chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Abdominal pain, Death, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Initial unsolicited report received from a physician on 27 April 2016. This case involves a four-year-old female patient who was vaccinated with a dose of DAPTACEL (batch number C4709AA, expiration date: 24 February 2017, via intramuscular route, dose, dose in series and site of administration was not reported) and a dose of IPOL (batch number L1001-1, expiry date: 14 January 2017, via intramuscular route, dose, dose in series and site of administration was not reported), both on 18 March 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not provided. On an unspecified date following the vaccination, the patient developed abdominal pain and returned to the physician's office on 23 March 2016 who requested that the child be taken immediately to the emergency room. It was reported that there was no information on what medical facility the patient was taken to or whether the patient was actually taken. On 24 March 2016, six days following vaccination, the patient died. Lab data and corrective treatment were not reported. Patient had not recovered from abdominal pain event at the time of death. It was reported that autopsy was pending. List of documents held by sender: none. Sender's Comments: This is a poorly documented death case of a child who was vaccinated with diphtheria-15/tetanus/5 AC pertussis vaccine and IPV (VERO). Five days after vaccination, patient experienced abdominal pain and died the next day. Patient was taken for physician consultation on having abdominal pain, however was referred to emergency room and no further details were provided. No information regarding any previous history of abdominal pain, relevant medical and birth history, underlying cause of death and any diagnostic testing reports were provided. Autopsy result was not available. Due to the very limited available information, causality cannot be assessed for now. Reported Cause(s) of Death: abdominal pain; death nos.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Upper respiratory tract infection
Clinical narrative: Initial unsolicited report received from a physician on 27 April 2016. This case involves a four-year-old female patient who was vaccinated with a dose of DAPTACEL (batch number C4709AA, expiration date: 24 February 2017, via intramuscular route, dose, dose in series and site of administration was not reported) and a dose of IPOL (batch number L1001-1, expiry date: 14 January 2017, via intramuscular route, dose, dose in series and site of administration was not reported), both on 18 March 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not provided. On an unspecified date following the vaccination, the patient developed abdominal pain and returned to the physician's office on 23 March 2016 who requested that the child be taken immediately to the emergency room. It was reported that there was no information on what medical facility the patient was taken to or whether the patient was actually taken. On 24 March 2016, six days following vaccination, the patient died. Lab data and corrective treatment were not reported. Patient had not recovered from abdominal pain event at the time of death. It was reported that autopsy was pending. List of documents held by sender: none. Sender's Comments: This is a poorly documented death case of a child who was vaccinated with diphtheria-15/tetanus/5 AC pertussis vaccine and IPV (VERO). Five days after vaccination, patient experienced abdominal pain and died the next day. Patient was taken for physician consultation on having abdominal pain, however was referred to emergency room and no further details were provided. No information regarding any previous history of abdominal pain, relevant medical and birth history, underlying cause of death and any diagnostic testing reports were provided. Autopsy result was not available. Due to the very limited available information, causality cannot be assessed for now. Reported Cause(s) of Death: abdominal pain; death nos.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema, Pruritus, Skin exfoliation, Skin lesion
Clinical narrative: Escalary erythema, edema, itchy, 11 cm X 8 cm skin lesion
Age: 0.36
Sex: F
Vaccine: DTAP
Symptoms: Crying, Diet refusal, Emotional distress, Flatulence, Insomnia
Clinical narrative: Fever, fussy, inconsoleable, crying, drawing up legs, gassy, refusing to eat, refusing to sleep. Infant TYLENOL did not alleviate symptoms. Symptoms persisted throughout the day.
Age: 0.36
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever, fussy, inconsoleable, crying, drawing up legs, gassy, refusing to eat, refusing to sleep. Infant TYLENOL did not alleviate symptoms. Symptoms persisted throughout the day.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Arthralgia, Myalgia, Pruritus, Rash generalised
Clinical narrative: Rash from head to toe, itching, severe muscle aches, unable to walk due to muscle aches in calf's which then went into back of thigh, joint pain.
Age: 0.01
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever of 102.5 x2 days and counting.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Escalating erythema, edema itchy 15.5 cm x 9.5 cm (R) anterior thigh.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome.
Age: 48.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Angioedema, Lip swelling, Pruritus, Throat irritation
Clinical narrative: 48 yo patient received PNEUMOVAX 0.5 ml IM in left Deltoid.  Manufacturer: Merck, Lot # L019835, Exp: 23/MAR/2017 and TDAP vaccine 0.5 cc IM given in the Rt Deltoid, Lot No.: ED2EN, Exp.: Dec 3, 2017, Manufacturer by: GlaxoSmithKline Biologicals. Approximately five days after receiving the vaccines the patient developed angioedema. Symptoms included swelling of the lips, body itching and bogginess of the throat. MEDROL DOSE PAK and ATARAX were given with improvement.
Age: 1.66
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site nodule, Injection site rash, Injection site warmth, Rash
Clinical narrative: Mom states, child had a knot in injection site day after injection. Next day, rash started. Red rash around injection with warmth to skin. Not tender. Measures 15 cm by 10 cm around right thigh. Warm to touch. No blistering noted.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Client was unaware of pregnancy at time of vaccination. Client was ~7 weeks gestation according to EDD.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 75 yo patient developed itching following Pneumococcal PCV 13 (PREVNAR 13) 0.5ml IM in Right Deltoid. Manufacturer: Wyeth Lot # M13067 Exp: 04/2017. The site was swollen with redness and warm to the touch.
Age: 33.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: No adverse event
Clinical narrative: This is only to inform you that the correct vaccine was administered HAVRIX 1440 1ml (Adult dose); but on the vaccine record HAVRIX 720 was listed. Vaccine was administered correctly. There was no effect.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Blood alkaline phosphatase normal, Bone densitometry, Bone scan, C-reactive protein normal
Clinical narrative: Patient received the PREVNAR 13 vaccine and 24 hours later developed severe musculoskeletal pain throughout his lower chest/rib area as well as abdominal pain. Various lab and radiographic testing done during the past 5 months, have turned up no cause for his pain. We wonder if the PREVNAR 13 vaccine might have something to do with causing our patient's symptoms.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray normal, Full blood count normal, Musculoskeletal chest pain, Red blood cell sedimentation rate normal, Spinal X-ray normal
Clinical narrative: Patient received the PREVNAR 13 vaccine and 24 hours later developed severe musculoskeletal pain throughout his lower chest/rib area as well as abdominal pain. Various lab and radiographic testing done during the past 5 months, have turned up no cause for his pain. We wonder if the PREVNAR 13 vaccine might have something to do with causing our patient's symptoms.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Bicep was swelled, red, hot and itched. Went to walk-in clinic and received prednisone-10 mg and ranitidine-150 mg.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Ear swelling, Erythema, Swelling face
Clinical narrative: Patient woke up at night with swollen ears, red cheeks, swelling face -> ER (night of immunization). In the ER, she was treated with steroids, BENADRYL and EPIPEN for allergy.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Periarthritis, X-ray
Clinical narrative: More pain than expected from tetanus vaccine.  Pain did not resolve for many weeks.  After a couple of months, I started to have pain beyond the injection area with some shoulder motions.  In February, 2016, PCP recommended PT which did not help.  In May, 2016, an orthopedist made the diagnosis of adhesive capsulitis of the left shoulder.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Itching, redness, swelling, hives at sight of administration.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Adverse reaction, Erythema, Urticaria
Clinical narrative: Fifteen minutes after vaccine administration, parent stated patient was having a reaction.  One hive noted on patient's left cheek and erythematous patches observed on patient's face, neck, chest, and abdomen.  No difficulty breathing noted.  Hive on left cheek resolved within 5 minutes.  Provider ordered diphenhydramine 4 ml every 6 hours by mouth as needed for hives if they return and parent was advised to call 911 or go to the ER for any reaction beyond a few hives to include difficulty breathing, etc.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: Patient received vaccine, less than 24 hours the injection site red silver dollar size, painful right deltoid. At 48 hr inj site larger red area and more painful. Patient was then put on antibiotic for infection. Resolving.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Localized rash, itchy pain - treated with BENADRYL and clindamycin - resolved after 4 days.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Rash macular, Tenderness
Clinical narrative: Blotchy redness (not single red spot) tender, on arm that got TRUMENBA. Have photo if needed.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L026741 exp date 18-MAY-2017, L022446 exp date 14-FEB-2017; L026740 exp date 16-APR-2017 and lot # L027726 exp date 10-MAY-2017)(dose not reported) orally. No adverse effects were reported. This is one of several reports  received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (unspecified lot/expiration date) . No information was provided regarding patient's concomitant medications. The reporter stated that the patient contacted the pharmacy on an unspecified  date and reported that they had "developed an unspecified rash on the left trunk as well as the arm the ZOSTAVAX was given in" the reporter did not know which arm the patient received the ZOSTAVAX in. The pharmacist reported that no treatment was provided at that time for the rash and the pharmacist advised the patient to follow up with their physician. The patient sought medical attention by contacting the pharmacy. The reporter stated that it is not determined if the patient has contacted their physician yet. The outcome of the event was not reported. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L048237, expiration date reported a 08-MAY-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 32.7 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Employee has had a sore, stiff left arm and neck since administration of the Influenza vaccine since November 5, 2015.
Age: 36.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Urticaria
Clinical narrative: Sudden stinging, burning, itching, red hives/small bump cluster flare up inner thighs. Time course around 4/17/16 to around 4/28/16. Treatment cold compress, Caladryl clear lotion, diaper rash ointment, A&D ointment, and Claritin D.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via a company representative, referring to an unspecified number of patients of unknown ages and genders. The medical history or concurrent conditions of the patients were not reported. Between 21-APR-2016 and 22-APR-2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route, anatomical sites, lot numbers and expiration dates were not provided. The concomitant medication of the patients was not reported. Additionally, it was reported that the shipment of ZOSTAVAX was inadvertently stored in refrigerator. No adverse effect had been reported and there was not product quality complaint involved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, Injection site pain, Pain
Clinical narrative: Initial unsolicited misuse report received from a Physician on 26 April 2016 and additional information received on 26 April 2016. This case involves a 53-years-old female patient who was vaccinated with an intramuscular dose of ADACEL (batch number UI543AC, expiration date, dose was not reported) in right deltoid on 21 April 2016. Patient had no illness at time of vaccination but had a fall and lacerations. Pre-existing physician diagnosed medical conditions was reported as  congenital heart disease. Pre existing allergies and birth defects were not reported. Concomitant medications were not reported. On an unspecified date post vaccination, the patient experienced pain at injection site. Patient had body aches, which could be a result of her fall per the physician. Patient had previously received a dose of ADACEL 7 months prior (date not specified). It was an extra dose administered case. Lab data and corrective treatments were not reported. The patient had not recovered from events. List of documents held by sender: none.
Age: 76.0
Sex: M
Vaccine: TD
Symptoms: Electromyogram, Injection site pain, Muscle atrophy, Muscular weakness
Clinical narrative: Pain in (L) shoulder. Gradual weakness (L) shoulder. Almost total atrophy of (L) supraspinatus and (L) infraspinatus muscles.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Rt arm swollen, red, itchy.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 3 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were vaccinated with improperly stored (temperature 47.5 Fahrenheit degrees (F), for 16 minutes) doses of ROTATEQ (lot #L035511, expiration date 21-MAY-2017, orally, dose was not provided). No adverse symptoms were reported. There was no previous temperature excursion. The call was made because of data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a social media user, as part of a marketing research program and refers to a male patient of unknown age. There was no information about the patient's concomitant therapies or medical histories provided. The patient's concurrent condition included puberty. On an unknown date, the patient was vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced adverse event (reported as "He might have had no reference for the things that were happening to his body as he came into puberty, or why things just did not work anymore"). The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L019286 exp date 14-SEP-2017, lot # L027282 exp date 21-SEP-2017 and lot # L028082 exp date 18-SEP-2017 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: 4 hrs after injection began to notice redness and tenderness at injection site. 4/21/16 at 8:00 PM went to acute care with same complaints, noted to have diffuse swelling and redness to elbow and into left axilla, sent to ER for treatment, treated with IV fluids BENADRYL, prednisone and TORADOL with immediate improvement.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anal incontinence, Chills, Erythema, Injected limb mobility decreased, Injection site erythema
Clinical narrative: 4 hrs after injection began to notice redness and tenderness at injection site. 4/21/16 at 8:00 PM went to acute care with same complaints, noted to have diffuse swelling and redness to elbow and into left axilla, sent to ER for treatment, treated with IV fluids BENADRYL, prednisone and TORADOL with immediate improvement.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: 4 hrs after injection began to notice redness and tenderness at injection site. 4/21/16 at 8:00 PM went to acute care with same complaints, noted to have diffuse swelling and redness to elbow and into left axilla, sent to ER for treatment, treated with IV fluids BENADRYL, prednisone and TORADOL with immediate improvement.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Urinary incontinence, White blood cell count increased
Clinical narrative: 4 hrs after injection began to notice redness and tenderness at injection site. 4/21/16 at 8:00 PM went to acute care with same complaints, noted to have diffuse swelling and redness to elbow and into left axilla, sent to ER for treatment, treated with IV fluids BENADRYL, prednisone and TORADOL with immediate improvement.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Approximately 24 hours following the injection she experienced tingling in her bilateral fingers that progressed past her PIP joints she also developed the same type of tingling in her bilateral toes. There was no muscle weakness or loss of fine motor control.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Pt described significant ankle edema with onset 4 days after receiving shot, duration of approximately 3 days.  While pt said she had experienced mild ankle edema in the past, she says she had never experienced ankle edema of such magnitude. Pt was concerned it might have been related to the vaccination.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm Swelling from pneumonia shot went to Hospital was given Solu Medrol and Benadryl for reaction and they may have already reported this event to you but want to be sure.
Age: 1.34
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting/Diarrhea
Sex: M
Vaccine: HPV4
Symptoms: Erectile dysfunction
Clinical narrative: This spontaneous report was received from a social media user, as part of a marketing research program and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced inability to gain and erection within weeks of the GARDASIL. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis infected, Injection site infection
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, route, lot# and expiration date were not reported). Concomitant drug was not reported. On an unknown date the patient experienced a localized infection at the injection site or an infection rash going up through the arm. The patient sought medical attention with the pharmacist, who then referred her to an unspecified physician. The physicians prescribed unspecified antibiotic therapies. On an unknown date, the patient was recovered after the antibiotic therapies were complete. The causality was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. The concurrent condition and medical history was not reported. The patient was allergic to codeine, sulfa drugs and VIOXX. She had no other pertinent medical histories. On 21-APR-2016, the patient was vaccinated with 1 dose of ZOSTAVAX on the back of her left arm in her tricep (incorrect route of drug administration) (dose and lot details unavailable). The concomitant medication was not reported. On the same day evening she developed itching, burning and redness around the injection site. Patient stated the area around the injection site felt "feverish" and looked very red and was hard to the touch and the reaction was approximately "the size of a golf ball". Patient also mentioned that the shot was "very painful". She also developed a "discolored location" on her arm around the injection site which still has persisted to the date of report. She applied BENADRYL cream a couple of times on her arm to try to relieve the itching she was experiencing. No lab testes were done. She saw her pharmacist on 03-MAY-2015 (about 30 minutes ago on the day of reporting) to let them know about her adverse reaction to the vaccine. The outcome of injection site discolouration was reported as not recovered. The outcome of all other events were resolving. The causality was not specified. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. The concurrent condition and medical history was not reported. The patient was allergic to codeine, sulfa drugs and VIOXX. She had no other pertinent medical histories. On 21-APR-2016, the patient was vaccinated with 1 dose of ZOSTAVAX on the back of her left arm in her tricep (incorrect route of drug administration) (dose and lot details unavailable). The concomitant medication was not reported. On the same day evening she developed itching, burning and redness around the injection site. Patient stated the area around the injection site felt "feverish" and looked very red and was hard to the touch and the reaction was approximately "the size of a golf ball". Patient also mentioned that the shot was "very painful". She also developed a "discolored location" on her arm around the injection site which still has persisted to the date of report. She applied BENADRYL cream a couple of times on her arm to try to relieve the itching she was experiencing. No lab testes were done. She saw her pharmacist on 03-MAY-2015 (about 30 minutes ago on the day of reporting) to let them know about her adverse reaction to the vaccine. The outcome of injection site discolouration was reported as not recovered. The outcome of all other events were resolving. The causality was not specified. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot # reported as L046293, expiration date reported as 17-FEB-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 8.8 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of  unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot #L024132 exp date 21-JAN-2017 and lot # L035686 exp date 16-FEB-2017) (dose and route not reported). NO adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L018351, expiry date 11-AUG-2017 and lot # L020015, expiry date 16-AUG-2017 (route and site of administration were not reported). The vaccines were exposed to temperature of 33.8 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # reported as L033589 exp date 02-SEP-2017) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician, concerns to a 15 year old female patient enrolled in a market research. The patient  did not have concurrent conditions, medical history, drug reactions or allergies. On an unknown date in 2015, after being vaccinated with the 3rd dose of GARDASIL (strength, dose number, anatomical location, lot #, expiry date, and route of administration were not provided), the patient fainted (10 minutes after vaccination), however, she did not lose consciousness. It was reported that the patient did not faint with prior vaccination of GARDASIL. The patient did not take any concomitant medication. No laboratories were performed. There was no product quality complaint involved. The outcome of the event was reported as recovered and resolved with sequelae. The relatedness between vaccination with GARDASIL 9 and syncope was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 22-APR-2016, the patient was vaccinated with a improperly stored dose of VAQTA (which had the lot number reported as L033316, with expiration date of 26-MAY-2016) (strength, dose and anatomical site were not reported). The patient's concomitant medication was not provided. Additionally, no adverse effects were reported. The vaccine experienced temperature of 50F, time frame 2 hours and 30 minutes, there had been no previous temperature excursions. Furthermore, no product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Genital disorder male
Clinical narrative: This spontaneous report was received from a social media user, as part of a marketing research program and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patient was vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). It was reported, that the patient told his parents, that "something was wrong down there" (date and details were unspecified). The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. 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: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L032391, expiration date reported as 26-AUG-2017, lot # L046884, expiration date reported as 23-NOV-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 8.8 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports 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 has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 27-APR-2016, the patient was inadvertently vaccinated with an improperly stored dose of VAQTA (lot # L023936 with an expiration date of 15-MAR-2017), (strength, dose and route of administration were not provided). The vaccine was exposed to -2.2 C of temperature with a time frame of 1 hour. There was no concomitant therapy reported. No adverse effects were reported. Additional information is not expected since there was no consent to follow up.
Sex: M
Vaccine: HPV4
Symptoms: Male sexual dysfunction, Physical disability
Clinical narrative: This spontaneous report was received from a social media user, as part of a marketing research program and refers to an unspecified number of male patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients (reported as "boys") were presenting new physical and physiological problems (details were unspecified). Some of these males could not perform sexually and they were hesitant to discuss their problems with parents. The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. This is one of several reports received 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 as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L037790 exp. 30-DEC-2016 or lot # L032397 exp. 26-NOV-2016 (dose, site and route of administration were unknown). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of max 10.2 degrees Celsius for 10 hours 45 minutes on an unspecified date. No product quality issue was involved. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Eyelid oedema, Rash, Tenderness
Clinical narrative: Rash, red cheeks, puffy eyelids, red patch on right knee.  Tender thenar eminences.
Sex: M
Vaccine: HPV4
Symptoms: Physical disability
Clinical narrative: This spontaneous report was received from an unspecified reporter, as part of a marketing research program and refers to an unspecified number of male patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients (reported as "boys") were presenting new physical and physiological problems (details were unspecified). The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered a unspecified number of improperly stored doses of LIQUID PEDVAXHIB (lot # L038502, expiration date 16-AUG-2018; lot # L042257, expiration date 17-AUG-2018; lot # reported as L051122, expiration date 12-OCT-2018) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 32F for 2 hours and 8 minutes. NO previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 11 year old male patient. None concomitant medication, pertinent medical history or drug allergies or reactions were reported. On 18-APR-2016, the patient was vaccinated with GARDASIL 9 (0.5 ml, once, lot # L043213, intramuscularly). Other suspect therapies included MENACTRA and BOOSTRIX (both administered on 18-APR-2016, dose and route were not reported). The physician reported that on 18-APR-2016 (after the patient was administered these vaccines), he experienced a "syncopal episode". The patient was sitting on the examination table and went down to the side. The physician reported that the patient was down for a little while and then woke back up. The physician kept the patient in the office for a half hour and gave him juice and candy as treatment for the syncopal episode as the patient had skipped breakfast and lunch. Lab diagnostic studies were not performed. The outcome of syncopal episode was reported as recovered on 18-APR-2016. Causality assessment was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Erectile dysfunction, Urinary incontinence
Clinical narrative: This spontaneous report was received from a social media user, as part of a marketing research program and refers to a male patient of unknown age (reported as "older teen"). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). It was reported, that the patient lost his girlfriend because he could no longer achieve an erection or hold his bladder (onset dates and details were unspecified). The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEP, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 year old patient. The patient's pertinent medical history and concurrent conditions were not provided. On 21-APR-2016, the patient was vaccinated with a dose of PROQUAD (route, lot number and expiration date were not provided). Concomitant therapies included a pediatric dose of ENGERIX-B also administered on the same date. On 21-APR-2016, there was an inappropriate schedule of drug administration as the patient who was 19 years of age was inadvertently administered PROQUAD. There was no adverse event. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M001151, expiration date reported as 05-JUL-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 8.8 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # K024700, expiry date 30-JUL-2016 (route and site of administration were not reported). No adverse effects were reported. The vaccines were exposed to 33.8 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion noted. The call was placed because of data logger. This is one of two reports received from the same source. 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 Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On  unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # reported as L045955 exp. 17-NOV-2017 or lot # L044525 exp. 09-NOV-2017 (dose, site and route of administration were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of max 10.2 degrees Celsius for 10 hours 45 minutes on an unspecified date. No product quality issue was involved. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were vaccinated with improperly stored (temperature 47.5 Fahrenheit degrees (F), for 16 minutes) doses of GARDASIL 9 (lot # L019297, expiration date 18-AUG-2017, dose and route of administration were not reported). No adverse symptoms were reported. There was no previous temperature excursion. The call was made because of data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 65 year old female patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date reported as "couple years ago", the patient was vaccinated with 0.65 ml one time shot ZOSTAVAX (route and site of administration, lot# and expiry date were not reported) for prevention of shingles. On an unknown date in approximately May 2016, reported as "within the last week", the patient experienced shingles. The patient's symptoms consisted of "pain and a rash" which resulted in the patient going to the Emergency Room for an unspecified duration. The outcome of the event was reported as recovering/resolving. On 05-MAY-2016, the patient did see the physician for a follow-up visit. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II, lot # reported as L039612, expiration date reported as 07-OCT-2017, lot # L007216, expiration date reported as 03-MAR-2017, lot # reported as L023386, expiration date reported as 25-JUN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 8.8 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a social media user, as part of a marketing research program and refers to an unspecified number of female patients of unknown age. There was no information about the patients concurrent conditions, concomitant therapies or medial histories provided. On unknown dates, the patients were vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported. It was reported that, the patients (reported as "girls") had suffered adverse effects from GARDASIL for years (onset dates and details were unspecified). The outcome of adverse effects was unknown. The reporter considered adverse event to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-MAY-2016, the patient was inadvertently vaccinated with expired PROQUAD lot # K020756, expiry date 30-APR-2016 (route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning unspecified number of patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 20-APR-2016 the patients received improperly stored doses of ROTATEQ (dosage not provided, lot # L035510 with expire date of 13-MAY-2017). The temperature of storage excursed to was 32.5F for 7 hours and 38 minutes. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.