chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Injection site pain, Pain in extremity
Clinical narrative: Employee states two hours after receiving the influenza vaccine she began to experience burning in her left upper arm, sharp pain in her wrist, extending to her fingers and thumb, weakness sensation and elbow pain.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction but vaccine error (pediatric pt got adult vaccine).
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt stated she had no discomfort at the time of injection. About 2 hours later, she developed numbness and tingling down to the fingers on the same arm as the vaccination. At present (1 week post vaccination), the symptoms have not resolved. Vaccine site was verified; was administered into center mass of the deltoid muscle.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune thyroiditis, Confusional state, Fall, Mobility decreased
Clinical narrative: Patient has a major thyroid Hashimoto event - confusion, loss of mobility in lower legs (resulted in fall).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Swelling
Clinical narrative: Patient had soreness/swelling (no redness this time), also had chills.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Migraine, Nausea, Tunnel vision, Visual impairment
Clinical narrative: "Really bad migraine (nausea, headache, tunnel vision that got so bad my vision almost went completely black). "
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hyperreflexia, Muscular weakness
Clinical narrative: Bilateral upper extremity weakness followed by generalized weakness, hyperreflexia in upper and lower extremities.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature decreased, Headache
Clinical narrative: Patient complained of severe headaches on and off for 3 to 5 days following vaccine. Also complained of low body temperature the first day of vaccine.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient came into pharmacy today to report pain in her left arm that she believes is still from her flu shot, recieved on 8/4/18. After asking a series of questions, the patient does not have any pain in her shoulder, no pain upon raising her arms or lifting her arms up from her sides, no constant pain, never experienced any sharp pain during injection, however she states that when she tries to move her arm across her body (from left to right) she experiences pain in the area she recieved her flu shot. She has Spoken with her Primary care provider about the pain, and he suggested giving her a cortisone shot in the arm to alleivate the pain, to which she declined. Patient also states that she plays tennis regularly and doesnt believe that she pulled any mucles while playing. Again, after multiple questions, patient does not appear to be experiencing any nerve pain, no constant pain, is not reporting symptoms of bursitis, but believes maybe a tendon was "hit" during injection. I informed her that I would complete an adverse event report, and suggested that she followed the advice of her primary care physician, to which she again declined. She is just hoping that there is something she can do to alleviate the pain because she "doesnt want to be in pain the rest of her life".
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: I had the flu vaccination. Within 24 hours I had nauseau, vomiting, headache. These symptoms lasted 24 hours.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Cough, Throat tightness
Clinical narrative: Received the flu vaccine on 10/30/18 at 1955. Started to cough within 5 mins of receiving the vaccine started experiencing tightness in her throat and was drinking water after 10 to 15 mins At 2028 took her inhaler Albuterol At 2031 50mg BENADRYL IM was given to RT Deltoid by nurse Lot #6400145 exp 4/1/2019 D1021L01 Needed to go to the ER for SOLUMEDEROL injection Has taken FLUBLOK in the past without issues In ED received Famotidine 40 mg 10/30/18 21:11 and methylprednisolone 125 mg IM 10/30/18 at 21:11. Was on steroids 20 mg PO X 4 days.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: RECEIVED ANTHRAX VACCINE ON 11/29/2018 AND REPORTED TO ER ON 11/30/2018 AT 2200 WITH PAIN/REDNESS AND TIGHTNESS TO LEFT UPPER EXTREMITY, VACCINE GIVEN IN L DELTOID. PEPCID 20MG PO AND PREDNISONE 40MG PO ADMINISTERED AT 0109 ON 12/01/2018 IN ER. MEDROL DS PACK, BENADRYL, AND PEPCID PRESCRIBED.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dry skin, Hypersensitivity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Severe rash on hands, neck, arms (up to elbows) Upper inside of legs, face. Severe drying and itching. Hands severely swollen. Symptoms began noticeably the next day but I thought I'd gotten into soap or something as itching and dryness began. Saturday morning hands severely swollen and rash on neck and facial dryness, and neighbor took me to hospital for allergic reaction. Given a shot and instructions to use BENADRYL.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: About 5 minutes after vaccination, patient started to feel lightheaded, tongue/lip was tingling/becoming numb and her right hand was feeling weird. I called 911 for an EMT who then came right away (5 min from phone call) and they assessed her and gave 1 dose of BENADRYL and water. Patient then started to feel better and walked out of store with husband and EMT (~15-20 min).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysstasia, Headache, Hypotension
Clinical narrative: Patient had to go to the Emergency Room because of having symptoms of chills, head hurt, couldn't stand up, low blood pressure for 3 days.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Gait inability, Heart rate increased, Infection, Injection site pain, Pyrexia
Clinical narrative: About 3.5 hours after the injection, my son was in too much pain to walk. He would not walk again for 3 days. He spiked a fever and had a rapid heart rate for 48 hours. He was hospitalized as it appeared as though he had an infection.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Gait inability, Heart rate increased, Infection, Inflammation, Inflammatory marker increased
Clinical narrative: About 3.5 hours after the injection, my son was in too much pain to walk. He would not walk again for 3 days. He spiked a fever and had a rapid heart rate for 48 hours. He was hospitalized as it appeared as though he had an infection.
Age: 3.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Pyrexia, Ultrasound scan, X-ray
Clinical narrative: About 3.5 hours after the injection, my son was in too much pain to walk. He would not walk again for 3 days. He spiked a fever and had a rapid heart rate for 48 hours. He was hospitalized as it appeared as though he had an infection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Laboratory test, Malaise, Tachycardia
Clinical narrative: Patient state she woke the next morning at 4am not feeling well. Took her own blood pressure and it was 70's/40's. She was seen in the Emergency Department for hypotension and tachycardia. She spent several hours in the ER, had labwork and other testing, was discharged feeling better.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Pruritus
Clinical narrative: Patient is due for second shingles vaccination however she states that with the first shot in August about 3 or 4 days later she had itchy, swollen, red arm and also some headache.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site warmth, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer refers to a 70-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # R016640 and expiration date 28-JAN-2020) (dose, units and frequency unknown). On an unknown date the patient experienced redness, localized pain and swelling, hot to the touch and tenderness at site of Injection and low fever. The doctor gave the patient MEDROL and KEFLEX. The assistant reported that the patient was doing fine. Causality of the events was not reported.
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a consumer refers to a 70-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # R016640 and expiration date 28-JAN-2020) (dose, units and frequency unknown). On an unknown date the patient experienced redness, localized pain and swelling, hot to the touch and tenderness at site of Injection and low fever. The doctor gave the patient MEDROL and KEFLEX. The assistant reported that the patient was doing fine. Causality of the events was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Amyotrophic lateral sclerosis, Gait disturbance, Muscle atrophy, Nerve degeneration, Orthosis user
Clinical narrative: This spontaneous report was received from a physician via an online article and refers to a 12-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in September 2008, the patient was vaccinated with a third dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, reported as after getting her last shot of GARDASIL, the patient began having trouble walking and then her muscles continued to deteriorate. On an unknown date, she used leg braces and a walker at home as her muscles and nerves continued to deteriorate. Patient's symptoms were suspected to be amyotrophic lateral sclerosis (ALS), however, no results of the ALS test were provided so far. The patient received the treatment, however it was stated that none of the treatments given was working. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of amyotrophic lateral sclerosis was considered to be medically significant. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA000379: US-009507513-1811USA012613.
Sex: F
Vaccine: HPV4
Symptoms: Walking aid user
Clinical narrative: This spontaneous report was received from a physician via an online article and refers to a 12-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in September 2008, the patient was vaccinated with a third dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, reported as after getting her last shot of GARDASIL, the patient began having trouble walking and then her muscles continued to deteriorate. On an unknown date, she used leg braces and a walker at home as her muscles and nerves continued to deteriorate. Patient's symptoms were suspected to be amyotrophic lateral sclerosis (ALS), however, no results of the ALS test were provided so far. The patient received the treatment, however it was stated that none of the treatments given was working. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of amyotrophic lateral sclerosis was considered to be medically significant. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA000379: US-009507513-1811USA012613.
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324608, 2018SA324602, 2018SA324605, 2018SA324604, 2018SA324607, 2018SA324609, 2018SA324606 and 2018SA324596. This case involves Elderly female patient received 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot number: UJ048AB, expiry date: 31-Nov-2019, dose in series was not reported) via intramuscular route in left deltoid. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. This was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324602, 2018SA324603, 2018SA324596, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324605, 2018SA324609 (same reporter). This case involves a female patient of unknown age who received vaccines FLUZONE HIGH DOSE after vaccines were exposed to the temperature excursion. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB (expiry date: 31-May-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was also reported that eight patients were administered a dose from the box that was exposed to the temperature excursion. It was unknown if patient experienced adverse event. 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. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: MMRV
Symptoms: Product appearance confusion, Wrong product administered
Clinical narrative: I had a co-worker show exactly where the vaccine was. Once we got to the freezer that it was kept in, my coworker looked at it and then I looked at it. The MMRV vaccine box was directly beside the MMR vaccinces. The boxes looked almost identical. I think that we were so busy that I only saw the MMR part of the vaccine. I realized the error when I tried to scan the vaccine into the computer and it did not scan. That is when I realized that I had given the MMRV and not the MMR. The patient was notified of the mistake and that she was still completely covered for the MMR.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Patient woke up having chills and a fever of 101 degrees Fahrenheit. She felt ill and stayed in bed for the day following the vaccine. Two mornings following vaccine administration, she reports that her arm turned red and painful. Her whole arm ached. She took TYLENOL to relieve the pain. Her arm was swollen and appeared as a rash which then turned red. Patient saw Dr. who prescribed Cephalexin 500mg three times daily. He did not know if the condition was an adverse reaction or infection. He advised patient to contact the office again if the condition does not improve in two days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient woke up having chills and a fever of 101 degrees Fahrenheit. She felt ill and stayed in bed for the day following the vaccine. Two mornings following vaccine administration, she reports that her arm turned red and painful. Her whole arm ached. She took TYLENOL to relieve the pain. Her arm was swollen and appeared as a rash which then turned red. Patient saw Dr. who prescribed Cephalexin 500mg three times daily. He did not know if the condition was an adverse reaction or infection. He advised patient to contact the office again if the condition does not improve in two days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient is complaining of arm pain for 4 months, starting the day after receiving the vaccine. He states that it hurts when he lifts his arm up.
Age: 1.67
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Pyrexia, Roseola
Clinical narrative: 105.8 fever, lethargy, roseola.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching
Clinical narrative: Muscle twitches many times a day and at night.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Fever, shivering, fatigue, soreness, headache, dizziness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, shivering, fatigue, soreness, headache, dizziness.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Flatulence
Clinical narrative: Abdominal discomfort/pain, semi-bloating sensation, flatulence.
Age: 0.42
Sex: M
Vaccine: UNK
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: My 6 month old perfectly healty son went to sleep didnt wake up. He passed from SIDS and he recieved his shots 2 weeks prior.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm hurts.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Croup infectious, Dyspnoea, Pyrexia
Clinical narrative: Within a few hours of the flu shot, she had a mild fever (101.3) through the night. Treated fever at home with rest, childrens ADVIL, and a gentle warm bath. The next morning she still had a fever, but still considered to be mild. This was a Friday morning. Throughout the day we alternated TYLENOL and ADVIL and were able to manage the fever symptoms. Late into the night, Friday night (24 hours after her flu shot) she started coughing, which became progressively worse through the night and into Saturday morning. Her fever went up to 103.1 at the highest, with alternating TYLENOL and ibuprofen medications. The cough sounded very croupy. She was having difficulty breathing. She had a reaction very similar in the past after another shot, and they had suggested using BENADRYL to help ease the symptoms. We began giving her BENADRYL around 1am Saturday morning when the cough was getting worse. Gave another dose early Saturday AM around 7am and then took her to the urgent care. At urgent care she was given a dose of DECADRON. The cough improved but the fever has remained. It is now 4 days later and she still has a mild fever and occasional cough. We will take her back to the doctor tomorrow AM if symptoms do not improve again.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Red, rash noted on 11/29/18. Notes to be resolving on 11/30/2018.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Patient reported: Red, swollen area on arm, "low-grade" fever, malaise. Reported that this started the day after she received the vaccine. She also stated that she had some small, red pimples on her hand and trunk. These have resolved, and were not itchy. Patient denied any breathing difficulty.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Patient stated she had nausea and vomiting after the immunization and also developed a rash on her right hand wrist.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: PATIENT STATES THAT HAD SEVERE PAIN, BLEEDING, BRUISING AT INJECTION SITE WITH LIMITED MOTION ABOVE SHOULDER LEVEL
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Flushing, Vision blurred, Vomiting
Clinical narrative: Within 10 minutes of receiving the immunization, the patient got flushed, hot, dizzy, blurred vision, and vomited. The symptoms resolved with time, water, and ice packs. Her primary care provider was notified immediately, but they did not think she required any further medical attention, as the adverse events dissipated in 20-30 minutes. Patient left facility with her mother as the driver. She was counseled to eat some food, take ibuprofen, and rest. She was also advised to immediately seek medical attention if she begins to feel bad again, or breaks out into hives or has trouble breathing.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately felt dizzy; dizzy resolved with lying down but then recurred and persisted 2.5 hrs after injection.
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: 6 hours after I received the flu shot, I had severe stomach pains and had loose stool. This has lasted a week so far.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Peripheral swelling
Clinical narrative: Patient was stating that she was having a lot of pain and her arm was swollen and was having some redness. Spoke with patient today 12/03/2018, Asked patient on how she was feeling. Patient stated that she was feeling a lot better and the pain went away and the swelling went down.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Altered state of consciousness, Constipation, Corneal reflex decreased, Crying, Delirium
Clinical narrative: Become unaware of things going on around him, delirious, spiked a fever of 103.5, vomiting, twitching, constipated, temperature went back down to normal 2 days later, but continued the twitching and started slow blinking for a couple days. 3 days post vaccines he was very irritable spending most of the day/night fussing or crying.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Irritability, Muscle twitching, Pyrexia, Vomiting
Clinical narrative: Become unaware of things going on around him, delirious, spiked a fever of 103.5, vomiting, twitching, constipated, temperature went back down to normal 2 days later, but continued the twitching and started slow blinking for a couple days. 3 days post vaccines he was very irritable spending most of the day/night fussing or crying.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection
Clinical narrative: Patient's son came in at 6:15p today 12/03/18 with a prescription for BACTRIM DS. Patient went to the ER today for an infection on the arm where she got the flu shot and the doctor had mentioned to them in the ER it was probably from the flu shot. Patient also had a root canal (unplanned) today as well. The doctor from the ER mentioned that the shot may have been too low so the patient's son let us know that may be the cause for the infection in her arm.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Urticaria
Clinical narrative: Had very painful aches in arm at site of injection lasting for 3 days; also had hives on her right knee and back of neck lasting for 3 days. Took 1 extra tramadol for the pain.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching, Pain, Paraesthesia
Clinical narrative: Customer states that she has "tingling and twitching" on the right side of philtrum of nose. Some pain involved as if cold sore coming. She does have history of cold sores, but not with the twitching that is happening. She requested this be sent in. She was just diagnosed with recurrence of cancer and that may be stress causing this.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Hypophagia, Irritability, Pyrexia, Rash
Clinical narrative: PROQUAD administered instead of MMR that was ordered. Varicella separate vaccine also administered therefore double dose of Varicella. Low grade fever, fussy. Mild rash, poor oral intake.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: PROQUAD administered instead of MMR that was ordered. Varicella separate vaccine also administered therefore double dose of Varicella. Low grade fever, fussy. Mild rash, poor oral intake.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in the upper left arm very sharp the day of vaccination, now not as acute but still present and limiting use of arm without significant pain. Perhaps the vaccine was given too high and not in muscle.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: Local swelling and erythema.
Age: 26.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Myalgia
Clinical narrative: Muscle ached in L arm lasting 2 months.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Patient reported a red swollen arm with a tingle sensation and pain.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Approximately 5 days after the vaccination the patient's right upper arm became red, her elbow became swollen and both areas became itchy. The patient had tried using hydrocortisone 1% cream and BENADRYL spray to the red area of the arm. Upon consulting with the patient on 12/3, she was advised to try cold compress for a minimum of 15 minutes and to take oral BENADRYL, if  worse or no better in a few days consult with physician.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea
Clinical narrative: Pt called 12/3 to report diarrhea (3 to 4 loose stools over the course of the day) that she believes was caused by her recent HAVRIX vaccination received 12/1. She has not sought treatment and plans to wait another day or two to see if it resolves on its own.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash
Clinical narrative: Patient complains of small rash appearing on abdomen approximately 24 hours after vaccination, lasting over the past 2 weeks. No pain or itching associated with rash. Patient complains of bilateral hamstring tingling inside (not on surface of legs). No visual changes to bilateral legs. Patient reports he will speak to his doctor today (12/3/18), wanted to report it as an adverse event for SHINGRIX vaccination. After further discussion, patient reports sometimes during cold weather he will get abdominal rash as he has now, but is unsure if it could be due to vaccination.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia
Clinical narrative: Patient stated her arm was numb after shot. Stopped back after 20 minutes and said it was still numb. I did talk to her tonight and she said numbness resolved, she is fine.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: PT RECEIVED BOTH IMMUNIZATION IN SAME ARM ON 11/16/18 PT RETURNED TO PHARMACY ON 11/19/18 AND EXPLAINED ADVERSE REACTION. PT VISITED URGENT CARE AND REPORTED MUSCLE REACTION ON ARM ON WHICH IMMUNIZATION ADMINISTERED. PHARMACIST NOTED REDNESS ON ARM ADMIN SITE.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling within hours of receiving the vaccine. Lasted for 3 weeks.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Continued aching and soreness in the left shoulder joint for 30 days now. Injection seems to have been administered a little too high and went into the shoulder joint instead of the muscle. No treatment sought yet. Considering having a Dr look at it if aching / soreness continue for a few more days or gets worse.
Age: 19.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: C-reactive protein, Differential white blood cell count, Full blood count, Gait disturbance, Metabolic function test
Clinical narrative: Vaccine was given during a flu mission conducted by clinic within the Medical home. Per medical record patient reported to the ED c/o of trouble moving his lower extremities the evening of the vaccination. Patient was admitted and White to r/o Guile-Barre. Patient was release on 29 NOV 2018 with the following restrictions for 14 days: "no prolong standing over 10 minutes, no running, no lifting over 1O pounds" Patient f/u on 3 DEC 2018 and Per medical record states that he can walk but does get "sensation of not being able to walk and it just comes and goes". Patient is currently enrolled in Physical Therapy.
Age: 19.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Red blood cell sedimentation rate, Sensory disturbance
Clinical narrative: Vaccine was given during a flu mission conducted by clinic within the Medical home. Per medical record patient reported to the ED c/o of trouble moving his lower extremities the evening of the vaccination. Patient was admitted and White to r/o Guile-Barre. Patient was release on 29 NOV 2018 with the following restrictions for 14 days: "no prolong standing over 10 minutes, no running, no lifting over 1O pounds" Patient f/u on 3 DEC 2018 and Per medical record states that he can walk but does get "sensation of not being able to walk and it just comes and goes". Patient is currently enrolled in Physical Therapy.
Age: 19.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Paralysis
Clinical narrative: Vaccine was given during a flu mission conducted by clinic within the Medical home. Per medical record patient reported to the ED c/o of trouble moving his lower extremities the evening of the vaccination. Patient was admitted and White to r/o Guile-Barre. Patient was release on 29 NOV 2018 with the following restrictions for 14 days: "no prolong standing over 10 minutes, no running, no lifting over 1O pounds" Patient f/u on 3 DEC 2018 and Per medical record states that he can walk but does get "sensation of not being able to walk and it just comes and goes". Patient is currently enrolled in Physical Therapy.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is pregnant, in the first trimester 10 weeks. Patient states her OB-GYN recommended patient to get flu shot.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: Localized, 5 cm x 9 cm zone of erythema w/ 4 cm central indurated area.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia
Clinical narrative: This is a new vaccine this year - patient said after she was given both shots she noticed difficulty swallowing upon each dose this is how she reported it down to the vaccine. No breathing problems.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large erythema 13 x 6 cm (L) ant. thigh at site of PENTACEL with 11 x 5 cm induration and warmth.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling face
Clinical narrative: Patient received her second SHINGRIX vaccine on 11/26/18. The patient reported redness and swelling of the left face and bilateral leg pain. She took a pain reliever and an antihistamine after and reported decreased symptoms. Patient reported on 11/29/18 to pharmacy.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling hot, Malaise
Clinical narrative: On 12-2-18, Patient called Pharmacist to say she had a bad reaction to the vaccine. She said a few hours after vaccination she became very ill. She experienced chills and felt hot. She then went to bed. Next morning she was better.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder
Clinical narrative: Loss of balance when standing or walking. Started 11-2-2018 day after vaccination. I still have loss of balance but not as bad as 11-2-18 or 11-3-18.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: 11/26/18 Pt was seen for post office testing. At time of visit C/O on 11/14/18 at 0200 C/O no energy, weak, fever 102 degrees achiness, stated symptoms lasted x4 days. C/O fever 1 1/2 days. At present visit 11/26/18 offered no further C/O above symptoms. 11/26/18 Lt delt site of vaccine area checked no redness, swelling or warmth upon touch.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Red; Sore; Flu-like symptoms; Body aches; Fever; Stomach ache; Weakness; All joints hurt; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in right deltoid. The patient presented with flu-like symptoms, including body aches, fever, stomach ache, weakness, and all joints hurting, that started 12 hours after receiving the Shingrix vaccine.   The patient also had pain at the injection site immediately upon vaccination and the injection site became red and sore.   All symptoms with the first vaccination lasted for three days and then resolved. For tolerance to 2nd dose, refer case US2018GSK213504.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Red; Sore; Flu-like symptoms; Body aches; Fever; Stomach ache; Weakness; All joints hurt; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in right deltoid. The patient presented with flu-like symptoms, including body aches, fever, stomach ache, weakness, and all joints hurting, that started 12 hours after receiving the Shingrix vaccine.   The patient also had pain at the injection site immediately upon vaccination and the injection site became red and sore.   All symptoms with the first vaccination lasted for three days and then resolved. For tolerance to 2nd dose, refer case US2018GSK213504.
Age: 65.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Unevaluable event
Clinical narrative: Pt states she received a pneumonia vaccine 10/31/18 and it made her very ill. Pt reported fever, body aches, arms tingling, insomnia, and nausea. Pt states she requested blood work. CMP showed abnormal liver function. (AST 76, Alkaline Phosphatase 239, and Alt 83.) Pt states sent for abdominal US on 11/20/18 which showed 8 cm cyst on liver. Pt had MRI 11/26/18. (Result 12 cm simple appearing unilocular cyst in the left lobe of liver without any finding to suspect malignancy).
Age: 65.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Hepatic cyst, Insomnia
Clinical narrative: Pt states she received a pneumonia vaccine 10/31/18 and it made her very ill. Pt reported fever, body aches, arms tingling, insomnia, and nausea. Pt states she requested blood work. CMP showed abnormal liver function. (AST 76, Alkaline Phosphatase 239, and Alt 83.) Pt states sent for abdominal US on 11/20/18 which showed 8 cm cyst on liver. Pt had MRI 11/26/18. (Result 12 cm simple appearing unilocular cyst in the left lobe of liver without any finding to suspect malignancy).
Age: 65.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Malaise, Metabolic function test abnormal, Nausea, Nuclear magnetic resonance imaging liver abnormal, Pain
Clinical narrative: Pt states she received a pneumonia vaccine 10/31/18 and it made her very ill. Pt reported fever, body aches, arms tingling, insomnia, and nausea. Pt states she requested blood work. CMP showed abnormal liver function. (AST 76, Alkaline Phosphatase 239, and Alt 83.) Pt states sent for abdominal US on 11/20/18 which showed 8 cm cyst on liver. Pt had MRI 11/26/18. (Result 12 cm simple appearing unilocular cyst in the left lobe of liver without any finding to suspect malignancy).
Age: 65.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Paraesthesia, Pyrexia, Ultrasound abdomen abnormal
Clinical narrative: Pt states she received a pneumonia vaccine 10/31/18 and it made her very ill. Pt reported fever, body aches, arms tingling, insomnia, and nausea. Pt states she requested blood work. CMP showed abnormal liver function. (AST 76, Alkaline Phosphatase 239, and Alt 83.) Pt states sent for abdominal US on 11/20/18 which showed 8 cm cyst on liver. Pt had MRI 11/26/18. (Result 12 cm simple appearing unilocular cyst in the left lobe of liver without any finding to suspect malignancy).
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever (102.2 F), headache, injection site pain, fatigue, shivering.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: BEGAN WITH SORENESS WITHIN A FEW HOURS. BECAME VERY TENDER TO TOUCH, SWOLLEN, RED, WARM TO THE TOUCH, ITCHED.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: BEGAN WITH SORENESS WITHIN A FEW HOURS. BECAME VERY TENDER TO TOUCH, SWOLLEN, RED, WARM TO THE TOUCH, ITCHED.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Dizziness
Clinical narrative: 1 hr. post vaccine-extreme soreness at injection site. 4 hrs post vaccine-muscle aches, low fever (99°-100°), chills, fatigue. 18 hrs post vaccine-vaccine site pain, muscle aches (whole body), fever of 102°, chills, diarrhea, headache, extreme fatigue, dizziness, weakness 36 hrs post vaccine- vaccine site pain, muscle aches, fever of 101°, chills, worsening headache, dry cough, fatigue, dizziness, weakness. 56 hrs post vaccine-vaccine site still red and painful to the touch, but less pain than before, less headache, muscle pain, and fatigue, low fever 99.5°.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: 1 hr. post vaccine-extreme soreness at injection site. 4 hrs post vaccine-muscle aches, low fever (99°-100°), chills, fatigue. 18 hrs post vaccine-vaccine site pain, muscle aches (whole body), fever of 102°, chills, diarrhea, headache, extreme fatigue, dizziness, weakness 36 hrs post vaccine- vaccine site pain, muscle aches, fever of 101°, chills, worsening headache, dry cough, fatigue, dizziness, weakness. 56 hrs post vaccine-vaccine site still red and painful to the touch, but less pain than before, less headache, muscle pain, and fatigue, low fever 99.5°.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: 1 hr. post vaccine-extreme soreness at injection site. 4 hrs post vaccine-muscle aches, low fever (99°-100°), chills, fatigue. 18 hrs post vaccine-vaccine site pain, muscle aches (whole body), fever of 102°, chills, diarrhea, headache, extreme fatigue, dizziness, weakness 36 hrs post vaccine- vaccine site pain, muscle aches, fever of 101°, chills, worsening headache, dry cough, fatigue, dizziness, weakness. 56 hrs post vaccine-vaccine site still red and painful to the touch, but less pain than before, less headache, muscle pain, and fatigue, low fever 99.5°.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Mobility decreased, Muscle twitching, Pain, Pain in extremity
Clinical narrative: Severe pain and aching in left arm began approximately 7-8 hrs after injection, along with intermittent muscle twitching in the tricep muscle between elbow and shoulder. Twitching lasted 10 hours. Increased pain with movement, unable to move arm above shoulder level. There was no pain, redness, swelling or warmth to at the injection site. No lumps noted at site. TYLENOL helped relieve the pain, taken every 6 hours. Symptoms began to subside after 24 hours. After 72 hours, all symptoms were gone. Called the Pharmacy the following day, 11-30-18 to report event.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Seizure
Clinical narrative: About 4 hours after vaccination he started having seizures. He was between 15 and 18 months old at the time.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Seizure
Clinical narrative: 4 to 8 hours after vaccination she had severe seizure stayed in the hospital overnight for observation unknown cause for seizure she was between 15 and 18 months when this happened.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was not provided. On 08-NOV-2018, the patient received two vaccines via the intramuscular route instead of the subcutaneous route. The two vaccines were M-M-R II (lot # N023149, expiration date was 24-AUG-2019, indication: prophylaxis, strength was not reported) and VARIVAX (lot # N034559, expiration date was 05-DEC-2019, indication: prophylaxis, strength was not reported). No adverse effects were reported in the patient.
Sex: U
Vaccine: MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history were not provided. On unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II lot #N024698, expiration date 08-SEP-2019 and lot # N023150, expiration date 24-AUG-2019 (dose, site and route of administration not reported) as well as ROTATEQ lot #R002517, expiration date 19-SEP-2019 (dose, site and route of administration not reported), both for prophylaxis. The doses of M-M-R II were reconstituted with properly stored sterile diluent. Administered doses of vaccines experienced the temperature excursion between 47 and 77 degrees Fahrenheit (F) (also reported as 50.9 F) for 46 minutes. The temperature was measured with Digital Data Logger. There were no previous excursions reported. No adverse effects were reported.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, medical history and drug reactions was not provided. On 21-MAR-2006, the patient was vaccinated with a first dose of VAQTA (lot # and expiration date were not reported) orally for prophylaxis at 2 years of age. On 19-SEP-2006, the patient received a second dose of VAQTA hepatitis which was 2 days early (Inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer refers to a 67-year-old female patient. The patient's medical history and concomitant medications were not reported. The patient's current condition included known allergy to penicillin. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # R016640 and expiration date 28-JAN-2020) (dose, units and frequency unknown). On an unknown date the patient experienced redness, localized pain and swelling, hot to the touch and tenderness at site of Injection and low fever. The doctor gave the patient MEDROL. The outcome of the events was unknown. Causality of the events was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report  was received from a office manager refers to a 6 month old patient. The patient's current condition, medical history, drug reactions or allergies and concomitant therapies were not provided. On 26-NOV-2018, the 6 months old patient was vaccinated with GARDASIL 9 (lot # R009614 and expiration date 30-NOV-2018) at a dose of 0.5 ml once (product administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint was reported.