chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash pruritic, Skin warm, Urticaria
Clinical narrative: This is a spontaneous report from a contactable medical assistant and from a health care professional reporting on behalf of a physician  via a Pfizer  sales representative. A 17-year-old female patient of an unspecified ethnicity received 0.5 ml single dose of TRUMENBA, Batch/Lot # M37315, Exp date APR2017, intramuscular in Left Deltoid on 08MAR2016 at 3:51 PM. Medical history included headache, nausea and dizzy on off lately. Concomitant Drug includes: JUNEL for birth control and multivitamins. The patient had a bad local reaction on her arm, skin rash, described as itchy. It has been located on the left arm on 09MAR2016. The patient was visited on 10MAR2016. No fever, chills, sore throat, cough or difficulty breathing. No hoarseness, lump in throat or enlarged lymph nodes. All systems otherwise negative expect as recorded above. The rash was macular, urticarial and erythematous. There was warmth. Clinical diagnosis was Localized allergic reaction with skin rash secondary to intramuscular vaccine. The patient had no history of heart disease, lung disease, hypertension or hyperlipidemia. No history of neurological disease, GI disease or diabetes mellitus. Social history: Never smoker, No alcohol use or drug use. Rash and symptoms improved with BENADRYL 25 mg 2DF orally every 4 hours as needed for itching and recovered on an unknown date. The physician assessed the adverse reaction as related to TRUMENBA and commented as follows: The patient had the headache before the product was given. Follow up 11APR2016: New information from a contactable health care professional included vaccination date, onset date and event description, medical history and concomitant medications. Follow up 19-MAY-2016: Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable certified practitioner nurse via a Pfizer sales representative. A patient of unspecified age, gender and ethnicity received TRUMENBA via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced big red circular rash around the site and severe headache requires an evaluation on unknown date. The outcome of the events was unknown. Follow-up (29APR2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 17-year-old female patient of unspecified ethnicity received TREMENBA (batch/lot # M37314 and expiration date 30APR2017 on 06APR2016 4:17 PM, at 0.5 ml single dose intramuscular on left arm. The patient medical history and the patient's concomitant medications were not reported. The patient fainted "like the next day" on 07APR20156 with outcome of recovered.  Follow-up  (17MAY2016): Additional information from the contactable physician incudes age of the patient , gender, date of vaccination, onset date of the event and  outcome.
Age: 16.0
Sex: F
Vaccine: FLUX, HPVX, MENB, MNQ
Symptoms: Headache, Musculoskeletal pain, Neck pain, Pain, Vomiting
Clinical narrative: A 16-year-old female patient received on 03Mar2016 around 14:00 or 14:30: TRUMENBA; lot L31514, expiry date Apr2017, NDC 00050100-10_ at 0.5 ml single, intramuscular, in right deltoid, MENVEO at 0.5 ml single, intramuscular, in right deltoid, HPV at 0.5 mg, single, intramuscular, in left deltoid and influenza vaccine at 0.5 mg, single, intramuscular, in left deltoid. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vomiting, pain across both shoulder and pain shooting up her neck, real bad headache, all on 03Mar2016 with outcome of recovered. Four hours after experiencing the side effects the patient went to the ER. During the ER visit the patient received IV fluids and was kept overnight for observation and then released. Symptoms lasted for about three or four days before resolving. The reporter considered the events related to all the vaccines (she believed it was the combination of all 4 vaccines that caused the events).
Sex: F
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse and physician communicated to a Pfizer sales representative. This nurse and physician reported similar events for two patients. This is the first of two reports. A female patient of an unspecified ethnicity received TRUMENBA on an unspecified date at single dose, and flu vaccine. The patient medical history was and concomitant medications were not reported. The patient experienced, fever, body stiffness and nausea on an unspecified date 3 or 4 days after vaccination, with outcome of unknown. Follow (20May1016): Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Headache, Motion sickness
Clinical narrative: This is a spontaneous report from a contactable Physician Assistant communicated to a sale representative. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 21MAR2016 at 0.5 ml, single and MENACTRA via an unspecified route of administration on 21MAR2016 at 1 DF, single. The patient medical history and concomitant medications were not reported. The patient experienced headache, dizziness, and motion sickness on 21APR2016 with outcome of not recovered. The patient was prescribed TYLENOL and MECLIZINE.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 17-year-old male patient of unspecified ethnicity received the second dose of TRUMENBA  via an unspecified route of administration, on unknown date, at single dose. The patient was allergic to antibiotics. Concomitant medications were not reported. The next day after receiving the vaccine, the patient experienced arm red, painful, and swollen. The patient received ice and ibuprofen and the effects lasted 24 hours. The outcome of the events was unknown. The patient was not sure if he should have the d 3ose of the vaccine.
Sex: U
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report obtained from a non-contactable nurse via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration on an unspecified date at 0.5 ml single dose. The patient medical history and the patient's concomitant medication were not reported. The patient experienced severe headache on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Inflammation, Musculoskeletal stiffness, Photophobia
Clinical narrative: The initial case was made invalid due to unspecified AE. Upon receipt of follow-up information on 28MAR2016 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and nurse via a Pfizer sales representative. This physician reported for 3 patients. This is the second of three reports. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA (batch/lot L13514. exp. date 21JUL2016) intramuscular on left deltoid at 0.5 ml single on 08MNOV2015. The patient medical history was not reported. The patient's concomitant medications were none. The patient experienced on 09NOV2015 large local inflammatory reaction and on 10NOV2015 severe headache, neck stillness and photophobia. The outcome for all events was reported as recovered on 13NOV2015. The patient was not hospitalized for the event.
Sex: U
Vaccine: MENB
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose. Relevant medical history and concomitant  medications were not reported. The patient experienced swelling at the site of injection of TRUMENBA resulting in a lemon size lump on the patient's upper arm, on an unspecified date with outcome of unknown. Follow-up (01APR2016): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Other HCP via a Pfizer sales representative.  A 16 years old female patient of an unspecified ethnicity received the first dose of TRUMENBA (batch/lot # L13514, expiration date JUL2015) at 0.5 ml single and the second dose of MENACTRA (Sanofi Pasture, lot A5178AA), both intramuscular in the left arm, on 04FEB2016 at 1:45 PM. The patient medical history and concomitant medications were not reported. The patient received a previous dose of meningococcal vaccine at the age of 12 years old. On 04FEB2016 the patient had pain in arm, on unspecified date the patient had lot of redness in flowing discomfort in her arm and swelling. The outcome of the events was recovered. The patient was not treated for pain in arm. Follow up (07MAR2016): New information from the same Other HCP included: patient age, administration details (lot and expiration date, administration site route), vaccination history, onset date, outcome of the events. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Malaise
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representatives. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient felt fatigue and malaise for a week after the immunization with TRUMENBA. The outcome was unknown. Follow-up (15-MAY-2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: The spontaneous report from a nurse via a sales representative reported similar events for two patients. This is the second of two reports. An 18-year-old female patient received the first dose of TRUMENBA (batch/lot number J29203, expiration date 01JUN2016)) intramuscular at 0.5 ml single in the left deltoid on 29JAN2016 at 4:34 PM. The patient medical history was not reported. Concomitant medications none. On 01FEB2016, the patient experienced severe redness, swelling in limb and arm and cannot move the arm with outcome of recovered on 04FEB2016. Patient chart indicated adverse reaction so patient will not get the 2nd dose. Follow-up (16MAR2016): New information from a contactable nurse includes: patient's details, administration details (batch/lot#, expiration date, dosages; route, anatomical location and date of administration). onset and outcome of the events, additional event (patient will not get the 2nd dose). Follow-up (13MAY2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: This spontaneous report via a sales representative from a nurse who reported similar events for two patients. This is the first of two reports. A patient of unspecified age ethnicity and gender received the first dose of TRUMENBA (batch/lot# J29203, exp date 01JUN2016), intramuscular on 01FEB2016 at 04:52 PM at 0.5 ml single dose. The patient medical history and concomitant medications were not reported. The patient experienced severe redness, swelling in limb and arm and cannot move the arm on an unspecified date with outcome of recovered. The patient was treated for the events.  Follow up (16MAR2016): New information from the same contactable nurse included administration details (batch/lot #, expiration date; dosage; route, site and date of administration), outcome of the events. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A patient of unknown age, gender and ethnicity received TURMENBA at single dose in the arm on an unspecified date. Concomitant medications and medical history were not reported. On an unspecified date after use of product, the patient experienced hives of arm injected. Outcome was not reported. Follow (20MAY2016): Follow-up attempts completed. No further information expected.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (office manager) received via a sales representative. This officer manager reported similar events for two patients. This is second of two reports. A 12-years-old male patient of an unspecified ethnicity received TRUMENBA (lot # M13066, exp date 30SEP2016), via an unspecified route of administration on the left arm on 25JAN2015 at 0.5 ml single. The patient medical history was not reported. There were no concomitant medications. The patient experienced fever, body ache, rash, red swollen arm, nausea and vomiting all on an unspecified date with outcome of recovered. IT was unknown if the patient had received any treatment.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Rash, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (office manager) received via a sales representative. This officer manager reported similar events for two patients. This is second of two reports. A 12-years-old male patient of an unspecified ethnicity received TRUMENBA (lot # M13066, exp date 30SEP2016), via an unspecified route of administration on the left arm on 25JAN2015 at 0.5 ml single. The patient medical history was not reported. There were no concomitant medications. The patient experienced fever, body ache, rash, red swollen arm, nausea and vomiting all on an unspecified date with outcome of recovered. IT was unknown if the patient had received any treatment.
Sex: M
Vaccine: MENB
Symptoms: Excessive eye blinking, Headache
Clinical narrative: The initial case was missing the following minimal criteria: unspecified product. Upon receipt of follow up information on 11FEB2016 this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways via contactable consumer who reported for her son. A 18-year-old male patient received TRUMENBA, in JUN2015 at 0.5 ml single. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache (had had a bad head ache) that lasted a month and blinking of his eyes that lasted for about 3 months. Events recovered on an unknown date.  Follow-up (08APR2016). Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Cough, Dizziness, Headache, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of unspecified age and ethnicity received TRUMENBA (lot number L13514, expiry date Jul2016) via an unspecified route of administration, on 06Nov2015, at single dose. Relevant medical history and concomitant medications were not reported. The patient was sick, with flu like symptoms, headache, mild cough, weak, fever, muscle pain and dizziness on unknown date. The patient had no vomiting. The patient was tested for the influenza virus through the nasal swab test and for mononucleosis it were negative. The events took place after the vaccination. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Influenza virus test positive, Malaise, Mononucleosis heterophile test negative, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of unspecified age and ethnicity received TRUMENBA (lot number L13514, expiry date Jul2016) via an unspecified route of administration, on 06Nov2015, at single dose. Relevant medical history and concomitant medications were not reported. The patient was sick, with flu like symptoms, headache, mild cough, weak, fever, muscle pain and dizziness on unknown date. The patient had no vomiting. The patient was tested for the influenza virus through the nasal swab test and for mononucleosis it were negative. The events took place after the vaccination. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Headache, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A child patient of an unspecified ethnicity and gender received the first dose of TRUMENBA (lot number L13514, expiration date Jul2016), via an unspecified route of administration at single dose on 08Dec2015. The patient medical history and concomitant medications were not reported. On 10Dec2015, the patient experienced headache, dizziness, flu like symptoms. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 15-year-old male patient received 1st dose of TRUMENBA, intramuscular in the left deltoid at 0.5 ml single dose on 22Dec2015 and the 2nd dose (Lot: J28923, Exp date 01Jun2016) intramuscular in the right deltoid at 0.5 ml single dose on 26Feb2016. The patient medical history and the patient's concomitant medications were not reported. With both vaccines the patient experienced the fever within 24 hours of receiving the vaccine, for just one day and the belly ache within 24 hours of receiving the vaccine, for 3 days. He has recovered completely from both side effects. The events were assessed as non serious. The nurse was not provided with the information regarding the adverse events by the patient. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (04Apr2016): New information reported from a contactable nurse included: reporter informed regarding the adverse events; reporter further contactability.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Axillary pain, Body temperature increased, Local swelling, Mobility decreased, Myalgia
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 17 year old male patient received, on 03Mar2016, TRUMENBA (Lot. M95612, Expiration date: Dec2016, NDC number: 00005-0100-05) intramuscular, in the left arm, at single dose. The vaccine was received at the doctor office. Relevant medical history included bronchitis. Concomitant medications included doxycycline, CLARINEX and NASACORT. On an unspecified date, the patient experienced reduction of arm movements, pain in left armpit, swelling in armpit and left pectoral muscle, muscle pain issues, and temperature elevation (he had temperature of 99.3 degrees Fahrenheit). Treatment was received (ibuprofen and acetaminophen). The patient did not recover from the events at time of this report. Follow (01MAY2016): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at 0.5 ml single; MENACTRA, via an unspecified route of administration, on an unspecified date, at unspecified dose, and Hepatitis A, via an unspecified route of administration, on an unspecified date, at unspecified dose. Relevant medical history and concomitant medications were not reported. On 07Mar2016 the patient fainted with outcome of recovered the same day when she got up.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Decreased appetite, Fatigue, Malaise, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Vaccines representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on 07Mar2016, at single dose, and MENACTRA, via an unspecified route of administration in the arm, on 07Mar2016, at 1 DF single. The patient's medical history and concomitant medications were not reported. Previously the patient received HPV vaccine (unspecified trade name) a year before, and experienced similar symptoms. Almost immediately after receiving vaccines the patient experienced did not feel well, general body aches, extreme fatigue and loss of appetite. She generally did not feel well and did not want to get out of bed the next morning. Outcome was unknown. Follow-up (05May2016): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Feeling cold, Headache, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for her son and from a contactable other HCP. A 18-year-old male patient received the second dose of TRUMENBA, via unknown route of administration, single dose on 10Mar2016 05:00. Medical history included attention deficit/hyperactivity disorder (ADHD) from 29Dec2011 and ongoing and Tourette's disorder from 2010 and ongoing. Concomitant medications included FOCALIN since 22Feb2014 and ongoing for ADHD at 10 mg BID orally. The patient had received the first dose of the same vaccine from batch/Lot MI3065, Exp: Apr2017 via intramuscular route on right upper arm on 06Jan2016 and had experienced local redness and swelling. On 10Mar2016 the patient experienced chills/teeth chattering, headache, shaking all over, all with outcome of unknown. Follow-up (19Apr2016): additional information received from a contactable other HCP includes past vaccination events, concomitant drug. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Lip swelling
Clinical narrative: This spontaneous report from a contactable Healthcare professional. A patient of unknown age, gender and ethnicity received TRUMENBA at 0.5 ml single dose on an unspecified date. Concomitant medications and medical history were not reported. The patient had lip swelling shortly after receiving it. Outcome was unknown. Follow-up (11MAY2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Eye swelling, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA (NDC number: 0005-0100-05; Lot M74096 and expiration date: 30Sep2016), intramuscular on left deltoid on 25Mar2016 at 11:06 am at 0.5ml. The patient medical history and concomitant medications were not reported. On 26Mar2016 the patient experienced temperature of 101 degrees, headache, muscle aches including the neck and swelling around eyes. Unspecified treatments were administered. Patient recovered from headache, muscle aches including the neck and swelling around eyes on 27Mar2016 and from pyrexia on 28Mar2016. The patient received ibuprofen to treat the events. Follow up (18Apr2016): New information received from the same includes: vaccine and event details. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Erythema, Fatigue, Influenza like illness, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable licensed practical nurse from a pediatric office. A 18 year-old male patient of unspecified ethnicity received TRUMENBA (lot number M13066, expiry date 30Sep2016) intramuscularly on 26Jan2016 at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced flu like symptoms, temperature of 101, fatigue, redness and swelling at injection site on unknown date in Jan2016, within 24 hours from the injection. The symptoms resolved within 3 days on an unspecified date in Jan2016. The nurse spoke with the doctor regarding the causality of the event and he/she said related to the product.
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 23-year-old male patient of unspecified ethnicity received TRUMENBA (NDC number: 0005-0100-10), intramuscularly on 04Mar2016 at 0.5 ml, single. No other vaccinations were administered. Relevant medical history and concomitant medications were not reported. The patient experienced swelling around the injection site and red abscess very hot to touch on unknown date. The patient recovered from the events on unknown date.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (lot number 731504/17, NDC number: 0005-0100-10), intramuscularly on the left deltoid on 16Mar2016 at 11:00 at 0.5 ml, single. Relevant medical history and concomitant medications were none. The patient experienced fever and arm was very painful and fatigued the day after vaccination on 17Mar2016. The events did not require emergency room or doctor visit and the patient was not hospitalized for the events. The patient recovered from the events. The physician stated that the patient provided to him/her information regarding the reported events with the use of the vaccine. The physician considered the vaccine had a causal effect to the adverse event. Follow-up (03May2016): New information reported from a contactable physician includes: patient's gender, lot number, site and time of vaccination, none medical history, onset date, no hospitalization, emergency room or doctor visit for the events, confirmation from the physician that the patient provided to him/her information regarding events with the use of the vaccine, causality assessment. Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 32 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 27 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # L014265, expiration date: 28-APR-2017, 1 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Menstrual disorder
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to an unspecified number of female patients of unknown age. Concurrent conditions and medical history were not reported. The reporter reported that he read on an unspecified web site on the internet that GARDASIL 9 or GARDASIL (route, dose, frequency, lot# and expiration date were not reported) impacted females' menstrual cycles. Outcome of the event was not reported. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple patients of unknown age and gender. The patients concurrent conditions, pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB (digital data logger) (lot # K007258, expiration date 04-MAR-2017). The vaccine was exposed to the temperature: 48.9F with the time frame of 1 hour 10 minutes. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple patients of an unknown age and gender. The patients concurrent conditions, pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (digital data logger) (lot # L019286, expiration date 14-SEP-2017). The vaccine was exposed to the temperature: 48.9F with the time frame of 1 hour 10 minutes. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 2 month old infant of an unknown gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 20-MAY-2016 (today), the patient was inadvertently vaccinated with an expired dose of ROTATEQ vial lot # K008140 (expiry date: 30-MAR-2016) (dosage not reported). No adverse effects noted. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple patients of unknown age and gender. The patients concurrent conditions, pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (digital data logger) (lot # K020182, expiration date 25-JUN-2016). The vaccine was exposed to the temperature: 48.9F with the time frame of 1 hour 10 minutes. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Information has been received from a pharmacist via a field representative referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (dose, route, lot# and expiration date were not reported). On unknown dates the patients experienced redness and a knot at the injection site following the administration of ZOSTAVAX. The outcome of the events and causality were not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The patient received both a dose of VAQTA and a dose of RECOMBIVAX HB on 14-DEC-2015 and on 14-MAR-2016 (lot # and dose unknown) intramuscularly (inappropriate schedule of vaccine administered). No known adverse effects were reported. It was unknown if any medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, drug reactions or allergies was provided. On 16-MAY-2016, the patient was subcutaneously vaccinated with a dose of expired dose of PROQUAD (Merck) (human serum albumin (HSA)) (lot # K022448, expiry date 13-MAY-2016) (dose was not reported). Concomitant medications were not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from the patient's mother, as part of a marketing research program and referred to two patients with unknown age and gender, who were currently 34 years old. The patient's concurrent conditions, medical history and allergies, as well as, concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (strength, dosage schedule, route, lot number and expiration date were not reported). On unknown dates, the patients had issues after the HPV vaccination. The outcome of adverse event was unknown. Additional information is not expected because the reporter refused to be contacted.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: 5/3/16 fever 103 - seen 5/4/16 with fever 103 rectally. Fevers started yesterday, 101.2, 102 today, received vaccines 2 days ago, PROQUAD and Hep A.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Hypoaesthesia, Migraine
Clinical narrative: When pt arrived for #3 GARDASIL mom ask it if was normal the patient had a migraine (already had hx of occ migraines) w/numbness on hands/arms (lasted for hrs) day of shot/vaccine - has had increased frequency of migraines - numbness resolved still having H/A.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 1 day swelling of the whole upper arm, red, tender induration. Got better a little bit the next day. Treated w/antibiotics.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pruritus, Pain, Pyrexia
Clinical narrative: Patient had PCV 13 on 5/21/2016. 12 hours later, patient had body ache, chills and fever, and then resolved in 1 day. 24 hours later, patient had erythema and itching on left upper arm.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Face injury, Fall, Laceration, Loss of consciousness
Clinical narrative: Pt received MENACTRA then HPV. He was sitting on exam table and told his mom he felt dizzy. He then became unconscious and fell off the table, hitting to left side of his face on the chair. He was back to normal in about 5 minutes. DERMABOND to small laceration on left forehead.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Brief syncope 1 minute after vaccine. LOC less than 1 minute.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: I had appointment for another issue. Dr. had given me a shot for pneumonia at my visit the previous year and advised I was due for a booster which she gave me on 04/28. 2 or 3 days later a 2 inch red square appeared where the injection had been done. The next day it had become a 5" X 3" oval which was hot and tender. It did eventually go away.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Pain and swelling at injection site 2 hrs. post vac. Red rash with swelling 24 hrs. post vac. Still swollen and red 48 hrs. post vac. Starting to dissipate 72 hrs. post vac.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swollen and fire red and slight itching.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Injection site swelling, Red blood cell abnormality, Skin warm
Clinical narrative: The vaccine was given in my son's right arm. Everything was fine after the shot was given. It was later that night into the next day, his arm around the injection site swelled up a lot to his shoulder. It became red and hot to touch. Lasted about 4 days. Gave BENADRYL to treat it.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Injection site induration, Injection site nodule, Injection site swelling, Nausea
Clinical narrative: 5/19/16 Day after injection pt. dev. approximately 1.5 inch area of induration and swelling at site of injection. Also nauseated - vomited x2. 5/20/16 - Tired but no more vomiting. Area of induration still present. 13-year-old received the HPV vaccination yesterday and has developed a firm knot under the site of injection and some swelling. He has also been nauseated today and vomited one time this evening. He is feeling better after vomiting. There has been no fever. Will Rx ondansetron to pharmacy. Will check with Mom in the morning.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: 5/19/16 Day after injection pt. dev. approximately 1.5 inch area of induration and swelling at site of injection. Also nauseated - vomited x2. 5/20/16 - Tired but no more vomiting. Area of induration still present. 13-year-old received the HPV vaccination yesterday and has developed a firm knot under the site of injection and some swelling. He has also been nauseated today and vomited one time this evening. He is feeling better after vomiting. There has been no fever. Will Rx ondansetron to pharmacy. Will check with Mom in the morning.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site bruising, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: 3 days after vaccine - Redness, warmth, bruising and edema. Fever 102.9. AM reactions occurring at site of injection. ER trip 5/19/16 with cortisone injection and release to home with dx. "allergic site reaction".
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: 3 days after vaccine - Redness, warmth, bruising and edema. Fever 102.9. AM reactions occurring at site of injection. ER trip 5/19/16 with cortisone injection and release to home with dx. "allergic site reaction".
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Face injury, Fall, Immediate post-injection reaction, Seizure, Tooth fracture
Clinical narrative: Pt was given MENACTRA and HPV in (R) arm. Seconds later was given Tdap in (L) arm and immediately fell forward off table and hit face on floor. Seizure for less than 20 seconds. Broke off tooth in process. Pt with hx anxiety with vaccines especially.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Bruising on side of right bicep and dark in center but yellowing on edges like it is healing approximately 3 weeks after shot was given. Pt has no other reason for bruising to last that long. Pt says it's been there since shot given.
Age: 0.53
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site discolouration
Clinical narrative: Patient has a brown mark where vaccines Hib and PREVNAR were administered. This was on 2/4/16 - and baby still has mark on thigh.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blood glucose increased, Chills, Pain, Pain in extremity
Clinical narrative: Event occurred on 5/25/16 - about 4 pm became very sleepy, shivering, fever, weakness, body aches, no appetite, entire left arm sore, elevated blood sugar (342). Pt reported this 5/26/16. 5/27/16 in afternoon - pt still tired. Her hand has stopped hurting but her arm still hurts. Afebrile now. Blood sugars are under good control now. Pt had declined office visit.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Somnolence
Clinical narrative: Event occurred on 5/25/16 - about 4 pm became very sleepy, shivering, fever, weakness, body aches, no appetite, entire left arm sore, elevated blood sugar (342). Pt reported this 5/26/16. 5/27/16 in afternoon - pt still tired. Her hand has stopped hurting but her arm still hurts. Afebrile now. Blood sugars are under good control now. Pt had declined office visit.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, VARCEL
Symptoms: Fall, Pain in extremity, Tremor
Clinical narrative: 2-3 minutes after shots were given, patient fell to the floor, and mom noted shoulder shaking for seconds. Patient was helped to get to examining bed and rested complaining of left leg pain. No known fear of needles nor blood. No vomiting. 30 minutes after patient stood up and went to lab for blood work. Patient referred to neurologist.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 15 year old male patient. The concurrent condition, medical history and concomitant medication was not reported. On 08-APR-2016, the patient was vaccinated with third dose in the series of GARDASIL 9 (lot # L019297). Approximately 20 to 30 minutes later, the patient had a tuberculosis test. When the patient went to the checkout counter in the medical office, he fainted. The patient had no injuries. His legs were kept elevated and he was given juice and crackers. He was reported to be fine at the time of report and needed no follow up. The medical assistant also reported that the patient had no reactions to the prior doses of GARDASIL 9. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition and medical history was not reported. On 02-MAY-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L051102 with expiration date of 17-JUN-2017, dose and route unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) (lot # L041629 with expiration date: 22-APR-2017, lot# L041626 with expiration date: 20-APR-2017; lot# L051101 with expiration date: 17-JUN-2017; lot# L050907 with expiration date: 14-JUN-2017, dose was unknown) which were improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 25-MAY-2016, the patient as vaccinated with VARIVAX (Merck) (lot number, expiry date, dose and route); and also, on the same date, the patient was vaccinated with PROQUAD (Merck) (lot number, expiry date, dose and route). Concomitant therapies were not provided. No adverse event was reported. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (which had the lot number of L040419, expiration date 14-OCT-2017) (dose, strength and anatomical site of vaccination were not reported). Information regarding concomitant medications were not reported. Therefore, no adverse effect was reported. Additionally it was also mentioned that the vaccines experienced a temperature of -4.1C, in a time frame of 13 hours, 15 minutes, there was not previous temperature excursion, and call was because of a "data logger". There was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring that doses of ZOSTAVAX were improperly stored. Additionally it was also mentioned that the vaccines experienced temperature of -4.1C, in a time frame of 13 hours, 15 minutes, there was not previous temperature excursion, and call was because of a "data logger". There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L041626, expiration date: 20-APR-2017, dose was unknown) which was improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with VARIVAX (lot # L042266 with expiration date: 27-OCT-2017, lot# L043624 with expiration date: 03-NOV-2017; lot# L049534 with expiration date: 08-DEC-2017, dose was unknown) which were improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via field representative refers to 2 female patients of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with GARDISIL (dosing details, strength, lot # and expiry were not reported). Fifteen minutes post vaccination, the patients fainted as they were about to leave the physician's office. The patients sought medical attention as they were in the doctor's office. The outcome of syncope was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.