chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia
Clinical narrative: Stomach ache/pain LUQ x 4 hours: no treatment.  resolved on its own Fever and chills between 101.6-102.6 intermittently for 40 hours, treated with q4hours ibuprofen, acetaminophen,plus  increased fluids, sleep, rest, inactivity Light-headed and balance issues with extreme weakness and fatigue: treated with sleep, rest, inactivity Severe aches and pains entire body including all joints: treated as for fever. Especially severe headache with photophobia: treated as above plus wearing sunglasses indoors and closing all drapes, avoiding all light. Most acute symptoms resolved within approximately 40 hours although I continued to have exagerated fatigue, muscle aches and intermittent temperature spikes for the next 08 days beyond initial severe reaction.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Mouth swelling, Swelling face
Clinical narrative: swelling left side of face/mouth and lips
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: About 12 hours after vaccination: fever (101 F), shaking chills, muscle aches. All resolved within 12 hours after onset.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: October 6th had 100.8 fever, fatigue and just didn't feel good. No fever on October 7th. Fatigue and didn't feel good until October 13th. Left Arm very sore from October 6 through October 12.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: "Flu shot given and five hours later patient became sick to her stomach and the room started spinning.  When she wakes up from sleep feeling like the room is spinning and struggles to focus on da-to-day tasks. Patient was still c/o of dizziness on 10/1/2020 when she contacted Health clinic. Health clinic sent referral for, Patient has not been to clinic as of 10/13/2020
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient called pharmacy on 10/13/2020 to report she was still experiencing pain in her shoulder following influenza vaccine given 10/08/2020.  Patient reported having tenderness, warm to the touch, and visible swelling on vaccinated arm that lasted approximately 36 hours. Patient reports she now has pain radiating out from injection site to the shoulder and while she has full range of motion in shoulder, she is self limiting her range due to the pain.  Patient took Ibuprofen 10/12/2020 in the evening for pain .  Pharmacist recommended patient continue with anti-inflammatory medication, ice for pain, and to follow up with physician for evaluation.
Age: 71.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Abdominal discomfort, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: I requested a flu vac, and  the tech told me I had'nt  yet had my 2nd pneumovax, and I wouldnt have immunity.  Told her I thought I had..she said it wasnt on the National Registry, and pharmacist said that meant it wasnt done.  I agreed to have it.  Later that night my arm began throbbing, so applied ice.  It was very painful all night with GI upset and chills for 45min.  Felt fatigued the next  day.  My arm felt some better.  My records showed I had Pneumoccal Polysaccharide vac 07012011, and Pnemococcal PCV13 12022016.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Immunization was expired.  No additional treatment was given. Patient tolerated well. No injury to patient.
Age: 38.0
Sex: M
Vaccine: FLUC4, HEP, MMR, VARCEL
Symptoms: Delirium, Dizziness, Feeling hot, Incoherent, Unresponsive to stimuli
Clinical narrative: Patient was delirious and unresponsive for ~ 90 seconds about two minutes after given the vaccines.   A couple of minutes prior, the patient was complaining of feeling dizzy and hot.  I went to fetch the patient a bottle of water.  When I returned, the patient was minimally responsive for a moment, then went unresponsive.   911 was promptly called, the emergency pack, with EpiPen was about to be prepared, and then the patient started to come back to coherence.  Paramedics arrived within 5 minutes, evaluated the patient for ~20 minutes, and departed as a result of patient refusing continued care.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt Fainted into her mother arms. Came back about 1 minute. was alert and oriented. no anaphylaxis. mom mentioned patient did not eat for the afternoon. she was given a pepsi and potato chips after anaphylaxis was ruled out and low blood sugar was suspected
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Nervousness, Vomiting
Clinical narrative: Patient vomited after vaccination; unclear if it was due to vaccine or nervousness.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Nodule, Pyrexia
Clinical narrative: Patient received shot on Friday with no issue. Patient stated Saturday that they observed no nausea but fever, chills, and general malaise that would spike several times a day. Patient said he felt terrible and when he woke up, he felt a knot the size of a tennis ball under left arm. Patient went to an ER and providers stated that it appeared to be a lymph node reaction with no further additional treatments to therapy. Patient called the pharmacy on Tuesday to say it was getting much better but knot, will smaller (approximately the size of a golf ball), is still present.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: 10/9/20 received vaccine at approximately 2:00pm.  Immediately felt soreness in arm.  Started feeling tired with terrible headache around 6:00pm.  Then around 9:00pm started having  muscle and joint aches.  Took tylenol and went to bed.  Woke up at 2:30 am on 10/10/20 with severe chills; took tylenol and added blankets.  On 10/10/20 stayed in bed all day/night; experienced fevers of 102 and extreme headaches, muscle and joint pain.  Took tylenol throughout the day and used ice packs for fever.  By 10/11/20 woke feeling better with no fever and less headache, muscle and joint pain.  By 10/12/20 all symptoms with exception of some arm soreness had subsided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: 10/9/20 received vaccine at approximately 2:00pm.  Immediately felt soreness in arm.  Started feeling tired with terrible headache around 6:00pm.  Then around 9:00pm started having  muscle and joint aches.  Took tylenol and went to bed.  Woke up at 2:30 am on 10/10/20 with severe chills; took tylenol and added blankets.  On 10/10/20 stayed in bed all day/night; experienced fevers of 102 and extreme headaches, muscle and joint pain.  Took tylenol throughout the day and used ice packs for fever.  By 10/11/20 woke feeling better with no fever and less headache, muscle and joint pain.  By 10/12/20 all symptoms with exception of some arm soreness had subsided.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient came in to the pharmacy and complained that ever since he got his shot (beginning the day after ) his left arm was hurting and he was unable to move his arm well - his range of motion was compromised. He was adamant that the shot caused it.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Inflammation
Clinical narrative: inflammation/cellulitis
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: The patient had a swollen arm for 6 that spread to under her breast and her lymphnode was swollen as well.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache
Clinical narrative: Patient reports waking up with a "bad headache that was not normal" the day after receiving this years flu shot.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: Patient reports waking up with a "bad headache that was not normal" the day after receiving this years flu shot.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache
Clinical narrative: Bad migraine headache, body aches, fever.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: Bad migraine headache, body aches, fever.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Angular cheilitis, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Had sore throat and "swollen glands" within 12 hours of vaccination, which attributed to side effect of HD vaccine.(Mon) Felt fine next day (Tues)  Had a can of diet AW root beer with lunch on Wed, and by 4 pm had a severe sore throat, swollen glands.  Had to rest, take Advil, suck losenges, and drink tea.   Better Thursday but then developed angular cheilitis/small cold sore following week, which is rare
Age: 44.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Influenza vaccine was administered, but type and lot are unknown at this time. Within 6 hours, injection site was red, itchy and painful. Swelling and redness continued to spread throughout night. Awoke with neck and back stiffness, in addition to inflammatory response adjacent to injection site.  Swelling progressed within 36 hours to a severity that produced numbness and tingling along median nerve (into hand and digits 1-3). Was seen at convenient care location, by a nurse practitioner, who prescribed a short dose of prednisone (3x 20mg tablets), ice and ibuprofen.
Age: 44.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pruritus, Musculoskeletal stiffness, Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: Influenza vaccine was administered, but type and lot are unknown at this time. Within 6 hours, injection site was red, itchy and painful. Swelling and redness continued to spread throughout night. Awoke with neck and back stiffness, in addition to inflammatory response adjacent to injection site.  Swelling progressed within 36 hours to a severity that produced numbness and tingling along median nerve (into hand and digits 1-3). Was seen at convenient care location, by a nurse practitioner, who prescribed a short dose of prednisone (3x 20mg tablets), ice and ibuprofen.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: pt woke up with redness at elbow fold, under breast and around neck the next morning after flu shot
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain
Clinical narrative: Patient's spouse called at 6:30pm on 10/13/20 to report that patient was experiencing chills, nausea, and achiness.
Age: 59.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Gait inability, Headache, Lip swelling, Swelling
Clinical narrative: Swelling of tongue, lips, and chin.  Next morning very dizzy could not walk and had a headache.
Age: 59.0
Sex: F
Vaccine: HPV9
Symptoms: Swollen tongue
Clinical narrative: Swelling of tongue, lips, and chin.  Next morning very dizzy could not walk and had a headache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient has a red and swollen rash on left arm that is hot to the touch. Patient has been taking tylenol and using a pain cream for pain and discomfort. She is concerned the rash would not go away.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Suicidal ideation
Clinical narrative: Suicidal ideation for 1 hour
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: Around 3 hours after injection some difficulty breathing/fully catching breath, chills, shakes, fever (100 degree). The next day had general aches and weakness.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Around 3 hours after injection some difficulty breathing/fully catching breath, chills, shakes, fever (100 degree). The next day had general aches and weakness.
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Diarrhoea, Fatigue, Hyperhidrosis, Induration
Clinical narrative: Fever up to 103 next day still  at 101.6. Third day  100.7( today).  Swollen right deltoid, hard, painful.  ( cut my finger with a chainsaws, shoulder hurts more than the finger!) , chills, sweating, diarrhea, achy, tired.
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever up to 103 next day still  at 101.6. Third day  100.7( today).  Swollen right deltoid, hard, painful.  ( cut my finger with a chainsaws, shoulder hurts more than the finger!) , chills, sweating, diarrhea, achy, tired.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Chills, Dyspnoea, Fatigue
Clinical narrative: Around 3 hours after getting immunization experienced difficulty breathing/catching breath fully/weight on chest, chills, shakes, fever of 100 degrees F. The next day experienced general weakness and fatigue, ongoing for a couple days after that.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Tremor
Clinical narrative: Around 3 hours after getting immunization experienced difficulty breathing/catching breath fully/weight on chest, chills, shakes, fever of 100 degrees F. The next day experienced general weakness and fatigue, ongoing for a couple days after that.
Age: 71.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Imaging procedure, Seizure
Clinical narrative: PT REPORTED HAVING A SEIZURE APPROXIMATELY 5 HOURS AFTER RECEIVING THE VACCINATION. HE REPORTS NO PRIOR HISTORY OF EPILEPSY. WAS SEEN IN EMERGENCY DEPARTMENT AND DISCHARGED SAME DAY. OTHER IMAGING PROVED INCONCLUSIVE FOR CAUSE.
Age: 71.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Computerised tomogram, Confusional state, Electrocardiogram, Electroencephalogram, Feeling abnormal
Clinical narrative: PT REPORTED HAVING A SEIZURE APPROXIMATELY 5 HOURS AFTER RECEIVING THE VACCINATION. HE REPORTS NO PRIOR HISTORY OF EPILEPSY. WAS SEEN IN EMERGENCY DEPARTMENT AND DISCHARGED SAME DAY. OTHER IMAGING PROVED INCONCLUSIVE FOR CAUSE.
Age: 71.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Generalised tonic-clonic seizure, Laboratory test, Magnetic resonance imaging, Myalgia
Clinical narrative: PT REPORTED HAVING A SEIZURE APPROXIMATELY 5 HOURS AFTER RECEIVING THE VACCINATION. HE REPORTS NO PRIOR HISTORY OF EPILEPSY. WAS SEEN IN EMERGENCY DEPARTMENT AND DISCHARGED SAME DAY. OTHER IMAGING PROVED INCONCLUSIVE FOR CAUSE.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Mass, Pain
Clinical narrative: Patient's wife called on 10-13-2020 stating patient received the pneumonia vaccine and since then, he has a large lump with  pain radiating to his back and other arm that is getting worse day by day since he received the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Pt experiencing red and sore arm that is warm to touch
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: "pain redness itching and swelling at injection site for 3 days"
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Inflammation, Rash, Rash erythematous, Skin warm
Clinical narrative: Red rash on left arm, inflammation, and warm to touch, informed patient to seek medical help or go to the emergency room, told patient to follow up with us, outcomes unknown
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: An hour and a half after the patient's second dose of Shingrix, he became severely exhausted and drained of energy. He also developed a headache and became very hot and sweaty. These symptoms lasted all day long, but subsided by the next day.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Lethargy, Pain, Pyrexia
Clinical narrative: Fever (about 101.5) for day and a half; lethargy, achy; weak.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Diarrhoea, Fatigue, Insomnia, Pyrexia
Clinical narrative: Well I was given the Shingrix AND a flu shot at the same time and was not advised not to do that. I did find out this morning (after a hellish night of no sleep and extreme fever) that they don't advise that...so why didn't they tell me not to do that or give me SOME sort of information of possible side effects, etc. I was up all night with a very high fever and I couldn't do anything today but stay in bed. I'm feeling a lot better now but I thought I was dying last night with nearly a 103 degree fever. I took Tylenol today and except for some diarrhea today, I am feeling a lot better (still tired).
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: The patient had flu like symptoms. Extreme sweating and a fever of 100 F. This  was reported by the patient to have  lasted for 6 hours
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: throbbing pain in entire arm
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: she has rash bigger than 10cm, and itching  after vaccination
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: swelling around injection site
Age: 51.0
Sex: M
Vaccine: FLUR4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that his arm hurt like normal last night after the shot. Today, he could tell it was bothering him more and more. In the afternoon, he got home and was able to take a closer look at it and his whole upper arm was swollen and got progressively more swollen during the day. Patient was advised to ice it and call MD. Also, he was told he may have to take Benadryl, but to call MD first in case MD wants to see him so that he would not be too drowsy to drive to the office. Requested that patient call pharmacy with an update later. Pharmacist attempted to reach out to patient later, but phone went to voicemail.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: itch at site of injection
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pruritus, Injection site reaction, Peripheral swelling, Rash erythematous
Clinical narrative: Mild itch beginning shortly after injection at injection site and surrounding area. Next day 9/27 after a jog in the evening, noticed red rash at injection site, 14 cm by 16 cm. Lateral left arm swollen. Took 50mg benadryl and went to sleep. Next day 9/28, redness slightly faded, but spread distally and arm was still swollen. Took 50mg benadryl that day. Next day 9/29, redness faded further and swelling reduced. 9/30 symptoms were gone.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Paraesthesia, X-ray limb
Clinical narrative: Immediately felt tingling down arm and into fingers of injection arm. Within 1 hour, couldn?t lift arm. Continued until 10/9/20 and is now gradually resolving. Was examined by Dr today. Not yet fully recovered.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: PATIENT COMPLAINED ABOUT DIARRHEA, CHILLS, NAUSEA AFTER 3 HOURS OF RECIEVING THE VACCINE.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure decreased
Clinical narrative: Patient experienced drop in blood pressure 4 hours after shot and went to hospital  where she received epinephrine
Age: 29.0
Sex: M
Vaccine: FLUR4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Inflammation, Injection site reaction, Nausea
Clinical narrative: Patient immediately had an inflammatory reaction after immuzation was given at injection site. Patient then began to sweat and then got nauseous and vomited.
Age: 29.0
Sex: M
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: Patient immediately had an inflammatory reaction after immuzation was given at injection site. Patient then began to sweat and then got nauseous and vomited.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: Patient reported redness at injection site that spread to her torso.  Also complained of possible swelling in back of throat.  The pharmacy was notified of these events 3 days post injection.
Age: 52.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT  STATED INJECTION SITE IS  RED, SORE, RAISED AND ITCHING.  SYMPTOMS STARTED ON 10/12/20 EVENING AROUND 8:00PM.  CALLED PHARMACY ON 10/13/20. NO OTHER ISSUES. RECOMMENDED PATIENT TO CONTACT DOCTOR.
Age: 68.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Chills, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Approximately 8 hours after vaccination, developed sudden malaise, nausea (no vomiting), then shaking chills which lasted about 8 hours, then ended with profuse sweating
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: Patient fainted after receiving shots.  He left health room and sat down in waiting area and fainted then.  Was very pale and felt nauseated.  Was able to walk on his own eventually.  Gave him water and some orange juice and he first laid down for a while, then sat down on floor, then on the chair.
Age: 23.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Syncope
Clinical narrative: patient fainted and no treatment was given.
Age: 55.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site pain, Injection site warmth, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Site of injection got very warm/hot and very sore. Swelling from elbow down to fingers (right arm).On the fingers there were a few little pockets of puss. Fingers were itchy and painful. (all of these were reported 2 days after immunizations administered). The Shingle vaccine was administered in Right Arm (top) and Flu vaccine Right Arm (bottom)
Age: 55.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Purulent discharge
Clinical narrative: Site of injection got very warm/hot and very sore. Swelling from elbow down to fingers (right arm).On the fingers there were a few little pockets of puss. Fingers were itchy and painful. (all of these were reported 2 days after immunizations administered). The Shingle vaccine was administered in Right Arm (top) and Flu vaccine Right Arm (bottom)
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Varicella vaccine given on 10-12-2020 @ 12:38pm by RN. Patient waited for 15 minutes after injection to monitor for adverse reactions. No reactions noted at that time. Patient's right arm started to feel warm, itchy, & visibly swollen around 1:30pm on 10/13/2020. She also stated she had a headache. No other actions noted.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Administered vaccine according to normal procedure. Patient reported she felt pain in her arm/shoulder. PCP called to advise of the adverse effect and that patient will be fine
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Rash
Clinical narrative: Patient stated a few days after vaccine he started feeling bumps under neath his arm (3 big bumps), numbness in the arm and pain down his leg on the Rt. side
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Pain + stiffness  Even told the nurse that it hurt when injection was given
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Dysgeusia, Musculoskeletal stiffness, Pain in extremity, Pruritus
Clinical narrative: had metal taste in mouth within the two hours my L Arm started to hurt more, it was burning / itching / feeling like it was stiffning, looked at sight and noticed something was wrong went and showed MA, she took me to show Dr. was advised that I was A having an reaction take some BenadryL go home f/u with
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysstasia, Nausea
Clinical narrative: patient Felt dizzy and nausea, unable to stand up.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt complains of pain in lt shoulder area. She has decreased range of motion
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injected limb mobility decreased, Malaise, Pain, Pain in extremity
Clinical narrative: Pt reports she immediately was dizzy, woozy and her arm was sore. She reported that she delevoped a fever of 100 F. She says she couldn't move her left arm due to the pain in her shoulder. She says she felt so sick she almost called an ambulance. She says she thinks she is just sensitive to vaccinations.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt reports she immediately was dizzy, woozy and her arm was sore. She reported that she delevoped a fever of 100 F. She says she couldn't move her left arm due to the pain in her shoulder. She says she felt so sick she almost called an ambulance. She says she thinks she is just sensitive to vaccinations.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Pain in muscle in left arm that I noticed the day after injection. I thought it was from the site but after a few days the pain was deep in the muscle and not at injection site. It still hurts to raise arm over my head or to swing arms. When sleeping, I have to sleep on my back so I do not put any pressure on arm. When walking, it feels best to hold arm close to my body so that it does not move (which causes pain).
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Sleep disorder
Clinical narrative: Pain in muscle in left arm that I noticed the day after injection. I thought it was from the site but after a few days the pain was deep in the muscle and not at injection site. It still hurts to raise arm over my head or to swing arms. When sleeping, I have to sleep on my back so I do not put any pressure on arm. When walking, it feels best to hold arm close to my body so that it does not move (which causes pain).
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Asthenia, Chest discomfort, Feeling abnormal, Influenza like illness, Pruritus
Clinical narrative: rash; fever; itching; couldn't breathe; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves female patient (age not reported) who experienced rash, fever (pyrexia), itching (pruritus) and couldn't breathe (dyspnoea) , while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing drug hypersensitivity of neomycin and hydrocortisone.   On 08-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 23-Sep-2020, the patient developed a non-serious rash, fever (pyrexia), itching (pruritus) and couldn't breathe (dyspnoea) 15 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.   The patient was treated with HYDROXYZINE (ATARAX [HYDROXYZINE]) and nebulizer.  The event outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Rash
Clinical narrative: rash; fever; itching; couldn't breathe; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves female patient (age not reported) who experienced rash, fever (pyrexia), itching (pruritus) and couldn't breathe (dyspnoea) , while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing drug hypersensitivity of neomycin and hydrocortisone.   On 08-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 23-Sep-2020, the patient developed a non-serious rash, fever (pyrexia), itching (pruritus) and couldn't breathe (dyspnoea) 15 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.   The patient was treated with HYDROXYZINE (ATARAX [HYDROXYZINE]) and nebulizer.  The event outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Dyspnoea, Pruritus, Pyrexia, Rash
Clinical narrative: rash; fever; itching; couldn't breathe; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves female patient (age not reported) who experienced rash, fever (pyrexia), itching (pruritus) and couldn't breathe (dyspnoea) , while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing drug hypersensitivity of neomycin and hydrocortisone.   On 08-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 23-Sep-2020, the patient developed a non-serious rash, fever (pyrexia), itching (pruritus) and couldn't breathe (dyspnoea) 15 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.   The patient was treated with HYDROXYZINE (ATARAX [HYDROXYZINE]) and nebulizer.  The event outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Was diagnosed with cellulitis; she has diabetes; This spontaneous report has been received from a 40 year old female patient referring to herself. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On 03-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for pneumonia. On the same date, at night the patient got sick with fever and she had the arm inflamed. The patient experienced headaches and nausea. On 05-OCT-2020, the patient went to the emergency room where was diagnosed with cellulitis and received 4 intravenous pain medication and antibiotics for 7 to 14 days. It was also mentioned that an ultrasound was performed, however, there was no result provided  On an unknown date in 2020, the patient developed diabetes mellitus and her glucose level was 680 (units were not provided). At the reporting time, the outcome of cellulitis and diabetes mellitus was reported as resolving. The causality assessment was not provided.  Upon internal review, cellulitis and diabetes mellitus were determined to be medically significant.
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Blood glucose increased, Cellulitis, Diabetes mellitus, Headache, Inflammation
Clinical narrative: Was diagnosed with cellulitis; she has diabetes; This spontaneous report has been received from a 40 year old female patient referring to herself. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On 03-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for pneumonia. On the same date, at night the patient got sick with fever and she had the arm inflamed. The patient experienced headaches and nausea. On 05-OCT-2020, the patient went to the emergency room where was diagnosed with cellulitis and received 4 intravenous pain medication and antibiotics for 7 to 14 days. It was also mentioned that an ultrasound was performed, however, there was no result provided  On an unknown date in 2020, the patient developed diabetes mellitus and her glucose level was 680 (units were not provided). At the reporting time, the outcome of cellulitis and diabetes mellitus was reported as resolving. The causality assessment was not provided.  Upon internal review, cellulitis and diabetes mellitus were determined to be medically significant.
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Nausea, Pyrexia, Ultrasound scan
Clinical narrative: Was diagnosed with cellulitis; she has diabetes; This spontaneous report has been received from a 40 year old female patient referring to herself. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On 03-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for pneumonia. On the same date, at night the patient got sick with fever and she had the arm inflamed. The patient experienced headaches and nausea. On 05-OCT-2020, the patient went to the emergency room where was diagnosed with cellulitis and received 4 intravenous pain medication and antibiotics for 7 to 14 days. It was also mentioned that an ultrasound was performed, however, there was no result provided  On an unknown date in 2020, the patient developed diabetes mellitus and her glucose level was 680 (units were not provided). At the reporting time, the outcome of cellulitis and diabetes mellitus was reported as resolving. The causality assessment was not provided.  Upon internal review, cellulitis and diabetes mellitus were determined to be medically significant.
Age: 7.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Expired product administered
Clinical narrative: expired FLUZONE QUADRIVALENT was given to a patient, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 7 years old male patient who was vaccinated 0.5 ml expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT6756NA  and expiry date: 30-Jun-2020) was given to a patient via intramuscular route in the left deltoid for prophylactic vaccination on 29-Sep-2020 (PT: Expired vaccine used).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medications were given to the patient.  It was an actual medication error case due to expired vaccine used (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired FLUZONE QUADRIVALENT was given to a patient, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 7 years old male patient who was vaccinated 0.5 ml expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT6756NA  and expiry date: 30-Jun-2020) was given to a patient via intramuscular route in the left deltoid for prophylactic vaccination on 29-Sep-2020 (PT: Expired vaccine used).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medications were given to the patient.  It was an actual medication error case due to expired vaccine used (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Acne, Blister, Blister rupture, Decreased appetite
Clinical narrative: I got a red boil which fills up as a blister on my left forearm on 09/26 the morning after my vaccine, the blister broke at the end of the day and refills with fluid. I had pain on that boil for several days and it is drier today but still not healed up. On 9/28, I called up  vaccination line to report this and was told to contact GSK the manufacturer..When I called them up, they asked me to go to my medical provider and give them their phone number to call I went t Clinic and saw the Nurse Practitionner. He gave me Valacyclovir for 5 days and Muripocin ointment to put on boil. Due to pain I went to ER on 10/03 was told to continue treatment, Today, I am waiting for complete healing.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Influenza like illness, Malaise, Nausea
Clinical narrative: I got a red boil which fills up as a blister on my left forearm on 09/26 the morning after my vaccine, the blister broke at the end of the day and refills with fluid. I had pain on that boil for several days and it is drier today but still not healed up. On 9/28, I called up  vaccination line to report this and was told to contact GSK the manufacturer..When I called them up, they asked me to go to my medical provider and give them their phone number to call I went t Clinic and saw the Nurse Practitionner. He gave me Valacyclovir for 5 days and Muripocin ointment to put on boil. Due to pain I went to ER on 10/03 was told to continue treatment, Today, I am waiting for complete healing.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: I got a red boil which fills up as a blister on my left forearm on 09/26 the morning after my vaccine, the blister broke at the end of the day and refills with fluid. I had pain on that boil for several days and it is drier today but still not healed up. On 9/28, I called up  vaccination line to report this and was told to contact GSK the manufacturer..When I called them up, they asked me to go to my medical provider and give them their phone number to call I went t Clinic and saw the Nurse Practitionner. He gave me Valacyclovir for 5 days and Muripocin ointment to put on boil. Due to pain I went to ER on 10/03 was told to continue treatment, Today, I am waiting for complete healing.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Blister rupture, Erythema, Furuncle, Pain of skin
Clinical narrative: I got a red boil which fills up as a blister on my left forearm on 09/26 the morning after my vaccine, the blister broke at the end of the day and refills with fluid. I had pain on that boil for several days and it is drier today but still not healed up. On 9/28, I called up  vaccination line to report this and was told to contact GSK the manufacturer..When I called them up, they asked me to go to my medical provider and give them their phone number to call I went t Clinic and saw the Nurse Practitionner. He gave me Valacyclovir for 5 days and Muripocin ointment to put on boil. Due to pain I went to ER on 10/03 was told to continue treatment, Today, I am waiting for complete healing.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Discharge, Erythema, Pain
Clinical narrative: I got a red boil which fills up as a blister on my left forearm on 09/26 the morning after my vaccine, the blister broke at the end of the day and refills with fluid. I had pain on that boil for several days and it is drier today but still not healed up. On 9/28, I called up  vaccination line to report this and was told to contact GSK the manufacturer..When I called them up, they asked me to go to my medical provider and give them their phone number to call I went t Clinic and saw the Nurse Practitionner. He gave me Valacyclovir for 5 days and Muripocin ointment to put on boil. Due to pain I went to ER on 10/03 was told to continue treatment, Today, I am waiting for complete healing.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Extreme redness, swelling, hot to touch, itching... treated as Cellulitis with high dose of Clindamycin. This is the second year in a row with severe reaction.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Extreme redness, swelling, hot to touch, itching... treated as Cellulitis with high dose of Clindamycin. This is the second year in a row with severe reaction.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Pain at injection > 30  days , Dull pain radiating down left arm, Pain radiating to left side of neck, elevated temp, headache, fatigue/tiredness,  muscular pain, left deltoid, pain
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Pain at injection > 30  days , Dull pain radiating down left arm, Pain radiating to left side of neck, elevated temp, headache, fatigue/tiredness,  muscular pain, left deltoid, pain
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dyspnoea, Eye swelling, Feeling cold, Lymphadenopathy
Clinical narrative: Difficulty breathing, swollen neck glands, sore throat.   Progressed to swollen eyes, body aches, pale/cold, and weak.   No dizziness nor fast heart beat.  Went to bathroom, came out in panick needed to lie down, and refused my attempts to take her to hospital, or call her Dr., said to wait until morning.  She is currently sleeping (11:45pm on 10/13/2020).
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pain, Pallor, Panic reaction
Clinical narrative: Difficulty breathing, swollen neck glands, sore throat.   Progressed to swollen eyes, body aches, pale/cold, and weak.   No dizziness nor fast heart beat.  Went to bathroom, came out in panick needed to lie down, and refused my attempts to take her to hospital, or call her Dr., said to wait until morning.  She is currently sleeping (11:45pm on 10/13/2020).
Age: 4.0
Sex: F
Vaccine: FLUA4
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: DTaP-IPV Combined Vaccine IM, Influenza Quadrivalent Preservative Free 0.5ml, MMRV
Age: 4.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site warmth, Pyrexia, Skin lesion
Clinical narrative: DTaP-IPV Combined Vaccine IM, Influenza Quadrivalent Preservative Free 0.5ml, MMRV
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Injection site swelling with rash covering upper arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Muscular weakness, Pain in extremity, Radicular pain
Clinical narrative: Severe radicular pain at injection site and traveling down arm, causing significant weakness of left arm.  Developed over several hours following injection.  No associated redness, warmth, discharge at injection site.  No systemic symptoms.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Culture urine, Headache, Pain, Pyrexia
Clinical narrative: Fever, Vomiting, Weakness, Headache and Body ache for 3 or more days
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test, Streptococcus test, Urine analysis, Vomiting
Clinical narrative: Fever, Vomiting, Weakness, Headache and Body ache for 3 or more days
Sex: U
Vaccine: HEP, HEP, HPV9, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Caller was checking stability for vaccines that have been administered since an excursion; she believes all of the vaccines have been administered; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unknown dates, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T009587 with expiration date of 18-MAR-2022 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. Other suspect therapies included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1659422 with expiration date of 04-SEP-2022(strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # T007984 with expiration date of 01-NOV-2022. The vaccines were stored at a temperature range between 47°F to 77°F during a time frame of 7 hours and 11 minutes which were called by a data logger.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No aditional adverse events reported; An unspecified patient received a dose of Pneumovax 23 that was expired when adminstered; This spontaneous report was received from a licensed practical nurse concerning a 86-year-old female patient.   The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Her concomitant medications included influenza virus vaccine inactivated (unspecified).  On 18-SEP-2020, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot number S004548, expiration date reported and validated as 12-AUG-2020) as prophylaxis (dose, dosage schedule, route of administration and site of administration were not provided). No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability