chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Cold sweat, Nausea
Clinical narrative: patient complains of clammy skin, chills, nausea
Age: 70.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Beginning the morning after his vaccinations, the patient began experiencing swelling and redness at the injection site. It began as hives, then the area became one large, swollen area approximately 5 inches in width and irregular in shape. I saw the patient at 5 pm on October 8th and the reaction was red, elevated, and he claimed it was tender to the touch. I advised him to see the doctor in order to rule out possible infection from injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Patient experienced low fever, muscle aches/pains, weakness over night. She treated with acetaminophen. 2 days after the vaccine the injection site was red/swollen/warm to the touch. Patient contacted the pharmacy as well as her primary care physician to let them know about the swelling.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced low fever, muscle aches/pains, weakness over night. She treated with acetaminophen. 2 days after the vaccine the injection site was red/swollen/warm to the touch. Patient contacted the pharmacy as well as her primary care physician to let them know about the swelling.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Patient came in 10 days after her vaccination complaining of ongoing pain in her arm. She stated that she had severe pain at times that radiated up to her neck. She had taken ibuprofen in the night when the pain had gotten worse.  She had not yet seen a doctor, but planned too.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Patient is feeling very sore on and around the injection site
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash from right buttock down to right ankle.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dysphonia, Dyspnoea, Ocular hyperaemia, Oral discomfort
Clinical narrative: I got a flu shot and within 30 minutes started to feel sinus pressure and slight dizziness.  The symptoms gradually got worse and 6-7 hours later I had sinus pressure and pain (like a sinus infection), the roof of my mouth and throat felt tight and swollen, I had hoarseness of breath, dizziness, my eyes were slightly red, and I had shortness of breath.  I took Benadryl over the next 8-12 hours which stopped the symptoms from progressing.  Approximately 20-24 hours after receiving the shot the only remaining symptoms were slight sinus pressure and pain (like a mild sinus infection).  All symptoms were completely gone within 48 hours.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Palatal swelling, Paranasal sinus discomfort, Pharyngeal swelling, Throat tightness
Clinical narrative: I got a flu shot and within 30 minutes started to feel sinus pressure and slight dizziness.  The symptoms gradually got worse and 6-7 hours later I had sinus pressure and pain (like a sinus infection), the roof of my mouth and throat felt tight and swollen, I had hoarseness of breath, dizziness, my eyes were slightly red, and I had shortness of breath.  I took Benadryl over the next 8-12 hours which stopped the symptoms from progressing.  Approximately 20-24 hours after receiving the shot the only remaining symptoms were slight sinus pressure and pain (like a mild sinus infection).  All symptoms were completely gone within 48 hours.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: THE DAY AFTER THE VACCINATION, PATIENT DEVELOPED HIVES ON HER LEFT ARM NEAR THE SITE OF INJECTION. SHE ALSO REPORTED ONE SINGLE HIVE ON HER RIGHT ARM.  PATIENT CALLED PHARMACY. PHARMACIST INSTRUCTED HER TO TAKE BENADRYL AND DRAW A CIRCLE AROUND THE AREA.  IF THE AREA INCREASED IN SIZE, SHE WAS INSTRUCTED TO SEE MEDICAL ATTENTION.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: pt reports swelling of about 3 inches in diameter
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site haemorrhage, Injection site urticaria, Pain
Clinical narrative: Patient called 2 days after immunization to complain of a welt/knot on the backside of the same arm she received the immunization (about 3-5 inches away from injection site).  This is creating substantial pain/redness for the patient.  She explains it as like a really deep bruise to the bone.  She also is having slight bleeding from the injection site (when she removes a new band-aid she still has a little blood).
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itchy neck within the hour.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Lethargy, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever 102.6, lethargy, chills
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Skin discolouration
Clinical narrative: Both arms became black, patient was itching uncontrollably for two days.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Hypoacusis, Rash macular, Vision blurred
Clinical narrative: Patient complained of blurred vision, momentary disturbance in hearing, dizziness, body sweats - all within 5 minutes of injection. Red splotches appeared but disappeared within 20 mins of injection. Denied any trouble breathing. Patient recovered back to normal after sitting for 20 mins!
Age: 32.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Asthenia, Cellulitis, Mobility decreased, Pain
Clinical narrative: Patient received the flu shot & pneumovax vaccine on Monday 09/28/20.  The following day patient stated she was in extreme pain. The patient went to the ER that day due to the pain.  She was diagnosed with cellulitis by the ER doctor.  The patient stated she lost arm mobility for 4 days and continues to struggle to get her strength back.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: The arm where PNEUMOVAX was administered was incredibly swollen, hot and red. I couldn't move it because of the pain.  I had fever for 24hrs (100F). I ingested 1,000 mg of  acetaminophen every 4hrs trying to decrease the fever.  I couldn't sleep because I couldn't take sides because pain on the arms. I have had this vaccine before and I never experienced something like this.  If fever and swollen persisted I was panning to go to the ER.   The arm where the  flu vaccine was administered was swollen and hot but not like  the PNEUMOVAX arm.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: The arm where PNEUMOVAX was administered was incredibly swollen, hot and red. I couldn't move it because of the pain.  I had fever for 24hrs (100F). I ingested 1,000 mg of  acetaminophen every 4hrs trying to decrease the fever.  I couldn't sleep because I couldn't take sides because pain on the arms. I have had this vaccine before and I never experienced something like this.  If fever and swollen persisted I was panning to go to the ER.   The arm where the  flu vaccine was administered was swollen and hot but not like  the PNEUMOVAX arm.
Age: 62.0
Sex: F
Vaccine: VARZOS, FLUA4
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Per patient 1/3 arm red, raised, inflamed, painful/itchy. Patient saw her Dr. I'm not sure when her reaction started, I guessed in the above questions.
Age: 62.0
Sex: F
Vaccine: VARZOS, FLUA4
Symptoms: Chest X-ray normal, Chills, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: Per patient 1/3 arm red, raised, inflamed, painful/itchy. Patient saw her Dr. I'm not sure when her reaction started, I guessed in the above questions.
Age: 62.0
Sex: F
Vaccine: VARZOS, FLUA4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Per patient 1/3 arm red, raised, inflamed, painful/itchy. Patient saw her Dr. I'm not sure when her reaction started, I guessed in the above questions.
Age: 62.0
Sex: F
Vaccine: VARZOS, FLUA4
Symptoms: Metabolic function test normal, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Per patient 1/3 arm red, raised, inflamed, painful/itchy. Patient saw her Dr. I'm not sure when her reaction started, I guessed in the above questions.
Age: 54.0
Sex: M
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Dry skin, Rash, Rash maculo-papular
Clinical narrative: Pt states 3 days after vaccination. Maculopapular rash developed on right arm, this rash then spread to right rib, then left arm. Also describes dry skin on earlobes. Denies any changes in detergents, lotions, or soaps. States he has been applying calamine and Neosporin to affected areas and that the skin eruption seems to be improving. Pt reports to provider for documentation purposes. Pt did not wish to come to the clinic for follow up, notified provider in passing her in the grocery store.
Age: 77.0
Sex: F
Vaccine: FLUR4
Symptoms: Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 100 degree, diarrhea, muscle aches, fatigue for 2 days
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Injection site haemorrhage, Syncope
Clinical narrative: after I gave the patient the flu shot, I noticed there was blood showing under the bandaid. I went to get cotton to give to the patient- when I got back , the patient told me she doesnot feel good and she was double over- I told her to take a deep breath and lean back. As she lean back, she fainted. I assist her in laying her down on the floor and asked my technician to call 911. The paramedics came and transport her to the hospital.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Discomfort, Injection site discomfort, Injection site pain, Limb discomfort
Clinical narrative: Patient received her Flucelvax injection in left arm on Tuesday 10/06/20 at around 1pm.    On Tuesday patient states she had some soreness and discomfort but didn't think it was abnormal for a injection.  When she went to bed that night she states that it was particularly uncomfortable throughout the night.  The next morning the patient states she woke up with radiating pain from her shoulder down her entire arm to her hand.  When asked to describe the pain, she described it as if she had a hard work out and her entire arm was sore.  This discomfort in her entire arm lasted all day on Wednesday.  Thursday morning, she states that she woke up and no longer had the radiating arm pain but had pronounced swelling and pain in her armpit.  She proceeded to call the pharmacy for information.  I received a call from the patient around 9:15am when I gathered all the information about her symptoms.  After hearing about her symptoms, I advised her to see a doctor to examine her for the adverse reaction she was reporting. She was working throughout the day and told me she would attempt to see her provider.  Again, I reiterated that she should see her provider as soon as possible and to let me know what is the result and determination of the adverse reaction.  I also advised that I would be more than happy to reimburse her for her doctors visit with a receipt.    I followed up with her at 4:45pm and she was able to see a Dr who gave her antibiotics.  I asked if she had a diagnosis or infection and she was not sure (said Dr was hard to understand).  She did not know which antibiotic she filled them at the clinic.  Her arm is still very painful, swollen and tender at her underarms.  She said she did not require any reimbursement for her visit and I told her I will follow up in a couple of days to see how she's doing.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Oedema peripheral, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient received her Flucelvax injection in left arm on Tuesday 10/06/20 at around 1pm.    On Tuesday patient states she had some soreness and discomfort but didn't think it was abnormal for a injection.  When she went to bed that night she states that it was particularly uncomfortable throughout the night.  The next morning the patient states she woke up with radiating pain from her shoulder down her entire arm to her hand.  When asked to describe the pain, she described it as if she had a hard work out and her entire arm was sore.  This discomfort in her entire arm lasted all day on Wednesday.  Thursday morning, she states that she woke up and no longer had the radiating arm pain but had pronounced swelling and pain in her armpit.  She proceeded to call the pharmacy for information.  I received a call from the patient around 9:15am when I gathered all the information about her symptoms.  After hearing about her symptoms, I advised her to see a doctor to examine her for the adverse reaction she was reporting. She was working throughout the day and told me she would attempt to see her provider.  Again, I reiterated that she should see her provider as soon as possible and to let me know what is the result and determination of the adverse reaction.  I also advised that I would be more than happy to reimburse her for her doctors visit with a receipt.    I followed up with her at 4:45pm and she was able to see a Dr who gave her antibiotics.  I asked if she had a diagnosis or infection and she was not sure (said Dr was hard to understand).  She did not know which antibiotic she filled them at the clinic.  Her arm is still very painful, swollen and tender at her underarms.  She said she did not require any reimbursement for her visit and I told her I will follow up in a couple of days to see how she's doing.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Chills, Fatigue, Paraesthesia, Polyarthritis, Skin burning sensation
Clinical narrative: Patient had two vaccines 9AM 10/2/20.  By 4 PM he had chills and felt tired.  By 6PM he went to bed.  At 9PM he remained awake and had excruciating polyarthritis that nearly took him to the hospital.  He also had burning scalp paresthesias.  He took a couple Tylenol and the symptoms resolved over 3 hours.  He has never responded to influenza vaccine in the past so felt it must be the Shingrix.  He's reported symptoms to me because he's afraid it could be worse if he gets a Shingrix booster as he is suppose to in 2-6 months.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient had injection site reaction (red area of arm, hot to the touch, and swelling). Patient also had headache, fever, and vomiting.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vomiting
Clinical narrative: Patient had injection site reaction (red area of arm, hot to the touch, and swelling). Patient also had headache, fever, and vomiting.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Fall, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: 09:20 - Verified patient name and DOB prior to start of appointment. Patient denied feeling unwell. Patient denied any allergies to latex, eggs, and/or vaccines. Patient was not pregnant. Patient denied any history of seizures, Guillan-Barre syndrome.  09:25 - Set up area to do appointment on kitchen table. Afluria seasonal flu shot administered to L deltoid.  09:25-09:40 - Stayed with patient per protocol. Denied any allergic reactions (shortness of breath, itchiness, redness, dizziness)  09:40 - Upon attempt to leave appointment, patient stated that he "felt short of breath." Patient walked towards kitchen counter from kitchen table (approximately 20-30 feet) and leaned on counter for 10 seconds. Patient appeared to be shaking. Patient fell back and hit L side of head and loss consciousness for approximately 15-30 seconds. Patient regained consciousness and was able to answer his name, date of birth, and verification of nurse.  Patient appeared to be diaphoretic and pale. Patient called his fiance to check up on him. Explained course of events to fiance. Notified her that I will be getting equipment in my car to check his vital signs and blood sugar.  09:50 - Checked patient's vital signs (BP 115/75, HR 64, O2 sat 99% on RA) and blood sugar (109mg/dL).  Educated patient regarding signs and symptoms to look out for including dizziness, shortness of breath, nausea, vomiting. Notified patient that a nurse from our clinical team will be contacting him around 2pm for a clinical check in.  10:58 - Left appointment. 14:33 - Clinical lead of the day had called patient to check on current status. Patient stated that he was feeling better than before.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Tremor
Clinical narrative: 09:20 - Verified patient name and DOB prior to start of appointment. Patient denied feeling unwell. Patient denied any allergies to latex, eggs, and/or vaccines. Patient was not pregnant. Patient denied any history of seizures, Guillan-Barre syndrome.  09:25 - Set up area to do appointment on kitchen table. Afluria seasonal flu shot administered to L deltoid.  09:25-09:40 - Stayed with patient per protocol. Denied any allergic reactions (shortness of breath, itchiness, redness, dizziness)  09:40 - Upon attempt to leave appointment, patient stated that he "felt short of breath." Patient walked towards kitchen counter from kitchen table (approximately 20-30 feet) and leaned on counter for 10 seconds. Patient appeared to be shaking. Patient fell back and hit L side of head and loss consciousness for approximately 15-30 seconds. Patient regained consciousness and was able to answer his name, date of birth, and verification of nurse.  Patient appeared to be diaphoretic and pale. Patient called his fiance to check up on him. Explained course of events to fiance. Notified her that I will be getting equipment in my car to check his vital signs and blood sugar.  09:50 - Checked patient's vital signs (BP 115/75, HR 64, O2 sat 99% on RA) and blood sugar (109mg/dL).  Educated patient regarding signs and symptoms to look out for including dizziness, shortness of breath, nausea, vomiting. Notified patient that a nurse from our clinical team will be contacting him around 2pm for a clinical check in.  10:58 - Left appointment. 14:33 - Clinical lead of the day had called patient to check on current status. Patient stated that he was feeling better than before.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Pt came in to the pharmacy and asked about ADR. She reported soreness on her armpit in the arm she got the vaccine. Pt does not have any redness, or heat at the site of injection. Also the muscle soreness at the injection site.
Age: 49.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Influenza like illness
Clinical narrative: About 10 to 15 minutes after receiving both immunizations and leaving the doctor's office.  I started to experience a cold sensation starting in the left side muscle of my upper back at the shoulder level.  It slowly radiated to the center of my back just below my neck and went across to the right shoulder area.  The sensation was also in noticeable to the touch on my skin.  The left side and middle of my back were the coldest.  I had someone touch my skin in those areas about 15 minutes after the sensation started and they said that it felt like I had been using ice packs on my skin.  The sensation lasted for about three to four hours before it finally started to warm back up.  At no time was it ever painful, either muscular or on the surface of my skin.  I have never felt a sensation like that before.  I would liken it to putting on icyhot or biofreeze and it staying at the cold feeling of either of those.   I experienced the start of this while I was driving home and phoned my doctor's office as soon as I reached home.  I talked with my doctor's assistant.  She told me that my symptom was not what they would consider 'normal' and is the one who advised me to report it to you. I got flu like symptoms on the following Saturday (10/03/2020) that eased up and went away by Tuesday (10/06/2020). Those symptoms were fever, chills, general fatuige and weakness.
Age: 49.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: About 10 to 15 minutes after receiving both immunizations and leaving the doctor's office.  I started to experience a cold sensation starting in the left side muscle of my upper back at the shoulder level.  It slowly radiated to the center of my back just below my neck and went across to the right shoulder area.  The sensation was also in noticeable to the touch on my skin.  The left side and middle of my back were the coldest.  I had someone touch my skin in those areas about 15 minutes after the sensation started and they said that it felt like I had been using ice packs on my skin.  The sensation lasted for about three to four hours before it finally started to warm back up.  At no time was it ever painful, either muscular or on the surface of my skin.  I have never felt a sensation like that before.  I would liken it to putting on icyhot or biofreeze and it staying at the cold feeling of either of those.   I experienced the start of this while I was driving home and phoned my doctor's office as soon as I reached home.  I talked with my doctor's assistant.  She told me that my symptom was not what they would consider 'normal' and is the one who advised me to report it to you. I got flu like symptoms on the following Saturday (10/03/2020) that eased up and went away by Tuesday (10/06/2020). Those symptoms were fever, chills, general fatuige and weakness.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: Patient immediately bled at injection site and was concerned since he had never bled previously from a flu vaccine
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Night sweats, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient had red rash down her arm. Also reported chills, fever, and night sweets
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient called the pharmacy on 10/3/2020 and reported pain in her upper left arm. She described the pain as being severe and that she could barely move her arm and it hurt to the touch and at times radiated. She had received a flu vaccine (FluAd) on 9/13/2020 in her left arm and was questioning whether her pain could be related to the flu vaccine. She denied any fever, swelling, redness, or bruising.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, pain, heat from shoulder to elbow, near bicep muscle, no fever
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Whole arm and shoulder pain for about 30 mins after receiving vaccine. Pt sat in the booth until the pain subsided and pt was able to safely drive home
Age: 12.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient received Fluarix  Quad instead of Boostrix Tdap requested.  Administration of wrong vaccine. Correct one is subsequently given. on right lower arm. Fluarix was given on right upper arm
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Bed rest, Chest pain, Dizziness
Clinical narrative: Around 8PM on 10/6/20 the patient experienced dizziness, shortness of breath, fainted, chest pain, couldn't breathe, neck & shoulder pain, back pain, suspected inflammation of the brachial plexis, hives from the neck to shoulder. Patient went to the hospital and was given antihistimines and a muscle relaxer. States she is on bedrest and still experiencing pain, feels tired, weak and lightheaded. Called the pharmacy today to inform us of what happened.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Fatigue, Inflammation, Neck pain, Syncope
Clinical narrative: Around 8PM on 10/6/20 the patient experienced dizziness, shortness of breath, fainted, chest pain, couldn't breathe, neck & shoulder pain, back pain, suspected inflammation of the brachial plexis, hives from the neck to shoulder. Patient went to the hospital and was given antihistimines and a muscle relaxer. States she is on bedrest and still experiencing pain, feels tired, weak and lightheaded. Called the pharmacy today to inform us of what happened.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Around 8PM on 10/6/20 the patient experienced dizziness, shortness of breath, fainted, chest pain, couldn't breathe, neck & shoulder pain, back pain, suspected inflammation of the brachial plexis, hives from the neck to shoulder. Patient went to the hospital and was given antihistimines and a muscle relaxer. States she is on bedrest and still experiencing pain, feels tired, weak and lightheaded. Called the pharmacy today to inform us of what happened.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness Swelling Localize rash with cellulitis at injection site Heat Pain hard to raise the arm Burning sensation  Itching at injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Redness Swelling Localize rash with cellulitis at injection site Heat Pain hard to raise the arm Burning sensation  Itching at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient is complaining of numbness and a  tingling sensation in left shoulder that radiates to finger tips, tingling sensation in left foot , tingling sensation on the right side of face upon awakening.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, hot swelling Injection site, possible cellulitis
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Patient called pharmacy on 09/18/2020 to speak to pharmacist about lingering muscle pain, difficulty lifting left arm all the way up, as when putting on a shirt and was concerned that it is lasting this long (over 2 weeks) with no improvement Patien went to primary care md, took pain relievers with minimal relief.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Cough, Dyspnoea, Full blood count, Hyperhidrosis
Clinical narrative: 5:00pm-SOB, cough, wheezing, diaphoretic
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test, Wheezing
Clinical narrative: 5:00pm-SOB, cough, wheezing, diaphoretic
Age: 74.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen painful right arm
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, & warm to the touch. Also, very itchy to the patient. Advised to keep skin cleaned with soap & water. Continue oral antihistamine & oral ibuprofen as needed. Cool compresses for comfort. Follow up if erythema worsening/spreading, red streaking. Fever, discharge.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient lost consciousness for approximately 5 seconds. She was awoken, given water, offered a snack, and left the waiting area approximately 15 minutes later.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Gait disturbance, Loss of consciousness, Presyncope
Clinical narrative: vasovagal reaction about 1-2 minutes after giving vaccine. Pt stumbled and fell. She did not hit her head on anything and was not injured. in less than a min., Pt opened her eyes and sat up but did not know that she passed out and fell. She sat in a chair for another 15 minutes (checked on her 3 more times) and she was okay.
Age: 10.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NoNe
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: patient noticed several hours after receiving the vaccine her arm was hot to touch & very sore No treatment
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Facial pain, Injection site pain, Neck pain, Pain
Clinical narrative: Pain at injection site reaching right side of neck and face, Took extra TYLENOL every 6 hours which slowly helped with the pain.Advised patient to consult with her doctor on 10-7-2020
Age: 11.0
Sex: F
Vaccine: FLU4, HPVX, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Pt received her 11 yr vaccines. Tdap, HPV in her (L) deltoid - Per Mom had swelling from injection site down to her fingers. Advice Elevate, Ice and Benadryl. No further complaints or swelling
Age: 75.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states that he has sharp pain in his right arm and is unable to raise his arm without pain. He says these symptoms subsided a little on the second day but he is afraid that some nerve damage has happened, He states that the vaccines were given on very high location on his arm very close to his shoulder and that's why he's concerned about nerve damage. He was recommended to contact his PCP to be evaluated.
Age: 16.0
Sex: M
Vaccine: MENB, HPV9, MENB, MNQ
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: severe allergic reaction; Fever; Severe pain all over body/body aches; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for five patients. This is the 4th of 5 patients. Only this case is serious.  A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CM1494), intramuscular on the left arm on 23Jul2020 14:55 at a single dose (reported as 1-1-1/2) for Men B/immunisation, 2nd dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, lot number: U6486AC), intramuscular on the right arm on 23Jul2020 at unknown dose for immunisation, 2nd dose of hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9, lot number: S028737), intramuscular on right arm on 23Jul2020 at unknown dose for immunisation. The patient previously took a 1st dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and 1st dose of hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9) both on an unspecified date. The patient had no medical history and no concomitant medications. The patient experienced fever, body aches and severe pain all over body on Jul2020 (onset reported as 21Jul2020-pending clarification). The patient went to the ER, received treatment and was diagnosed with severe allergic reaction. Due to severe pain/body pain, patient was given hydrocodone in the emergency room and took Advil for fever. The patient was not hospitalized due to the events. The outcome of event fever was recovered on 03Aug2020 while for other events was unknown. It was reported that there is a reasonable possibility that the event is related to the suspect product. The event/s (unspecified) was reported as serious due to being life-threatening, or due to persistent or significant disability/incapacity or any other reason.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events drug allergy and fever were related to TRUMENBA based on known drug safety profile. Based on the temporal relationsihp, the association between the event pain with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020343033 Same reporter, similar drug and events, different patient
Age: 16.0
Sex: M
Vaccine: MENB, HPV9, MENB, MNQ
Symptoms: Hypersensitivity, Pain, Pyrexia
Clinical narrative: severe allergic reaction; Fever; Severe pain all over body/body aches; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for five patients. This is the 4th of 5 patients. Only this case is serious.  A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CM1494), intramuscular on the left arm on 23Jul2020 14:55 at a single dose (reported as 1-1-1/2) for Men B/immunisation, 2nd dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, lot number: U6486AC), intramuscular on the right arm on 23Jul2020 at unknown dose for immunisation, 2nd dose of hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9, lot number: S028737), intramuscular on right arm on 23Jul2020 at unknown dose for immunisation. The patient previously took a 1st dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and 1st dose of hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9) both on an unspecified date. The patient had no medical history and no concomitant medications. The patient experienced fever, body aches and severe pain all over body on Jul2020 (onset reported as 21Jul2020-pending clarification). The patient went to the ER, received treatment and was diagnosed with severe allergic reaction. Due to severe pain/body pain, patient was given hydrocodone in the emergency room and took Advil for fever. The patient was not hospitalized due to the events. The outcome of event fever was recovered on 03Aug2020 while for other events was unknown. It was reported that there is a reasonable possibility that the event is related to the suspect product. The event/s (unspecified) was reported as serious due to being life-threatening, or due to persistent or significant disability/incapacity or any other reason.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events drug allergy and fever were related to TRUMENBA based on known drug safety profile. Based on the temporal relationsihp, the association between the event pain with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020343033 Same reporter, similar drug and events, different patient
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Lethargy, Nausea, Pain in extremity, Vomiting
Clinical narrative: severe pain at the injection site and down the arm; nauseated; threw up; left sided headache; left arm became painful; the consumer could not move the arm or fingers, at all; the consumer was in bed all day, 'sick all over' and had a 'flu-type sickness'; the consumer was in bed all day, 'sick all over' and had a 'flu-type sickness'; This spontaneous report was received from a family member and refers to a currently 71-year-old male patient. Concurrent condition included chronic migraine headaches. There was no information about the patient's concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 28-SEP-2020 (reported as on Monday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot number: T020639, expiration date was provided as 20-MAR-2022, but upon internal validation established as 13-MAR-2022, for prophylaxis (exact dose and route of administration were not provided).  On the same date, the patient was ok for about 4-5 hours, after receiving the vaccine, and then his left arm became painful and the patient could not move the arm or fingers, at all.  On 29-SEP-2020 (reported as on Tuesday), the patient was able to move the fingers a little bit, but that there was severe pain at the injection site and down the arm. On the same day by 11 am, he felt nauseated and threw up. The patient had a left sided headache.   On an unknown date in in September (reported as by 30-SEP-2020, by Wednesday), the patient was able to move the arm, but he did not feel great.  On an unknown date in September 2020 (reported as by 01-OCT-2020, by Thursday), he was in bed all day, sick all over and had a flu-type sickness. The patient was able to move the arm.   On 02-OCT-2020 (reported as Today), the patient was up and he was doing well so far.  It was reported that the patient sought for medical attention. No treatment was given for the adverse events.  The outcome of the event injected limb mobility decreased was recovered on an unknown date in September 2020. The outcome of rest of the events was unknown. The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Influenza like illness, Injected limb mobility decreased, Injection site pain, Malaise
Clinical narrative: severe pain at the injection site and down the arm; nauseated; threw up; left sided headache; left arm became painful; the consumer could not move the arm or fingers, at all; the consumer was in bed all day, 'sick all over' and had a 'flu-type sickness'; the consumer was in bed all day, 'sick all over' and had a 'flu-type sickness'; This spontaneous report was received from a family member and refers to a currently 71-year-old male patient. Concurrent condition included chronic migraine headaches. There was no information about the patient's concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 28-SEP-2020 (reported as on Monday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot number: T020639, expiration date was provided as 20-MAR-2022, but upon internal validation established as 13-MAR-2022, for prophylaxis (exact dose and route of administration were not provided).  On the same date, the patient was ok for about 4-5 hours, after receiving the vaccine, and then his left arm became painful and the patient could not move the arm or fingers, at all.  On 29-SEP-2020 (reported as on Tuesday), the patient was able to move the fingers a little bit, but that there was severe pain at the injection site and down the arm. On the same day by 11 am, he felt nauseated and threw up. The patient had a left sided headache.   On an unknown date in in September (reported as by 30-SEP-2020, by Wednesday), the patient was able to move the arm, but he did not feel great.  On an unknown date in September 2020 (reported as by 01-OCT-2020, by Thursday), he was in bed all day, sick all over and had a flu-type sickness. The patient was able to move the arm.   On 02-OCT-2020 (reported as Today), the patient was up and he was doing well so far.  It was reported that the patient sought for medical attention. No treatment was given for the adverse events.  The outcome of the event injected limb mobility decreased was recovered on an unknown date in September 2020. The outcome of rest of the events was unknown. The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: severe pain at the injection site and down the arm; nauseated; threw up; left sided headache; left arm became painful; the consumer could not move the arm or fingers, at all; the consumer was in bed all day, 'sick all over' and had a 'flu-type sickness'; the consumer was in bed all day, 'sick all over' and had a 'flu-type sickness'; This spontaneous report was received from a family member and refers to a currently 71-year-old male patient. Concurrent condition included chronic migraine headaches. There was no information about the patient's concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 28-SEP-2020 (reported as on Monday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot number: T020639, expiration date was provided as 20-MAR-2022, but upon internal validation established as 13-MAR-2022, for prophylaxis (exact dose and route of administration were not provided).  On the same date, the patient was ok for about 4-5 hours, after receiving the vaccine, and then his left arm became painful and the patient could not move the arm or fingers, at all.  On 29-SEP-2020 (reported as on Tuesday), the patient was able to move the fingers a little bit, but that there was severe pain at the injection site and down the arm. On the same day by 11 am, he felt nauseated and threw up. The patient had a left sided headache.   On an unknown date in in September (reported as by 30-SEP-2020, by Wednesday), the patient was able to move the arm, but he did not feel great.  On an unknown date in September 2020 (reported as by 01-OCT-2020, by Thursday), he was in bed all day, sick all over and had a flu-type sickness. The patient was able to move the arm.   On 02-OCT-2020 (reported as Today), the patient was up and he was doing well so far.  It was reported that the patient sought for medical attention. No treatment was given for the adverse events.  The outcome of the event injected limb mobility decreased was recovered on an unknown date in September 2020. The outcome of rest of the events was unknown. The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Syncope
Clinical narrative: Pt received flu shot on left upper arm. He left with his girlfriend and her mother to go upfront to buy something in the store.  While in line, he fainted.  He woke up and felt a bad headache but never lost consciouness after that.
Age: 6.0
Sex: M
Vaccine: FLUA3
Symptoms: Body temperature increased
Clinical narrative: Temperature of 103.8
Age: 85.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Muscle injury, Pain in extremity
Clinical narrative: Patient got both shots in her left arm and now she can no longer lift her left arm. She went to the doctor and the doctor told her that she has muscle damage from the shot.patient is still in pain from the shot.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no immediate reaction upon discovery of medication error; Reports dose of PROQUAD given at the same time as VARIVAX.; This spontaneous report was received from a physician via a field representative referring to a 12 months old male patient. The patient had eczema and was otherwise health and had a normal delivery, no hospitalization. He was recommended weight-based dose of ibuprofen. Information about drug reactions/allergies was not reported.  On 11-SEP-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 dosage form, lot # was reported as SO30211, expiration date not reported, upon internal evaluation changed to the valid lot# S030211 (therapy type: rHA) with expiration date 25-MAR-2021, route was not reported) for prophylaxis. On the same date, at the same time, the patient was also vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 dosage form, lot # was reported as SO15463, expiration date not reported, upon internal evaluation changed to the valid lot# S015463 with expiration date 20-MAY-2021, route was not reported) for prophylaxis (inappropriate schedule of product administration) and the patient was also given a dose of hepatitis a vaccine, inactivated (VAQTA) (1 dosage form, lot # was reported as SO25993, expiration date not reported, upon internal evaluation changed to the valid lot# S025993 with expiration date 17-OCT-2020, route was not reported) for prophylaxis. The patient had no immediate reaction upon discovery of the medication error (no adverse event).
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. Information about concomitant medication, pertinent medical history, drug reactions or allergies was unknown.  On 28-AUG-2020, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (also reported as therapy start date unknown) (lot # S038701, expiration date: 01-DEC-2021, dose was not reported, subcutaneous) for prophylaxis (reported as "well check") (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine was exposed to temperature from minus 9 Celsius degree to 8 Celsius degree (also reported as minus 6.1 Celsius degree) (multiple excursions). The time frame was unknown by reporter. No previous temperature excursion. Another varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine (lot# S032355, expiration date: 14-OCT-2021, dose was not reported, subcutaneous) was involved. The vaccine was exposed to temperature from minus 14 Celsius degree to minus 10 Celsius degree for 116 hours and from minus 9 Celsius degree to 8 Celsius degree for 13 hours. Time frame was reported as 129 hours. No previous temperature excursion. Data logger was involved for both vaccines.