chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old female patient who received KINRIX (batch number NS74P, expiry date 20th March 2017). Previously administered products included MMR II. Concurrent medical conditions included nausea. Concomitant products included Hepatitis B. On 8th June 2015, the patient received KINRIX. On 8th June 2015, less than a day after receiving KINRIX, the patient experienced contraindication to vaccination. On 9th June 2015, the patient experienced injection site swelling and injection site erythema. On 10th June 2015, the patient experienced extensive swelling of vaccinated limb, large arm swelling and blister. The patient was treated with dermatologists nos (Topical agent). On an unknown date, the outcome of the extensive swelling of vaccinated limb, large arm swelling, injection site swelling, injection site erythema and blister were not recovered/not resolved and the outcome of the contraindication to vaccination was unknown. The reporter considered the extensive swelling of vaccinated limb, large arm swelling, injection site swelling, injection site erythema and blister to be almost certainly related to KINRIX. Additional information received: Patient received KINRIX for her 5th DTaP series and her 3rd IPV series. There was no puff from the needle point so no sign of an infection. The big clear blisters were about an inch in size located less than 1/2-inch below the injection site. Her arm (entire bicep down to the elbow) was really big and swollen. The patient was prescribed AUGMENTIN but she has currently only been treated with topicals. If the patient is not better by tomorrow then AUGMENTIN will be started.
Age: 17.0
Sex: F
Vaccine: HIBV
Symptoms: Aphasia, No adverse event, Wrong drug administered
Clinical narrative: No adverse events, this is to report a medication error. Patient was to receive MENACTRA vaccine and was given PEDVAXHIB in error. No adverse reaction required.
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: This case was reported by a consumer via cell center representative and described the occurrence of throat swelling in a adult female patient who received FLUARIX QUADRIVALENT. Previously administered products included flu vaccine (patient has a history of reactions to flu vaccines (unknown manufacturer) from the last three years). Concurrent medical conditions included multiple allergies (Patient does have allergies and takes CLARITIN for it). On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced throat swelling and hives. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the throat swelling and hives were recovered/resolved. It was unknown if the reporter considered the throat swelling and hives to be related to FLUARIX QUADRIVALENT. Additional information received: Within an hour of injection, patient experienced: throat, arm and chest hives. Patient had no other issues with any other vaccines.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Agitation, Pyrexia, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: Diffuse pruritic rash; fever, agitation (rash: papular, round, 4-6 mm in diameter, some with vesicular centers)-ongoing. Prednisone 15mg/5ml, 3cc po x 5d.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site vesicles
Clinical narrative: Given Tdap (L) deltoid on 6/16/15. Revisit 6/17/15-blister (bleb) noted at injection site-0.8 x 0.2 cm. No itching/burning/pain/redness.
Sex: M
Vaccine: HEP
Symptoms: Abdominal discomfort, Abdominal distension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal bloating in a adult male patient who received ENGERIX B adult. On an unknown date, the patient received ENGERIX B adult at an unknown dose. On an unknown date, unknown after receiving ENGERIX B adult, the patient experienced abdominal bloating and stomach discomfort. On an unknown date, the outcome of the abdominal bloating and stomach discomfort were unknown. It was unknown if the reporter considered the abdominal bloating and stomach discomfort to be related to ENGERIX B adult. Additional information received: Patient reported the above-noted potential side effects after being administered ENGERIX-B. He refused to provide his initials or any further information related to this complaint. No further details were available at the time of this report.
Age: 0.26
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness/discomfort around injection site on left thigh.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site discomfort, Joint range of motion decreased, Pain in extremity
Clinical narrative: Severe arm pain radiating to his hand with extension contraction of his wrist-unable to passively or actively straighten or move the wrist. Approximately 20 min before resolution and then experienced mild discomfort in the muscle at area of injection.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3" red area and swelling around site of injection-sxs lasted 3 days.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth, Pain
Clinical narrative: Pt rcv'd Tdap on 6/15/15, that night she woke and arm had a knot at injec site. The next morning area red, warm and painful to touch, hurts to move arm up and down.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Skin discolouration, Skin swelling, Vaccination site swelling
Clinical narrative: Given PCV-13 6/16/15 early afternoon. Awoke with swollen red area at vaccine site and swollen initially bluish discoloration of skin over left lymph gland. -> skin became reddened and swollen w/in 24 hours over lymph gland. Also has yeast diaper rash. Cephalexin (antibiotic) and yeast cream rx given.
Age: 0.44
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Irritability, Pyrexia, Urticaria
Clinical narrative: Pt given Hib vaccine in left leg developed 2 cm area of erythema and hives immediately. Watched in clinic without progression 14 min at home developed fever irritability, total body hives resolved after 48 2 doses BENADRYL.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Adenoidal hypertrophy, Computerised tomogram abnormal, Intensive care, Mechanical ventilation, Mononucleosis heterophile test positive
Clinical narrative: Pt. was mildly ill with tonsillitis when vaccine given. 2 days later went to urgent care for worsening (throat swelling). 2 days later went to hospital ED for throat swelling and transported to another hospital. In PICU now x 3 days on ventilator. They think severe EBV infection, but unsure.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Pharyngeal oedema, Tonsillar hypertrophy
Clinical narrative: Pt. was mildly ill with tonsillitis when vaccine given. 2 days later went to urgent care for worsening (throat swelling). 2 days later went to hospital ED for throat swelling and transported to another hospital. In PICU now x 3 days on ventilator. They think severe EBV infection, but unsure.
Age: 0.36
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: KINRIX was administered instead of IPV+DTaP. No problem was reported.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Redness at injection site, tender to touch, inflammation.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Erythema of face, legs, edema of feet.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Dull pain at injection site for over 3 months.
Age: 21.0
Sex: M
Vaccine: ANTH, JEV1, MMR
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Pt. complains of nausea vomiting and a headache.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: KINRIX was administered instead of IPV+DTaP. No problem was reported.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: 26 hours later came down with like symptoms temperature with 100 degrees F, headache, fatigue, body ache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site streaking
Clinical narrative: Red Streaking and itchiness at injection site.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Pruritus
Clinical narrative: Experienced facial burning sensation and itchiness on cheeks, chin and neck.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: The primary reporter for this case is the patient. Pt explained that during her vaccination with MMR II vaccine on 10/17/2012 she had a urine pregnancy test that came back negative. On 10/21/2012 she took a second urine pregnancy test that came back positive. No Further AE information was provided. This is an amended report. The gender was entered as female, the pregnancy field was marked as, prospective was checked as report type and unknown was added as pregnancy outcome.
Age: 0.62
Sex: U
Vaccine: HIBV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 7 month old patient (gender unknown) with unknown medical history or concurrent conditions. On 23-FEB-2011, the patient was administered ACTHIB and on 23-FEB-2011 the patient was administered the second dose of ACTHIB. On 01-AUG-2011, the patient was vaccinated with an unspecified HIB vaccine, before 12 months of age, which could have been PEDVAXHIB (vaccine interchange). All vaccines were administered. No adverse effects were reported. The outcome of interchange of vaccine products was unknown. Additional information is not expected since no permission to contact HCP was provided.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pain in extremity
Clinical narrative: 6 hours after receiving, PREVNAR 13 patient had diarrhea that lasted 5 1/2 days. 2 days later patient experienced dry heaves and sores in mouth, headache, stomach pains, sore arm, wheezing, coughing, w/phlegm and chills that lasted 2 days.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Productive cough, Retching, Stomatitis, Wheezing
Clinical narrative: 6 hours after receiving, PREVNAR 13 patient had diarrhea that lasted 5 1/2 days. 2 days later patient experienced dry heaves and sores in mouth, headache, stomach pains, sore arm, wheezing, coughing, w/phlegm and chills that lasted 2 days.
Age: 54.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Dyspnoea, Rash, Swollen tongue
Clinical narrative: Rash on chest and arm, difficult breathing and tongue swollen. Patient used Epipen at the restaurant where she visit on 06/21/2015 PM.
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Vomiting
Clinical narrative: Vomiting multiple times over the next 4 hours followed by sleeping.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently gave Hep B vaccine to a patient who was supposed to receive a Hep A vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to 2 patients of unknown age and gender. Between 09-JUN-2015 and 10-JUN-2015, GARDASIL (lot: K007828; expiration date: 02-MAR-2017 and lot: K008213; expiration date: 17-DEC-2016) was improperly exposed to 20 F for 15 hours. Then, after this on 10-JUN-2015, 2 patients each received a dose of this improperly stored GARDASIL (intramuscularly, dose not reported). It was unspecified which patient received which lot. No known adverse effects. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness 6 1/2 by 5 in. soreness, swollen arm. Patient felt all down arm. Redness below injection site on arm.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Papule, Rash
Clinical narrative: Facial rash papules and erythema to face.
Sex: F
Vaccine: HEP
Symptoms: Seizure
Clinical narrative: Hand convulsions.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: Fatigue, dizziness.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 11 patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On 18-MAY-2015, in the afternoon, 6 of the patients were vaccinated with one of two improperly stored lots of LIQUID PEDVAXHIB lot # K011077, expiration date: 30-MAR-2017 and lot # K025006, expiration date: 22-JUL-2017 intramuscular which were improperly exposed to 19.2 Fahrenheit (F) for 17 minutes in the early morning of the same date. On 28-MAY-2015, in the afternoon, another 5 patients were vaccinated with one of the two improperly stored lots of LIQUID PEDVAXHIB lot # K011077, expiration date: 30-MAR-2017 and lot # K025006, expiration date: 22-JUL-2017 intramuscular which were improperly exposed to 31.5 F for 6 hours and 5 minutes in the early morning of the same date. No known adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 3 patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On 18-MAY-2015, in the afternoon, 2 of the patients were vaccinated with a dose of GARDASIL lot # K007264, expiration date: 02-MAR-2017 (route and dose were not provided) which was improperly exposed to 19.2 Fahrenheit (F) for 17 minutes in the early morning of the same date. On 28-MAY-2015, in the afternoon, another patient was vaccinated with a dose of GARDASIL lot # K007264, expiration date: 02-MAR-2017 (route and dose were not provided) which was improperly exposed to 31.5  F for 6 hours and 5 minutes in the early morning of the same date. No known adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: Pt has a red blistery rash on her (L) arm where her vaccine. It measures 8cm x 10cm. It is painful. Pt Rxd prednisone 10mg.
Age: 1.03
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Blood culture negative, Full blood count normal, Metabolic function test normal, Pyrexia
Clinical narrative: Pt. received PROQUAD and Hep A vaccine on 6/12/15. Parents report fever to 104 that started on 6/14/15. Saw Dr. on 6/15/15. Exam by MD and labs drawn. 6/18/15 Fever subsided and no more symptoms.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Throat irritation, Urticaria
Clinical narrative: Whelps all over entire body-spreading throat itchy and difficult to breathe - responded to BENADRYL given 6/21/15 by parent.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pain, Pyrexia, Swelling
Clinical narrative: Post injection local pain, swelling, headache, fever.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient with drug hypersensitivity to penicillin. There was no pertinent medical history for the patient. On 30-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (lot number reported as: L003215 and expiration date: 30-APR-2016). No concomitant therapies were reported. Following vaccination the patient developed a blister at the injection site (injection site vesicles), which bursts open the next day on 31-MAY-2015. The patient contacted his pharmacist in regards to the event, however no treatment was given. The outcome of injection site vesicles was unknown at the time of this report. The reporter did not provide a causality assessment for the event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refer to an unspecified number of patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored of ZOSTAVAX, (dose, route of administration, injection site, lot number and expiration date were not reported). 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: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding an unspecified 15 year old patient. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in June 2015 (reported as about a week ago), the patient was inadvertently administered with a dose of PROQUAD (Merck) (dose/frequency, therapy route, lot #/ expiry date unspecified) (inappropriate schedule of drug administration). Concomitant medications were not reported. No adverse effect was reported. Additional information has ben requested.
Sex: M
Vaccine: PPV
Symptoms: Cerebrovascular accident, Death
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program, and refers to his/her father of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporter stated that the patient died 3 months (also reported as 6 months) after being vaccinated from a stroke (cerebrovascular accident), for which the patient was hospitalized (dates not reported). The outcome of the cerebrovascular accident was reported as fatal. The cause of death was reported as cerebrovascular accident and it was unknown if an autopsy was performed. The relatedness between the cerebrovascular accident the Pneumococcal vaccine (manufacturer unknown) was not reported. Additional information is not expected, since the reporter did not want the company to contact the physician to discuss further.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer on behalf on his unknown age wife who is the patient. The patient's medical history or concurrent conditions were not reported. On 18-JUN-2015, the patient was vaccinated with the first dose of an expired PNEUMOVAX 23 lot # K009809, expiration date 16-MAY-2015. The dose and route were not reported. No other suspect or concomitant medications were provided. No adverse events were reported. At the time of reporting the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Allergy test, Full blood count, Rash, Swelling face
Clinical narrative: This spontaneous report was received from a medical assistance referring to a 9 year old male patient. Concurrent condition was reported as Attention Deficit Hyperactivity disorder (ADHD). Drug reactions and allergies were reported as none. On 09-APR-2015, the patient received the first dose of GARDASIL (dosage unknown; intramuscular, lot no. K007828, Exp 02-MAR-2017). On 09-JUN-2015, the patient was vaccinated with the second dose of GARDASIL (lot # K007828:exp date 02-MAR-2017), intramuscularly (dosage, anatomical location and concentration were not reported). Concomitant medication reported as METADATE. On 09-JUN-2015, the patient experienced unspecified facial swelling and unspecified facial rash. The mother of the patient then gave her son BENADRYL on the same date. On 11-JUN-2015, the patient was seen in the physicians office and prescribed Hydrocortisone (formulation and manufacturer unknown). On 16-JUN-2015, the patient was prescribed an epinephrine pen and ordered to receive unspecified allergy test and a complete blood count. Results were not available yet. At the time of the report the outcome of facial swelling and unspecified facial rash was unknown. Upon internal review the events were considered to be medically significant. 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 Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX Lot# K008823, expiration date 19-JUN-2016; Lot# K011800, expiration date 21-AUG-2016; Lot# K021935, expiration date 10-NOV-2016; Lot# K16129, expiration date 23-SEP-2016 and Lot# L002217, expiration date 21-JAN-2017, (route and anatomical location were not reported). There was no concomitant therapy reported. No adverse effect was reported. This is a linked case with 1506US010763 from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via direct contact, Eye irrigation, Skin burning sensation
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown age female healthcare worker patient with unspecified pertinent medical history, drug reactions or allergies. On 17-JUN-2015, the patient was drawing up a dose of vaccinated with ZOSTAVAX (lot number and expiration were not reported) and some inadvertently splashed in her eye and got on her skin. Her eyes were flushed with water for 15 minutes and were fine but some of her facial skin currently had a burning sensation but no redness. The outcome of burning sensation was reported as not recovered/not resolved. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a 23 year old male patient concerning himself. The patient had no drug reaction/allergies. The patient's medical history included liver transplant on unknown date. On 09-JUN-2015 the patient was vaccinated with (Oka/Merck) VARIVAX injection, subcutaneously for prevention of varicella (dose, strength and lot# were not reported) at a clinic. Concomitant therapy included unspecified immunosuppressive drugs (the patient receiving immunosuppressive drugs was vaccinated with (Oka/Merck) VARIVAX was a drug administration error). On 10-JUN-2015 the patient experienced fever, injection site pain and swelling. The patient had not sought medical attention. No treatment was given for the adverse event. No lab diagnostic studies were performed. It had been three days since he received the vaccine and was still experiencing these adverse reactions. At reporting time the patient did not recovered. Additional information is not expected as there was no patient's contact information.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored of PROQUAD (Merck) Lot# K013867, expiration date 05-MAR-2016; Lot# L004005, expiration date 05-AUG-2016; Lot# L002213, expiration date 21-JUL-2016; (route and anatomical location were not reported). There was no concomitant therapy reported. No adverse effect was reported. This is a linked case with 1505USA014199 from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report was received on 18JUN2015 from a licensed practical nurse who reported unspecified patients may have received improperly stored (Oka/Merck) VARIVAX, exposed to -10C for 20 minutes. No adverse effects were reported. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the unspecified number of patients received improperly stored ROTATEQ (Lot number and dose were not reported) orally. No adverse effects were reported. 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 nursing assistant and refers to 2 patients of unspecified age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with ROTATEQ (dose, lot# and expiration date were not reported; route of administration defaulted to oral) that was stored improperly. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the unspecified number of patients received improperly stored GARDASIL (Lot number, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. 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 was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the unspecified number of patients received improperly stored RECOMBIVAX HB (Lot number, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Breast feeding
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of an unknown age, who was nursing. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. The reporter was calling to inquire about recommendations for the administration of GARDASIL 9 (dose, route of administration, lot# and expiry date were not reported) to a patient, who was nursing. The patient was not in the office at the time of report. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Cough, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: Started to get sick on Saturday 5/30. Had sore throat and not feeling well. By 6/3 went to urgent care where was diagnosed with pneumonia on both lungs. Was prescribed antibiotic (Z pack) but was not strong enough. Also received cough medicine. On 6/12 went back to doctor and received doxycycline (10 days). Finished medicine yesterday. He is doing better with lingering cough. Had severe fatigue when sick. Received pneumonia vaccine on 2013 with no problems.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Started to get sick on Saturday 5/30. Had sore throat and not feeling well. By 6/3 went to urgent care where was diagnosed with pneumonia on both lungs. Was prescribed antibiotic (Z pack) but was not strong enough. Also received cough medicine. On 6/12 went back to doctor and received doxycycline (10 days). Finished medicine yesterday. He is doing better with lingering cough. Had severe fatigue when sick. Received pneumonia vaccine on 2013 with no problems.
Sex: U
Vaccine: HPV2
Symptoms: Muscular weakness, Nervous system disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of muscle weakness in a patient who received CERVARIX. In 2015, the patient received CERVARIX. In 2015, 152 days after receiving CERVARIX, the patient experienced muscle weakness and neurological disorder nos. On an unknown date, the outcome of the muscle weakness and neurological disorder nos were unknown. It was unknown if the reporter considered the muscle weakness and neurological disorder nos to be related to CERVARIX. Additional information provided: Five months after vaccination with CERVARIX, the patient experienced muscle weakness and nerve disorder. At the time of this report she was still in therapy.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Abdominal distension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal bloating in a adult male patient who received HAVRIX. Co-suspect products included ENGERIX B. On 7th June 2015, the patient received HAVRIX (intramuscular) and ENGERIX B. On 7th June 2015, less than a day after receiving HAVRIX and ENGERIX B, the patient experienced abdominal bloating. On an unknown date, the outcome of the abdominal bloating was unknown. It was unknown if the reporter considered the abdominal bloating to be related to HAVRIX and ENGERIX B. Additional information received: Patient received HAVRIX on 07 June 2015 but unable to confirm specific admin date for ENGERIX B. Implied by patient that ENGERIX B administered on the same day as HAVRIX. For the previous 3 days, stomach bloated was 'on and off', and the bloating is typically worse after eating. After asking Safety question for HAVRIX product, patient then decided that he did not want to answer additional questions on Safety form. Patient denied contact for follow-up.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Lip swelling, Peripheral swelling, Pruritus
Clinical narrative: Had a TWINRIX injection at the pharmacy. I had swelling of the lips, fingers, arms and legs with severe itching. BENADRYL did not help the situation. I had the injection on 6/9/15 at 5 pm and as of today, 6/10/15 at 912pm, I still have the symptoms of swelling in the lips, fingers and itching of the extremities.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about concomitant medications, pertinent medical history and drug allergies was provided. On unknown dates, an unspecified number of patients had been administered improperly stored (since 22-APR-2015) doses of VARIVAX (Merck) (dose, frequency, route of administration not reported), (lot # K002928, expiration date 26-FEB-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Balance disorder, Headache, Injection site erythema, Injection site reaction, Lethargy
Clinical narrative: 6/19 - headache (within hours of shot), by evening there was a big (3") raised red welt on his upper arm at the site of the injection 6/20 - woke up nauseated, changes in equilibrium (he described it as "sea legs"), headache, lethargic (napped for hours), spiked a fever of 104.1 by evening.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: 6/19 - headache (within hours of shot), by evening there was a big (3") raised red welt on his upper arm at the site of the injection 6/20 - woke up nauseated, changes in equilibrium (he described it as "sea legs"), headache, lethargic (napped for hours), spiked a fever of 104.1 by evening.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: Vomiting, headache, fatigue.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt presented with pain in his thigh where he received the Pneumovax vaccine with redness.  Physician concerned about localized reaction to vaccine vs. cellulitis.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR
Symptoms: Bacterial test, Lymphadenopathy, Rash generalised, Rash papular, Rash pustular
Clinical narrative: Generalized papular eruption x 3 wks after MMR, became vesicular and pustular a week after; had bilateral inguinal adenopathy 10 days after vaccination.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash vesicular, Viral test
Clinical narrative: Generalized papular eruption x 3 wks after MMR, became vesicular and pustular a week after; had bilateral inguinal adenopathy 10 days after vaccination.
Age: 1.08
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a one year old patient of unknown gender. On an unknown date in June 2015 (reported as "last week"), the patient was inadvertently vaccinated with a dose of RECOMBIVAX HB (strength was reported as 2.5/0.5 (unit was unknown) and a dose of PEDIARIX simultaneously (dose, lot# and route were unknown for both vaccines) (overdose). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients medical history or concurrent conditions was provided. Since 01-APR-2015 (dates of specific vaccinations not reported), the patients were vaccinated with doses of GARDASIL (strength, dose, frequency, route of administration and injection anatomical location were not reported) (lot # J012212, expiry date 18-FEB-2016; lot # K006124, expiry date 02-FEB-2017; lot # H020901, expiry date 05-JUL-2015; lot # H017698, expiry date 02-JUL-2015) which were exposed to temperature outside of the recommended range since the same day. The reporting nurse was not aware of any adverse effects at the time of this report. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of ROTATEQ, orally (dose, lot#, expiration date were not reported) that were improperly stored. No adverse experience was reported. 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 healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 21-JAN-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-APR-2015 the patient was received was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 25-FEB-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant mediations provided. On 19-JUN-2015, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (route subcutaneous, dose was not reported, lot # reported as L004652, expiration date 11-FEB-2017) that was improperly stored. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On unknown dates, the patients were vaccinated with doses of GARDASIL (doses and routes were not reported) lot # H021608, expiration date 13-AUG-2015 and lot # K006117, expiration date 14-JAN-2017, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of (Oka/Merck) VARIVAX (doses and routes were not reported) lot # J008982, expiration date 19-JUL-2015, and lot # reported as K010442, expiration date 22-JUL-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. 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 as received from a registered nurse refers to a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of VAQTA (doses and routes were not reported) lot # K004856, expiration date 07-DEC-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old female patient. The patient's medical history included pneumonia, eczema and itching of her skin. No known drug allergies. On 04-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K018528, expiry date: 14-APR-2016, 0.5 ml, subcutaneously for her low titer level. Concomitant therapies included fluticasone, hydroxyzine hydrochloride, montelukast sodium (manufacturer unknown), hydrocortisone (manufacturer unknown) and mometasone furoate (manufacturer unknown). On 05-JUN-2015, the patient experienced fever of 104 Fahrenheit and cellulitis and the patient was taken to emergency room. The patient was then treated with cephalexin 4 times daily. The patient sought medical attention. Action taken with the suspect drug was not applicable. The patient was recovering from the events on therapy. Causality was not reported. No product quality complaint reported. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 2-year-old patient of an unknown age and gender. No information about concomitant medication, pertinent medical history and drug reactions or allergies was provided. On 17-JUN-2015, the patient was administered GARDASIL (0.5ml/once, intramuscularly, lot # K006960, expiration date: 19-FEB-2017) outside the prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 2 unspecified patients of unknown age and gender. On an unknown dates the patients were administered improperly stored dose of (Oka/Merck) VARIVAX (strength, lot#, dosage, frequency and route unspecified). No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a  healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-APR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. Medical history and drug allergy were not reported. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot# and expire date were not reported). Concomitant drug was not reported. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from an office manager via a company representative concerning a 25 year old female patient. It was reported that the patient was no pregnant. The patient had no pertinent medical history or drug reactions or allergies. On 11-JUN-2015 the patient was vaccinated with a dose of GARDASIL 9 (Lot # K026247; Expiration date: 29-JUN-2017), intramuscular. There were no concomitant medications. On an unspecified date in June 2015, the patient experienced an injection site reaction with localized hardness after receiving GARDASIL 9. The reporter also stated that this was the third dose of the series but that the patient's first and second dose was just GARDASIL, which was other than indicated in the prescribing information. The patient was given BENADRYL as treatment for the adverse events. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by a phone call. Additional information has been requested.