chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm started to swell and was very sore.  4 days later arm still hurts. Swelling is down but arm is red and hot to the touch.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Antibody test positive, Body temperature increased, Culture urine negative, Febrile convulsion, Motor dysfunction
Clinical narrative: Febrile seizure, 104f temp, 26.2 WBC, admitted with possible UTI, Later found out to be pneumonia from titers through immunologist. Kidney xrays were normal. She also lost some motor functions.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pneumonia, Ultrasound kidney normal, Urinary system X-ray, White blood cell count increased, X-ray normal
Clinical narrative: Febrile seizure, 104f temp, 26.2 WBC, admitted with possible UTI, Later found out to be pneumonia from titers through immunologist. Kidney xrays were normal. She also lost some motor functions.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received the first shot of PREVNAR 13 intramuscular at 0.5ml, single in arm on 06Oct2016 for  immunization. The patient medical history was not reported. Concomitant medication included ongoing FLAXSEED OIL, ongoing NATURE THROID, ongoing DIGESTIVE ENZYME, PROBIOTICS.  The patient previously took PNEUMOVAX 23 (indicated as Pneumonia 23).  On 06Oct2016 the patient experienced over the arm where she got it (injection) was little sore/ hurt/ with outcome of unknown, tightness at injection site with outcome of recovering, extremely red at the injection site with outcome of unknown, swollen, inflamed and hot to the touch at the injection site with outcome of unknown, swollen, inflamed and hot to the touch at the injection site with outcome of unknown, it was like a sort of a big oval circle of red swelling from her elbow area that goes almost completely up to her armpit area with outcome of unknown. The patient experienced itching at injection site on an unspecified date with outcome of unknown. Treatment: she has tried to put Anti-itch spray on it to see if she could stop the itching initially and that did nothing and she have tried two or three different kind of Anti-itch sprays in the beginning and nothing helped there so anything that she have tried (Intent: for itching) was meaningless. Clinical course: She had really good health but initially over the arm where she got it (injection) was little sore and then in about a week and a half or so she ended up where the muscle area (injection site) felt like it had like a tightness and that (tightness) kind of diminished but in the last few days it was like the whole upper part of the arm again where the shot was given was extremely red, swollen and it was like inflamed and it was hot to the touch and it was like a sort of a big oval circle of red swelling from her elbow area that goes almost completely up to her armpit area and it seemed really odd, she meant that it had been a little bit over a month and they seemed to just be something going on continuing about the shot and she wanted to check in some information about that. She confirmed that right away injection site was red and tight and they started to seem to subside and then in about a week and a half it was like at the injection site, it was like a muscle area itself became a kind of tight, the fibers became a kind of tight and it ached and that was for about 3 to 4 days and ache subsided out and now in the last three days or so it was like a renewed whole red or intense red, felt hot, itches, hurt and feels inflamed and swollen when touched, she meant that she was not running a temperature but at touch the whole arm it feels like, her husband touched the area and it was really hot to the touch when compared to the other arm for example this arm where the injection happened was like extremely swollen.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received the first shot of PREVNAR 13 intramuscular at 0.5ml, single in arm on 06Oct2016 for  immunization. The patient medical history was not reported. Concomitant medication included ongoing FLAXSEED OIL, ongoing NATURE THROID, ongoing DIGESTIVE ENZYME, PROBIOTICS.  The patient previously took PNEUMOVAX 23 (indicated as Pneumonia 23).  On 06Oct2016 the patient experienced over the arm where she got it (injection) was little sore/ hurt/ with outcome of unknown, tightness at injection site with outcome of recovering, extremely red at the injection site with outcome of unknown, swollen, inflamed and hot to the touch at the injection site with outcome of unknown, swollen, inflamed and hot to the touch at the injection site with outcome of unknown, it was like a sort of a big oval circle of red swelling from her elbow area that goes almost completely up to her armpit area with outcome of unknown. The patient experienced itching at injection site on an unspecified date with outcome of unknown. Treatment: she has tried to put Anti-itch spray on it to see if she could stop the itching initially and that did nothing and she have tried two or three different kind of Anti-itch sprays in the beginning and nothing helped there so anything that she have tried (Intent: for itching) was meaningless. Clinical course: She had really good health but initially over the arm where she got it (injection) was little sore and then in about a week and a half or so she ended up where the muscle area (injection site) felt like it had like a tightness and that (tightness) kind of diminished but in the last few days it was like the whole upper part of the arm again where the shot was given was extremely red, swollen and it was like inflamed and it was hot to the touch and it was like a sort of a big oval circle of red swelling from her elbow area that goes almost completely up to her armpit area and it seemed really odd, she meant that it had been a little bit over a month and they seemed to just be something going on continuing about the shot and she wanted to check in some information about that. She confirmed that right away injection site was red and tight and they started to seem to subside and then in about a week and a half it was like at the injection site, it was like a muscle area itself became a kind of tight, the fibers became a kind of tight and it ached and that was for about 3 to 4 days and ache subsided out and now in the last three days or so it was like a renewed whole red or intense red, felt hot, itches, hurt and feels inflamed and swollen when touched, she meant that she was not running a temperature but at touch the whole arm it feels like, her husband touched the area and it was really hot to the touch when compared to the other arm for example this arm where the injection happened was like extremely swollen.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site oedema, Injection site rash, Injection site vesicles
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 65-year-old patient of an unspecified race and gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced like a huge circular rash around the injection site/ a big rash and blisters at the injection site, in the middle of the rash, it may be boil or inflated balloon, more like a edema, more kind of like blister type. The outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for the mother-in-law. A 67-year-old female patient received a single dose of PREVNAR 13 and a dose of influenza vaccine in Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. In Nov2016 she had an injection site reaction with initially limited arm movement and then progressed to becoming swollen and red. She has since taken ADVIL for the swelling and pain as well as applied an ice pack to the injection site. The final outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported for two patients. This is the first of the two patients. An elderly patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm (not further specified) on an unknown date at 0.5ml single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced significant swelling in the arm from injection site in the upper deltoid down toward the elbow. Laboratory data was not reported. The clinical outcome of the event, significant swelling in the arm from injection site in the upper deltoid down toward the elbow, was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016526435 same reporter/ drug/ AE, different patient.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of an unspecified age and race received pneumococcal PREVNAR 13 at 0.5 ml single and FLU VACCINE, both via an unspecified route of administration, on an unspecified date, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Since an unknown date the patient developed a reaction as it looked like larger than normal rash, swelling and pain at the site of injection. Events outcome was unknown.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Eyelid oedema, Headache, Malaise
Clinical narrative: My son first reported a headache at 5 PM and gave him 200MG of MOTRIN and he kept saying he didn't feel well. The MOTRIN did not help his headache. At 7pm, his eyes started looking puffy so we gave him 25mg of BENADRYL. At 7:15 his eyes swelled shut and his face was swollen, he said it was difficult to breathe and his chest hurt. We gave him an albuterol nebulizer and took him to the ER at 7:30 pm. Between 7:30 and 7:45 his facial swelling started to go down and his breathing became easier. He complained of chest pain for approximately 2 hours. While at the ER, he was given a double dose of steroids and the swelling came down to about 25% and we were discharged with instructions to continue BENADRYL every 6 hours for swelling, nebulizers for breathing difficulty and continue steroids at home.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: My son first reported a headache at 5 PM and gave him 200MG of MOTRIN and he kept saying he didn't feel well. The MOTRIN did not help his headache. At 7pm, his eyes started looking puffy so we gave him 25mg of BENADRYL. At 7:15 his eyes swelled shut and his face was swollen, he said it was difficult to breathe and his chest hurt. We gave him an albuterol nebulizer and took him to the ER at 7:30 pm. Between 7:30 and 7:45 his facial swelling started to go down and his breathing became easier. He complained of chest pain for approximately 2 hours. While at the ER, he was given a double dose of steroids and the swelling came down to about 25% and we were discharged with instructions to continue BENADRYL every 6 hours for swelling, nebulizers for breathing difficulty and continue steroids at home.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the site of injection.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, WARM TO THE TOUCH; PATIENT USED COLD PACK AND HELPED REDUCE SWELLING.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Wheezing
Clinical narrative: EXTREME SWELLING AND WHEEZING.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Musculoskeletal stiffness
Clinical narrative: Stiffness in left arm (injection arm) lasting for 3 days. Large bruising in left arm (injection arm) lasting from 10/22/16 to 11/12/16. Both of these were fully resolved on 11/15/16 when patient reported to pharmacy.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Swollen and puffy eyes.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Day 3 after receiving vaccine, patient reports red, swollen arm. Redness extended about 3-4 inches and oval in shape. Area was warm to the touch. Patient reported some itching as well. No pain per patient.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: After getting his flu shot, he is still experiencing a sore arm - he has full freedom of movement - it only hurts at a specific point when he raises his arm - not up high or when relaxed - only on raising at one point.
Age: 36.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Rash
Clinical narrative: Day after vaccines given, patient developed a rash from her bottom rib cage to her ankles.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nasal congestion, Pain, Seasonal allergy, Somnolence
Clinical narrative: A day or two after symptoms started sore muscle at injection site, chronic stuffiness in nose similar to seasonal allergy. Patient complains of being achy and groggy. Continued through today 11/15/16.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling hot, Hypoacusis
Clinical narrative: In the few minutes (15 mins) following the administration FLUCELVAX vaccine, the patient complained of feeling warm then hearing diminished, felt light headed. Had patient lay down, given fluids and rest. Nurse practitioner at clinic examined her. BP fine/pt fine.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Patient informed pharmacy a few days after her shot (FLUARIX) that her lips swelled after the shot. She took BENADRYL and was better.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: (L) deltoid injection site swelling/erythema, warmth. Erythema from (L) deltoid traveling down lateral aspect at elbow, (+) fatigue, (+) pruritus. TX: Doxycycline 100 mg po bid x 10 d.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Tremor, Vomiting
Clinical narrative: Severe chills. Very bad shaking. Vomiting. Received flu shot at 7:00 p.m. Woke up at 2:00 a.m. with chills and vomited. Vomited 2 more times within 10 minutes, still experiencing severe chills. All symptoms seem to pass after 1 hour.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Syncope, sweats, no other complaint. Patient kept awake, alert, given water, vitals taken. Pt became hypotensive from initial vitals - O2 given. BS 90 check. 911 called. Pt transfer to hospital.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Raised circle around injection site with a rash.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, swollen arm at site where pneumonia vaccine given.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Red rash, left arm, itchy morning after shot. Pt took ALLEGRA as usual.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth. Pt went to quick care/prescribed corticosteroids 10/30/16 phone conversation.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Rash, Swollen tongue
Clinical narrative: Patient received the flu shot (FLUVIRIN) around 6:40pm within 10 minutes she developed a rash on her chest. She then took 25 mg of oral BENADRYL. One minute later she stated that her tongue was feeling fat and starting to swell. She sat next to the Pharmacist with an EPIPEN ready in case needed. After sitting for 10 minutes, the rash started to fade. Her husband then came to pick her up and take her to emergency room.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Grip strength decreased, Muscular weakness
Clinical narrative: Patient in office today, received Prevnar-13 and high dose influenza vaccines. He went home and took a nap.  Woke up and at dinner could not grasp a utensil or feed himself. It is bilateral hands. This hand weakness persists at 18 hours later.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Chest discomfort, Cough, Dyspnoea, Speech disorder
Clinical narrative: At approx 1300-scratchy throat and cough. 2130-SOB, tight chest, cough. 2145-severe SOB, unable to talk due to SOB, severe coughing. 2200-arrived at ED, treated with Albuterol and nebulizer, Benadryl IV, Pepcid IV, Solumedrol IV.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: At approx 1300-scratchy throat and cough. 2130-SOB, tight chest, cough. 2145-severe SOB, unable to talk due to SOB, severe coughing. 2200-arrived at ED, treated with Albuterol and nebulizer, Benadryl IV, Pepcid IV, Solumedrol IV.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient states she broke out and her arm got swollen after getting 2 shots in her left arm few inches apart. She has had FLUZONE HD before (year ago).
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Patient developed rash starting on legs and spreading to armpits and neck. He rarely gets headaches and complained of a headache lasting a few days in the past week. The last 3 days his eyes hurt. Patient saw Dr. today and he suggested diphenhydramine 25mg four times a day.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Seizure
Clinical narrative: One day after vaccines my son experience a Seizure, that was not acknowledge by hospital because the time we got to hospital it was over. He got the 2nd one 3 weeks later.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: I started with Shingles symptoms at this time.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes virus infection
Clinical narrative: HSV2 Outbreak.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Contusion, Dysgeusia, Dyspnoea, Erythema
Clinical narrative: Received shot on 10/19/16. That following Monday, patient's arm was red, hot, burning, itchy and swollen. She also experienced high blood pressure, body aches, difficulty breathing, and high fever. Metallic taste and throat tightness also occurred. Arm remained an itchy bruise one week later.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Hypertension, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Received shot on 10/19/16. That following Monday, patient's arm was red, hot, burning, itchy and swollen. She also experienced high blood pressure, body aches, difficulty breathing, and high fever. Metallic taste and throat tightness also occurred. Arm remained an itchy bruise one week later.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Throat tightness
Clinical narrative: Received shot on 10/19/16. That following Monday, patient's arm was red, hot, burning, itchy and swollen. She also experienced high blood pressure, body aches, difficulty breathing, and high fever. Metallic taste and throat tightness also occurred. Arm remained an itchy bruise one week later.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Lt shoulder pain that became progressively worse leading to impaired range of motion.  Patient has been treated with NSAIDS, Medrol dose pack, and physical therapy and continues to have symptoms; still currently treating.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on arms & torso is still persisting a week later.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Pruritus generalised
Clinical narrative: Arm swollen and hurt. States has problems with it hurting ever since went to MD and was prescribed topical steroids. He itched all over.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: Within a few hours of getting the vaccine I developed a sore throat which became severe overnight. This morphed into a strong upper respiratory infection which ravaged my whole respiratory system. Took OTC ROBITUSSIN and gargled with apple cider vinegar. It gradually dwindled down over 5-6 weeks.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pruritus
Clinical narrative: Patient experienced dizziness, nausea, itching. BENADRYL was given. Itching and nausea had improved by the following day.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Fainting, dizziness, weakness. 4 am and 9 am next morning. (Vaccine admin at 6:00 pm the night before).
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pruritus, Rash, Rash erythematous
Clinical narrative: Rash on right mid-back, 3" diameter, round, itching - just above waistline, red-spots inside. Red eyes.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest discomfort, Chills, Cough, Decreased appetite, Discomfort
Clinical narrative: Chills, fever 101, dry cough, upper back pressure, vomiting, no appetite, chest tightness.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills, fever 101, dry cough, upper back pressure, vomiting, no appetite, chest tightness.
Sex: F
Vaccine: MENB
Symptoms: Abasia, Activities of daily living impaired, Hypoaesthesia, Migraine, Paraesthesia
Clinical narrative: This is a spontaneous report from a non-contactable nurse via a Pfizer sales representative. A female patient of an unspecified age and race received TRUMENBA on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was a high school senior going to school with the reporter's daughter. She was a very active student playing soccer and horse-back riding. After vaccination, she claimed she was unable to walk for several weeks due to the numbness and tingling in her legs. She also experienced migraine headache (started 7 hours after vaccination), tingling in arms and legs with some numbness in her legs. She was better at the time of report, walking and returning to school. Outcome of migraine headache was unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Muscle rigidity, Seizure like phenomena
Clinical narrative: This is a spontaneous report from a contactable nurse. A female patient of unknown age and race/ethnicity received first dose of TRUMENBA at single dose on an unknown date. Medical history and concomitant medications were not reported. After vaccination, on an unknown date, the patient became very rigid, almost like they were having a seizure (not just like a regular syncopal episode). The patient was not going to receive the second dose. The patient was currently in clinic. Her mother would like to know how effective it is going to be with her just getting the one dose of meningococcal group b rlp2086. Outcome was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 63.0
Sex: F
Vaccine: FLUR3
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Heart rate decreased
Clinical narrative: Shortness of breath, chest tightness, elevated blood pressure, decreased HR, admitted through Emergency Dept.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Conjunctivitis, Discomfort, Eye irritation, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 59 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were unknown. On 11-OCT-2016, the patient was vaccinated with ZOSTAVAX, (dose, lot # and expiry date not reported), parenterally. On 12-OCT-2016 (reported as following day of administration), the patient developed eye irritation for an unspecified reason. The patient sought medical attention from an unspecified urgent care location and he was diagnosed with pink eye which was treated with an unspecified eye drops. On an unknown date in 2016, he was still experiencing discomfort, hence he sought medical attention from a physician and he was diagnosed with shingles. No laboratory tests were performed. At the time of this report, the patient was recovering from the events. Causality was not provided by the reporter. Product quality complaint was not involved. Upon internal review, Herpes zoster ophthalmic was determined to be medically significant. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine
Clinical narrative: Patient received flu shot in November and was allergic! She had to go to an urgent care for treatment.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pain, Rash, Swelling
Clinical narrative: Rash, Pain and Swelling. Patient went to Dr and was diagnosed with Cellulitis.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Received flu vaccination at 12:30PM. At home that evening, patient developed maculopapular rash bilaterally on wrists and the next morning woke up with rash bilaterally on arms. The rash continued to spread to torso and neck. No difficulty breathing. No swelling in throat or mouth.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm sore and swollen, itching, at and around injection site. Induration of about 6 - 10 cm diameter.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache, injection site pain and swelling, redness at injection site, myalgia, diarrhea.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia
Clinical narrative: Headache, injection site pain and swelling, redness at injection site, myalgia, diarrhea.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Pain and tenderness in left shoulder, hurts to make certain movements, saw onsite nurse on 10/24/16, took over the counter Naproxen on and off through 11/14/16. Saw family physician on 11/15/16. Was prescribed topical anti-inflammatory for 10 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Flushing, Muscle spasms, Pain
Clinical narrative: Severe lower back spasm with SOB due to pain and flushing of facial cheeks. Pt seen again by PCP then given Dexamethasone 4mg mixed with DEPO-MEDROL 40mg IM (advised it would spike glucose). Patient kept for observation and gave verbal that she was feeling ok after sitting up for 45 mins and had spouse drive her home.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Encephalitis post immunisation
Clinical narrative: Acute postvaccinal encephalitis.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Muscle atrophy, Pain
Clinical narrative: Very Painful for a week.  Redness in bicep muscle for a bit over a week.  Then the bicep shrank by 30-40% (still smaller) and tricep shrank by 50% and became very floppy and hangs down. I work out and have had very firm arm muscles. The one with the shot is now very flimsy - not firm at all - hangs down (muscle).  I'm very concerned about what it has done to my muscle(s).
Age: 53.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Pain
Clinical narrative: Cellulitis and pain.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Blood test, Confusional state, Eye movement disorder
Clinical narrative: Child became pale, head fell back, eyes went into blank stare and rolled back. Child reported he couldn't hear or see or speak. Child sat in chair for approx. 5 min with cold towels on his forehead, drank some water then with assistance was moved onto exam table to lie down. He laid for 5-7 min before color came back to face and lips, child began speaking more and reports he is feeling better. Mom reports child did not sleep well that night, had moments of being confused, hands drawing up and blank staring. Next day child went to school but had to be picked up early due to weakness, not feeling good, unable to walk without assistance. Mom took child to hospital. He was admitted from 11/10-11/14. Many tests were done including spinal tap. Mom reports this was considered a neurological side effect to the TDAP or HPV vaccine. It is recommended that those vaccines not be given again by neuro.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Gait disturbance, Hypoacusis, Laboratory test, Lumbar puncture
Clinical narrative: Child became pale, head fell back, eyes went into blank stare and rolled back. Child reported he couldn't hear or see or speak. Child sat in chair for approx. 5 min with cold towels on his forehead, drank some water then with assistance was moved onto exam table to lie down. He laid for 5-7 min before color came back to face and lips, child began speaking more and reports he is feeling better. Mom reports child did not sleep well that night, had moments of being confused, hands drawing up and blank staring. Next day child went to school but had to be picked up early due to weakness, not feeling good, unable to walk without assistance. Mom took child to hospital. He was admitted from 11/10-11/14. Many tests were done including spinal tap. Mom reports this was considered a neurological side effect to the TDAP or HPV vaccine. It is recommended that those vaccines not be given again by neuro.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Muscle contractions involuntary, Nervous system disorder, Pallor, Poor quality sleep, Posture abnormal
Clinical narrative: Child became pale, head fell back, eyes went into blank stare and rolled back. Child reported he couldn't hear or see or speak. Child sat in chair for approx. 5 min with cold towels on his forehead, drank some water then with assistance was moved onto exam table to lie down. He laid for 5-7 min before color came back to face and lips, child began speaking more and reports he is feeling better. Mom reports child did not sleep well that night, had moments of being confused, hands drawing up and blank staring. Next day child went to school but had to be picked up early due to weakness, not feeling good, unable to walk without assistance. Mom took child to hospital. He was admitted from 11/10-11/14. Many tests were done including spinal tap. Mom reports this was considered a neurological side effect to the TDAP or HPV vaccine. It is recommended that those vaccines not be given again by neuro.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Speech disorder, Staring, Visual impairment
Clinical narrative: Child became pale, head fell back, eyes went into blank stare and rolled back. Child reported he couldn't hear or see or speak. Child sat in chair for approx. 5 min with cold towels on his forehead, drank some water then with assistance was moved onto exam table to lie down. He laid for 5-7 min before color came back to face and lips, child began speaking more and reports he is feeling better. Mom reports child did not sleep well that night, had moments of being confused, hands drawing up and blank staring. Next day child went to school but had to be picked up early due to weakness, not feeling good, unable to walk without assistance. Mom took child to hospital. He was admitted from 11/10-11/14. Many tests were done including spinal tap. Mom reports this was considered a neurological side effect to the TDAP or HPV vaccine. It is recommended that those vaccines not be given again by neuro.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENT. FOR FILLED OUT AS PRECAUTIONARY MEASURE D/T LATEX ALLERGY.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Contusion, Disorientation, Face injury, Fall
Clinical narrative: Patient lost consciousness (passed out) after shot was administered. EMT were called and patient was assessed. Patient regained consciousness in less than one minute and was disoriented and flushed. Gave cold compress and water to drink. She did not to go to ER at the time, she felt she was ok. A friend picked her up as she was advised not to drive home. She was still feeling weak when she left. No additional treatment was given.  Patient did bruise her cheek and bit her lip when she passed out. Likely due to counter that was directly in front of her. Pharmacist caught her as she fell but she still had slight injury.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Lip injury, Loss of consciousness
Clinical narrative: Patient lost consciousness (passed out) after shot was administered. EMT were called and patient was assessed. Patient regained consciousness in less than one minute and was disoriented and flushed. Gave cold compress and water to drink. She did not to go to ER at the time, she felt she was ok. A friend picked her up as she was advised not to drive home. She was still feeling weak when she left. No additional treatment was given.  Patient did bruise her cheek and bit her lip when she passed out. Likely due to counter that was directly in front of her. Pharmacist caught her as she fell but she still had slight injury.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt got sore arm and had fever the next day.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Insomnia
Clinical narrative: Change in behavior, child unable to sleep through the night.  Crying for no obvious reasons.  4 days later and still waking up in the middle of the night, crying with no discernable cause.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient reports itching, swelling and redness in hands and feet, somewhat relieved by taking diphenhydramine every 4 hours.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Flushing, Hyperventilation, Paraesthesia
Clinical narrative: Two minutes post flu vaccination, patient stated she felt dizzy, flushed and had tingling in her arms. A red rash appeared on her face. Patient complained of tightening in her chest and throat. On-site nurses had her lie down. Coached her to slow down her breathing as she appeared to be hyperventilating. Vital signs were taken and monitored. 0.5 ml of epinephrine administered. 911 was called. After EMS arrived, Patient appeared to be in stable condition. Rash had dissipated and tightening was resolving. This writer contacted patient on 11/15/16 to follow-up. Patient reported that she was transported to ER where they administered a steroid and monitored her for a few hours. She was discharged to home with steroids to take for the next 2 days.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Throat tightness
Clinical narrative: Two minutes post flu vaccination, patient stated she felt dizzy, flushed and had tingling in her arms. A red rash appeared on her face. Patient complained of tightening in her chest and throat. On-site nurses had her lie down. Coached her to slow down her breathing as she appeared to be hyperventilating. Vital signs were taken and monitored. 0.5 ml of epinephrine administered. 911 was called. After EMS arrived, Patient appeared to be in stable condition. Rash had dissipated and tightening was resolving. This writer contacted patient on 11/15/16 to follow-up. Patient reported that she was transported to ER where they administered a steroid and monitored her for a few hours. She was discharged to home with steroids to take for the next 2 days.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Injection site hypoaesthesia, Muscle twitching, Presyncope
Clinical narrative: Numbness down left arm into left hand then up into left neck and left side of face. One week after vaccine admin progressive generalized weakness and presyncope with tremors and muscle twitching requiring hospitalization.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Numbness down left arm into left hand then up into left neck and left side of face. One week after vaccine admin progressive generalized weakness and presyncope with tremors and muscle twitching requiring hospitalization.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Tenderness
Clinical narrative: About 4-5 hours following the injection started to feel aching at injection site and including entire upper arm. Still concerns regarding tenderness at this date.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Local reaction
Clinical narrative: Nausea, aches, fatigue, chills, night sweats, then on 11/15/2016, localized reaction: redness and swelling (5" diameter) hot.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Nausea, Night sweats, Pain, Swelling
Clinical narrative: Nausea, aches, fatigue, chills, night sweats, then on 11/15/2016, localized reaction: redness and swelling (5" diameter) hot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Patient experienced significant swelling around injection site. Saw MD on 11/15/16 and was treated for cellulitis MD believed related to vaccine administration.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Paraesthesia, Tremor
Clinical narrative: Patient said she had tingling in her hands and was cold and shaky. She was very concerned so she went to ER but was not seen and then scheduled an appt at urgent care for approx 430pm.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Nausea, Pain, Paraesthesia oral
Clinical narrative: Onset with extreme muscle weakness, later extreme achiness.  At first just upper body symptoms then eventually his whole body. His mouth started tingling and he had extreme nausea.  Finally went to ER about 2pm. Patient says he suffered for about 2 hours before finally going to the ER.
Age: 0.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Noticed a raised rash on leg and buttock of injection site then spread to other leg. Went to ED and they gave him Benadryl hives started to disappear and then were back in the morning on the legs and arms.
Age: 27.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Axillary vein thrombosis, Subclavian vein thrombosis, Ultrasound abdomen
Clinical narrative: Came in to see MD on 10/7/2016 for edema to left arm from shoulder to fingers. Recent Left ACL tear from playing soccer with use of crutches. Nexplanon implant in Left arm. Ibuprofen used following vaccines.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash in Right Deltoid Area.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Asthma, Crying, Eczema, Hypersensitivity, Irritability
Clinical narrative: Son was extremely fussy and ended up having extended high pitched crying episodes starting that night and lasting for two weeks.  Within 3 days, he had developed eczema (with no dietary or environmental triggers), which spread over his whole body.  He went from a happy, easy-going baby to a very fussy unhappy baby overnight.  He continues to show signs of asthma and allergies.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient's upper arm near vaccination was red, swollen, and hot.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Cough, Night sweats, Peripheral swelling, Productive cough
Clinical narrative: She stated it was almost 24 hours "to the minute" from when she got the flu shot.  She had swelling in her arm, joint pain, night sweat, she is now coughing and feels phlegm in her lungs.  She has not seen her primary care physician.
Age: 54.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Eye swelling
Clinical narrative: PT DESCRIBED HER EYE SWELLING "IT LOOK LIKE SHE GOT HIT IN THE EYE".
Age: 54.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Eyelid exfoliation, Eyelid oedema, Skin discolouration
Clinical narrative: PT DESCRIBED HER EYE SWELLING "IT LOOK LIKE SHE GOT HIT IN THE EYE".
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Fatigue, Headache, Muscular weakness
Clinical narrative: Had flu shot in the morning and by afternoon was very tired. Went to bed and had chills, muscle aches and pains, severe headache, weakness, possible fever but felt too bad to check it. Symptoms improved over 2-3 days but kept coming back milder. After 9 days, started to feel much better. However, have continual periods of severe leg weakness and aches as well as headache. Did use Tylenol on day 2 which helped with the headache. Have had flu shots for over 30 years and this was the first time I had a reaction. Also was the first time I had the Fluzone.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Had flu shot in the morning and by afternoon was very tired. Went to bed and had chills, muscle aches and pains, severe headache, weakness, possible fever but felt too bad to check it. Symptoms improved over 2-3 days but kept coming back milder. After 9 days, started to feel much better. However, have continual periods of severe leg weakness and aches as well as headache. Did use Tylenol on day 2 which helped with the headache. Have had flu shots for over 30 years and this was the first time I had a reaction. Also was the first time I had the Fluzone.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: C-reactive protein increased, Mobility decreased, Red blood cell sedimentation rate increased, Speech disorder
Clinical narrative: Patient developed inability to speak or move. She already had underlying right sided hemiparesis from MS. Also found to have very high ESR/CRP in hospital that was not fully attributed to the UTI and no other cause found.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Condition aggravated, Fibromyalgia, Influenza like illness, Pain
Clinical narrative: PATIENT SAYS HER WHOLE BODY HURTS FEELS LIKE SHE HAS THE FLU AND FEELS LIKE HER FIBROMYALGIA IS FLARED UP.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Did not hurt at time of injection, but it got sore that evening.  It got better but not gone, around Nov 1, 2, 3 then severity of symptoms returned. It never hurt to touch the arm at injection site, it hurt inside. Now unable to sleep due to pain described as burning and aching.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient called pharmacy on 11-15-16 and stated she has received Fluvirin PF 2016-2017 0.5 ml IM Deltoid on 11-10-16. On 11-13-16, she notice bumpy rash under the breast. She has used hydrocortisone otc and it has been better.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around the area of injection.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Rotator cuff syndrome
Clinical narrative: Shoulder impingement diagnosed by regular doctor.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site.
Age: 11.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Incontinence, Neurological examination, Syncope
Clinical narrative: Fainting spell with incontinence.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Acne, Breast pain, Erythema, Musculoskeletal pain, Nipple pain
Clinical narrative: Pain in right shoulder blade and around to right breast and nipple.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Ultrasound biliary tract, Ultrasound scan normal
Clinical narrative: Pain in right shoulder blade and around to right breast and nipple.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Sore arm, swollen, red, hot injection site, headache, muscle aches.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Sore arm, swollen, red, hot injection site, headache, muscle aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Pain in extremity
Clinical narrative: Patient complaints include arm pain in left arm and a numb tongue with onset occurring during administration of vaccine in subcutaneous tissue left arm lower deltoid region. Sx resolved at 4:25 PM and patient was released. MD notified 4:22 PM 11/15/2016.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Exposure during pregnancy, Immediate post-injection reaction, Injection site pain, Peripheral coldness
Clinical narrative: Immediately after vaccination, the patient began complaining of pain and soreness at the injection site ("more than any other injections" she'd received).  She was advised to stay in the store for a few minutes.  This was her first flu shot.  About 15 to 20 minutes later, the patient came back to the pharmacy complaining of arm coldness and a feeling of the "circulation being cut off."  She also said her back was itching.  I took her blood pressure (133/81 with pulse 96).  This was most likely due to anxiety over getting the shot.  I told her it was probably okay to just wait and monitor the condition.  However, I also told her to possibly seek medical treatment as this was her first flu shot and she was pregnant.  That would maybe provide peace of mind.  There were no signs of anaphylaxis at any time I saw the patient.  The patient said she'd probably call her OB.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Immediately after vaccination, the patient began complaining of pain and soreness at the injection site ("more than any other injections" she'd received).  She was advised to stay in the store for a few minutes.  This was her first flu shot.  About 15 to 20 minutes later, the patient came back to the pharmacy complaining of arm coldness and a feeling of the "circulation being cut off."  She also said her back was itching.  I took her blood pressure (133/81 with pulse 96).  This was most likely due to anxiety over getting the shot.  I told her it was probably okay to just wait and monitor the condition.  However, I also told her to possibly seek medical treatment as this was her first flu shot and she was pregnant.  That would maybe provide peace of mind.  There were no signs of anaphylaxis at any time I saw the patient.  The patient said she'd probably call her OB.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Appendicectomy, Intestinal resection, Intussusception
Clinical narrative: Diagnosed with intussusception 10-16-16 S/P bowel resectioning and appendectomy.