chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Chest pain, Neck pain, Pain, Pain in extremity
Clinical narrative: My arm has been sore ever since the injection.  It has radiated out to my neck & chest.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 101.5 fever 15 hours later; extreme headache, body ache; fever decreased 2 hours later to 100.1. Also, extreme fatigue after just sleeping 7 hours.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site warmth, Livedo reticularis
Clinical narrative: developed temp 100.5F temporal and by 8pm it was 102F temporal. Reddened, warm, tender areas on bilateral thighs lateral to injection sites and wrapping around to back of thighs/butt. Extremities (hands/feet) purple-ish tone and cool to touch. Arms and legs mottled appearance. Gave Tylenol. She slept through the night. 7am temp 100.7F temporal and by 8am 101F temporal. Gave Tylenol. Hands/feet cool to touch but not distinct purple. Reddened area absent on left thigh but still on right side warm/tender/red. Appetite has maintained. Wet diapers. She has times where we can get her to laugh between not feeling well. No cough, no labored breathing
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Peripheral coldness, Skin discolouration
Clinical narrative: developed temp 100.5F temporal and by 8pm it was 102F temporal. Reddened, warm, tender areas on bilateral thighs lateral to injection sites and wrapping around to back of thighs/butt. Extremities (hands/feet) purple-ish tone and cool to touch. Arms and legs mottled appearance. Gave Tylenol. She slept through the night. 7am temp 100.7F temporal and by 8am 101F temporal. Gave Tylenol. Hands/feet cool to touch but not distinct purple. Reddened area absent on left thigh but still on right side warm/tender/red. Appetite has maintained. Wet diapers. She has times where we can get her to laugh between not feeling well. No cough, no labored breathing
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient says arm is still sore, no sign of any redness or swelling or anything
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Headache, Nausea, Pyrexia
Clinical narrative: The vaccine was PPV23.  Headache, Chills, fever of 103, vomiting, nauseu, cellulitis.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: The vaccine was PPV23.  Headache, Chills, fever of 103, vomiting, nauseu, cellulitis.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Myalgia, Presyncope, Pyrexia
Clinical narrative: fever - 102.8 myalgia- left work near syncope
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Redness; that spread over Left thigh, warmth at site: Mother took to ER & hydrocodone give. Instructed to stop Hydrocodone; give Benadryl and hydrocortisone for area discomfort. Continuing to monitor area for other symptoms.
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted after receiving the vaccine. He was standing in line w/his mom post the vaccine & passed out on the floor for a second.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-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; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Age: 71.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Hepatitis A antibody positive, Hepatitis B antibody negative, Hepatitis B test negative, Therapy non-responder
Clinical narrative: Hep B was nonreactive; Hepatitis B antibody negative; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 72-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Twinrix. On 30th October 2019, the patient received the 2nd dose of Twinrix. On 22nd November 2019, the patient received the 3rd dose of Twinrix. On an unknown date, less than a year after receiving Twinrix, Twinrix and Twinrix, the patient experienced therapy non-responder and hepatitis b antibody negative. On an unknown date, the outcome of the therapy non-responder and hepatitis b antibody negative were unknown.   It was unknown if the reporter considered the hepatitis b antibody negative to be related to Twinrix, Twinrix and Twinrix.  Additional details were provided as follows: The patient received 3 Twinrix doses on the accelerated dosing schedule and he had an antibody test which showed Hep B was nonreactive, and Hep A & Hep AB showed reactive. No other symptoms were reported. The reporter consented to follow up. The HCP did not had the lot and exp at the time of report.  The patient was expected to get the booster dose.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Swelling face, Throat irritation
Clinical narrative: Immediate redness and prurtitis at injection site.  About an hour later, throat itching and tightness and facial swelling. Responded to oral Benadryl.  Symptoms did not return
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Throat tightness
Clinical narrative: Immediate redness and prurtitis at injection site.  About an hour later, throat itching and tightness and facial swelling. Responded to oral Benadryl.  Symptoms did not return
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's entire upper arm above elbow was painful, swollen, red, and hot.  Referred to PCP to rule out cellulitis.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Patient came to pharmacy around 2:30pm 10/20/20 to speak with pharmacist. Stated that she received 3 vaccines on 10/15/2020 and is experiencing redness, irritation, and warm to the touch feeling in her right arm at the site of injection. Instructed patient to seek medical treatment at her Dr. office - may just be an irritation but would feel  better if she had it looked at.
Age: 59.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: PT HAD REACTION AT INJECTION SITE: ITCHY RASH EXTENDING TO INSIDE OF ARM ABOUT 6IN X 4 IN
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Myalgia, Pain
Clinical narrative: patient reports: headache, muscle ache, fatigue, hives around my neck and an alarming red patch on my arm just below the injection site; while symptoms lessened over time, as of today (day 4), they are still ongoing.  Red patch does not look like hives, borders are regular, slightly raised, painful and warm to the touch and quite itchy.  Sx resolved as of day 5 or 6.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular, Skin warm, Urticaria
Clinical narrative: patient reports: headache, muscle ache, fatigue, hives around my neck and an alarming red patch on my arm just below the injection site; while symptoms lessened over time, as of today (day 4), they are still ongoing.  Red patch does not look like hives, borders are regular, slightly raised, painful and warm to the touch and quite itchy.  Sx resolved as of day 5 or 6.
Age: 37.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: pt c/o pain in left arm and shoulder X 4 weeks. EDD 12/6/20
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood glucose increased, Electrocardiogram normal, Lethargy, Somnolence
Clinical narrative: patient was extremely nervous to get the vaccination and finally was able to receive the FLUMIST product without any issues.  The patient then proceeded to leave the area after about 10 minutes of remaining in the vaccine room with her family.  When the family was near the check out of the store the patient reported severe drowsiness and felt very lethargic.  Patient returned to the pharmacy and continued to report severe drowsiness and "just wanted to go home".  Patient was provided a cool cloth on the rear of her neck, cool water to sip and a couple pieces of candy to suck on when she was more calm.  paramedics did evaluate her for heart arrhythmias, none detected, they then tested her blood sugars and she came in at 133.  Patient began feeling a lot better and left without further medical care.  Mom of patient reports that patient ate her full dinner and drank and had no further issues for the evening.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on trunk and upper extremeties
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site vesicles
Clinical narrative: Blistering of skin at injection site
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: No immediate reaction. 24h later, pain in left shoulder from elbow to left chin, swelling in same area, nausea, some flu-like symptoms but no documented fever. Pain when moving fingers. As of 20OCT2020, 95% improved per patient.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Peripheral swelling
Clinical narrative: Arm swelling and general malaise
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Lacrimation increased, Ocular hyperaemia, Swelling face, Swollen tongue
Clinical narrative: Eyes watering and bloodshot. Facial and tongue swelling.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: THE PATIENT REPORTS REDUCED MOBILITY IN LEFT ARM AND INABILITY TO RAISE ARM.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: She reports that the shot and may have been administered higher than usual and felt the injection distributed into her upper arm. She tells me that she had not felt that type of reaction previously. She reports the pain worsened the next day and has not improved since and has intermittently worsened.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haematoma, Injection site swelling
Clinical narrative: Hematoma at injection site, starting the day after injection.  Patient has been applying a cool compress and watching injection site for changes.  There has been a reduction in swelling.
Age: 20.0
Sex: M
Vaccine: FLUR4, HPV9
Symptoms: Altered state of consciousness, Blood glucose normal, Blood pressure decreased, Loss of consciousness
Clinical narrative: Patient received dose of Gardasil and within a minute passed out and had difficulty maintaining consciousness.  We quickly called 911 as I made sure the patient as breathing and had a pulse which he did. Paramedics where on scene within 5 minutes and took over the situation.  Patient was transported to the ER as his blood pressure would not recover as quickly as they would have liked.  The patient was responding better as time went on.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hyperaesthesia, Injection site warmth, Pain, Swelling
Clinical narrative: 59-year-old employee was getting mandatory influenza vaccination on 10/13/2020. She reports that the next day in the afternoon she developed profound redness and swelling and felt hot to touch about the injection site and presented to employer health clinic. She was started on Ibuprofen and feels that she is somewhat improved. She rates her pain 4/10 at rest which waxes and wanes, and is made worse with direct pressure. She reports the redness and swelling resolved and denies any numbness, tingling, further redness or swelling.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Fluarix vaccine given to client at approximately 0955 on 10/19/2020.  Fluarix quad LOT # 47G53, given IM in left deltoid.  Between 1200-1300, I was contact by a co-worker of client and was informed that clients tongue was swelling.  I instructed client should be taken to ED.   On 10/20/2020, I called and spoke with client.  He shared he was taken to  clinic to see his primary Dr.  He told me she gave him a shot of epinephrine and a 5 day Rx or some oral medications.  When I asked him if MD thought it was flu vaccine, client shared she never said.  Clients main concern was that the flu vaccine did not have the same component of Lisinopril.  As client has not tolerated that medication in the past.
Age: 37.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Localised infection, Pain in extremity, Pyrexia
Clinical narrative: On October 14, 2020, both Flucelvax and Pneumovax 23 was administered to a Type 2 diabetic patient. On the same day, the patient noticed that the soreness and pain in her arm was getting progressively worse, as well as her fever. It was so bad that it kept her awake at night. Within the next 2 days, her fever went up to 103 degrees F. After taking Tylenol and Motrin, the fever went down, but as the medication wore off, the fever went back up. By October 16, 2020, the symptoms did not get better, so the patient went to the emergency room. After running tests, they concluded that the patient had an infection in the left arm. However, they could not determine what caused the infection. The patient said they were doing better after receiving antibiotics.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Patient went swimming directly after receiving the shot, during which time she felt fine. Upon finishing, her arm began to stiffen and throb with pain. Patient could not move her arm at all.  The stiffness worsened to the point where she could not remove her jacket when she got home.  RPh followed up with the patient the next day: pain had subsided but stiffness persists and patient cannot lift her arm at all.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: 55-year-old female was getting mandatory influenza vaccination on 09/28/2020, where she felt the inoculation was inserted superior to customary landmarks developed pain rated 8/10 in her left shoulder during the injection. She reports that pain has since improved but continues to be present. On presentation she rates her pain 1-2/10 at rest which waxes and wanes. The pain is made worse with cross shoulder movement (up to 4/10). She has been using Ibuprofen 600mg po intermittently. She denies any numbness, tingling, redness or swelling. She denies allergies, PMH or possibility of pregnancy.
Age: 65.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Vision blurred
Clinical narrative: Customer says that he has had blurred vision that has not gone away. started 1 day after being vaccinated. encouraged him to check with doctor
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's husband reported she had swelling and redness from the injection site to the elbow after receiving vaccine
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Malaise, Nasal discomfort, Nausea, Pain
Clinical narrative: Patient's husband called in morning and said patient was deathly ill all night after the shots.  She had pain all over body, burning nose and nausea
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain
Clinical narrative: 25-year-old female administrative assistant received the flu shot on September 28th in her right deltoid. She points to just below her axial line in the mid deltoid as the injections site. Since the injection she reports progressive pain in the right shoulder which has been worsening. She rates her pain as an 8/10 constant, sharp and radiating distally from her anterior shoulder made worse with flexion and abduction, and reaching.  She denies pain around her injections site.  She denies numbness or tingling, and denies loss of power. She has been using Ibuprofen OTC for pain.
Age: 21.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB
Symptoms: Arthralgia
Clinical narrative: The patient called his Dr complaining of should pain following the vaccination. Dr advised him to try OTC pain remedies as the pain is expected to resolve within 1 day. The patient stated that the pain did not resolve in one day.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Nausea started around 8:00 p.m., first vomit was at around 8:30, then vomiting occurred every hour for 5 plus hours, headache, and  diarahea,  Lasted  until around 1:00 a.m. with nausea throughout the next day, slept from 5:00 p.m. through the morning, waking at 6:30 a.m. feeling somewhat better. No nausea or headaches.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Body temperature increased, Bone pain, Decreased appetite, Headache
Clinical narrative: About 6 hours later, no desire to eat dinner. Was in bed by 7:30 pm. Had a terrible night. Had severe headaches, knot in stomach, leg pain felt like muscle pain from right heel to hip even though the vaccine was given in left arm. right leg looks like he was in a fire still have pain feels like the bone is bruised and has inflammation and left leg does not.  Leg hurts if it's touched or rubbed. No pain as long as it's stationary. Had 101.4 temp on Sunday morning and text it to his boss. Also had a Covid test which was negative. Woke up this morning in a pool of sweat.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Inflammation, Pain, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: About 6 hours later, no desire to eat dinner. Was in bed by 7:30 pm. Had a terrible night. Had severe headaches, knot in stomach, leg pain felt like muscle pain from right heel to hip even though the vaccine was given in left arm. right leg looks like he was in a fire still have pain feels like the bone is bruised and has inflammation and left leg does not.  Leg hurts if it's touched or rubbed. No pain as long as it's stationary. Had 101.4 temp on Sunday morning and text it to his boss. Also had a Covid test which was negative. Woke up this morning in a pool of sweat.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: About 6 hours later, no desire to eat dinner. Was in bed by 7:30 pm. Had a terrible night. Had severe headaches, knot in stomach, leg pain felt like muscle pain from right heel to hip even though the vaccine was given in left arm. right leg looks like he was in a fire still have pain feels like the bone is bruised and has inflammation and left leg does not.  Leg hurts if it's touched or rubbed. No pain as long as it's stationary. Had 101.4 temp on Sunday morning and text it to his boss. Also had a Covid test which was negative. Woke up this morning in a pool of sweat.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain of skin, Pyrexia
Clinical narrative: Chills, fever 100.4, skin hurts, body aches.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, Pruritus, Rash erythematous, Rash papular
Clinical narrative: Client reports soreness in left arm approximately 1 to 2 hours after vaccination. The next day his left arm was hurting from injection site to halfway to elbow,  some tenderness also noted on back of left arm. Area was itchy and fine red raised bumps noted on arm. Client took Tylenol and Benadryl for itching. He reported adverse reaction on 10/20/20, vaccination was given on 10/14/20. Client states it is getting better not as sore or itchy. denies the need to go to his doctor for evaluation. reports no pain and full mobility in shoulder on left side
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Client reports soreness in left arm approximately 1 to 2 hours after vaccination. The next day his left arm was hurting from injection site to halfway to elbow,  some tenderness also noted on back of left arm. Area was itchy and fine red raised bumps noted on arm. Client took Tylenol and Benadryl for itching. He reported adverse reaction on 10/20/20, vaccination was given on 10/14/20. Client states it is getting better not as sore or itchy. denies the need to go to his doctor for evaluation. reports no pain and full mobility in shoulder on left side
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Depressed level of consciousness, Disorientation, Dizziness, Pallor, Syncope
Clinical narrative: Pt was given flu vaccine, left room alert and oriented x 3. Pt was checking out with Mom and became pale and started to feel dizzy with blurred vision. Pt then had syncopal episode. Pt became alert and oriented to verbal stimulation. Vital signs were taken: BP= 88/50, HR 100, O2 100% pt given juice and chips. Pt stated she had not eaten anything all day. Blood sugar obtained= 110. Pt remained under medical observation x 15 min. Pt left office alert and oriented x 3.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Pt was given flu vaccine, left room alert and oriented x 3. Pt was checking out with Mom and became pale and started to feel dizzy with blurred vision. Pt then had syncopal episode. Pt became alert and oriented to verbal stimulation. Vital signs were taken: BP= 88/50, HR 100, O2 100% pt given juice and chips. Pt stated she had not eaten anything all day. Blood sugar obtained= 110. Pt remained under medical observation x 15 min. Pt left office alert and oriented x 3.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in left upper arm since day 3 after injection.  It hurts to raise left arm or move it into certain positions.
Age: 25.0
Sex: U
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm hurt a lot, arm numb
Age: 34.0
Sex: F
Vaccine: FLUC4, HEP, MMR
Symptoms: Feeling hot, Heart rate decreased, Hypotension, Posture abnormal, Syncope
Clinical narrative: 10/12/2020 34 yr female reported to clinic for vaccinations (MMR, Hep B & Flu). After administration of 3rd vaccine employee reported feeling hot and stated "I'm going down". Employee head moved forward, upper body slumped over, RN was at employee side, called out her name, no response, RN called for Syncope assistance at 0908 am. Employee was called by her name and she responded, AAO x 3 (awake, alert-recalled her name, location she was at, and todays date). Employee legs were elevated, wet cloth placed to forehead, sugary drink given, vitals 0908 am BP 96/60, HR 59, RR 17. Employee denies Hx of fainting during injection/vaccinations, Denies any chest pain, no wheezing, no tongue swelling, no neurological deficits noted, and no respiratory deficit. The reason for fainting is unclear-employee assessed by Dr stated possible vagal syncope.  Vitals: Sitting- 0908 am BP 96/60, 59 HR 0912 am BP 98/67 , HR 58 0914 am BP 95/65 , HR 73 0916 am BP 98/67 , HR 58  0920 am 108/69, HR 67 0936 am standing- BP 114/71, HR 74, MD Assessment in progress 0951 D/C sitting vitals BP 113/82, HR 64; standing BP 113/86, HR 77, cleared for discharge by Dr/ RN
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Proquad expired on 9/16/2020, but was administered on 10/12/2020. No adverse reactions were reported. Patient was scheduled to repeat the vaccine in 3 months. Mother verbalized understanding.
Age: 1.17
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein increased, Culture stool negative, Decreased appetite, Full blood count normal, Haemoglobin decreased
Clinical narrative: Fever for 5 days, body aches, decreased appetite, mood changes.
Age: 1.17
Sex: F
Vaccine: FLU4
Symptoms: Mood altered, Pain, Platelet count increased, Pyrexia, Streptococcus test negative
Clinical narrative: Fever for 5 days, body aches, decreased appetite, mood changes.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain in extremity, Sleep disorder
Clinical narrative: Patient stated that 1 hour after she received her pneumonia vaccine she had pain and lack of movement in her arm/hand.  Today 10/20/2020 she is still having pain that keeps her awake at night.  She is unable to use her left hand and uses her right to do task like open refrigerator.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Few hours after vacc. Pat started having arm stiffness followed by next day pain, heat and swelling  for 3 days. Applied arnacan medication to arm for relief. Felt achy day 2 .
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia oral, Rash, Rash pruritic
Clinical narrative: Right bicep was red and swollen when she awoke on 10/08/20.  Over the next week her symptoms progressed.  She developed a rash all over her whole body. Has some tingling in the mouth.  She developed a right lower leg ulcer.  On 10/15/20 she was referred to wound care for the ulceration on the right lower leg.  The injection site reaction on the right bicep she was trying to manage at home with the use of hydrocortisone and Benadryl. Patient states that she feels as though the rash is continuing to get worse.  It is itchy.  Was sent to the Emergency Room for further treatment and evaluation to rule out Stevens-Johnson syndrome.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Skin ulcer
Clinical narrative: Right bicep was red and swollen when she awoke on 10/08/20.  Over the next week her symptoms progressed.  She developed a rash all over her whole body. Has some tingling in the mouth.  She developed a right lower leg ulcer.  On 10/15/20 she was referred to wound care for the ulceration on the right lower leg.  The injection site reaction on the right bicep she was trying to manage at home with the use of hydrocortisone and Benadryl. Patient states that she feels as though the rash is continuing to get worse.  It is itchy.  Was sent to the Emergency Room for further treatment and evaluation to rule out Stevens-Johnson syndrome.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Blister, Blister rupture, Erythema, Full blood count normal, Metabolic function test normal
Clinical narrative: During care  on 10/17/2020 at  1 am resident found to have intense reddened area covering center and right side of back measuring 15x8 cm with 2 blisters in center of back measuring 2.5x1 cm and 1x 0.5 cm. Right posterior and lateral hip found to have intense red area measuring 12x9 cm with blister measuring 4x2 cm.  Tylenol prn ordered  with Aloe Vesta ointment and nonstick dressing. Followup on 10/19/2020 at 9am revealed an overall decrease in the erythema with rupture of blisters to back with weeping of serous fluid and peeling of skin. Right hip blister intact with clear/light yellow fluid . No oral ulcers or additional blisters noted to any other skin surfaces or membranes.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Secretion discharge, Skin exfoliation
Clinical narrative: During care  on 10/17/2020 at  1 am resident found to have intense reddened area covering center and right side of back measuring 15x8 cm with 2 blisters in center of back measuring 2.5x1 cm and 1x 0.5 cm. Right posterior and lateral hip found to have intense red area measuring 12x9 cm with blister measuring 4x2 cm.  Tylenol prn ordered  with Aloe Vesta ointment and nonstick dressing. Followup on 10/19/2020 at 9am revealed an overall decrease in the erythema with rupture of blisters to back with weeping of serous fluid and peeling of skin. Right hip blister intact with clear/light yellow fluid . No oral ulcers or additional blisters noted to any other skin surfaces or membranes.
Age: 80.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Genital rash, Periorbital swelling, Rash
Clinical narrative: patient experienced rash in groin area, trunk , and arms starting 48 hours after vaccine admin. patient also experienced swelling around the eyes.   patient recognized symptoms and began diphenhydramine 25mg for 4 consecutive doses starting friday 10/09/20 through sat 10/10/20. Syptoms resolved over the next 48 hours. patient came to pharmacy 10/20/20 to report adverse event
Age: 29.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Mobility decreased, Pain
Clinical narrative: A few hours after receiving influenza vaccine at pharmacy, began to have shoulder pain, pain with ROM/difficulty with ROM. Symptoms persist to this day. feels better with NSAIDS. No numbness/tingling. No swelling, redness, fevers.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Loss of consciousness, Seizure, Visual impairment
Clinical narrative: Patient reported to his mother in clinic lobby of feeling lightheaded and seeing spots but felt better after 5 minutes, per mother. Patient and mother started walking to car and patient proceeded to feel lightheaded and lost conciseness. Mother reported a small seizure. Clinic RN went to the scene but got there as the seizure stopped. Mother called EMS. Patient was transported to Hospital through Ambulance as a precaution.   Please note. I was unavailable during this incident, I was assisting a different patient, and therefore did not respond to incident. I was made aware of this incident after patient was transported to ED by EMS. Responders will be an RN and an MA. This is my doctor's patient and therefore I am filing incident report.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Malaise
Clinical narrative: patient not feel wells and went to ER.
Age: 74.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt got a rash (no blisters) on wide area at sigh of injection, 4wks today and rash still there. 2 inches wide 4 inches long, upper left arm.   Pt got flu shot at pharmacy same day as Zoster vacc.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: pt states no pain on injection or for  4 days after woke up on day 5 with a very sore shoulder.  no redness or temperature noted.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Shivering & tiredness
Sex: M
Vaccine: UNK
Symptoms: Bone pain, Chills, Headache, Myalgia
Clinical narrative: aches in muscles and bones, headaches chills
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Pharyngeal swelling
Clinical narrative: Throat swelling and eye itching
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure. No treatment required.
Age: 85.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: Patient had severe rash in legs and left arm 2 hours after adm.
Age: 1.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt was given pediarix and should have received infanrix, pt did not have any side effects after 30 minutes of receiving vaccine as pt was in office being monitored, pt mom was informed and instructed to continue to monitor pt and present to ER if needed
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to pharmacy complaining of pain,redness,warmth, and swelling in Left upper arm. Pneumovax vaccine given in left arm previous evening at our pharmacy. Patient had mobility and recommended to take acetaminophen, ice, benedryl and to contact primary care provider or urgent care if condition worsens
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Arm pain from injection point and down, worsened on overnight period
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Hypoaesthesia, Induration, Injection site pain, Mobility decreased, Nausea
Clinical narrative: day after shot, high fever 103.3, nausea, couldn't move arm, arm numb.  Went to ER.  Sunday the nausea got better,  Fever broke about 7am Sunday, hard knot in the arm. Boostrix vaccine spot he could tell was the one hurting.  Has had Tetnus vaccination before. No history in state immunization system of which one to find out if contained Pertussis.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Nodule, Pyrexia
Clinical narrative: day after shot, high fever 103.3, nausea, couldn't move arm, arm numb.  Went to ER.  Sunday the nausea got better,  Fever broke about 7am Sunday, hard knot in the arm. Boostrix vaccine spot he could tell was the one hurting.  Has had Tetnus vaccination before. No history in state immunization system of which one to find out if contained Pertussis.
Age: 51.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Axillary mass
Clinical narrative: pt complained of a lump underneath  her right armpit
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: chills, fever, headache, muscle aches
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Severe itching all over body lasting at least ten days. Rash apparent in higher-scratch areas.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Hyperhidrosis, Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Immediate swelling,    sweating.   The worst of the swelling subsided within 15 minutes, although it remains painful.  No anaphylactic symptoms at all.  Sweating was probably due to anxiety over event.
Sex: U
Vaccine: FLUR4, PPV, TDAP, VARZOS
Symptoms: Blood pressure increased, Dizziness, Ear discomfort, Heart rate increased, Loss of consciousness
Clinical narrative: After the dose is given patient started dizziness, and complained about her ears being filled, and then started to loose consciousness and started shaking the hands and legs. I helped her lay on the floor. I gave the patient a dose of  epipen and she regained her senses immediately. EMS came and checked on her , she had her blood pressure and heart rate checked and was slightly elevated and they stayed with the patient for 15 to 20 minutes and left as the patent denied further treatment. Patient stayed at the pharmacy until her family member picked her up to take home. I called at 5.30 pm to check on her and she said she is doing fine and was back to normal.
Sex: U
Vaccine: FLUR4, PPV, TDAP, VARZOS
Symptoms: Tremor
Clinical narrative: After the dose is given patient started dizziness, and complained about her ears being filled, and then started to loose consciousness and started shaking the hands and legs. I helped her lay on the floor. I gave the patient a dose of  epipen and she regained her senses immediately. EMS came and checked on her , she had her blood pressure and heart rate checked and was slightly elevated and they stayed with the patient for 15 to 20 minutes and left as the patent denied further treatment. Patient stayed at the pharmacy until her family member picked her up to take home. I called at 5.30 pm to check on her and she said she is doing fine and was back to normal.
Age: 68.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Feeling cold, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: headache, chills, fever 101.8, shakes, muscle aches, pain, soreness over 2 days
Age: 68.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Tremor
Clinical narrative: headache, chills, fever 101.8, shakes, muscle aches, pain, soreness over 2 days
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: Acute myocardial infarction, Arthralgia, Chills, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: patient stated that within 15 to 20 minutes after receiving vaccines she developed severe shaking, chills, and shortness of breath. She also noted achiness in her shoulders bilaterally. She called 911 and was placed on oxygen and transported to the hospital. She was later transferred to a hospital in another city after having a troponin level of 1.4 for a higher level of care. She was admitted to the hospital and Later determined she had a non-ST elevated myocardial infarction. She was discharged from the hospital on 10-03-2020 but was antigen positive for COVID. She has recovered and is doing fine as of 10-19-2020.
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Troponin increased
Clinical narrative: patient stated that within 15 to 20 minutes after receiving vaccines she developed severe shaking, chills, and shortness of breath. She also noted achiness in her shoulders bilaterally. She called 911 and was placed on oxygen and transported to the hospital. She was later transferred to a hospital in another city after having a troponin level of 1.4 for a higher level of care. She was admitted to the hospital and Later determined she had a non-ST elevated myocardial infarction. She was discharged from the hospital on 10-03-2020 but was antigen positive for COVID. She has recovered and is doing fine as of 10-19-2020.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain
Clinical narrative: 10/17/2020 PATIENT STATES THAT IN THE EVENING SHE STARTED TO HAVE SEVER PAIN IN THE BACK AND KNEE.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Neck pain, Neuralgia
Clinical narrative: back/neck nerve pain
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Left arm swollen and red. Some swelling noted to go into the neck region. Advised to go to Urgent Care, parent agreed.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash erythematous, Rash papular
Clinical narrative: Raised pink bumps on the thigh at the injection site about a day after injection, several days later also developed similar bumps on abd on same side  Patient was doing well, no other symptoms..
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: generalized itching, localized hives. started about 1.5 hours after vaccination administration
Age: 75.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Extensive swelling of vaccinated limb, Insomnia, Pyrexia
Clinical narrative: Patient's right arm swelled up. It became painful and red. It was severe enough that he could not sleep. It happened several hours after the shot's were given. Patient experienced chills and a fever of 100.8. He had not tried anything for treatment.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Starting the day after vaccination, patient states her arm was red and warm to the touch from her shoulder down to her elbow. Stated redness is a side effect of the vaccine but she states it was not just around the injection site but rather her entire upper arm.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Arthritis, Bursa injury, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: I had went to work that morning and worked all day , I went in to get my flu shot around 1:05 p.m. As soon as I got my flu shot I immediately knew something was wrong. The shot was given very high on my shoulder and when the medication was going in it burned really bad way more than normal. It wasn't five minutes and my shoulder started hurting. The pain was a 9/10. By the time I left work at 3 I could not move my shoulder it was a struggle to get my truck in gear. Over night the pain got worse and the next morning I went to Urgent Care. They coded the visit as suspect injury to bursa from flu shot. They said to take ibuprohen and rest. Monday morning was sent to another Urgent care and the assessment was injury of shoulder and upper arm-shoulder injury related to vaccination administration. They sent me for a MRI. I then went to an ortheprdic doctor that said I need a reverse total shoulder replacement.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging abnormal, Product administered at inappropriate site, Rotator cuff syndrome, Shoulder injury related to vaccine administration
Clinical narrative: I had went to work that morning and worked all day , I went in to get my flu shot around 1:05 p.m. As soon as I got my flu shot I immediately knew something was wrong. The shot was given very high on my shoulder and when the medication was going in it burned really bad way more than normal. It wasn't five minutes and my shoulder started hurting. The pain was a 9/10. By the time I left work at 3 I could not move my shoulder it was a struggle to get my truck in gear. Over night the pain got worse and the next morning I went to Urgent Care. They coded the visit as suspect injury to bursa from flu shot. They said to take ibuprohen and rest. Monday morning was sent to another Urgent care and the assessment was injury of shoulder and upper arm-shoulder injury related to vaccination administration. They sent me for a MRI. I then went to an ortheprdic doctor that said I need a reverse total shoulder replacement.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient states her arm is red at a different location than where bandaid is applied.  She was concerned injection might not have been given IM.  Spoke to drug information at GSK and they stated injection site redness very common, especially for second dose.  Drug information also said they have studies of SQ injection instead with similar efficacy.  Patient is ok knowing that it would be effective either way.
Age: 29.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site discomfort, Injection site pain, Wrong product administered
Clinical narrative: PT WAS INCORRECTLY GIVEN FLUAD 65+ WHEN WE REGISTERED HIM FOR AFLURIA. WE MADE A FOLLOWUP CALL TO THE PT 3 DAYS LATER AND HE HAD NO COMPLAINTS OR SIDE EFFECTS. THE ONLY THING THAT HAPPENED WAS SLIGHT PAIN/PRESSURE AT THE INJECTION SITE WHICH WE ASSURED PT WAS NORMAL
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site urticaria, Nausea, Pain
Clinical narrative: Urticaria at site of injection that appeared the morning  after vaccine was administered.  Shortly after injection: Fatigue, Nausea, Pain
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient had swelling and redness along the entire upper arm/bicep along with pain and itchiness. Started the evening following vaccination and continuing through to the next day. Advised patient after ER visit to follow up with primary provider if symptoms do not improve within the next day or two
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Aphasia, Blindness, Disturbance in attention, Hypoaesthesia
Clinical narrative: Patient reported loss of vision, stumbling on words, numbness in arms and hands and unable to focus mind set.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pt called on 10/20/20 complaining of continued pain after recieving vaccine, has been self treating with otc pain relievers and ice and the pain has not improved. Pt states he recieved a steroid injection about 3 months prior and the underlying condition seems to have been aggravated.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chills, Dizziness, Pyrexia
Clinical narrative: About 3 to 4 hours after receiving shot, patient had fever >102, Significant Chills, dizziness and unsteadiness when walking.  Pt took advil and went to lie down, and fell asleep.  In the morning, she felt weak, but improved, and no longer chilled . Patient did not seek medical attention, but was very concerned about such abad effect.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: PATIENT SAID SHE EXPERIENCED SUDDEN HEARING LOSS
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia, Rash
Clinical narrative: On 10/19/2020, the morning after receiving the vaccine, patient stated to feel sick. She had fever/chills and felt sick. The next day (10/20/2020), patient broke out in a rash that went from her breast down her abdomen and fully covered her back. Patient went to her family physician on 10/20/2020 who said he suspected this to be an allergic reaction to the vaccine. According to patient, family doctor did not prescribe her any medications as he didn't want to suppress immune response to vaccine.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Patient woke up sunday morning with hives
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Asthenia, Dizziness, Dysstasia, Eye irritation, Hypokinesia
Clinical narrative: Saturday Night - patient started to have trouble staying asleep Sunday morning- reports nausea, eye burning sensation, fever , body aches, trouble moving body parts Today 10.20.2020- feeling weak and dizzy. Not feeling chills or fever. Patient feels that she cannot stand for a long period of time.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Insomnia, Nausea, Oral herpes, Pain
Clinical narrative: Saturday Night - patient started to have trouble staying asleep Sunday morning- reports nausea, eye burning sensation, fever , body aches, trouble moving body parts Today 10.20.2020- feeling weak and dizzy. Not feeling chills or fever. Patient feels that she cannot stand for a long period of time.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: shoulder pain, now recurring month later
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient is experienced redness and warmness on the underside of the arm (in which the injection was given).  The reaction occurred the day after the injection.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Eye irritation, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Patient experienced flu-like symptoms, headaches, extremity pain, and burning eyes.  Patient said the symptoms start the night after receiving the vaccine.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Immediately following vaccine administration, patient went to stand up but slumped forward to the floor.  She lost color and fainted for a brief moment. She immediately came to. Her mother was in the room, mom explained this has happened before during vaccinations but that was the first time it was immediate.  The prior history was not disclosed in the pre-screening questions.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site with tenderness and flu-like symptoms; fluids and tylenol
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Hyperhidrosis, Palpitations
Clinical narrative: sweats, palpitations, chills
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: Red hard area at injection site with local pain lasting 4 days
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Blistery rash on my face that won?t go away and has spread. It started a couple of weeks after I had the shot.