chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Thirst, Tinnitus, Vomiting
Clinical narrative: Starting from about  9:30 or 10:30 pm on Tues night,  I had about 5 bouts of liquid stools and cramping over an hr or so.   I went to bed and woke up and threw up at about 1:00pm.   I was awake until at least 4 feeling very thirsty, a bit dizzy, light headed and in general sick.  I was extremely thirsty and got up on the hour and drank 8 to 10 oz of water until about 4 am or so.    I slept then for a while and woke up again around 7 am or so, by then my stomach and cramps were ok but then I had a little ringing in the left hear and had a low grade head ache.    I called the Dr. around the time the office opened and spoke with the nurse and ate a breakfast cookie.    We decided that I was much better than during the night but that I should get gatorade or coconut milk to replace electrolytes.  Over the next couple of hours I drank 2 cans of coconut milk ,stayed in bed feeling like I had the flu and slept pretty much all day until I got up and had rice when my husband had dinner.    The next day, I felt like I had a mild flu and was up and out of bed all day.  I took my temperature with a mercury oral themometer just once and it read 101.2 at about 7 am.   Usually I would be 98 or a little below.   The following day I felt a bit better yet.     It is now a week out on Wed.   Except for my stomach and intestines getting back to normal, I feel fine.  Except, I went out to dinner last night, had a substantial meal and had one liquid stool and one throwing up episode.  Because , I feel like I should be fine, I saw my Dr. today who ran some blood work to make sure that nothing else is brewing along with this "reaction."  Temperature at the Dr. office was 98. The first shot, I had mild flu like symptoms for a couple of days but this was far worse.    My arm did hurt and had a little bump at the site but was not red over any of the three days.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Wrong product administered
Clinical narrative: Patient received in error. Requested to receive meningitis
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Influenza like illness, Muscle fatigue, Musculoskeletal disorder, Pain
Clinical narrative: Pain, muscle fatigue, flu like symptoms.  Shingrix shot was given in her left arm and she is left handed.  The pain was so intense she lost use of her left arm for a week.  Within 2 hours a sore arm.  Within 6 hours my brother took mom  to a local urgent care at 8:30pm, said take a pain pill.   My brother put her to bed.  She did not answer her phone in morning. I found her on the floor as she was not able to get up to go to the bathroom and ended up on the floor.  No use of left arm and entire body had muscle fatigue.  Used walker to move her to my house for rehab.  After a week she could walk again without walker but still had Flu like symptoms. Almost 2 weeks now and she is still a little off balance in feeling.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: Pain, muscle fatigue, flu like symptoms.  Shingrix shot was given in her left arm and she is left handed.  The pain was so intense she lost use of her left arm for a week.  Within 2 hours a sore arm.  Within 6 hours my brother took mom  to a local urgent care at 8:30pm, said take a pain pill.   My brother put her to bed.  She did not answer her phone in morning. I found her on the floor as she was not able to get up to go to the bathroom and ended up on the floor.  No use of left arm and entire body had muscle fatigue.  Used walker to move her to my house for rehab.  After a week she could walk again without walker but still had Flu like symptoms. Almost 2 weeks now and she is still a little off balance in feeling.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Patient describes numbness and tingling in upper arm of injection site starting 9/28/19 and began to subside the morning of 10/2/19.  Soreness had not been present until the morning of 10/2/19.  During the early afternoon, patient describes the numbness and tingling "returned with a vengeance" and proceeded to call me as I instructed if the numbness and tingling returned.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal chest pain
Clinical narrative: Patient called pharmacy to report of pain "where the bra line is" and "throughout the back area". She also listed the pain as "around her rib area and around the back". Patient said pain has been continuing for 3 days since receiving the vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: NEXT DAY ARM STARTED TO HURT AND SWELL, ALSO WAS HOT TO TOUCH. WENT TO PHARMACY AND THEY SAID TO SEE THE DOCTOR, WENT TO DOCTOR THEY SAID IT WAS A REACTION TO THE INJECTION SITE, AND TO TAKE BENADRYL AND DO COLD PACKS. WENT TO PHARMACY AND DOCTOR ON OCT 3RD.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Immunisation, Product preparation issue, Somnolence
Clinical narrative: Patient received the dtap/ipv portion of Pentacel vaccine without reconstitution with the hib portion of the vaccine. The patient was then revaccinated with dtap/ipv/hib (pentacle) that was reconstituted properly. These were given the same day but in separate sites. The parents were notified same day of error and the only reaction noted by  parents and reported to provider was that the patient slept more than usual, patient did not have any adverse effects from vaccination. No fever, no adverse site reaction. Patient was monitored by parents and reported above to provider more then 24 hours after vaccination.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: According to caregiver, site of injection red and hot feeling.  Started day after injection and continues to today.  Recommended she call her doctor.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Culture urine positive, Dehydration, Delirium, Seizure, Urinary incontinence
Clinical narrative: Patient was experiencing urine problems and leakage leading up to the vaccine on 9/24/19. No fever was present at time of vaccination.  on 9/23/19 patient had a urine culture but did not get results of culture back until 9/26.  On 9/25/19 patient had a 10 second seizure and his brain was "disorganized".  Mother thought that this may have been because it was the result of having an undiagnosed UTI (which was confirmed on 9/26) and being dehydrated from hot temperatures/travel on the days leading up to the vaccine.  Patient also was experiencing delirium symptoms on 9/26/19.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Chills, Nausea, Pyrexia
Clinical narrative: patient's wife reports when patient got home, he had fever, chills that his teeth were clattering, nausea, and high bloog glucose.  they called 911 and paramedics came and checked his blood pressure.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pt presented at pharmacy today with redness swelling and tenderness at the injection site and around injection site area
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Adverse reaction: lightheadedness and sweating. Place pt in supine position, Monitored VS continuously. BP stabilized prior to discharged @ 1PM BP 106/74 HR 68
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pharyngeal swelling, Sensory disturbance
Clinical narrative: Per MD office, patient got vaccination in Left arm. She experienced "strange" sensation across her chest/body, aching pain in Right arm, and also had some swelling in the throat.  They called pharmacy on 10/2 to inform pharmacy of reaction.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site nodule
Clinical narrative: on 10/2, patient work up with redness and hard knot at injection site. pt complains of numbness in entire arm, including  fingers. I advised her to contact md immediately
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient called at 10am on 10/2/2019 stating that this morning when she woke up she had a rash on her lower legs. Rash did not cause any pain or irritation. Just small red bumps. Confirmed no changes in any detergent, soaps or fragrances. Stated only change was Shingrix and flu shot given on 9/30/2019. She knows a rash can occur but was surprised on lower legs. Patient knows if gets worse to see provider.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test, Computerised tomogram, Electrocardiogram, Injection site erythema
Clinical narrative: Caused blood pressure to be very high (BP 198/95), REALLY BAD NAUSEA AND VOMITING, FELT SICK, PAIN AND REDNESS AT INJECTION SITE, PATIENT STATE SHE WENT TO THE ER, PER PT THEY ONLY MONITORED HER AND DID NOT GET ANY TREATMENT; FOLLOWED UP WITH PCP AND WAS GIVEN CLONIDINE 0.1MG FOR BP >160 AND ONDANSETRON 8MG FOR NAUSEA AS NEEDED
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Laboratory test, Malaise, Nausea, Vomiting
Clinical narrative: Caused blood pressure to be very high (BP 198/95), REALLY BAD NAUSEA AND VOMITING, FELT SICK, PAIN AND REDNESS AT INJECTION SITE, PATIENT STATE SHE WENT TO THE ER, PER PT THEY ONLY MONITORED HER AND DID NOT GET ANY TREATMENT; FOLLOWED UP WITH PCP AND WAS GIVEN CLONIDINE 0.1MG FOR BP >160 AND ONDANSETRON 8MG FOR NAUSEA AS NEEDED
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Rash with welts over 80% of body with concentration to neck and torso.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Red pigment to L hand below wrist. pt denied any itching, swelling, discomfort.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pruritus
Clinical narrative: Within 30 minutes of injection, she started having all over body itching and flushing of her cheeks.  Dexamethasone IM, Benadryl IM.  Prescribed a Medrol Dose Pack to start the following day and ranitidine to start this evening.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: cellulltius    swollen red arm, low grade temperature
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal discomfort
Clinical narrative: pt came in for 2nd dose and reported pain/soreness of his nose for almost 1 month after 1st dose. Pt reports history of nasal cancer. Contacted Dr. (PCP) for a recommendation on how to proceed after this reaction and whether to give 2nd dose. Spoke with nurse and Dr. himself - PCP has ok'd second dose of Shingrix as he does not believe it is due to the vaccine. He advised patient to call office immediately if any reaction occurs after 2nd dose.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Duplicate prevnar 13....Doctor's office called 10/2/19 informing us they gave pt prevnar 13 back on 1/6/16 (before pt was 65 years old). When pt was in pharmacy in August, she was getting something else and we screened for prevnar due to age and she said yes (had no memory of it) and we administered it in August 2019..insurance company paid for it as well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site reaction, Limb discomfort, Pain
Clinical narrative: Sore arm at injection site; aching body; shivering all day 10/2/19.    Took Excedrin, helped a little.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, White blood cell count normal
Clinical narrative: PATIENT PRESENTED WITH RAISED AND RED AREA AROUND MOST OF THE TOP OF UPPER LEFT ARM.  DID NOT REPORT ANY OTHER SYMPTOMS.  CALLED PATIENT'S PRIMARY CARE OFFICE AND THEY WERE ABLE TO GET HER IN TO BE SEEN.  PT RETURNED WITH RX AND DID NOT REPORT ANY RAISED WBC COUNTS PER MD TESTING AND PRESENTED WITH STEROID RX AND CLARITIN TO BE TAKEN AT REQUEST OF MD
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Malaise, Pyrexia, Tremor
Clinical narrative: Fever, shaking awakened patient presented to clinic still not feeling well. Responded well to naproxen otc
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood potassium decreased, Cardioversion, Diarrhoea
Clinical narrative: patient developed diarrhea after receiving two shots in office, diarrhea persisted x3 weeks causing low potassium resulting in shock for defibrillator.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Influenza like illness, Nausea
Clinical narrative: Pt reports abdominal pain, nausea, diarrhea, loss of appetite. St's she feels like she has the flu.
Age: 61.0
Sex: F
Vaccine: FLU4, UNK, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: I was given the shot 9/27/19 mid-morning and by early afternoon my arm hurt, I was getting achy feeling, like I was coming down with something.  I took two regular Aspirins and felt so much better after a short time.  I went home and slept.       I woke up the next day and felt achy again, like I did before I took Aspirins.  I got to work and I ached all over, my hand, my knees, my back, everywhere.. just like I would feel had I been coming down with something.  So I took two more regular Aspirins and they helped so much!  I was able to go about my day to day routine, as normal once the Aspirins kicked in!  I took a couple of regular Aspirins on Saturday and Sunday too.   By Monday I felt normal again and didn't  need any Aspirins,  I did not take my temp and I wish I had... sorry
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cyanosis
Clinical narrative: Patient came in 10-02-19 to get second vaccine but stated that immediately after getting first dose his arm turned BLACK. He states it did not itch, swell, become hardened, or ache. He states it was severely discolored like this for nearly 6 weeks.   I cannot find literature if this is allergic reaction, hesitant to give second dose if this is allergy.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration
Clinical narrative: Patient came in 10-02-19 to get second vaccine but stated that immediately after getting first dose his arm turned BLACK. He states it did not itch, swell, become hardened, or ache. He states it was severely discolored like this for nearly 6 weeks.   I cannot find literature if this is allergic reaction, hesitant to give second dose if this is allergy.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Polymerase chain reaction, Rotavirus test positive
Clinical narrative: PT TAKEN TO EMERGENCY ROOM  07/12/19 FOR DIARRHEA X5 DAYS. GASTROENTERITIS PCR PANEL COLLECTED TO IDENTIFY SOURCE AND PT WAS POSITIVE FOR ROTAVIRUS A.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort, Muscular weakness
Clinical narrative: Arm pain immediately after vaccine given. Pain radiates down arm weakness in arm PT with only partial relief
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: patient presented to the emergency department with a generalized tonic clonic seizure (in the setting of fever to 103.5
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the pharmacy on 10/2/19 saying she will not be getting any other injections here. When asked what she meant, she pulled up her sleeve to expose her left arm.  It was red, hot, and swollen at and below injection site. She said she began to have fever and chills on 10/1/19 around 8AM and today could not hardly move her left arm so she sought medical care. She  was given an oral antibiotic and topical steroid ointment as Urgent Care staff told her they were afraid it may get infected.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient presented to the pharmacy on 10/2/19 saying she will not be getting any other injections here. When asked what she meant, she pulled up her sleeve to expose her left arm.  It was red, hot, and swollen at and below injection site. She said she began to have fever and chills on 10/1/19 around 8AM and today could not hardly move her left arm so she sought medical care. She  was given an oral antibiotic and topical steroid ointment as Urgent Care staff told her they were afraid it may get infected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm has a pink area approximately 3"x5", warm to touch, mild swelling, tender with palpation.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Skin warm, Urticaria
Clinical narrative: 10/2/19 - Pt called to report that she had welts on her left arm that were warm to the touch and reddish pink.  She also had pain in her underarm area.  It began on 10/1 and she went to the Dr today (before reporting it to pharmacy).  Her Dr told her to ice the area TID and take OTC Ibuprofen prn.  Dr also told her to let her know if the condition worsened.  At the end of the pt?s explanation, I told her to let us know the same.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Skin reaction, Swelling
Clinical narrative: severe swelling and tissue loosening - discomfort from shoulder to wrist - skin reaction
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue
Clinical narrative: Patient received Shingrix without any active drug. Diluent shot into powder vial and did not check whether or not drug dissolved. The powder did not dissolve in the diluent.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: High dose Influenza was given instead of regular dose. No adverse reaction
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Extra dose administered, Peripheral swelling, Wrong product administered
Clinical narrative: Patient received Pneumovax 23 last year in September. He came in this year to get his next pneumonia shot and was given another Pneumonia 23 instead of Prevnar 13. Patient stated today (10-2-19) that his arm started to swell Sunday evening, got worse Monday, then started to get better on Tuesday. I advised him to call his doctor. I also called his doctor and spoke with employee. She gave the information to the doctor and said they will follow up with the patient. Patient already had an appointment scheduled for Friday, 10-4-19 prior to this event.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Infection, Injection site swelling
Clinical narrative: Patient received Pneumovax 23 last year in September. He came in this year to get his next pneumonia shot and was given another Pneumonia 23 instead of Prevnar 13. Patient stated today (10-2-19) that his arm started to swell Sunday evening, got worse Monday, then started to get better on Tuesday. I advised him to call his doctor. I also called his doctor and spoke with employee. She gave the information to the doctor and said they will follow up with the patient. Patient already had an appointment scheduled for Friday, 10-4-19 prior to this event.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient claims the arm in which the vaccine was given has had pain and numbness since he received the vaccine.  We called his doctor and advised the patient to do the same.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Cellulitis, Dizziness, Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Gave patient flucelvax  (right upper deltoid) and pneumovax 23 (right lower deltoid) at flu clinic . Patient was concerned with fusion in left arm so we decided to administer both in her right deltoid. By that evening (about 4 - 5 hours later) patient started feeling light headed and having warmth and redness at the injection site. Patient went to the emergency room later that evening because arm became worse and she developed a fever. She was given IV antibiotics in the ER and told to return the following day for another dose of IV antibiotics. Her fever broke after the second dose, but the arm still had some redness/swelling. She was diagnosed with cellulitis. Patient is doing better now. Will follow up again with her tomorrow (1 week after notification).
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pyrexia
Clinical narrative: Gave patient flucelvax  (right upper deltoid) and pneumovax 23 (right lower deltoid) at flu clinic . Patient was concerned with fusion in left arm so we decided to administer both in her right deltoid. By that evening (about 4 - 5 hours later) patient started feeling light headed and having warmth and redness at the injection site. Patient went to the emergency room later that evening because arm became worse and she developed a fever. She was given IV antibiotics in the ER and told to return the following day for another dose of IV antibiotics. Her fever broke after the second dose, but the arm still had some redness/swelling. She was diagnosed with cellulitis. Patient is doing better now. Will follow up again with her tomorrow (1 week after notification).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue
Clinical narrative: No adverse reaction but diluent without the powder drug was injected. Vaccine dissolving in vial was not observed.  Diluent was injected and drawn out from powder vial.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever of 101.8, chills, nausea, headache. Lasted about 36 hours
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: redness, swollen, and bruising underneath injection site. patient was advised to decrease swelling via an ice pack and to call Dr as a steroid may need to be prescribed &/or administered if no relief after 1-2 days.  patient still has some redness as of 10/2/19 but the swelling has reduced. pt has yet to contact her Dr.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Vomiting
Clinical narrative: patient got ill, vomit and sickness - no local reaction -severe sickness she describes went to urgent care vitals were not good she stated and went to hospital- stable today doing better - on prednisone
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Myalgia, Pyrexia, Tinnitus
Clinical narrative: Fever, acky sore muscles, ringing in ears, exhaustion,
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pruritus
Clinical narrative: One day following the vaccine, patient begun experiencing bruising all over the body. the sizes range from about 2mm to 12 mm. Patient states that the spots are itchy from the inside and feel very uncomfortable. The largest bruised area was underneath the breasts, but those ones have reduced in size as of the 2nd of October. There some bruised spots on the trunk and one on the fore head and the nose and well as a little one close to the corner of the left eye. Patient had not taken any medication to try and mitigate the situation-Suggested an antihistamine until she's able to see  her physician.  Patient has an appointment to see her primary doctor on the 3rd of October.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema multiforme, Henoch-Schonlein purpura
Clinical narrative: He developed erythema multiforme or Henoch Schonein purpura
Age: 58.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Patient, - came into the pharmacy on 10/2/19 at 1:25 pm and reported that her right arm is very red and swollen from her immunizations. The patient reported that the arm "feels warm to the touch." The patient stated that the arm does not itch. The patient also reports that she is not experiencing any breathing problems, and no other systemic reactions reported. The patient showed me her arm, and I observed the arm to be very bright red and swollen from the top of the arm up near the shoulder down to the elbow. It was a fairly large area affected on the outside of the right arm. Due to the severity of the reaction, I advised the patient to seek medical care. Recommended the patient see a physician to rule out reactions suchas cellulitis/infection versus an allergic reaction. The reaction is severe enough that it should not be treated OTC. The patient was going into her doctor office about this today per my recommendation to follow up with physician about this. I looked up the patient's recent immunization history in our computer: on 9/30/2019, this pharmacy gave the patient 3 immunizations ... Fluzone Quad and Pneumovax 23 were administered in the right arm, and Shingrix was administered in the left arm. The patient did not experience any reactions in the left arm where the Shingrix was administered. This IMZ reaction in the right arm would be from either the Fluzone Quad and/or the Pneumovax 23.  CALLED THE PT. TO CHECK UP ON HER 10/2/19 8:55 PM - PT. SAID SHE WENT TO HER DR. AND THEY GAVE HER AN ORAL ANTIBIOTIC BECAUSE DR. THOUGHT IT MIGHT BE INFECTED DUE TO "RED STREAKS" - HER DR. TOLD HER THAT IF SHE DOES NOT GET BETTER, TO GO TO THE ER.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: Hives that got progressively worse for up to 7 hours
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Seizure
Clinical narrative: About 2-5 minutes after giving the vaccine the patient started to convulse in the waiting area while I was administering flu vaccine to her friend.  This lasted for about 10 seconds and she was conscious and not convulsing when I ran to her to ensure her safety and 911 was called. I returned to administer the vaccine to her friend where she began convulsing again and fell to the floor, in which I instructed her to lay on the floor until help arrived.  About 5 minutes later the paramedics arrived and took her and her friend to the hospital.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal discomfort
Clinical narrative: 6 months pregnant. Due date of 12/12/19  Left shoulder is locking up as a reaction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Migraine, Myalgia, Nausea
Clinical narrative: MYALGIA, CHILLS, HEADACHES, MIGRAINE HEADACHE, SEVERE NAUSEA, VOMITING, (NO FEVER) FOR 10 DAYS  VISION DIFFICULTY WITH MIGRAINE HEADACHE
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment, Vomiting
Clinical narrative: MYALGIA, CHILLS, HEADACHES, MIGRAINE HEADACHE, SEVERE NAUSEA, VOMITING, (NO FEVER) FOR 10 DAYS  VISION DIFFICULTY WITH MIGRAINE HEADACHE
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort
Clinical narrative: Patient states at the time of call that he was experiencing a little bit of chest tightness. It was hard to say the severity of his condition, because he was also speaking normally and ordering other medications on the phone.  I advised that he should go to the emergency room if he has reasonable doubt.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Red, swollen, hot, injection site is low on the arm (beneath deltoid above elbow)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Headache, Neck pain
Clinical narrative: Patient stated that she received the vaccination the evening of 9/19/19, and on the morning of 9/20/19 she experienced pain on the top of her head, right side of her face, and the right side of her neck. She stated that she does not know of any other reason why she experienced this pain. She did not present to a doctor or seek care for her symptoms. She stated that the pain lasted for a few days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site warmth, Lethargy, Muscle spasms
Clinical narrative: Lethargic and sleepy day after and not as much on 2nd day. Had extreme leg cramping on day after.  Center back and down both legs.  Tears because i had no control of pain. 3rd day site sore and warm bruising still there but not painful.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Tearfulness
Clinical narrative: Lethargic and sleepy day after and not as much on 2nd day. Had extreme leg cramping on day after.  Center back and down both legs.  Tears because i had no control of pain. 3rd day site sore and warm bruising still there but not painful.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Very red rash, lower then injection site. Told patient to take some Benadryl and use ICE topically & come back tomorrow.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Urticaria
Clinical narrative: Patient woke up with red bumpy hives on both arms. No itching, no swelling and no shortness of breath or difficulty swallowing.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Red 2 inX2in ring on right lower thigh
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Hot flush, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I was have fevers/body aches/hot flashes/neck/left shoulder pain/itchy/numbness/tingling. Has red spot on site area with swelling & heat.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Neck pain, Pain, Paraesthesia, Pruritus
Clinical narrative: I was have fevers/body aches/hot flashes/neck/left shoulder pain/itchy/numbness/tingling. Has red spot on site area with swelling & heat.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: I was have fevers/body aches/hot flashes/neck/left shoulder pain/itchy/numbness/tingling. Has red spot on site area with swelling & heat.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Headache, Laboratory test, Mood altered, Rash
Clinical narrative: 7 PM - started with hives on her legs, torso, and face. Subsided after an hour. Went to sleep. Woke up at 6AM, red rash present on legs, torso, & chest. Had coughing throughout night needed nebulizer. Pt did not need hospitalization; she did develop a headache and mood changes resulting in frequent doctors visits. Patient also now is going through testing for auto-immune encephalitis.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Urticaria
Clinical narrative: 7 PM - started with hives on her legs, torso, and face. Subsided after an hour. Went to sleep. Woke up at 6AM, red rash present on legs, torso, & chest. Had coughing throughout night needed nebulizer. Pt did not need hospitalization; she did develop a headache and mood changes resulting in frequent doctors visits. Patient also now is going through testing for auto-immune encephalitis.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Felt faint about 1 hours after injection. Headache and fatigue.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Pain, Swelling
Clinical narrative: Pt given Pneumovax in (L) arm 10/01/19. Within hours severe pain and very significant swelling. 5 hours later felt nauseated. Went to ER and was given Prednisone and diphenhydramine. Sent with the same Rx's to take for 4 days.
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Injection site urticaria, Rash, Rash erythematous, Urticaria
Clinical narrative: Pt noticed hives from top of left shoulder down to top of hand just red dots all over / no fever no SOB.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Diarrhoea, Headache, Malaise, Myalgia
Clinical narrative: Headache, muscle aches diarrhea felt very "sick" (3 day duration) Was going to go to ER but did not
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, erythymatous, sore & hot to the touch near & surrounding injection site. (4" x 6" area!)
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Gait disturbance, Peroneal nerve palsy
Clinical narrative: Patient seen on 9/30/19 with right foot drop. Cannot roll her right foot when walking - weakness barrier. Received Bexsero vaccine in Right thigh on 09/11/19 and Menactra IM in left thigh on 9/11/19.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Local irritation at / nearby injection site very red, hot, harden and swole area. Patient reports no systemic effects, was seen by her doctor w/ medications to reduce inflammation will monitor.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of Tenivac at an unknown extreme temperature, for a cumulative time of 10 minutes due to being prepared and then finding out the patient did not need the dose because of handling error/No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a patient of unknown demographics.  This case involves a temperature excursion of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] at an unknown extreme temperature, for a cumulative time of 10 minutes due to being prepared and then finding out the patient did not need the dose excursion was due to handling error (lot number: U6187AA and expiry date: 06-Feb-2021).  It was a potential medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: HEP, TD
Symptoms: Loss of consciousness
Clinical narrative: Pt was given TD IM in Right arm. Then given Hep-B in Left arm. Pt  passed out for a brief moment. Awake and alert within 30 seconds.
Age: 13.0
Sex: F
Vaccine: HPVX, MENB, MNQ, HPVX, MENB, MNQ
Symptoms: Dermatitis acneiform, Rash, Rash papular
Clinical narrative: rash is pimply; RASH ON FACE/RASH ON BODY; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) (batch number RO24271 ?, expiry date 8th May 2021) for prophylaxis and MENACTRA (batch number U6521AA, expiry date 26th January 2021) for prophylaxis.   On 27th August 2019, the patient received Bexsero, HPV vaccine and MENACTRA. In August 2019, less than a week after receiving Bexsero and HPV vaccine, the patient experienced generalized rash and papular rash. The patient was treated with doxycycline and prednisone. On an unknown date, the outcome of the generalized rash was recovered/resolved and the outcome of the papular rash was unknown.   It was unknown if the reporter considered the generalized rash and papular rash to be related to Bexsero and HPV vaccine.  Additional information received were as follows: The licensed vocational nurse stated that received Bexsero and Menactra a week before the reporting date and experienced a rash on their face and body that was not itchy. The reporter consented to follow up. No additional details regarding patients or product were available but LVN was agreeable to follow up recontact.  patients. This case is 1 of the 4 linked cases, reported by the same reporter.
Age: 13.0
Sex: F
Vaccine: HPVX, MENB, MNQ, HPVX, MENB, MNQ
Symptoms: Rash, Rash papular
Clinical narrative: rash is pimply; RASH ON FACE/RASH ON BODY; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) (batch number RO24271 ?, expiry date 8th May 2021) for prophylaxis and MENACTRA (batch number U6521AA, expiry date 26th January 2021) for prophylaxis.   On 27th August 2019, the patient received Bexsero, HPV vaccine and MENACTRA. In August 2019, less than a week after receiving Bexsero and HPV vaccine, the patient experienced generalized rash and papular rash. The patient was treated with doxycycline and prednisone. On an unknown date, the outcome of the generalized rash was recovered/resolved and the outcome of the papular rash was unknown.   It was unknown if the reporter considered the generalized rash and papular rash to be related to Bexsero and HPV vaccine.  Additional information received were as follows: The licensed vocational nurse stated that received Bexsero and Menactra a week before the reporting date and experienced a rash on their face and body that was not itchy. The reporter consented to follow up. No additional details regarding patients or product were available but LVN was agreeable to follow up recontact.  patients. This case is 1 of the 4 linked cases, reported by the same reporter.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received a Fluzone HD and he was younger than 65, There were no side effects; patient received a Fluzone HD and he was younger than 65, There were no side effects; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 59 year old male patient who was vaccinated with 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Lot UJ251AC, expiration date: 01May2020 via unknown route in the right deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. Fluzone High-Dose is approved for use in persons 65 years of age and older.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: patient received a Fluzone HD and he was younger than 65, There were no side effects; patient received a Fluzone HD and he was younger than 65, There were no side effects; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 59 year old male patient who was vaccinated with 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Lot UJ251AC, expiration date: 01May2020 via unknown route in the right deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. Fluzone High-Dose is approved for use in persons 65 years of age and older.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: shingles / outbreak of shingles on the right side of the neck and right side of the scalp; pain on neck; redness on neck; headache; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number BY2Y4, expiry date unknown) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 14th September 2019, the patient experienced shingles, neck pain, red neck and headache. On an unknown date, the outcome of the shingles, neck pain and red neck were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the shingles, neck pain, red neck, headache and injection site pain to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in her left arm. On 19th September 2019, the patient was diagnosed with shingles on her neck. The patient again called and reported that, she had an outbreak of shingles on the right side of the neck and right side of the scalp on 27th September 2019.  The patient consented to follow up and she planned to continue follow-up with her physician. There was a discrepancy in the reported outcomes of the events shingles, neck pain and red neck. In one database, outcome was mentioned as recovering/resolving and in another database, it was reported as not recovered. However outcome of these events is captured as per second database.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Herpes zoster, Injection site discomfort, Neck pain
Clinical narrative: shingles / outbreak of shingles on the right side of the neck and right side of the scalp; pain on neck; redness on neck; headache; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number BY2Y4, expiry date unknown) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 14th September 2019, the patient experienced shingles, neck pain, red neck and headache. On an unknown date, the outcome of the shingles, neck pain and red neck were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the shingles, neck pain, red neck, headache and injection site pain to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in her left arm. On 19th September 2019, the patient was diagnosed with shingles on her neck. The patient again called and reported that, she had an outbreak of shingles on the right side of the neck and right side of the scalp on 27th September 2019.  The patient consented to follow up and she planned to continue follow-up with her physician. There was a discrepancy in the reported outcomes of the events shingles, neck pain and red neck. In one database, outcome was mentioned as recovering/resolving and in another database, it was reported as not recovered. However outcome of these events is captured as per second database.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The caller did not want to answer any adverse event questions.  The patient had experienced many reactions for 2 days after getting Shingrix vaccine. No further details were provided. This case linked with US2019171869, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The caller did not want to answer any adverse event questions.  The patient had experienced many reactions for 2 days after getting Shingrix vaccine. No further details were provided. This case linked with US2019171869, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Erythema, Headache, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: Saturday-Wednesday Severe headaches, moderate temperature 100.5(while on Tylenol), extreme fatigue (slept for more than 22 hours straight ) swelling in ijections arm and expanding redness, serious pain 5-8 pain scale Sunday-Monday vomiting when awake.  Monday Pharmacist called to ask about my condition.She stated they had had several adverse from the same day and lot no and advised me to see my physician. Tuesday I went to see Dr I was diagnosed with cellulitis in my injection arm. I was given a 5 day course of Cephalexin 500. I am still suffering form headaache arm pain swelling
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Somnolence, Vomiting
Clinical narrative: Saturday-Wednesday Severe headaches, moderate temperature 100.5(while on Tylenol), extreme fatigue (slept for more than 22 hours straight ) swelling in ijections arm and expanding redness, serious pain 5-8 pain scale Sunday-Monday vomiting when awake.  Monday Pharmacist called to ask about my condition.She stated they had had several adverse from the same day and lot no and advised me to see my physician. Tuesday I went to see Dr I was diagnosed with cellulitis in my injection arm. I was given a 5 day course of Cephalexin 500. I am still suffering form headaache arm pain swelling