chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Metabolic function test, Nausea, Prothrombin time, Syncope
Clinical narrative: The shot was received at Drug Store. State registry says shot given 10/1, but patient reports she received on 10/2/18. Report from ED: 71-year-old female states had a flu shot yesterday and felt slightly off after that last night started having chills and this morning she was coming down to have breakfast fell lightheaded nauseous diaphoretic and then had a syncopal episode. Husband took blood pressure at home and it was in the 70s. No associated chest pressure tightness or heaviness. She states she is feeling better now.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Troponin, Urine analysis
Clinical narrative: The shot was received at Drug Store. State registry says shot given 10/1, but patient reports she received on 10/2/18. Report from ED: 71-year-old female states had a flu shot yesterday and felt slightly off after that last night started having chills and this morning she was coming down to have breakfast fell lightheaded nauseous diaphoretic and then had a syncopal episode. Husband took blood pressure at home and it was in the 70s. No associated chest pressure tightness or heaviness. She states she is feeling better now.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Chest X-ray normal, Chest pain, Dizziness, Troponin normal
Clinical narrative: Patient return to the facility at approx. 1600 complaining of Chest Pain, burning to bilateral facial cheeks, feeling faint/dizzy approx. 30 minutes after vaccine injection, had not returned to the office due to weather and lack of transportation. Provider evaluated and instructed to have Patient transfer to higher level of care due to chest pain.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Patient return to the facility at approx. 1600 complaining of Chest Pain, burning to bilateral facial cheeks, feeling faint/dizzy approx. 30 minutes after vaccine injection, had not returned to the office due to weather and lack of transportation. Provider evaluated and instructed to have Patient transfer to higher level of care due to chest pain.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Patient reported to pharmacy 2 days after IMZ. Right arm was swollen down to elbow, very red, hot, and hard to the touch. Symptoms started about 24 hours after receiving the vaccine. Patient has been taking acetaminophen and applying cold compress. Advised patient to keep us informed of the progression and gets worse, patient will see her physician.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash. BENADRYL. Resolved in 2 days
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Herpes zoster, Rash vesicular
Clinical narrative: She woke up the following morning and noticed her right eye was bothering her. It slowly progressed throughout the day and over the weekend into a blister in the corner of her eye and a rash. The rash spread down the right side of her face and onto her chin. She went to urgent care on Monday and got diagnosed with shingles and filled a prescription for Valtrex here at our pharmacy and told us about her reaction.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Dysgeusia, Headache
Clinical narrative: As soon as after the vaccination, patient claimed that he was having headache and "weird" taste in mouth. Patient instructed to stay for observation. In about 10 minutes, patient said the headache went away but he still felt there was some unusual taste in his mouth. In 45 minutes, patient stated he is doing fine with the "weird" taste subsiding and left. Instructed patient to seek help if he any symptoms returns or worsens. Called and followed up with patient and spoke to him 10/3/18 via phone and he stated all symptoms went away with no recurrence.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Vomiting
Clinical narrative: PATIENT FELT LIGHT HEADED IMMEDIATELY AFTER SHINGRIX SHOT WHICH WAS ADMINISTERED SECOND AFTER THE FLU VACCINE. PATIENT PUT HEAD DOWN AND PASSED OUT FOR A FEW SECONDS. LAID DOWN ON THE FLOOR FOR A FEW MINUTES THEN VOMITED. PATIENT FELT BETTER RIGHT AFTER VOMITING AND WAS ABLE TO SIT UP AND DRINK WATER.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Sore arm and shoulder lasting greater than 1 month.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling
Clinical narrative: Patient's mother called and stated that patient had a swollen arm around then injection site.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Full blood count, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient had the PNEUMOVAX on 9/17 and was hospitalized 9/18 with fever/sepsis. There was no obvious fever source. He had significant leukocytosis on admission. After he was in the hospital one day he started to develop a tender, red patch of skin on his left upper arm which was the site of his PNEUMOVAX. Dx- cellulitis related to the injection.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Leukocytosis, Pyrexia, Sepsis, White blood cell count increased
Clinical narrative: Patient had the PNEUMOVAX on 9/17 and was hospitalized 9/18 with fever/sepsis. There was no obvious fever source. He had significant leukocytosis on admission. After he was in the hospital one day he started to develop a tender, red patch of skin on his left upper arm which was the site of his PNEUMOVAX. Dx- cellulitis related to the injection.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: Erythema/minor pain at injection site. Bump (4 inches x 2 inches), itching.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness and injection at and around injection site the day following the injection and does not show sign of worsening or healing.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Joint injection, Periarthritis
Clinical narrative: Pt was contacted to schedule second dose of Shingrix and reported immediate pain in left shoulder after 1st dose. Had been a long time since getting a shot and though it was typical arm pain.  A week later she was still in pain and saw an orthopedist, who diagnosed it as frozen shoulder. Pt reported that Dr said the needed went through the muscle and out the other side. Had to get cortisone injection in that shoulder. Rph apoligized and investigated what happened.  Pt still wants to get second dose but would prefer in alternative site, not arm because arthritis in Right shoulder.  RPh following up with Dr.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Balance disorder, Body temperature increased, Discomfort, Headache, Lymph node pain
Clinical narrative: Injections were administered an inch apart. Pt experienced excruciating head ache and pressure. Felt pain in lymph nodes under the arms and neck. Ran a temp of about 101. She felt off-balance. Went to ER and they administered benadry, meclizine and reglan.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: After about 40 hours after the time of injection, I started having a runny nose and watery eyes. 4 hours after those onset symptoms, I became dizzy and started sweating. Headaches/back aches, severe fatigue, congestion, and sore throat presented throughout that evening, and persists with equal intensity 50 hours after symptom onset.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Lacrimation increased, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: After about 40 hours after the time of injection, I started having a runny nose and watery eyes. 4 hours after those onset symptoms, I became dizzy and started sweating. Headaches/back aches, severe fatigue, congestion, and sore throat presented throughout that evening, and persists with equal intensity 50 hours after symptom onset.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase normal, Angiogram cerebral normal, Arteriogram carotid normal, Aspartate aminotransferase normal, Blood creatinine normal
Clinical narrative: Non-intractable vomiting, nausea, non-intractable headache, chills, full body aches. Symptoms were sever enough that Patient went to the Emergency Room for care. Patient was given toradol, solumedrol, Compazine, Benadryl and fluids. Patient fully recovered and went home that night. It is unknown what caused the significant symptoms for the patient (vaccine received earlier that day vs viral infection). Definite cause of patients symptoms wasn't found. Could be related to her 2nd dose of Shingrix she received earlier that day?  She was otherwise healthy at the time of the immunization.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood electrolytes normal, Blood glucose normal, Blood test normal, Blood urea normal, Body temperature normal
Clinical narrative: Non-intractable vomiting, nausea, non-intractable headache, chills, full body aches. Symptoms were sever enough that Patient went to the Emergency Room for care. Patient was given toradol, solumedrol, Compazine, Benadryl and fluids. Patient fully recovered and went home that night. It is unknown what caused the significant symptoms for the patient (vaccine received earlier that day vs viral infection). Definite cause of patients symptoms wasn't found. Could be related to her 2nd dose of Shingrix she received earlier that day?  She was otherwise healthy at the time of the immunization.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram head normal, Full blood count normal, Headache, International normalised ratio normal
Clinical narrative: Non-intractable vomiting, nausea, non-intractable headache, chills, full body aches. Symptoms were sever enough that Patient went to the Emergency Room for care. Patient was given toradol, solumedrol, Compazine, Benadryl and fluids. Patient fully recovered and went home that night. It is unknown what caused the significant symptoms for the patient (vaccine received earlier that day vs viral infection). Definite cause of patients symptoms wasn't found. Could be related to her 2nd dose of Shingrix she received earlier that day?  She was otherwise healthy at the time of the immunization.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lipase normal, Oxygen saturation normal, Pain, Prothrombin time normal, Red blood cell sedimentation rate normal
Clinical narrative: Non-intractable vomiting, nausea, non-intractable headache, chills, full body aches. Symptoms were sever enough that Patient went to the Emergency Room for care. Patient was given toradol, solumedrol, Compazine, Benadryl and fluids. Patient fully recovered and went home that night. It is unknown what caused the significant symptoms for the patient (vaccine received earlier that day vs viral infection). Definite cause of patients symptoms wasn't found. Could be related to her 2nd dose of Shingrix she received earlier that day?  She was otherwise healthy at the time of the immunization.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Non-intractable vomiting, nausea, non-intractable headache, chills, full body aches. Symptoms were sever enough that Patient went to the Emergency Room for care. Patient was given toradol, solumedrol, Compazine, Benadryl and fluids. Patient fully recovered and went home that night. It is unknown what caused the significant symptoms for the patient (vaccine received earlier that day vs viral infection). Definite cause of patients symptoms wasn't found. Could be related to her 2nd dose of Shingrix she received earlier that day?  She was otherwise healthy at the time of the immunization.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: LARGE AREA OF SWELLING, REDNESS, FEVERISH AT INJECTION SITE, MALAISE, BODY ACHES, WEAKNESS, FEVER IN EVENING AFTER INJECTION.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: LARGE AREA OF SWELLING, REDNESS, FEVERISH AT INJECTION SITE, MALAISE, BODY ACHES, WEAKNESS, FEVER IN EVENING AFTER INJECTION.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Dizziness, Nausea
Clinical narrative: Client received vaccination and immediately reported feeling lightheaded and stated "I feel like I am going to black out and I feel nauseated". VS WNL. No other symptoms reported. A & O x3. Immediately had client lay down with feet elevated. Client also reported not eating all day. Lollipop given to help with possible low blood sugar. After laying down and lollipop client reported feeling better after 15minutes. Advised client to go home eat and rest. Called and spoke to client on 10/05/18 and she stated all of her symptoms resolved after she ate.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient experiencing aches and burning sensation in his shoulder joint. Patient does report the vaccine was administered high on the shoulder. Patient intends to visit his doctor for further evaluation.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: One hour after receiving influenza injection client described a dull ache that radiated down to her elbow with occasional shooting pain to the 5th finger. Denies shoulder pain. Encouraged follow up with primary care if symptoms do not resolve. Client has been taking anti inflammatory medications, icing, and using topical ICY/HOT. Spoke with client 10/4/18 and 10/8/18. Client states slow improvement with good range of motion but states it is weak. Client states she will make appt. for exam this week if pain does not improve/resolve.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient stated she had headache, fever, redness and swellen of left arm.  Arm was still warm to the touch today.
Age: 50.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Accidentally gave patient a 2nd dose of PREVNAR 13 (1st dose was given on 9/30/17). As of 10/8/18, the patient was not experiencing any side effects other than sore arm at site of injection.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema
Clinical narrative: Patient presented at the pharmacy on Friday, Oct 5, with what appeared to be bruising about 4 inches below the injection sight. She said the bruising had started up a little higher and had moved down. She reported no pain, no swelling, no fever, no itching. She just happened to notice the redness on her arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Pain in left deltoid within 3 hours; lasted 72 hours. Slight headache within 6 hours; lasted 48 hours.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site irritation, Skin irritation
Clinical narrative: Patient has experienced redness/irritation on face and at site of injection.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient received both FLUAD and PNEUMOVAX 23 in the left arm on 10/6/18. The patient has redness, swelling and pain afterwards. Swelling was reduced by 10/8/18 but redness and pain still present. Patient has had flu shots before with no issue.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Otitis media, Urticaria
Clinical narrative: Hives began about 8 hours after the immunization, on Day 2 was found to have hives continuing and found to have an Otitis Media, therefore Abx treatment started. Ear did not clear exceptionally well, and so switched to Azithromycin in hopes that ears would clear really well which would indicate hives and OM=Mycoplasma, and therefore not due to Flu Vaccine, but after azithro treatment, still not enough improvement to say that hives were likely from Mycoplasma instead of from Flu Vaccine.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Patient called in reporting diarrhea, abdominal pain, and nausea that she believes to be caused by the flu vaccine she received.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Muscle twitching, Strabismus
Clinical narrative: Lip twitching, head twitches and going cross eyed September 2016, lasting approximately a couple months.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Spoke with the patient 2 weeks after the immunization was given. The Immunization was given on 9/21/18. That was the 2nd dose of the Shingrix given to this patient. The patient did not have any reaction after the 1st dose. The patient reported that she had a rash about 1 inch in diameter around her naval and also a sore arm. The patient did not seek any medical attention or inform her doctor. The patient self treated herself with Cortisone-10 and the rash cleared up after 3 days.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Chest pain, Heart rate increased, Swelling face, Swelling of eyelid
Clinical narrative: Entire face swollen, including eyes swollen shut. Rapid heart beat, moderate chest pain.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Periorbital swelling, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Patient received his flu shot around 9:15am on Friday Oct 5th. He did well with the injection and went to school for the day. At pick up, around 5:30pm, he was noted to be feeling unwell. He was febrile upon temperature check at home by 6:00pm to 101.3F.  His fever persisted through Saturday afternoon Oct 6th with minimal other symptoms. Upon waking up on Sunday morning, Oct 7th, he had a prominent red rash (erythematous confluent maculopapular rash) over his face with some periorbital swelling and involvement of cheeks and ears bilaterally. He also had a rash over the dorsal and palmar sides of both hands. He received loratadine and BENADRYL with some improvement but the rash persisted all day into Monday Oct 8th. By Monday, he had a noticeable rash on his legs/feet as well. His torso and back were much less affected. No oral lesions or hand/foot lesions were noted.
Age: 47.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Asthenia, Erythema, Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: 9/29/18: Patient's left shoulder and upper arm started getting to red, painful and swollen. 9/30/18: Redness, pain, swelling worsening. Pt felt a large knot on Right deltoid. He says it looked like a large bone was sticking out. Since 9/30, hands started getting achy. Patient states he started feeling very fatigued, dazed, and weak. Unsure if this was related. Since 9/30, Left shoulder and arm were hot to the touch. Patient reports arm and shoulder felt tender and numb in places. He took ibuprofen which gave possible slight relief. Appointment at our office on 10/2/18. Patient's arm was red, swollen, warm to the touch. Doctor started prednisone 40mg by mouth daily for 5 days. CMA 10/5/18
Age: 47.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nodule
Clinical narrative: 9/29/18: Patient's left shoulder and upper arm started getting to red, painful and swollen. 9/30/18: Redness, pain, swelling worsening. Pt felt a large knot on Right deltoid. He says it looked like a large bone was sticking out. Since 9/30, hands started getting achy. Patient states he started feeling very fatigued, dazed, and weak. Unsure if this was related. Since 9/30, Left shoulder and arm were hot to the touch. Patient reports arm and shoulder felt tender and numb in places. He took ibuprofen which gave possible slight relief. Appointment at our office on 10/2/18. Patient's arm was red, swollen, warm to the touch. Doctor started prednisone 40mg by mouth daily for 5 days. CMA 10/5/18
Age: 47.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: 9/29/18: Patient's left shoulder and upper arm started getting to red, painful and swollen. 9/30/18: Redness, pain, swelling worsening. Pt felt a large knot on Right deltoid. He says it looked like a large bone was sticking out. Since 9/30, hands started getting achy. Patient states he started feeling very fatigued, dazed, and weak. Unsure if this was related. Since 9/30, Left shoulder and arm were hot to the touch. Patient reports arm and shoulder felt tender and numb in places. He took ibuprofen which gave possible slight relief. Appointment at our office on 10/2/18. Patient's arm was red, swollen, warm to the touch. Doctor started prednisone 40mg by mouth daily for 5 days. CMA 10/5/18
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Severe pain in left shoulder especially when lifting arm or moving it behind. Went to pharmacy next day and was told to take TYLENOL which helped; however, I still experience some "residual" ache after 13 days.
Age: 1.0
Sex: U
Vaccine: HEP, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Fever T max 102.8 degrees F. Treated with paracetamol 100 mg/ml. Fever has started 54 hours after the injections.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Chills, Diplopia, Fatigue, Headache, Malaise
Clinical narrative: 9-29-18 Started not feeling well-headache, chills. Double vision 9-29 and 10-1, 10-3 reported arm weakness. Fatigue started 9/30/18. Treatment: Ibuprofen (also: TRUMENBA and Flu: 9/21/17; presyncope, headache, fatigue, nausea, tingling (feet, fingers). 10/4/18: Symptoms almost fully resolved.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Muscular weakness, Nausea, Paraesthesia, Presyncope
Clinical narrative: 9-29-18 Started not feeling well-headache, chills. Double vision 9-29 and 10-1, 10-3 reported arm weakness. Fatigue started 9/30/18. Treatment: Ibuprofen (also: TRUMENBA and Flu: 9/21/17; presyncope, headache, fatigue, nausea, tingling (feet, fingers). 10/4/18: Symptoms almost fully resolved.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Erythema
Clinical narrative: Symptoms started showing up either on the day of the injection or the second day after the shot but did not get noticed. On the 29th of September I, the husband, noticed that the color of her arm was deep red to pink around the edge of the muscle. Took my wife to immediate care and had her examined and they diagnosis it as cellulitis of the left upper limb.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Fever, flushing, redness/swelling at site of injection, severe arm pain but no loss of motor function.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Headache, Inflammation, Local reaction
Clinical narrative: Stomach upset/nausea - started 10/6/18 - Fever/body aches - started 10/6/18 - Local reaction - inflamed, even with ice - started 10/7/18 - Joint pain - mostly knees - started 10/8/18 - Headache - started 10/6/18.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Stomach upset/nausea - started 10/6/18 - Fever/body aches - started 10/6/18 - Local reaction - inflamed, even with ice - started 10/7/18 - Joint pain - mostly knees - started 10/8/18 - Headache - started 10/6/18.
Age: 70.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Chills, Injected limb mobility decreased, Loss of consciousness, Pyrexia
Clinical narrative: On 9/10/2018 I received two shots at pharmacy. FLUAD Syringe and PNEUMOVAX-23 Syringe, and had chills and fever and passed out while driving and I had 5 MI and By-Pass 1992, 3 MI and stent in 2003 I could not lift left arm where shots were, for 4 days.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: 3 1/2" x 4 1/2" area of redness, hot to the touch, slight swelling and pt. report itchiness.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On right arm: area below where PNEUMOVAX 23 (deltoid IM) 5 1/2 inches height x 5 1/2 width redness, swelling, lot of pain to pt. Can't raise up arm all the way and hot to touch starting at 2 PM and got worse overnight. She has not slept a bit; hurt all night and all day and has not let up. Has taken APAP with no relief of pain. Review w/pt. that if the onset on hives, swelling of lips, closing of throat to seek medical attention. 9/30/18 at 3:35 PM - pt's daughter called back saying that the area had spread to her elbow. We informed her that in adult patient they were at increased risk of injection site redness, muscle pain, limitation of arm movement, and injection site swelling. Day 2 spread to elbow told patient to contact Dr. if symptoms worsen after 3 days, or if symptoms last longer than 7 days. After review complete patient management of local reaction.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Local reaction
Clinical narrative: On right arm: area below where PNEUMOVAX 23 (deltoid IM) 5 1/2 inches height x 5 1/2 width redness, swelling, lot of pain to pt. Can't raise up arm all the way and hot to touch starting at 2 PM and got worse overnight. She has not slept a bit; hurt all night and all day and has not let up. Has taken APAP with no relief of pain. Review w/pt. that if the onset on hives, swelling of lips, closing of throat to seek medical attention. 9/30/18 at 3:35 PM - pt's daughter called back saying that the area had spread to her elbow. We informed her that in adult patient they were at increased risk of injection site redness, muscle pain, limitation of arm movement, and injection site swelling. Day 2 spread to elbow told patient to contact Dr. if symptoms worsen after 3 days, or if symptoms last longer than 7 days. After review complete patient management of local reaction.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Malaise, Pyrexia
Clinical narrative: Complained of feeling sick, high fever and problems with equilibrium.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Pt. received PPSV23 on 10/1/18 - 24 hours after began redness, swelling of lymph nodes. Red streaks began in the axilla to the (L) breast. Fatigue and low fever also present. Pt. went to ED.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Dyskinesia, Fatigue, Headache, Seizure, Somnolence
Clinical narrative: Patient received a Hep A (dose#2) vaccine on 10/01/18. At 12 midnight 10/02/18 his parents awakened to him 'having convulsions". This involved jerking of the upper extremities and leg movement. He also had drowsiness x 20 min. Through the next day he was fatigued. There was headache, which resolved by 10/02/18.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Eye disorder, Palpitations, Pyrexia
Clinical narrative: Heart racing (4 hours on and off evening of), eyes bugging feeling, fever. All resolved 24 hours.
Age: 46.0
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Hypoaesthesia, Jaw disorder, Limb discomfort, Palpitations
Clinical narrative: Pt states had numbness on left side, (left arm, left side of face), dizziness. Left jaw also affected. Pt feels discomfort from left arm to fingers. Pt said symptoms started 15 minutes after flu shot. Pt states was having heart palpitations. Pt called around 6 pm and stated going to ER. Pharmacist called answering service for primary care Dr. Dr was not on call. Answering service stated they would leave message for office and nurse practitioner on call.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Patient seen today 09/26/2018 for allergic reaction (hives all over body) to FLUBLOK given 09/24/2018 started medication today.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphonia, Ear congestion, Fatigue, Pain, Pain in extremity
Clinical narrative: Aches, fatigue, hoarseness, congested ears results in treated w/prednisone urgent care. Soreness left arm.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Blood test normal, Chest X-ray, Dizziness, Erythema, Injection site reaction
Clinical narrative: Swelling, redness, dizziness, nausea. Main reaction at PNEUMOVAX site.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Nausea, Swelling
Clinical narrative: Swelling, redness, dizziness, nausea. Main reaction at PNEUMOVAX site.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Redness, swelling, light bruising.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Erythema, Swelling
Clinical narrative: Severe redness upper arm, swelling. Now, back pain (left side).
Age: 32.0
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased
Clinical narrative: Flu shot and not being able to lift arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Allergy test, Blood immunoglobulin A, Differential white blood cell count, Ear swelling, Full blood count
Clinical narrative: 09/18/18 received vaccines MMR, VZV, KINRIX. 09/19/18 patient returned with complains of bil. swelling ears and rash over body, BENADRYL started. 09/21/18 patient presented to emergency room with persistent hives and swelling of lips and tongue. EPI given which failed to resolve. Patient admitted to hospital. 09/23/18 discharged home on prednisone and BENADRYL. 09/28/18 seen for hospital follow up and referred to allergy immunology.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Immune complex assay, Lip swelling, Radioallergosorbent test, Rash generalised, Swollen tongue
Clinical narrative: 09/18/18 received vaccines MMR, VZV, KINRIX. 09/19/18 patient returned with complains of bil. swelling ears and rash over body, BENADRYL started. 09/21/18 patient presented to emergency room with persistent hives and swelling of lips and tongue. EPI given which failed to resolve. Patient admitted to hospital. 09/23/18 discharged home on prednisone and BENADRYL. 09/28/18 seen for hospital follow up and referred to allergy immunology.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urine analysis, Urticaria
Clinical narrative: 09/18/18 received vaccines MMR, VZV, KINRIX. 09/19/18 patient returned with complains of bil. swelling ears and rash over body, BENADRYL started. 09/21/18 patient presented to emergency room with persistent hives and swelling of lips and tongue. EPI given which failed to resolve. Patient admitted to hospital. 09/23/18 discharged home on prednisone and BENADRYL. 09/28/18 seen for hospital follow up and referred to allergy immunology.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity, Pain, Swelling
Clinical narrative: Pain, swelling, sensitivity.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Pt returned to clinic on 10/5/2018: Pt reports initially had site swelling and redness; report redness did subside but has noticed increased left upper arm swelling primarily to left AC fossa; no pains to left arm; injection site was without any inflammation or redness.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Patients Dr called pharmacy to report that the pt. has cellulitis at the injection site where the PREVNAR 13 vaccine was administered. Dr. ordered ABx for the patient.
Age: 81.0
Sex: M
Vaccine: FLUA3
Symptoms: Hemiplegia, Pain in extremity
Clinical narrative: Patient reported feeling dizzy and had pain in left arm and leaving his left side paralyzed. He also reported that he talked with his doctor and seeing if it was due to a stroke to rule it out.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Patient was diagnosed with shingles on 10-6-18. Symptoms were rash with blisters on back and right buttocks and groin. Treatment was to continue betamethasone cream and start Valacyclovir 1 gram tid.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: Patient was given vaccine by an extern student. Parent did no call to report any symptoms or complications after vaccination.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported arm swelled and hurt and having typical flu symptoms, went to ER.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: All over body aches - severe, fever over 100 degrees F, uncontrollable chills initially (approximately 8hrs after shot), then chills - all symptoms last about 24 hrs. - 36 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Macule, Pyrexia
Clinical narrative: She developed a scattering of 2-3 mm raised, red macules on her arms, approximately 12, and popliteal area/approximately 10. Patient seen on 10/5/18 for fever (102 degrees) and redness at injection site.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Patient called pharmacy 10-8-18 to complain that arm (right) was still hurting after flu shot. Patient stated that arm was sore immediately after shot and discomfort has continued to increase. Currently patient states that lifting arm over head is painful. Advised patient to contact MD for additional pain relief instead of over the counter remedies.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Patient bled after injection and had a hard bump at the injection site that was almost the color of a bruise. This happened almost immediately (1-2 min) after injection. Advised pt. to go to urgent care.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: Symptoms started 13 hrs after shot-felt like throwing up for about 2 hrs had very severe body aches all over-which lasted 12 hours.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Limb injury, Pain in extremity, Tremor, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable consumer (daughter who reported for her mother) and a contactable physician. A 89-year-old female patient received PREVNAR 13 (lot # L35183, expiration date 17Sep2016) intramuscular, in right deltoid, on 23Jun2015 at 17:37, at 0.5 ml single dose, for immunisation. Medical history included ongoing chronic rotator cuff tear, ongoing chronic DJD cervical spine, arthritis, hearing impaired and visual impairment. Concomitant medication included PRINIVIL, ATROVENT and NASACORT. On 24Jun2015 at 04:00 the patient experienced her arm was hurting very badly from her shoulder all the way down to her hand, tremor/pretty constant shaking in the arm and site hurt constantly. These events required a physician visit but the patient was not hospitalized. The patient received treatment for these events with MOTRIN. On an unspecified date she was diagnosed with shoulder injury related to vaccine administration (SIRVA). The outcome of SIRVA was unknown, while the other events outcome was reported as not yet resolved. Follow-up (19Oct2015): Additional information received from a contactable physician includes, Batch/Lot # and expiration date of vaccine, route, anatomical location of the administration of the vaccine. Follow-up attempts completed. No further information expected. Follow-up (28Sep2018): New information from a contactable consumer includes: additional event (SIRVA).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Pain in extremity, Pruritus generalised, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. On 6th July 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, loss of energy, fever and pruritus. On an unknown date, the outcome of the injection site pain, loss of energy, fever and pruritus were recovered/resolved. It was unknown if the reporter considered the injection site pain, loss of energy, fever and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient received SHINGRIX and felt pain to the injection site, lack of energy, fever and itching for 3 days.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Injection site pain, Pruritus, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. On 6th July 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, loss of energy, fever and pruritus. On an unknown date, the outcome of the injection site pain, loss of energy, fever and pruritus were recovered/resolved. It was unknown if the reporter considered the injection site pain, loss of energy, fever and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient received SHINGRIX and felt pain to the injection site, lack of energy, fever and itching for 3 days.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via other and described the occurrence of pain in arm in a adult patient who received SHINGRIX (batch number Y24KE, expiry date unknown) for prophylaxis. On 18th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. In 2018, after vaccination with SHINGRIX the patient sustained left arm pain and it was lasted for couple of weeks.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Discomfort, Injection site erythema, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received HAVRIX for prophylaxis. On 22nd August 2018, the patient received HAVRIX. On 22nd August 2018, less than a day after receiving HAVRIX, the patient experienced injection site swelling, injection site erythema and fever. On an unknown date, the outcome of the injection site swelling, injection site erythema and fever were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and fever to be related to HAVRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient received HAVRIX on the right arm. On the same day in the evening, the patient started feeling some swelling and redness to her arm near vaccination sight, later on then it began to spread to the later part of her arm and she felt like she had fever. The patient sought the medical treatment.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received HAVRIX for prophylaxis. On 22nd August 2018, the patient received HAVRIX. On 22nd August 2018, less than a day after receiving HAVRIX, the patient experienced injection site swelling, injection site erythema and fever. On an unknown date, the outcome of the injection site swelling, injection site erythema and fever were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and fever to be related to HAVRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient received HAVRIX on the right arm. On the same day in the evening, the patient started feeling some swelling and redness to her arm near vaccination sight, later on then it began to spread to the later part of her arm and she felt like she had fever. The patient sought the medical treatment.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, FLUC4, PPV
Symptoms: Rash, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57-year-old non-pregnant female patient. The patient had no known pertinent medical history, concomitant medication, drug reaction and allergies. On 25-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N030849, expiration date 09-JUN-2019 (route and dose were not provided) for routine vaccination. On 25-SEP-2018 (reported as at the same time), the patient was vaccinated with FLUCELVAX (dose, lot number, route, indication and expiration date were not provided). On 27-SEP-2018, the patient experienced rash on the back side of an unspecified arm which migrated down the elbow. The patient received treatment for the event of rash and sought medical attention. No laboratory diagnostics or studies were performed due to the event. The outcome of the rash and relatedness between the event rash and the PNEUMOVAX23 and FLUCELVAX were not provided. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1810USA001533.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, FLUC4, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57-year-old non-pregnant female patient. The patient had no known pertinent medical history, concomitant medication, drug reaction and allergies. On 25-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N030849, expiration date 09-JUN-2019 (route and dose were not provided) for routine vaccination. On 25-SEP-2018 (reported as at the same time), the patient was vaccinated with FLUCELVAX (dose, lot number, route, indication and expiration date were not provided). On 27-SEP-2018, the patient experienced rash on the back side of an unspecified arm which migrated down the elbow. The patient received treatment for the event of rash and sought medical attention. No laboratory diagnostics or studies were performed due to the event. The outcome of the rash and relatedness between the event rash and the PNEUMOVAX23 and FLUCELVAX were not provided. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1810USA001533.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Influenza like illness, Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 11 hrs 30 min after receiving SHINGRIX, the patient experienced fever. On 25th September 2018, the patient experienced injection site pain, pain and stiffness. On 26th September 2018, the patient experienced upset stomach and headache. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain, fever, upset stomach, pain and stiffness were not recovered/not resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the injection site pain, fever, upset stomach, pain, stiffness and headache to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Less than a day after receiving vaccination, the patient reported soreness at the injection site (on same day of vaccination). Two and half to three hours following the vaccination, the patient felt achy and stiff. On 26th September 2018, at four am the patient woke with a fever of 102 degree F. The patient took TYLENOL and the fever was 101 degree F an hour later. One day after receiving vaccination at morning the patient experienced headache and upset stomach. The fever measured 99 degree F on the date of reporting. The injection site pain was better but was not resolved. This case was linked to the case US2018177049, reported by the same reporter. .
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 11 hrs 30 min after receiving SHINGRIX, the patient experienced fever. On 25th September 2018, the patient experienced injection site pain, pain and stiffness. On 26th September 2018, the patient experienced upset stomach and headache. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain, fever, upset stomach, pain and stiffness were not recovered/not resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the injection site pain, fever, upset stomach, pain, stiffness and headache to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Less than a day after receiving vaccination, the patient reported soreness at the injection site (on same day of vaccination). Two and half to three hours following the vaccination, the patient felt achy and stiff. On 26th September 2018, at four am the patient woke with a fever of 102 degree F. The patient took TYLENOL and the fever was 101 degree F an hour later. One day after receiving vaccination at morning the patient experienced headache and upset stomach. The fever measured 99 degree F on the date of reporting. The injection site pain was better but was not resolved. This case was linked to the case US2018177049, reported by the same reporter. .
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 11 hrs 30 min after receiving SHINGRIX, the patient experienced fever. On 25th September 2018, the patient experienced injection site pain, pain and stiffness. On 26th September 2018, the patient experienced upset stomach and headache. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain, fever, upset stomach, pain and stiffness were not recovered/not resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the injection site pain, fever, upset stomach, pain, stiffness and headache to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Less than a day after receiving vaccination, the patient reported soreness at the injection site (on same day of vaccination). Two and half to three hours following the vaccination, the patient felt achy and stiff. On 26th September 2018, at four am the patient woke with a fever of 102 degree F. The patient took TYLENOL and the fever was 101 degree F an hour later. One day after receiving vaccination at morning the patient experienced headache and upset stomach. The fever measured 99 degree F on the date of reporting. The injection site pain was better but was not resolved. This case was linked to the case US2018177049, reported by the same reporter. .