chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: STATES THROAT SWELLED.  NO OTHER SYMPTOMS.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest X-ray, Pneumonia, Pyrexia
Clinical narrative: The fist symptom to appear was a fever ranging from 101 to 102 degrees F.  On 10/1/2016 the fever rose to 103.8 degrees F and the child was taken to the emergency room where pneumonia was diagnosed.
Age: 3.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Gave a pediatric flu instead of 36+ month Fluarix.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Three days after getting the vaccine had a fever, sore throat, and body aches, and it last for six days.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Musculoskeletal pain, Pain
Clinical narrative: Pt states that she experienced sharp throbbing pain that radiated up her shoulder increasing burns. Onset approx. 10-15 post vaccination which progressively worse within the hour.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme leg pain - aching; stabbing pain. Patient was afraid she had a blood clot. Chills, fever, achey body. Symptoms resolved within 48 hours. Patient did not seek treatment. She walked a lot.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash, went to ER for Prednisone 20 mg QD x5 days.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Tenderness, redness, swollen Left arm at injection site. Mild fever, lasted 5 days.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Erythema, Injection site induration, Musculoskeletal stiffness, Tenderness
Clinical narrative: 4 hours diarrhea and redness today, vaccinated yesterday. Feels stiff and firm approximately 2cm of induration on (R) deltoid. With axillary tenderness. Mild Rxn.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Sore throat (red) 9/28/16- evening, body aches 9/28/16- morning-day.
Age: 10.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, myalgias, fatigue - began evening of TDAP and flu shot administrations.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling encompassing right deltoid, pruritus, erythema- one day following vaccine administration. Treated with ZYRTEC.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site exfoliation, Injection site swelling
Clinical narrative: Patient reported large portion of upper right arm became red and swollen then a week or so later her arm began to peel over her upper arm. It looked like she had a sun burn that had peeled.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Rash
Clinical narrative: Diffuse rash. Provider suspect erythema multiformal.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted immediately after receiving the 4 vaccines.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Axillary pain, Impaired driving ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in left arm starting at site then spreading to shoulder and underarm. Unable to do everyday tasks or drive using arm.  Could not put arm up over head.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pyrexia, Swelling face
Clinical narrative: Fever, chills, muscle aches, facial swelling.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site rash
Clinical narrative: Rash around vaccine.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Pruritus, Throat tightness
Clinical narrative: Diffuse Itching, tightness in throat, anaphylaxis.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Dermatitis contact, Injection site reaction, Pharyngeal oedema, Throat irritation
Clinical narrative: Diffuse Itching, tightness in throat, anaphylaxis.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: My legs became itchy Friday morning and that eventually the itch spread to my arms and torso. By Friday evening I started developing hives. Saturday morning the hives were covering the majority of my body. I went to see a doctor and was given a prescription. Sunday I woke up even worse (severe itching, pain/sensitivity) so my doctor instructed me go to urgent care where I was given an IV. That helped to clear it up. Monday morning I woke up with hives starting to develop again. I took the medication that was prescribed and it helped calm it down. It is Monday morning at the time of this report.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Diarrhea, nausea, vomiting, fever.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Nasal congestion, Pruritus, Scleral hyperaemia
Clinical narrative: Itching, lips swelling, redness of sclera nasal congestion.  Epinephrine 1:1000, 0.5ml IM given in left deltoid.  911 called.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Site of injection became very itchy, burning, warm to touch and hard. Size was about 1 inch in diameter. These symptoms lasted about 4 days.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Severe tenderness/stiffness of arm in which injection was given with redness. Symptoms initially noted by patient later in day after receiving vaccine and progressed into the following day. Exact time of onset unknown. Pt went to physician- he told her to continue OTC NSAID and felt allergic reaction to pneumonia vaccine.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Dysgeusia, Loss of consciousness, Nausea, Presyncope, Tremor
Clinical narrative: Patient received vaccine. Proceeded downstairs to office. Became nauseated and got a bad metallic taste in mouth. Got up to get help then passed out, someone caught her. She shaked for a few seconds and broke out in hives. No loss bowel/bladder function, no postictal state likely vasovagal syncope.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Patient received vaccine. Proceeded downstairs to office. Became nauseated and got a bad metallic taste in mouth. Got up to get help then passed out, someone caught her. She shaked for a few seconds and broke out in hives. No loss bowel/bladder function, no postictal state likely vasovagal syncope.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness/swelling/red streaks/tenderness 24 hour post vaccine.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Rx- Prednisone, BENADRYL Total Body Hives - Pruritic, red, raised, Urticarial rash - arms, legs, trunk, abdom. (sparing face and palms and soles).
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: (L) upper arm pain increased overnight woke patient from sleep due to level of pain. Ice and Ibuprofen were given by parent. Pain continued for >48 hours, slowly resolved.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Redness at site of flu shot, some discomfort, no fever.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Blood pressure increased, Flushing, Heart rate increased
Clinical narrative: Some flushing on 9-23-16. Increased blood pressure 159/84 and high blood sugar (up to 700) and increased heart rate on 9-24-16. Went to ER at 5 pm on 9-24-16 and sent home at 12 midnight same day. Treated with IV insulin.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine injected into left deltoid. Pt developed red swollen rash on left bicep. By 9/29/16 swelling decrease, rash is tender to touch and red and warm about 6 inch by 6 inch size.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen, red, warm to touch. Required no treatment.
Age: 39.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Syncope
Clinical narrative: Client fainted after receiving vaccinations.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: Dizziness, body aches, chills, fever, loss of feeling in arm w/ injection, sweating, loss of appetite, a lot of pain and near death feelings!
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Dizziness, body aches, chills, fever, loss of feeling in arm w/ injection, sweating, loss of appetite, a lot of pain and near death feelings!
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Hypotension
Clinical narrative: After returning home from vaccination the patient began to feel weak and tired. He checked his blood pressure and it was 78/37 with Hr of 65.  The following day his blood pressure remained low (systolic under 100) but the patient reported feeling a little better.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling
Clinical narrative: Patient received the Flu vaccine in the right deltoid and developed swelling and the swelling spread through out the arm and still present (Extensive Limb swelling).
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: Arm became hard and red. Parent applied ice and gave ADVIL with no relief. Was seen by NP 10/1/16. Placed on KEFLEX for cellulitis.
Age: 57.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at the site of injection on left arm where she had her flu and Tdap. It has now spread to a bigger area as of 10/03/16. No itching but has slight pain, redness, and feeling of heat. Pt was told to put Ice, Ibuprofen, and BENADRYL on 10/3/16.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood test, X-ray
Clinical narrative: Hip joint pain before dinner, has not resolved since.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: Redness approximately 2" diameter around injection area.
Sex: F
Vaccine: FLU4
Symptoms: Hyperaesthesia, Injection site pain, Injection site reaction, Nasopharyngitis, Skin sensitisation
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received FLUARIX TETRA. On 16th September 2016, the patient received FLUARIX TETRA. In September 2016, less than a day after receiving FLUARIX TETRA, the patient experienced cold. On 16th September 2016, the patient experienced injection site pain, hyper sensation skin and wrong injection technique. On an unknown date, the outcome of the injection site pain and hyper sensation skin were recovered/resolved and the outcome of the cold was not recovered/not resolved and the outcome of the wrong injection technique was unknown. The reporter considered the injection site pain and hyper sensation skin to be related to FLUARIX TETRA. The reporter considered the cold to be unrelated to FLUARIX TETRA. Additional details were provided as follows: The patient experienced pain, specifically burning, at and around the injection site and also reported skin sensitivity around injection site, went up the back of her neck. The symptoms lasted for few days and diminished. At the time of reporting the patient was also experiencing cold which appeared around the same time as the FLUARIX injection. The nurse administering vaccine swabbed injection site with alcohol prior to injection. Nurse did not wait full 15 seconds before injecting, but reporter continued to fee like these reactions were due to the FLUARIX. Specific event onset dates were unknown. The reporter had lot number if required further. This case is one of the three cases reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received FLUARIX TETRA. On 16th September 2016, the patient received FLUARIX TETRA. In September 2016, less than a day after receiving FLUARIX TETRA, the patient experienced cold. On 16th September 2016, the patient experienced injection site pain, hyper sensation skin and wrong injection technique. On an unknown date, the outcome of the injection site pain and hyper sensation skin were recovered/resolved and the outcome of the cold was not recovered/not resolved and the outcome of the wrong injection technique was unknown. The reporter considered the injection site pain and hyper sensation skin to be related to FLUARIX TETRA. The reporter considered the cold to be unrelated to FLUARIX TETRA. Additional details were provided as follows: The patient experienced pain, specifically burning, at and around the injection site and also reported skin sensitivity around injection site, went up the back of her neck. The symptoms lasted for few days and diminished. At the time of reporting the patient was also experiencing cold which appeared around the same time as the FLUARIX injection. The nurse administering vaccine swabbed injection site with alcohol prior to injection. Nurse did not wait full 15 seconds before injecting, but reporter continued to fee like these reactions were due to the FLUARIX. Specific event onset dates were unknown. The reporter had lot number if required further. This case is one of the three cases reported by the same reporter.
Sex: M
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. An adolescent male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced shake extremely/ body was shaking on an unspecified date with outcome of unknown.  The event lasted for about 5 minutes.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Discomfort, Erythema, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received PREVNAR 13 via an unspecified route of administration in upper right arm at 0.5ml single on 27Jun2016 at 10:30 for immunization at general physician's office. Medical history included sulfa drugs allergy ongoing since Mar2016 and he was overweight (not diagnosed by MD). The patient previously took DEMEROL; he had not been taking it since 1970. Concomitant medications were none. The patient experienced horrible welts/ridges described as raised areas from 3" to 6" wide on both sides of his upper, mid and lower back and chest on 27Jun2016 at 22:00 with outcome of recovering, itching on 27Jun2016 at 22:00 with outcome of recovered on 04Jul2016, allergic reaction to vaccination on 27Jun2016 with outcome of recovered on 27Jun2016 at 18:30, tiny pin point red dots/rash on 28Jun2016 at 08:00 with outcome of recovered, was slightly nauseous on 27Jun2016 at 11:45 with outcome of recovered, could hardly move arm on an unspecified date in 2016 with outcome of recovered, hard red knot at the injection site on an unspecified date in 2016 with outcome of recovered, rash in a lighter form spread to, chest, skin of both legs and tops of both feet on an unspecified date in 2016 with outcome of recovered, swelling, redness, pain at injection site on an unspecified date in 2016 with outcome of recovered. The events required doctor visit on 28Jun2016. Therapeutic measures included max dose of liquid BENADRYL per pharmacist's recommendation, and Cold compressed, the itchiness and welts resolved. The patient reported horrible 3-6 inch red and itching ridges or welts across upper, mid and lower back; also same rash spread to sides, chest, skin of both legs and tops of both feet. Rash included small red dots as well as red, itching 3-6 inch welts or ridges. He further stated he was sure that pneumococcal 13-val conj vac (dipht crm197 protein) contained no Demerol. Maybe, if it did, the vaccination would not have been the most extremely painful vaccination that at 64 years old, he had ever received. He could hardly move his arm for 24 hours and had a hard red knot at the injection site. The pain and discomfort paled in comparison to the 3-4 inch itching, red welts that covered his back, sided and chest for 8 days. Eventually, the rash in a lighter form spread to both sides and tops of both feet. It was horrible. Follow up (10Aug2016): New information reported from a contactable consumer included: information regarding Demerol; details on course of events. Follow-up (31Aug2016): New information from the same contactable consumer includes: clarification about past drug history, additional events, clinical course of events details. Follow-up (19Sep2016): New information reported from a contactable consumer included: outcome, treatment received.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pain, Pruritus, Rash pruritic, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received PREVNAR 13 via an unspecified route of administration in upper right arm at 0.5ml single on 27Jun2016 at 10:30 for immunization at general physician's office. Medical history included sulfa drugs allergy ongoing since Mar2016 and he was overweight (not diagnosed by MD). The patient previously took DEMEROL; he had not been taking it since 1970. Concomitant medications were none. The patient experienced horrible welts/ridges described as raised areas from 3" to 6" wide on both sides of his upper, mid and lower back and chest on 27Jun2016 at 22:00 with outcome of recovering, itching on 27Jun2016 at 22:00 with outcome of recovered on 04Jul2016, allergic reaction to vaccination on 27Jun2016 with outcome of recovered on 27Jun2016 at 18:30, tiny pin point red dots/rash on 28Jun2016 at 08:00 with outcome of recovered, was slightly nauseous on 27Jun2016 at 11:45 with outcome of recovered, could hardly move arm on an unspecified date in 2016 with outcome of recovered, hard red knot at the injection site on an unspecified date in 2016 with outcome of recovered, rash in a lighter form spread to, chest, skin of both legs and tops of both feet on an unspecified date in 2016 with outcome of recovered, swelling, redness, pain at injection site on an unspecified date in 2016 with outcome of recovered. The events required doctor visit on 28Jun2016. Therapeutic measures included max dose of liquid BENADRYL per pharmacist's recommendation, and Cold compressed, the itchiness and welts resolved. The patient reported horrible 3-6 inch red and itching ridges or welts across upper, mid and lower back; also same rash spread to sides, chest, skin of both legs and tops of both feet. Rash included small red dots as well as red, itching 3-6 inch welts or ridges. He further stated he was sure that pneumococcal 13-val conj vac (dipht crm197 protein) contained no Demerol. Maybe, if it did, the vaccination would not have been the most extremely painful vaccination that at 64 years old, he had ever received. He could hardly move his arm for 24 hours and had a hard red knot at the injection site. The pain and discomfort paled in comparison to the 3-4 inch itching, red welts that covered his back, sided and chest for 8 days. Eventually, the rash in a lighter form spread to both sides and tops of both feet. It was horrible. Follow up (10Aug2016): New information reported from a contactable consumer included: information regarding Demerol; details on course of events. Follow-up (31Aug2016): New information from the same contactable consumer includes: clarification about past drug history, additional events, clinical course of events details. Follow-up (19Sep2016): New information reported from a contactable consumer included: outcome, treatment received.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse and from a contactable physician. A 17-year-old male patient received TRUMENBA; (NDC number 0005010001; lot M68769, expiry date Apr2017) intramuscular, in left deltoid, on 19Jul2016, at 16:30, at 0.5 mg single, for immunisation. No other vaccines were given on the same date or within four weeks. The patient medical history was not reported. There were no concomitant medications. Few minutes after vaccination, on 19Jul2016, the patient experienced fever, chills, headache and rigors, all resolved on 19Jul2016. The patient was treated with ibuprofen. The events did not require an emergency room or doctor visit. The physician considered the vaccine had a causal effect to the adverse events. Follow-up (20Sep2016): New information from a contactable Physician included: causality assessment. Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner and another contactable nurse. A 17-year-old male patient of an unspecified ethnicity and race received, on 10Aug2016, the first dose of TRUMENBA, (lot M74091, expiry date Jun2017) intramuscular, in the deltoid (unspecified if left or right), at 0.5 ml, single dose, for immunization (prevention of meningococcal B). The patient medical history was not reported. Concomitant medication included intramuscular human papilloma vaccine (GARDASIL 9, Lot. L043214, Expiration date: 30Aug2017), received on 10Aug2016, for immunization. The patient experienced chills and fever, both on an 10Aug2016 with outcome of unknown. Emergency room or physician visit and hospitalization were not required. Specific tests and/or treatment were not required. The patient's mother did not think that the patient's experience was a reaction to the medication when the patient received the product. The nurse stated that there was a reasonable possibility that the events were related to meningococcal group b rlp2086. Follow-up (26Sep2016): New information reported from the contactable nurse includes: patient details, suspect drug and concomitant medication details, reaction data and reporter's assessment. Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported for a 50 year-old female patient who received the first dose of TRUMENBA, (lot number N16808, expiration date 31Jul2017) at 0.5 ml single intramuscular in the left deltoid on 24Aug2016 at 10:30 am for immunization. Medical history included seasonal allergies for which she was receiving ZYRTEC 10 mg once daily orally as concomitant medication. On 13Jul2016, the patient received pneumococcal vaccine (PNEUMOVAX 23, Merck, Lot 431459, expiration date: 30Apr2017) in the left upper arm intramuscular for immunization with no reaction. Ten days after vaccination, on 04Sep2016, the patient had redness, swelling, soreness and itchiness at the injection site and local injection site reaction (probably about 8 cm by 8 cm area). The patient was evaluated in the reporter's office due to the events and treatment including cool compresses was given. No tests were needed. The patient recovered on 09Sep2016. The reporter stated that it would be basically a delayed local reaction, not like cellulitis or anything like that. She considered there was a reasonable possibility that the events were related to meningococcal group b rlp2086. Follow-up (27Sep2016): New information reported from the same contactable nurse includes: suspect vaccine details (dose number, updated time of administration), reaction data (updated events outcome), updated lot number and company trade name of the past vaccine, details on visit by nurse practitioner due to the events, absence of tests, causality assessment. Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Oedema
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 70-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unknown date at 0.5 ml single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced severe edema and erythema after the vaccine was delivered. It was reported that the doctor administered diphenhydramine hydrochloride (BENADRYL). The outcome of severe edema and erythema was unknown.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable Caucasian Consumer reported for herself. A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on an unspecified date in 2015, about a year before this report, for pneumonia immunisation.   Medical history included ongoing high blood pressure, ongoing glucose tolerance impaired (pre-diabetic).  There were no concomitant medications. On an unspecified date the patient experienced itching at site of injection after the shot for about three weeks or something and now occasionally it still itches at that spot, she had little bumps at the side of injection where she itched with outcome of not recovered. The first three weeks when it was itching so bad, she took Prednisone and it did not even stop itching, it slowed it up but it did not stop it. As treatment of itching she have used the BENADRYL and everything which she had in her house to try to keep it away from itching so bad but she had all those little bumps under the skin.  She was still experiencing itching but it was not as bad and further added that it was severe for about 3 weeks and it was really bad and after that it was kind of flared up but then it was just came back. She added that itching was not gotten worst but it was just still there. No lab test performed. A Product Complaint was filed.
Sex: U
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Haemorrhage
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date a year before this report (in 2015) for immunisation. The patient medical history was and concomitant medications were not reported.   On an unspecified date the patient experienced there was a lot of bleeding after the injection The consumer was concerned that perhaps that injection was given into a vein by mistake rather than into the muscle. The outcome was unknown.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Bronchitis, Cholelithiasis, Cough, Ultrasound scan abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself. A 68-year-old male patient received a single dose of PREVNAR 13, in Jan2016 at about 10am, in left arm for immunisation. Medical history included high blood pressure for about 2 years and ongoing, cholesterol for about a year and ongoing, vitamin D deficiency for about 2 years and ongoing, enlarged liver from Aug2015 and ongoing, gallbladder stones from Aug2015 (found on an ultrasound). Past drug event included hives with penicillin about 10 years before the report. Concomitant medication included lisinopril tablet at 20 mg daily  oral from about two years and ongoing for blood pressure high, pravastatin at 20 mg 1x/day oral from about a year and ongoing for cholesterol, amlodipine at 5 mg, 1x/day oral from 2015 and ongoing for blood pressure high, precautionary BABY ASPIRIN at 81 mg 1x/day  oral from about two years and ongoing, VITAMIN D3 softgel 2000 IU once a day from about two years and ongoing for Vitamin D deficiency.  The patient got pneumonia shots every year for the last 2 years, in Jan2014 and in Jan2015 (unsure if they were PREVNAR 13). In Feb2016 he had a persistent cough that he associated with bronchitis. He went to went to urgent care (not hospitalized) and was placed on unspecified antibiotics. The patient recovered from the event in Feb2016.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Eye pain, Eyelid oedema, Eyelid pain
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her daughter. A 22-year-old female patient received the 1st dose of TRUMENBA, (NDC # 00005-0100) via an unspecified route of administration as Injection in her left bicep on 30Jul2016, possibly at 14:00-16:00, for immunization (Prevention of meningitis B). The patient medical history was none. There were no concomitant medications.  No other Vaccines were administered on same date. No prior vaccinations within 4 weeks. The patient previously took DPT vaccine at the age of 10 months, possibly on 27Oct1994, for immunization and was lethargic and had a muted mechanical cry. On 30Jul2016 Immediately after receiving the vaccine, the patient experienced pain on administration with outcome recovered on 06Aug2016. On 30Jul2016 within 2 hours after receiving the vaccine, she started feeling ill and it worsened on 30Jul2016 with outcome of unknown.  On 30Jul2016 within 2 hours after receiving the vaccine, she experienced pain and swelling at the injection site, severe nausea, vomiting, severe headache, stiff neck, pain and swelling at the injection site, weak, shaky, dizzy, may have been running a fever, all with outcome recovered on 06Aug2016. On 01Aug2016, within 48 hours following administration,  the patient experienced pressure in her eyes, eye pain, eyelids seemed sore and swollen, and eyelids seemed sore and swollen, all with outcome recovered on 06Aug2016. No investigations performed. No event required a visit to ER or physician office. Course of events: On 30Jul2016, immediately upon receiving the injection, it was very painful. Within 2 hours after receiving the vaccine, she started feeling ill and it worsened. The most severe parts of the adverse events were the first 3-4 days. The patient may have been running a fever, but they did not have a thermometer to take a temperature.  About 48 hours after the vaccine injection on 01Aug2016, she developed the additional symptoms in her eyes. Consumer was wondering if there were any advice if her daughter should get the second dose or not. She queried whether these events could occur when she get the next dose and whether will they last as long.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her daughter. A 22-year-old female patient received the 1st dose of TRUMENBA, (NDC # 00005-0100) via an unspecified route of administration as Injection in her left bicep on 30Jul2016, possibly at 14:00-16:00, for immunization (Prevention of meningitis B). The patient medical history was none. There were no concomitant medications.  No other Vaccines were administered on same date. No prior vaccinations within 4 weeks. The patient previously took DPT vaccine at the age of 10 months, possibly on 27Oct1994, for immunization and was lethargic and had a muted mechanical cry. On 30Jul2016 Immediately after receiving the vaccine, the patient experienced pain on administration with outcome recovered on 06Aug2016. On 30Jul2016 within 2 hours after receiving the vaccine, she started feeling ill and it worsened on 30Jul2016 with outcome of unknown.  On 30Jul2016 within 2 hours after receiving the vaccine, she experienced pain and swelling at the injection site, severe nausea, vomiting, severe headache, stiff neck, pain and swelling at the injection site, weak, shaky, dizzy, may have been running a fever, all with outcome recovered on 06Aug2016. On 01Aug2016, within 48 hours following administration,  the patient experienced pressure in her eyes, eye pain, eyelids seemed sore and swollen, and eyelids seemed sore and swollen, all with outcome recovered on 06Aug2016. No investigations performed. No event required a visit to ER or physician office. Course of events: On 30Jul2016, immediately upon receiving the injection, it was very painful. Within 2 hours after receiving the vaccine, she started feeling ill and it worsened. The most severe parts of the adverse events were the first 3-4 days. The patient may have been running a fever, but they did not have a thermometer to take a temperature.  About 48 hours after the vaccine injection on 01Aug2016, she developed the additional symptoms in her eyes. Consumer was wondering if there were any advice if her daughter should get the second dose or not. She queried whether these events could occur when she get the next dose and whether will they last as long.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Nausea, Ocular discomfort, Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her daughter. A 22-year-old female patient received the 1st dose of TRUMENBA, (NDC # 00005-0100) via an unspecified route of administration as Injection in her left bicep on 30Jul2016, possibly at 14:00-16:00, for immunization (Prevention of meningitis B). The patient medical history was none. There were no concomitant medications.  No other Vaccines were administered on same date. No prior vaccinations within 4 weeks. The patient previously took DPT vaccine at the age of 10 months, possibly on 27Oct1994, for immunization and was lethargic and had a muted mechanical cry. On 30Jul2016 Immediately after receiving the vaccine, the patient experienced pain on administration with outcome recovered on 06Aug2016. On 30Jul2016 within 2 hours after receiving the vaccine, she started feeling ill and it worsened on 30Jul2016 with outcome of unknown.  On 30Jul2016 within 2 hours after receiving the vaccine, she experienced pain and swelling at the injection site, severe nausea, vomiting, severe headache, stiff neck, pain and swelling at the injection site, weak, shaky, dizzy, may have been running a fever, all with outcome recovered on 06Aug2016. On 01Aug2016, within 48 hours following administration,  the patient experienced pressure in her eyes, eye pain, eyelids seemed sore and swollen, and eyelids seemed sore and swollen, all with outcome recovered on 06Aug2016. No investigations performed. No event required a visit to ER or physician office. Course of events: On 30Jul2016, immediately upon receiving the injection, it was very painful. Within 2 hours after receiving the vaccine, she started feeling ill and it worsened. The most severe parts of the adverse events were the first 3-4 days. The patient may have been running a fever, but they did not have a thermometer to take a temperature.  About 48 hours after the vaccine injection on 01Aug2016, she developed the additional symptoms in her eyes. Consumer was wondering if there were any advice if her daughter should get the second dose or not. She queried whether these events could occur when she get the next dose and whether will they last as long.
Sex: U
Vaccine: MENB, UNK
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An adolescent patient of an unspecified age, race, ethnicity and gender received TRUMENBA via an unspecified route of administration on an unspecified date at 0.5 ml single for immunization.  The patient medical history was not reported. The patient received other unspecified multiple vaccines that same day, at the same time. On an unspecified date in 2016 the patient experienced faint. The patient recovered on an unspecified date in 2016.
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Rash erythematous, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age and ethnicity received PREVNAR 13 on an unspecified date at single dose for immunisation.  Medical history included egg allergy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced a rash on her right arm, it was about the size of a hand which was red and hot to the touch. The rash hurt and the patient had aches and itches. Events outcome was unknown. The reporter considered there was a reasonable possibility that the events were related to the suspect vaccine.
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of unknown age and race received PREVNAR 13 at single dose for immunization. On unknown date the patient may had internal bleeding as there was a huge bruise around shot area. The outcome of the event was unknown. No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a adult female patient who received FLUARIX TETRA. On 16th September 2016, the patient received FLUARIX TETRA (intramuscular). On 16th September 2016, less than a day after receiving FLUARIX TETRA, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with EPIPEN (Nos). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. The reporter considered the anaphylactic reaction to be related to FLUARIX TETRA. Additional details were reported as follows: The age at vaccination was not reported. The sales representative reported on behalf of the health care professional. EPIPEN was administered and the patient taken to the emergency room. The health care professional had lot number if needed. This was 1 of the 3 cases reported by the same reporter.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Local reaction. 9/01/16 10:00 am erythematous triangular shaped area approximately 5cm below injection site. Area warm, slightly indurated and measures 6cm x 12 cm. No pruritic. ZYRTEC given.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Barium enema, Enema administration, Haematochezia, Intussusception
Clinical narrative: Patient developed projectile vomiting and grossly bloody stool 1 day after receiving rotavirus vaccine. She was found to have ileocolic intussusception which was reduced w/barium enema.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting projectile
Clinical narrative: Patient developed projectile vomiting and grossly bloody stool 1 day after receiving rotavirus vaccine. She was found to have ileocolic intussusception which was reduced w/barium enema.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Throat irritation, Upper-airway cough syndrome
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of throat irritation in a 48-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). On 21st September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular). On 21st September 2016, 15 min after receiving FLULAVAL QUADRIVALENT, the patient experienced throat irritation, headache and postnasal drip. The patient was treated with BENADRYL. On 22nd September 2016, the outcome of the throat irritation, headache and postnasal drip were recovered/resolved. It was unknown if the reporter considered the throat irritation, headache and postnasal drip to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The reporter was a GlaxoSmithKline health care provider and an employee. At approximately 15 to 20 minutes after vaccination, the patient began to experience a scratchy throat, post nasal drip and headache. In the morning of 22nd September 2016, the patient was examined. The patient was treated with 25 mg of BENADRYL as a precaution.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Immediate post-injection reaction, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Pt was given injection and complained immediately that she was lightheaded and that this usually happens. She passed out with her eyes open and was unresponsive w/difficulty breathing. 911 was called she was taken to hospital. She returned to normal w/in a few minutes.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Mobility decreased, Pyrexia
Clinical narrative: The day after vaccine was administered, the patient says she developed a fever, had chills, and had to spend the day in bed.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Vaccination failure
Clinical narrative: Information has been received from the authors of the published study literature article titled as stated below. The authors performed a transcriptome (mRNA-Seq)-profiling study after in vitro viral stimulation of PBMCs from 30 measles vaccine recipients. A total of 30 subjects were selected for an mRNA-Seq transcriptome-profiling study based on their plaque reduction micro neutralization assay (PRMN) antibody titers (15 highest and 15 lowest antibody responders) from a combined cohort of 764 randomly selected healthy schoolchildren and young adults (age 11-22 years). The informed consent was obtained from subjects' parents/guardians, as well as written assent from age-appropriate subjects at the time of enrollment. Demographic information from the subjects in the two cohorts was: Sixty per cent of the participants were male and 40% of them were females. Thus, it is important to note that gene expression in PBMCs and all immune measures (neutralizing antibody and cytokine measures after in vitro viral stimulation) were quantified in samples approximately sever years after the last/second measles (MMR) vaccine. Their median age at the time of enrollment was 15 years. On an unknown date, the subjects received two doses of (Wistar RA 27-3) MMR II that contained the Edmonston strain of measles virus (TCID50 >=1,000) (dose, route of administration, lot number and expiration date were not reported). The exact interval between the doses was unknown, but the authors reported that their median age at first immunization was 15 years and by the second immunization, the median time between the first and second immunization was 8 years and the median time since second immunization to enrollment was 7 years. Information concerning the subjects' concomitant medication was not reported. On an unknown date, the subjects' plaque reduction micro neutralization assay had a median titer of 88 mlU/mL (negative) (Measles antibody negative), which suggested lack of protection against measles (vaccination failure). At the reporting time the outcome of vaccination failure and measles antibody test negative was unknown. The investigators considered no therapeutic response to be related to (Wistar RA 27-3) M-M-R II. A copy of the published article has been attached as further documentation of the subjects' experience. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site nodule
Clinical narrative: Patient bled immediately after needle was retracted. Bleeding was stooped with cotton ball and applied pressure. Knot formed immediately after. Knot at injection site (left deltoid) about the size of a quarter. Patient reported feeling fine. Patient had high-dose vaccine in 2015 with no reactions.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: On 9/17 (2 days after shot given) pt. presented with quarter - half dollar size red itchy spot at injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Gastrooesophageal reflux disease, Headache, Myalgia
Clinical narrative: Had FLUZONE high dose flu shot. Suffered diarrhea-vomiting-severe headache-dizzy-acid reflux -muscle aches- general body pain-wheezing-feeling sleepy.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Somnolence, Vomiting, Wheezing
Clinical narrative: Had FLUZONE high dose flu shot. Suffered diarrhea-vomiting-severe headache-dizzy-acid reflux -muscle aches- general body pain-wheezing-feeling sleepy.
Age: 22.0
Sex: M
Vaccine: FLUC4, HEP, HEPA, MMR
Symptoms: Condition aggravated, Fall, Head injury, Mass, Seizure
Clinical narrative: Patient received 4 vaccines, 2 in each arm. Patient stood up to put on his jacket and was waiting on paperwork from nurse and fell backwards hitting head on the floor causing his glasses to fly off. Seizure activity noted for less than 30 sec. Knot noted to back of head, ice pk applied and vls. taken B/P=122/70 (R) arm, 58 pulse, 16 resp.
Age: 81.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist, via a company representative, concerning an about 80 years old male patient. The patient's pertinent medical history and concurrent conditions were not informed. In 2012, reported as "four years ago", the patient was vaccinated with the first dose of ZOSTAVAX (lot # and expiration date were not provided) administered per subcutaneous route. Concomitant therapies were not informed. The pharmacist reported that on an unknown date, the patient was inadvertently administered a second dose of ZOSTAVAX. No adverse experience was reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Rash on thighs 2 days following vaccines with left greater than R at the site of the vaccines. Rash was papular/red/similar reaction happened with first set of vaccines.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at and around injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed herpes zoster in a dermatomal distribution to right mandible. Saw general practitioner on 10/3/2016 and received Valtrex prescription
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma
Clinical narrative: EMPLOYEE REPORTS HAVING AN ASTHMA ATTACK LASTING ABOUT 1 HOUR. USED AN INHALER. USE PREDNISONE FROM A PREVIOUS EPISODE.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: BRUISING AT INJECTION SITE.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cytogenetic analysis, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Seizures started one week after vaccines.. multiple seizures a day. Hospitalized for one week and no answers were found as to what was causing the seizures. Was put on seizure medicines that did not stop the seizures. They just randomly stopped two months after they began.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Ear pain, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: The day after receiving vaccine patient began c/o a sore throat, H/A, ear pain, abdominal pain, and a fever ranging from 101-102F.