chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Pain in extremity, Pyrexia, Rash macular, Skin discolouration, White blood cell count increased
Clinical narrative: 4/9/14 Pt had stuffy nose from allergies in morning and otherwise felt fine. Had immunizations at 10 am. Felt fine until 5 pm when she felt tired and weak. Temp was 101 around 7 pm. Left arm throbbing and numbing at around 7 pm, resolved in 30 minutes. Fever peaked at 102.3 at 9 pm. Took Advil. Woke up at 2 a.m. with 102 temp and chills and took more Advil. 4/10/14 Temp 8:30 am  101. Took Advil 400 mg. Seen by MD at 9:30 am. Feels tired, slightly achy. Temp 102.4. Left arm sore to raise arm and to palpate but not painful at rest. WBC 13.9 with neutrophilia, no bands. Mild tenderness and induration for 3-4 cm around left deltoid injection site. Took Advil alternating with Tylenol at 2pm, 6 pm and at 12 midnight. 4/11/14 Temp reported by patient: 101.6 Took Tylenol. Left deltoid: 10 cm erythema and warmth, tenderness, no streaking. This is location of pneumococcal vaccine. Due to progression of erythema around injection site, and leukocytosis and continued fever, will treat for possibility of injection site infection. Start Keflex TID. 4/12/14  L upper arm with 8 x 7 cm area of induration deltoid area. 3 blotchy areas of redness over lower deltoid extending to 10 cm above elbow ( 8 x 5, 7 x 4 and 7 x 5 cm each). Entire area mod tender and mod warm to touch. 4 cm area of ecchymosis just distal to area of erythema. 4/15/14  Left arm discoloration has stopped advancing and started fading. No paresthesias or numbness.  Presumed cellulitis after pneumococcal vaccine vs severe immunologic reaction causing severe local and also systemic sx (fever, malaise, headache, nausea, leukocytosis). All sx resolving.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Developed rash about 2 1/2 inches diameter on his rear lateral right torso. Severe itching on the same area on 4/16. Took BENADRYL tab - seem to improved it a bit.
Sex: M
Vaccine: ANTH
Symptoms: Death, Hepatic enzyme increased
Clinical narrative: On 14APR2014, information was received from a consumer on behalf of his cousin. The reporter stated that his male cousin had received the Anthrax vaccine (date, dose, lot# not reported). On an unspecified date he experienced high liver enzyme levels. Subsequently, he died. Date of death, unknown. Cause of death, unknown. Follow up information has been requested.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chest X-ray normal, Crying, Influenza virus test negative, Laboratory test normal, Pain
Clinical narrative: Fever since immunizations performed, T-max 103 degrees in office. Pt with nearly inconsolable screaming greater than or equal to 12 hours (described as a painful cry). Tachypnea, tachycardia. Admitted for 24 hour observation.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Respiratory syncytial virus test negative, Screaming, Tachycardia, Tachypnoea
Clinical narrative: Fever since immunizations performed, T-max 103 degrees in office. Pt with nearly inconsolable screaming greater than or equal to 12 hours (described as a painful cry). Tachypnea, tachycardia. Admitted for 24 hour observation.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urinary system X-ray, Urinary system x-ray normal
Clinical narrative: Fever since immunizations performed, T-max 103 degrees in office. Pt with nearly inconsolable screaming greater than or equal to 12 hours (described as a painful cry). Tachypnea, tachycardia. Admitted for 24 hour observation.
Sex: M
Vaccine: ANTH
Symptoms: Crohn's disease
Clinical narrative: On 14APR2014, information was received from a consumer on behalf of his brother. The reporter stated that his brother had received the Anthrax vaccine (date, dose, lot# not reported). On an unspecified date the male was diagnosed with Crohn's disease. At the time of report, the Crohn's disease was in remission. The reporter stated that there was no prior family history of Crohn's disease. Reporter stated that the subject is in remission. Follow-up information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: Tues 4/15/14 I was given the shingles vaccine. On Weds I experienced a headache, fever, chills and overall achiness. The soreness in my arm increased Weds and Thurs and with a larger area of redness and swelling. I saw my Dr. on Fri who recommended treatment with VALTREX.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Tues 4/15/14 I was given the shingles vaccine. On Weds I experienced a headache, fever, chills and overall achiness. The soreness in my arm increased Weds and Thurs and with a larger area of redness and swelling. I saw my Dr. on Fri who recommended treatment with VALTREX.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102; extremely painful arm; arm swollen and red; severe headache (note: this was a pneumonia shot, not a flu shot).
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pt reports right arm pain/numbness since receiving Tdap vaccine at outside facility. Previously diagnosed with tendonitis.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal discomfort, Computerised tomogram head normal, Delusional perception, Drug screen negative, Electroencephalogram normal
Clinical narrative: Immediate upset stomach, headache, fever - eleven days later - vomiting, hallucinating and delusional, 6 hour vertical blank stare, loss of faculties - full psychotic break. 4 wk. hospitalized and again 6 months later.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Hallucination, Headache, Immediate post-injection reaction, Psychotic disorder, Pyrexia
Clinical narrative: Immediate upset stomach, headache, fever - eleven days later - vomiting, hallucinating and delusional, 6 hour vertical blank stare, loss of faculties - full psychotic break. 4 wk. hospitalized and again 6 months later.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Staring, Vomiting
Clinical narrative: Immediate upset stomach, headache, fever - eleven days later - vomiting, hallucinating and delusional, 6 hour vertical blank stare, loss of faculties - full psychotic break. 4 wk. hospitalized and again 6 months later.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age. The nurse reported that a provider's office (demographics unspecified) reported that unspecified number of doses of (Oka/Merck) VARIVAX (which captured in MARRS# 1404USA008265) and (Oka/Merck) PROQUAD were administered to patients after experiencing varied, and multiple excursions. PROQUAD, (lot# reported as j1131, expiration date: 13-MAR-2015) were exposed to 28F for 403.5 hours, and 295 hours at 4F. Next, (Oka/Merck) PROQUAD, (lot# j013858, expiration date: 01-MAY-2015) were exposed to 28F for 392.5 hours. PROQUAD, (lot# k000712, expiration date: 16-JUL-2015) were exposed to 216 hours 16F. No adverse effects reported. Lot number j1131 is an invalid lot number for PROQUAD (Oka/Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Pt was pale and felt light headed.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (lot number and frequency unknown) (dose regimen and frequency unknown) that was out of temperature and was not supported the in house stability. No concomitant medications were reported. No product quality issue was reported. No adverse events were reported. This case is related to case numbers 1404USA010833 and 1404USA010834 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 16-APR-2014 the patient was vaccinated with 2 doses of VARIVAX (lot #, expiry date, dose and route unknown). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-APR-2014, the patient was vaccinated with ZOSTAVAX, ZOSTAVAX VIAL 19400 PFU (plaque forming units), for unknown indication. No concomitant medications were reported. Pharmacist reported that patient also received ZOSTAVAX on 19-NOV-2012. No adverse symptoms reported. No product quality complaint was involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient. On 17-APR-2014 the patient was vaccinated with GARDASIL (lot # not reported) dose 1, 0.5 ml, intramuscular through a public vaccination found. On 17-APR-2014, the patient experienced vomiting. The outcome of vomiting was reported as recovered at the time of reporting. The relationship between vomiting and therapy with GARDASIL was unknown. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at site, fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and demographics. The nurse reported that sometime in March 2014 the patients were vaccinated with VARIVAX (Merck), subcutaneous that was improperly stored. Concomitant medications were not reported. No symptoms reported. The outcome of administered improperly stored was unknown. Follow up information has been received from the registered nurse. The reporter was unable to provide the patient's initials, dates of birth or dates of vaccination. It was reported that there were two patients vaccinated with VARIVAX (Merck), one was vaccinated with the following lot; (lot number reported as J009987, expiration date 12-AUG-2015), dose and anatomical location unspecified, subcutaneously that experienced a temperature excursion. This report is linked with case 1403USA013203 via same reporter link. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle aches, joint pains.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Fatigue, Headache, Local swelling
Clinical narrative: Redness, swelling of entire deltoid muscle and surrounding area and fever, tiredness, headache, malaise, chills.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Pyrexia
Clinical narrative: Redness, swelling of entire deltoid muscle and surrounding area and fever, tiredness, headache, malaise, chills.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Chest discomfort, Cough, Lip swelling, Pallor, Rash erythematous
Clinical narrative: Vaccinated at 345 w/ DTaP, IPV, MMR, et VZV. 400 Swelling around eyes, red flat rash blanching with pressure. Mostly upper chest. 410 BENADRYL 12.5 mg given moist cough at that time. 440 Swelling upper lip, epinephrine given by paramedic et. transported to ER. Released from ER after observation that evening.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Sensation of pressure
Clinical narrative: Vaccinated at 345 w/ DTaP, IPV, MMR, et VZV. 400 Swelling around eyes, red flat rash blanching with pressure. Mostly upper chest. 410 BENADRYL 12.5 mg given moist cough at that time. 440 Swelling upper lip, epinephrine given by paramedic et. transported to ER. Released from ER after observation that evening.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: 3 x 5 cm redness, raised area, hot to touch. No treatment.
Age: 48.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Chills, Decreased appetite, Headache, Muscle spasms, Nausea
Clinical narrative: Headache, body ache, fever, chills, muscle spasms, leg cramps, nausea, loss of appetite x 48 hrs.
Age: 48.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, body ache, fever, chills, muscle spasms, leg cramps, nausea, loss of appetite x 48 hrs.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No signs, symptoms, adverse events - pt received expired dose of ZOSTAVAX will return 28 days to repeat per Merck recommendations.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Biopsy muscle, Electromyogram, Muscular weakness
Clinical narrative: Weakness in my back and both arms. Ache/sore lower back and both ribs areas. I had a shingles vaccine on 1-7-13. I started having these symptoms about 1 month after 1-7-13. I've had several dr. appts with different drs. I'm currently taking gabapentin and tram-dol and nortriptyline.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Nuclear magnetic resonance imaging, Post herpetic neuralgia, X-ray
Clinical narrative: Weakness in my back and both arms. Ache/sore lower back and both ribs areas. I had a shingles vaccine on 1-7-13. I started having these symptoms about 1 month after 1-7-13. I've had several dr. appts with different drs. I'm currently taking gabapentin and tram-dol and nortriptyline.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Full blood count normal, Grand mal convulsion, Metabolic function test normal
Clinical narrative: The patient experienced a 4 minute generalized tonic-clonic seizure. She was hospitalized overnight for close observation. No additional seizure activity occurred.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: (R) arm markedly swollen and erythematous.
Sex: U
Vaccine: HPV4
Symptoms: Depression
Clinical narrative: This spontaneous report as received from a registered nurse who read a life story of a patient of unknown age on a website. On an unknown date the patient was vaccinated with GARDASIL (dose, lot no and route not reported). On an unknown date the patient experienced depression after vaccination. The outcome of depression was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Viral rash
Clinical narrative: Rash appeared 4/12/14 on back and by ears, spread over body on 4/13/14 - not itchy, acted normal. Fever up to 102.7 Friday and Sat. (4/12-4/13/14). Likely viral exanthem, but had MMR and Varicella immun. on 4/4/14.
Age: 2.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: She received a Tdap, MCV40 injection on 4/16/14. The next morning mom noticed that the area was red, it hurt to touch the area. The redness continues to spread so mom brought her in to the clinic on 4/18/14. She had a 7cm x 7cm area of erythema , warmth, induration on her (L) arm in the deltoid region at the injection site. Mild pain with palpation. She was told to return to the clinic if sx got worse or didn't improve.
Age: 2.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Pain
Clinical narrative: She received a Tdap, MCV40 injection on 4/16/14. The next morning mom noticed that the area was red, it hurt to touch the area. The redness continues to spread so mom brought her in to the clinic on 4/18/14. She had a 7cm x 7cm area of erythema , warmth, induration on her (L) arm in the deltoid region at the injection site. Mild pain with palpation. She was told to return to the clinic if sx got worse or didn't improve.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Urticaria
Clinical narrative: Hives, rash - 6 cm diam surrounding injection site.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Condition aggravated, Convulsion, Cough, Crying, Febrile convulsion
Clinical narrative: Last night (4/15/14), he woke up from sleep screaming, and had a convulsion lasting about 5 minutes. He was limp and lethargic for about 10 minutes postictally. Mom called rescue when she found him seizing and by the time paramedics arrived, the seizure had abated. He was taken to the ER, and evaluated. By the time he arrived at the ER, he was awake and crying. They dx Febrile Seizure, and OM, but did not treat the OM. Fever for 2 days and cough. Scheduled for ear tubes 4/23/14.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Hypotonia, Lethargy, Otitis media, Postictal state, Pyrexia
Clinical narrative: Last night (4/15/14), he woke up from sleep screaming, and had a convulsion lasting about 5 minutes. He was limp and lethargic for about 10 minutes postictally. Mom called rescue when she found him seizing and by the time paramedics arrived, the seizure had abated. He was taken to the ER, and evaluated. By the time he arrived at the ER, he was awake and crying. They dx Febrile Seizure, and OM, but did not treat the OM. Fever for 2 days and cough. Scheduled for ear tubes 4/23/14.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Screaming
Clinical narrative: Last night (4/15/14), he woke up from sleep screaming, and had a convulsion lasting about 5 minutes. He was limp and lethargic for about 10 minutes postictally. Mom called rescue when she found him seizing and by the time paramedics arrived, the seizure had abated. He was taken to the ER, and evaluated. By the time he arrived at the ER, he was awake and crying. They dx Febrile Seizure, and OM, but did not treat the OM. Fever for 2 days and cough. Scheduled for ear tubes 4/23/14.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a medical assistant who stated that multiple temperature excursions involving the PNEUMOVAX23 (lot # J010396, expiration date 16-FEB-2015) took place from 20-FEB-2014 through 06-MAR-2014. Improperly stored vaccines of PNEUMOVAX23 (lot # J010396, expiration date 16-FEB-2015) were administered to unspecified patients on unspecified dates (dosages and routes of administration were not provided). No adverse effects reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Increased heart rate 90's to low 120's (normal being 60-80's). Periodic dizziness.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site swelling
Clinical narrative: Pt stated he felt mild flu-like symptoms with a headache and a felt a small bump at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom noted redness and swelling warmth at site of injection.  Redness spread over upper leg 7.5cm in diameter.  Painful to touch Treated with amoxicillin.
Age: 1.06
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Diarrhoea, Nasal congestion, Rash generalised, Viral rash
Clinical narrative: Pt with what appears to be viral exanthem. Mom reported generalized rash, over trunk, back, arms, legs. Mild nasal congestion and diarrhea x 1 day (approx. 9 days after vaccine given).
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a medical assistant who stated that multiple temperature excursions involving ROTATEQ took place from 20-FEB-2014 through 06-MAR-2014. Improperly stored vaccines of ROTATEQ (lot # J009725, expiration date 04-MAR-2014) were administered to unspecified patients on unspecified dates (dosages not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Musculoskeletal disorder
Clinical narrative: This spontaneous report as received from a registered nurse who read a life story of a patient of unknown age on a website. On an unknown date the patient was vaccinated with GARDASIL (dose, lot no and route not reported). On an unknown date the patient experienced musculoskeletal disorders after vaccination. The outcome of musculoskeletal disorders was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old female patient. The patient was administered an initial dose of PEDIARIX on 02-JAN-2014. Patient was administered a second dose of PEDIARIX on 18-APR-2014 and additionally a dose of RECOMBIVAX HB (lot # H018689, exp date as 07-NOV-2014, 0.5 ml, intramuscularly) instead of the prescribed dose of PEDVAXHIB on 18-APR-2014. This was a staff error only. No adverse events were reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unspecified demographics. On 08-APR-2014, the patient was vaccinated with ZOSTAVAX, dose and frequency were unspecified, (lot number J011550, expiry date 19-DEC-2014) that had been improperly stored. No adverse effects reported. The outcome of patient was administered ZOSTAVAX that had been improperly stored was unknown. No product quality complaint was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from an unidentified nurse via a field representative refers to 2 unspecified patients of unknown ages and genders. On unknown dates, the patient were vaccinated with doses of GARDASIL (lot#, route and dose not reported). The nurse mentioned 2 patients fainted after administration of GARDASIL on unspecified dates. The patients sought medical attention in office. No treatment was given for adverse event. Both patients recovered on unspecified dates. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPIPV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction or s/s. KINRIX given too early.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash consistent with erythema multiforme minor noted approximately 40 hour after vaccine administration. No other symptoms.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender who on 07-APR-2014, was vaccinated with an expired dose of ROTATEQ (lot # H016259, expiration date 26-MAR-2014), 2 ml, oral. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchospasm, Eyelid oedema, Lip swelling, Local swelling, Rash generalised
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with no pertinent medical history. The patient was allergic to ZITHROMAX, AUGMENTIN, CEFZIL and penicillin. On 31-OCT-2014 and 03-DEC-2014, the patient was vaccinated with the first and second doses of GARDASIL (lot #, dose and route not reported0, respectively. On 11-MAR-2014 the patient was vaccinated with the third dose of GARDASIL, 120 Y injection, lot # reported as K000146, expiration date 16-AUG-2016, (dose and route not reported). There was no concomitant medication. On 21-MAR-2014, the patient developed a diffuse rash on her entire body after receiving a third dose of GARDASIL. The healthcare worker also mentioned the patient developed swelling of her hands and feet, puffiness under her eyelids and puffy lips, bronchospasm and wheezing, discoloration of her feet and "serum sickness to the unknown". The healthcare worker mentioned the patient was seen in the emergency room. The patient had no previous reactions to GARDASIL before receiving her third dose and the patient was sent to an unspecified allergist. BENADRYL, DECADRON and prednisone were given for adverse event. The outcome of the event was recovered on 03-APR-2014. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Serum sickness, Skin discolouration, Wheezing
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with no pertinent medical history. The patient was allergic to ZITHROMAX, AUGMENTIN, CEFZIL and penicillin. On 31-OCT-2014 and 03-DEC-2014, the patient was vaccinated with the first and second doses of GARDASIL (lot #, dose and route not reported0, respectively. On 11-MAR-2014 the patient was vaccinated with the third dose of GARDASIL, 120 Y injection, lot # reported as K000146, expiration date 16-AUG-2016, (dose and route not reported). There was no concomitant medication. On 21-MAR-2014, the patient developed a diffuse rash on her entire body after receiving a third dose of GARDASIL. The healthcare worker also mentioned the patient developed swelling of her hands and feet, puffiness under her eyelids and puffy lips, bronchospasm and wheezing, discoloration of her feet and "serum sickness to the unknown". The healthcare worker mentioned the patient was seen in the emergency room. The patient had no previous reactions to GARDASIL before receiving her third dose and the patient was sent to an unspecified allergist. BENADRYL, DECADRON and prednisone were given for adverse event. The outcome of the event was recovered on 03-APR-2014. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck) (lot number unknown, expiry date 24-JUL-2015) (lot number and frequency unknown) (dosing regimen and frequency unknown) that were exposed to temperatures of 22 degrees F for 716 hours and was not supported the in house stability. There were multiple excursions over 72 hours going back into and out of range more than once. According to the Prescribing Information for these products, the products should be stored frozen between 58 degrees Fahrenheit and +5 degrees Fahrenheit (-50 degrees Celsius and -l5 degrees Celsius). Use of dry ice may subject these products to temperatures colder than -58 degrees Fahrenheit (-50 degrees Celsius). No concomitant medications were reported. No product quality issue was reported. No adverse events were reported. This case is related to case numbers 1404USA010834 and 1404USA010632 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) that was out of temperature and was not supported the in house stability. No concomitant medications were reported. No product quality issue was reported. No adverse events were reported. This case is related to case numbers 1404USA010833 and 1401USA010632 via same reporter link. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Rash pruritic
Clinical narrative: This spontaneous report as received from a 63 year old consumer refers to herself with PERCOCET, AUGMENTIN and prednisone tablets allergy. In January 2012 the patient was vaccinated with ZOSTAVAX, routed reported as injection (lot #, expiry date and dose unknown). Concomitant medication included unspecified medication for migraine headaches. The patient had no pertinent medical history. The patient reported that she developed shingles in February of 2014. It started as a rash on her face that itched. It was in her left eye and scalp as well. She was diagnosed by her physician as having a mild case of shingles that last about 2 weeks. She had no nerve damage. Blood work was performed. The patient sought medical attention by making a doctor visit. The patient was treated with VALTREX and prednisone injection (no manufacturers were specified). The patient was recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: This spontaneous report as received from a consumer refers to her now 22 year old daughter who received dose one of GARDASIL sometime in August 2007, dose two sometime in October 2007 and dose three sometime in March 2008 (dose, route were not reported). The reporter confirmed that the patient was 16 years of age at the time all three doses of GARDASIL were administered. The reporter stated the patient had recently (on an unspecified date) been diagnosed with moderate dysplasia of the cervix. The outcome of moderate dysplasia of the cervix was unknown. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 63 years old female patient. On 13-APR-2014 the patient was vaccinated with ZOSTAVAX, 0.65ml, lot # J007211, expiration date 20-SEP-2014, subcutaneous. On 13-APR-2014 the patient experienced developed a "round yellow red patch" at the injection site. The patient informed the pharmacist in person of the injection site reaction on 13-APR-2014. The pharmacist informed the patient to apply ice and take TYLENOL. The outcome of the event was reported as recovering/resolving. The patient had sought medical attention. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a registered nurse who read a life story of a 16 year old patient on a website called "Inspire". On an unknown date the patient was vaccinated with GARDASIL (dose, lot no and route not reported). On an unknown date the patient experienced headaches after vaccination. The outcome of headaches was unknown. This is one of the several reports received from the same source. Additional is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of 70 years old with none pertinent medical history or drug reactions/allergies. About "4-5 years ago" (in 2009 or 2010), the patient was vaccinated with ZOSTAVAX, lot# and expiration date not reported, single dose, subcutaneous. There was no concomitant medication. In 2014 ("recently"), the patient developed shingles on her torso. At the time of the report, the patient was planning to schedule an appointment with her unspecified physician for an evaluation. No treatment was given for the adverse event. None lab diagnostics studies was performed. The outcome of the event was reported as not recovered. The patient had sought medical attention by calling the pharmacy. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendon rupture
Clinical narrative: EE states L arm became very painful by end of day she received Flu vaccine IM. Administration record is for R arm. EE's complaint is L arm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 55 year old female patient with no drug reactions/allergies and with a prior history of shingles. On 16-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX, 19400 PFU (lot# and expiry not reported), 0.65 ml, subcutaneous. Concomitant therapies included Omeprazole (manufacturer unknown), KLONOPIN and Simvastatin (manufacturer unknown). The pharmacist reported that the patient had developed shingles 3 times on unspecified dates since receiving ZOSTAVAX. The pharmacist reported the patient was seen by her physician on an unspecified date. The patient was prescribed acyclovir a "couple days ago". The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood glucose normal, Hypertension, Somnolence
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a male patient of unknown age. On 16-APR-2014 the patient was vaccinated with the first dose of GARDASIL, 120 Y, lot # J006236, expiration date 25-FEB-2016 (dose and route not reported). On 16-APR-2014, the patient became "very sleepy after receiving a first dose of GARDASIL. The physician mentioned the patient had been extremely sleepy for almost an hour and mentioned the patient received MENACTRA (lot#, dose and route not reported) at this same visit. The patient sought medical attention in the office. The patient was OK for 15 minute observation, but around minute 16 or 17 the patient became very sleepy and had trouble staying awake. The patient did not lose consciousness cognitively the patient was OK. The patient became slightly hypertensive. Patient was not hypoglycemic (given candy, etc. in case that was the issue, but the candy did nothing to change patient status). The physician stated that he did not think it was pre-syncope and he did not think it was a seizure. After about 1 hour, the patient was allowed to go home, but was still not recovered. The physician followed up with patient later in the evening and the patient said they were feeling much better and were more alert and were watching TV on couch at home. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site vesicles, Swelling
Clinical narrative: Vaccine admin 4/18/14, small blister back of (R) arm at inj site 4/19/14, 4/20/14 swelling and erythema developed and blister became larger 4/20/14.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Local swelling, Pain, Pruritus
Clinical narrative: Patient awoke this morning and noticed an area (now 4.5 cm) itching and burning. Area is painful to touch, warm, red and raised - localized only.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: Patient awoke this morning and noticed an area (now 4.5 cm) itching and burning. Area is painful to touch, warm, red and raised - localized only.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Bumps, rash, chicken-pox like blisters starting from navel and spread to legs and all the way around patient's waist.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Injection site discomfort, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: Medial to the site of the Hepatitis B (#3) injection sight swelling and a cluster of papules approximately 20 mm in circumference were seen. This area caused discomfort and itching.   Patient was afebrile.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Cardiac enzymes normal, Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: Chest pain, difficulty breathing, severe swelling in area where shot was received, redness, fever.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pyrexia, White blood cell count increased
Clinical narrative: Chest pain, difficulty breathing, severe swelling in area where shot was received, redness, fever.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Hyperhidrosis, Infection
Clinical narrative: FEVER, CHILLS, NAUSEA, SWEATS, CHILLS, RED SWOLLEN ARM, SORENESS, KNOT AT THE SITE, CELLULITIS SET IN.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Local swelling, Nausea, Pyrexia, Ultrasound scan
Clinical narrative: FEVER, CHILLS, NAUSEA, SWEATS, CHILLS, RED SWOLLEN ARM, SORENESS, KNOT AT THE SITE, CELLULITIS SET IN.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Aplastic anaemia, Constipation, Hepatic failure, Hepatitis
Clinical narrative: After receiving her third and last Gardasil vaccine on 2/11/12, my daughter started having stomach pain. We went to see another doctor. Doctor advised that it was probably constipation. The stomach pain never went away. Two weeks later, she was admitted to the hospital with Hepatitis Associated Severe Aplastic Anemia.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Patient developed rashes on the extremities, face and trunk. It looks like varicella rashes.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Back pain, Erythema, Injection site pain, Musculoskeletal chest pain, Neck pain
Clinical narrative: Developed pain at injection site and then pain moved down her Rt arm and into her upper back, around to rib cage area and up into her neck. Developed redness, swelling and fever.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Developed pain at injection site and then pain moved down her Rt arm and into her upper back, around to rib cage area and up into her neck. Developed redness, swelling and fever.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV5, DTAPHEPBIP, HPV4, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV5, DTAPHEPBIP, HPV4, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Computerised tomogram head normal, Convulsion, Crying, Dyskinesia, Dyspnoea
Clinical narrative: Screaming and when picked up, patient turned "beet red" and tensed up. Crying to point of he couldn't catch his breath. Mother blew in face after which eyes rolled back and head fell back and he started convulsing with arms flexed. This lasted for about 1 minute. Afterwards patient was crying but not responsive to mom and just "staring off". Also had some upper body jerks intermittently for 20 mins. until EMS arrived.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electrocardiogram normal, Erythema, Eye movement disorder, Full blood count normal, Metabolic function test normal
Clinical narrative: Screaming and when picked up, patient turned "beet red" and tensed up. Crying to point of he couldn't catch his breath. Mother blew in face after which eyes rolled back and head fell back and he started convulsing with arms flexed. This lasted for about 1 minute. Afterwards patient was crying but not responsive to mom and just "staring off". Also had some upper body jerks intermittently for 20 mins. until EMS arrived.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Posture abnormal, Screaming, Staring, Tension, Unresponsive to stimuli
Clinical narrative: Screaming and when picked up, patient turned "beet red" and tensed up. Crying to point of he couldn't catch his breath. Mother blew in face after which eyes rolled back and head fell back and he started convulsing with arms flexed. This lasted for about 1 minute. Afterwards patient was crying but not responsive to mom and just "staring off". Also had some upper body jerks intermittently for 20 mins. until EMS arrived.
Sex: U
Vaccine: PPV
Symptoms: Burning sensation, Hypersensitivity, Neuralgia, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (injection, route, dose, injection site and lot number (unknown). On an unknown date, the patient developed adverse effects after receiving the vaccine. The patient experienced burning, and nerve pain, in the vaccinated arm, post vaccination with the PNEUMOVAX 23. The patient called the pharmacy because the sensation was so painful they believed they were having an allergic reaction to the vaccine. Pharmacy called the EMS (Emergency Medical Service) who were sent to the patient's home. EMS determined the reaction the patient was having was not life threatening. The patient was reported as recovered/resolved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: Lt arm swelling, erythema, rash. KEFLEX 250mg/5ml Rx on 4/20.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: Severe arm pain and nausea x 36 hrs.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Excoriation, Fall, Unresponsive to stimuli
Clinical narrative: 2 minutes post vaccination pt found on floor after thumping sound - unresponsive - revived with ammonia capsule - moving all extremities - responsive to all commands - no apparent injury except brushburn (L) elbow - denied pain - left with parent.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: This spontaneous report as received from a nurse concerning 2 siblings of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant therapies were not reported. On an unspecified date, the patients experienced swelling and redness at the injection site and nausea. The outcome of nausea, redness at the injection site and swelling at the injection site was unknown. This case is linked to MARRS 1404USA009349. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: This spotaneous report as received from a nurse refers to a 57 year old female patient with a healthy status. On 01-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). There was no concomitant therapy. On 01-APR-2014, the patient experienced swelling and redness at the injection site and nausea. The patient did not sought medical attention and no treatment was given for the adverse event. The outcome of nausea, redness at the injection and swelling at the injection site was reported as recovering. The case is linked to MARRS 1404USA011213. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Roughly a 3 1/2 diameter swelling and redness around site of injection. Symptoms appeared/noticed about 1 1/2 days after injection. ZYRTEC 10mg and Hydrocortisone 1% cream was given for tx.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red, warm and hard area 3cm x 2cm to outer aspect of (L) upper arm. Painful with palpation. BENADRYL and CEPHALEXIN x 5 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Child developed swelling and redness around the area of the injection site. Erythema was 6 inch around site. Also had some difficulties with breathing.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 66 year old male patient who is her husband. The patient's concurrent condition included hypertension, allergy to latex and allergy to aspirin. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX, (lot # J006831, expired date: 14-SEP-2014), intramuscularly, (dose and frequency were not reported) instead of PNEUMOVAX23. Concomitant therapy included blood pressure medication. Patient experienced pain around the injection site on the following day. The patient was not received treatment for adverse event. The patient did not seek medical attention. No lab diagnostics were performed. Action taken of therapy with ZOSTAVAX and outcome of adverse events was not reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to approximately 27 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported by the reporter. On an unknown date the patient was vaccinated with GARDASIL dose 2 (dosage, route, lot# not reported). No concomitant medications were reported. It was reported that on an unknown date the patient had received two doses of GARDASIL had turned 27 on an unspecified date before she could receive her third dose of GARDASIL. The pharmacist was discussing this occurrence because she was saying that the last reminder didn't come for the patient, and the representative suggested that the patient's turning 27-years-old before the third dose of GARDASIL was administered may be the reason the third reminder didn't come. The representative specified she did not ask the pharmacist if company could follow-up with her about this scenario. No adverse effect had been reported. The patient sought medical attention not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 62 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported by the reporter. On 18-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J 0004460, 0.65 ml, subcutaneous, expiration date 11-APR-2014. No concomitant medications were reported. On 18-APR-2014, the patient was vaccinated with expired ZOSTAVAX and the patient experienced no adverse effect. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 58 year old female patient. Concomitant medications included FOSAMAX and aspirin. No information about medical history concurrent conditions was reported. On 09-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J011338 expiration date 19-DEC-2014, route subcutaneous in the back of arm and the patient developed big re area, swelling and white bumps around the injection site on 09-APR-2014. No lab investigations were performed. The outcome of big red area, swelling and white bumps around the injection site was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 16-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date unspecified), subcutaneous that was improperly exposed to 8F for 8 hours. No known adverse effects. Additional information has been requested.