chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 27-JUL-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II injection (expiry date 22-JUL-2016; lot# was not reported), 0.5 ml subcutaneously (reported as "under the skin"). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. 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 Practical Nurse referring to an unspecified number of patients of unknown ages and gender. Information about medical history, concurrent condition and concomitant medications was unspecified. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (lot # L034931 with expiration date of 03-MAR-2017 and lot# M006106 with expiration date 01-AUG-2017; strength, dosage, frequency and route unspecified). No adverse event was reported. Excursion details: Temperature/ time frame of PROQUAD with lot# L034931 was 10.8 F for 4 hours 48 minutes and previously temperature excursion was 30 F for 10 hours 45 minutes. Temperature/ time frame of PROQUAD with lot# M006106 was 10.8 F for 4 hours 48 minutes and there was no previously temperature excursion. This is one of two report 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 medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9, lot number was L024993 and expiration date of 17-OCT-2017 (strength, dose and route of administration were unknown), which was stored at 49 Fahrenheit Degree for 8 hours and 9 Fahrenheit Degree for 39 hours and 20 minutes. Then, the vaccines were back in range. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not mentioned. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L046885, expiry date: 23-NOV-2017 and lot# M000757, expiry date: 06-JAN-2018 (dose# and site of administration not reported). The vaccine underwent temperature excursion at -13.50C for 181 hours. No adverse effects were reported. Product quality complaint was not filed. 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 nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of Gardasil 9 (lot # M004116, expiration date 12-OCT-2017; exact doses and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information was received 25-JUL-2016 regarding a case in litigation for GARDASIL from a lawyer and the mother of a 15 year old girl (see case # 1503USA006173, same reporter and case # 1607USA010910, same reporter). The mother reported that she began to explore the internet and found many mothers who had similar problems when their daughters were given GARDASIL. Additional information is not expected
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a non-pregnant female patient of unknown age. The patient had no pertinent medical history. On 27-JUL-2016, the patient was vaccinated with a dose of GARDASIL (lot#, dose and route of vaccination were not reported) in the left arm. On the same day, the patient experienced dizziness, light headedness. The patient did not seek medical attention. No treatment was given for the adverse event. The outcome of dizziness was reported as recovering/resolving. The relatedness between dizziness and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an immunization official, refers to an unspecified number of patient of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not mentioned. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX of lot # L042264, expiry date: 26-OCT-2017  and lot# M000760, expiry date: 06-JAN-2018 (dose#, site of administration and route not provided). No adverse effect were reported. No additional information was provided. Product quality complaint was not filed. Additional information is not expected as the reported did not wish further contact. This is one of the two reports form the same reporter.
Sex: U
Vaccine: HEP
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 ages and genders. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with improperly stored dose of RECOMBIVAX HB lot number M001578 expiration date 21-NOV-2018. Dose, the patient's frequency, anatomical location and route of administration were not provided. Temperature: 32.9 Fahrenheit degrees, time: 5 hours. Digital data logger was involved, no previous exposures and no product quality complain involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. This is one of four 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 Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ lot number M004508 expiration date 29-JUN-2017. Dose, the patient's frequency, anatomical location and route of administration were not provided. Temperature: 32.9 Fahrenheit degrees, time:5 hours. Digital data logger was involved, no previous exposures and no product quality complain involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. This is one of four reports received from the same reported. (1607USA008403-1607USA009533-1607USA009534). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JUL-2016, the patient was vaccinated with an expired dose of ROTATEQ, orally, lot # L004453 and expiration date 27-MAY-2016 (Dosage and dose number were not reported). No other suspect or concomitants therapies were reported. No adverse effects were reported. No product complain was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 22-JUL-2016 the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M011663, expiration date 08-SEP-2017, dose and route were not reported). The vaccine had been stored under temperature of 52.3 degree Fahrenheit for 11 hours. No previous excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from  a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K011562, expiration date 08-APR-2017; exact doses and route of administration were not reported). No adverse effects were reported. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Product contamination, Vaccination complication
Clinical narrative: Information was received 25-JUL-2016 regarding a case in litigation for GARDASIL from a lawyer and the mother of a 15 year old girl (see case # 1503USA006173, same reporter and case # 1607USA010909, same reporter). This mother reported she went to medical literature searches and she found research that was done by a professor at a university who researched reports of GARDASIL adverse reactions. The professor found that Gardasil was contaminated and caused adverse reactions as a result. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified medical Assistant refers to a multiple unspecified patients of unknown ages and genders. The patient's medical histories and concurrent conditions were not reported. On an unknown date between 01-JUL-2016 and 14-JUL-2016 the patients were vaccinated with improperly stored dosses of ROTATEQ orally (lot number, expiration date, dose and frequency were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with the dose GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown ages and genders. Medical history and current conditions were not reported. On an unknown dates over unspecified 7 month period, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot number L024118, expiration date 26-MAR-2017, and lot number L027732, expiration date 23-FEB-2017. Dose and route of administration were not provided. No other suspect or concomitant medications were reported. As reported, temperature: uncertain, surmising worst case 51 F and 7 months; digital data logger was involved. Previous: uncertain. No adverse effects were reported. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a medical assistant concerning a female child of unknown age. The patient's medical history and concurrent conditions were not reported. On 12-JUL-2016. the patient was vaccinated with an expired dose of ROTATEQ, oral liquid, orally, expiration date: 10-JUL-2016 (strength and lot number were not provided). The lot number was not available for this dose as the practitioner discarded the container. No adverse effects were reported and no product quality complaint was involved. Additional information is not expected as the reported did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route of administration were not reported) lot #K007828; expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effect reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Information has been received from a physician who refers to himself, a male patient of unknown age and medical records. On 20-JUN-2016, about 10:00 a.m., the patient was vaccinated with PNEUMOVAX 23 lot # L033707 in the left arm. the patient stated that the injection technique seem normal; alcohol wipe, no pain on injection or immediately afterwards. At mid afternoon, on 20-JUN-2016, within a few hours of receiving PNEUMOVAX 23, the patient developed pain in bending at the elbow, swelling in his left upper arm and elbow, tenderness, redness, and soreness. There was no itching or fever. the patient reported the pain was severe enough so that he needed to take a VICODIN in the evening on 20-JUN-2016 which was very rare for him. The patient reported that he never had an immunization reaction like this. On 21-JUN-2016 at 7:21 p.m., the patient went to a Urgent Care Clinic for treatment where he was diagnosed with cellulitis and was given ROCEPHIN IM and a prescription for AUGMENTIN. the patient's current medications included AVODART, CIALIS, simvastatin, and SYNTHROID. The patient was instructed to apply ice/heat for 15 minutes each 4 times daily and monitor the redness. If the redness spread, the patient was instructed to go to the emergency room. The outcome of cellulitis is unknown. Upon internal review cellulitis was considered an important medical event. All available medical records will be provided upon request. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Started same day as immunizations temp 100.1, puking, diarrhea, pt had same symptoms with last shots on 5/24/16.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a total number of six patients of unspecified age and gender. No concurrent conditions, historical conditions or concomitant therapies were reported. The reporter stated that at different times since January 2016 through 18-JUL-2016, the patients were vaccinated with improperly stored VARIVAX lot # L013826, expiration date 21-APR-2017 (dose and route of administration not provided). It was reported that the vaccine was stored in 26.5 F for 3 hours and previously in 46F for 50 hours 20 minutes. The temperature excursion was captured via a Data Logger. No adverse effects were reported. Additional information had been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pt. reported fever 100 degrees and sleepiness x 1 day. Inj. site was not tender or red.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unknown number of patients of unknown age and gender. On unknown dates incorrectly stored doses of ROTATEQ lot # M004885, Exp date: 23-OCT-2017could have been administered. It was reported that, on an unknown date, the refrigerator was out of range for 22 hours, with a highest temperature of 48.6 F. Temperature was back in range at the time of call. The Registered Nurse that vaccines could have been administered before the excursion was identified. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 25-JUL-2016, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot#K010220 with expiry date: 22-JUN-2016 (dosing detail were not reported). No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 83 year old male patient. Pertinent medical history included hypertension and high cholesterol. Drug allergies/reactions were reported as none. Concomitant therapies included DIGOXIN, TOPROL, sacubitril, ENTRESTO and aspirin. On 21-JUN-2016, the patient was vaccinated with ZOSTAVAX, vial 19400 PFU, lot # L035506, expiry date 16-DEC-2016, subcutaneous. And then on 30-JUN-2016 the patient's physician, called the pharmacist to report that he saw the patient on 30-JUN-2016 in his office and the physician reported to the pharmacist that the patient has a "rash, that was diagnosed as shingles" that began on an unspecified date. Physician reported to pharmacist that the patient was now being treated with VALTREX. Lab diagnostic studies performed were reported as none. The outcome of the shingles was not recovered. Causality assessment was not provided. No product quality complaint (PQC) was involved. Call was disconnected before pharmacist provided tax  number to have VZV packet sent. No additional 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 Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of VAQTA lot number M003011 expiration date 15-NOV-2017. Dose, the patient's frequency, anatomical location and route of administration were not provided. Temperature: 32.9 Fahrenheit degrees, time: 5 hours. Digital data logger was involved, no previous exposures and no product quality complain involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Visual impairment
Clinical narrative: This spontaneous report was received from a physician refers to a 19 year old female patient. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 01-JUL-2016, the patient was vaccinated with the first dose of GARDASIL (dose, dosage number, route of administration, lot # and expiration date were not reported). No other suspect or concomitant therapies were reported. On an unspecified date in July 2016 (reported as 2 weeks later), it was stated that the patient felt light headed, felt weak and also experienced seeing black. At the time of the report, the outcome of visual impairment, asthenia and dizziness was unknown. The relatedness between visual impairment, asthenia and dizziness and GARDASIL was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with allergy to Sulfa antibiotics. The patient has no pertinent medical history. On 16-JUL-2016 the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously on the back of her upper arm below the deltoid area. The patient was not taking concomitant medication. On 17-JUL-2016, the patient developed redness at the injection site (injection site erythema); the area of redness was described as 3 inches by 2.5 inches around the injection site. The patient also developed swelling at the injection site (injection site swelling), described as really raised, as if there is fluid underneath. Additionally, the patient developed pain (injection site pain) and itching at the injection site (injection site pruritus); the area of itching was described as originating at the injection site but had begun to "radiating down to her elbow and down her side to her left breast" (pruritus). Furthermore, the patient also had "5 very small faint flat circles" around the injection site (injection site discolouration), although she could not determine whether these "circles" may be part of the patient's normal skin appearance. The patient sought medical attention, she called the physician and visited the pharmacist and the treatment provided for the events included BENADRYL and MEDROL DOSEPACK. The outcome of the events was not recovered. The causality between the therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with allergy to Sulfa antibiotics. The patient has no pertinent medical history. On 16-JUL-2016 the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously on the back of her upper arm below the deltoid area. The patient was not taking concomitant medication. On 17-JUL-2016, the patient developed redness at the injection site (injection site erythema); the area of redness was described as 3 inches by 2.5 inches around the injection site. The patient also developed swelling at the injection site (injection site swelling), described as really raised, as if there is fluid underneath. Additionally, the patient developed pain (injection site pain) and itching at the injection site (injection site pruritus); the area of itching was described as originating at the injection site but had begun to "radiating down to her elbow and down her side to her left breast" (pruritus). Furthermore, the patient also had "5 very small faint flat circles" around the injection site (injection site discolouration), although she could not determine whether these "circles" may be part of the patient's normal skin appearance. The patient sought medical attention, she called the physician and visited the pharmacist and the treatment provided for the events included BENADRYL and MEDROL DOSEPACK. The outcome of the events was not recovered. The causality between the therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative concerning to a 69 years old patient of unknown gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, and lot number were not provided); the route of administration was reported as injection. The pharmacist reported that on an unknown date in approximately July 2016, reported as "last week", the patient developed shingles after receiving the dose of ZOSTAVAX. Also the pharmacist reported that the patient was being treated by a doctor. At the time of reporting, the outcome of shingles was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pruritus, Sleep disorder, Throat tightness, Urticaria
Clinical narrative: Woke up in middle of night with sensation of throat tightness, intense itching, and hives.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Wrist and thumb pain and swelling, began 1 day after vaccine administered in ipsilateral extremity.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site pruritus
Clinical narrative: Redness, itching, swelling at injection site. Pt stated numbness in arm that radiated from hand up to jaw on patients left side (injection arm)and also headache.  Pt went to physician and was given a dose of steroid, but she was unsure which one. Symptoms resolved after approximately one week.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Redness, itching, swelling at injection site. Pt stated numbness in arm that radiated from hand up to jaw on patients left side (injection arm)and also headache.  Pt went to physician and was given a dose of steroid, but she was unsure which one. Symptoms resolved after approximately one week.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Pain in left shoulder, pain with range of motion.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction. Patient was given a TD vaccine with an expiration date of 10 days prior (Expired 02JUL2016). Patient will be revaccinated.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Hypoacusis, Loss of consciousness, Posture abnormal
Clinical narrative: Patient received GARDASIL-9, BEXSERO, VAQTA, and MENACTRA. Pt and mother were instructed to wait 10-15 minutes in waiting room following vaccine. Pt exited to waiting room to wait and was seated next to her mother. Pt reported at that time she felt "fine". A few minutes later mother came to door yelling for assistance. Pt was found slumped over on chair and appeared unconscious. Pt was lowered to the floor by staff. At that time, pt became conscious and was stating she could not hear. Pt was allowed to rest lying on the floor with ice pack. Pt reported she was feeling better and sat up to drink a cup of water. Pt was alert and oriented x3 at that time. Pt then stood and rested in the chair for additional five minutes. Pt reported she was feeling fine and mother wanted to take her to get something to eat. Nurse walked pt and mother to the car. Pt appeared to have recovered from episode at that time.
Age: 58.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Injection site reaction (itching, rash, and skin warm to the touch) along with fever of 102.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash to face, neck, and upper back for 2 weeks.
Age: 35.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Erythema, Wrong drug administered
Clinical narrative: Mild redness.
Age: 35.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Wrong drug administered
Clinical narrative: Mild redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Right thigh indurated, lateral aspect.  Hot to touch, erythematous, painful.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Red, hard, swollen area.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Fatigue, Hypersensitivity, Hypoaesthesia, Oral discomfort
Clinical narrative: Patient stated got shot on Monday 7/25/16, on Tuesday her arm was red, not, hurting, hand going numb at times. On Wednesday she started developing allergy symptoms stated runny nose, throat hurt and fatigued and arm itching.  Stated today, Thursday, 7/28/16 the day she called that her lips were burning and felt like having a reaction from this shot, arm still itching, felt like was getting a cold sore. Was instructed to inform physician.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Oral herpes, Oropharyngeal pain, Pain in extremity, Pruritus, Rhinorrhoea
Clinical narrative: Patient stated got shot on Monday 7/25/16, on Tuesday her arm was red, not, hurting, hand going numb at times. On Wednesday she started developing allergy symptoms stated runny nose, throat hurt and fatigued and arm itching.  Stated today, Thursday, 7/28/16 the day she called that her lips were burning and felt like having a reaction from this shot, arm still itching, felt like was getting a cold sore. Was instructed to inform physician.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: Patient stated got shot on Monday 7/25/16, on Tuesday her arm was red, not, hurting, hand going numb at times. On Wednesday she started developing allergy symptoms stated runny nose, throat hurt and fatigued and arm itching.  Stated today, Thursday, 7/28/16 the day she called that her lips were burning and felt like having a reaction from this shot, arm still itching, felt like was getting a cold sore. Was instructed to inform physician.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy. I am starting round 2.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever 101.8, and headache.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site pruritus, Pyrexia
Clinical narrative: Pt's guardian called us and notified her child had a fever of 102.6 after receiving 4 month shots yesterday. Her daughter was also scratched a bit at the site.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: AFTER RECEIVING VACCINE, EMPLOYEE BECAME DIZZY AFTER WALKING A FEW MINUTES. REMAINED DIZZY FOR A DURATION OF 30 MINUTES. EMPLOYEE MONITORED AND GIVEN WATER TO DRINK.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: 3X1 welt at injection site warm to touch.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Discomfort, Herpes zoster, Paraesthesia, Rash, Rash vesicular
Clinical narrative: After administering the zoster vaccine, patient feel uncomfortable the next day and begin to develop rash on 7/21. The blister rash appeared on his back and it is tingling and painful. We advised him to see his doctor right away and his doctor confirmed that it is shingle. Doctor gave him medication to treat it. Today is the 8th day from the time he develop the rash and it is still pain, especially at night that he couldnt sleep.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Sleep disorder
Clinical narrative: After administering the zoster vaccine, patient feel uncomfortable the next day and begin to develop rash on 7/21. The blister rash appeared on his back and it is tingling and painful. We advised him to see his doctor right away and his doctor confirmed that it is shingle. Doctor gave him medication to treat it. Today is the 8th day from the time he develop the rash and it is still pain, especially at night that he couldnt sleep.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Chills, Mobility decreased, Nausea, Paraesthesia
Clinical narrative: Arthralgia, Nausea, limb mobility decreased, paresthesia, chills.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Hyperhidrosis, Hypotension, Pallor, Syncope
Clinical narrative: Patient fainted briefly within 5 minutes of receiving BOOSTRIX and MENACTRA, cool clammy and sweaty skin, pale color, low blood pressure, no other injury made sure patient stayed hydrated with water and monitored blood pressure for the next half hour in store, monitored how patient felt and symptoms as they improved.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on arms, hands, feet, stomach and neck. Took over the counter Benadryl and ibuprofen.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, ITCHING, SWELLING, WARMTH, PAIN, MUSCLE PAIN AT INJECTION SITE.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: NONE, PT MAY OR MAY NOT HAVE RECEIVED VACCINE WHO'S STORAGE MAY NOT HAVE BEEN CONSISTENT.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Electroencephalogram, Seizure
Clinical narrative: Seizure.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: High fever, excruciating headache, nausea, vomiting, pain in arms and legs. Two emergency room visits required. IV Saline, Toradol and Zofran administered on both visits.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Back pain, Blood test normal, Computerised tomogram head normal, Electrocardiogram normal, Fall
Clinical narrative: Mid back soreness, tingling right arm and hand, tingling both feet, mental and physical fatigue. Passed out while at the jewelry counter in store. Fell back and struck head on tile floor. Unconscious less than 15 seconds with blank stare. Woke up did not know what happened. Then complained of headache and neck pain.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Fatigue, Head injury, Headache, Loss of consciousness, Mental fatigue
Clinical narrative: Mid back soreness, tingling right arm and hand, tingling both feet, mental and physical fatigue. Passed out while at the jewelry counter in store. Fell back and struck head on tile floor. Unconscious less than 15 seconds with blank stare. Woke up did not know what happened. Then complained of headache and neck pain.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Neck pain, Paraesthesia, Spinal X-ray normal, Staring, Urine analysis normal
Clinical narrative: Mid back soreness, tingling right arm and hand, tingling both feet, mental and physical fatigue. Passed out while at the jewelry counter in store. Fell back and struck head on tile floor. Unconscious less than 15 seconds with blank stare. Woke up did not know what happened. Then complained of headache and neck pain.
Age: 12.0
Sex: M
Vaccine: HEPA, HPVX, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Eye movement disorder, Feeling abnormal, Hyperhidrosis
Clinical narrative: Within 15 mins of getting the Vaccines he passed out. Tdap, mcv4p,. After saying I 100% did NOT want the HPV it is marked as it was given on the documentation. There were two needles and three vitals laying on her tray when she came in to the exam room to administer.  I did not want Hep A and it is also marked on the documentation. As we were leaving the department my 12 yr old got light headed, said he felt funny, started sweating, became clammy his eyes rolled back in his head and passed out. His skin was pale gray blue and took several minutes to come around. The "nurses" applied wet paper towels to his neck and wrist. No crash cart available, No O2 offered and no follow up treatment. Escorted to the car and said "this is normal". Even though they were saying this was normal they acted like this was NOT normal by their response.
Age: 12.0
Sex: M
Vaccine: HEPA, HPVX, MNQ, TDAP
Symptoms: Loss of consciousness, Skin discolouration
Clinical narrative: Within 15 mins of getting the Vaccines he passed out. Tdap, mcv4p,. After saying I 100% did NOT want the HPV it is marked as it was given on the documentation. There were two needles and three vitals laying on her tray when she came in to the exam room to administer.  I did not want Hep A and it is also marked on the documentation. As we were leaving the department my 12 yr old got light headed, said he felt funny, started sweating, became clammy his eyes rolled back in his head and passed out. His skin was pale gray blue and took several minutes to come around. The "nurses" applied wet paper towels to his neck and wrist. No crash cart available, No O2 offered and no follow up treatment. Escorted to the car and said "this is normal". Even though they were saying this was normal they acted like this was NOT normal by their response.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Hypoaesthesia, Injection site discomfort
Clinical narrative: Extreme fatigue, headache, swelling discomfort redness and pain at and around injection site in right arm, fever and chills, nausea, numbness and extreme weakness in left arm.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness, Nausea
Clinical narrative: Extreme fatigue, headache, swelling discomfort redness and pain at and around injection site in right arm, fever and chills, nausea, numbness and extreme weakness in left arm.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, headache, swelling discomfort redness and pain at and around injection site in right arm, fever and chills, nausea, numbness and extreme weakness in left arm.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Intussusception, Irritability, Somnolence, Ultrasound abdomen abnormal
Clinical narrative: Intussusception diagnosed after presenting to ED with vomiting / alternating sleepiness and fussiness. Treated with air contrast enema.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Intussusception diagnosed after presenting to ED with vomiting / alternating sleepiness and fussiness. Treated with air contrast enema.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB lot number was L045117 and expiration date of 06-OCT-2018(strength, route of administration and dose were not reported) which was stored at 49 Fahrenheit Degree for 8 hours and 9 Fahrenheit for 39 hours and 20 minutes. Then, the vaccines were back in range. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases 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 multiple patients of unknown ages and genders. Medical history and current conditions were not reported. On an unknown dates over an unspecified 7 month period, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number L037554, expiration date 25-DEC-2017, and lot number L016429, expiration date 09-AUG-2017. Dose and route of administration were not provided. No other suspect or concomitant medications were reported. As reported, temperature: uncertain, surmising worst case 51 Fahrenheit degrees for 7 months; digital data logger was involved. Previous: uncertain. No adverse effects were reported. Lot number L037554 is an invalid lot number for GARDASIL 9. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of female patients of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. In approximately July 2016 (reported as "after June 2016"), the patients were vaccinated with VARIVAX injection, subcutaneously, lot # L050956, expiration date: 17-DEC-2017(strength, dose and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse events were reported and no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No averse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (albumin status was not reported) lot # L041455, expiration date 22-OCT-2016 and an improperly stored dose of VARIVAX, lot #L048468, expiration date 02-12-2017 (dose and route of administration were not reported for both vaccines). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 70 degrees Fahrenheit for 1 hour. There were no previous temperature excursions. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On and unknown date, the patient was vaccinated with an improperly stored dose of VAQTA lot # L045713; expiration date 14-JAN-2016 and M-M-R II lot # L001336; expiration date 13-JAN-2017 (dose and route of administration were not reported). Concomitant medication was not reported. No adverse effect reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a Physician Assistant (PA) via a company representative concerning to a female patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL, (dosage schedule, concentration, route, anatomical location, lot number, and expiration date were not provided). Other suspect therapies included two unspecified vaccines (manufacturer unknown). Concomitant therapies were not provided.  The PA reported that on an unknown date, the patient developed Guillain-Barre Syndrome after receiving an unspecified dose of GARDASIL and the two unspecified vaccines (manufacturer unknown). The reporter stated that the patient went to an unspecified hospital on an unspecified date in regards to this event, however, it was unspecified if the patient was admitted to the hospital. No product quality complaint was involved. The outcome of Guillain-Barre Syndrome was unknown. The relatedness between the Guillain-Barre Syndrome and therapy with GARDASIL and the two unspecified vaccines (manufacturer unknown) was not reported. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. 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 Registered Nurse refers to multiple patients of unknown ages and genders. Medical history and current conditions were not reported. On an unknown dates over an unspecified 7 month period, the patients were vaccinated with improperly stored doses of ROTATEQ lot number L033693, expiration date 31-MAY-2017, and lot number L033694, expiration date 16-JUN-2017. Dose and route of administration were not provided. No other suspect or concomitant medications were reported. As reported, temperature uncertain, surmising worst case 51 F for 7 months; digital data logger was involved. Previous: uncertain. No adverse effects were reported. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of PEDVAXHIB (lot # L038502, expiry date 06-AUG-2018; dose and route not provided) that was improperly stored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with dose of GARDASIL (lot # K014191; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.