chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Eye movement disorder, Grip strength decreased, Hypersomnia, Hypotonia, Respiratory arrest
Clinical narrative: Baby has eyes that vibrated or tremored, she stopped breathing for a period in my husband's arms, but quickly recovered, slept almost to the point of not waking for two weeks, even when water was applied, baby was floppy and was missing grasping reflex only on one side. She is fine now, smiling and reflexes are intact. She seems very normal now...I thought it was just related to the birth, but we had an easy birth. I truly thought this child had neurological damage at one point, not realizing it could be from shots she was given. We have a history of genetic issues on husband's side, so it may explain why she reacted poorly to shots, like with mthfr mutation or so.  She is happy now, but I don't think I will further imuunize this child. I had 10 other children, so I can tell when something was not right with this one.
Age: 27.0
Sex: F
Vaccine: PER
Symptoms: Injection site pain, Migraine, Nausea
Clinical narrative: Pain at injection Site, Nausea, and Severe Migraine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient developed a large red bump on her arm which was warm to the touch where the vaccine was administered. It started the day after she received the immunization and was worse the following morning. The area is not painful, it is only slightly itchy for the patient.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Periarthritis, X-ray normal
Clinical narrative: Excessive soreness over a period of months. I did not seek treatment until increasing and significant loss of mobility at about 1 year later.  At that time I was diagnosed with adhesive capsulitis.  Treatment consisted of cortisone injection and physical therapy.  Pain still present in shoulder.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Malaise, Nausea, Pain in extremity
Clinical narrative: Redness in right arm, warmth, chills, nausea, malaise, pain in arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Redness in right arm, warmth, chills, nausea, malaise, pain in arm.
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site reaction, Myalgia, Osteoarthritis, X-ray limb abnormal
Clinical narrative: 3 days after vaccination, either Tdap or influenza vaccine, both given in left deltoid, began to hurt in the muscular region. Still hurting almost x year. Was sent to get x-ray of left shoulder on 03/30/2015, showed "mild degenerative disease involving acromicroclavicular joint". Patient seen again today on 09/03/2015 by same provider who asked to report to VAERS.
Age: 13.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Disorientation, Dizziness, Pallor, Somnolence
Clinical narrative: Client had sat for at least 10 minutes after administration of the Tdap and Gardasil4 but after leaving the room he was exiting building when he became dizzy and disoriented.  His Step-father got him seated and called for assistance.  Same nurse responded.  Client had circumoral and nasal pallor and appeared sleepy but did not lose consciousness.  He was offered sips of water and his condition and color improved in 3-5 minutes.  He then admitted that he had not eaten much lunch at school that day and step-father said he had also not had his usual after-school snack.  It was also a very hot day in the school and he had not drunk much water.  When he was steady to stand, this nurse walked to car with him with step-dad on the other side.  He was steady on his feet by that time.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Syncope
Clinical narrative: Patient got fainted after a Dose of Twinrix and Fluvirin injected separately.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Lymphadenopathy, Pyrexia, Sneezing, Urticaria
Clinical narrative: Pt states sneezing, rapid heartbeat, fever of 101, swollen lymph nodes, and welps on lower arms (not vaccination site); treated at hospital 8/31/15 and prescribed Keflex and Bactrim for cellulitis.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: 18 cm X 18 cm on left arm red, swollen and hot to the touch.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, swelling, itching, and a "hot" sensation developed the day after the patient received the injection.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Oral pruritus
Clinical narrative: Felt nauseous and his mouth felt itchy, gave Benadryl and monitored.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Round, raised, reddened area about the size of palm of hand with "tail" at 5o'clock. Systemic fever reported of 100.5. Seen in ER given Doxycycline. Back to ER on 9/3/2015 given clindamycin for redness extending outside of drawn border from yesterday.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, Swollen, Warm area approximately 3 inches round at site of injection. Vaccine administered 8-27-15. Reaction occurred 9-2-15.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site warmth
Clinical narrative: My wife noticed the area where I received the vaccine was red, warm, and having a reaction. She then noticed the Tdap vaccine was given to me subcutaneous, instead of intramuscular.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Patient's arm turned a whiteish color from the site of the injection down to her wrist.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, WARMTH IN AREA OF TDaP IMMUNIZATION. WENT TO DOCTOR. WAS TOLD TO TAKE TYLENOL AND COMPRESSES
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Eye movement disorder, Hyperhidrosis, Tremor, Vision blurred
Clinical narrative: Vomiting, shaking, sweating, unfocused eyes, eyes rolling towards back of head, stomachache. Possible low grade fever.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Vomiting, shaking, sweating, unfocused eyes, eyes rolling towards back of head, stomachache. Possible low grade fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Arm had been very sore after Prevnar 13 vaccination, more than a usual vaccination.  But on 8/16, entire upper arm was becoming warm and itchy.  On 8/17, two large red patches appeared (each approx 4" across) on the upper arm.  The lower patch also had a large knot that was movable.  Both patches became very itchy. Contacted and was seen by family phys on 8/18, who felt it was hives and started on steroid dose pack and two antihistamines.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Arm had been very sore after Prevnar 13 vaccination, more than a usual vaccination.  But on 8/16, entire upper arm was becoming warm and itchy.  On 8/17, two large red patches appeared (each approx 4" across) on the upper arm.  The lower patch also had a large knot that was movable.  Both patches became very itchy. Contacted and was seen by family phys on 8/18, who felt it was hives and started on steroid dose pack and two antihistamines.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Allergic respiratory symptom, Headache, Influenza like illness, Pain, Rhinorrhoea
Clinical narrative: Patient stated with symptoms: Flu-like symptoms. Headache. Body Ache. Allergies like symptoms (running nose).
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure, Syncope
Clinical narrative: Fainted, and convulsions-fire department called and vitals taken released after obervation.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Chest discomfort, Eye swelling, Headache, Lip swelling
Clinical narrative: Severe Headache, swelling of the lips and eyes, some chest tightness.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Crying, Dizziness, Dyspnoea, Eye swelling, Headache
Clinical narrative: Severe Headache, swelling of the lips and eyes, some chest tightness.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: Aches, fever, cough.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Swelling, redness and a hard bump at the injection site (Right thigh IM). NP recommended OTC Benadryl for patient's symptoms.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted several minutes after receiving both vaccinations.  She turned pale and fainted for a couple minutes. She was fine after we rehydrated her with orange juice.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Rash pruritic, Rosacea
Clinical narrative: Pt reports rosacea like rash in half crescent shape showing up on her back the next day that was very itchy.  Last approximately 2 days.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Local reaction
Clinical narrative: LOCAL INJECTION SITE REACTIONS INCLUDING RASH, TENDERNESS, SWELLING. PRIMARY CARE PHYSICIAN PRESCRIBED TRIAMCINOLONE OINTMENT AND BENADRYL TABLETS WHICH DID NOT HELP. NEXT TREATMENT PICKED UP TODAY IS AMOXICILLIN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site abscess, Injection site cellulitis, Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was severely swollen, red and hot to the touch around vaccine site. Swelling continued to increase. Emergency room visit was made 9/3/2015 due to increase swelling. Diagnosis: Cellulitis and abscess of upper arm and forearm. Cephalexin was prescribed to be administered twice a day for seven days. Child must be monitored if swelling continues to spread or fever develops he must go back to ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Arm was severely swollen, red and hot to the touch around vaccine site. Swelling continued to increase. Emergency room visit was made 9/3/2015 due to increase swelling. Diagnosis: Cellulitis and abscess of upper arm and forearm. Cephalexin was prescribed to be administered twice a day for seven days. Child must be monitored if swelling continues to spread or fever develops he must go back to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Hypersensitivity, Rash generalised, Urticaria
Clinical narrative: Pt. presented back to office 45 minutes after vaccinations of IPOL and DTaP for allergic reaction (hives and rash head to toe). O2 saturation 94% room air in room.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Tremor, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Day after administration patient experienced uncontrollable shaking of extremities and also went to sleep & woke upon floor. But doesn't remember. Went to hospital diagnosed with UTI.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Patient had pain & swelling of shoulder where injection was administered, and was unable to lift arm by herself.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Vaccinated 9/2/15. Site warm, red, swelling 9/2/15, 9/3/15 itching 9/2.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via market research programs and described the occurrence of injection site pain in a elderly male patient who received Influenza vaccine). Co-suspect products included investigational drug, unspecified unknown for chronic obstructive pulmonary disease (for more information on ADVAIR 00165 report see linked case A1070161A). Concurrent medical conditions included chronic obstructive pulmonary disease. In 2014, the patient received Influenza vaccine. On an unknown date, the patient started investigational drug, unspecified at an unknown dose and frequency. In 2014, several days after receiving Influenza vaccine and not applicable after starting investigational drug, unspecified, the patient experienced injection site pain (shot spot was sore). Investigational drug, unspecified was continued with no change. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza. The reporter considered the injection site pain to be unrelated to investigational drug, unspecified. This case was linked to A1070161A as it was reported for the same patient.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unkonwn age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of PROQUAD (Merck) lot # L007230, expiration date 03-SEP-2016 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same source. 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 nurse refers to unknown number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with VAQTA lot # L002717, expiration date 02-JUN-2017 (dose strength, route unspecified) post temperature excursion with no adverse effects. No product quality complaint was involved. This case is linked to the case via 1509USA001396 same reporter link. 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 nurse refers to an unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of M-M-R II lot # K024035, expiration date 26-DEC-2016 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site rash
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. No information about medical history, concurrent conditions was reported for the patient. On an unknown date in June 2015 the patient was vaccinated with RECOMBIVAX HB 2.5mcg/0.5ml) (route unspecified) for vaccination. On an unknown date in June 2015 the patient experienced an allergic reaction to RECOMBIVAX HB and developed a rash at the injection site. The outcome of hypersensitivity and injection site rash was reported as recovered/resolved approximately on an unknown date in 2015. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified pediatric patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. ON 28-APR-2014, the patient was vaccinated with first dose of VAQTA vial 25/0.5 ml (lot #, dose, frequency and  route not provided) Then, subsequently, on 07-OCT-2014, the patient was vaccinated with the second dose of VAQTA (less than six months after which was outside there commendations in the VAQTA prescribing information). No adverse effect reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse and refers to a patient of unknown age and gender (colleague of the nurse). On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route of administration not reported) and developed cellulitis post vaccination (date unspecified). The outcome of the event was unknown The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding her son, a 16 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were reported. On an unknown date, the patient began the vaccination series with GARADSIL. On 24-AUG-2015, the patient also received GARDASIL 9 as the second dose, in the vaccination series. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, an unspecified number of patients were vaccinated with unspecified doses in series of improperly stored VAQTA lot # L007559, expiry date 01-JUN-2017 (dose, site and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, an unspecified number of patients wer4 vaccinated with unspecified doses in series of improperly stored RECOMBIVAX  HB (lot # L014418, expiry date 13-APR-2017, (dose, site and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, an unspecified number of patients were vaccinated with unspecified doses in series of improperly stored ROTATEQ (dose, site and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. 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 health care worker refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored M-M-R II (lot number and expiration date were unspecified, dose, frequency and route of administration were not reported). No adverse events were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: The spontaneous report was received from a pharmacist regarding three unspecified children of 17 or 18 years of age. There was no information about concurrent condition and historical medication. ON an unknown date, the children of 17 or 18 years of age were vaccinated with ZOSTAVAX vial 19400 PFU (drug administered to patient of inappropriate age instead ov VARIVAX) (wrong drug administered). No concomitant medication was reported. No adverse event was reported. No product quality complaint PQC was involved. Reporter stated that she doe not know whether or not medication confusion was involved in this error, since she was not the person who prepared the doses for the three children. The outcome of children of 17 or 18 years of age was vaccinated with ZOSTAVAX instead of (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with 4 doses of improperly stored GARDASIL (lot # K010215 with expiration date 05-MAY-2017; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Autism, Vaccination complication
Clinical narrative: This spontaneous non-valid report was received from internet from a consumer, who was reporting on her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot # and expiry date were not reported). M-M-R II vaccination had adverse reaction to the reporter's daughter, she was autistic. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old male patient. On an unknown date in SEP-2014, the patient was vaccinated with ZOSTAVAX. On an unknown date in  SEP-2014, the patient experienced last of efficacy. The pharmacist stated that he had patients who had the vaccine who have had shingles. The outcome of the event was reported as recovered/resolved with sequelae. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Vomiting
Clinical narrative: This spontaneous report as received from a healthcare worker who is a medical assistant refers to a 17 year old female patient. The patient had no concurrent conditions, pertinent medical history, drug reactions or allergies. On 06-AUG-2015, the patient was vaccinated with the first 0.5 ml dose of GARDASIL lot # K010574, expiration date 08-APR-2017, intramuscular in the left deltoid. Concomitant therapies included MENACTRA which the patient was vaccinated with in her right arm on the same day, prior to GARDASIL. Immediately after the administration of GARDASIL the patient vomited, passed out and was "jerking". No further explanation of "jerking" was provided. The patient recovered from the events on the same day, after 30 seconds. The patient has been instructed by her physician not to receive further dosing with GARDASIL, due to the adverse events, the patient would not be completing the series. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of PEDVAXHIB lot # K026533, expiration date 07-AUG-2017 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same source. 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 nurse refers to an unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL 9 lot # K026246, expiration date 28-JAN-2017 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same source. 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 nurse refers to an unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of ZOSTAVAX lot # L006381, expiration date 25-MAY-2016 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports 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 nurse refers to an unspecified number of patient of unknown age and gender. No information about medical history, concurrent conditions was reported to the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of (Oka/Merck) VARIVAX lot # L005301, expiration date 17-FEB-217 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports 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 physician refers to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # K021483, expiration date: 05-NOV-2016, (dose, route of administration and injection site were not reported). NO adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Administration site warmth, Injection site erythema
Clinical narrative: Presented to pharmacy at 11:25 am on 9/1/2015 with large, hot, red area at administration site. Pt was directed to go to physician and received BACTRIM DS.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing
Clinical narrative: Flushing all over body for day (facial and body redness) relieved by BENADRYL.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, General physical health deterioration, Headache, Malaise, Mental status changes
Clinical narrative: The patient has complex symptoms which he notes began as declining health following the varicella zoster infection in Sep/Oct 1999. His question asking did the AVA cause his health to weaken, leading to the varicella zoster and subsequent symptoms over the next several years. Altered mental status, generalized pain, headache, malaise and fatigue NEC, symptom, nervous/muscskltl systems NEC.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal disorder, Nervous system disorder, Pain, Varicella zoster virus infection
Clinical narrative: The patient has complex symptoms which he notes began as declining health following the varicella zoster infection in Sep/Oct 1999. His question asking did the AVA cause his health to weaken, leading to the varicella zoster and subsequent symptoms over the next several years. Altered mental status, generalized pain, headache, malaise and fatigue NEC, symptom, nervous/muscskltl systems NEC.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K006960, expiration date: 19-FEB-2017, (dose, route of administration and injection site were not reported). No adverse experiences were 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: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Left arm - swelling, redness and pain at injection site. Symptoms started 9-2-15. 9-3-15 increase in redness noted, no change in swelling.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple, unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of PROQUAD, lot # K023365, expiration date: 20-MAY-2016, (dose, route of administration and injection site were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received  from a consumer and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the reported inquired if they could give the second dose of hepatitis A vaccine, inactivated (manufacturer unknown) before 6 months, 2-3 weeks early, or if they had to revaccinated (inappropriate schedule of drug administration). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to patients of unspecified demographics. The nurse stated that doses of PROQUAD (Merck) (lot # K014798, exp 12-MAR-2016), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 02-JUN-2015 (Incorrect product storage). No adverse experience has been reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a  medical assistant concerning to a multiple unspecified patients of unknown ages and genders. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # reported as 1007226, expiration date 09-MAY-2017) (routes, anatomical locations and doses were not reported). Co-suspect therapies at concomitant medications were not provided. No adverse effect was reported. Lot # 1007226 is an invalid lot number for vaccinated (Oka/Merck VARIVAX. 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 was received from a nursing assistant referring to a patients of unknown age and gender. Since 03-AUG-2015, the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose and route of vaccination were not reported, lot # L004741 exp. date: 04-MAR-2017). No adverse events have been reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Between 28-APR-2016 and 17-AUG-2015, the patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX lot # L03777 with expiration date 04-FEB-2017 and lot # L011082 with expiration date 01-APR-2017; dose and route of administration were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age. There was no information about patient's concurrent conditions, medical history or concomitant therapies provided. On unknown dates the patient was vaccinated with two doses of GARDASIL (dose, route of administration, lot # and expiration dates not reported). On 18-AUG-2015, the patient was administered a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date not reported) as a third dose of HPV vaccine series (interchange of vaccine products). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concomitant medications, past drug and medical history information were unknown. Approximately on an unspecified date in 2013 (reported as "a year or two ago") the patient was vaccinated with a dose of ZOSTAVAX (lot #, strength, dosage, frequency and route unspecified). On an unknown date after receiving ZOSTAVAX, the patient experienced a big rash and was treated with an unknown anti-viral. It was unknown if there was any relevant lab work. As of 30-AUG-2015, it was unknown if the patient continued on ZOSTAVAX and the outcome of the big rash was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Hypoaesthesia, Inappropriate schedule of drug administration, Neck pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fatigue in a 44-year-old male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult.  Previously administered products included Engerix B adult (1st dose in 13 AUGUST 2013). On 2nd December 2013, the patient received the 2nd dose of Engerix B adult. In May 2014, the patient received the 3rd dose of Engerix B adult. On 2nd December 2013, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B adult, the patient experienced drug dose administration interval too long. In 2015, the patient experienced fatigue and numbness in fingers. On an unknown date4, the patient experienced neck pain. On an unknown date, the outcome of the fatigue, numbness in fingers, neck pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the fatigue, numbness in fingers and neck pain to be related to Engerix B adult. Additional details were provided as follows: The patient received the 2nd dose of Engerix B on 2nd December 2014, which led to lengthening of vaccination schedule. A year later the patient began to experience numbness in fingers and fatigue. After receiving the 3rd dose of Engerix B in May 2014, the patient began to experience pain in his neck.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: This case was reported by a physician via call representative and described the occurrence of pale skin in a 11-year-old female patient who CERVARIX (batch number BF7A2, expiry date 28th May 2016). Concomitant products included MENVEO. On 7th August 2015, the patient received CERVARIX .5 ml. On 7th August 2015, 5 min after receiving CERVARIX, the patient experienced pale skin and dizziness. On an unknown date, the outcome of the pale skin and dizziness were unknown. It was unknown if the reporter considered the pale skin and dizziness to be related to CERVARIX. Additional details were provided as follows: The patient had unremarkable medical history and was not on concomitant medication. On 7th August 2015, 5 to 7 minutes after receiving CERVARIX, the patient experienced pale in skin Colour and dizziness. The reporter was wondering about any clinical studies regarding adverse events after CERVARIX, so the caller was escalated to MIS scientist. The reported batch number B1782 for CERVARIX, which does not exist as per sales data sheet and updated as BF7A2.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Expired product administered, Exposure during pregnancy, Premature delivery
Clinical narrative: This is a prospective pregnancy case. This 30-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX (intramuscular) .5 ml on 5th March 2015 13:30. The subject's last menstrual period was on 14 August 2014 and estimated date of delivery was 21st May 2015. The subject received BOOSTRIX at week 29 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included expired vaccine used. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included vaccine used (unknown). The pregnancy was ongoing. Additional information: The last menstrual period was not reported but was calculated with the due date. The vaccine was expired since 15 February 2015. Follow-up information received on 14 July 2015: The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 24th April 2015 after 36 weeks and 1 day, 50 days after receiving BOOSTRIX the subject gave birth to a male neonate via cesarean delivery. The neonate weighed 2268 grams (5 lbs) at birth and lengthed 50 cm. APGAR scores were 8 and 9. It was unknown if the investigator considered the live birth and premature labor to be related to BOOSTRIX.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Corneal abrasion, Exposure via direct contact, Eye irritation, Eye pain
Clinical narrative: This case was reported by a nurse and described the occurrence of corneal abrasion in a 59-year-old female patient who received BOOSTRIX. On 12th October 2014, the patient received BOOSTRIX. On 12th October 2014, less than a day after receiving BOOSTRIX, the patient experienced corneal abrasion, burning in eye, eye pain, blurry vision in eye and inadvertent exposure to vaccine. The patient was treated with antibiotics nos, (Antibiotics (Drug Name Unknown)). On an unknown date, the outcome of the corneal abrasion, burning in eye, eye pain and blurry vision in eye were not recovered/not resolved and the outcome of the inadvertent exposure to vaccine was unknown. Additional information: Reporter was a nurse and was also the patient. Yesterday at 11 am at work she was drawing a BOOSTRIX vaccine and by mistake the BOOSTRIX vaccine splashed on her right eye. Reporter experienced right away and is still experiencing burning in her right eye, pain in her right eye, blurry vision in her right eye. Reporter immediately went to ER and was diagnosed with a corneal abrasion. She also said that she is currently seeing a floater for some reason. Patient is taking antibiotics.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred, Vitreous floaters
Clinical narrative: This case was reported by a nurse and described the occurrence of corneal abrasion in a 59-year-old female patient who received BOOSTRIX. On 12th October 2014, the patient received BOOSTRIX. On 12th October 2014, less than a day after receiving BOOSTRIX, the patient experienced corneal abrasion, burning in eye, eye pain, blurry vision in eye and inadvertent exposure to vaccine. The patient was treated with antibiotics nos, (Antibiotics (Drug Name Unknown)). On an unknown date, the outcome of the corneal abrasion, burning in eye, eye pain and blurry vision in eye were not recovered/not resolved and the outcome of the inadvertent exposure to vaccine was unknown. Additional information: Reporter was a nurse and was also the patient. Yesterday at 11 am at work she was drawing a BOOSTRIX vaccine and by mistake the BOOSTRIX vaccine splashed on her right eye. Reporter experienced right away and is still experiencing burning in her right eye, pain in her right eye, blurry vision in her right eye. Reporter immediately went to ER and was diagnosed with a corneal abrasion. She also said that she is currently seeing a floater for some reason. Patient is taking antibiotics.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 25-AUG-2015,  the patient was indicated for ZOSTAVAX and accidentally received a dose of (Oka/Merck) VARIVAX instead (dose, route, lot number and expiration date were not provided). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On unspecified dates since 08-JUL-2015, the patients were vaccinated with GARDASIL (lot # J011272 and expiration date 21-APR-2016) (dose and route were not reported) which were exposed to temperatures outside of the recommended range. No adverse effects were reported. No Product Quality Complaint (PQ) was involved. This is one of the two reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given only the diluent, the vaccine had not been added to the syringe.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given diluent only, the vaccine was not added to syringe.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Patient was given diluent only, the vaccine was not added to syringe.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: KINRIX vaccine was given for 2nd and 3rd dose DTaP and 2nd and 3rd dose polio. This was noted upon review of immunization record for school entrance. CDC consulted - doses are valid. Letter R/T incident mailed to vaccine administrator.
Age: 59.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Pt. visited to HD 9/2/15 concerned about her condition since Imm administered on 6/26/15. Fever (3 days) and generalized rashes subsided but she still has (R) upper inner arm with small area reddened and slightly swollen and said painful. She c/o prickling pain on both (R) arm and leg and swelling, (+) edema noted on both legs. No treatment provided. Refer to PCP for further evaluation. BP 184/84, P-91, T-98.3.
Age: 59.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Peripheral swelling, Pyrexia, Rash generalised
Clinical narrative: Pt. visited to HD 9/2/15 concerned about her condition since Imm administered on 6/26/15. Fever (3 days) and generalized rashes subsided but she still has (R) upper inner arm with small area reddened and slightly swollen and said painful. She c/o prickling pain on both (R) arm and leg and swelling, (+) edema noted on both legs. No treatment provided. Refer to PCP for further evaluation. BP 184/84, P-91, T-98.3.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Left arm: local reactin, mild 4x5 cm redness, mild induration-no blisters.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Fibrin D dimer, Full blood count, Pain, Red blood cell sedimentation rate
Clinical narrative: Swelling, redness, pain. Patient given antibiotic, allergy medication and labs were taken at time of visit.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Swelling
Clinical narrative: Swelling, redness, pain. Patient given antibiotic, allergy medication and labs were taken at time of visit.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given only diluent, the vaccine was not added to the syringe.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given only diluent, the vaccine was not added to the syringe.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given only diluent, the vaccine was not added to the syringe.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given only diluent, the vaccine was not added to the syringe.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt presented with swollen red bump on injection site.