chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination failure
Clinical narrative: Case number PHEH2017US005138 is initial spontaneous report received from consumer on 15 Feb 2017. This report refers to 17-year-old female patient (weight-72.3 kg and height- 160.3 cm). The patient's medical history included: hematochezia, teratoma. FLUCELVAX QUADRIVALENT was administered on 08-Oct-2016 (Dosage: 0.5ml, route of administration: intramuscular, batch number: 185327, expiry date: 30-Apr-2017). After administration of FLUCELVAX QUADRIVALENT, on 15-Feb-2017 the patient experienced influenza (Seriousness criteria: Medically Significant), (Outcome - recovered), Associated Symptoms: cough, fever, chills, sore throat. It is reported that patient experienced flu because of vaccination failure. This was considered as vaccination failure (seriousness criteria: medically significant), (outcome - not reported). Batch review report (1021211) received from quality assurance department on 03-Jun-2017: Based on the document review, it was stated that the concerned FLUCELVAX QUADRIVALENT, batch number: 185327 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Treatment medications: TAMIFLU is administered for flu. The Consumer assessed the events as serious (medically significant) and the causality related (possibly) for vaccination failure and not related for Influenza. This case report was considered as serious (medically significant). Follow up received on 12-Apr-2017: Added reporter's details, updated patient details (height, weight and race), medical history (hematochezia, teratoma), added treatment drug (TAMIFLU), added events vaccination failure and influenza with symptoms (influenza with symptoms fever, chills and sore throat), updated outcome and causality for the events, accordingly updated narrative. Follow up received on 03-Jun-2017: Start date, batch number and expiry date of suspect vaccine was updated and batch review report (1021211) from quality assurance department was updated.
Sex: U
Vaccine: FLU4
Symptoms: Death, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on the internet about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what's your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness around the injection site about the size of a half dollar, warm to touch. Pain from the elbow to the neck on the right arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Gait disturbance, Hypersomnia, Middle insomnia, Mobility decreased
Clinical narrative: Patient actually received the SHINGRIX (NOT the ZOSTAVAX), but it was not an option to select above so I selected ZOSTAVAX. Following the night of the day she got the vaccine, patient woke up in the middle of the night with pain and soreness from head to toe. Patient said she could barely walk, move, get out of bed, or get dressed the next day. She also reported frequent sleeping for long periods of time during the 36 hours following vaccination. Patient also reported that her arm was red, swollen, and warm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Patient actually received the SHINGRIX (NOT the ZOSTAVAX), but it was not an option to select above so I selected ZOSTAVAX. Following the night of the day she got the vaccine, patient woke up in the middle of the night with pain and soreness from head to toe. Patient said she could barely walk, move, get out of bed, or get dressed the next day. She also reported frequent sleeping for long periods of time during the 36 hours following vaccination. Patient also reported that her arm was red, swollen, and warm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient reported that he was at the MD office for other reason and showed his arm to the MD and MD said it looked like a reaction. Arm presented with red rash about 4 inches in diameter.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Fatigue, Nausea
Clinical narrative: Patient approached consultation area, and appeared tired. I approached her and she fell down slowly, and was down for a couple of seconds. I went up to her and made sure she was okay, asked her if she had any trouble breathing. She had no trouble breathing, however she felt nauseous and lightheaded. We got her water and asked if she wanted anything to eat.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, hot, swollen arm.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Loss of consciousness, Nausea
Clinical narrative: Upon receiving the vaccine he stood up quickly from the chair and passed out immediately after. He fell back and his mom caught him and lowered him to the ground. He woke up quickly and said he felt nauseated. He drank a little water and cold rag. He sat there for a few minutes then got up and appeared to be alright and left with his family.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: The patient fainted about 2 minutes after the injection was administered. I moved her on the floor. I checked for breathing and she was breathing. She became conscious about 1 minute afterwards. She waited about 30 minutes and was given some cranberry juice and her color began to return.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt wife reports pt has been having arm soreness and dec range of motion on arm post injection to this day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Abnormal behaviour, Amino acid level, Autism spectrum disorder, Blood cortisol, Blood heavy metal normal
Clinical narrative: Beginning about 1 week after vaccination and rapidly progressing, patient has decreased all meaningful social interaction. He now paces constantly, verbalizes imaginary play without interacting with toys, parents or peers. He was diagnosed with late onset Childhood disintegrative disorder on 1/23/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: C-reactive protein normal, Drug screen negative, Dyskinesia, Full blood count normal, Metabolic function test normal
Clinical narrative: Beginning about 1 week after vaccination and rapidly progressing, patient has decreased all meaningful social interaction. He now paces constantly, verbalizes imaginary play without interacting with toys, parents or peers. He was diagnosed with late onset Childhood disintegrative disorder on 1/23/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate normal, Social avoidant behaviour, Urine organic acid test
Clinical narrative: Beginning about 1 week after vaccination and rapidly progressing, patient has decreased all meaningful social interaction. He now paces constantly, verbalizes imaginary play without interacting with toys, parents or peers. He was diagnosed with late onset Childhood disintegrative disorder on 1/23/18.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Altered state of consciousness, Dizziness, Hyperhidrosis, Hypoacusis, Nausea
Clinical narrative: Patient stated that she was experiencing nausea lightheadedness, dizziness and felt like she was going to pass out. Patient was not have breathing complication. She was sweating and said her ears were muffled for about 30 seconds.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Headache, Influenza, Oropharyngeal pain, Pyrexia
Clinical narrative: Received vaccine early afternoon Thursday, Jan 18, began to develop sore throat, coughing, running nose Friday afternoon, Jan 19, fever and severe headache Friday night, and continued to experience all the symptoms through Sunday evening, bed bound. I went to an Urgent Care Clinic that sent me to ER, where I was diagnosed with flu. I began to take TAMIFLU since Monday afternoon, improved, but as of now (Wed, Jan 24), hives appear on my upper lip.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: Received vaccine early afternoon Thursday, Jan 18, began to develop sore throat, coughing, running nose Friday afternoon, Jan 19, fever and severe headache Friday night, and continued to experience all the symptoms through Sunday evening, bed bound. I went to an Urgent Care Clinic that sent me to ER, where I was diagnosed with flu. I began to take TAMIFLU since Monday afternoon, improved, but as of now (Wed, Jan 24), hives appear on my upper lip.
Age: 20.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Headache
Clinical narrative: Developed severe headache lasting for 3 days that has been recurrent since 2006. Causality process results are that probably no causal relationship. Note influenza vaccine on the same day was FLUMIST, but not available on dropdown.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site movement impairment, Injection site pain, Limb injury, Product administered at inappropriate site, Vaccination complication
Clinical narrative: Adverse event included the vaccine being administered too high on patient left deltoid and inducing SIRVA shoulder injury related to vaccine administration- pain, limited range of motion to L shoulder.  Treatment has included NSAIDs, MEDROL dose pack and eventually referral to orthopedics for unresolving limited range of motion.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: CELLULITIS, PATIENT WAS GIVEN ANTIBIOTIC CEPHALEXIN.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Laboratory test normal, Mobility decreased
Clinical narrative: She hold her left arm like it is in a sling. While she can extend her arm and raise her arms it is not to the full ability as before or as her right can lift currently. She has not shown any signs of discomfort unless we try to manipulate her left arm and get it to extend. Things started at 11:00am and there was no fall or incident which is obvious that started it. We noticed it when she would not lift her arm to eat. We sought medical attenion that day at 1:30pm in which the physcian put her through supination test of her arm to rule out Nurse Maids Elbow. There were not clicks, or pops and the physican was positive that he could rule out that condition.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Pt. is G1 P0000, EDD: 2/25/2018 and was seen today in clinic. She  was given a flu vaccine on 10/11/2017 and, in error, she was given the vaccine again today, on 1/24/2018.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Crying, Injection site pain, Pain in extremity
Clinical narrative: Patient got vaccination for PPSV23 along with the flu shot each in separate arms. At the time patient did not receive any pain for the flu shot, but was mildly irritated from the PPSV23 shot in the other arm when the vaccine was shot in, but not when the needle entered. I told the patient that she can wait around for 20 minutes if she wanted to take caution or just let the pharmacy know as soon as possible, so patient left, but was feeling mild pain but did not complain about it while leaving. Hours later patient comes in crying and reports radiating pain only on the side with the PNEUMOVAX shot, but no pain with the flu shot side to the other pharmacist on duty, and the pharmacist tells the patient to go to urgent care. Have not heard from patient since that night...
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On unspecified dates on or after 01/03/2018, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot N000291, exp 02/23/2019; lot M037248, exp 02/21/2019; lot N009802 exp 12/19/2019) for prophylaxis, which had a temperature excursion of 32F up to 35F for 12 Minutes. It was reported that the vaccines did not have previous temperature excursion and It was detected because of a data logger. No adverse events were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # M041514, Exp. 11-OCT-2018; Lot# N021315, exp. 07-AUG-2019; N017395, exp. 07-JUN-2019; and PROQUAD, Lot# N024563, exp 06-MAR-2019; Lot# N0199825, exp. 19-JAN-2019, Lot# N013270, exp. 25-OCT-2018, Lot# N010867, exp. 01-OCT-2018, Lot# M041083, exp. 04-APR-2018, both for prophylaxis, which had a temperature excursion of 15F to 46F (17.2F) for 2 hours. It was reported that no the vaccines did not have previous temperature excursion and it was detected by a data logger. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event was reported.
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse prescriber concerning multiple patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M036056, exp 18-MAY-2019 and VARIVAX Lot# N017399, exp. 07-JUN-2019 for prophylaxis which had a temperature excursion of -9 C to 8 C for 59 hours. It was reported that the vaccines had a previous temperature excursion of -9 C to 8 C for 44 hours. The reported temperature excursion was because of a data logger. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 09-JAN-2018, the patient was inadvertently vaccinated with PROQUAD, by intramuscular route for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a grandmother referring to her grandson, a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with either hepatitis b vaccine (recombinant) (manufacturer unknown) or hepatitis a vaccine, inactivated (manufacturer unknown) for prophylaxis (dose, route of administration, lot# and expiry date were not reported). On an unknown date, the patient developed "hives from the face down to the feet" (urticaria). The grandmother reported that the patient received the vaccine as an infant but at the time of the report, the patient was 25 year old. The outcome of urticaria was unknown. The causality assessment between the aforementioned suspect therapies and the event of urticaria was not reported.
Sex: F
Vaccine: MENB
Symptoms: Chills
Clinical narrative: This is a spontaneous report received from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is 1st of three reports. An adolescent female patient of unspecified ethnicity received on an unknown date a single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. Next day after vaccination, the patient experienced chills. Outcome was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2018031110 Same reporter/product/event, different patient.;PFIZER INC-2018031111 Same reporter/product/event, different patient.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported to the pharmacy that her right arm became red, swollen, heated in a band where the injection was given, pt applied a cold pack with no relief. The reaction to the inj occurred fairly quickly.  The reporter is unsure of when the symptoms resolved due to the patient's incomplete reporting.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Joint crepitation, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Limited range of motion due to pain. Pain in arm, shoulder, neck. Popping sound. Pain in showering, shampooing, doing laundry, household chores, cooking (any pressure applied to arm), lifting, dressing. Had steroid shot in shoulder for pain, 01/15/18. Will begin physical therapy 01/26/18.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Limited range of motion due to pain. Pain in arm, shoulder, neck. Popping sound. Pain in showering, shampooing, doing laundry, household chores, cooking (any pressure applied to arm), lifting, dressing. Had steroid shot in shoulder for pain, 01/15/18. Will begin physical therapy 01/26/18.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given pediatric dose instead of adult dose. Waited in room 20 plus minutes with no reaction.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: RASH, HEAT AND SWELLING OF A 3 TO 4 INCH DIAMETER AREA WITH A HARD LUMP DEVELOPING UNDER THE EXACT INJECTION SITE ABOUT ONE INCH IN DIAMETER. THE AFFECTED AREA WAS SEVERELY ITCHY AND PAINFUL TO THE TOUCH. ON THE FIRST DAY 1/12/18 A FEVER OCCURED. THE PHARMACIST RECOMMENDED THAT SHE TAKE BENADRYL AND USE HYDROCORTISONE CREAM. SHE ROUTINELY TOOK BENADRYL EVERY 6 HOURS OR SO FOR THE FIRST 7 DAYS. ON TUESDAY 1/16/18 OR SO THE PATIENT SHOWED THE ARM TO THE VACCINATING PHARMACIST AND WAS TOLD TO TAKE BENEDRYL. ON FRIDAY 1/19/18 SHE RETURNED CONCERNED AS THE PAIN AND ITCHING WAS INTENSE. SHE WENT TO THE WALK-IN CLINIC IN TOWN AND WAS TURNED TO THE HOSPITAL EMERGENCY ROOM BUT DECLINED TO GO AS SHE WAS PREVIOUSLY ADVISED THAT SHE WAS NOT HAVING AN EMERGENCY.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: RASH, HEAT AND SWELLING OF A 3 TO 4 INCH DIAMETER AREA WITH A HARD LUMP DEVELOPING UNDER THE EXACT INJECTION SITE ABOUT ONE INCH IN DIAMETER. THE AFFECTED AREA WAS SEVERELY ITCHY AND PAINFUL TO THE TOUCH. ON THE FIRST DAY 1/12/18 A FEVER OCCURED. THE PHARMACIST RECOMMENDED THAT SHE TAKE BENADRYL AND USE HYDROCORTISONE CREAM. SHE ROUTINELY TOOK BENADRYL EVERY 6 HOURS OR SO FOR THE FIRST 7 DAYS. ON TUESDAY 1/16/18 OR SO THE PATIENT SHOWED THE ARM TO THE VACCINATING PHARMACIST AND WAS TOLD TO TAKE BENEDRYL. ON FRIDAY 1/19/18 SHE RETURNED CONCERNED AS THE PAIN AND ITCHING WAS INTENSE. SHE WENT TO THE WALK-IN CLINIC IN TOWN AND WAS TURNED TO THE HOSPITAL EMERGENCY ROOM BUT DECLINED TO GO AS SHE WAS PREVIOUSLY ADVISED THAT SHE WAS NOT HAVING AN EMERGENCY.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Patient was given PCV 13 vaccine that expired 7/11/2017.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Barium swallow, Computerised tomogram, Dysphagia, Electromyogram, Feeding disorder
Clinical narrative: Loss of muscle control. Swallowing difficulty. Muscle spasms/weakness legs/arms. Headache. Unable to eat solid food for months. Left side of throat and tongue paralyzed.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Laboratory test, Muscle contractions involuntary, Muscle spasms, Muscular weakness
Clinical narrative: Loss of muscle control. Swallowing difficulty. Muscle spasms/weakness legs/arms. Headache. Unable to eat solid food for months. Left side of throat and tongue paralyzed.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Oesophagogastroduodenoscopy, Paralysis, Tongue paralysis
Clinical narrative: Loss of muscle control. Swallowing difficulty. Muscle spasms/weakness legs/arms. Headache. Unable to eat solid food for months. Left side of throat and tongue paralyzed.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site reaction, Malaise, Pyrexia, Rash erythematous
Clinical narrative: Patient states he had a round, orange sized, red, itchy rash around the injection site since the injection date. Rash was visibly not noticible on 1/24/18 but patient complained site still was itchy. He also stated he had feelings of weakness, fever, malaise since injection. He stated he had been applying calamine lotion on the itch as well as another unknown cream to help the itching.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient states he had a round, orange sized, red, itchy rash around the injection site since the injection date. Rash was visibly not noticible on 1/24/18 but patient complained site still was itchy. He also stated he had feelings of weakness, fever, malaise since injection. He stated he had been applying calamine lotion on the itch as well as another unknown cream to help the itching.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient received PNEUMOVAX 23 and FLUZONE HD on 1/22/18. Later that night he had fever and local injection site swelling/redness. By the next morning the fever had subsided, but the injection site reaction continued to spread down his arm stopping about 3 inches above elbow. Patient reported to the pharmacy on 1/24 and was advised by pharmacist to take BENADRYL and monitor closely for any worsening or new symptoms, and seek immediate medical attention if so.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Electromyogram, Injection site pain, Injection site swelling, Joint range of motion decreased, Muscular weakness
Clinical narrative: 12/22/17 - left shoulder Swelling & pain then Neck pain after shoulder pain moved to neck x 3 weeks. 1/4/18 - Seen in Urgent Care - starting a week ago right shoulder pain and neck pain. Decreased ROM & has tried shoulder exercises. Taking Motrin & Norco for pain. Referred to Orthopedic physician. 1/8/18 - Seen in Orthopedics - Frozen shoulder (neck & right shoulder pain) - Weakness at right shoulder (xray was normal). Referred to Neurology for EMG study. 1/11/18 - Seen in Neurology - for right arm weakness. Referred to Physical Therapy before EMG study conducted. 1/23/18 - Seen in Physical Therapy - will be seen 1-2 times per week for 12 weeks.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Neck pain, Periarthritis, X-ray limb normal
Clinical narrative: 12/22/17 - left shoulder Swelling & pain then Neck pain after shoulder pain moved to neck x 3 weeks. 1/4/18 - Seen in Urgent Care - starting a week ago right shoulder pain and neck pain. Decreased ROM & has tried shoulder exercises. Taking Motrin & Norco for pain. Referred to Orthopedic physician. 1/8/18 - Seen in Orthopedics - Frozen shoulder (neck & right shoulder pain) - Weakness at right shoulder (xray was normal). Referred to Neurology for EMG study. 1/11/18 - Seen in Neurology - for right arm weakness. Referred to Physical Therapy before EMG study conducted. 1/23/18 - Seen in Physical Therapy - will be seen 1-2 times per week for 12 weeks.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented today with pain/soreness in her left arm claiming it has been sore and hard to use since receiving an PREVNAR and a FLUZONE HIGH DOSE shots on 12/29/17. She stopped in to ask if this was normal, since it is almost 4 weeks out she was informed that it is usually not still sore this far from the immunization date. She also claimed it had a "bump" on her arm. She claims she has had flu shots before so it would not be from the flu shot, and assumed it was from the PREVNAR. She has not gone to the dr as she has no insurance. Patient said she may have to be seen by a doctor since soreness from the immunizations is not "typical" for this length of time.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Eructation, Erythema, Flatulence, Flushing
Clinical narrative: Shortly after the shot was given the patient came back to the pharmacy because she started feeling dizzy and nauseous. The patient had redness and flushing of the face. She also exhibited symptoms of gassiness such as flatulence and burping. I asked the patient if it was okay for me to administer an EPI-PEN but she repeatedly denied the offer even after telling her the importance of it. I then insisted that the patient sit down for a few minutes and I grabbed a water bottle for her to drink. Every 5 minutes, I checked on the patient for continuous updates and she stated she felt better after drinking the water. She sat down for approximately 15 minutes before leaving the store and I walked her out to ensure everything was okay.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Shortly after the shot was given the patient came back to the pharmacy because she started feeling dizzy and nauseous. The patient had redness and flushing of the face. She also exhibited symptoms of gassiness such as flatulence and burping. I asked the patient if it was okay for me to administer an EPI-PEN but she repeatedly denied the offer even after telling her the importance of it. I then insisted that the patient sit down for a few minutes and I grabbed a water bottle for her to drink. Every 5 minutes, I checked on the patient for continuous updates and she stated she felt better after drinking the water. She sat down for approximately 15 minutes before leaving the store and I walked her out to ensure everything was okay.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Local erythema and swelling, approximately 10cm in greatest diameter.
Age: 25.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chest discomfort, Chest pain, Muscle tightness
Clinical narrative: Chest pain and tightness of chest and back started about 15 minutes following administration, patient's blood pressure was 120/80, respirations normal, pulse 72. 911 was called and patient was transported to hospital.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pyrexia
Clinical narrative: Red, feverish, inflamed area on arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Cellulitis, Erythema, Induration, Musculoskeletal pain
Clinical narrative: Initially had 4x5 inch area of swelling/induration directly below injection site a few hours after vaccine, blanched in the middle and red peripherally. Very painful; edges itchy/burning. Continued to grow. By next morning entire upper arm circumferentially from elbow up and including shoulder was swollen, indurated, and painful. No redness till later in the day when redness appeared over some of affected area. Very painful. Went back to MD's office. Now on KEFLEX for suspected cellulitis, and prednisone.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: Initially had 4x5 inch area of swelling/induration directly below injection site a few hours after vaccine, blanched in the middle and red peripherally. Very painful; edges itchy/burning. Continued to grow. By next morning entire upper arm circumferentially from elbow up and including shoulder was swollen, indurated, and painful. No redness till later in the day when redness appeared over some of affected area. Very painful. Went back to MD's office. Now on KEFLEX for suspected cellulitis, and prednisone.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Presyncope
Clinical narrative: Patient had vasovagal response to vaccination. Called 911 and cared for patient per CPR instructions - placed patient on ground, placed on side and observed breathing watching for any signs of allergic reaction or syncope. Paramedics arrived. Took patient vitals, which were all in normal range - BP and BG. Patient was able to leave on her own will. Followed up with patient 4 hours later via phone call. Said she felt fine - little tired.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Very red, swollen, & sore arm. Hard to move. Nausea & vomiting. Headache. Pt had to go to urgent care and got MEDROL dose pack, ZOFRAN ODT, & naproxen.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: Very red, swollen, & sore arm. Hard to move. Nausea & vomiting. Headache. Pt had to go to urgent care and got MEDROL dose pack, ZOFRAN ODT, & naproxen.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Local reaction
Clinical narrative: Large local reaction.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient developed rash.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Pt came in the store to complain about pain in her shoulder. She said the RPh who gave her the shot injected high in the arm. She wants a supervisor to contact her.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given PREVNAR 13 twice respectively on 1/14/2017 and 1/17/2018 patient said no adverse effect per conversation with PharmD.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Pt received both AFLURIA and PNEUMOVAX in the same arm and ended up getting cellulitis.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Induration 4 to 5 cm with centralized swelling at the site about 2 to 3 inches. Red and warm to the touch. She gave BENADRYL and ibuprofen to help the reaction.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Pt. presents to the clinic with mom on 1/20/18 with complains of new rash on head,torso and legs. Mom reports that it started Friday afternoon 1/19/20. Denies itching and other symptoms. It completely resolved yesterday 1/23/18,no fever. RN
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with 23 of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 16-year-old adolescent patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 27-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number: 1022277) received from quality assurance department on 29-Jul-2017: Quality assurance investigation results were updated and the narrative was amended accordingly. Non significant case correction received on 10-Aug-2017: Narrative and case comment were corrected.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left upper arm with 13cm x 13cm area of erythema and induration with swelling expanding from injection site. Tx plan: Ice, elevate, BENADRYL.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a male patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter's husband and she received the 1st dose of SHINGRIX on Friday. The patient had no side effects other than sore injection site. The reporter stated that I did not know if GSK wanted this to be reported or not. This case has been linked with case US2018GSK010905 (wife's case), reported by the same reporter.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Nausea on an off for 1 week. Patient is stable and fine. No vomiting only has nausea for 1 week on an off.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of frozen shoulder in a 54-year-old female patient who received Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced frozen shoulder. The patient was treated with non-drug therapy (Physical therapy). On an unknown date, the outcome of the frozen shoulder was recovered/resolved. It was unknown if the reporter considered the frozen shoulder to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporting office manager or clinical supervisor was not aware of any concomitant medications or vaccines, or any other medical history. The patient did not know brand (s) of flu vaccine (s) used in the past, and did not have lot numbers or expiration dates. The patient experienced frozen shoulder at least twice after the administration of an unknown brand of flu vaccine. The reporter stated that the patient believed that this happened on both sides, and that symptoms lasted for 4 months.
Age: 79.0
Sex: M
Vaccine: HEPA
Symptoms: Contusion, Pruritus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pruritus in a 79-year-old male patient who received HAVRIX. Concomitant products included FLUZONE, Aspirin, COQ10, COREG, hydrochlorothiazide and PRALUENT. On 1st September 2017, the patient received HAVRIX. On 1st September 2017, less than a day after receiving HAVRIX, the patient experienced pruritus and contusion. On an unknown date, the outcome of the pruritus and contusion were recovered/resolved. It was unknown if the reporter considered the pruritus and contusion to be related to HAVRIX. Additional details were provided as follows: This case was reported by the physician who himself was the patient. Concomitant medication also included PROTONIX. The patient experienced itching and bruising.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of stiffness in a female patient who received SHINGRIX. On 20th January 2018, the patient received SHINGRIX. In January 2018, 1 day 3 hrs after receiving SHINGRIX, the patient experienced stiffness, shivering and headache. On an unknown date, the outcome of the stiffness, shivering and headache were unknown. It was unknown if the reporter considered the stiffness, shivering and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At time of reporting, the reporter stated that approximately 27 hours ago she had SHINGRIX vaccine and the same morning the patient woke up feeling stiff and had been progressing throughout the day, had shivers, and slight headache. The aching the patient had a question on how long it would last. The reporter did not know what to expect and had gone on different websites.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Drug administered to patient of inappropriate age, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 39-year-old female patient who received SHINGRIX. On 20th January 2018, the patient received the 2nd dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 20th January 2018, the patient experienced inappropriate age at vaccine administration. On 21st January 2018, the patient experienced fever, injection site pain and weakness. On an unknown date, the outcome of the influenza-like symptoms, weakness and inappropriate age at vaccine administration were unknown and the outcome of the fever and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. The reporter considered the fever, injection site pain and weakness to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The 39 year old patient received SHINGRIX, which led to inappropriate age at vaccine administration. Last night from the day of reporting, less than a day after vaccination, the patient experienced flu like symptoms. One day after vaccination, the patient had weakness, fever and injection site pain.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with eighth report of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 19-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 18-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore, no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number: 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. The narrative was amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative was corrected.
Age: 17.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who all received flu vaccine. This case deals with fifteenth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 22-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative and case comment were corrected.
Age: 17.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This serious initial spontaneous case, was received on 01-Jun-2017, reported by other health professional (registered nurse) and concerns students in an academic campus, who all received flu vaccine. This case deals with thirteenth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 18-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative was corrected.