chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Sensation of foreign body, Throat irritation, Throat tightness
Clinical narrative: The employee/patient was receiving a flu vaccine for the first time. Afterwards, the nurse had the employee wait in a chair for 15 minutes to monitor for any S/S of allergy since this was her first time receiving the vaccine. Approximately 8 minutes after the vaccine, the employee stated her throat felt funny. About 30 seconds later she states her throat felt like it had a lump that was getting larger and felt like her airway was being constricted suddenly. No hives, itching, or tongue swelling noted. EpiPen was administered and employee was transported to the hospital per protocol after Epi administration.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Large round red rash size of a baseball at injection site appeared approx 5pm CST on Sat, Oct 31, 2020.  Applied Triamcinolone Acetonide cream, 0.1%, per recommendation of pharmacist via phone call Sun, Nov 1, 2020 at 12:52pm CST.  Rash slowly dissipated over the course of 2 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Monoplegia
Clinical narrative: patient had difficulty raising right arm over the first week then developed paralysis in right arm and hand. patient currently getting physical therapy
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Gait disturbance, Hypotension, Nausea
Clinical narrative: Patient started feeling dizzy, nauseous and feeling like she may faint.  She reported back after about 15 minutes after the shot.  I had her lay down and brought her some water.  I check her BP which was low and offered to call emergency services for her, but patient refused saying that she doesn't feel that bad, but still couldn't walk.  She was laying down for about 45 minutes before her BP returned to normal and with just rest and some water she felt better after about 30 -45 min.  After one hour patient was back to normal and she left home.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Eye discharge, Eye swelling
Clinical narrative: right eye swelling and aching and draining in first 24 hours. treatment by eye doctor
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Feeling hot, Urticaria
Clinical narrative: Heeling hot and turned red/hives all over her upper body.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Patient's whole arm down to hand was swollen
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Patient still  feels adverse reactions after receiving her first dose Shingrix after 10 days. The adverse reactions she reported are  as follows: nausea, chills , headache, fatigue, bodyaches
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: patient reported shoulder pain and tingling...this was reported on 11/3/20.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pyrexia, Tremor, Urinary tract infection, Urine analysis normal
Clinical narrative: patient felt freezing, shaking, and had fever of 101.9 degrees
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Pain, Pallor, Somnolence, Thirst
Clinical narrative: Within 5 minutes after inoculating on her left arm ( after Menveo, Tdap and Flu )  PT complained of being thirsty and in a lot of pain.  At this point pt was moved to a chair from the exam table, soon after patient turned her head to the left and became pale and drowsy.  Managed to answer a few questions with her eyes closed.  This went on for 5 minutes.  Her heart rate was in the low 60's with 02 at 97-98 on room air  but stayed at 99 % on 02 /mask.  Temp was 98.2  . Patient was observed in exam room for a full hour and improved.  We sat her up and she remained asymptomatic .  She was then moved to Nurses's station , left office without any symptoms and was ambulatory.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Somnolence
Clinical narrative: Extreme tiredness, sleepiness, some chills and a little achy.  All symptoms recovering after several hours of sleep.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: Approximately 3 & 1/2 hours after injection I began to break out in large area hives.  Tge reaction first started in both arm pits. Wherever my skin touched something, like an arm resting on a chair; that  area would warm up and break out. I continued on braking out in various areas of my body, with my back being the worst. Each area that broke out swelled and itched for 2 to 4 hours before subsiding.  My breathing was not effected. The entire problem ran its course and was gone 28 hours after receiving the shot. I did not contact my doctor until a two days after the episode was over.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Myalgia, Pyrexia
Clinical narrative: Upset stomach, fever, chills, muscle aches
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Swelling and pain in upper left arm.  Redness and tenderness of muscle.  Started 11-3-2020.  Pt is elevating arm and icing and taking Tylenol.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle aches, chills, fever
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Erythema, Flushing, Immediate post-injection reaction, Pruritus
Clinical narrative: The patient states that he had flushing, red spots, hives, itching, and felt mentally unclear 30 minutes immediately after the vaccine.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: The patient states that he had flushing, red spots, hives, itching, and felt mentally unclear 30 minutes immediately after the vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Skin warm, Swelling
Clinical narrative: patient reported redness, swelling, hot to touch and trouble moving arm
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Fat necrosis
Clinical narrative: Patient was diagnosed with fat necrosis on back of arm just below deltoid (about 3 inches below injection site).
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site indentation, Injection site reaction, Injury, Magnetic resonance imaging abnormal, Soft tissue disorder
Clinical narrative: Patient was diagnosed with fat necrosis on back of arm just below deltoid (about 3 inches below injection site).
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Tissue irritation
Clinical narrative: Patient was diagnosed with fat necrosis on back of arm just below deltoid (about 3 inches below injection site).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever, nausea fatigue headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pustule, Injection site warmth
Clinical narrative: redness, heat, and pustules developed near the injection site (closer to bicep).  Reaction started the evening the vaccine was given worsened for 1-2 days before getting better about 2 days after the vaccine.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen arm 6 inches from the injection site, advised to take Benadryl and ice site, as pt cannot take motrin due to kidney function.  She also iced the site.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea
Clinical narrative: After 10 minutes, patient came back to pharmacy with shortness of breath, dizziness, lightheadedness. Patient's blood pressure, temperature were taken and both were within normal limits. Patient sat down for 5-7 minutes and drank some water but reported feeling better. Patient reported stomach upset without nausea/vomiting. Patient was advised to go to the ER or the urgent care if symptoms did not resolve after 15 minutes. Patient was supervised by pharmacist for 15-20 minutes after symptom onset, which seemed to improve with time, but was strongly encouraged for the patient to be taken the to emergency room if symptoms continued/worsened within 5 minutes.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dry mouth, Dyspnoea, Erythema, Immediate post-injection reaction
Clinical narrative: Within 30 seconds of administering the vaccine the patient began to complain she was experiencing a reaction to the vaccine. She stated that she felt her mouth was beginning to get dry and felt lightheadedness. Provider immediately evaluated the patient. Patient begin to get very red in the face and was grabbing for her throat. She was making a clearing of her throat sound and nodded her head when asked if she was having trouble breathing. IM epinephrine administered within 4 minutes. The patient refused further medical evaluation and left the clinic against medical advice.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Throat clearing, Vaccination complication
Clinical narrative: Within 30 seconds of administering the vaccine the patient began to complain she was experiencing a reaction to the vaccine. She stated that she felt her mouth was beginning to get dry and felt lightheadedness. Provider immediately evaluated the patient. Patient begin to get very red in the face and was grabbing for her throat. She was making a clearing of her throat sound and nodded her head when asked if she was having trouble breathing. IM epinephrine administered within 4 minutes. The patient refused further medical evaluation and left the clinic against medical advice.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was accidentally given High dose instead of regular dose. No harm has actually occured to the best of my knowledge, but pt is unreachable because her phone does not accept incoming calls. I did not realize till after the patient left the site. The patient did not provide a primary care doctor at time of vaccination so only dr I had to put for contact is the protocol physician.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Fall
Clinical narrative: started feeling dizzy,  started to fall, and mom caught him
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: terrible chills, fever 102-103, uncontrollable shaking for all that night , nausea, headache, fatigue took ibuprofen, stayed in bed. fever lasted 2 days. nausea lasted thru 1st night, headache and fatigue  lasting 3 days.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tremor
Clinical narrative: terrible chills, fever 102-103, uncontrollable shaking for all that night , nausea, headache, fatigue took ibuprofen, stayed in bed. fever lasted 2 days. nausea lasted thru 1st night, headache and fatigue  lasting 3 days.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: A few hours after injection. Bleeding, pain and bruising at injection site that has persisted at least 3 weeks. No treatment.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mass, Skin warm, Tenderness
Clinical narrative: A few hours after administration of Fluzone HD and Pneumovax 23, patient reported a raised lump under her right ear, along her jawline. She reported that the lump is warm and tender to touch. I did advise the patient to apply cold compress to the area to reduce swelling and discomfort.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Chest discomfort, Dyspnoea, Immunisation reaction, Impaired work ability, Laryngitis
Clinical narrative: Got the shot on Friday, 10/9. Woke up Monday morning with laryngitis, tightness in chest, shortness of breath, pressure in sinuses. During the week I got worse. Second week I could not speak at all, went to my doctor, who told me I had reaction to flu shot. Singular and Albuterol did nothing. Monday I went to Urgent care to get prednisone. Wednesday back to Urgent care to get Z-Pak. Extreme amount of phlem in my lungs. Today is 11/2 and I am still suffering. I haven't been able to work for 2 weeks and this is starting the 3rd week. If I cannot talk, I cannot work. Right now I'm trying to find out what exactly happened to me. I have never reacted to a vaccine.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Paranasal sinus discomfort, Productive cough
Clinical narrative: Got the shot on Friday, 10/9. Woke up Monday morning with laryngitis, tightness in chest, shortness of breath, pressure in sinuses. During the week I got worse. Second week I could not speak at all, went to my doctor, who told me I had reaction to flu shot. Singular and Albuterol did nothing. Monday I went to Urgent care to get prednisone. Wednesday back to Urgent care to get Z-Pak. Extreme amount of phlem in my lungs. Today is 11/2 and I am still suffering. I haven't been able to work for 2 weeks and this is starting the 3rd week. If I cannot talk, I cannot work. Right now I'm trying to find out what exactly happened to me. I have never reacted to a vaccine.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: large red swollen area that itches
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Patient came in with her mother to get a meningitis and Tdap vaccine.  Our new form has all vaccines listed for patient to circle which they are here to receive.  The immunization was processed as a fluarix instead of meningitis/Tdap.  Pharmacist checked label printed and administered the patient a fluarix instead of menveo/boostrix which is what the parent wanted.  After the flu shot was administered the mother asked which immunization her daughter received and that is when the error was found.  The mother was very upset, she did not want her daughter to receive a flu shot.  She did report that the daughter developed a fever that was brought down by OTC fever reducers. She did bring her daughter back on 11/2/20 for the menveo and boostrix immunizations.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports red, hot, swollen arm at injections site
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chest discomfort, Dizziness, Gastrooesophageal reflux disease, Paraesthesia oral
Clinical narrative: Flu vaccine was administered to employee at 1210 on 10/30/20. Agency was contacted by employee at 1220 to report feeling GI discomfort, tingling sensation in mouth that lasted approximately 5 minutes, chest pressure that lasted approximately 5 minutes, and dizziness which lasted approximately 2 minutes. As per employee GI discomfort and acid reflux s/s remain but all other s/s subsided. Employee was given oral fluids (Gatorade 360 mL), employee tolerated well. First set of vitals taken at 1230 BP 125/80 P 84. Vitals retaken at 1248 BP 118/80 P 80. Last set of vitals taken at 1300 BP 116/78 P 88. Agency was contacted by Agency for further guidance. Agency was advised to provided employee with phone number in case s/s returned. Employee was released home in stable condition.
Age: 32.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site haematoma, Periorbital swelling, Urticaria
Clinical narrative: Unknown vaccine information - Given at the Pharmacy 24 hours after the immunization patient had "puffy eyes" and hematoma at injection site 6 days after the immunization he developed urticaria which has persisted.  Unsure which brand of immunization pt was given as it was at a different facility.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Product administered at inappropriate site
Clinical narrative: PT SAID SHE THINKS THE SHOT WAS GIVEN TOO HIGH BECAUSE SHE IS UNABLE TO LIFT HER ARM
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Cheilitis, Environmental exposure, Rash, Rash papular, Rash pruritic
Clinical narrative: Few hours later pt developed itchy, swollen rash around right eye, nose, around lips, posterior neck and then arms.  Pt reports skin irritation around the lips, but no lip/tongue swelling and no trouble breathing at anytime.   The patient has a history of eczema and hikes regularly.  He admits that the rash could also be related to plant exposure from a hike a few days prior to 10/30/2020 (date of flu vaccine and onset of rash).
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Hyperhidrosis, Posture abnormal
Clinical narrative: Patient noted a history of fainting in past. We discussed staying seated a few minutes after just to make sure. She said she did not feel right so she remained seated. I went to check on her because she did not answer when I asked a few minutes later if she felt better. I walked in front of her and she dropped her phone and slumped. I called her name, no response. My technician brought me an ice pack. I had her call 911. Once I placed the ice pack on her neck, patient responded. She was very sweaty. We gave her a small glass of water, then was able to get some ice water for her. The ambulance arrived and checked her vitals, she was feeling better and did not want to go to the hospital. Family also came to drive her and her car home.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Patient here for nurse visit for MENVEO: Apple juice given prior to injection. 5 min post injection, patient said she felt light headed. Chair reclined. BP taken 97/61. 5 min later 97/62. 10 min later 103/69. Patient monitored in office 20+ min. Left with dad.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received vaccine while seated. Patient was then standing and using her phone. After five minutes patient fainted on their back. Patient was rolled over to side. Patient then regained consciousness and asked what happened. The ambulance was called to the scene and took the patient to the hospital for further testing. Blood pressure and blood sugar readings were taken by EMT. EMT asked patient how she felt and patient stated she felt light headed. EMT spoke with parent and parent stated to take daughter to hospital for further tests. Parent called back stated all tests were normal and daughter was fine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Loss of consciousness, Nausea, Paraesthesia
Clinical narrative: Patient was given Menactra intramuscularly at 5:30pm on 11/02/20 .  As soon as I finished giving her the shot, patient claimed she felt sleepy and passed out for a brief 2 seconds.  Patient opened her eyes back after the quick 2 seconds and asked me what happened.  Patient then claimed that she felt drowsy and nauseous.  She also said that her fingers feel numbed and tingling.   Patient was given some water as well as orange juices after which she had more colors on her face and the numbness in her hands went away.   Patient was seated to rest for 30 minutes and felt much better.  She was able to get up and walk on her own and felt completely recovered.  She was accompanied by her brother and her mother who told us that patient has vasovagal syncope.  She had fainted in the past whenever she got blood drawn or got too excited.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Somnolence
Clinical narrative: Patient was given Menactra intramuscularly at 5:30pm on 11/02/20 .  As soon as I finished giving her the shot, patient claimed she felt sleepy and passed out for a brief 2 seconds.  Patient opened her eyes back after the quick 2 seconds and asked me what happened.  Patient then claimed that she felt drowsy and nauseous.  She also said that her fingers feel numbed and tingling.   Patient was given some water as well as orange juices after which she had more colors on her face and the numbness in her hands went away.   Patient was seated to rest for 30 minutes and felt much better.  She was able to get up and walk on her own and felt completely recovered.  She was accompanied by her brother and her mother who told us that patient has vasovagal syncope.  She had fainted in the past whenever she got blood drawn or got too excited.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix given in the back of the right arm instead of IM
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient called the pharmacy complaining of joint pain following her immunization.  She said her arm was sore and she felt like it was very challenging to raise her arm above her head (specifically in the joint). Symptoms began the night of 11/2/20.  Told patient that injection site reactions are common and to try to see if Tylenol would help relieve her pain.  She called pharmacy back 11/3/20 and said that pain had improved but her joint was still sore.  I administered the vaccine in her deltoid muscle but she had a very small arm. She is concerned about bursitis based on our conversation on 11/3.  I told patient to reach out to primary care provider if it does not heal within 3-5 days.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia, Soft tissue swelling, Weight bearing difficulty
Clinical narrative: Muscle or soft tissue pain and swelling, next to patella, R knee. Weightbearing difficult.  Duration: 2.5 wks. NO falls, exercise issues or other likely causes
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: I know this was a meningitis vaccine, but I don't know exactly which one of the above it was. The day after the vaccine was given, her arm started feeling weak to the point that she couldn't raise it. It was causing great pain. It was swollen, red and very painful to the touch.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Eye movement disorder, Grunting, Tremor
Clinical narrative: After receiving The vaccine patient stated she was feeling like she needed to lay down, her eyes rolled back and she kind of grunted and shook a little, the other pharmacist and I laid her down.  She at that time was alert and knew where she was.  The paramedics came and ran some tests.  They stayed with her for probably 20 minutes and decided to take her to hospital
Age: 90.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Fatigue, Malaise
Clinical narrative: Patient reports feeling very fatigued for 2-4 days after receiving the vaccines. She felt "out of sorts", no energy and exhausted. reported/completed this report done by providers office staff as an FYI No need to contact us. Thank you.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Mobility decreased, Muscular weakness, Pyrexia
Clinical narrative: Patient received high dose influenza vaccine on 9/23/20 in hospital(first time receiving high dose influenza vaccine, previously tolerated regular dose influenza vaccine without issues). During his recent PCP f/u visit on 9/30/20, he reported fever/headache, and weakness in all four extremities that he could not get up from his chair, he did not seek medical attention, but took 2 APAP. The above symptoms then resolved next morning at 5:30. Patient denied taking any medications around that time that could have contributed or related to those symptoms.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: Approximately 5 minutes after vaccine administered, patient started to complain of nausea and lightheadedness. As patient was being led from the waiting area back to the exam room, patient lost consciousness. She was guided gently to the floor and did not sustain any fall-related injury. Loss of consciousness estimated to be less than 30 seconds. Patient's face covering was removed, and she was allowed to rest. Hydration and cold compresses were provided. Patient ultimately left the office ambulatory, stable, accompanied by her mother and father. Call was made to patient later that evening. She was resting comfortably without any further pre/syncopal symptoms.  Pre-vaccine BP 108/72 Post-syncopal BP 90/52
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Palpitations
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Fatigue, Rash, Swelling
Clinical narrative: Local swelling & rash of upper arm plus fatigue and shortness of breath
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Nausea, Vomiting
Clinical narrative: please note product was the FLUZONE HIGHDOSE QUAD 20- 21 PF - unable to select that product above.  NauseaVomiting and weakness
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed rash about 12 days after administration of Fluzone -HD vaccine and was diagnosed as shingles by her doctor She is currently taking antiviral medication for the condition.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Breast pain, Herpes zoster, Influenza, Rash
Clinical narrative: Patient developed rash about 12 days after administration of Fluzone -HD vaccine and was diagnosed as shingles by her doctor She is currently taking antiviral medication for the condition.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: (L) shoulder pain at certain angle
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Peripheral swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: After receiving shingrix, she started experiencing chills, aches, and inflammation on her arm. she finally called & stopped by the pharmacy, and the RPH sent her to a clinic to further exam the site of vaccination. It was swollen and red & warm
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site warmth
Clinical narrative: After receiving shingrix, she started experiencing chills, aches, and inflammation on her arm. she finally called & stopped by the pharmacy, and the RPH sent her to a clinic to further exam the site of vaccination. It was swollen and red & warm
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pruritus
Clinical narrative: Patient reports pruritis all over body
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt. was just finished receiving vaccine. She said she felt fine. So I had her stay seated to help another customer. 2 min. later, her mom called me over for  water b/c pt. was very pale. Got a water bottle and gave it  to the patient, who was seated. Pt. laid her head down  on counter and briefly passed out.  She woke up around 30 seconds later and continued drinking water. Mom assured me she was fine, and color returned to her cheeks. Patient  stated she felt fine and needed no medical attention. Patient was walking around store with no issues.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Contusion, Mobility decreased, Pain, Swelling
Clinical narrative: Hurting a lot  bruise, swelling, bump  could not move arm
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Cellulitis, Nausea
Clinical narrative: Patient developed nausea and left upper arm cellulitis after receiving flu vaccine on friday 10-30-20. Treatment: Cephalexin 250mg/5ml for 10 days.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: PAtient woke up next morning with soreness in her ARm. The pAin is from the top of the shoulder to her elbow And is constant. It sometimes rAdiAtes to her wrist. Dr. suggested Aleve twice daily for 5 dAys. If it does not get better thAn physicAl therApy. PAtient sAw doctor 11/2/20, plus pAin with lifting ARM.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient experienced arm pain since flu vaccine administration. Has been taking Ibuprofen with little relief. Doesn't have full range of motion in arm, sensitive to touch. Scheduled appointment with doctor to discuss
Age: 3.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: a 3 year old received FLUBLOK/ No AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case is linked to 2020SA272861 (6 years old patient, same reporter).  This case involves a 3 years old male patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: UJ446AA, expiry date: 18-Mar-2021), via intramuscular route in the left vastus lateralis, on 30-Sep-2020 for prophylactic vaccination (Product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were unknown.  It was a case of an actual medication error due to the inappropriate age at vaccine administration (latency: same day).  At the time of report no adverse event was reported.  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: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 11 years old patient was inadvertently given Flublok vaccine/ No AE; Initial information received on 03-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: UJ463AA, expiry date: 19-Mar-2021), via intramuscular route in the left arm inadvertently for prophylactic vaccination on 03-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines was given to the patient.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report no adverse event was reported.  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: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor
Clinical narrative: passed out; very pale; Information has been received from Food and Drug Administration (FDA) (VAERS# 839229) on 25-SEP-2020.   This spontaneous report as received from a certified medical assistant refers to an 11-year-old White (not Hispanic or Latino), non-pregnant female patient. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, no allergies to medications, food, or other products, no chronic or long-standing health conditions. No illnesses at the time of vaccination and up to one month prior were reported. There was no concomitant therapy.   On 01-OCT-2019 at 10:18, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R017251 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 04-MAY-2021, intramuscularly in the right arm (dose was not provided)); with a first dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) (lot# 2T923, expiration date and dose were not reported, intramuscularly in the left arm); and with a first dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (lot# U6346AA, expiration date and dose were not reported, intramuscularly in the right arm). After the 3rd shot, at 10:20, the patient passed out. She awoke quick very pale, lying down on exam table. The physician was called immediately to check the patient. The outcome of loss of consciousness and pallor was reported as recovered/resolved. The relatedness between the events and vaccines was not provided by the reporter.  Follow-up information was received on 02-NOV-2020. A nurse called to obtain more information and complete the forms their office received. The reporter would be in the office on the next day and they would attempt to find the correct patient and fill out forms. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R017251; expirationdate: 04-MAY-2021; 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 suggest a causal association with the device or device constituent
Age: 5.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event
Clinical narrative: 5 year old male patient administered dose of FLUBLOK QUADRIVALENT, no AE; child is allergic to eggs; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse in.  This case involves a five year old male patient who by mistake received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  No concomitant and no other vaccine administered to the patient  At the time of the event, the patient had ongoing allergic to eggs.  On 22-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2012 and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  It was also case of contraindication to vaccination since the patient had egg allergy and was administered flublok quadrivalent.  At the time of report no adverse event was reported.  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: 5.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 year old male patient administered dose of FLUBLOK QUADRIVALENT, no AE; child is allergic to eggs; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse in.  This case involves a five year old male patient who by mistake received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  No concomitant and no other vaccine administered to the patient  At the time of the event, the patient had ongoing allergic to eggs.  On 22-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2012 and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  It was also case of contraindication to vaccination since the patient had egg allergy and was administered flublok quadrivalent.  At the time of report no adverse event was reported.  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: 60.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Arthralgia, Injection site injury, Insomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: I wanted to make you aware of a shoulder injury I sustained while  having my flu shot.  It happened on Friday, October 16th at the office.  I have attached the content of the report I filed. The complete report is not available to save or copy.   I happened to have a previous PT appointment scheduled prior to the incident for a different issue and planned to cancel it over the weekend as that had resolved itself. I decided to keep it to have the PT look at my right shoulder as it continued to have limited range of motion and was incredibly painful.  I did receive a referral for an ultrasound to confirm the specific injury. I called medical office today but they are not sure what to do with the request ? they have never heard of a shoulder ultrasound before.  They will call me back on Friday, October 30th to schedule an appointment.
Age: 60.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Pain, Pain in extremity, Poor quality sleep, Product administered at inappropriate site, Sleep disorder
Clinical narrative: I wanted to make you aware of a shoulder injury I sustained while  having my flu shot.  It happened on Friday, October 16th at the office.  I have attached the content of the report I filed. The complete report is not available to save or copy.   I happened to have a previous PT appointment scheduled prior to the incident for a different issue and planned to cancel it over the weekend as that had resolved itself. I decided to keep it to have the PT look at my right shoulder as it continued to have limited range of motion and was incredibly painful.  I did receive a referral for an ultrasound to confirm the specific injury. I called medical office today but they are not sure what to do with the request ? they have never heard of a shoulder ultrasound before.  They will call me back on Friday, October 30th to schedule an appointment.
Age: 60.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Arthralgia, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: I wanted to make you aware of a shoulder injury I sustained while  having my flu shot.  It happened on Friday, October 16th at the office.  I have attached the content of the report I filed. The complete report is not available to save or copy.   I happened to have a previous PT appointment scheduled prior to the incident for a different issue and planned to cancel it over the weekend as that had resolved itself. I decided to keep it to have the PT look at my right shoulder as it continued to have limited range of motion and was incredibly painful.  I did receive a referral for an ultrasound to confirm the specific injury. I called medical office today but they are not sure what to do with the request ? they have never heard of a shoulder ultrasound before.  They will call me back on Friday, October 30th to schedule an appointment.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, RV1
Symptoms: Chills, Crying, Malaise, Pallor, Vomiting
Clinical narrative: Vomiting, pale, malaise, chills, crying
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Neuropathy peripheral
Clinical narrative: I do not know which of the flu vaccines I had. I had ZERO idea there were choices. I thought you got the "FLU VACCINE" necessary for that year. I got Guillain Barre, however I did not know that is what I had. Severe Neuropathy in fingers, could not touch anything.. lasted 24 hour at severe and another 24 hours at mild to moderate... was gone by third day. My skin doctor let is the one who said  Guillain Barre. I also called the pharmacy and they said don't come back we won't give you anymore shots.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE reported; VARIVAX had a temperature excursion on 10-OCT-2020 and was administered; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 10-OCT-2020, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T002846, expiration date reported as 22-JAN-2022, but upon internal validation established as 23-JAN-2022; strength was not reported) was improperly stored under minus 14 degree Celsius (C) to minus 10 degree Celsius (minus 14.3 C) for 1 hour and 15 minutes, and then under minus 9 degree Celsius to 8 degree Celsius (minus 9.3 C) for 32 minutes, as recorded by digital data logger. There was no previous temperature excursion.   On 12-OCT-2020, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route and frequency were unknown) for prophylaxis. No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA007244:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: the patient received a double dose of Varicella; They thought they had given MMR II and not MMR with Varicella (ProQuad); Both ProQuad and Varicella were administered; This spontaneous report was received from a nurse referring to 2 year old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 27-OCT-2020, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously in the left arm and varicella virus vaccine live (oka/merck) (manufacturer unknown) subcutaneously in the right arm, both for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). They thought they had given Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) and not measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) since they didn't realize this last one contained varicella. The patient received a double dose of varicella. No treatment for receiving a double dose of varicella was given at the time of reporting. The patient also received other unknown vaccines on 27-OCT-2020.; Sender's Comments:  US-009507513-2010USA011527:
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Patient was administered Improperly Stored ROTATEQ and PEDVAX HIB; This spontaneous report was received from a nurse referring to a 4-month-old patient on unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 29-OCT-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dosage form, lot number S040483, expiration date 19-JUN-2021 and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 1 dosage form, lot number T000886, expiration date 29-MAY-2022 (route of administration was not provided for the vaccines). Both for prophylaxis.      The vaccines underwent a temperature excursion above 9 degrees Celsius (°C), with an average of 9.7°C for 45 minutes. There were no previous temperature excursions. The call was due to digital data logger. ; Sender's Comments:  US-009507513-2010USA012181:
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza A virus test positive, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: INFLUENZA VIRUS POSITIVE; FEVER; TESTED NEGATIVE FOR COVID-19; A spontaneous report has been received from a health professional. The report concerns a male patient (height 51 in, weight 68 lb).    No medical history was reported.     No concomitant products were reported.    On 16-Oct-2020, the patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number MH2024) 0.2 ml as required, via nasal route, for prevention.     On 19-Oct-2020 patient returned to medical office with fever (preferred term: Pyrexia) of 103 degrees Fahrenheit and tested positive for A strain of the influenza virus (preferred term: Influenza A virus test positive). Both parents of the patient tested positive for Covid-19, although patient tested negative for Covid-19 (preferred term: SARS-CoV-2 test negative).    The outcome of the events of influenza virus positive, fever and tested negative for covid-19 was unknown.     The event of tested negative for covid-19 have been identified by the company physician from the source document and added as adverse event.    Company physician assessed the event of tested negative for covid-19  as non serious. The event of influenza virus positive considered serious due to important medical event and the event of fever was considered as non serious by the reporter.; Sender's Comments: Influenza A virus test positive is not listed in the core company data sheet for flumist quadrivalent (Q/Laiv). Due to limited information on event details including the circumstances leading to the event, relevant medical history, concomitant medications, concurrent conditions (pulmonary and immune system disorders), discussion on lifestyle and specific risk factors (contact with infected person with known influenza), it is not possible to make a conclusive assessment of the causal relationship between the event and the suspect drug.
Sex: F
Vaccine: FLUX, UNK
Symptoms: Migraine
Clinical narrative: very bad migraine; This case was reported by a consumer via patient support programs and described the occurrence of migraine in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included belimumab (Benlysta) solution for injection in pre-filled pen for product used for unknown indication and belimumab autoinjector device (Benlysta Autoinjector Device) administration system for product used for unknown indication.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Benlysta 200 mg at an unknown frequency and Benlysta Autoinjector Device. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, Benlysta and Benlysta Autoinjector Device, the patient experienced migraine. The action taken with Benlysta was unknown. On an unknown date, the outcome of the migraine was unknown.   The reporter considered the migraine to be possibly related to Influenza vaccine Quadrivalent unspecified season. The reporter considered the migraine to be unrelated to Benlysta and Benlysta Autoinjector Device.  Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient received Benlysta. After receiving Influenza vaccine Quadrivalent unspecified season, Benlysta and Benlysta Autoinjector Device, the patient had very bad migraine.