chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-MAY-2017 the patient was vaccinated with ROTATEQ lot # M040268 for prophylaxis. On 25-MAY-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA011937: US-009507513-1709USA001552: US-009507513-1709USA001553: US-009507513-1708USA003630.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple unspecified patients of unknown ages. On 27-JUL-2017 the patient was vaccinated with PROQUAD for prophylaxis. Concomitant therapies included sterile diluent. On 27-JUL-2017, the patients experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Sender's Comments: US-009507513-1709USA000361: US-009507513-1709USA001607.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified multiple patients of unknown ages.  On 27-JUL-2017 the patients' were vaccinated with VAQTA for prophylaxis. Concomitant therapies included sterile diluent. On 27-JUL-2017, the patients experienced incorrect product storage. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Sender's Comments: US-009507513-1709USA001606: US-009507513-1709USA000361.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified multiple patients of unknown age. On an unknown date the patients were vaccinated with PEDVAXHIB lot # N007751 for prophylaxis.  On an unknown date the patient experienced incorrect product storage and no adverse event.  The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Sender's Comments: US-009507513-1709USA000333.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unspecified dates, the patients were administered improperly stored M-M-R II lot # L043704 with expiration date of 04-NOV-2017; strength, dosage, frequency and route unspecified for prophylaxis which was reconstituted with sterile diluent. Sterile diluent was not involved in the temperature excursion. No adverse effects were reported. Temperature was from 9 to 25 degree C (11.3 degree C) for 2 hours (refrigerated vaccine). On 14-APR-2017, there was a previous excursion with temperature from 9 to 25 degree (9.7 degree C) for 30 minutes. This is one of 4 cases received from the same reporter. Sender's Comments: US-009507513-1709USA001898: US-009507513-1709USA001897: US-009507513-1708USA003787.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unspecified dates, the patients were administered improperly stored GARDASIL 9 lot # M032650 with expiration date of 31-MAR-2019; strength, dosage, frequency and route unspecified for prophylaxis which was reconstituted with sterile diluent. Sterile diluent was not involved in the temperature excursion. No adverse effects were reported. Temperature was from 9 to 25 degree C (11.3 degree C) for 2 hours (refrigerated vaccine). On 14-APR-2017, there was a previous excursion with temperature from 9 to 25 degree (9.7 degree C) for 30 minutes. This is one of 4 cases received from the same reporter. Sender's Comments: US-009507513-1708USA003787: US-009507513-1709USA001896: US-009507513-1709USA001898.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unspecified dates, the patients were administered improperly stored VAQTA (lot # reported as L004559 with expiration date of 01-JUN-2017, strength, dosage, frequency and route unspecified) for prophylaxis which was reconstituted with sterile diluent. Sterile diluent was not involved in the temperature excursion. No adverse effects were reported. Temperature was from 9 to 25 degree C (9.7 degree C) for 30 minutes (refrigerated vaccine). There was no previous excursion. This is one of 4 cases received from the same reporter. Lot#L004559 is not valid for VAQTA. Sender's Comments: US-009507513-1708USA003787: US-009507513-1709USA001896: US-009507513-1709USA001897.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain, Abdominal pain upper, Amenorrhoea, Barium swallow normal, Computerised tomogram normal
Clinical narrative: Complained of headaches constantly, and stomach pain and nausea over the 2 1/2 months after last HPV shot Dec 30 2016. Then in March 2017 the pain was so bad she couldn't eat, stayed out of school due to pain, lost alot of weight. (20 lbs in 3weeks) currently 96 lbs. She stopped having periods after last shot. She was hospitalized 3x in 3 months due to pain and weight loss and a low heart rate. Abdominal pain was so severe no pain meds helped. Finally decided diagnosis of chronic abdominal pain. She is always cold. Has a slow digestive motility. Currently 6mths after last shots still has severe abdominal pain and headaches. Has to take drink supplements for food replacements to get more calories in her. At the age of 16, told it will be a life long problem and will have to learn how to manage pain.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dyspepsia, Echocardiogram normal, Feeding disorder, Feeling cold, Gastrointestinal hypomotility
Clinical narrative: Complained of headaches constantly, and stomach pain and nausea over the 2 1/2 months after last HPV shot Dec 30 2016. Then in March 2017 the pain was so bad she couldn't eat, stayed out of school due to pain, lost alot of weight. (20 lbs in 3weeks) currently 96 lbs. She stopped having periods after last shot. She was hospitalized 3x in 3 months due to pain and weight loss and a low heart rate. Abdominal pain was so severe no pain meds helped. Finally decided diagnosis of chronic abdominal pain. She is always cold. Has a slow digestive motility. Currently 6mths after last shots still has severe abdominal pain and headaches. Has to take drink supplements for food replacements to get more calories in her. At the age of 16, told it will be a life long problem and will have to learn how to manage pain.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Headache, Heart rate decreased, Hepatobiliary scan, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Complained of headaches constantly, and stomach pain and nausea over the 2 1/2 months after last HPV shot Dec 30 2016. Then in March 2017 the pain was so bad she couldn't eat, stayed out of school due to pain, lost alot of weight. (20 lbs in 3weeks) currently 96 lbs. She stopped having periods after last shot. She was hospitalized 3x in 3 months due to pain and weight loss and a low heart rate. Abdominal pain was so severe no pain meds helped. Finally decided diagnosis of chronic abdominal pain. She is always cold. Has a slow digestive motility. Currently 6mths after last shots still has severe abdominal pain and headaches. Has to take drink supplements for food replacements to get more calories in her. At the age of 16, told it will be a life long problem and will have to learn how to manage pain.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pain, Ultrasound abdomen, Ultrasound chest, Ultrasound scan normal, Weight decreased
Clinical narrative: Complained of headaches constantly, and stomach pain and nausea over the 2 1/2 months after last HPV shot Dec 30 2016. Then in March 2017 the pain was so bad she couldn't eat, stayed out of school due to pain, lost alot of weight. (20 lbs in 3weeks) currently 96 lbs. She stopped having periods after last shot. She was hospitalized 3x in 3 months due to pain and weight loss and a low heart rate. Abdominal pain was so severe no pain meds helped. Finally decided diagnosis of chronic abdominal pain. She is always cold. Has a slow digestive motility. Currently 6mths after last shots still has severe abdominal pain and headaches. Has to take drink supplements for food replacements to get more calories in her. At the age of 16, told it will be a life long problem and will have to learn how to manage pain.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Pt reported hives and swollen tongue 2 days after injection. This occurred with exercise and exertion. Pt took BENADRYL that helped with her symptoms. She had recurrent hives 2 more days only with exercise. All relieved with BENADRYL.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Rash, Swelling
Clinical narrative: Historical report to PCP on Rxn to Flu vaccine obtained at outside facility. Rash, swelling, dyspnea.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Tenderness
Clinical narrative: Pain and soreness in left bicep muscle and shoulder at injection site. Most pain I've experienced from flu shot. Difficulty in moving left arm. Tenderness over large area, from shoulder to elbow, concentrated in bicep muscle. Lasted 3 days, but finally went away.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin lesion, Varicella post vaccine
Clinical narrative: Developed a varicella rash at day 10 post vaccination; said rash continued to evolve over a 2 week period developing over 50 lesions.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Vaccination error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with drug hypersensitivity and diabetes mellitus. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included PNEUMOVAX 23. On an unknown date the patient experienced vaccination error. The outcome of vaccination error is unknown. The reporter considered vaccination error to be not related to PNEUMOVAX 23 and ZOSTAVAX.  {Additional information has been requested. / Additional information is not expected.}
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient with prophylaxis. On 28-AUG-2017 the patient was vaccinated with PNEUMOVAX23 lot # M040004 for prophylaxis. Other suspect therapies included PREVNAR 13. On 28-AUG-2017 the patient experienced no adverse event. On an unknown date the patient experienced wrong drug administered. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered and no adverse event to be not related to PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # m041990 with expiry date: 28-JUN-2019 Lot# n014470 with expiry date:17-JUN-2019 and lot# n004798 with expiry date: 31-OCT-2019 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 31F or colder (31.2F) for 2 hours and 32F to 35F for 356.5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA002052: US-009507513-1709USA002053.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent condition and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD lot # N010865 with expiration date 01-OCT-2018 (also reported as 11-OCT-2018), albumin status: recombinant human albumin (rHA) (dose and route of administration were not reported) and with lot# N013270, expiration date: 25-OCT-2018, albumin status: recombinant human albumin (rHA) (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from 15 to 46 degrees Fahrenheit (also reported as 25 degrees Fahrenheit) for the time frame of 1 hour and 15 minutes. No previous temperature excursion was involved. Digital data logger was used. No adverse events were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA002079.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot# N011491 with expiry date: 04-NOV-2018 and lot# N011867 with expiry date: 08-NOV-2018 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 31F or colder (31.2F) for 2 hours and 32F to 35F for 356.5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA002052: US-009507513-1709USA000595.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent condition and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # N012618 with expiration date 21-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from 15 to 46 degrees Fahrenheit (also reported as 25 degrees Fahrenheit) for the time frame of 1 hour and 15 minutes. No previous temperature excursion was involved. Digital data logger was used. No adverse events were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000884:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Gait inability, Injection site pain, Pyrexia, Vomiting
Clinical narrative: 1130AM - HAD 2 SHOTS GIVEN AT MD OFFICE. 4PM - COMPLAINED LEG HURT AND COULD NOT WALK FOR THE REST OF THE EVENING WITHOUT EXTREME PAIN. 130AM - WOKE UP WITH FEVER OF 104.2.  LEG STILL HURT TO MUCH TO WALK. 7AM - WOKE UP STILL WITH FEVER OF 104 AND STILL COULD NOT WALK BECAUSE OF THE PAIN IN INJECTION LEG. 10AM - STARTED VOMITING, FEVER NOW AT 103.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, HEP, MNQ, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: Recruit with undisclosed PCN allergy received Bicillin. Noted he had patchy rash across chest and back. Received Benadryl 50mg.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Nasopharyngitis
Clinical narrative: Client called 2 days after receiving 2nd dose of HPV 9 and reported having muscle aches in legs, arms, shoulders and wrists bilaterally. She also c/o head cold symptoms at the same time. Stated she wasn't sure if that had started before receiving vaccines. Instructed client to call back if s/s do not subside. Also instructed client that a VAERS report would be made and that this RN reporting would ask the experts if she should receive the 3rd dose.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in (2) days later c/o swelling, warmth and redness to L) deltoid.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Headache, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Employee began with localized symptoms of warmth and burning at injection site. Progressed to headache and nausea then tingling and SOB. Employee brought to ED where she was given BENADRYL and I believe a steroid shot. Symptoms subsided and employee was allowed to return to orientation. Still not feeling well employee went home. I spoke to employee later in the day and she reported feeling much better.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Paraesthesia
Clinical narrative: Employee began with localized symptoms of warmth and burning at injection site. Progressed to headache and nausea then tingling and SOB. Employee brought to ED where she was given BENADRYL and I believe a steroid shot. Symptoms subsided and employee was allowed to return to orientation. Still not feeling well employee went home. I spoke to employee later in the day and she reported feeling much better.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder, Presyncope, Unresponsive to stimuli
Clinical narrative: Patient tolerated Tdap well. After administering the MCV, patient was seated and leaned back into her mother and I observed her eyes rolling into the back of her head. Patient then stopped responding for less then 15 seconds. Then came to. Called for help, then laid patient down with feet elevated. Vitals were taken. Dr. examined patient, patient appeared to have vasovagal response to the injection. Observed patient for 30 minutes, gave orange juice and brownie. Patient after 30 minutes verbalized that she felt better and was able to leave ambulatory accompanied by mother.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective
Clinical narrative: This spontaneous report was received from a physician assistant via Pfizer, Inc (manufacturer report  # 2017325014) referring to a female patient of unknown age with rheumatoid arthritis. The physician assistant reported that the patient who was on immunosuppressive therapy with tofacitinib citrate (XELJANZ) and methotrexate (METHOTREXATE) for rheumatoid arthritis was administered a dose of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis on an unknown date which was obtained on her own without consulting with the healthcare professional. The healthcare professional decided to discontinue citrate (XELJANZ) for lack of efficacy during the same visit when the healthcare professional learned about the patient's administration with ZOSTAVAX. No additional information provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a 41 year old female patient (who was also the physician or the pharmacist) with hypertension. In 2004, the patient was vaccinated with 2 doses of VARIVAX, 1 DF for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown) and nifedipine (PROCARDIA). On AUG-2017, the patient experienced antibody test negative. The outcome of antibody test negative was unknown. The relatedness between the event and the vaccine was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. In 2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # L046884 for prophylaxis. Concomitant therapies included sterile diluent. No adverse event. Sender's Comments: US-009507513-1709USA002168: Original Case: 1709USA002093.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. In 2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # N014018 for prophylaxis. Concomitant therapies included sterile diluent. No adverse event. Sender's Comments: US-009507513-1709USA002093: Original Case: 1709USA002093.
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site reaction
Clinical narrative: Initial unsolicited report received from a pharmacist on 28-Aug-2017. This case involves a female patient (age not reported), who was vaccinated FLUZONE HD via intramuscular route (batch number, expiry date, dose and dose in series not reported) on an unknown date of Aug-2017. Patient's medical history and concomitant medication was not reported. On an unknown date of Aug-2017, after the vaccination, patient had an injection site reaction. Patient was seen by her PCP (patient required ER/doctor visit) and it was diagnosed as a cellulitis. Lab test and concomitant medication was not reported. Outcome of the event was unknown. Documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Insomnia, Rash, Rash morbilliform, Rash pruritic
Clinical narrative: About 14 hours after the vaccine was given pt woke up with itchy rash. It bothered him enough that he couldn't sleep. Seen in office next morning. On PE had no fever and no other symptoms besides rash. Rash : morbilliform, symmetrical, chest, trunk, back, faintly on arms, slight on neck. Spares palms and soles and lower legs. no mucosal changes: eyes, throat normal.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Localised infection
Clinical narrative: Pt reported getting an infection in her arm after her vaccinations.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Pain and swelling in left shoulder, limited range of motion.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Received injection in the left deltoid. Had circumferential swelling with some erythema and warmth to touch of the left upper extremity extending from the shoulder/axilla to about 1 inch proximal to the wrist. Child complains of itchiness and mild pain. Asked mother to give ibuprofen and Benadryl to symptomatic treatment, as well as cold compress. Pt was followed up on 2 subsequent visits. Reports had to visit the ED one time due to vomiting and subjective fever, was reassured by ED as vaccine reaction. Patient last returned for follow up 5 days after vaccine injection, symptoms improved greatly but not yet resolved at that time.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Skin warm, Swelling, Vomiting
Clinical narrative: Received injection in the left deltoid. Had circumferential swelling with some erythema and warmth to touch of the left upper extremity extending from the shoulder/axilla to about 1 inch proximal to the wrist. Child complains of itchiness and mild pain. Asked mother to give ibuprofen and Benadryl to symptomatic treatment, as well as cold compress. Pt was followed up on 2 subsequent visits. Reports had to visit the ED one time due to vomiting and subjective fever, was reassured by ED as vaccine reaction. Patient last returned for follow up 5 days after vaccine injection, symptoms improved greatly but not yet resolved at that time.
Age: 66.0
Sex: M
Vaccine: MMR
Symptoms: Pain in jaw
Clinical narrative: Patient complained of mild bilateral jaw pain for a few days - then all symptoms resolved.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child was fine throughout day after receiving vaccine. When mother woke child up at 07:30 next morning left arm was "swollen from shoulder to elbow, red and hot to touch" per mom. Family physician advised mom to use cold compress and give oral Benadryl.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye irritation, Rash erythematous
Clinical narrative: Patients husband came in letting us know that his wife (patient) had a reaction to a vaccination administered. The reaction was described as a "huge red rash over 6 inches covering her whole arm, with burning pain"
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Intermittent weal at injection site since the 8/16 vaccine was given, it is describes as a large red welt that would appear approx. every other day since injection, this reduce to every other week since 4/16, reports itching but no pain, no open areas.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported to the clinic at approximately 0900 on 06 Sep 17 with hives all up her left arm extending onto the left side of her chest and the left side of her neck. Pt states that they are very itchy and put Benedryl on them the night before. Pt denies any difficulty breathing.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Itchiness, redness, swelling, pain. Applied hydrocortisone ointment and prescribed cephalexin 500mg , 1tab, PO, q 8hrs for 1wk.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives with itching.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: The patient had a raised red rash at the site of injection that got better, then larger again.  after triple abx treatment patient did say it got better.  This am she said it became round  with red ring and a white center (like ring worm) and itchy.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a male patient of unknown age regarding himself. Medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (unknown dose, route, frequency, lot number, and expiration date) for prophylaxis. On an unknown date the patient experienced redness, itching, and swelling near the injection area. The outcome of injection site swelling, injection site pruritus and injection site erythema was unknown. No product quality complaint was filed. Causality was not reported for all events.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 29-AUG-2017, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # L020157 for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a patient of an unknown age. The patient's medical history and concomitant medications were not reported.  On an unknown date the patient received a dose of PROQUAD and then received a dose of VARIVAX (Dose, frequency, route and lot# were unknown) for prophylaxis instead of PREVNAR 13 (Wrong drug administered). It was unknown if VARIVAX was administered in error due to product confusion.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-SEP-2017 the patient was vaccinated with PROQUAD lot # M044720 for prophylaxis.    Concomitant therapies included sterile diluent. On 01-SEP-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. This is one of several reports from the same reporter. Lot number N013863 has been verified to be a valid lot number for PROQUAD. Sender's Comments: US-009507513-1709USA002186.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-SEP-2017 the patient was vaccinated with VARIVAX lot # M049127 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 01-SEP-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. This is one of everal reports from the same reporter. Lot number N010107 has been verified to be a valid lot number for VARIVAX.; Sender's Comments: US-009507513-1709USA002098:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site vesicles
Clinical narrative: Fever - lasting one week, large, hard lump at injection site - severe swelling of arm, soreness, redness from shoulder to elbow, two large red blisters at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Fever - lasting one week, large, hard lump at injection site - severe swelling of arm, soreness, redness from shoulder to elbow, two large red blisters at injection site.
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia
Clinical narrative: Fever 100.4.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Awoke the next morning with an extremely swollen arm - at injection site. The swelling is firm and is approximately 3" wide and over 4" long.  No apparent fever.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Palatal disorder, Rash
Clinical narrative: 2 days post-vaccine patient reported a painful rash/lesion approximately 2" in diameter on the palate of the mouth.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Drug administered at inappropriate site, Increased tendency to bruise, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: On Dec. 1, 2016 I went into Clinic and received a flu vaccine. The nurse hesitated after she injected the shot and the site was high up on my shoulder. Within 24 hours my arm was extremely sore and becoming difficult to move and sleep. Within a week, I was unable to sleep more than 45 min at a time because of the pain. I was unable to use my left arm or put pressure on it.  I could not straighten or raise that arm. I went to Urgent care and had an Xray. The doctor prescribed a stronger ibuprofen and a pain medication so that I could sleep. Over the course of the next week my shoulder became more stiff and still was not able to sleep. My primary doctor ordered an MRI and there was swelling to my should.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Limb injury, Loss of personal independence in daily activities, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain
Clinical narrative: On Dec. 1, 2016 I went into Clinic and received a flu vaccine. The nurse hesitated after she injected the shot and the site was high up on my shoulder. Within 24 hours my arm was extremely sore and becoming difficult to move and sleep. Within a week, I was unable to sleep more than 45 min at a time because of the pain. I was unable to use my left arm or put pressure on it.  I could not straighten or raise that arm. I went to Urgent care and had an Xray. The doctor prescribed a stronger ibuprofen and a pain medication so that I could sleep. Over the course of the next week my shoulder became more stiff and still was not able to sleep. My primary doctor ordered an MRI and there was swelling to my should.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Rotator cuff syndrome, Swelling, X-ray
Clinical narrative: On Dec. 1, 2016 I went into Clinic and received a flu vaccine. The nurse hesitated after she injected the shot and the site was high up on my shoulder. Within 24 hours my arm was extremely sore and becoming difficult to move and sleep. Within a week, I was unable to sleep more than 45 min at a time because of the pain. I was unable to use my left arm or put pressure on it.  I could not straighten or raise that arm. I went to Urgent care and had an Xray. The doctor prescribed a stronger ibuprofen and a pain medication so that I could sleep. Over the course of the next week my shoulder became more stiff and still was not able to sleep. My primary doctor ordered an MRI and there was swelling to my should.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood culture, Caffeine consumption, Full blood count, Laboratory test, Oxygen consumption increased
Clinical narrative: INFANT WAS ALREADY ON MAINTENANCE DOSAGE OF CAFFEINE DAILY, APPROXIMATELY 12 HOURS AFTER VACCINES WERE ADMINISTERED, INFANT BEGAN HAVING INCREASED PERIODIC BREATHING SPELLS AND AN INCREASED O2 DEMAND WHICH RESULTED IN INCREASES IN CAFFEINE DOSAGE X2 AND INCREASED O2 ADMINISTRATION.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Respiration abnormal
Clinical narrative: INFANT WAS ALREADY ON MAINTENANCE DOSAGE OF CAFFEINE DAILY, APPROXIMATELY 12 HOURS AFTER VACCINES WERE ADMINISTERED, INFANT BEGAN HAVING INCREASED PERIODIC BREATHING SPELLS AND AN INCREASED O2 DEMAND WHICH RESULTED IN INCREASES IN CAFFEINE DOSAGE X2 AND INCREASED O2 ADMINISTRATION.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Computerised tomogram normal, Measles, Nasoendoscopy, Pyrexia, Rash generalised
Clinical narrative: Shots were given on 7-21-17; 7-28-17 / started running a fever and ran a fever until 7-30-17.  7-31-17/ Patient woke up with a measles rash all over his chest, back and one side of his face. - we notified the doctor's office; 8-1-17 / While bathing, we noticed that patient's lymph node in his groin was the size of a cherry. - we notified the doctor's office; Rash continued to be very itchy, and groin was very swollen. 8-4-17 Symptoms seemed to subside. Then on 8-5-17 a new problem occurred.  8-5-17 / Patient woke up and his left cheek was very swollen. We notified the doctor's office right away. By 9pm that night, the swelling had moved all the way up to his temple area. We rushed him to the Hospital Emergency Room. Ultrasound was done - could not find the cause of swelling. A catscan was done, could still not find the cause of swelling. 8-6-17 - Took him to his Pediatrician, they could not figure out why his face was so swollen. 8-11-17 Took patient to Hospital where he was seen in the Clinic - they could not figure out why his cheek was so swollen. 8-31-17 He was seen by Dr. / ENT he performed a scope into pt's nasal cavity and he could not find a reason for the cheek swelling. There are just too many coincidences surrounding the time of patients getting his shots and we feel that all of these symptoms even the unexplained cheek swelling may have been due to the MMR or other vaccine that he received that day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash pruritic, Swelling, Swelling face, Ultrasound scan normal
Clinical narrative: Shots were given on 7-21-17; 7-28-17 / started running a fever and ran a fever until 7-30-17.  7-31-17/ Patient woke up with a measles rash all over his chest, back and one side of his face. - we notified the doctor's office; 8-1-17 / While bathing, we noticed that patient's lymph node in his groin was the size of a cherry. - we notified the doctor's office; Rash continued to be very itchy, and groin was very swollen. 8-4-17 Symptoms seemed to subside. Then on 8-5-17 a new problem occurred.  8-5-17 / Patient woke up and his left cheek was very swollen. We notified the doctor's office right away. By 9pm that night, the swelling had moved all the way up to his temple area. We rushed him to the Hospital Emergency Room. Ultrasound was done - could not find the cause of swelling. A catscan was done, could still not find the cause of swelling. 8-6-17 - Took him to his Pediatrician, they could not figure out why his face was so swollen. 8-11-17 Took patient to Hospital where he was seen in the Clinic - they could not figure out why his cheek was so swollen. 8-31-17 He was seen by Dr. / ENT he performed a scope into pt's nasal cavity and he could not find a reason for the cheek swelling. There are just too many coincidences surrounding the time of patients getting his shots and we feel that all of these symptoms even the unexplained cheek swelling may have been due to the MMR or other vaccine that he received that day.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: Rash developed after flu vaccine (3 days) in centrifugal distribution macular, non itching suggestive of possible flu vaccine reaction, unlikely to be due to amoxil, reviewed PI no mention of rash with flu vaccine though.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Hyperacusis, Injection site pain, Neck pain
Clinical narrative: PATIENT CALLED TODAY 09/06/2017 AT 12.30PM AND STATES THAT SHE WAS SUFFERED PAIN AT RIGHT BICEPS,RIGHT NECK AND RIGHT EAR PAIN. PATIENT ALSO STATES THAT HER HEARING BECAME VERY SENSITIVE. PATIET WAS TREATING THEM WITH VINEGAR AND SOAKING THE AREA WITH SOAP WATER.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and referred to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD with one of the following lot# M002056 (rHA) and expiration date: 11-JUL-2017 or lot# M043307 (rHA) and expiration date: 24-APR-2018 or lot# N001488 (rHA) and expiration date: 12-JUL-2018. Other suspect therapies included an improperly stored dose of VARIVAX with one of the following lot# M043582 and expiration date: 28-OCT-2018 or lot# N001530 and expiration date: 13-JAN-2019 or lot# M039316 and expiration date: 20-SEP-2018. Concomitant therapies included sterile diluent. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 8 year old patient with preexisting disease. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date, the patient experienced drug administered to patient of inappropriate age and no adverse event.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Feeling hot, Headache, Insomnia
Clinical narrative: Patient received Tdap vaccine from The Clinic on 09/01/17 at 9:16 am. Started to have symptoms at 3pm that day. Patient started to feel weak, at 5:30pm patient had body aches, felt hot, and had chills. Patient had a headache and felt nauseous. She had difficulty sleeping that night. Patient felt better the next day, and notified our office 2 days after vaccine was given to update us on her symptoms. She is better now.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Patient received Tdap vaccine from The Clinic on 09/01/17 at 9:16 am. Started to have symptoms at 3pm that day. Patient started to feel weak, at 5:30pm patient had body aches, felt hot, and had chills. Patient had a headache and felt nauseous. She had difficulty sleeping that night. Patient felt better the next day, and notified our office 2 days after vaccine was given to update us on her symptoms. She is better now.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity
Clinical narrative: 72 HRS AFTER INJECTION C/O PAIN TO ARM ESPECIALLY WHEN TRYING TO RAISE IT, CALLED CLINIC W/COMPLAINTS 5 DAYS LATER, INSTRUCTED TO GIVE OTC NSAIDS & APPLY COMPRESSES ALTERNATING WARM & COOL, ROM. IF NO IMPROVEMENT F/U W/PMD. 12 DAYS LATER CALLED CLINIC AGAIN. GIVEN SAME INSTRUCTIONS. CHECKED ON PATIENT 3 WEEKS POST INJECTION, NOT VERBALIZING COMPLAINTS ANY FURTHER.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Pruritus, Urticaria
Clinical narrative: Mother reported that pt noticed red welts looking like a bug bite the next day (early about noon) starting on leg, over the next day the number of welts grew and child informed mother the next morning (9/3). Welts have spread over both legs, torso, back, both arms, and neck (not face). Welts were described as about quarter size, pink, painful and itchy. Doctor directed her to take Benadryl. Mother reported to us today 9/6 and asked for us to inform the FDA about the side effect/interaction.
Age: 1.0
Sex: F
Vaccine: HEPAB, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: The patient developed fever for 48 hours post vaccination with MMR, Hep A, Varicella and PCV13. Subsequently on day 5 developed a maculopapular rash - diffuse. No fever at that time.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Petechiae, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site reaction
Clinical narrative: Rash, erythema, tenderness and petchiae at both sites of vaccinations (Both thighs). Patient was seen in office after 2 days. Pt seen in office with erythema, tenderness bot none injection; was improving after 2 days.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Hypotonia, Somnolence
Clinical narrative: Within 5 minutes of receiving his first PCV13 immunization, mom reports that the patient "went limp" and called for help. Assessed by CNA and RN in the office who noted that pt's "respirations [were] even and unlabored ... and [his] eyes [were] closed." Pulse ox 100%. I was called to see the patient who was drowsy-appearing but responsive to pain and mom with pulse 145, pulse ox 100%, Lungs CTA. No evidence of respiratory distress. No hives/erythema/induration/bleeding at site of injection or otherwise. During the exam, pt became more awake and interactive. He was able to open his eyes and make good eye contact with mom and respond to her. Good muscle strength and tone. Moved all extremities well.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Pain, Pyrexia
Clinical narrative: The patient had reddish rash at injection site. Patient also had a little fever and pain. Patient talked to his primary doctor over the phone and the doctor sent him antibiotic, Azithromycin 250mg pack.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL, VARCEL
Symptoms: Rash generalised, Varicella, Viral test
Clinical narrative: Patient develop chicken pox rash to body.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL, VARCEL
Symptoms: Disseminated varicella zoster vaccine virus infection, Rash pustular, Varicella post vaccine
Clinical narrative: Patient develop chicken pox rash to body.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Pharyngeal oedema, Pruritus
Clinical narrative: Patient experienced itching almost immediately. About 10-15 minutes later she had trouble breathing and her throat was swelling.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient has large red circle on (L) upper arm around injection site. Upper arm doesn't hurt but is hot to touch. Pt stated had fever-night of injection.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient came back to the pharmacy 3 days after getting the vaccine to report side effects of soreness on the injection site and she could not lift or move her left arm.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient experienced syncope during the vaccine administration. She was sitting on the examination table and was laid down; with legs flexed immediately. Patient regained consciousness after approximately 10-15 seconds. She was instructed to remain sitting; was monitored for approximately 20 minutes for other adverse reactions. No other reactions noted or reported by the patient.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Head discomfort, Influenza like illness, Injection site pain, Pain
Clinical narrative: Arm at site of injection is sore when raising arm in any direction. Also sore to the touch. This is more so than I remember my last flu vaccine being in 2008. This began about an hour after the shot. 9/6/2017 around 10am I began experiencing flu like symptoms - heavy head, achy body especially my back. I didn't have these symptoms during the last vaccine in 2008.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Urticaria
Clinical narrative: Pt reported experiencing hives as well as a flu-like syndrome (aches and pains). The flu-like syndrome is normal for her but the hives were a new adverse event.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local injection site reaction.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient reports swelling, tenderness, redness at site of injection with headache and body aches within 24 hours of receiving the varicella vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient received the ZOSTAVAX vaccine on 08/28/17, did not pay attention and just realized in the evening  of 09/05/17 redness around the injection site. The redness is approximately 3 quarter sizes big, no fever, no itching , no soreness, no inflammation. Asked patient to watch for any change and may take or apply Benadryl  if needed.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient started experiencing redness and a little swelling on the mid part around the arm just about the elbow later in the day after receiving the vaccines earlier in the same arm. Advised patient to take some BENADRYL and if no improvement to see a doctor.