chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Nasopharyngitis, Pyrexia
Clinical narrative: On October 16, 2020 at around 6 pm Fluzone HD was administered on the left deltoid. After 4 hours she develops a fever of 101 Fahrenheit with fatigue and joint pains. She took some Tylenol and symptoms went away. Then on October 26 fatigue and cold symptoms came back. I waited up to this date to report  because she told me she will be tested with COVID 19. I tried calling her for the past couple of days but no answer.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Breast pain, Cellulitis, Discomfort, Dyspnoea
Clinical narrative: Patient said around 7 in the evening on 11/5/20 she couldn't lift her right arm to pull off her shirt. When she laid down at night she couldn't  close her fist to pull her blanket over her. When she laid down she said the pressure was unbearable and her back and breast would hurt. On 11/6/20 she began to have difficulty breathing and went to the ER. She said at they ER they told her she had an infection from the vaccine and it caused cellulitis. Patient reports they gave her steroid shot, antibiotics and pain medication. She reports today 11/7/20, mobility in her arm has increased but she is still in discomfort in the right arm and her back.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Infection, Limb discomfort, Mobility decreased, Musculoskeletal discomfort
Clinical narrative: Patient said around 7 in the evening on 11/5/20 she couldn't lift her right arm to pull off her shirt. When she laid down at night she couldn't  close her fist to pull her blanket over her. When she laid down she said the pressure was unbearable and her back and breast would hurt. On 11/6/20 she began to have difficulty breathing and went to the ER. She said at they ER they told her she had an infection from the vaccine and it caused cellulitis. Patient reports they gave her steroid shot, antibiotics and pain medication. She reports today 11/7/20, mobility in her arm has increased but she is still in discomfort in the right arm and her back.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid rash, Rash pruritic
Clinical narrative: Patient said she has an itchy rash on her right eyelid in the crease
Sex: M
Vaccine: HEP
Symptoms: Electroencephalogram abnormal, Lumbar puncture normal, Magnetic resonance imaging normal, Seizure
Clinical narrative: baby now requiring oxygen (not at time of vaccine), baby now on phenobarb
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Syncope
Clinical narrative: VACCINE WAS ADMINISTERED AT APPROXIMATELY 4:10PM.  AT APPROXIMATELY 4:15PM PT WAS STANDING NEXT TO HER MOTHER AT COUNTER AND FAINTED.  911 WAS CONTACTED. PT CAME TO AND SEEMED CONFUSED.  I STAYED WITH PT UNTIL  EMS ARRIVED.  PT WAS TAKEN OUT OF PHARMACY BY EMS FOR FURTHER EVALUATION.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Her daughter called and stated that she "had a baseball sized lump in her arm" and it was warm to the touch and extremely red. She also stated that "she was having trouble moving the arm at all."
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Exercise tolerance decreased, Mobility decreased, Pain, Pruritus, Sleep disorder
Clinical narrative: Patient complained of itching and pain after administration. 1 months post vaccination, patient is still suffering from pain. She is awaken at night from the pain and is unable to fully move arm. She complains that it is difficult to exercise. She has been advised by her physician to take ibuprofen.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Administration site rash, Administration site warmth, Diarrhoea, Rash, Rash erythematous
Clinical narrative: Patient received a Flu vaccine on 11/05/2020, did not experience any immediate discomfort or adverse events. Patient presented back at the pharmacy on 11/7/2020 with the following symptoms Diarrhea that started on the night of 11/6, painful, red, warm to touch rash at the site of administration that was noticed on the morning of 11/7.  I examined the rash, it was well defined and localized to the deltoid region. Patient also reported that the rash was itchy. Patient was asked to update the pharmacy within 24 hours.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash pruritic
Clinical narrative: Patient received a Flu vaccine on 11/05/2020, did not experience any immediate discomfort or adverse events. Patient presented back at the pharmacy on 11/7/2020 with the following symptoms Diarrhea that started on the night of 11/6, painful, red, warm to touch rash at the site of administration that was noticed on the morning of 11/7.  I examined the rash, it was well defined and localized to the deltoid region. Patient also reported that the rash was itchy. Patient was asked to update the pharmacy within 24 hours.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: pt's arm was red and swollen from the top of her shoulder to the past the bend of the elbow.  It itched and displayed redness.  When pt reached the pharmacy she had pictures of the swelling. The swelling at reduced but the arm still displayed redness and fever along with itching.  Pt contacted the md and was given a antibiotic along with told by md to place cold patches on her arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Swelling
Clinical narrative: soreness, swelling, nausea,  headache, chills,
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site mass
Clinical narrative: Left Shoulder Sore after 22 days.  Lumpy mass about 2 inches in diameter at the injection site.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Induration, Inflammation, Pruritus, Rash, Swelling
Clinical narrative: Patient reported to pharmacy for refills and asked about the reaction she is having on the back of her arm from a vaccine received a month ago. The area became swollen up with a knot and has a red circle around it the day after the vaccine. Patient reports that it itches and I recognized that there is a rash underneath the knot. The patient is concerned that it is still there after a month and it hurts if she touches it or bumps her arm on something. Patient reports using hydrocortisone cream to help with the itching and states that it has improved some. I could not find any guidance on how long a person can have a reaction after a live vaccine.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Tenderness
Clinical narrative: Patient reported to pharmacy for refills and asked about the reaction she is having on the back of her arm from a vaccine received a month ago. The area became swollen up with a knot and has a red circle around it the day after the vaccine. Patient reports that it itches and I recognized that there is a rash underneath the knot. The patient is concerned that it is still there after a month and it hurts if she touches it or bumps her arm on something. Patient reports using hydrocortisone cream to help with the itching and states that it has improved some. I could not find any guidance on how long a person can have a reaction after a live vaccine.
Sex: U
Vaccine: FLUR4
Symptoms: Dyspnoea, Injection site pruritus, Injection site urticaria
Clinical narrative: Itchy and hives at injection site, labored breathing
Age: 64.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received two vaccines in left arm on 10/4/2020 . Patient states to have pain in left arm still to this day. Went previously to prescribers office and received medication for pain, but insist to have pain when laying down on that arm and when raising arm at a certain angle. Patient mentioned he will be attending his doctors office for second time this upcoming week.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Fatigue, Injection site rash, Rash
Clinical narrative: patient developed rash on injection site. started as sore red patches then progressing to large, swollen, circular, red patch about 8in long and 6 in wide that wrapped around the patient's arm. rash is painful and hot to the touch. patient complained of general fatigue and discomfort. swelling has gone down considerably on 11/5/2020 but is still red.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: patient developed rash on injection site. started as sore red patches then progressing to large, swollen, circular, red patch about 8in long and 6 in wide that wrapped around the patient's arm. rash is painful and hot to the touch. patient complained of general fatigue and discomfort. swelling has gone down considerably on 11/5/2020 but is still red.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: Pharmacy intern gave a flu shot to the patient. 10 minutes later the patient had fallen to the ground. Patient lied on the ground for about 5 minutes and then got up. Patient states they are feeling fine. Paramedics came for assistance.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Chest discomfort, Cough, Productive cough
Clinical narrative: Tightness of chest.  Coughing Production of phlegm
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Urticaria
Clinical narrative: pt called around 12pm. stated she started getting welts all over her body which started around 9am 11/6/20. Advised to take Benadryl got to ER/urgent care. Called back @ 245pm and pt stated she was having laboured breathing. Advised call 911/go to ER STAT. Some welts were going down but more were emerging.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Rash erythematous, Swelling
Clinical narrative: Erythematous rash, swelling, Induration at the site and proximally near elbow area
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration
Clinical narrative: Blue coloured area around the site.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pruritus, Joint swelling
Clinical narrative: Pt experienced swelling in both ankles and itchy eyes three hours after vaccine. Took a benadryl and symptoms subsided overnight.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: APPROXIMATELY 3" BELOW INJECTION SITE, ROUND RED AREA WARM, SWELLING + PAIN. SLIGHTLY ITCHY. STARTED DAY OF FLU VACCINE. TREATED WITH BENADRYL, THEN DIAGNOSED AS CELLULITUS TX WITH AMOXICILLIN.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site warmth
Clinical narrative: APPROXIMATELY 3" BELOW INJECTION SITE, ROUND RED AREA WARM, SWELLING + PAIN. SLIGHTLY ITCHY. STARTED DAY OF FLU VACCINE. TREATED WITH BENADRYL, THEN DIAGNOSED AS CELLULITUS TX WITH AMOXICILLIN.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Erythema, Skin warm
Clinical narrative: Her arm (elbow up) was hot & red but  improving without intervention. She saw her doctor 11-6-20 who told her to report the  reaction (thought may be an allergy). Approximately 8 days  since vaccination. Pt has been icing site only.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Shingles like rash started on thighs and spread locally over one week
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Got shingles several daysa fter receiving flu vaccine injection (not sure the type or manufacturer) , of course possible a coincidence however if you search the web you will see dozens of people were diagnosed with Shingles several days after getting a Flu shot. Enough that it should be looked into with a medical research study.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 99.7 F.                                                                                                                                                                                                              Began around 11:30 PM on 11/07/2020 and continuing at time of this submission 6:25 AM 11/08/2020
Age: 44.0
Sex: M
Vaccine: FLUA4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Muscle spasms, Muscle twitching
Clinical narrative: Patient received vaccine yesterday in left arm and complained of immediate "twitching/spasm" feeling in left bicep muscle. "Twitching/Spasm has lasted for 23 hours at time of reporting. Patient has attempted ice, heat, massage and ibuprofen to relieve spasm. Patient also reports continued tenderness at the injection site. There is no redness, swelling, or obvious deformity. There are no noted issues regarding strength or range of motion.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Feeling abnormal, Mobility decreased
Clinical narrative: Intense Chills Hard time moving Most likely had a fever but I couldn't get off the couch to check
Age: 24.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Foaming at mouth, Immediate post-injection reaction, Loss of consciousness, Mental status changes
Clinical narrative: Upon immediate administration of vaccine, patient felt dizzy, sustained altered mental status and started to lose consciousness.  Patient was placed supine on an exam table where he appeared to start convulsing and frothing at the mouth.  Patient regained consciousness after a few seconds and could start to answer questions regarding his location and name.
Age: 24.0
Sex: M
Vaccine: HEPAB
Symptoms: Seizure, Vital signs measurement
Clinical narrative: Upon immediate administration of vaccine, patient felt dizzy, sustained altered mental status and started to lose consciousness.  Patient was placed supine on an exam table where he appeared to start convulsing and frothing at the mouth.  Patient regained consciousness after a few seconds and could start to answer questions regarding his location and name.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: Patient's mother called on 11/7/2020 to report an adverse event for her daughter. She states that her daughter has been experiencing a rash on her forearm near her wrist and numbness/tingling on her forearm which started on Thursday after receiving her flu shot. Her mother stated that she does not have a primary care doctor, but will continue to monitor the condition and seek medical attention if her condition continues or worsens.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Patient noticed itching at site, redness and edema one day after receiving vaccine. Patient states she put ice on site and took 50 mg oral Benadryl. Patient states redness has subsided slightly. Edema has improved as well.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Shivering and shaking 13 hours after initial dose
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness postural, Gait disturbance, Headache, Muscular weakness
Clinical narrative: approx 4 hours after shot pt experience symptoms of chills, nausea, vomitting, head ache, muscle weakness and difficulty walking - diff walking when getting up slight dizziness dyscopia - symptoms were most present on night of vaccination - most are getting better slowly - ha still present
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: approx 4 hours after shot pt experience symptoms of chills, nausea, vomitting, head ache, muscle weakness and difficulty walking - diff walking when getting up slight dizziness dyscopia - symptoms were most present on night of vaccination - most are getting better slowly - ha still present
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Injected limb mobility decreased, Pain in extremity, Sleep disorder, Weight bearing difficulty
Clinical narrative: Arm continues to be sore. Patient has a hard time lifting, driving and sleeping or putting weight on shoulder. Pt's left arm is the sore arm. Patient reports pain has not lessened since 10/6/2020 when shot was received in shoulder. Patient BELIEVES shot may have been inserted too high above deltoid muscle. Reports pain from shot in shoulder joint. Recommended patient call primary doctor. Patient reported that they will call Monday 11/9/20
Sex: F
Vaccine: HEP
Symptoms: Atelectasis neonatal, Blood glucose decreased, Chest X-ray abnormal, Hypoglycaemia neonatal, Neonatal hypoxia
Clinical narrative: 1. Oxygen desaturation. Respiratory problem. Hypoxia. 2 episodes on 2/12/20 She required blow by O2 for desaturations. Given oxygen need, CXR was done with low lung volumes and left upper patchy atelectasis. She was placed briefly on oxyhood on 2/12/20 for a few hours.  The information was taken from discharge summary. 2. Low blood sugar. Hypoglycemia. Required dextrose containing IV fluids. IV fluids were weaned on 02/15/20.  I am the mother. My  blood sugar was a fine during my pregnancy. Glucose test was good.I kept tracking my sugar during my pregnancy, and it was all good. It should not happen with my baby.
Sex: F
Vaccine: HEP
Symptoms: Respiratory disorder neonatal, Total lung capacity decreased
Clinical narrative: 1. Oxygen desaturation. Respiratory problem. Hypoxia. 2 episodes on 2/12/20 She required blow by O2 for desaturations. Given oxygen need, CXR was done with low lung volumes and left upper patchy atelectasis. She was placed briefly on oxyhood on 2/12/20 for a few hours.  The information was taken from discharge summary. 2. Low blood sugar. Hypoglycemia. Required dextrose containing IV fluids. IV fluids were weaned on 02/15/20.  I am the mother. My  blood sugar was a fine during my pregnancy. Glucose test was good.I kept tracking my sugar during my pregnancy, and it was all good. It should not happen with my baby.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT HAD SWELLING AND REDNESS AT INJECTION SITE
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Myalgia, Poor quality sleep
Clinical narrative: dizziness, muscle pain, inability to sleep well, weakness
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: patient states that her deltoid area / upper arm are very red and swollen and painful
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site thrombosis, Pain, Pyrexia
Clinical narrative: Fever, massive softball size thrombosis at injection site, and pain for two weeks.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Dizziness, Product administered to patient of inappropriate age
Clinical narrative: Patient received Fluzone high dose based on the information entered in the profile (69yo). Patient came back about 10 minutes later saying that he was not 69yo but 59yo and because he received high dose he started getting dizzy. The pharmacist called the patient about an hour later and when asked, the patient said he was doing better. The pharmacist was unable to contact the patient the following day.
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient received Fluad vaccine on 10/17/20, she noted no pain at initial injection.  Later that evening began experiencing shooting pain radiating down her arm from the shoulder.  Stated that the condition has continued from the date of vaccination until now with no improvement.  She stated that she hsa taken advil without much benefit.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever of 101, headache, chills, body aches. Lasted for 18 hours.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Feeling jittery, Headache, Injection site erythema
Clinical narrative: Client stated: redness and warmth at injection site. Had jitters in bed that night with mild dizziness some SOB, headache and heart racing. He stated that he checked his Blood Pressure and that his BP was normal. Highest HR=109 at 6:25am on 10/2 and decreased to 84 at 11:00am same day. On 10/2/20 he also stated a headache, sore red and swollen shoulder area (LA) and around to armpit. He stated that symptoms subsided throughout the next couple of days.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral, Palpitations
Clinical narrative: Client stated: redness and warmth at injection site. Had jitters in bed that night with mild dizziness some SOB, headache and heart racing. He stated that he checked his Blood Pressure and that his BP was normal. Highest HR=109 at 6:25am on 10/2 and decreased to 84 at 11:00am same day. On 10/2/20 he also stated a headache, sore red and swollen shoulder area (LA) and around to armpit. He stated that symptoms subsided throughout the next couple of days.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Pyrexia
Clinical narrative: The day after the vaccinations, patient had fever of 100.5 F, tiredness, redness at the local site. Her daughter took her to Urgent Care.  Her daughter called us to report on 11/2/20
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Ear pain, Hypoacusis, Pyrexia, Rash
Clinical narrative: fever for one day -101 degrees-began and ended 11/1- took a Tylenol rash on backs of thighs-ongoing severe  ear pain and pressure as well as impaired hearing - left ear-began 11/3-ended that evening after doctor recommended that I take an antihistamine.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain
Clinical narrative: shoulder ached and couldn't move full range of motion without pain
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Fall, Hypoaesthesia, Presyncope, Syncope, Unresponsive to stimuli
Clinical narrative: After patient received vaccination he went to the pharmacy register with his family for checkout. Child fainted and fell to the ground. At first he was awake but somewhat unresponsive. After a few seconds he said he could not feel his legs. We had child sit on the ground and I asked him if he was able to breath okay. He stated he was. He stated that he regained feeling in his legs and was able to wiggle his toes. Child was given a drink of water that he was able to drink without issue. We kept child on the ground until it seemed he had stabilized. After his mom helped him to his feet he walked around the store for a little while and then the family took him home. They declined offer to contact 911 and I recommended they follow up with child's healthcare provider. Incident appears to be a vasovagal reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Sore swollen injections site like a baseball Mild fever. Body aches all over and lack of energy
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a blotchy rash later in the evening (exact time unknown) after receiving first dose of vaccine at about 2 pm at pharmacy.  Patient's husband took her to the emergency room.  Patient received prescription for prednisone 20mg and Benadryl 25mg (bought Benadryl otc as was not covered by insurance).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: She started with hives and itch all over her body on Saturday around 2 pm. she put some hydrocortisone OTC to alleviate the itch but didn't help her out. On Monday morning, her arm become purple and very swollen. Her scalp was very itchy,. she was very tired and weak. She went to pharmacy around noon and pick up Benadryl. She took the first dose which didn't help her, so she took the second dose which makes her super drowsy. She called us at  pharmacy, and I recommend calling her PCP. her PCP advise her to take the Benadryl for couple of more days. Her redness and swollen arms got better over the week. I spoke with her, and she's better.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Patient received 3 total vaccines that day including Pneumovax 23 and the seasonal flu vaccine, Fluzone HD.  Patient is unsure if her symptoms are related to the vaccines received or if she is Covid-19 positive.  Patient said she was getting tested today to rule out a Covid-19 diagnosis.  Her symptoms include fever, nausea, chilling, and headaches.  She said her arm is slightly red where she received two vaccines.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: SARS-CoV-2 test
Clinical narrative: Patient received 3 total vaccines that day including Pneumovax 23 and the seasonal flu vaccine, Fluzone HD.  Patient is unsure if her symptoms are related to the vaccines received or if she is Covid-19 positive.  Patient said she was getting tested today to rule out a Covid-19 diagnosis.  Her symptoms include fever, nausea, chilling, and headaches.  She said her arm is slightly red where she received two vaccines.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 11-2-20. PPD test was administered  11-07-20.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity
Clinical narrative: redness under the arm and a very sore arm. patient said that she could barely move her arm. Patient states her arm is still sore and has limited range of motion but redness is gone now.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache, body aches, fatigue
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: CELLULITIS Patient came to pharmacy stating site of injection was red, swollen, and very painful, RPh on duty advised patient to call MD, due to possible cellulitis, patient returned to pharmacy later in the day to state it was in fact cellulitis and MD sent an RX antibiotic to treat
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood test, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain in left hand. Swelling of knuckles on hand of last two fingers. Cannot bend hand or make a fist. Bodily pains all over.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Bone pain, Injected limb mobility decreased, Myalgia, Peripheral swelling
Clinical narrative: Severe pain in left hand. Swelling of knuckles on hand of last two fingers. Cannot bend hand or make a fist. Bodily pains all over.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Blood pressure increased, Nausea, Vomiting
Clinical narrative: Patient recieved a Flublock vaccine on at 1:25-1:46PM on November 5, 2020. I, the pharmacist-in-charge and certified immunizer, recieved a call from the patient around 3:15-3:30PM , stating that she was expericing nausea and vomiting shortly after leaving the pharmacy. The patient belived that this event was due to her recieving the flu vaccine. I told her I was not aware that vomiting was an adverse event associated with the flu vaccination. I recommended that she immediately contact her primary care physician regarding this event. The patient stated that he suggested she contact the pharmacy wher she recieved the vaccine. I called my attending district supervisor, and nottified her of what was going on. I then contacted the patient's PCP office, in which I left a message with his medical staff. After reporting the event, I contacted the patient, and she did not anwser. I then called several times and still no response.  After a few attempts, I reached out to her husband, the patient's husband on 11/5/20, becuase he was scheduled for a flu shot the same day, he notified me that the paramedics were at their home tending to the patient, his wife. The EMT stated that they didn't know what the contributing factor was to her vomiting and that her blood pressure was elevated. I called the patient to confirm information for the report and she stated she follwed up with her PCP office.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Headache, Pain
Clinical narrative: Patient was given 3 vaccinations on Monday, 11/02/2020. The patient's spouse called me, (Pharmacist), here to Pharmacy on Sunday, 11/08/20 at around 2:15pm to inquire whether the vaccines given can cause any lasting side effects. She informed me that on Tuesday, 11/03/2020, her husband started experiencing headaches, which have been persistent throughout the whole week since getting the vaccinations. She stated the her husband has been taking Extra Strength Tylenol to help manage the pain, but he has not felt any relief. I asked if he has had any previous reactions to vaccines or if he has experience this situation in the past. They said that this was his first time getting a flu vaccine, and they believe that was the cause. I informed the patient that they should try and see their primary physician or, if the situation gets worse, to go to an urgent care facility or hospital.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Product administered at inappropriate site
Clinical narrative: Left upper arm numb and required assistance to move..  Patient went to doctor a received prescriptions for  diclofenac and tizandine. Patient was told the injection was given to high on the arm and the needle hit a nerve and possibly the bone. Symptoms resolved on 11/2/20.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Fluzone Hd instead of Flublok. Patient did not experience any adverse symptoms.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Wednesday received vaccine. Thursday right arm broke out in rash that was itchy. Friday morning rash spread to left arm, both upper legs. Friday night took 50mg Benadryl. Saturday rash continued to grow to include back and abdomen, 200mg Benadryl taken that day. Sunday rash was still present, spreading to both lower legs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: stomach cramps, diarrhea, vomiting, sweating followed by shivering
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular, Skin disorder, Skin warm
Clinical narrative: PATIENT REPORTS RASH COVERING MAJORITY OF BOTH CHEEKS, WITH THE LEFT CHEEK MORE AFFECTED THAN THE RIGHT. RASH IS RED, BLOTCHY, AND WARM TO THE TOUCH. SKIN APPEARS "SHINY." NO FEVER, PAIN, OR ITCHINESS.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Immediate post-injection reaction, Malaise, Postictal state, Seizure like phenomena
Clinical narrative: Patient reported not feeling well immediatley post-vaccine and proceeded to slide off chair to floor and have seizure like activity for approximately 30-60 seconds.  Post-ictal confusion.  Vitals stable post seizure.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Injection site bruising, Neck pain
Clinical narrative: pt said she bruished from her shoulder to neck area.  bruise went away except for site of injection.  but she said she has a lot of pain running from shoulder to neck area .
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills
Clinical narrative: On Sunday morning, the patient had severe chills, took a nap, and felt very weak after her nap.
Age: 18.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Syncope
Clinical narrative: light-headed and fainted within 5 minutes of receiving vaccine while still sitting.  Pt never lost consciousness.  When pt's father and myself asked her if she was ok she responded immediately with a head nod and was able to slowly sit up and talk to us.  She commented that she always does this- however on her consent form she marked "no" to ever fainting following vaccination
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Antibody test, Cerebral haemorrhage, Cerebrovascular accident, Encephalitis autoimmune, Immunoglobulin therapy
Clinical narrative: Patient is homeschooled and has a history of good memorization skills.  Problems with memorization started during her mock trial study in April 2020.  These issues escalated until mid-May when her personality started changing drastically for the worse.  We took her to two local emergency rooms in mid and late May.  She then had about two weeks of "coming back to normal" before her personality went bad again.  She was admitted to Hospital on June 14 and stayed there for 25 days.  While there, she underwent multiple tests every day and was treated for autoimmune encephalitis even though blood and spinal fluid antibodies didn't match those known at the Clinic.  After steroid and IVIG treatments, patient had a stroke and was admitted to the intensive care ward.  The time in intensive care was about 10 of the 25 days.  We have continued to give patient LOVENOX shots 2X/Day since mid-July and have been weaning her off of Valium which she now takes once/day (Diazepam 10-mg).  She still takes a blood pressure pill once/day (Amlodipine Besylate - 10mg).  The LOVENOX is for clotting so her brain clot doesn't grow and so her brain bleed behind the clot doesn't get larger.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Intensive care, Laboratory test, Memory impairment, Personality change, Thrombosis
Clinical narrative: Patient is homeschooled and has a history of good memorization skills.  Problems with memorization started during her mock trial study in April 2020.  These issues escalated until mid-May when her personality started changing drastically for the worse.  We took her to two local emergency rooms in mid and late May.  She then had about two weeks of "coming back to normal" before her personality went bad again.  She was admitted to Hospital on June 14 and stayed there for 25 days.  While there, she underwent multiple tests every day and was treated for autoimmune encephalitis even though blood and spinal fluid antibodies didn't match those known at the Clinic.  After steroid and IVIG treatments, patient had a stroke and was admitted to the intensive care ward.  The time in intensive care was about 10 of the 25 days.  We have continued to give patient LOVENOX shots 2X/Day since mid-July and have been weaning her off of Valium which she now takes once/day (Diazepam 10-mg).  She still takes a blood pressure pill once/day (Amlodipine Besylate - 10mg).  The LOVENOX is for clotting so her brain clot doesn't grow and so her brain bleed behind the clot doesn't get larger.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Nodule, Pain, Pain in extremity
Clinical narrative: A huge knot raised on my arm and was incredibly sore to the touch and painful.  The knot diminished, but the pain at the injection site did not and continues, although diminished compared to initial intensity at this time, which is six weeks from the time of the shot approximately. I still cannot raise my arm above my head or take it to my back as to unhook a bra with normal motion range and without pain. If I lay on that arm while I am sleeping, it can be in pain when I go to get up. The shot went in effortlessly with absolutely no pain at the time of injection. I have not had a similar reaction or intensity to any other flu shot I typically take the flu shot, but I would guess that this one was stronger than those I typically take. I did have some reaction of similar nature to shingles shots, but that did not last as long or limit motion. I believe I have correctly identified the shot I was given above, as it is the only high dose quadrivalent listed.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: A huge knot raised on my arm and was incredibly sore to the touch and painful.  The knot diminished, but the pain at the injection site did not and continues, although diminished compared to initial intensity at this time, which is six weeks from the time of the shot approximately. I still cannot raise my arm above my head or take it to my back as to unhook a bra with normal motion range and without pain. If I lay on that arm while I am sleeping, it can be in pain when I go to get up. The shot went in effortlessly with absolutely no pain at the time of injection. I have not had a similar reaction or intensity to any other flu shot I typically take the flu shot, but I would guess that this one was stronger than those I typically take. I did have some reaction of similar nature to shingles shots, but that did not last as long or limit motion. I believe I have correctly identified the shot I was given above, as it is the only high dose quadrivalent listed.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: shooting pain when moving arm certain directions
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient received vaccine on 10/29. Experience soreness for few days but then it started hurting on 11/01. It got progressively worse over the next week. she reports that it is in constant pain and she cannot lift her arm as of 11/08
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity
Clinical narrative: following administration patient reports a small amount of bruising that evening and then by the next morning had a large amount of bruising from her elbow to her wrist and said it was very painful- but not a lot of bruising at site of injection.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Arthralgia, Injection site pruritus, Injection site swelling, Myalgia, Neck pain
Clinical narrative: During the  first night after the shot, I awoke with pain that radiated down the left side of my body from neck all the way down.  The pain felt muscular and joint...by morning it was all over my whole body.  So much joint pain.  I developed a huge bulge at the injection site...the size of my hand.  On the day following injection, we were heading out of town for the weekend.  The pain was pretty bad all over my body.  It got a little better each day...today 11/8, i still have a huge bulge on my arm...it is still painful to touch, just not as bad as it was.  Now the injection site itches really bad...but the bulge is still there.  Body aches are better so I?m hopeful that I?m on the upswing.  I?ve taken some ibuprofen...can?t really tell if it lessened the symptoms.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: During the  first night after the shot, I awoke with pain that radiated down the left side of my body from neck all the way down.  The pain felt muscular and joint...by morning it was all over my whole body.  So much joint pain.  I developed a huge bulge at the injection site...the size of my hand.  On the day following injection, we were heading out of town for the weekend.  The pain was pretty bad all over my body.  It got a little better each day...today 11/8, i still have a huge bulge on my arm...it is still painful to touch, just not as bad as it was.  Now the injection site itches really bad...but the bulge is still there.  Body aches are better so I?m hopeful that I?m on the upswing.  I?ve taken some ibuprofen...can?t really tell if it lessened the symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: large hive / welt at the site of injection
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: Pt had rash at the local injection site. told the pt to ice the area and she says that it got better
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Took flu vaccine. a little more than 24 hrs later, developed rash and hives all over the body. Itchy over the entire body.  taking Benadryl not really helping, this is still ongoing and more than 24 hrs since initial onset.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site bruising
Clinical narrative: Pt. stated that after the Flu vaccine was given her whole arm became bruised. She is not experiencing any pain currently from the vaccine however she is going to make a doctors appointment and have a proper diagnosis.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Breast pain, Breast tenderness, Fatigue, Injection site pain
Clinical narrative: Woke with intense pain in left thumb, left breast(cancer surgery 2011) incision site, left hip, left knee, arch in left foot. This pain continued for 10 days but slowly got better. I was extremely tired for this period and although I still worked, I shouldn't  have but have no sick time. I now have tenderness and a scab on my left areola which I must see the doctor about since prior breast cancer. I didn't see the doctor for this problem but had a prior telehealth appointment scheduled on Nov 4 and discussed my symptoms  resulting from this flu shot. I still have some transient pain in all areas listed above. I had no fever or pain on right side except my right arm where the vaccine was administered (due to prior ca in left breast).
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Scab
Clinical narrative: Woke with intense pain in left thumb, left breast(cancer surgery 2011) incision site, left hip, left knee, arch in left foot. This pain continued for 10 days but slowly got better. I was extremely tired for this period and although I still worked, I shouldn't  have but have no sick time. I now have tenderness and a scab on my left areola which I must see the doctor about since prior breast cancer. I didn't see the doctor for this problem but had a prior telehealth appointment scheduled on Nov 4 and discussed my symptoms  resulting from this flu shot. I still have some transient pain in all areas listed above. I had no fever or pain on right side except my right arm where the vaccine was administered (due to prior ca in left breast).
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Heart rate increased, Paraesthesia, Respiratory rate increased
Clinical narrative: Approximately 10 minutes after injection the patient experienced increased Heart rate, rapid breathing, "body tingles". Injection site was unremarkable. Contacted EMS to evaluate Spoke w/Pt 10/1/20. Went to Hosp via EMS. in ER app. 6 hours. Per patient given Diphen in ER + cont'd FoR 2 days experienced rapid respirations, rapid HR dizziness + tingling in extremities. Feeling Better @ onset on phone call.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: 1 day after vaccination, pt developed erythema, swelling, pain, induration and small bruise at site of vaccine on left deltoid. Seen  by PNP 2 days after vaccination, about 70 x 50 mm area of blanchable erythema. Pain improved, allowed palpation without complaint. Moving arm and using normally. Induration already improving her guardian
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Dizziness, Erythema, Feeling abnormal, Headache
Clinical narrative: Reported by the patient on the next day: Within 20-30 minutes of vaccination patient had congestion, headache, redness and swelling of the face and felt dizzy. During next 28 hours he felt dehydrated and suffered from hot flushes and "foggy brain" that completely resolved in the afternoon of the next day. Pt used ORS only
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Hot flush, Nasal congestion, Swelling face
Clinical narrative: Reported by the patient on the next day: Within 20-30 minutes of vaccination patient had congestion, headache, redness and swelling of the face and felt dizzy. During next 28 hours he felt dehydrated and suffered from hot flushes and "foggy brain" that completely resolved in the afternoon of the next day. Pt used ORS only
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2 hours after vaccine given patient developed severe redness, swelling and pain over injection site spreading to the chest and down the ipsilateral arm to the wrist; patient required antihistamines with gradual improvement
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Mobility decreased, Pain, Pyrexia, Rash macular
Clinical narrative: unable to lift right arm; soreness; red blotchiness on right upper arm; tiredness; high fever; indication: flu prophylaxis; This spontaneous report was received from a 70-year-old female patient, referring to herself. Her concurrent condition included thyroid disorder, acid reflux and high blood pressure. Her concomitant therapies included levothyroxine sodium, omeprazole, and losartan potassium (reported as losartan) (manufacturer unknown). Her history condition and drug allergies were unknown.   On 22-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route of administration, batch/lot# and expiration date were unknown) in the right upper arm for flu prophylaxis (product use in unapproved indication).   On the same day, the patient experienced a high fever, red blotchiness on right upper arm, soreness, unable to lift right arm and tiredness. The patient sought medical attention by contacting physician. No therapies were given to events. On 27-SEP-2020, the patient recovered from the events.  The causalities between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: GARDASIL 9 was administered to 4 patients on 10/26/2020 after a temperature excursion and prior to having vaccines evaluated/Separate AE's filed for each patient.; This spontaneous report has been received from an other healthcare professional referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 26-OCT-2020, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: T007035, expiration date: 01-MAY-2022; route and dose details were unknown) was administered to the patient for prophylaxis, after a temperature excursion (product storage error). The vaccine was stored below 36 degrees Fahrenheit/ 2 degree Celsius (0.9 degree Celsius to 1.9 degree Celsius) for 10 hours and above 47 degrees Fahrenheit/ 9 degree Celsius (9.1 degree Celsius) for 30 minutes. There were no previous temperature excursions. There was no digital data logger was involved.  This is one of several reports received from the same reporter.      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: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA011190:same reporter US-009507513-2010USA011367:same reporter US-009507513-2010USA011375:same reporter
Sex: F
Vaccine: PPV
Symptoms: Product administered at inappropriate site
Clinical narrative: It was administered in her right arm but lower than the deltoid, it was not in the deltoid; This spontaneous report was received from a 69 year old female nurse referring to herself. The patient's vaccination history included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) approximately a year ago. The patient's pertinent medical history was not reported.  On 02-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot# and additional dosage regimen information were not provided) in the right arm but lower than the deltoid. She mentioned that she knew that her vaccination was not in the deltoid. Additionally, she reported that her husband and several family members also received unspecified vaccinations that were also administered lower in the arm but close to the deltoid, therefore she could not say if they were correctly administered or not.