody): Negative, Blood immunoglobulin M (IgM): Negative, Blood Immunoglobulin G (IgG): Negative, Serum: Negative. Serum Epstein Barr virus: HIV: Negative, Amylase: Normal (reported as Negative). Units were not provided for any of the tests. Treatment suggested was rest and unspecified fever management. The nurse stated that in 2015, the parotid gland enlargement, malaise, pyrexia and fatigue had fully resolved. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Mumps antibody test negative, Parotid gland enlargement, Pyrexia, Serology negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old male patient. No concurrent or historical conditions were reported. On 05-SEP-2013 the patient was vaccinated with the first dose of GARDASIL and on 23-FEB-3015, the patient was vaccinated with the second dose of GARDASIL which was reported as inappropriate schedule of drug administration. On 05-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K023435, Expiration date 5-NOV-2015) 0.5 ml, intramuscular in the left deltoid. The nurse confirmed that product was not GARDASIL 9. No concomitant medication was reported. On 25-MAR-2015, 567 days after onset of third dose of GARDASIL therapy the patient experienced pyrexia reported as "fevers up to 103F", fatigue, malaise and parotid gland enlargement reported as "bilateral swelling of parotid glands". The nurse stated that no adverse effect were experienced by the patient post administration of first and second dose of GARDASIL. On an unspecified date, the patient call to the physician office to seek for medical attention. Treatment suggested was rest and unspecified fever management. In 2015, laboratory diagnostics studies were performed: Full blood count (CBC): Normal (reported as Negative), Cytomegalovirus test (CMV): Negative, Mumps antibody test (Mumps Virus Antibody): Negative, Blood immunoglobulin M (IgM): Negative, Blood Immunoglobulin G (IgG): Negative, Serum: Negative. Serum Epstein Barr virus: HIV: Negative, Amylase: Normal (reported as Negative). Units were not provided for any of the tests. Treatment suggested was rest and unspecified fever management. The nurse stated that in 2015, the parotid gland enlargement, malaise, pyrexia and fatigue had fully resolved. No further information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient had a red, raised, sore, hot, swollen lump at the injection site. It grew to maybe 3 inches diameter. Her doctor prescribed her beta methasone steroid. Decreased to 1 1/2 inches, decreased size, softer, decreased hot as of 4/18/15 (phone call). Started on 4/14/15, stated, she had to sit home entire day because it was painful, put ice on it. Still has rash/lump.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a red, raised, sore, hot, swollen lump at the injection site. It grew to maybe 3 inches diameter. Her doctor prescribed her beta methasone steroid. Decreased to 1 1/2 inches, decreased size, softer, decreased hot as of 4/18/15 (phone call). Started on 4/14/15, stated, she had to sit home entire day because it was painful, put ice on it. Still has rash/lump.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient had a red, raised, sore, hot, swollen lump at the injection site. It grew to maybe 3 inches diameter. Her doctor prescribed her beta methasone steroid. Decreased to 1 1/2 inches, decreased size, softer, decreased hot as of 4/18/15 (phone call). Started on 4/14/15, stated, she had to sit home entire day because it was painful, put ice on it. Still has rash/lump.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Haematoma, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 61 year old female patient with no drug reactions or allergies. The patient's medical history or concurrent conditions were not provided. On 29-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (0.65 ml, subcutaneous, lot number reported as K019921, expiration date 24-JAN-2016). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and pravastatin. On 30-JAN-2015, the patient experienced swelling and a hematoma at the injection site. On 31-JAN-2015, the hematoma resolved, however the patient began to experience pain in her arm. The pain had gradually increased in intensity since it was onset to the point that the patient was experiencing at the time of the report constant pain and limited mobility from her elbow to her shoulder. The patient went to see a doctor on an unspecified date in 2015, who prescribed an unspecified topical analgesic and ibuprofen for pain management as well as ordered that the patient receive a magnetic resonance imaging (MRI) of the affected arm. The patient had not received a MRI yet due to financial issues. Other laboratories diagnostic studies were not performed. At the time of the report, the patient had not recovered from swelling at injection site and pain in arm with limited mobility. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site haematoma, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 61 year old female patient with no drug reactions or allergies. The patient's medical history or concurrent conditions were not provided. On 29-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (0.65 ml, subcutaneous, lot number reported as K019921, expiration date 24-JAN-2016). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and pravastatin. On 30-JAN-2015, the patient experienced swelling and a hematoma at the injection site. On 31-JAN-2015, the hematoma resolved, however the patient began to experience pain in her arm. The pain had gradually increased in intensity since it was onset to the point that the patient was experiencing at the time of the report constant pain and limited mobility from her elbow to her shoulder. The patient went to see a doctor on an unspecified date in 2015, who prescribed an unspecified topical analgesic and ibuprofen for pain management as well as ordered that the patient receive a magnetic resonance imaging (MRI) of the affected arm. The patient had not received a MRI yet due to financial issues. Other laboratories diagnostic studies were not performed. At the time of the report, the patient had not recovered from swelling at injection site and pain in arm with limited mobility. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Skin discolouration
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 61 year old female patient with no drug reactions or allergies. The patient's medical history or concurrent conditions were not provided. On 29-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (0.65 ml, subcutaneous, lot number reported as K019921, expiration date 24-JAN-2016). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and pravastatin. On 30-JAN-2015, the patient experienced swelling and a hematoma at the injection site. On 31-JAN-2015, the hematoma resolved, however the patient began to experience pain in her arm. The pain had gradually increased in intensity since it was onset to the point that the patient was experiencing at the time of the report constant pain and limited mobility from her elbow to her shoulder. The patient went to see a doctor on an unspecified date in 2015, who prescribed an unspecified topical analgesic and ibuprofen for pain management as well as ordered that the patient receive a magnetic resonance imaging (MRI) of the affected arm. The patient had not received a MRI yet due to financial issues. Other laboratories diagnostic studies were not performed. At the time of the report, the patient had not recovered from swelling at injection site and pain in arm with limited mobility. Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Condition aggravated, Kawasaki's disease
Clinical narrative: 9/12/2014: Starting around 9pm, non-stop screaming for over 2 hours. 9/13/2014: Start of stomach aches, leg jerking, very fussy/uncomfortable. Cheeks very red. Irritable, stopped smiling, aloof. 10/8/2014: Visit doctor for stomach aches, continually bringing legs to stomach and slamming down, seemed very uncomfortable. 10/23/2014: First noticed high temp (100.3). Lips appeared very red. Incredibly fussy. 10/25/2014: Hard time breathing, eating, high temp (102). Went to ER. Temp 103.9. Had fever induced seizure. Stopped eating. Body rash began. Cold like symptoms (mild cough, stuffy nose).  10/26/2014: Admitted to hospital. Hard time breathing. Red eyes, cracked and bleeding lips. Very aloof. 10/29/2014: Difficulty breathing, worsening of all symptoms above. Diagnosed as Kawasaki disease. IVIG treatment. 10/31/2014: Hospital discharge. No more fever. 11/3/2014: New rash on arms and legs. Biopsied - rare psoriasi from Kawasaki disease. 11/12/2014: Stridor. Between 11/12/2014 - 12/25/2014: Skin on fingers and toes began peeling, nails pushed out from psoriasis, etc...
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain upper, Abnormal behaviour, Biopsy skin abnormal, Chapped lips, Cheilitis
Clinical narrative: 9/12/2014: Starting around 9pm, non-stop screaming for over 2 hours. 9/13/2014: Start of stomach aches, leg jerking, very fussy/uncomfortable. Cheeks very red. Irritable, stopped smiling, aloof. 10/8/2014: Visit doctor for stomach aches, continually bringing legs to stomach and slamming down, seemed very uncomfortable. 10/23/2014: First noticed high temp (100.3). Lips appeared very red. Incredibly fussy. 10/25/2014: Hard time breathing, eating, high temp (102). Went to ER. Temp 103.9. Had fever induced seizure. Stopped eating. Body rash began. Cold like symptoms (mild cough, stuffy nose).  10/26/2014: Admitted to hospital. Hard time breathing. Red eyes, cracked and bleeding lips. Very aloof. 10/29/2014: Difficulty breathing, worsening of all symptoms above. Diagnosed as Kawasaki disease. IVIG treatment. 10/31/2014: Hospital discharge. No more fever. 11/3/2014: New rash on arms and legs. Biopsied - rare psoriasi from Kawasaki disease. 11/12/2014: Stridor. Between 11/12/2014 - 12/25/2014: Skin on fingers and toes began peeling, nails pushed out from psoriasis, etc...
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Discomfort, Dyskinesia, Dyspnoea, Eating disorder
Clinical narrative: 9/12/2014: Starting around 9pm, non-stop screaming for over 2 hours. 9/13/2014: Start of stomach aches, leg jerking, very fussy/uncomfortable. Cheeks very red. Irritable, stopped smiling, aloof. 10/8/2014: Visit doctor for stomach aches, continually bringing legs to stomach and slamming down, seemed very uncomfortable. 10/23/2014: First noticed high temp (100.3). Lips appeared very red. Incredibly fussy. 10/25/2014: Hard time breathing, eating, high temp (102). Went to ER. Temp 103.9. Had fever induced seizure. Stopped eating. Body rash began. Cold like symptoms (mild cough, stuffy nose).  10/26/2014: Admitted to hospital. Hard time breathing. Red eyes, cracked and bleeding lips. Very aloof. 10/29/2014: Difficulty breathing, worsening of all symptoms above. Diagnosed as Kawasaki disease. IVIG treatment. 10/31/2014: Hospital discharge. No more fever. 11/3/2014: New rash on arms and legs. Biopsied - rare psoriasi from Kawasaki disease. 11/12/2014: Stridor. Between 11/12/2014 - 12/25/2014: Skin on fingers and toes began peeling, nails pushed out from psoriasis, etc...