chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Bed rest, Consciousness fluctuating, Eye movement disorder, Nasopharyngitis, Pyrexia
Clinical narrative: 5 days of non activeness, bed rest, mini seizures going in and out of consciousness, fever of 104. Gave Tylenol and Motrin and fever would go down for an hour or so but would remain bed ridden and then would spike back up again. Called Doctor and they said it was "normal". This was not normal for patient, visited Dr about a week later, they said he "just had a cold" and to keep giving him Tylenol and Motrin.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Seizure
Clinical narrative: 5 days of non activeness, bed rest, mini seizures going in and out of consciousness, fever of 104. Gave Tylenol and Motrin and fever would go down for an hour or so but would remain bed ridden and then would spike back up again. Called Doctor and they said it was "normal". This was not normal for patient, visited Dr about a week later, they said he "just had a cold" and to keep giving him Tylenol and Motrin.
Age: 1.4
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Burning sensation, Herpes simplex serology negative, Injection site rash, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: Patient developed a rash on left thigh that then spread to the groin area and the majority of the medial thigh.  Patient also stopped bearing any weight on this leg and described the rash as burning. Patient was admitted and started on Acyclovir and Rocephin.  HSV and Varicella Zoster PCR testing were completed on the rash - HSV PRC was NEGATIVE, Varicella Zoster PCR was POSITIVE. Patient continued on Acyclovir (10 mg/kg/dose every 8 hours) and the Rocephin was discontinued.
Age: 1.4
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Weight bearing difficulty
Clinical narrative: Patient developed a rash on left thigh that then spread to the groin area and the majority of the medial thigh.  Patient also stopped bearing any weight on this leg and described the rash as burning. Patient was admitted and started on Acyclovir and Rocephin.  HSV and Varicella Zoster PCR testing were completed on the rash - HSV PRC was NEGATIVE, Varicella Zoster PCR was POSITIVE. Patient continued on Acyclovir (10 mg/kg/dose every 8 hours) and the Rocephin was discontinued.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PPV
Symptoms: Injection site rash, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: Patient developed a rash on his right leg (the same leg that he received the Varicella vaccine in) that continued to spread to other areas of the right leg. Rash was not painful or itchy. Patient was started on Acyclovir.  Over the next few days the rash continued on right leg. The wound was cultured and tested for Varicella Zoster PCR which came back positive.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site haematoma
Clinical narrative: Date of onset unknown-- reported on 10/23/15  3cm x 3.5 cm Hematoma left deltoid non tender; 0 induration; negative fever  Treatment: cool compresses.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: SWELLING, REDNESS, AND WARM TO TOUCH. PATIENT STATED CONSTANT THROBBING PAIN WITH RASH THAT HAD SPREAD FROM MID INTO INNER AND BACK-PART OF ARM. ARM WAS WARM TO TOUCH.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain began after vaccine administered. Reported as persistent, mild to moderate pain for 3 weeks (since date of vaccination).
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Chills, Cough, Heart rate increased, Lacrimation increased
Clinical narrative: Severe abdominal pain, cough, sore throat, watery eyes, wheezing, vomiting, chills, increased heart rate.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Vomiting, Wheezing
Clinical narrative: Severe abdominal pain, cough, sore throat, watery eyes, wheezing, vomiting, chills, increased heart rate.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site discolouration, Pain in extremity
Clinical narrative: Flu: greenish/yellow bruise appearance on the entire upper portion of arm (left arm). Prevnar: pain x 1.5 weeks, aches.
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB, UNK
Symptoms: Decreased appetite, Diarrhoea, Irritability, Pyrexia, Somnolence
Clinical narrative: Fever, Irritability, lack of appetite, sleepiness, puking and diarrhea.  He received shots Monday morning (11/02/2015) and showing side effects Monday night and now just getting back to normal Thursday(11/05/2015).
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB, UNK
Symptoms: Vomiting
Clinical narrative: Fever, Irritability, lack of appetite, sleepiness, puking and diarrhea.  He received shots Monday morning (11/02/2015) and showing side effects Monday night and now just getting back to normal Thursday(11/05/2015).
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: PATIENTS ARM BECOME VERY SORE, HOT TO THE TOUCH AND RED FROM THE SHOULDER DOWN TO THE ELBOW.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on entire body the morning after the flu shot was given, severe itching. Patient took antihistamine and symptoms were relieved.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Chest pain, Chills, Confusional state
Clinical narrative: Fever, headache, nausea, swelling and soreness at site, weakness, extreme fatigue,  exhaustion confusion, muscle aches, chest aches and pain, chills, difficulty breathing, back and neck stiffness and pain, difficulty recovering.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Fever, headache, nausea, swelling and soreness at site, weakness, extreme fatigue,  exhaustion confusion, muscle aches, chest aches and pain, chills, difficulty breathing, back and neck stiffness and pain, difficulty recovering.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Pyrexia
Clinical narrative: Fever, headache, nausea, swelling and soreness at site, weakness, extreme fatigue,  exhaustion confusion, muscle aches, chest aches and pain, chills, difficulty breathing, back and neck stiffness and pain, difficulty recovering.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Severe itching started 1 hr after immunization given. Antihistamine obtained from pharmacy. No further complications.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Employee complaining of arm pain 3 weeks post vaccination- under treatment by primary MD.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site bruising, Pain in extremity
Clinical narrative: BRUISING UP AND DOWN INJECTION ARM WITH SLIGHT ARM PAIN.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Urticaria
Clinical narrative: Injection site stung and itched all day. Following morning 9/16/2015 woke up with hives lasting the two following days. 9/17/2015 saw doctor and was put on Benadryl and a steroid for 5 days.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or drug reactions/allergies were not provided. It was reported that "over a year ago" on unknown date, the patient received the first dose of GADASIL (route, dose, lot # and expiry date were not provided), and at the time of the report the patient received the second dose of GARDASIL (route, dose, lot # and expiry date were not provided). Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site swelling, Pain in extremity, Sleep disorder
Clinical narrative: Pt. reported pain in right arm and difficulty sleeping on her arm that night. More discomfort 11/1/15. Swelling in right arm began 11/1/15 curving downward from injection site and curves around to the front and down to the elbow. Pt. took BENADRYL 11/1/15 and looked better 11/2/15. By 11/3/15, arm was almost back to normal.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Tendonitis
Clinical narrative: Pain at shoulder site lasting 3 weeks after injection.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash erythematous
Clinical narrative: Pt. came into pharmacy on 11/5/15 with large red rash on arm. She asked if she should see the doctor. I told her yes Large, red area on arm about the size of a cell-phime. Referred patient to physician.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Approximately 3 days after influenza vaccine patient developed fine red raised rash on bicep of arm in which flu vaccine was administered. Size of rash approximately 2 inch diameter. Administration site is sore but no redness or rash identified there. Pt reports rash feels deep in skin. Pt doctor contacted and instructed to go to Doctor, however, pt called and stated rash appears to be dissipating. Did not seek further medical attention. Unclear if at all related to vaccine.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 30-OCT-2015, the patient was administered one dose of ZOSTAVAX subcutaneously, lot# L021612 exp. 10-SEP-2016 (dose was not reported) as indicated and inadvertently administered one dose of (Oka/Merck) VARIVAX intramuscularly lot # L012035 exp. 07-APR-2017 (dose was not reported) as well. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unspecified dates, the patients were vaccinated with an unspecified improperly stored doses of ROTATEQ, oral, lot # L008996 and expiration date 11-NOV-2015. No adverse symptoms were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number K012919, dose, route of administration and expiration date were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Pruritus, Urine analysis, Varicella
Clinical narrative: This spontaneous report was received from the consumer's wife referring to her husband, a 60 year old male patient. The patient had no pertinent medical history and he had VICODIN allergy. On 31-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date were unspecified, route of administration was reported as vaccine) one time vaccine. Concomitant medications included unspecified medications. On 05-SEP-2015, the patient developed chickenpox symptoms on his chest (varicella) which itch (pruritus). It was reported that the patient sought for medical attention. No product quality complaint was involved. The patient underwent blood and urine tests on approximately October 2015 (reported as 2 weeks ago), but the results were not provided. At the time of the report, the outcome of pruritus and varicella was unknown. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information is not expected since there is no consent from the physician to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-OCT-2015, (reported as "today"), the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L011537, expiration date: 03-JUL-2016 (dose and route were not reported). No adverse experiences had been reported and there was no PQC involved. No concomitant medication provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified dates, the patients were vaccinated with an unspecified improperly stored doses of GARDASIL, lot # K008931 and expiration date 03-APR-2017, lot # K011562 and expiration date 08-APR-2017, (routes of administration and anatomical locations were not provided). No adverse symptoms were reported. There was no product quality issues involved. This is one of several cases from the same reporter. Additional information has ben requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis around injection site that required treatment with antibiotic.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lip blister, Oral mucosal blistering, Pain in extremity, Pyrexia, Rash
Clinical narrative: Rash on (L) arm, (L) arm pain, blisters on lips and buccal mucosa of mouth, fever of 102 within 12 hours when 2 vaccines were administered. Fever for 2 days, better with TYLENOL. Rash, blisters lasted 6 days.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid with swelling involving the epidermis with edema building up in a layer the lower portion of the deltoid within and outside the redness. Redness with min vesicle production and significant warmth over the red areas. Non-tender on palpation. Moving left shoulder and elbow easily without tenderness or stiffness. Keflex x7 days for developing cellulitis but believed to be a localized reaction. Patient had the Pneumovax vaccine on December 29 2009.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: Left deltoid with swelling involving the epidermis with edema building up in a layer the lower portion of the deltoid within and outside the redness. Redness with min vesicle production and significant warmth over the red areas. Non-tender on palpation. Moving left shoulder and elbow easily without tenderness or stiffness. Keflex x7 days for developing cellulitis but believed to be a localized reaction. Patient had the Pneumovax vaccine on December 29 2009.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient noticed her arm red and itching around the injection site.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pruritus, Skin exfoliation, Skin warm
Clinical narrative: Red, raised, hot, peeling, almost had a scald effect. Rt arm. 6" long area. Itchiness.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant participant was vaccinated with Influenza vaccine, Fluvirin Novartis.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Toothache
Clinical narrative: Participant received the FLU shot and about 45 min after administration she advised of teeth pain that subsided and pressure in chest.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Injection site bruising, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Fever 101. Lasting for 4 days. Loss of appetite. Swelling and bruising at injection site; hard finger shaped lump formed diagonally from injection site to front of arm. Approx. 2 inches in length.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever 101. Lasting for 4 days. Loss of appetite. Swelling and bruising at injection site; hard finger shaped lump formed diagonally from injection site to front of arm. Approx. 2 inches in length.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site reaction, large red area to right deltoid muscle where vaccine was administered; pain to site.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Balance disorder, Fall, Fatigue, Pyrexia, Tremor
Clinical narrative: After the last set of immunizatoins his equilibruim was off for about 10 days. It seemed that he was really tired all day and kept falling.  For about  5-6 days after getting last set of shots, when Pt was falling asleep at night, Pt would shake all over for less than 15 seconds and then fall asleep. He has not done it since. He had a little bit of a fever for 3 days after the last set of shots. Otherwise he has been fine. He is eating a variety of foods. He is talking, climbing, playing... he is having no neuro symptoms now.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Influenza, Tremor
Clinical narrative: Patient got the high dose flu vaccine and she reports within 4 hours of getting the vaccine she was trembling and had diarrhea which resulted in her son calling EMS. They told her she had the flu and she was not transported to the hospital. She reports her symptoms lasted about 3 days. This has not been the first report of these types of symptoms following the high dose flu vaccine this year so wanted to report this to the FDA Medwatch.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Flushing
Clinical narrative: Patient was in our outpatient infusion center receiving DACOGEN IV and received her FLUZONE (Sanofi) vaccine. Patient started having back pain, flushing and breathing problems. Patient received SOLU-MEDROL IV and MD called. Patient did recover, she finished her infusion, and no further problems were reported.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Swollen tongue, Throat irritation
Clinical narrative: Patient received FLUZONE in our outpatient center- had office visit only, so received IM injection in MD area. Patient called 2 hours later stating tongue swelling, cough, and throat itching. Instructed to take BENADRYL and go to the ED. Patient was admitted. Waiting to hear condition.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Nausea, Vertigo, Vertigo positional
Clinical narrative: I'm a 55 yo who had their flu vaccine at health dept on 10.20.15 secondary to volunteer position as a Physician Asst there. About 48 hrs. later vertigo episodes began and mostly occurred with positional change (eg. from sitting to standing) but sometimes spontaneously. I was afraid to walk because of my imbalance and certainly wouldn't have driven a vehicle. I had moderate nausea as well except it was severe during episodes. My symptoms lasted for 4 days. I had no fever, vomiting or diarrhea. I have no known drug allergies. I am not allergic to eggs. My current meds include 100mg lamotrigine QD (have been on this x 3 yrs), fish oil capsules, and Vit D.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: Patient received the FLUARIX flu vaccine, the next day she experienced severe pain and limited mobility. She claims she cannot move her arm over a 45 degree angle, and pain when moving her arm backwards. She say she cannot sleep from the pain, and saw the doctor for this.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX 23 on 11/3/15 returned to clinic due to redness and warmth from shoulder to elbow on 11/4/15.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chest X-ray abnormal, Headache, Pneumonia, Pyrexia
Clinical narrative: Per staff at PCP office: cellulitis in the arm, fever, headache. Developed pneumonia.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Laboratory test
Clinical narrative: Numb (L) side of my face.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Lip swelling, Urticaria
Clinical narrative: Large bruise at injection site. On the next day (11-3) pt. experienced large hives and lips swelled - went to ER for treatment.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Burning sensation, Injection site pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Customer got the Flu shot on 8/25/15. First she felt tingling sensation and then burning at different times: Then gradually developed pain at the site of the injection after 2 weeks. Pain is radiating towards neck, arm and diffusing.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lip swelling, Pharyngeal oedema, Pyrexia, Tongue disorder
Clinical narrative: I had the FLUZONE HD PF 15-16 INJ vaccine (RX #7859429) on 10/31/15. Within 2 to 3 hours I had a large swelling in my throat and also felt swelling in my upper lip. I could also feel something on both sides of my tongue. Next, I developed a severe headache, began to shake violently, felt feverish, and vomited. I did not go to the ER but thought I might need to. It was obviously a reaction to the flu vaccine and I thought I should report it. I was told they were mixing a stronger dose because of my age. I probably will never have another one but wanted someone to know about it.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: I had the FLUZONE HD PF 15-16 INJ vaccine (RX #7859429) on 10/31/15. Within 2 to 3 hours I had a large swelling in my throat and also felt swelling in my upper lip. I could also feel something on both sides of my tongue. Next, I developed a severe headache, began to shake violently, felt feverish, and vomited. I did not go to the ER but thought I might need to. It was obviously a reaction to the flu vaccine and I thought I should report it. I was told they were mixing a stronger dose because of my age. I probably will never have another one but wanted someone to know about it.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Peripheral coldness
Clinical narrative: I went to pharmacy and received an seasonal influenza shot (lot # 11849211A) and immediately after the needle was withdrawn, my arm went completely cold. It felt like it was cold, and when I said this to the NP, he touched my arm and said that my arm was physically cold. He then had me stay there until the cold feeling left. I have had multiple other flu shots over the years, and this is the first time this has ever happened. As far as I know, I am not allergic to any of the ingredients, or anything for that matter.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Local reaction, Vaccination site pain, Vaccination site swelling
Clinical narrative: Localized adverse reactoin at vaccination site including redness, swelling, itching and pain. Several inches in diameter.
Age: 70.0
Sex: M
Vaccine: RAB
Symptoms: Discomfort, Neck pain, Pain
Clinical narrative: Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased neck and body soreness after series of injections. Pt. continues to c/o discomfort. Lot number 559011a, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1500 units. 150 I. U/ml Grifols lot number exp unknown. ND13533-0618-10.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Injection site bruising
Clinical narrative: My mother received a PREVNAR vaccine on Tuesday, October 27th, 2015. That evening she began experiencing severe flu-like symptoms, including fever, chills, loss of appetite, aches and pains and exhaustion. These symptoms continued throughout Wednesday. At the same time she was also experiencing redness and bruising at the injection site. By Thursday her flu-like symptoms had gone away, but the redness and itching all over her arm, from the shoulder down to the elbow. On Friday night she took some BENADRYL to help with the itching, but by Saturday morning the redness was worse still. According to the product labeling, some flu-like symptoms were expected, although not quite as bad as her experience. We are concerned now with the on-going and prolonged injection-site reactions.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Pain, Pruritus, Pyrexia
Clinical narrative: My mother received a PREVNAR vaccine on Tuesday, October 27th, 2015. That evening she began experiencing severe flu-like symptoms, including fever, chills, loss of appetite, aches and pains and exhaustion. These symptoms continued throughout Wednesday. At the same time she was also experiencing redness and bruising at the injection site. By Thursday her flu-like symptoms had gone away, but the redness and itching all over her arm, from the shoulder down to the elbow. On Friday night she took some BENADRYL to help with the itching, but by Saturday morning the redness was worse still. According to the product labeling, some flu-like symptoms were expected, although not quite as bad as her experience. We are concerned now with the on-going and prolonged injection-site reactions.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Erythema, Peripheral swelling
Clinical narrative: My mother received a PREVNAR vaccine on Tuesday, October 27th, 2015. That evening she began experiencing severe flu-like symptoms, including fever, chills, loss of appetite, aches and pains and exhaustion. These symptoms continued throughout Wednesday. At the same time she was also experiencing redness and bruising at the injection site. By Thursday her flu-like symptoms had gone away, but the redness and itching all over her arm, from the shoulder down to the elbow. On Friday night she took some BENADRYL to help with the itching, but by Saturday morning the redness was worse still. According to the product labeling, some flu-like symptoms were expected, although not quite as bad as her experience. We are concerned now with the on-going and prolonged injection-site reactions.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pruritus, Pyrexia
Clinical narrative: My mother received a PREVNAR vaccine on Tuesday, October 27th, 2015. That evening she began experiencing severe flu-like symptoms, including fever, chills, loss of appetite, aches and pains and exhaustion. These symptoms continued throughout Wednesday. At the same time she was also experiencing redness and bruising at the injection site. By Thursday her flu-like symptoms had gone away, but the redness and itching all over her arm, from the shoulder down to the elbow. On Friday night she took some BENADRYL to help with the itching, but by Saturday morning the redness was worse still. According to the product labeling, some flu-like symptoms were expected, although not quite as bad as her experience. We are concerned now with the on-going and prolonged injection-site reactions.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Bursa injury, Drug administered at inappropriate site, Nerve injury, Pain in extremity, Peripheral swelling
Clinical narrative: I had shoulder injury due to vaccine administration when getting the PREVNAR 13 vaccine at a local pharmacy. The vaccine was administered too high on the arm, hitting a nerve or going into bursa. This resulted in a swollen painful arm for 4 days. According to an article in a news paper, much more severe injuries can result from inappropriate placement of an intramuscular vaccination too high on the arm. This needs to be publicized nationwide since it is related to a medical practice and not to any one particular vaccine.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Headaches - after 1st vaccine 8/18/15 - pt reported x 2-3 days. After 2nd vaccine 10/28/15 pt reported 1 wk of headaches.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Rash
Clinical narrative: Sore, local rash, mild swelling at site.
Age: 10.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swollen right arm. Sq of softball. Warm to touch. Patient was given alternative shot schedule to follow due to him getting pancreas out in Jan. 2015.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Influenza like illness, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Client states she developed flu-like sx with body aches, fever and soreness of injection site the evening after vaccination. She woke up at 3:00 AM with her right arm throbbing with pain and she has had severe pain ever since. 800 mg of ibuprofen taken every 5-6 hours has slightly alleviated the severity. No swelling, redness to the site or warm to touch has occurred. Client states she was moving arm, massaging it and icing alternating with heat as well with no relief.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: 5 minutes after vaccine given she C/O throat tightness. HR 100. No stridor. Left department against advised and then went to ED for worsening sx with 30 minutes of vaccine. Refused to stay in department or have us transport to ED.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Injected limb mobility decreased, Malaise, Pain in extremity
Clinical narrative: Patient states she feels generally sick, she cannot move her arm sometimes (the one that received the vaccine), her arm is sore sometimes, and she has a cough.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Rash erythematous, Urticaria
Clinical narrative: Pt says she developed a rash on her neck and upper chest several hours after receiving the flu shot.  She said she had welts under her arms.  She said she felt achy.  She did not have breathing difficulty.  Two days after the injection she still has a red rash on her neck and upper chest.  She has taken Benadryl.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Patient had ZOSTAVAX administered on 10/30/15. On 10/31/15 the site was itchy, warm to touch and there was a lump. She applied hydrocortisone cream. On 11/1/15 she didn't feel good so she went to clinic and was prescribed cephalexin.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Rash, Skin warm
Clinical narrative: Patient has rash and redness on the arm she was given the shot at which is hot to touch. Patient also complains she doesn't feel good.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient reported initial pain and swelling at vaccine site which resolved. Patient then developed pain with shoulder abduction and localized swelling within deltoid at vaccine site which was delayed in onset, about one week after vaccine.
Age: 51.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Patient states red, swollen, and hot and states dr diagnosed cellulitis.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema to area of left deltoid where injection was given.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt states she started feeling pain at the site of injection 3 to 4 days after the shot and is still there 6 weeks later.
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Conjunctival hyperaemia, Eye swelling, Urticaria, Wheezing
Clinical narrative: Peri-orbital swelling, conjunctival injection, mild bilateral wheezing, a few hives on face.
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Cough, Dyspnoea, Lacrimation increased, Rhinorrhoea
Clinical narrative: Peri-orbital swelling, conjunctival injection, mild bilateral wheezing, a few hives on face.
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Sneezing
Clinical narrative: Peri-orbital swelling, conjunctival injection, mild bilateral wheezing, a few hives on face.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Malaise
Clinical narrative: Patient called pharmacy and complained of having trouble breathing/not feeling well. Pharmacist suggested she go to the hospital immediately. According to husband, she was admitted around 9PM to the hospital. She stayed one night on 11/4 and will stay at least 11/5 for one night for further observations.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Hypoacusis, Influenza
Clinical narrative: Had symptoms of the flu and felt the same. Fever, chills, muscle aches, headache, diarrhea, vomiting. Had these symptoms for approx 36 hours. What I'm most concerned about is that after these symptoms disappeared I was left with somewhat muffled hearing.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Had symptoms of the flu and felt the same. Fever, chills, muscle aches, headache, diarrhea, vomiting. Had these symptoms for approx 36 hours. What I'm most concerned about is that after these symptoms disappeared I was left with somewhat muffled hearing.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Dyspnoea, Feeling abnormal, Tachycardia
Clinical narrative: Complaints of asthma like symptoms after receiving vaccine, tachycardia, feeling 'funny'.  Used rescue inhaler for shortness of breath.
Age: 10.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis, Erythema, Hypersensitivity, Skin warm, Tenderness
Clinical narrative: 5" area of redness on left arm.  Warm & tender to touch. Had Fluzone and Tdap both in L arm.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium increased, Hypernatraemia, Mental status changes
Clinical narrative: Progressive hypernatremia to 180, with severe mental status changes.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Parvovirus B19 test positive, Peripheral swelling
Clinical narrative: Progressive back pain ascending up the spine, 3 day history of bilateral hand swelling and pain in multiple joints.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: REDNESS, ITCHING, WARMTH AROUND THE SITE OF INJECTION.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness developed and continued to spread approximately 5 inches below injection site up to her shoulder.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Pruritus, Rash, Skin exfoliation
Clinical narrative: REDNESS, RASH, SLIGHT SWELLING, WARMNESS TO THE TOUCH, SLIGHT ITCHY, DRY/SCALY SKIN.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: REDNESS, RASH, SLIGHT SWELLING, WARMNESS TO THE TOUCH, SLIGHT ITCHY, DRY/SCALY SKIN.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Insomnia, Malaise
Clinical narrative: Patient came in 10 days after administration and stated that on the night of administration she experienced "chills" and felt sick all night and couldn't sleep....she didn't know if she had a fever or not. She stated that she was fine on the day she came in to report.
Age: 2.0
Sex: M
Vaccine: FLUX, HEPA, MNQ
Symptoms: Injection site pain, Injection site rash
Clinical narrative: A painful rash the size of your palm over the injection site. It spread out at about 5pm. Medicine has not helped the pain or the rash.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Headache, Hearing impaired, Malaise, Neck pain
Clinical narrative: Violent shaking, 101 degree fever, severe headache and pain in upper cervical region, malaise, body aches, dry mouth and white tongue turned to red tongue and tongue paresthesia which worsened over 3 days and persisted for 2 weeks, hearing difficulty and sloughing of skin on palms of hands and feet.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia oral, Pyrexia, Skin exfoliation, Tongue discolouration
Clinical narrative: Violent shaking, 101 degree fever, severe headache and pain in upper cervical region, malaise, body aches, dry mouth and white tongue turned to red tongue and tongue paresthesia which worsened over 3 days and persisted for 2 weeks, hearing difficulty and sloughing of skin on palms of hands and feet.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Violent shaking, 101 degree fever, severe headache and pain in upper cervical region, malaise, body aches, dry mouth and white tongue turned to red tongue and tongue paresthesia which worsened over 3 days and persisted for 2 weeks, hearing difficulty and sloughing of skin on palms of hands and feet.
Age: 37.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Drug administered at inappropriate site, Injection site pain, X-ray limb
Clinical narrative: PATIENT STATES THAT SINCE THE INJECTION HE HAS HAD SEVERE PAIN RUNNING DOWN HIS LEFT UPPER ARM FROM THE INJECTION SITE. STATES THAT THE INJECTION WAS GIVEN HIGH ON HIS ARM.  HE WENT TO A PHYSICIAN TO BE CHECK OUT.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Erythema, Headache, Injection site rash
Clinical narrative: Itching, redness swelling, fever, chill, body aches in joints, with a headache. Small bumps developed around injection site which turned into sores that lasted up to two weeks.  I used antibiotic ointment on the site.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: Itching, redness swelling, fever, chill, body aches in joints, with a headache. Small bumps developed around injection site which turned into sores that lasted up to two weeks.  I used antibiotic ointment on the site.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Headache, Hypoaesthesia, Injection site discolouration, Injection site pain
Clinical narrative: Started with pain at injection site, in the upper arm, got worse over time, numbness down the arm, at some points, with tingling to the fingers, swelling onset, more pain, right upper part of the body began to hurt the evening of 11/4, glands began to hurt on the right side, throat began to feel weird this morning 11/5/15..took Benadryl, severe headache onset, cannot move arm to good today fingers feel very stiff, obvious swelling, discolored injection site, lighter than usual barely able to dress myself.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Mobility decreased, Musculoskeletal stiffness, Pain, Paraesthesia
Clinical narrative: Started with pain at injection site, in the upper arm, got worse over time, numbness down the arm, at some points, with tingling to the fingers, swelling onset, more pain, right upper part of the body began to hurt the evening of 11/4, glands began to hurt on the right side, throat began to feel weird this morning 11/5/15..took Benadryl, severe headache onset, cannot move arm to good today fingers feel very stiff, obvious swelling, discolored injection site, lighter than usual barely able to dress myself.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pharyngeal disorder, Swelling
Clinical narrative: Started with pain at injection site, in the upper arm, got worse over time, numbness down the arm, at some points, with tingling to the fingers, swelling onset, more pain, right upper part of the body began to hurt the evening of 11/4, glands began to hurt on the right side, throat began to feel weird this morning 11/5/15..took Benadryl, severe headache onset, cannot move arm to good today fingers feel very stiff, obvious swelling, discolored injection site, lighter than usual barely able to dress myself.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient reported redness, swelling and itching below the infection site. Estimated at 6 inches long and 3 inches wide. A little worse than it was 11/4.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphemia
Clinical narrative: My daughter has a stutter in her speech now after talking very well before her shot, the day after she began talking with the stutter.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Fatigue, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: Fatigue, runny nose, nasal congestion, sneezing. Given cetitrizine at 09:30 pm, symptoms worsened.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient received a duplicate flu shot at the pharmacy (patient got a flu shot at doctors office).
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient reported erythema, and edema of left arm traveling towards her left hand. Treatment by PCP with clindamycin 3x/day for 5 days.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: 5 minutes after vaccination, patient left leg feel little numb. Asked her to get up and moving around. She still feel little numb but still able to walk (watch her walk about 50 feet) she wants to go home and not seeking any treatment. Called patient about 30 minutes after she return home.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Patient passed out approximately 5 mins after flu hosts was administered. Called 911 -EMS said his BP was low - they gave pt. oxygen - kept him in ambulance for approximately 20-30 mins and then he came back in store to say he was feeling better.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hyperaesthesia, Infection
Clinical narrative: Patient received PREVNAR 13 on 10/29/15 w/o any reaction. Around approximately 1 week noticed it was red w/margins and sensitive to touch. Left arm. Went to her son/Dr. and he diagnosed it as infected.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient have severe muscle ache for 2 weeks with stiffness.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Myalgia, Pruritus, Swelling, Tenderness
Clinical narrative: Very itchy, muscle soreness, redness and swelling around the arm, tender to the touch. Dr. gave her Doxycycline and MEDROL 4 mg dose pack.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L016283, expiration date: 07-AUG-2016) (dose, anatomical location, route of administration and frequency were unspecified). No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Injection site discomfort
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 62-year-old male patient who received Hepatitis B vaccine. On 1st October 2015, the patient received the 1st dose of Hepatitis B vaccine .5 ml. On 1st October 2015, less than a day after receiving Hepatitis B vaccine, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown. It was unknown if the reporter considered the injection site discomfort to be related to Hepatitis B vaccine. Additional details provided were as follows: This case was previously reported to a doctor.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Skin discolouration, Swelling
Clinical narrative: This spontaneous report as received from an 82 year old female patient with penicillin allergy reporting on herself. The patient's pertinent medical history included herpes zoster. On 18-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiry date were not provided). Co-suspect therapies and concomitant medications were not provided. On approximately 26-OCT-2015, reported as "the last week" the patient developed shingles. The patient self-diagnosed and returned to the pharmacy to confirm. The patient had discoloration, redness, swelling and itchiness on her face base of scalp, and ear area about the size of an egg. The patient indicated that she was sure of her diagnosis as she had had shingles in the past, prior to receiving the ZOSTAVAX dose on 18-FEB-2015. No laboratory diagnostic test was performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered from shingles. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unspecified dates, the patients were vaccinated with an unspecified improperly stored doses of PNEUMOVAX23, lot # L014458 and expiration date 11-FEB-2017, (routes of administration and anatomical locations were not provided). No adverse symptoms were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has bee unspecified.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 02-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck) and VARIVAX (Merck), (dose, route, anatomical location, lot number and expiration date of the both vaccines above described were not reported). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site rash in a adult patient who received FLULAVAL quadrivalent (batch number 99LN2, expiry date May 2016). In 2015, the patient received FLULAVAL quadrivalent. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced injection site rash, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site warmth and injection site swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: This case was reported by a pharmacy director. This case was 1 of the 2 cases reported for the employees of the pharmacy who experienced an adverse reaction after the vaccination. The two patients received the FLULAVAL QIV vaccine from different vials purchased at the same time. In 2015, the patient experienced large red rash, warm and puffy (swelling) surrounding the injection site of the FLULAVAL QIV vaccine. The reactions lasted for few days. The reporter was not aware of any other issues regarding either of the vials containing the vaccine. This case has been linked to case US2015GSK155182, reported by the same reporter.