chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 20 year old patient with unknown gender. On 20-JUN-2016 the patient was inadvertently vaccinated with a pediatric dose of VAQTA (lot # M009377, expiration date: 17-JUN-2017; dose not reported) instead of the intended adult dose intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report was received from a pharmacist via a company employee, referring to a non-pregnant female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneous (dose, anatomical location and lot number were not reported). Concomitant medications were not reported. The patient came into the pharmacy on 20-JUN-2016, reporting that she had 'red welts' on or near the injection site of ZOSTAVAX vaccination. The pharmacist advised the patient to use BENADRYL and to consult with her prescribing physician, however the patient did not seek medical attention and no treatment was given. At the time of reporting, the outcome of the event and its causal relationship with the vaccine were unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a health professional via a company representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, route of administration, lot#, expiry date were not reported). On an unknown date, the patients experienced mumps. The outcome of mumps was unknown. The relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (also reported as registered nurse) refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016, starting on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD, lot # reported as M006104, expiration date 01-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 12.3 degrees Fahrenheit for 23 hours and 17 minutes. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (also reported as registered nurse) refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016, starting on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L046885, expiration date 23-NOV-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 12.3 degrees Fahrenheit for 23 hours and 17 minutes. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent condition and medical history of the patient were not reported. On 15-JUN-2016 (reported as "one week ago" at the reporting time), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route unspecified). On an unknown date in June 2016, the patient experienced injection site redness. The outcome of the event was reported as recovered/resolved on an unknown date in June 2016. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a nurse via field representative concerning a 21 year old female patient. There was no concurrent condition, medical history or concomitant therapy reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot# and dose not provided) intramuscularly and she completed the series of the vaccine in approximately June 2011 (reported as five years ago). In approximately 2016 (reported as recently), test showed that she was positive for HPV. The outcome of the event and causality were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions and allergies were not reported. On -7-JUN-2000, the patient was vaccinated with first dose of GARDASIL, intramuscular. On 01-JUN-2004 the patient was vaccinated with second dose of GARDASIL. The patient has not received the third dose yet. No adverse effects were reported. Additional information is not expected as reporter denied consent to be contacted for follow up information.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 and 02-APR-2016, the patients were vaccinated with an improperly stored doses of PEDVAXHIB (lot#, expiration date, dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# K023007 with expiration date 24-SEP-2017, lot# L017417 with an expiration date 02-FEB-2018, lot# L015432 with expiration date 24-JAN-2018, lot# reported as L03221 with unspecified expiration date; dose and route of administration) was used. No hours. There was no previous temperature excursion and no data logger was involved. This is one of several reports received from the same reporter. Lot# L03221 has been verified to be an invalid lot# for sterile diluent. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Redness below injection site of 3-4 inches long.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Induration, Pruritus, Skin warm
Clinical narrative: Pruritic induration with maximum diameter of 4-5 in. Began within 24 hours of MENVEO. Area feels warm to touch. No vesicular lesions present. Placed on oral hydroxyzine TID and steroid cream.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 and 02-APR-2016, the patients were vaccinated with an improperly stored doses of VARIVAX (lot# K020761 with an expiration date 31-OCT-2016; lot# L037560 with and expiration date 29-SEP-2017, lot# K010336 with an expiration date 22-JUL-2016; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# K023007 with expiration date 24-SEP-2017, lot# L017417 with expiration date 02-FEB-2018, lot# L015432 with expiration date 24-JAN-2018, lot# reported as L03221 with unspecified expiration date; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot # L03221 had been verified to be an invalid lot # for sterile diluent. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 12 year old male patient with seasonal allergy. The patient presented no drug allergies/reactions. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L048459 with expiry date on 22-FEB-2018, intramuscular (dose and anatomical location were not reported). No concomitant medications were reported. On 07-JUN-2016, the patient experienced stomach cramps shortly after getting the dose and that hives started about 4 days after the vaccination. Patient sought medical attention via a phone call; however, no lab diagnostic studies were reported. Nurse reports that the patient's mother gave the patient an unspecified dose of BENADRYL on unspecified date, and that the hives and stomach cramps did resolve on an unspecified date. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 24-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 25-MAY-2016, the patient was vaccinated with improperly stored doses of VAQTA lot # L039659, expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Altered state of consciousness, Confusional state, Dizziness, Loss of consciousness, Tremor
Clinical narrative: Patient became lightheaded and lost consciousness while sitting on the exam table. She had some shaking before she lost consciousness. As the patient came to she has an altered level of consciousness for 3-4 min. She was awake and was orientated, but confused she did not remember what happened.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 and 02-APR-2016, the patients were vaccinated with an improperly stored doses of ZOSTAVAX (lot # L029484 with expiration date 06-NOV-2016, lot # L035505 with expiration date 16-DEC-2016, dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# K023007 with an expiration date 24-SEP-2017, lot# L017417 with and expiration date 02-FEB-2018, lot # L015432 with expiration date 24-JAN-2018, lot # reported as L03221 with an unspecified expiration date; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 for 2400 hours. There was no previous temperature excursion and no data logger was involved. This is one of several reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 to 02-APR-2016, the patients were vaccinated with an improperly stored doses of VAQTA (pediatric dose with lot # L007559, expiration date 01-JUN-2017; lot# L028666 with expiration date 04-NOV-2016; adult dose with lot# L027735, expiration date 12-JAN-2017; lot# M009786 with expiration date 26-MAY-2017; dose, anatomical location and route of administration were not reported). It was reported that an improperly stored sterile diluent (lot# K023007 with expiration date 24-SEP-2017; lot# L017417 with expiration date 02-FEB-2018; lot# L015432 with expiration date 24-JAN-2018; lot# reported as L03221 expiration date was not reported; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot# L03221 was verified to be an invalid lot# for sterile diluent. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.38
Sex: M
Vaccine: PNC13
Symptoms: Feeling abnormal, Hypotonia, Pallor, Social avoidant behaviour
Clinical narrative: 45 mins after administration child became limp, lifeless, pale. Took 15 mins or so to arouse him back to normal. Subsequently he acted "off" to parents - not as social. Approximately 2 wks later was back to normal.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates, between 02-FEB-2016 to 02-APR-2016, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot# M012495, expiration date 09-OCT-2017, dose was not reported; orally). It was also reported that an improperly stored sterile diluent (lot# K023007 with expiration date 24-SEP-2017, lot# L017417 with expiration date 02-FEB-2018, lot# L015432 with expiration date 24-JAN-2018, lot# reported as L03221 with unspecified expiration date; dose was not reported, oral route of administration) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot# L03221 has been verified to be an invalid lot# for sterile diluent. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 and 02-APR-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX (pediatric dose with lot # K010216, expiration date 07-SEP-2016, lot # K021444 with expiration date 17-SEP-2016; adult dose with lot # L026598, expiration date 26-JUN-2017; lot# reported as M007763 with expiration date 15-SEP-2017; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# K023007 with an expiration date 24-SEP-2017, lot# L017417 with and expiration date 02-FEB-2018, lot # L015432 with expiration date 24-JAN-2018, lot # reported as L03221 with an unspecified expiration date; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot# L03221 has been verified to be an invalid lot # for sterile diluent. This is one of several reports received from the same reporter. Additional information had been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Rash
Clinical narrative: Weeping rash and surrounding cellulitis developed the day after vaccine administration. Treatment with cephalexin and mupirocin.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX with lot/batch # L027287, expiry date 21-JUL-2017 (dose, dose number, strength, vaccination site and route of administration not provided). Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Red, itchy, burning spot around and on injection site.
Age: 0.34
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: No adverse event
Clinical narrative: None.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Blood glucose normal, Cold sweat, Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: Client complained of blurred vision, clammy, pale, and sweating, 5 minutes after vaccine. Vitals monitored. Cold compresses applied and clnt given to raise BS once symptoms improved.  Monitored x 20 minutes.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (lot# L008355 with expiration date 11-SEP-2016; lot# M0101476 with expiration date 01-SEP-2017; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# K023007 with expiration date 24-SEP-2017, lot# L017417 with expiration date 02-FEB-2018, lot# L015432 with expiration date 24-JAN-2018, lot# reported as L03221 with unspecified expiration date; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) on 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of PROQUAD with lot/batch # L033698, expiry date 28-FEB-2017 (dose, dose number, strength, vaccination site and route of administration not provided). Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Inflammation, Skin warm, Swelling
Clinical narrative: Local inflammatory reaction consisting of redness/swelling/heat/induration measuring 11 x 12 cm over area of right deltoid/triceps.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Ear pain, Headache, Myalgia, Nausea
Clinical narrative: Approximately 1 1/2 hours after receiving vaccines pt started with myalgia, very bad headache, nausea, chills throughout the evening. (Approx 12 hours). Pt also c/o ear and jaw pain, fever and arm pain.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Approximately 1 1/2 hours after receiving vaccines pt started with myalgia, very bad headache, nausea, chills throughout the evening. (Approx 12 hours). Pt also c/o ear and jaw pain, fever and arm pain.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 6/24 - Mom said (R) upper arm red and swollen, hard to touch. Mom drew a circle around the injection site - area larger. Advised per doctor to apply cool compress, give BENADRYL every 8 hours, site should improve over 48 hours/if red streak N/T seek emergent care.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: Patient developed a large bump - raised area approximately 8 cm in diameter - reported by nurse to us where patient is assumed to work. No itching or hives. Looked like a spider bite. Starting to recovery 06/23/2016.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Redness, swelling, had lump in area of L upper deltoid, redness and bump have gone away, but still small area of hard bump inside muscle area where immunization was administered. Today redness is gone, hard skin.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of MMR II (lot# K012472 with expiration date 11-JUN-2016; lot# K009956 with expiration date 14-JUL-2016; lot# L043704 with expiration date 04-NOV-2017; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored STERILE DILUENT (lot# K023007 with expiration date 24-SEP-2017; lot# L017417 with expiration date 02-FEB-2018; lot# L015432 with expiration date 24-JAN-2018, lot# reported as L03221 with unspecified expiration date; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot# L03221 has been verified to be an invalid lot# for sterile diluent. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Mom reported 2 episodes of vomiting that started this morning. No other S/S "Pt has no appetite" per mom. DOH recommended to call pediatrician for treatment if needed.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Redness (R) arm upon waking this morning. Pain and induration (L) arm, no fever.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Local reaction, Vaccination site reaction
Clinical narrative: Localized reaction at vac site. Redness 3x6. Rec TYLENOL, MORTIN, BENADRYL.
Age: 50.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site swelling, Pyrexia
Clinical narrative: Starting with fever and headache several hours after vaccine. Fever to 101 degrees F, relieved with TYLENOL. Fever returned next day about 10 hours post TYLENOL. Instructed to take ibuprofen. This did relief fever and headache. F/u on 06/24/16 no further fever or headache, sight has mild swelling at injection site now. Will apply ice to site.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal, Headache, Induration, Injection site erythema
Clinical narrative: Noted soreness in RT shoulder am of 21st. Then developed 102 fever, body aches, swelling, noted shoulder size increased size of "baseball", redness developed - spreading down to RT elbow. Dev. nausea and vomited on 22nd. Felt fatigued/miserable. Used ice/head on shoulder as palpable "hard" spot. Noted evening 23rd area decrease 2 redness down to elbow. Returned to clinic on 24th with symptoms currently.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Noted soreness in RT shoulder am of 21st. Then developed 102 fever, body aches, swelling, noted shoulder size increased size of "baseball", redness developed - spreading down to RT elbow. Dev. nausea and vomited on 22nd. Felt fatigued/miserable. Used ice/head on shoulder as palpable "hard" spot. Noted evening 23rd area decrease 2 redness down to elbow. Returned to clinic on 24th with symptoms currently.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Noted soreness in RT shoulder am of 21st. Then developed 102 fever, body aches, swelling, noted shoulder size increased size of "baseball", redness developed - spreading down to RT elbow. Dev. nausea and vomited on 22nd. Felt fatigued/miserable. Used ice/head on shoulder as palpable "hard" spot. Noted evening 23rd area decrease 2 redness down to elbow. Returned to clinic on 24th with symptoms currently.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Insomnia, Malaise
Clinical narrative: Coughing, malaise, difficulty sleeping, has visited Dr. twice, no treatment recommended by them.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a consumer refers to a 42 year old female patient. On an unknown date the patient was vaccinated with GARDASIL 9 dose 1. Other suspect therapies included GARDASIL. On 21-JUN-2016, 1 day after onset of therapy the patient experienced interchange of vaccine products. On an unknown date the patient experienced adverse event. The outcome of interchange of vaccine products and adverse event is unknown. The reporter considered interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL. The reporter considered adverse event to be not related to GARDASIL and GARDASIL 9. {Additional information has been requested. Additional information is not expected.}
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (lot #L015460, expiration date: 20-JUL-2017 and lot# M009377, expiration date: 17-JUN-2017 (dose and route unspecified). These vaccines had been through a temperature excursion at 34 degree Fahrenheit for 10 minutes (incorrect storage of drug). Previous temperature excursion of the vaccines included 35 degree Fahrenheit for 10 minutes. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via a company representative referring to a 13 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 07-JUN-2016, the patient was vaccinated with her second dose of GARDASIL 9 intramuscularly (dose unspecified). The patient was fainted after vaccination in doctor's office. The outcome of the event was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea, Skin irritation, Skin warm
Clinical narrative: She has a red, slightly raised area at the site office shingles vaccine. The next day she had vertigo when she woke, she also has nausea. The local area is slightly warm and irritated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: She has a red, slightly raised area at the site office shingles vaccine. The next day she had vertigo when she woke, she also has nausea. The local area is slightly warm and irritated.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received from registered nurse concerning a patient of unknown age and gender. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. In approximately 2015 (reported as about a year ago), the patient was vaccinated with the first dose in the series of GARDASIL 9 injection and on 21-JUN-2016, the patient received the second dose of GARDASIL 9 injection (dose, route, lot# and expiration dates were not reported). No adverse effect was reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, IPV, MNQ
Symptoms: Cellulitis
Clinical narrative: Mild cellulitis at day 6-7 after administration of vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Neck pain, Pain, Paraesthesia
Clinical narrative: Pain left side body, neck, abdomen, headache "feels like needle pricks".
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown. The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 24-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2107 (dose, strength, and route unknown) (incorrect product storage). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has bee requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report was referring to a 16 year old patient of unknown age received from the patient's mother. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot number, route and anatomical location was not reported). One week later, the patient developed swollen lymph nodes. Field employee reports that the patient was seen by an unspecified physician, was given antibiotics (it was also reported that no treatment was given) and within "about a week" the swollen lymph nodes resolved. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown) (incorrect product storage). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown) (incorrect product storage). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown) (incorrect product storage). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications  were not reported. On 25-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 25-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L037921 expiration date: 31-MAY-2017 (dose, strength, and route unknown) (incorrect product storage). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red, warm, very painful injection site. Erythema 3.5 cm diameter, induration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Skin reaction
Clinical narrative: Local skin reaction. Redness/induration at injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Patient developed a rash (blisters) on injection site after 7 days - put on BENADRYL cream.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: My son complained headache @ 12pm and it went away after eating lunch, then 6:30pm he was experiencing a severe headache, lying and feeling nausea. I called Dr. who gave him the vaccine yesterday and asked for his advise. I gave him Tylenol to reduce the headache.  @7:00PM he vomited a lot and fell asleep right after that.  He woke up @9:40pm and said headache got reduced yet still exist.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling, Heat.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, RVX
Symptoms: Crying, Opisthotonus, Pain, Pyrexia, Vomiting
Clinical narrative: UNCONTROLLABLE CRYING FROM 2:30 PM UNTIL 3:30 AM. VOMITING AFTER EATING. KICKING LEGS AND ARCHING BACK. FEVER OF 100.9. GAVE TYLENOL STARTING AT 2:30 EVERY 4 HOUR FOR PAIN AND FEVER. BABY IS STILL VOMITING AFTER EVERY FEEDING MORE THAN 48 HOURS AFTER VACCINATIONS.
Age: 18.0
Sex: F
Vaccine: DTP, MEN
Symptoms: Seizure
Clinical narrative: Three vaccines were given (tetanus booster, meningitis and meningitis B) and after the third patient had a seizure.  911 was called and she was sent to the ER from the doctor's office.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Aspiration bone marrow, Biopsy bone marrow, Contusion, Petechiae, Platelet count decreased
Clinical narrative: Child began showing irregular bruising. Child also had present petechia.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: X-ray
Clinical narrative: Child began showing irregular bruising. Child also had present petechia.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Death, Laboratory test
Clinical narrative: Death.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction.  Became red and swollen and painful.  Let red mark with lump underneath skin.  Patient says it has been improving day by day.  He did not seek medical treatment.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: My arm was sore the evening of the injection, but just "normal" soreness. The day after the injection, I was hanging plaques in my office in the afternoon and I noticed my arm was more sore and it felt weak when I was holding items.  By the morning of November 1, 2015, I couldn't lift my left arm to wash my hair, etc. in the shower.  There was considerable pain with trying to lift and some swelling.  The injection was given at my workplace so I contacted HR for guidance on Monday, November 2, 2015.  I have been seen by occupational health physician, orthopedic surgeon, and had physical and massage therapy.  Medications of ibuprofen, Flexoril, pain patch, and steroid injection to the left shoulder.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: My arm was sore the evening of the injection, but just "normal" soreness. The day after the injection, I was hanging plaques in my office in the afternoon and I noticed my arm was more sore and it felt weak when I was holding items.  By the morning of November 1, 2015, I couldn't lift my left arm to wash my hair, etc. in the shower.  There was considerable pain with trying to lift and some swelling.  The injection was given at my workplace so I contacted HR for guidance on Monday, November 2, 2015.  I have been seen by occupational health physician, orthopedic surgeon, and had physical and massage therapy.  Medications of ibuprofen, Flexoril, pain patch, and steroid injection to the left shoulder.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash on hip area/ wais and both shoulder blades.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: REDNESS ( 2 X 3 INCH AREA )WARM TO TOUCH-NOT PAINFUL.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Blood test normal, Chest X-ray normal, Chest pain, Cold sweat
Clinical narrative: Sharp right side chest pain. dizzy, blacked out , clammy went to urgent care. blood work done. cbc, chest x ray, ekg. All came back negative.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Colonoscopy normal, Computerised tomogram abdomen normal, Diarrhoea, Dizziness, Dysphagia
Clinical narrative: Sharp right side chest pain. dizzy, blacked out , clammy went to urgent care. blood work done. cbc, chest x ray, ekg. All came back negative.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Electrocardiogram normal, Endoscopy normal, Full blood count normal, Hepatobiliary scan
Clinical narrative: Sharp right side chest pain. dizzy, blacked out , clammy went to urgent care. blood work done. cbc, chest x ray, ekg. All came back negative.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Hepatobiliary scan normal, Local swelling, Loss of consciousness, Nausea, Stool analysis normal
Clinical narrative: Sharp right side chest pain. dizzy, blacked out , clammy went to urgent care. blood work done. cbc, chest x ray, ekg. All came back negative.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Sharp right side chest pain. dizzy, blacked out , clammy went to urgent care. blood work done. cbc, chest x ray, ekg. All came back negative.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Pt noticed itchy red area at injection site,came to pharmacy 48 hours after injection. Pharmacist contacted primary care doctor who advised pt to come into office for exam. Topical steroid cream prescribed with instructions to monitor rash and return to office if rash not improved in three days.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Feeling cold, Gait disturbance, Muscular weakness
Clinical narrative: Nausea, weakness, feeling cold and lightheadedness that seemed initially to improve but she returned to office 2 days later reporting persistent muscle pain in the legs and left arm and weakness of the legs such that she had difficulty walking.  She reported improvement on the second day.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Nausea, Neurological examination normal
Clinical narrative: Nausea, weakness, feeling cold and lightheadedness that seemed initially to improve but she returned to office 2 days later reporting persistent muscle pain in the legs and left arm and weakness of the legs such that she had difficulty walking.  She reported improvement on the second day.
Age: 43.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: MMR II Live Inj vaccine adminstered 6/25/16 and expired 6/11/2016, no known ADR, waiting to call manufacturer Monday 6/27 (currently closed), per CDC revaccination is advised unless serologic testing indicates a response to the vaccine.