chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness around injection site. Swollen and very painful. From shoulder to elbow. Has spread to entire upper arm all the way around arm. Describes feeling like 1000 yellow jackets stinging constantly. Sought medical attention. Received Bactrim DS.
Age: 66.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient had swelling and redness at site of injection and down his arm.
Age: 17.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Unevaluable event
Clinical narrative: None reported - vaccine just administered.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Decreased appetite, Depression, Feeling cold
Clinical narrative: Headache, sweating, feeling cold, loss of appetite, severe mental depression, weakness, shaky, nightmares.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Nightmare, Tremor
Clinical narrative: Headache, sweating, feeling cold, loss of appetite, severe mental depression, weakness, shaky, nightmares.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Patient has a bruise about 1.5 inches in diameter around injection site.  There is no swelling or itching at the injection site.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash appearing under the right breast/abdominal area.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Scab
Clinical narrative: Patient called today (09/02/2015 @ 9:30am) and reported that she has rash on her stomach and back and the rash or stomach looks like a scab. Called manufacturer and manf. did advise that rash should be on the area of injection.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea
Clinical narrative: Patient reported shivering and nausea about 30 minutes after vaccine.
Age: 85.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Contusion
Clinical narrative: Significant bruise that spread almost entire length of upper arm.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Flu vaccine given on 8/14/15. Patient developed worsening pain over the next 2 weeks. Pain got to the point where patient could hardly move the arm the vaccine was given in. Tried Tylenol, Aleve, and a topical pain reliever with no relief.  Patient went to urgent care and was given prescription for prednisone and advised to take her Flexeril she already had at home. Condition improved but patient is still on the prednisone and Flexeril. Urgent care provider diagnosed patient with rotator cuff tendonitis and said it was due to flu shot.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Sharp pain in top of shoulder. Hard to move arm.. this is 4 days after quad flu vaccine.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth
Clinical narrative: PT DESCRIBED AS "PUCKERY" LIPS (NOT PUFFY); NO TROUBLE BREATHING; CONTACTED HER PCP WHO SAID GIVE 50MG LIQUID BENADRYL PO AND IF NOT ANY BETTER W/N 1 HR GO TO ER; PT CONTACTED AFTER 1HR AND SAID NO MORE OF SAME SENSATION; FELT BETTER.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Bed rest, Chest discomfort, Chills, Dyskinesia, Dyspnoea
Clinical narrative: Sore arm at injection site; chills and sweats; chest tightness and labored breathing; right eye blurry; seizures: irregular body movements and gait; thought disruption; light sensitivity; headaches; nausea.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Injection site pain, Mental impairment
Clinical narrative: Sore arm at injection site; chills and sweats; chest tightness and labored breathing; right eye blurry; seizures: irregular body movements and gait; thought disruption; light sensitivity; headaches; nausea.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Photophobia, Seizure, Vision blurred
Clinical narrative: Sore arm at injection site; chills and sweats; chest tightness and labored breathing; right eye blurry; seizures: irregular body movements and gait; thought disruption; light sensitivity; headaches; nausea.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Chest pain, Drooling, Headache, Pyrexia
Clinical narrative: Started with pacing and repeating a strange phrase and drooling.  Then headache and chest ache.  Followed by fever of 103 degrees.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: CSF test normal, Coordination abnormal, Dizziness, Dysphagia, Fall
Clinical narrative: Malaise,-within 1 day of 1st dose, lightheaded, decreased coordination. Day 3 vaccination (8/25/15)-new onset dysphagia with liquid, headache, and numbness in bilateral lower extremities-> mechanical fall dysphagia resolved within a few days. LE numbness continues.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Hypoaesthesia, Malaise
Clinical narrative: Malaise,-within 1 day of 1st dose, lightheaded, decreased coordination. Day 3 vaccination (8/25/15)-new onset dysphagia with liquid, headache, and numbness in bilateral lower extremities-> mechanical fall dysphagia resolved within a few days. LE numbness continues.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blood culture negative, Culture urine negative, Full blood count normal, Metabolic function test normal, Pyrexia
Clinical narrative: Child develoepd fever >103 was seen in ER and transported to Hospital. Labs were drawn. No antibiotics were given. Observed 30 hrs at Hospital - discharged home.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Laboratory test normal, Rotavirus test negative, Urinary system x-ray normal, Vomiting
Clinical narrative: Approx 8 hours after immunizations given, vomiting 8-10 times. ER: emesis continued despite ZOFRAN - admit. Developed diarrhea. Mom now with similar symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, HEPA, MMRV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year old female patient with no medical history, drug reactions or allergies. On 11-AUG-2015, the patient was vaccinated with doses of PROQUAD (Merck) (lot # L008354, expiration date 11-SEP-2016, dose were not reported) subcutaneously in her lower left thigh and VAQTA (lot# K019560, expiration date 02-JUN-2017, dose were not reported) intramuscularly in her upper left thigh. The patient did not take any concomitant medications. On 12-AUG-2015, the patient developed a "4 to 5-inch diameter" of redness around both injection sites. No treatment was given. There were no lab diagnostics studies performed. The outcome of the event was unknown. The patient visited physician office. The relatedness between the event and PROQUAD (Merck), VAQTA was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US012027, is an initial spontaneous report received from a medical assistant on 22 Jun 2015. This report refers to a 20 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with BEXSERO (batch number: 146101A) intramuscularly at a dose of 0.5 ml on 15 Jun 2015. It was reported that the BEXSERO was administered to the patient following a temperature excursion of 49 degree F for about 4 hours on 10 Jun 2015. No adverse events reported after the maladministration.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: FLUZONE HD PF NDC 49281-0397-88 lot #: UI430AA Exp: 20Mar2016. Swollen & painful left arm after receiving vaccine.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Grip strength decreased
Clinical narrative: Pt got HIGH DOSE flu vaccine NDC: 49281-0397-65 on 8/31, then 9/1 woke up with no grip in hand and wrist pain (on arm where vaccine was administered). Pt advised to seek med attention per Sanofi (manufacturer).
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Grip strength decreased, Injected limb mobility decreased
Clinical narrative: Pt got HIGH DOSE flu vaccine NDC: 49281-0397-65 on 8/31, then 9/1 woke up with no grip in hand and wrist pain (on arm where vaccine was administered). Pt advised to seek med attention per Sanofi (manufacturer).
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Swelling in arm following down vien. About 9 inches. No symptoms. When reported signs have disappeared.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was administered 2 vaccines in the left deltoid on 8/23/15. Patient returned 8/24/15 with feelings of dizziness and swelling in the upper left arm with itching. Patient was given 25mg Diphenhydramine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Nausea, Pain, Sleep disorder, X-ray limb abnormal
Clinical narrative: Hours after shot given, pain began and continues 10 mo. later. Her been seen by orthopedist and 2 internists, had xrays, medication, therapy and 2 cycles of steroids. Nothing helped. All 3 agreed shot given too high in bursa/tendon area and nauseous. This pain, pain is severe at night and I must sleep in "mummy" position. Can hardly use my left arm as movement or event even minor lifting causes additional pain. Tried to get help from pharmacy but they had a rude attorney call me. I just wanted freedom from pain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient noticed significant shoulder pain upon waking 8/19/15. Pain has not disappeared and resulted in a dr. visit 8/31/15.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: Patient described allergic reaction of rash all over her belly.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Feeling hot, Respiratory rate increased
Clinical narrative: < 1 hr after vaccinated: chest pain, rapid breathing, feeling hot.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 24 hours post-vaccination, developed localized swelling advancing erythema, tenderness over deltoid just caudal to inject site - suspect secondary cellulitis given si/sx, but cannot r/o localized vaccination reaction.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Bedridden, Nausea
Clinical narrative: Patient experienced debilitating weakness and nausea. She was bedridden for two full days before recovering.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Woke up next-morning with back pain down to right leg. Throbs, soreness, numbness until morning.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Thirst
Clinical narrative: Numbness in face, lips, dizzy and thirsty.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX (unknown route, injection site and batch number). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during unknown trimester. At the time of reporting, the pregnancy was ongoing. This case was 1 of the 94 cases reported by the same reporter. Follow up information received on 24 August 2015: No further information can be obtained from the reporter, the patient has been lost to follow up.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: None, pt was asked if pregnant told both MA and DO no HPV administered and then pt told provider she was 6 weeks pregnant.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Crying, Drooling, Wheezing
Clinical narrative: About 25-30 minutes after vaccine administration, pt. started coughing, crying, and drooling at the mouth, taken back to exam room. T: 98.2 O2 sats 90%. Received ATROVENT/Albuterol and BENADRYL. O2 sats 94%. Stopped coughing, was talking and walking ok. Monitored for 30 minutes. When in parking lot started coughing/wheezing taken to ED. Received O2 sats 100% dexamethasone.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Hot, swollen rash, size of half dollar at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea starting at 0500 on 09/02/15.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration
Clinical narrative: Induration left arm where HPV vaccine was given.
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a child (under 2 years old) patient of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the child patient was vaccinated with PNEUMOVAX 23 by mistake (dose, route, lot#, expire date not reported). The pharmacist queried whether administration of PREVNAR 13 was safe instead. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 8-year-old female patient who received KINRIX (batch number T325H, expiry date 17th February 2017). On 23rd August 2015, the patient received KINRIX. On 23rd August 2015, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On 25th August 2015, the patient experienced extensive swelling of vaccinated limb and injection site redness. The patient was treated with BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site redness were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the extensive swelling of vaccinated limb and injection site redness to be almost certainly related to KINRIX. Additional details were provided as follows: The patient received KINRIX at the age of 8 years, which led to an inappropriate age at vaccination. On 25th August 2015, 2 days after receiving KINRIX, the patient returned to the office with a 9 x 12 cm red and swollen area over the injection site. The patient was a healthy child and at the time of reporting, she was not on any medication except after the injection site reaction. No other information was reported.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pt developed severe pain at injection site the day the vaccine was administered (8/18/15). Patient visited MD while visiting family and was prescribed methylprednisolone dose pak to treat this pain. Pt contacted pharmacy regarding pain approximately 10 days after vaccination. Pharmacist on duty believed pain she was describing was within normal expected discomfort for this particular vaccine.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient reports right arm and shoulder pain starting about one week after receiving the PREVNAR 13 injection. Symptoms progressed to difficulty in raising arm to comb hair or touch head. Methocarbamol 1500 mg QID, diclofenac 75 mg BID.
Age: 51.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cough, Pain, Pyrexia, Vomiting, Wheezing
Clinical narrative: Subjective fever, body aches, cough, wheezing, vomiting. Started within 24 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist, referring to an approximately 69 year old female patient. Patient was allergic had an anaphylactic reaction to penicillin (on an unspecified date). On 14-APR-2008, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route, lot # and expiration date were not reported). Concomitant therapies included estrogens (unspecified). On an unknown date, the reporter stated that the patient experienced shingles about "4-5 times" since receiving the ZOSTAVAX. The patient saw the physician for medical attention (unspecified date), none lab diagnostics studies were performed, but the patient was treated with acyclovir. The pharmacist reported patient currently had an active case of shingles. At the time of the report, the outcome of shingles was reported as not recovered/not resolved. No product quality complaints were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 7 unspecified patients of unknown ages and genders. Pertinent medical history or concurrent conditions were not provided. On an unspecified dates, the 7 unspecified patients were improperly stored doses of GARDASIL 9 (lot # L011846, expiration date 04-MAR-2017, dose and frequency were not provided). Concomitant medications were not provided. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 28-AUG-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J013453, expiration date 24-JAN-2015 (administration route was not provided). No concomitant therapies were reported, neither was any adverse effect. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tongue ulceration
Clinical narrative: This spontaneous report was received from a 62 year old female patient with history of allergy and drug reaction to sulfa and lidocaine. On 28-AUG-2015, at the pharmacy, the patient was vaccinated with a dose of ZOSTAVAX (lot # L011537, expiration date July 2016) (strength, dose number and route were not reported). Concomitant therapies included metformin and DIOVAN. The patient reported that on 29-AUG-2015, she had a rash beyond her elbow to her shoulders and then on an unspecified date in 2015 she experienced ulcers on her tongue as well. The patient went to her physician's office, to the pharmacy, as well as an unidentified urgent care clinic for medical attention and she was not hospitalized. No lab diagnostics studies were performed. The patient was treated with BENADRYL and prednisone. The patient stated that she was recovering from rash and tongue ulceration. The reporter did not  assess the relatedness of ZOSTAVAX. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old female patient who had none pertinent medical history or drug reactions or allergies. Concurrent conditions were not reported. On 21-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L008357, expiration date: 11-JUN-2016) (route of administration, dose and frequency were not reported). The patient had none concomitant medications. On 22-AUG-2015, the patient developed redness (injection site erythema) and inflammation (injection site inflammation) at the injection site that was about the size of a softball. It was stated that the patient sought medical attention with the pharmacist and that she was treated with ice for the adverse events, that no laboratory diagnostic studies were performed, that intervention to prevent serious criteria was not necessary, that the patient did not die and that the adverse events were not life threatening and did not cause significant disability or incapacity or hospitalization. At the time of the report, the outcome of injection site inflammation and injection site erythema was reported as recovering. The relatedness of ZOSTAVAX with injection site inflammation and injection site erythema was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old female patient who had none pertinent medical history or drug reactions or allergies. Concurrent conditions were not reported. On 21-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L008357, expiration date: 11-JUN-2016) (route of administration, dose and frequency were not reported). The patient had none concomitant medications. On 22-AUG-2015, the patient developed redness (injection site erythema) and inflammation (injection site inflammation) at the injection site that was about the size of a softball. It was stated that the patient sought medical attention with the pharmacist and that she was treated with ice for the adverse events, that no laboratory diagnostic studies were performed, that intervention to prevent serious criteria was not necessary, that the patient did not die and that the adverse events were not life threatening and did not cause significant disability or incapacity or hospitalization. At the time of the report, the outcome of injection site inflammation and injection site erythema was reported as recovering. The relatedness of ZOSTAVAX with injection site inflammation and injection site erythema was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 31-JUL-2013, the patient was vaccinated with the first dose of GARDASIL intramuscular injection (strength, route, lot # and expiration date not reported). Subsequently, they received the second and third doses of GARDASIL on 27-AUG-2015 (this was considered as an inappropriate schedule of vaccine administered) and on 07-JAN-2015; then, the series was completed. Later, on 24-AUG-2015, the patient received a dose of GARDASIL 9 injection (strength, route, lot # and expiration date not reported), dose reported as "the fourth", (this was also considered as an inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a 4 patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 27-AUG-2015, the patient were vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K016295, expiration date 28-APR-2016) (strength and route of administration were not reported). There was no concomitant medication reported. No adverse effects were reported and no product quality complaint was involved. additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified number of female patients over the age of 26 years. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. No adverse effects reported. Additional information is not expected. No allowed to contact physician.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 13 year old female patient with no relevant drug reactions or allergies and with no pertinent medical history reported. On 14-AUG-2014, the patient was vaccinated with a first dose of GARDASIL (lot#, route and anatomical location was not reported). Other suspect vaccines included a first dose of VAQTA (lot#, route and anatomical location was not reported), administered on the same day. There was no concomitant medication. The registered nurse reported that the patient experienced an injection site rash, following the administration of the vaccines approximately in August 2014. Additionally, it was also mentioned that the patient reported that the rash spread all over her body, on an unspecified date in 2014. The treatment was prescribed by an unspecified physician in the form of BENADRYL, 10 mg, every 6 hours for 24 hours. No laboratory tests were performed. The patient sought medical attention by calling the physician's office. Finally, the registered nurse reported that following the treatment with BENADRYL, the patient's rash and injection site rash had currently resolved (stop date unspecified). The relatedness between the events and suspect vaccines were not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. The nurse stated that the patient received first dose of GARDASIL (lot #, exp. date, dose, frequency and route were not reported) on 18-AUG-2014, and then she received GARDASIL 9, (lot # L011846 exp. date 16-JUN-2017) 0.5 ml intramuscular on 20-AUG-2015. No adverse effects were reported. No product quality complaint was involved. 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 physician refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patient was vaccinated with doses of MMR II Subcutaneous Injection, (lot # L009213, expiration date 17-MAR-2017 and lot # J013431, expiration date 24-OCT-2015 (strength, dose series and route not reported), that were inappropriately stored. No specific dates of vaccination for each lot # were provided and no adverse effects were reported. This patient was also vaccinated on 25-AUG-2015 with a dose of VAQTA that was inappropriately stored (captured in MARRS # 1509USA000495). This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K007973, expiration date 03-JUN-2016) (lot # L003775, expiration date 04-FEB-2017) (dates of vaccination, dose, strength and route of administration were not provided). There was no concomitant medication reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.92
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a medical assistant referring to an approximately 12 month old female patient, who had none pertinent medical history, drug reactions, allergies or concomitant medications. Concurrent conditions were not reported. On an unknown date in June 2002, the patient received the first dose of RECOMBIVAX HB (dose, frequency and route of administration were not reported). Then, on an unknown date in March 2003, the patient was vaccinated with the second dose of RECOMBIVAX H 5/0.5 mcrg/ml (dose and frequency were not reported) intramuscular, also for prophylaxis. It was stated that the patient never received a third dose of the vaccine. The reporter stated that due to school requirements, the patient had titers drawn on 24-AUG-2015, which showed she was negative for immunity to hepatitis B. It was stated that no intervention to prevent serious criteria was necessary, that the patient did not die, that the adverse events were not life threatening and did not cause significant disability or incapacity or hospitalization. At the time of the report, the outcome of hepatitis b antibody negative was unknown. The relatedness of RECOMBIVAX HB with the adverse events was not reported. 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 physician refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 25-AUG-2015, the patient was vaccinated with a dose of VAQTA Intramuscular Injection, batch/lot # reported as L021361, expiration date reported as 30-MAR-2017 (strength, dose series and route not reported), that was inappropriately stored. No adverse effects were reported. It was also reported that the patient was vaccinated on unspecified dates with doses of MMR II that were inappropriately stored (captured in MARRS # 1508USA013125). This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender.  On unspecified dates, the patients were administered an unspecified number of improperly stored doses of GARDASIL (lot # K006124, expiration date: 02-FEB-2017, route, strength and dose were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unspecified dates, the patients were administered an unspecified number of improperly stored doses of Oral ROTATEQ (lot # K016278, expiration date: 21-APR-2016 and lot# K023534, expiration date: 22-MAY-2016, oral, strength and dose were unknown). No adverse experiences 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: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unspecified dates, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (Lot# J005078, expiration date: 20-SEP-2015 and lot# J006511, expiration date: 28-JAN-2016, route, strength and dose were unknown). No adverse experiences were reported. 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 registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K025006; expiration date 22-JUL-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a female patient of unknown age. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date in July 2015 (reported as "last month"), the patient was vaccinated with a dose of ZOSTAVAX (lot# L011534, expiration date and route were unknown). No concomitant medication was reported. On an unknown date the patient developed redness and swelling at the injection site. The patient sought medical attention via going to pharmacy on an unspecified date and reporting the event to the pharmacist. The outcome of injection site erythema and injection site swelling is unknown. The causality between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Skin tightness
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. The patient's pertinent medical history was not reported. On 25-AUG-2015, the patient was vaccinated with ZOSTAVAX (dose, frequency and lot# were not reported) subcutaneously. Concomitant medications were not reported. On an unknown date in August 2015 (reported as now), the patient experienced rash, redness, tightness and thickness at the injection site. The rash was approximately one inch in diameter. The patient did not sought medical attention. The outcome of the events was unknown. The relatedness of the events with ZOSTAVAX was not reported. Additional information in not expected as the reporter contact details were not provided.
Age: 11.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a registered nurse via a company representative referring to an 11 year old male patient. Pertinent medical history and drug allergies were not reported. On an unspecified date in July 2015 (reported as "last week") the patient was vaccinated with GARDASIL 9 (lot # and strength not reported, 0.5 ml, intramuscular injection) with 3 other vaccines: DTaP and MENACTRA (dose, strength and route unknown) (manufacturers unspecified) and hepatitis a vaccine (dose, strength and route unknown) (manufacturer unknown). The patient turned white and complained of being woozy right after receiving the 4 vaccines. No lab diagnostics studies were performed. Nurse observed him in the office for 15 minutes and gave him cold compress on injection site and some juice. Patient fully recovered within 15 minutes and was sent home. Causality was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple number of patients (also reported as "a lot") of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified series of M-M-R II (therapy type, dose, dose number, intervals, anatomical location and route of administration were not reported). On unknown dates, after receiving M-M-R II the patients "were testing negative for titers of some of the antigens". The outcome of the event of was unknown. The relatedness between the event of and M-M-R II was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a female patient of unknown age. The patient's relevant medical history, concomitant medications and past drug history are unknown. On an unknown date, the patient started on VAQTA (dose, frequency, route, start date and indication were unknown) as a series of hepatitis A shots because she was going out of the country. On 17-AUG-2015, the patient received a VAQTA vaccine that expired on 01-AUG-2015. It was unknown if there was any relevant lab data. As of 17-AUG-2015, it was unknown if the patient continues on the VAQTA and the outcome of her receiving the expired VAQTA was unknown. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) via a company representative concerning a 49 year old patient of unknown gender with negative titers for varicella. On 24-AUG-2015, the patient was vaccinated with an expired dose of VARIVAX (Merck) (Lot No. J009165 Expiration date: 24-JUL-2015) subcutaneous  (dose and anatomical location of administration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 months 2 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information has been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored PROQUAD (Merck) (dose, route, frequency, lot# and expiration date 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, frequency, lot# and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 49 years old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and lot# were not reported) (Inappropriate schedule of vaccine administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and concurrent condition were not reported. On an unknown date the unspecified number of patients received improperly stored PEDVAX HIB (dose, frequency and route were unknown, lot # K008879, expiration date 30-MAR-2017). No concomitant medication was reported. No adverse effects reported. There was no product quality complaints (PQC) involved. 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 registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # K015464; expiration date 09-SEP-2017) dose and route of administration were not reported. Concomitant therapy was not reported No adverse events have been 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 a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot# K026247, expiration date: 29-JAN-2017), dose and route were not reported. No adverse effects reported. This is one of three reports received from the same source. Additional information is not expected, because there was no consent to contact the physician.
Age: 0.4
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) concerning a 4 month old infant. No concurrent conditions or medical history were reported. On 10-AUG-2015, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (dose, route, Lot No. and anatomical location of administration were not reported). No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a consumer a 63-year-old patient refers to himself. There were no concomitant medications, concurrent conditions and medical history reported. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, lot number and expiration date were not reported). In November 2014, reported as approximately 3 weeks after receiving ZOSTAVAX, the patient developed a rash over various parts of the body. The outcome of this event was unknown. The patient stated the rash "comes and goes" with the last episode being on 25-AUG-2015. The outcome of the last event was reported as not recovered, at the time of this report. The patient did not seek medical attention. The patient was treated with an unspecified over the counter medications. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed nurse practitioner referring to multiple patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (dose and route were not reported, lot # K021548, expiration date 06-MAY-2016). Concomitant drug was not reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. No pertinent medical history or drug allergies were reported. A few months ago (date unspecified), the patient was vaccinated with ZOSTAVAX (strength, dose and route unknown). There was no concomitant medication reported. On an unknown date, the patient developed reoccurring rashes on unspecified body sites. The patient sought medical attention from her unspecified primary physician. The outcome of rash was reported as not recovered. The causality between rash and ZOSTAVAX was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth at site of injection about 1 week. Did treat for possible cellulitis when erythema worsened and sxs improved and then resolved.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Feeling abnormal, Headache, Vaginal haemorrhage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11-year-old female patient - her daughter. The patient's concurrent conditions included asthma. The patient did not have any allergies. There were no concomitant medications and medical history reported. On 10-AUG-2015, the patient was vaccinated with first dose of GARDASIL (route of administration, dose, lot number and expiration date were not reported). On 10-AUG-2015, after vaccination, the patient experienced a headache and was "not feeling right". On 15-AUG-2015, the patient started to experience "severe abdominal cramping" that lasted between 2-3 hours. Since the abdominal cramping started, the patient experienced sporadic, bright red, vaginal bleeding. The vaginal bleeding was described as "gushing" and/or "spotting" at different times. The patient did not receive any treatment. There was no lab diagnostics studies performed. The outcome of the events was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Decreased appetite, Pyrexia, Rash, Rash maculo-papular, Viral rash
Clinical narrative: Had vaccine 8/10/15. Rash on back 8/11/15 resolved within one day. Had fever 102, cranky, decreased appetite and activity on 8/17/15. No further fever but not crawling, eating or talking like usual since then.  Maculopapular pink rash developed over trunk and extremities on 8/20/15. Seen in walk in clinic. Treated with BENADRYL. Seen by me 8/21. Alert and nontoxic. Normal neuromuscular exam, pink maculopapular rash c/w viral exanthema.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017; dose, route of administration and anatomical location were 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: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In approximately July 2015, the patient received one dose of ZOSTAVAX (subcutaneously, dose, lot # and expiration date were not provided) and approximately 3 weeks later, on approximately 10-AUG-2015 (reported as 'approximately 3 weeks go') the patient received another dose of ZOSTAVAX (lot# and expiration date were not provided, 0.65 ml, subcutaneously). The patient did not seek medical attention. No treatment was given for the event. No adverse effect reported. Additional information has been requested.