chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Eye swelling, Hypersensitivity, Rash
Clinical narrative: Allergic reaction: The patient has had a skin rash but not had trouble swallowing. He has had swelling (periorbital). No difficulty breathing or dizziness. This started just prior to arrival and is still present. A cause has been identified (tdap injection). He had recently taken medication (tdap). No treatment prior to arrival.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Left thigh redness - given XYZAL (3" by 5.5"). ER gave them antibiotic and ZYRTEC 3 days prior to attending PCP.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Joint crepitation, Joint range of motion decreased, Muscular weakness
Clinical narrative: Morning after injection arm was stiff, sore and weak. Pain increased with each couple of days around rotator cuff. Range of motion was greatly diminished. Trying to do daily activities aggravates shoulder joint w/ intense pain and clicking.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Morning after injection arm was stiff, sore and weak. Pain increased with each couple of days around rotator cuff. Range of motion was greatly diminished. Trying to do daily activities aggravates shoulder joint w/ intense pain and clicking.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased appetite, Nausea
Clinical narrative: Parents stated: nausea, feeling sick to stomach, loss of appetite. No treatment given by parents. Tdap was given day before symptoms began.
Age: 0.78
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased
Clinical narrative: Temp 103.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching, hot to touch at injection site.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Became faint, passed out.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Became faint, passed out.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Baby received vaccines on 4/21 - PENTACEL, PREVNAR and Rotavirus (3) - and on 4/28 presented to ED. Diagnosed with ileo-ileal intussusception.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of right arm 4 x 3 cm with warmth and erythema.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Eye swelling, Lip swelling, Local swelling, Pruritus, Urticaria
Clinical narrative: 8/23/14-> Swelling, itching and hives on th e(L) arm that lasted for 2-3 days. 8/26/14-> lip and eye swelling -> improvement with BENADRYL.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Flushing
Clinical narrative: Approx 6 hrs after vaccine administered, pt c/o "flushing" - redness to face and neck.
Age: 20.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Full blood count normal, Grand mal convulsion, Metabolic function test normal
Clinical narrative: Pt had a tonic clonic seizure lasting 1-2 minutes about 2 minutes after Tdap, meningococcal and PPD were administered/placed. 911 called.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Pallor
Clinical narrative: Became pale and nauseated. Wanted to lay down. Never lost consciousness. Last about 5 min. VSS at HR-71-22-97/54.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Presyncope
Clinical narrative: Patient had vasovagal response post injections while walking out of clinic. Patient was found on the floor conscious, alert and oriented x3. Stable VS: BP 110/72, P 88, R 12. Patient waited to feel completely better before leaving office. Had no questions, was instructed to call with any concerns.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Diet refusal, Eye pain, Lethargy, Pyrexia, Rash
Clinical narrative: High persistent fever (104.0); lethargy; refusal to eat; complaints of eye pain; mild rash; one episode of vomiting.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: High persistent fever (104.0); lethargy; refusal to eat; complaints of eye pain; mild rash; one episode of vomiting.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Autism, Crying, Decreased eye contact, Pyrexia
Clinical narrative: She stopped smiling and looking into our eyes she no loner was playing holding rattlers binkies or fingers she cried all the time the first 2 days after the shots you could see she had went from smiling happy baby to a quite distant baby..
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rotavirus infection
Clinical narrative: She stopped smiling and looking into our eyes she no loner was playing holding rattlers binkies or fingers she cried all the time the first 2 days after the shots you could see she had went from smiling happy baby to a quite distant baby..
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Fatigue, Pyrexia, Rash generalised
Clinical narrative: Fever, severe rash over entire body, diarrhea, fatigue.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Polymerase chain reaction, Pyrexia, Rash morbilliform
Clinical narrative: Measles-like rash, fever.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Decreased appetite, Ear pain, Fatigue
Clinical narrative: Woke up feeling very nauseous. Tried to go back to sleep, around 8 am still very nauseous my throat, ears, and joints were aching. Felt very tired and weak. No appetite all day. Continued feeling all over joint pain and sore throat all day, took a five hour nap until my husband woke me up to eat and drink water. Felt a little better after eating soup, but my joints were still hurting and around 7 pm a headache started. Pulse rate 100 just sitting on the couch, my resting pulse is normally around 62. I was in touch with my Midwife who informed me to take Tylenol and see how I felt the following day. Woke up 08/27/2014 with mild headache, but feeling much better.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Oropharyngeal pain
Clinical narrative: Woke up feeling very nauseous. Tried to go back to sleep, around 8 am still very nauseous my throat, ears, and joints were aching. Felt very tired and weak. No appetite all day. Continued feeling all over joint pain and sore throat all day, took a five hour nap until my husband woke me up to eat and drink water. Felt a little better after eating soup, but my joints were still hurting and around 7 pm a headache started. Pulse rate 100 just sitting on the couch, my resting pulse is normally around 62. I was in touch with my Midwife who informed me to take Tylenol and see how I felt the following day. Woke up 08/27/2014 with mild headache, but feeling much better.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Ultrasound scan normal
Clinical narrative: Left upper arm pain, redness, and swelling with progression down to elbow and underside of upper arm.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, HEPAB, MNQ, TDAP
Symptoms: Pruritus, Rash, Throat irritation
Clinical narrative: Throat and facial itching and rash after recieving immunizations and bicillin injections.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Insomnia, Malaise, Myalgia, Rhinorrhoea
Clinical narrative: Patient began to experience myalgia that prevented sleep.  Has had headache, malaise, and a runny nose.  Has taken 600 mg Ibuprofen q 8 hours since and had had to use albuterol nebulizer x 2. Patient called clinic to report her symptoms.  Advised patient that myalgia, headache, and malaise are common side effects to the flu vaccine, particularly the high dose flu vaccine.  Patient was directed to call her PCP to arrange for follow up given history of COPD and use of albuterol nebulizer x 2 today.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Entire upper arm swollen, hard, red and warm to touch.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother noticed large red circular area at immunization site when giving a bath the next night. No c/o from child, ie. itching/pain. Redness was approx. 8 cm in diameter, with darker raised area in middle two thirds of site.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Wed. night noticed lymph nodes under L arm swollen and tender. Thurs. was achy, chilled and fever of 100.4. Friday felt normal. Sun. night noticed a red spot on her L bicep the size of an egg. Not warm to touch or having any red streaks.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Cough, Fatigue, Headache, Increased upper airway secretion
Clinical narrative: Developed severe headache, fever, hacking cough and coughing up sticky phlegm, and accompanying achy tiredness. (TDaP vaccine). Had to stay in bed 2 days.  Hacking cough and spitting up lasted over 9 days.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Productive cough, Pyrexia
Clinical narrative: Developed severe headache, fever, hacking cough and coughing up sticky phlegm, and accompanying achy tiredness. (TDaP vaccine). Had to stay in bed 2 days.  Hacking cough and spitting up lasted over 9 days.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: PATIENT STATES THAT IN THE AREA WHERE HE RECEIVED THE ZOSTAVAX VACCINE THAT HE DEVELOPED A RASH THAT WAS APPROXIMATELY 4 INCHES WIDE AND 3 INCHES LONG.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Nausea, emesis, dizziness immediate post vaccine. Resolved that night, returned to work next day.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Student reports swelling started right after vaccination on 08/25/2014, swelling is 5.5x2.5 inches on left deltoid.
Age: 0.39
Sex: F
Vaccine: DTAP
Symptoms: Cough, Diarrhoea, Pyrexia, Rash, Sneezing
Clinical narrative: Began with a fever then liquid diarrhea since. 8/25 coughing an sneezing began 8/27 left side of face swollen with rash.
Age: 0.39
Sex: F
Vaccine: DTAP
Symptoms: Swelling face
Clinical narrative: Began with a fever then liquid diarrhea since. 8/25 coughing an sneezing began 8/27 left side of face swollen with rash.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Asthenia, Influenza like illness, Myalgia, Nausea
Clinical narrative: Flu Like Symptoms. Nausea, Weakness, Muscle Aches, Stomach Cramps.
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Generalised erythema, Inflammation, Rash generalised
Clinical narrative: Full body rash, redness and inflammation lasting 3 days. Exhibited symptoms primarily in face and chest.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Hyperhidrosis, Injection site erythema, Injection site oedema
Clinical narrative: C/O sweats, chills, fever T: 100. degrees F, left upper lateral arm (+) edema, erythema, warmth, measured apprx. 15 x 8 cm. Also small central area with blistering/vesicles and scant amt. of clear fluid drainage. Tx with Cephalexin 500mg BID x 10 day, TYLENOL PRN.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Injection site warmth, Pyrexia, Secretion discharge
Clinical narrative: C/O sweats, chills, fever T: 100. degrees F, left upper lateral arm (+) edema, erythema, warmth, measured apprx. 15 x 8 cm. Also small central area with blistering/vesicles and scant amt. of clear fluid drainage. Tx with Cephalexin 500mg BID x 10 day, TYLENOL PRN.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Injection site erythema, Injection site warmth, Malaise, Myalgia
Clinical narrative: Site erythema, warmth. Pt. reports nausea, malaise, fever of 102, and myalgias.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Site erythema, warmth. Pt. reports nausea, malaise, fever of 102, and myalgias.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at site started immediately after shot rednes and warmth week after giving shot.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Dyspepsia, Migraine
Clinical narrative: Pt went to hospital by ambulance because at around 6pm she had indigestion after dinner and it went to severe pain after that. She had a severe migraine as well, her blood pressure went low too, they lowered dose. Patient is still recovering, is very weak and dizzy.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Pt went to hospital by ambulance because at around 6pm she had indigestion after dinner and it went to severe pain after that. She had a severe migraine as well, her blood pressure went low too, they lowered dose. Patient is still recovering, is very weak and dizzy.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 13 year old male patient. On an unspecified date in 2002 the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (dose, route and lot # unknown). The patient was never administered a second dose of (Oka/Merck) VARIVAX. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 who on an unknown date, within a one month period the patient was vaccinated with ZOSTAVAX (dose, route, frequency and indication not provided) dose 1, on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, frequency and indication not provided) dose 2, on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, frequency and indication not provided) dose 3. Nurse reporting that someone she knows has received 3 doses of ZOSTAVAX within a one month period. This person is not a patient where the nurse is employed. The person received the doses from 3 different pharmacies. No symptoms reported. No other details. The outcome of received 3 doses of ZOSTAVAX within a one month period was unknown. The reporter considered received 3 doses of ZOSTAVAX within a one month period to be not related to ZOSTAVAX. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red circle at administration site about 3" in circumference, itchy.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Calcinosis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Warmth and swelling of (L) upper arm noted in 1st 24 hrs, persistent ring of erythema 5 days later and calcinosis at injection site. No apparent cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pain in extremity
Clinical narrative: Arm (left started hurting and getting worse as evening goes so then she look it was red (big area) down her arm and swollen. Dx with cellulitis.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pyrexia
Clinical narrative: Fever, redness
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Patient received his first VARIVAX immuniz. 7/22/2014 without incident. On 8/22/14 patient given his second VARIVAX injection. 5 min. later developed facial puffiness/itching and hives on his back. Lasted 90 mins.; took 25mg BENADRYL.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Patient was given 3 vaccines, Tdap, MENACTRA and GARDASIL. After last vaccine (GARDASIL) given patient immediately fainted. She was sitting but slumped over and became very pale. Pt rested in reclining position was monitored and given fluids.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 5 year old male patient. On an unknown date, the patient was vaccinated with the first 0.5 ml dose of RECOMBIVAX HB (lot # not reported) intramuscularly and received his second dose 8 months after the first dose, and the third dose after 6 months, At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 08-JUL-2014 the patient was vaccinated with a dose of M-M-R II (HSA, lot # J015503, EXP date: 05-DEC-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 year old male patient. On 25-MAY-1995, the patient was vaccinated with first 0.5 ml dose of M-M-R II (lot # not reported) subcutaneously in the left posterior lateral arm. On 26-AUG-1998, the patient received the second 0.5 ml dose of M-M-R II (lot # not reported) subcutaneously and on 25-AUG-2014, the patient received a third 0.5 ml improperly stored booster dose of M-M-R II (lot # not reported) subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction, Injection site vesicles, Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse practitioner via field representative refers to a 1 year old patient of unknown gender. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot#, strength, dosage and route unknown). On an unknown date, "1 week" after an unspecified patient received VARIVAX (Merck) the patient developed a "varicella rash and blisters" around the injection site. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-AUG-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23, 0.5ml, expiration date 10-AUG-2014. No adverse experience reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old patient of unknown gender. The patient's current conditions or medical history were not reported. On an unknown date, the patient was inadvertently vaccinated with an adult dose of VAQTA 50/1.0 micrograms/ml, 1 ml (route, lot number and expiration date not reported) instead of the pediatric dose. No symptoms reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 11 year old male patient. On 03-JUN-2014, the patient was vaccinated by licensed vocational nurse (LVN) with a first dose of GARDASIL that was out of range temperature (dose and route of administration were not provided) lot # J006850, expiration date: 31-MAR-2016, in the right gluteus. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 11 year old male patient. On 03-JUN-2014, the patient was vaccinated by licensed vocational nurse (LVN) with a first dose of GARDASIL that was out of range temperature (dose and route of administration were not provided) lot # J006850, expiration date: 31-MAR-2016, in the right gluteus. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Chest discomfort, Incomplete course of vaccination, Muscle spasms, Pruritus, Swollen tongue
Clinical narrative: A 12 year old female patient received MENACTRA (batch number, route and site of administration was not reported) on a date in August 2014 described as "this past Monday". On the same day she was vaccinated with a first dose of GARDASIL, batch number K001631, expiry date 11/6/2016. Concomitant medications, medical history, and drug reactions were not reported. The patient experienced muscle spasms, tightness in chest, swollen tongue and itchy face after receiving GARDASIL. Laboratory tests were not reported. The patient was treated with BENADRYL, details not provided. The patient will not receive any further doses in the series. The reporter state that all adverse event fields apply to GARDASIL and no further adverse event information was provided. The patient recovered on an unreported date. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Chest discomfort, Muscle spasms, Pruritus, Swollen tongue
Clinical narrative: A 12 year old female patient received MENACTRA (batch number, route and site of administration was not reported) on a date in August 2014 described as "this past Monday". On the same day she was vaccinated with a first dose of GARDASIL, batch number K001631, expiry date 11/6/2016. Concomitant medications, medical history, and drug reactions were not reported. The patient experienced muscle spasms, tightness in chest, swollen tongue and itchy face after receiving GARDASIL. Laboratory tests were not reported. The patient was treated with BENADRYL, details not provided. The patient will not receive any further doses in the series. The reporter state that all adverse event fields apply to GARDASIL and no further adverse event information was provided. The patient recovered on an unreported date. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: Pt received shot on Saturday; came to walk in clinic and was diagnosed with cellulitis and extremity swelling. Was prescribed KEFLEX to treat.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: Pt received shot on Saturday; came to walk in clinic and was diagnosed with cellulitis and extremity swelling. Was prescribed KEFLEX to treat.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Apnoea, Condition aggravated, Continuous positive airway pressure, Full blood count abnormal, Lethargy
Clinical narrative: Apnea requiring supplemental oxgyen and nasal CPAP, sepsis evaluation, starting of IV antibiotics, IV fluids, lethargy.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Platelet count decreased, Shift to the left, Thrombocytopenia
Clinical narrative: Apnea requiring supplemental oxgyen and nasal CPAP, sepsis evaluation, starting of IV antibiotics, IV fluids, lethargy.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Injection site swelling, Injection site warmth
Clinical narrative: Patient cried after administration.  Later, the area where the injection was given was swollen and hot to the touch.  Parents brought patient back to the doctors office in the evening.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Rash a couple inches below the injection site that is about 5 inches in length, 2 inches wide, that is raised, red, and warm to the touch. Informed patient to call primary care doctor to get treatment if needed.
Age: 10.0
Sex: F
Vaccine: DTAP, MNQ, PPV
Symptoms: Abdominal pain, Crying, Dehydration, Disorientation, Dizziness
Clinical narrative: Started with fatigue, at 3:45 acetaminophen was given in childrens 80mg tablet by mouth. at 6:15 child was crying with a severe headache, and fever of 103.2. Went to urgent care and saw physician at 6:45pm. Ibuprofen suspension by mouth was administered fever was 103.1. Child complained of nausea, dizziness, mid abdominal pain, pain and red swollen lump appox 1.5 and mild dehydration inches in diameter at injection site. at 7:26pm fever was 102.9 Referred to ER.  During ride to ER child started vomiting. Arrived at ER at 8:30, dizziness, disorientation, vomiting, listness, fatigue, pain in arm, severe headache, dehydration persisted. Child was rehysrated, Tylenol suppositories, Toradol, anti nausea medication.
Age: 10.0
Sex: F
Vaccine: DTAP, MNQ, PPV
Symptoms: Erythema, Fatigue, Full blood count, Headache, Injection site reaction
Clinical narrative: Started with fatigue, at 3:45 acetaminophen was given in childrens 80mg tablet by mouth. at 6:15 child was crying with a severe headache, and fever of 103.2. Went to urgent care and saw physician at 6:45pm. Ibuprofen suspension by mouth was administered fever was 103.1. Child complained of nausea, dizziness, mid abdominal pain, pain and red swollen lump appox 1.5 and mild dehydration inches in diameter at injection site. at 7:26pm fever was 102.9 Referred to ER.  During ride to ER child started vomiting. Arrived at ER at 8:30, dizziness, disorientation, vomiting, listness, fatigue, pain in arm, severe headache, dehydration persisted. Child was rehysrated, Tylenol suppositories, Toradol, anti nausea medication.
Age: 10.0
Sex: F
Vaccine: DTAP, MNQ, PPV
Symptoms: Mass, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Started with fatigue, at 3:45 acetaminophen was given in childrens 80mg tablet by mouth. at 6:15 child was crying with a severe headache, and fever of 103.2. Went to urgent care and saw physician at 6:45pm. Ibuprofen suspension by mouth was administered fever was 103.1. Child complained of nausea, dizziness, mid abdominal pain, pain and red swollen lump appox 1.5 and mild dehydration inches in diameter at injection site. at 7:26pm fever was 102.9 Referred to ER.  During ride to ER child started vomiting. Arrived at ER at 8:30, dizziness, disorientation, vomiting, listness, fatigue, pain in arm, severe headache, dehydration persisted. Child was rehysrated, Tylenol suppositories, Toradol, anti nausea medication.
Age: 10.0
Sex: F
Vaccine: DTAP, MNQ, PPV
Symptoms: Urine analysis, Vomiting
Clinical narrative: Started with fatigue, at 3:45 acetaminophen was given in childrens 80mg tablet by mouth. at 6:15 child was crying with a severe headache, and fever of 103.2. Went to urgent care and saw physician at 6:45pm. Ibuprofen suspension by mouth was administered fever was 103.1. Child complained of nausea, dizziness, mid abdominal pain, pain and red swollen lump appox 1.5 and mild dehydration inches in diameter at injection site. at 7:26pm fever was 102.9 Referred to ER.  During ride to ER child started vomiting. Arrived at ER at 8:30, dizziness, disorientation, vomiting, listness, fatigue, pain in arm, severe headache, dehydration persisted. Child was rehysrated, Tylenol suppositories, Toradol, anti nausea medication.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy
Clinical narrative: None at this time.  Pt was pregnant and received Anthrax vaccine.
Age: 22.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Exposure during pregnancy
Clinical narrative: Patient could have potentially been pregnant at time of vaccine administration.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Asthma, Cough, Nasopharyngitis
Clinical narrative: Initial report was received on 25 August 2014 from a consumer who is also the patient's parent. A 25 month-old male patient had received on 12 December 2013, ACTHIB (lot number UH869AA) and an unidentifiable time later experienced asthma. According to the patient's parent, reports after receiving ACTHIB that pt developed asthma. "He had normal colds before and recovered since receiving the ACTHIB with each cold he got his symptoms worsened. He has a constant cough during the night, in the am and with activity. He has seen multiple Doctors both in the county and when we are traveling out of the country. In August he saw an allergist and he has now been diagnosed with asthma due to illness he is on VENTOLIN albuterol Queva arvestin and xudal." The patient's parent states "she is very upset as her child has had multiple issues after vaccines and she is very frustrated. She found a link to receiving ACTHIB and asthma she wants to know what we will do for her?" Made aware she can have her Pediatrician or other specialist speak with our Medical directors if needed for information on the vaccine he received." No further information received. Outcome was not recovered. This patient had additional events captured in cases 2013-05918, 2013-06117, 2013SA113995 and 2014SA104021. Documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown patient of unknown age and gender. The nurse reported that an unknown number of doses of GARDASIL (lot#, dose, route not reported) that were exposed to temperatures between 34F and 35F for 13 hours may have been administered to the unknown patient on an unknown date. Concomitant medications were not provided. No adverse effect was reported. 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 health care worker refers to unspecified number of patients of unknown age. On unknown dates the patients were vaccinated with GARDASIL (0.5 ml, lot# and expiration date were unknown) intramuscularly which underwent a temperature excursion. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 10-MAR-2014 was vaccinated with (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date these unspecified amount of patients were vaccinated with ROTATEQ (lot #, dose not reported, default route: oral) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 05-MAR-2014 was vaccinated with PROQUAD (merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 26 year old female patient regarding herself. The patient's drug allergies and pertinent medical history was none. On 23-JUN-2014 the patient was vaccinated with GARDASIL (Dose/Frequency: three shots, got one shot) in the right arm. Concomitant medications were unspecified. The patient became pregnant with LMP of 06-JUN-2014 and EDD of 13-MAR-2015. The patient became pregnant on 20-JUN-2014. The pregnancy outcome was unknown. On 23-JUN-2024, the patient received her first shot of GARDASIL on 23-JUN-2014 after she became pregnant on 20-JUN-2014. The patient inquired as to any side effects she may encounter from receiving GARDASIL. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 07-FEB-2014 the patient was accidentially vaccinated with PNEUMOVAX23 (lot #, expiration date unspeciifed), 0.5 ml, one shot, intramuscular when the patient was supposed to instead receive (Oka/Merck) VARIVAX. No product quality complaint (PQC) was involved because the mistake involved "only user error, and there was no confusion due to any kind of product defect or packaging defect". No adverse effects were reported.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Bilirubin conjugated decreased, Blister, Blood bilirubin increased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased
Clinical narrative: The reports concerns a 11 year old male presented with 24 pruritic papular, vesicular and crusted skin lesions typical of varicella, macrocytic anemia, jaundice and sclera icterus. Family history was positive for hereditary spherocytosis (HS). Labs: Hemoglobin 9.7 g/dl, MCV 92FL, Reticulocytes 7.7%, Haptoglobin <8 mg/dl, Bilirubin (total/direct) 4.3/0.0 mg/dl, Lactate Dehydrogenase 957 IU/L. No spherocytes on peripheral blood smear. Day 3: Hb 11.1 g/dl and Reticulocytes 13%. Four weeks after presentation Hb 12.5g/dl, MCV 86 FL, Reticulocytes 2.0% and total bilirubin 1.4 mg/dL. OCT (Direct Coomb's Test) was negative. Varicella IgG was 3.5 (positive) and IgM was <0.9(negative). Osmotic fragility testing confirmed HS. In BTV skin involvement may not progress beyond the papule stage and production of acute phase anti-varicella IgG and IgM (and so hemolysis) may be short lived and so not detected. Our patient's skin lesions were most helpful in making the diagnosis. Hemolysis was likely mediated by anti I/anti P IgM antibodies and hence the negative OCT with polyspecific Coomb's reagent (IgG and C3d) at room temperature in our patient. It is possible that in patients with HS hemolysis is induced by alteration of splenic function induced by the varicella infection. Conclusion: Though now very rare the hematological complications of varicella infection continue into th post varicella vaccination era. Through this report we hope to encourage early recognition of these problems. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood lactate dehydrogenase increased, Capillary fragility abnormal, Coombs direct test negative, Haemoglobin decreased, Haemolysis
Clinical narrative: The reports concerns a 11 year old male presented with 24 pruritic papular, vesicular and crusted skin lesions typical of varicella, macrocytic anemia, jaundice and sclera icterus. Family history was positive for hereditary spherocytosis (HS). Labs: Hemoglobin 9.7 g/dl, MCV 92FL, Reticulocytes 7.7%, Haptoglobin <8 mg/dl, Bilirubin (total/direct) 4.3/0.0 mg/dl, Lactate Dehydrogenase 957 IU/L. No spherocytes on peripheral blood smear. Day 3: Hb 11.1 g/dl and Reticulocytes 13%. Four weeks after presentation Hb 12.5g/dl, MCV 86 FL, Reticulocytes 2.0% and total bilirubin 1.4 mg/dL. OCT (Direct Coomb's Test) was negative. Varicella IgG was 3.5 (positive) and IgM was <0.9(negative). Osmotic fragility testing confirmed HS. In BTV skin involvement may not progress beyond the papule stage and production of acute phase anti-varicella IgG and IgM (and so hemolysis) may be short lived and so not detected. Our patient's skin lesions were most helpful in making the diagnosis. Hemolysis was likely mediated by anti I/anti P IgM antibodies and hence the negative OCT with polyspecific Coomb's reagent (IgG and C3d) at room temperature in our patient. It is possible that in patients with HS hemolysis is induced by alteration of splenic function induced by the varicella infection. Conclusion: Though now very rare the hematological complications of varicella infection continue into th post varicella vaccination era. Through this report we hope to encourage early recognition of these problems. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Haptoglobin decreased, Hereditary spherocytosis, Mean cell volume normal, Papule, Pruritus
Clinical narrative: The reports concerns a 11 year old male presented with 24 pruritic papular, vesicular and crusted skin lesions typical of varicella, macrocytic anemia, jaundice and sclera icterus. Family history was positive for hereditary spherocytosis (HS). Labs: Hemoglobin 9.7 g/dl, MCV 92FL, Reticulocytes 7.7%, Haptoglobin <8 mg/dl, Bilirubin (total/direct) 4.3/0.0 mg/dl, Lactate Dehydrogenase 957 IU/L. No spherocytes on peripheral blood smear. Day 3: Hb 11.1 g/dl and Reticulocytes 13%. Four weeks after presentation Hb 12.5g/dl, MCV 86 FL, Reticulocytes 2.0% and total bilirubin 1.4 mg/dL. OCT (Direct Coomb's Test) was negative. Varicella IgG was 3.5 (positive) and IgM was <0.9(negative). Osmotic fragility testing confirmed HS. In BTV skin involvement may not progress beyond the papule stage and production of acute phase anti-varicella IgG and IgM (and so hemolysis) may be short lived and so not detected. Our patient's skin lesions were most helpful in making the diagnosis. Hemolysis was likely mediated by anti I/anti P IgM antibodies and hence the negative OCT with polyspecific Coomb's reagent (IgG and C3d) at room temperature in our patient. It is possible that in patients with HS hemolysis is induced by alteration of splenic function induced by the varicella infection. Conclusion: Though now very rare the hematological complications of varicella infection continue into th post varicella vaccination era. Through this report we hope to encourage early recognition of these problems. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Reticulocyte count increased, Scab, Skin lesion
Clinical narrative: The reports concerns a 11 year old male presented with 24 pruritic papular, vesicular and crusted skin lesions typical of varicella, macrocytic anemia, jaundice and sclera icterus. Family history was positive for hereditary spherocytosis (HS). Labs: Hemoglobin 9.7 g/dl, MCV 92FL, Reticulocytes 7.7%, Haptoglobin <8 mg/dl, Bilirubin (total/direct) 4.3/0.0 mg/dl, Lactate Dehydrogenase 957 IU/L. No spherocytes on peripheral blood smear. Day 3: Hb 11.1 g/dl and Reticulocytes 13%. Four weeks after presentation Hb 12.5g/dl, MCV 86 FL, Reticulocytes 2.0% and total bilirubin 1.4 mg/dL. OCT (Direct Coomb's Test) was negative. Varicella IgG was 3.5 (positive) and IgM was <0.9(negative). Osmotic fragility testing confirmed HS. In BTV skin involvement may not progress beyond the papule stage and production of acute phase anti-varicella IgG and IgM (and so hemolysis) may be short lived and so not detected. Our patient's skin lesions were most helpful in making the diagnosis. Hemolysis was likely mediated by anti I/anti P IgM antibodies and hence the negative OCT with polyspecific Coomb's reagent (IgG and C3d) at room temperature in our patient. It is possible that in patients with HS hemolysis is induced by alteration of splenic function induced by the varicella infection. Conclusion: Though now very rare the hematological complications of varicella infection continue into th post varicella vaccination era. Through this report we hope to encourage early recognition of these problems. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 07-APR-2014 was vaccinated with (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 28-APR-2014 was vaccinated with PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 05-MAY-2014 was vaccinated with PROQUAD lot # J015595, expiration date 05-Jun-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen positive
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 41 year old female patient who had negative titers, with no drug reactions. No pertinent medical history was reported. On an unknown date, the patient received a 3 dose series of an unspecified RECOMBIVAX HB could not be ruled out, (dose, frequency and route not reported). On an unspecified dates, the patient had "titers drawn" in January 2014, which showed "a surface antibody of 3.1 when it should be higher than 10". The patient then received another 3 dose series of RECOMBIVAX HB (each dose was 1.0 ml given via the intramuscular route) on 27-JAN-2014 (1st dose), 28-FEB-2014 (2nd dose) and 08-AUG-2014 (3rd dose), for routine vaccination because she had negative titers. The patient had titers drawn again on 08-AUG-2014 which showed "surface antigen positive and core antibody negative". No treatment was given for the events. The outcome of the events was unknown. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unkonwn gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 05-MAY-2014 was vaccinated with PROQUAD (Merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 23-APR-2014 was vaccinated with PROQUAD (Merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 14-APR-2014 was vaccinated with (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reporter as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 25-FEB-2014 was vaccinated with a dose of PROQUAD (Merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.