chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye movement disorder, Irritability, Somnolence, Tremor, Vomiting
Clinical narrative: Vomited x1 after leaving appointment. Fell asleep and upon waking became fussy. Mom gave patient TYLENOL (first dose ever given). Patient vomited up TYLENOL. Patient began trembling x 1-2 minutes, with abnormal eye movement. Patient then brought to clinic.
Sex: U
Vaccine: MMRV
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. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 18-JUL-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M010478, expiration date: 01-SEP-2017, route of administration was not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unspecified dates between 11-SEP-2016 and 14-SEP-2016, the patient s were vaccinated with unspecified doses of improperly stored GARDASIL (lot # M014929, expiry date: 27-MAY-2017). No adverse reactions were reported. This is one of the five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 20 year old patient of an unknown gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was erroneously vaccinated with a dose of ZOSTAVAX instead of VARIVAX (lot number/expiry date and dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a multiple unspecified number of patients of unknown age and gender. Information on pertinent medical history, concurrent conditions and drug allergies of the patient were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # L048464, expiry date 02-DEC-2017 (dose number, units, route and anatomical location were not specified) subcutaneous. Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. This report is cross linked to MARRS# 1609USA008428 (same reporter link). Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, Tendon pain
Clinical narrative: Shoulder/tendon pain with movement.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Myalgia, Oropharyngeal pain, Tremor
Clinical narrative: Elevated temperature , shaking chills, sore throat, Muscle pain.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysaesthesia, Head banging, Myalgia, Nausea
Clinical narrative: Myalgia, chills, headache, low-grade fever (99.9F), nausea (no vomiting), dysesthesia.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Myalgia, chills, headache, low-grade fever (99.9F), nausea (no vomiting), dysesthesia.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site pain, Injection site swelling, Joint range of motion decreased, Pyrexia
Clinical narrative: Greater than 101 degree F fever within an hour, vaccine injection site Pain/Swelling. Arm swelling and decreased range of motion. Upper chest pain.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Feeling hot, Nausea
Clinical narrative: Dizziness, nausea, hot, clammy.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: Developed shaking spells after vaccines EEG and MRI were normal sx have resolved.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Red area, slightly warm, spread to elbow.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Bone pain, Chills, Nasal congestion, Pain, Pyrexia
Clinical narrative: 12 y.o. child. Father called in AM on 9/16/16 et stated his dtr. wasn't feeling will after Td vaccine. He stated she was "running a fever and her bones hurt" went to observe child. Site of vaccine admin not red or swollen. Mom states temp high was 100.5. Child stated she is "sore all over". She states she has had chills and stuffy nose. Denies sore throat or cough. No other children sick at the time of visit. 9/19/16-spoke with father et he stated child is feeling better.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 08-SEP-2016, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (lot # M001745, expiration date 07-APR-2017; dose was unknown) subcutaneously. The vaccine was exposed under temperature of 31 degrees Fahrenheit for 5 hours. The previous temperature excursions were 35.7 degrees Fahrenheit for 3 hours, total cumulative excursion details: 35.7 degrees Fahrenheit for 8 hours. Data Logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Accidental exposure to product, Exposure via direct contact, No adverse event, Product quality issue
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, concurrent conditions and concomitant medications was provided. On an unknown date, as the reporting pharmacist was administering a dose of PNEUVMOVAX 23 injection, lot # L035687, expiration date: 16-FEB-2017, (dose and dose number were not provided), the medication leaked out onto the patient's skin. Another dose was administered successfully. No adverse effect was reported. Product quality complaint (PQC) had been filed for leaking PNEUMOVAX 23 syringe. Additional information is noted expected because the reporter did not wish to be contacted.
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 42 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 01-SEP-2016, the patient was inadvertently vaccinated with a dose of PROQUAD lot # L039269, expiration date 05-APR-2017 (dose not reported) subcutaneously. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L017407 and expiration date 15-AUG-2017, lot # L026602 and expiration date 19-OCT_2017, lot # L038503 and expiration date 18-DEC-2017; doses, site and route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L023870 and expiration date 20-APR-2017, lot # L039141 and expiration date 16-AUG-2017, lot # M004883 and expiration date 02-OCT-2017, lot # M019707 and expiration date 25-OCT-2017, orally; exact doses were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients; concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9, (dose, route of administration, lot# and expiration date were not reported). Administered dose of GARDASIL 9 was exposed to temperature of -1 degree of Celsius for 16 hours and 35 minutes, on an unknown date. There was previous temperature excursion which took 8 hours with the temperature 14 degrees of Celsius, on an unknown date. Digital data logger was no involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a multiple unspecified number of patients of unknown age and tender. Information on pertinent medical history, concurrent conditions and drug allergies of the patient were not reported. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD 9lot# M006103, expiry date 01-AUG-2017 (dose number, units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. This report is cross linked to MARRS# 1609USA002435 (same reporter link). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Body aches, fatigue, chills, fever 102 degree F.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, current condition and concomitant therapy were not reported. On unknown dates, the patient was vaccinated with 3 doses of GARDASIL (dose, route, lot # and expiration date not reported). The doses were not following the recommended schedule, across a period of 2 years. On 18-AUG-2016, the patient was administered a dose of GARDASIL 9 (lot # L048459, expiration date 28-FEB-2018, dose and route not reported). No adverse effect was reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Injection site pain
Clinical narrative: This spontaneous report was received from a 73 year old female patient. Patient's concurrent conditions included allergy to drug hypersensitivity. Historical drug included azithromycin (reported as arithromyacin), the patient had no pertinent medical history. On an unknown date in July 2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number, units, route and anatomical location were not specified). There were no concomitant medication. Approximately in an unknown date in July, the patient experienced severe pain at the injection site. Approximately in an unknown date in July, the patient also felt "lightheaded and exhausted". Approximately on an unknown date in 2016, outcome of dizziness, fatigue and injection site pain were reported as recovered/resolved. There were no Product Quality Concerns (PQC) involved. Relationship between the events and PNEUMOVAX 23 were not related. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unspecified dates between 11-SEP-2016 and 14-SEP-2016, the patients were vaccinated with unspecified doses of improperly stored M-M-R II (lot # L047133, expiry date: 24-NOV-2017). No adverse reactions were reported. This is one of the five reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 40 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 01-SEP-2016, the patient was inadvertently vaccinated with a dose of PROQUAD lot # L039269, expiration date 05-APR-2017, (dose not reported) subcutaneously. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. In 2009 (reported as "6 or 7 years ago"), the patient was vaccinated with an unspecified hepatitis A vaccine (manufacturer unknown) (dose, route, lot # and expiration date not reported). On 01-SEP-2016, the patient was in the office to receive a booster dose of the Hepatitis A vaccine in which VAQTA (dose, route, lot # and expiration date not reported) was going to be administered as the booster dose, which was outside of the dosage recommendations in the VAQTA prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 18-AUG-2013, the patient was vaccinated with GARDASIL dose 1 and dose 2 on 17-JUN-2016, dose 3 on 18-AUG-2014, intramuscular. On 30-AUG-2016, fourth dose was administered of GARDASIL 9. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacy student referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 31-AUG-2016, the patient was administered with a dose of PROQUAD intramuscularly instead of subcutaneously (product use issue). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored PROQUAD (lot # L016393, expiration date 08-NOV-2016; lot # L045678, expiration date 09-MAY-2017; lot # M004891, expiration date 25-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L008034, expiration date 05-AUG-2016, lot # L006184, expiration date 13-DEC-2016; dose was unknown) orally. No adverse effects was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (route, dose, lot number and expiration date were unknown). There were no reports of adverse effects. This is one of the three reports received from the same source. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also reported as an office administrator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VAQTA injection (lot# L043209, expiration date 17-SEP-2017, dose and route were unknown). The vaccines were exposed under 49 Fahrenheit degree (F) for 24 hours. No digital data logger was involved. There was no prior temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Lethargy, Malaise, Pruritus, Skin warm
Clinical narrative: Redness at and around injection site. Swelling, tenderness, warmth, itching, malaise, lethargy.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Redness at and around injection site. Swelling, tenderness, warmth, itching, malaise, lethargy.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema
Clinical narrative: RED PATCH AROUND HER ARM AT THE INJECTION SITE.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash
Clinical narrative: Rash/redness on neck/lower face and chest developed.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient is experiencing significant pain at injection site with, swelling the size of a baseball, redness, and is warm to the touch.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Headache, Rash
Clinical narrative: Headache. Red, raised rash on back, buttocks, and left leg.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Paraesthesia, Pyrexia
Clinical narrative: Fever yesterday to 101.  No meds. Had pain at injection site soon after vaccine administration.  Fever yesterday lasted most of the day but none today also redness at the injection site. This am little while after waking had numbness and tingling lateral half of hand and little distal ulnar aspect of forearm. Strength is okay. Advise cool compress to warm and tender area on arm. Tylenol for pain.  If not improving in one week return or sooner if worse.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Tenderness
Clinical narrative: Fever yesterday to 101.  No meds. Had pain at injection site soon after vaccine administration.  Fever yesterday lasted most of the day but none today also redness at the injection site. This am little while after waking had numbness and tingling lateral half of hand and little distal ulnar aspect of forearm. Strength is okay. Advise cool compress to warm and tender area on arm. Tylenol for pain.  If not improving in one week return or sooner if worse.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Severe bruising.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient did not report any adverse event on that FLUVIRIN was administered instead of FLUARIX.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Diarrhoea, Diet refusal, Gastrooesophageal reflux disease, Weight decreased
Clinical narrative: He started refusing food the morning after his vaccine. Initially eating very little on Thursday and by Friday eating almost nothing other than formula. By the weekend he was eating no solid food and was progressively taking less formula. His reflux had flared terribly, to the point of choking up liquid, and sometimes spitting up during his reflux episodes. At his worst, we were barely getting him to take 25 ounces of formula in a day, and he entirely refused solid food for about a week (on day 9 he ate a few bites of peaches, on day 11 he ate a small amount of turkey, and on day 12 he began eating small amounts of food on a more regular basis). He also developed diarrhea around Fri or Sat after the vaccine. The diarrhea initially lasted about 5 or 6 days, and has returned on and off for the past few months. His reflux flare lasted approximately 6 weeks and then became controlled again. He still suffers from bouts of diarrhea, which had not been a problem for 6 months before the vaccine.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event, inadequate vaccine dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Tenderness
Clinical narrative: Redness extending to 5 inches in radius within 72 hours, small blisters, mild tenderness - expected common side effects - size was reason for documentation.
Age: 1.42
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: Broke out in varicella rash diffusely - later shown by genotyping to be the vaccine strain. Responded well to acyclovir.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Rash
Clinical narrative: Rash of arms, legs, chest, back, eye swelling. Took Benadryl and fell asleep. Rash minimally improved, and swelling of eye improved. Was advised for worsening sx to seek emergent medical attention.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Inflammation, Skin warm
Clinical narrative: Patient's left arm was red, inflamed, and warm to the touch. She also had a headache 24 hours post vaccine administration.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: Injected only portion of vaccine in syringe; revaccinated with new dose per medical director instructions.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Rash, Rash macular
Clinical narrative: Directly from online message to MD from patient on 9/13/16 -  No reaction for 24 hours except for a headache which lasted 2-3 days. Day two I started to get a reaction at the site which spread as far as my collar bone. There were about 6 or more red splotches (I don't believe they were hives) and they were hot and itchy. I also got a mild rash on my legs and chest but that only lasted about 12 hours. I spoke with the advice nurse and she recommended I use ice on the red splotches-I did that and within 24 hours they had diminished significantly. I did not have a fever.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Injection site discomfort
Clinical narrative: Complained about arm where he recieved injection feeling "funny" then slowly fell forward from seated position on exam table and fell to the ground assisted by his mom and RN.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The nurse practitioner reported that the patient received her first dose of GARDASIL 9 on 19-MAY-2016, her second dose of GARDASIL 9 on 28-JUL-2016, and her third dose of GARDASIL 9 on 30-AUG-2016 (lot numbers, expiration date, dose and route of administration were not provided); which was outside of the recommendations in the GARDASIL 9 prescribing information. No adverse effect was reported. Additional information is not expected as the reporter did not wish to be contacted.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: High dose Flu vaccine for age 65 and older, given to 49 yr old. Called pt to inquire of condition - voice mailbox not set up.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nausea, Peripheral swelling
Clinical narrative: Pt Left arm red swollen, painful within hours of injection High dose FLUZONE. Pt felt nauseous.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist via field employee refers to multiple unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the multiple unspecified patients were vaccinated with ZOSTAVAX vial 19400 PFU (lot number/expiry date and dose not reported) subcutaneously. On an unknown date, the patients had experienced "tingling at injection site". The patient did not receive any treatment for the event. No Product Quality Complaint (PQC) was involved. The outcome of the event was recovered. The reporter did not provide any causality assessment between event and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unspecified dates between 11-SEP-2016 and 14-SEP-2016, the patients were vaccinated with unspecified doses of improperly stored PNEUMOVAX 23 (lot # M022086, expiry date: 09-OCT-2017). No adverse reactions were reported. This is one of the five reports received from the same reporter. 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 an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # M018636, expiration date 11-OCT-2017; lot # reported as M022400, expiration date 01-NOV-2017; lot # M018636, expiration date 11-OCT-2017, dose and route were not reported). No adverse symptoms were reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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, concurrent conditions and concomitant therapies were not reported. On 01-AUG-2016, the patient was vaccinated with a dose of improperly stored of PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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, concurrent conditions and concomitant therapies were not reported. On 26-JUL-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030871, expiration date 10-JUN-2016, lot # L042835, expiration date 19-AUG-2018; dose and route were unknown. No adverse effects was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse via company representative referring to an unspecified patient. No medical history or concurrent condition was reported. On 16-SEP-2016 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M017290, expiration date 07-Apr-2018, dose unspecified, subcutaneous). No concomitant medications were included. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also reported as an office administrator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # L033694, expiration date 16-JUN-2017, dose unknown) orally. The vaccines were exposed under 49 Fahrenheit degree (F) for 24 hours. No digital data logger was involved. There was no prior temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inflammation, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Swelling/inflammation/stiffness of the shoulder and upper arm. Pt experiencing residual stiffness as of 9/19. Advised pt to apply cool pack, take a dose of anti-inflammatory, and stretch arm and shoulder as tolerated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Altered state of consciousness, Presyncope
Clinical narrative: Vasovagal, regained consciousness right away. Gave water to drink with no issues.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: Patient reports knot under injection site (induration) about the size of a quarter with minor itching.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Induration
Clinical narrative: Patient reports knot under injection site (induration) about the size of a quarter with minor itching.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus
Clinical narrative: Patient began to feel some itching sensation around the upper lip and left temple area on face. This happened about 10 minutes after receiving the Havrix vaccination. Patient then took two diphenhydramine capsules and was observed for the next 40 minutes without any further escalation of symptoms. She then left the pharmacy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site arm got really red, swollen, and hot. Also had a red stripe horizontally 4 inches below injection site. Injection site was painful.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a 49 or 50 years old female patient. The patient had unspecified comorbidity. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, route and lot# were not reported). After receiving PNEUMOVAX 23, the patient was "unable to lift" her unspecified arm due to experiencing "a lot of pain under the arm" on an unspecified time. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Flushing, Injection site erythema
Clinical narrative: Information has been received from a medical assistant via a company representative referring to an 11 years old male patient. The patient's concomitant medication, medical history and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (3 dose series; lot #, expiration date dose were unknown; intramuscular). It was reported that the patient had a small red circle at injection site when given the second dose. The patient was flushed and ice pack was given to site of injection. Then the patient was kept lying down until he was ok. No lab diagnostics studies were performed. The dose series was continued. At the reporting time, the patient had recovered from the events. The causality was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus. Hydroxyzine 25 mg BID.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-SEP-2016, the patient inadvertently received and a dose of VARIVX (lot # L011083, expiration date: 01-APR-2017) and a dose of PROQUAD therapy type was not provided (lot # M017335, expiration date: 05-DEC-2017) (route of administration and injection site were not provided for both vaccine). No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Rash on hands, feet and scalp 24 hrs after receiving vaccine. No other symptoms.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Cellulitis
Clinical narrative: Vaccines given on Thursday 9/15/16. SISx of bacterial cellulitis developed on 9/16/16. Patient went to an outpatient clinic and was given antibiotic and dx.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Left arm: Pt has swelling and redness under arm neat armpits. Redness is about 4 inches.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Chronic throat clearing, Dysphonia, Pruritus, Throat irritation
Clinical narrative: Hoarse voice, throat clearing, chest tightening, tongue felt "strange", itching chest and back approximately 1-2 hours after vaccines; epi given SQ 1 hour after sym. started - also gave KARBINAL 15ml x 1and 30 mg prednisone po.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Nervousness
Clinical narrative: 102 degree F temperature starting 9/8/16 at night to 9-10-16. patient also stated feeling shaky that night.
Sex: U
Vaccine: MMRV
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. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 01-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M010478, expiration date: 01-SEP-2017, route of administration was not reported). No adverse effects were reported. This is one of several reports received from the same source, Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: Nearly lymph swelling; not at site of injection. Fever and swelling, fatigue. Ibuprofen
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Swelling
Clinical narrative: Erythema Multiform and Swelling. Diphenhydramine 0.5 ml once.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Rash about 3 inches wide, hot/warm to the touch. Rash not associated with any pain or itching. No fever, Patient feels fine/healthy.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and edema around injection site.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Adverse reaction
Clinical narrative: Patient went to the hospital for adverse reactions.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Pain, Sneezing
Clinical narrative: Cough, sneezing, sore throat, aches, elevated temp (but not above normal of 98.6).
Age: 78.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Diplegia, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling in extremities, numbness in legs. Progressed to temporary paralysis of legs.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Fatigue, Influenza like illness, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Pt presented to pharmacy on 9/18/16 complaining of feeling exhaused, drained, excessively tired, nauseous, and like she was getting the flu. She also reported having significant swelling and redness at the injection site shortly after receiving vaccine, which has slowly subsided over the next few days. She was concerned that at 5 days post-vaccination, she was left with a large blackish bruise at the injection site with tenderness still in her arm. She stated that even her t-shirt rubbing against her arm still hurt. When asked about treatments she has tried, she reported icing the injection site and surrounding areas and also using a heating pad on other sore/painful areas of her body.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Nausea, Pain, Tenderness
Clinical narrative: Pt presented to pharmacy on 9/18/16 complaining of feeling exhaused, drained, excessively tired, nauseous, and like she was getting the flu. She also reported having significant swelling and redness at the injection site shortly after receiving vaccine, which has slowly subsided over the next few days. She was concerned that at 5 days post-vaccination, she was left with a large blackish bruise at the injection site with tenderness still in her arm. She stated that even her t-shirt rubbing against her arm still hurt. When asked about treatments she has tried, she reported icing the injection site and surrounding areas and also using a heating pad on other sore/painful areas of her body.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: 9/18/16 MD Notes: Left upper arm - erythematous, warm and slightly swollen on inner surface of entire upper arm. Doesn't pass elbow or armpit. Injection site of vaccine clear. Symptoms consistent with allergy.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 9/18/16 MD Notes: Left upper arm - erythematous, warm and slightly swollen on inner surface of entire upper arm. Doesn't pass elbow or armpit. Injection site of vaccine clear. Symptoms consistent with allergy.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Pain, Urticaria
Clinical narrative: Hive-like welts on arm where vaccine was administered. Did not present as typical hives as the area was not itchy. Area had welts and was inflammed red. Patient reported some soreness. Welts appeared two days after vaccine administration.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema
Clinical narrative: She had redness at the injection site that had spread up her arm (toward shoulder). We recommended BENADRYL or CLARITIN and a topical hydrocortisone. I also recommended putting ice on the area.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Patient experienced redness and swelling and soreness at injection site and upper arm. Also had inflamed rash on upper back/neck area.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient got a swollen arm from the shoulder to the elbow. It is also red and painful.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Fracture treatment, Wrist fracture
Clinical narrative: Seen 9/7/2016 - open fx (L) wrist. To OR for repair. Discharge same day.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 23-MAY-2016, the patient was vaccinated with improperly stored VAQTA (lot # K008333, expiry date: 10-MAR-2017 or M011116, expiry date: 17-JUN-2017) (dose and route of administration were not reported) and improperly stored GARDASIL 9 (L045711, expiry date: 08-MAY-2017, or M004116, expiry date: 12-OCT-2017, or L011846, expiry date: 16-JUN-2017) (dose and route of administration were not reported), both. No concomitant therapy was reported. Maximum temperature excursion was 22.7 Celsius degree for 3 hours 48 minutes and minimum temperature was 0.2 Celsius degree for 31 hours 1 minute. Time frame and date of excursion were unknown. It was not reported, if data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a  17 year old female patient via social media. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route of administration were not reported). Patient's concomitant medication was not reported. On an unknown date, the patient experienced an unspecified adverse event (reported as another life ruined by the GARDASIL vaccine). The outcome of the unspecified event was not reported. The reporter did not provided the relationship between the unspecified event and GARDASIL. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, as there is no contact information.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA, for prophylaxis (dose, route of administration, lot# and expiration date were not reported). Administered dose of VAQTA was exposed to temperature of -1 degree of Celsius for 16 hours and 35 minutes, on an unknown date. There was previous temperature excursion which took 8 hours with the temperature 14 degrees of Celsius, on unknown date. Digital date logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse who refers to multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in January 2016, multiple patients were vaccinated with improperly stored doses of M-M-R II lot # L020189 expiration date 03-MAR-2017, L026551 expiration date 16-JUL-2017. Dose, route and anatomical location were not provided. No other concomitant medications were reported.. Excursion details: The vaccine was exposed to 9 degree F for a total of 9 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Needle issue, No adverse event, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of adult patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the unspecified number of adult patients were vaccinated with unspecified doses of M-M-R II (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported) with a 29 gauge, 1/2 inch needle. No symptoms were reported. Product quality complaint (PQC) was not filed. As of 15-SEP-2016 all telephone attempts to obtain follow-up information has been unsuccessful. Additional information has been requested. The report details, event, and narrative were update.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a 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 15-SEP-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # reported as M022947, expiration date 12-NOV-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 68 degrees Fahrenheit for 50 hours. Data logger was involved. 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 licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 35.8 degrees Fahrenheit for 45 minutes. Data logger was involved. Previous excursions were at the temperature of 35 degrees Fahrenheit for 1 hour. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.