chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a other health professional refers to a 20 years old male patient with immunization. The patient was vaccinated with lot # (1291AA) dose 1, .5 ml GARDASIL on 26-SEP-2011. No other co-suspects were reported. Concomitant medications included: VYVANSE. On 29-NOV-2012 the patient experienced hives, 431 days after onset of therapy. Treated with ZYRTEC. The relatedness for hives is unknown for GARDASIL. He received the first injection 9/26/2011 there were no adverse effects reported. The second injection was received 12/29/2011, after which he developed mild hives and did not report it to his healthcare provider. He received his third dose 11/28/2012 and two days after developed hives all over his body and was seen in the office for treatment. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Gait disturbance, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 44 years old female patient with asthma, amoxicillin allergy, sulfa allergy and tretinoin allergy who on 13-NOV-2012 was vaccinated with dose 1, 0.5 ml of PNEUMOVAX 23 intramuscularly in the gluteus maximus, right side (lot number H012650, expiration date 27-FEB-2014). No other co-suspects were reported. Concomitant medications included: albuterol (manufacturer unknown). The nurse practitioner reported that the patient developed an injection site reaction described as cellulitis. The reaction site was described as tender swollen, erythematous area at the injection site 3 by 4 inches that was accompanied by generalized fever and chills. The exact development of the event was unspecified, but on 16-NOV-2012 the patient contacted the office and the nurse noted that the patient had a slight limp from the swelling and cellulitis. It was also reported that the patient could not walk right due to the limp. No laboratory tests were performed. The patient sought medical attention and had received Z-PAK as treatment. At the time of the report, it was unknown if the patient had recovered from the events. The relatedness for cellulitis, slight limp and could not walk was unknown for PNEUMOVAX 23. The nurse practitioner considered the event of could not walk right to be significant disability or incapacity and cellulitis to be life threatening. This is one of several reports received from the same source (other MARRS number 1212USA005195 and 1212USA005209). Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 44 years old female patient with asthma, amoxicillin allergy, sulfa allergy and tretinoin allergy who on 13-NOV-2012 was vaccinated with dose 1, 0.5 ml of PNEUMOVAX 23 intramuscularly in the gluteus maximus, right side (lot number H012650, expiration date 27-FEB-2014). No other co-suspects were reported. Concomitant medications included: albuterol (manufacturer unknown). The nurse practitioner reported that the patient developed an injection site reaction described as cellulitis. The reaction site was described as tender swollen, erythematous area at the injection site 3 by 4 inches that was accompanied by generalized fever and chills. The exact development of the event was unspecified, but on 16-NOV-2012 the patient contacted the office and the nurse noted that the patient had a slight limp from the swelling and cellulitis. It was also reported that the patient could not walk right due to the limp. No laboratory tests were performed. The patient sought medical attention and had received Z-PAK as treatment. At the time of the report, it was unknown if the patient had recovered from the events. The relatedness for cellulitis, slight limp and could not walk was unknown for PNEUMOVAX 23. The nurse practitioner considered the event of could not walk right to be significant disability or incapacity and cellulitis to be life threatening. This is one of several reports received from the same source (other MARRS number 1212USA005195 and 1212USA005209). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with dose 1 of GARDASIL (lot number, expiry date, dose and route were not reported). No concomitant medications were reported. On an unspecified date, the patient received the 2nd dose of GARDASIL (lot number, expiry date, dose and route were not reported) 11 months after the first dose and then was given the third dose of GARDASIL (lot number, expiry date, dose and route were not reported) 2 months after the second dose and no adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: DTP
Symptoms: Abdominal pain upper, Allergy test, Bacterial test positive, Colonoscopy, Condition aggravated
Clinical narrative: Initial report was received from a consumer through another manufacturer on 06 December 2012 under service request, number 1-5728549810. A female patient had received a "subdermal one injection in each arm" of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (manufacturer, lot number and exact date of administration not reported) sometime in 2011. A couple hours of getting the vaccine, the patient fell on the floor, her stomach was hurting very badly and she was nauseated. A physician told her to place on wash cloth on her forehead and go to bed. The patient remained in bed the entire weekend except she had to keep getting up due to diarrhea. The patient stated it might have been due to eating some fish that could have been not cooked properly and it was perhaps a type of food poisoning. The patient "tested positive for compo factor bacterium in her colon that could have been caused from the food she ate." A few days later, the patient broke out in a rash all over her body that has lasted for about five months and is still present. The patient also experienced constipation due to the colon bacteria that lasted a long time. The patient stated this happened another time prior to vaccination as she has irritable bowel syndrome. Treatment included cold wash cloth on forehead, bed rest, antibiotics and cortisone injections. Laboratory diagnostic testing included "colonoscopy, allergy studies and lab work - different variety recently". The patient had a history of irritable bowel syndrome with constipation, auto immune disease, depression, gastritis, GERD, arthritis and carpal tunnel. Allergies included sulfa, the myacin family of meds, bees, "some type of cream that goes in the vagina" and "iodine stuff they put in the machines for radiographic x-rays". Concomitant medications included WELLBUTRIN and PROZAC. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: DTP
Symptoms: Constipation, Diarrhoea, Fall, Laboratory test, Nausea
Clinical narrative: Initial report was received from a consumer through another manufacturer on 06 December 2012 under service request, number 1-5728549810. A female patient had received a "subdermal one injection in each arm" of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (manufacturer, lot number and exact date of administration not reported) sometime in 2011. A couple hours of getting the vaccine, the patient fell on the floor, her stomach was hurting very badly and she was nauseated. A physician told her to place on wash cloth on her forehead and go to bed. The patient remained in bed the entire weekend except she had to keep getting up due to diarrhea. The patient stated it might have been due to eating some fish that could have been not cooked properly and it was perhaps a type of food poisoning. The patient "tested positive for compo factor bacterium in her colon that could have been caused from the food she ate." A few days later, the patient broke out in a rash all over her body that has lasted for about five months and is still present. The patient also experienced constipation due to the colon bacteria that lasted a long time. The patient stated this happened another time prior to vaccination as she has irritable bowel syndrome. Treatment included cold wash cloth on forehead, bed rest, antibiotics and cortisone injections. Laboratory diagnostic testing included "colonoscopy, allergy studies and lab work - different variety recently". The patient had a history of irritable bowel syndrome with constipation, auto immune disease, depression, gastritis, GERD, arthritis and carpal tunnel. Allergies included sulfa, the myacin family of meds, bees, "some type of cream that goes in the vagina" and "iodine stuff they put in the machines for radiographic x-rays". Concomitant medications included WELLBUTRIN and PROZAC. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: DTP
Symptoms: Rash generalised
Clinical narrative: Initial report was received from a consumer through another manufacturer on 06 December 2012 under service request, number 1-5728549810. A female patient had received a "subdermal one injection in each arm" of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (manufacturer, lot number and exact date of administration not reported) sometime in 2011. A couple hours of getting the vaccine, the patient fell on the floor, her stomach was hurting very badly and she was nauseated. A physician told her to place on wash cloth on her forehead and go to bed. The patient remained in bed the entire weekend except she had to keep getting up due to diarrhea. The patient stated it might have been due to eating some fish that could have been not cooked properly and it was perhaps a type of food poisoning. The patient "tested positive for compo factor bacterium in her colon that could have been caused from the food she ate." A few days later, the patient broke out in a rash all over her body that has lasted for about five months and is still present. The patient also experienced constipation due to the colon bacteria that lasted a long time. The patient stated this happened another time prior to vaccination as she has irritable bowel syndrome. Treatment included cold wash cloth on forehead, bed rest, antibiotics and cortisone injections. Laboratory diagnostic testing included "colonoscopy, allergy studies and lab work - different variety recently". The patient had a history of irritable bowel syndrome with constipation, auto immune disease, depression, gastritis, GERD, arthritis and carpal tunnel. Allergies included sulfa, the myacin family of meds, bees, "some type of cream that goes in the vagina" and "iodine stuff they put in the machines for radiographic x-rays". Concomitant medications included WELLBUTRIN and PROZAC. Outcome was not recovered. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Lip swelling, Swelling face
Clinical narrative: Initial report was received from a healthcare professional on 06 December 2012. A 30-year-old female patient had received a dose one intramuscular injection of ADACEL, lot number and site not reported, on 03 December 2012. Seventy-two hours later on 06 December 2012, the patient experienced facial swelling, lip swelling and the site was sore with some induration. The swelling was somewhat relieved by BENADRYL and a steroid. The patient had no illness at the time of vaccination and an unknown past medical history. Outcome was not recovered. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Eye pruritus, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Patient experienced sore throat, cough, wheezing, red, itchy eye, hoarseness, sore. Went to see care doctor & being prescribed steroid & allergy medication. Patient felt better after the medication treatment after couple days. (Called pt on 12/17/12 follow-up).
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Wheezing
Clinical narrative: Patient experienced sore throat, cough, wheezing, red, itchy eye, hoarseness, sore. Went to see care doctor & being prescribed steroid & allergy medication. Patient felt better after the medication treatment after couple days. (Called pt on 12/17/12 follow-up).
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Vertigo
Clinical narrative: Vertigo upon awakening next morning. Subsided in about 1/2 hour (w/ mild nausea).
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Inflammation, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder; given in tendon/bursa as noted by MD. Inflammation noted by MD also. Patient treated with 800mg Ibuprofen and tramadol for pain; also range of motion issues.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on trunk - fine, red, itchy - 8 hrs post vaccine administration. This is the first flu shot (ever) for this patient.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder; limited range of motion. Treated at MD's office; MD noted that shot was given in tendon; Prescribed meloxicam 15mg for pain.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Gradual increase in pain (L) upper arm where injection was given. No weakness or tingling. No swelling or lump.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Pt states her left arm is swollen & red. She called her MD & MD stated it should drain soon. She also stated her shoulder was painful for 5 day after her flu shot.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Patient stated he "felt funny" and fainted.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Altered state of consciousness, Body temperature increased, Vomiting
Clinical narrative: Presented in E.D. with change in consciousness and elevated temp & vomiting. 12/10 Temp. at 2015 38.4 at 2135 39.2 at 2239 38.2 at 2311 38.2 at 2348 36.7. No further increased temp.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Vertigo
Clinical narrative: 24 hrs after vaccination severe vertigo, nausea vomiting 48 hrs then malaise fever muscle pains 3 days.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: 24 hrs after vaccination severe vertigo, nausea vomiting 48 hrs then malaise fever muscle pains 3 days.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Dizziness
Clinical narrative: Pt. complained of feeling dizzy within 5 min of receiving flu vaccine. Pt was asked to sit and given water. When asked if he felt short of breath he replied no, but within 15 more min. he complained of chest pain and tightness. 911 was called at this point, firemen and paramedics arrived quickly and began evaluating.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with a dose of PNEUMOVAX23 (lot #, dose and route not reported)sometime this year, in 2012. No other co-suspects were reported. No concomitant medications were reported. The nurse mentioned that at another office in their practice had a report of cellulitis following vaccination with PNEUMOVAX23 in 2012. No treatment information was reported. It was unknown if the patient sought medical attention. The nurse had no other information about the other office in their practice. The outcome of cellulitis was unknown. The relatedness for cellulitis was not provided for PNEUMOVAX23. The reporting nurse considered cellulitis to be life threatening. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperventilation, Pruritus generalised
Clinical narrative: Pt given Flu intradermal to (L) arm at 830 AM; at 835AM pt came out of exam room c/o itchiness all over and hyperventilating.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient rep reported swelling after flu shot. We gave her an ice pack and left a message to follow-up. I called patient on 12/12 & he reported swelling better but area is puffy. Patient did not feel as if MD visit is necessary.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Tachycardia
Clinical narrative: Cellulitis, tachycardia.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Pt developed localized rash to tricep area. Rash was itchy and irritating. Developed 2 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Ear infection, Sinusitis, Urticaria
Clinical narrative: Began to have urticarial rash within a couple of hours of receiving 4-year-old vaccines (DTaP, IPV, MMR, Varicella). Has been having sinus/ear infection for one week prior to receiving vaccines. Was given CLARITIN and Hydroxytine to treat infection. Say rash began on (R) though near site of DTaP/IPV injection.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2008 the patient was vaccinated with dose 1 GARDASIL (lot #, expiration date and route not reported). No concomitant medications were reported. On 12-DEC-2012 the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date and route not reported). No adverse effect reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule
Clinical narrative: Pt reports "knot" at injection site immediately after Tdap injection. The next day she noted area of erythema, which increased all around injection site over next 2 days (approx 3") & pt felt fine. Today (12-10-12), erythema mostly resolved."
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Injection site nodule, Irritability, Pyrexia
Clinical narrative: 1) Fever up to 102.2 x 3 days. 2) Excessive crying/fussiness x 3 days. 3) Large knot (quarter sized) at injection site.
Sex: U
Vaccine: HEP, HEPA, HPV4, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients of unknown age. The patients might have received improperly stored RECOMBIVAX HB, GARDASIL, PEDVAXHIB, Live, oral, ROTATEQ, and VAQTA since May of 2012 to the reporting time. Lot numbers of all therapies were not provided. No concomitant medications were reported. No adverse event reported. It was unspecified if the patients had sought medical attention. Additional information is not expected.
Age: 1.41
Sex: M
Vaccine: DTAPHEPBIP, MMR, MMRV, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 16 month old male patient. On 04-DEC-2012(reported as today), the patient was vaccinated with a dose of 0.5 ml PROQUAD (Merck),(lot number, expiration date and route not reported) on the right arm. On the same day the patient was also administered with a dose of MMR II,(lot number, expiration date and route not reported) in the left arm. Concomitant medications included PREVNAR 13 and PEDIARIX which were also administered on 04-DEC-2012. No adverse effects were reported. It was unspecified if the patient had sought medial attention. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blood test normal, Burning sensation, Chest discomfort, Chills, Cough
Clinical narrative: This spontaneous report as received from a consumer refers to a 61-year-old female patient who is allergic to sulfa. Patient had no pertinent medical history. On 14-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were not reported) subdermally. On the same day she also received Influenza Virus Vaccine (manufacturer unknown) (lot number, expiry date, dose and route were not reported). Concomitant medications included CLARINEX, vitamins (unspecified) Over-The-Counter (OTC), fish oil and glucosamine. On 14-NOV-2012, the patient went for swimming as usual and about 2-3 hours she started to experience wheezing, tightness in her chest, trembling, coughing and as well as chills. The symptoms lasted the entire night until the next morning. On 15-NOV-2012, the events wheezing, tightness in her chest, trembling, coughing and chills were resolved. The patient went swimming again 2 days later and the symptoms reappeared about 2-3 hours later. The patient attempted swimming on 2 more occasions and the exact thing appeared. On 03-DEC-2012, the patient went to the allergist and was prescribed VENTOLIN though she had no asthma. The patient reported that every time she went for swimming the same symptoms reappeared. She used VENTOLIN as directed and it only helped a little bit and very temporally. On 07-DEC-2012, about an hour ago of reporting, 08:30 MT (meridian time) the patient noticed a red rash that resembled a sun burn around the front part of her waist. The patient stated that the rash was not raised and was itching and burning and was also hot to touch. Blood work was done on 17-NOV-2012, everything came back normal. The outcome of the reported events were unknown. Patient did not seek medical attention and said she called the doctor and had an appointment on Monday. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Skin warm, Tremor, Wheezing
Clinical narrative: This spontaneous report as received from a consumer refers to a 61-year-old female patient who is allergic to sulfa. Patient had no pertinent medical history. On 14-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were not reported) subdermally. On the same day she also received Influenza Virus Vaccine (manufacturer unknown) (lot number, expiry date, dose and route were not reported). Concomitant medications included CLARINEX, vitamins (unspecified) Over-The-Counter (OTC), fish oil and glucosamine. On 14-NOV-2012, the patient went for swimming as usual and about 2-3 hours she started to experience wheezing, tightness in her chest, trembling, coughing and as well as chills. The symptoms lasted the entire night until the next morning. On 15-NOV-2012, the events wheezing, tightness in her chest, trembling, coughing and chills were resolved. The patient went swimming again 2 days later and the symptoms reappeared about 2-3 hours later. The patient attempted swimming on 2 more occasions and the exact thing appeared. On 03-DEC-2012, the patient went to the allergist and was prescribed VENTOLIN though she had no asthma. The patient reported that every time she went for swimming the same symptoms reappeared. She used VENTOLIN as directed and it only helped a little bit and very temporally. On 07-DEC-2012, about an hour ago of reporting, 08:30 MT (meridian time) the patient noticed a red rash that resembled a sun burn around the front part of her waist. The patient stated that the rash was not raised and was itching and burning and was also hot to touch. Blood work was done on 17-NOV-2012, everything came back normal. The outcome of the reported events were unknown. Patient did not seek medical attention and said she called the doctor and had an appointment on Monday. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Feeling hot, Injection site warmth, Joint swelling
Clinical narrative: Rash on extremities, hive on face & arm, red burning hands, knees swelling & hot. Injection site hot, throat irritation, (itching generalized). Ears hot & red, tremors.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash, Skin warm, Throat irritation, Tremor
Clinical narrative: Rash on extremities, hive on face & arm, red burning hands, knees swelling & hot. Injection site hot, throat irritation, (itching generalized). Ears hot & red, tremors.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Rash on extremities, hive on face & arm, red burning hands, knees swelling & hot. Injection site hot, throat irritation, (itching generalized). Ears hot & red, tremors.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Body temperature increased, Chest X-ray, Oropharyngeal pain, Pain
Clinical narrative: Woke with sore throat, worsening throughout the day by 3 PM low grade temp, body aches, pain, runny nose.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: Woke with sore throat, worsening throughout the day by 3 PM low grade temp, body aches, pain, runny nose.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Allergy test, Generalised erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Redness and swelling in right leg (Hepatitis A and Flu vaccine given day prior in that leg) that then progressed throughout his body- presumed hives and respiratory difficulties - taken by EMS to ED - treated with albuterol by EMS.  In ED - normal exam except for urticaria -given oral steroids; Benadryl and Pepcid.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Redness and swelling in right leg (Hepatitis A and Flu vaccine given day prior in that leg) that then progressed throughout his body- presumed hives and respiratory difficulties - taken by EMS to ED - treated with albuterol by EMS.  In ED - normal exam except for urticaria -given oral steroids; Benadryl and Pepcid.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: I developed a small itchy bump on the left hand side of my torso which spread across the majority of my left torso over the next two days. So VERY itchy and on 12/13 I contacted my Dr. who said to contact pharmacist so they could make a note of it in their records. He recommended Benadryl and cortisone cream. I used them twice a day with little to no improvement and went to an urgent care center on 12/17. The Dr. identified the rash as shingles then administered a steroid injection and prescribed two medications, Valtrex and Prednisone.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Flu-like symptoms within one-two hrs - dizziness, nausea, fever, flush - lasting up to time of this form completion. Reaction at injection site up to 4 days after, swollen, hotness, reddened area.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: Flu-like symptoms within one-two hrs - dizziness, nausea, fever, flush - lasting up to time of this form completion. Reaction at injection site up to 4 days after, swollen, hotness, reddened area.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Fever 102, arm swelling.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Redness, pain and circular patch on left deltoid @ site of the vaccine, isolated to site, treated with Keflex, prednisone and Ibu.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Confusional state, Disorientation, Laboratory test normal
Clinical narrative: Patient experienced confusion, memory loss, and had no sense of direction. She was driving with her husband and couldn't recall where she was going or why. Her husband instructed her to pull over and then took her to the ER. At the hospital, she began to regain awareness and memory. As of now, she still does not recall the time period when she was driving. Patient states that she has a good memory and is always alert. Hospital ran tests for stroke but nothing medically wrong was found. On Monday 12/17/12, the patient called me to ask about ingredients in the Fluzone she received on Saturday. She believes it was an allergic reaction to the vaccination. The hospital provided no treatment as the symptoms had resolved on their own. The hospital did not call regarding the vaccination.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Pt had onset of rigors about 1 hr after administration of vaccine.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Started with swollen gland in neck on 12/9. On 12/11 started feeling bad (achy and tired). On 12/12, call facility and was told adverse reactions are rare and to take Tylenol. 12/12 PM went to Hospital. Was diagnosed with acute viral illness with reactive leukopenia. Was given a shot and sent home. After feeling worse and a call to CDC, went to Medical Center. Was diagnosed with neutropenia post yellow fever injection and was admitted. Symptoms were: tingling down legs,  severe pain everywhere, especially lower back, severe joint pains, even her toe joints and fingers joints hurt, but especially her lower back, stiffness in neck, but she said it hard to move everything, headache, fever, swollen lymph node in neck, nauseous, dizzy when she moved, excessive fatigue.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Headache, Leukopenia, Lymphadenopathy, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Started with swollen gland in neck on 12/9. On 12/11 started feeling bad (achy and tired). On 12/12, call facility and was told adverse reactions are rare and to take Tylenol. 12/12 PM went to Hospital. Was diagnosed with acute viral illness with reactive leukopenia. Was given a shot and sent home. After feeling worse and a call to CDC, went to Medical Center. Was diagnosed with neutropenia post yellow fever injection and was admitted. Symptoms were: tingling down legs,  severe pain everywhere, especially lower back, severe joint pains, even her toe joints and fingers joints hurt, but especially her lower back, stiffness in neck, but she said it hard to move everything, headache, fever, swollen lymph node in neck, nauseous, dizzy when she moved, excessive fatigue.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Nausea, Neutropenia, Pain, Paraesthesia, Pyrexia
Clinical narrative: Started with swollen gland in neck on 12/9. On 12/11 started feeling bad (achy and tired). On 12/12, call facility and was told adverse reactions are rare and to take Tylenol. 12/12 PM went to Hospital. Was diagnosed with acute viral illness with reactive leukopenia. Was given a shot and sent home. After feeling worse and a call to CDC, went to Medical Center. Was diagnosed with neutropenia post yellow fever injection and was admitted. Symptoms were: tingling down legs,  severe pain everywhere, especially lower back, severe joint pains, even her toe joints and fingers joints hurt, but especially her lower back, stiffness in neck, but she said it hard to move everything, headache, fever, swollen lymph node in neck, nauseous, dizzy when she moved, excessive fatigue.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Viral infection
Clinical narrative: Started with swollen gland in neck on 12/9. On 12/11 started feeling bad (achy and tired). On 12/12, call facility and was told adverse reactions are rare and to take Tylenol. 12/12 PM went to Hospital. Was diagnosed with acute viral illness with reactive leukopenia. Was given a shot and sent home. After feeling worse and a call to CDC, went to Medical Center. Was diagnosed with neutropenia post yellow fever injection and was admitted. Symptoms were: tingling down legs,  severe pain everywhere, especially lower back, severe joint pains, even her toe joints and fingers joints hurt, but especially her lower back, stiffness in neck, but she said it hard to move everything, headache, fever, swollen lymph node in neck, nauseous, dizzy when she moved, excessive fatigue.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Back pain, Fatigue, Neutropenia, Paraesthesia, Pyrexia
Clinical narrative: Started with swollen gland in neck on 12/9. On 12/11 started feeling bad (achy and tired). On 12/12, call facility and was told adverse reactions are rare and to take Tylenol. 12/12 PM went to Hospital. Was diagnosed with acute viral illness with reactive leukopenia. Was given a shot and sent home. After feeling worse and a call to CDC, went to Medical Center. Was diagnosed with neutropenia post yellow fever injection and was admitted. Symptoms were: tingling down legs,  severe pain everywhere, especially lower back, severe joint pains, even her toe joints and fingers joints hurt, but especially her lower back, stiffness in neck, but she said it hard to move everything, headache, fever, swollen lymph node in neck, nauseous, dizzy when she moved, excessive fatigue.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Sensation of foreign body, White blood cell count
Clinical narrative: Started with swollen gland in neck on 12/9. On 12/11 started feeling bad (achy and tired). On 12/12, call facility and was told adverse reactions are rare and to take Tylenol. 12/12 PM went to Hospital. Was diagnosed with acute viral illness with reactive leukopenia. Was given a shot and sent home. After feeling worse and a call to CDC, went to Medical Center. Was diagnosed with neutropenia post yellow fever injection and was admitted. Symptoms were: tingling down legs,  severe pain everywhere, especially lower back, severe joint pains, even her toe joints and fingers joints hurt, but especially her lower back, stiffness in neck, but she said it hard to move everything, headache, fever, swollen lymph node in neck, nauseous, dizzy when she moved, excessive fatigue.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: CSF test, Dysarthria, Dysphagia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Patient presented to ED with left facial droop, slurred speech, difficulty swallowing, speaking, tongue swelling, tingling in hands and feet.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Speech disorder, Swollen tongue, VIIth nerve paralysis
Clinical narrative: Patient presented to ED with left facial droop, slurred speech, difficulty swallowing, speaking, tongue swelling, tingling in hands and feet.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: JUST FEELING BAD.  MUSCLE PAIN.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Mass, Pain, Pruritus
Clinical narrative: Large Red lump on left buttock, the size of a fifty cent piece, thought it was an insect bite. Apply Benadryl. By Sunday morning spot very larger and now spreading. Hot, burning and very itching down the back of my leg.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Large Red lump on left buttock, the size of a fifty cent piece, thought it was an insect bite. Apply Benadryl. By Sunday morning spot very larger and now spreading. Hot, burning and very itching down the back of my leg.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right deltoid redness, pain, and swelling.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain to left arm, difficult to lift or touch, fever, chills, body aches.  Symptoms improved within 24 hours. No treatment given.
Age: 24.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Headache, Sensation of pressure
Clinical narrative: See additional paged for medical records. Particularly details of both visits related to the adverse event. The patient is a 24 year old female who presents with a complaint of headache. The onset of the headache has been sudden and has been occurring on a persistent pattern for 3 days. The headache is characterized as throbbing and a pressure sensation. The headache is described as being located in the back of head. Note for "Headache": Patient state she had three bumps on her head one behind right ear two behind left ear.
Age: 1.05
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Development of fever to 104 degrees F with some irritability. Admitted to local hospital for observation. Medical treatment limited to acetaminophen. Pt discharged to home the following day.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Balance disorder, Central nervous system lesion, Coordination abnormal, Decreased appetite
Clinical narrative: Nausea that came on and continued, loss of appetite, vision problems,  balance problems most significant in early morning 4 am but nausea was the presenting symptom then developed into neuro logic-type symptoms involving coordination, vision and inability to eat due to constant nausea.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Nausea, Neurological symptom, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Nausea that came on and continued, loss of appetite, vision problems,  balance problems most significant in early morning 4 am but nausea was the presenting symptom then developed into neuro logic-type symptoms involving coordination, vision and inability to eat due to constant nausea.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Nausea that came on and continued, loss of appetite, vision problems,  balance problems most significant in early morning 4 am but nausea was the presenting symptom then developed into neuro logic-type symptoms involving coordination, vision and inability to eat due to constant nausea.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Oedema peripheral, Pain in extremity
Clinical narrative: Patient had complaint of pain and swelling, numbness of entire left arm. Sought medical attention on 11/14/2012.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Cystitis interstitial
Clinical narrative: Since having the Hep. B vaccine with a few other vaccinations I have developed interstitial cystitis. I was healthy before this event occurred and now have to live with this debilitating disease.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. The patients were vaccinated with a dose of PNEUMOVAX23 (lot #, dose and route not reported) about two years ago, in approximately 2010. No other co-suspects were reported. No concomitant medications were reported. The nurse mentioned that another unspecified office in their practice had two cases of cellulitis following vaccination with PNEUMOVAX23, which occurred about two years ago (approximately in 2010). No treatment information was reported. It was unknown if the patients sought medical attention. The outcome of cellulitis was unknown. The relatedness for cellulitis was not provided for PNEUMOVAX23. The reporting nurse considered cellulitis to be life threatening. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Conjunctivitis infective, Rash pruritic, Secretion discharge
Clinical narrative: W/in 48 hours I had 4 oozing, itchy bumps on scalp - 3 have mostly cleared up but one (attempted photo att'd) remains 4 days later. Also, I now have what I think is pink eye.
Sex: U
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 patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 26-JUL-2012 and dose 2 10-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced inappropriate schedule of vaccine administered, 138 days after onset of therapy. No adverse event reported. No treatment information was reported,. The outcome of inappropriate schedule of vaccine administered and no adverse event is unknown. Inappropriate schedule of vaccine administered and no adverse event is not related to GARDASIL. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Headache, Respiratory tract congestion, Sinus congestion
Clinical narrative: Congestion in chest, throat, sinuses. Headache. Coughing. General tiredness. Symptoms improved but not gone. Appeared 1 1/2 days after vaccination. No treatment sought yet.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cough, Dyspnoea, Headache, Myalgia
Clinical narrative: Headache, nasal congestion, runny nose, cough-productive-yellowish sputum, wheezing, SOB. Coughing-so hard that I would vomit and muscles sore from coughing; Violent coughing episode & increased temp. 100.2. MD KEFLEX, BIAXIN, VENTOLIN inhaler.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Nasal congestion, Productive cough, Rhinorrhoea, Vomiting, Wheezing
Clinical narrative: Headache, nasal congestion, runny nose, cough-productive-yellowish sputum, wheezing, SOB. Coughing-so hard that I would vomit and muscles sore from coughing; Violent coughing episode & increased temp. 100.2. MD KEFLEX, BIAXIN, VENTOLIN inhaler.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: Expired GARDASIL (HPV) given to patient.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Headache, Injection site mass, Injection site swelling, Myalgia, Nausea
Clinical narrative: Pt. developed a lump/swelling in his left deltoid about the size of a baseball. He also experienced a mild fever, nausea, and headache, along with general muscle aches throughout his body. When I followed up with this patient on the 23rd of February, the swelling was only slightly reduced with an intermittent headache. All other symptoms were resolved. Pt. treated himself with one ALLEVE a day.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Pyrexia
Clinical narrative: Pt. developed a lump/swelling in his left deltoid about the size of a baseball. He also experienced a mild fever, nausea, and headache, along with general muscle aches throughout his body. When I followed up with this patient on the 23rd of February, the swelling was only slightly reduced with an intermittent headache. All other symptoms were resolved. Pt. treated himself with one ALLEVE a day.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain, Pyrexia
Clinical narrative: Fever. Body aches.
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dyspnoea, Throat tightness
Clinical narrative: Had upset stomach about 1 minute, then her throat felt like it was closing and it was hard to breathe. Called 911, then administered EPIPEN JR. She began to feel better, paramedics came quickly, took her to hosp.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Patient given ZOSTAVAX. After injection, it was discovered that patient was receiving BCG for Bladder Cancer. Patient is under ongoing monitoring and had not had any adverse reactions.
Age: 6.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Blood glucose normal, Loss of consciousness
Clinical narrative: Pt was given 3 immunizations and approx. 5 minutes later, after a small amount of water, passed out - (pt had not eaten prior to immunizations).
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted the minute I administered flu vaccine (AFLURIA) to him. He regained consciousness immediately.
Age: 17.0
Sex: M
Vaccine: FLUN3
Symptoms: Abnormal behaviour, Activities of daily living impaired, Disturbance in attention, Feeling abnormal, Psychomotor hyperactivity
Clinical narrative: Within 30 min was acting "odd". Head felt "buzzed", "foggy". Difficulty concentrating. Unable to do certain activities. After several hours foggy feeling left then was "antsy", couldn't sit still. Fell asleep - awoke fine.
Age: 52.0
Sex: F
Vaccine: FLU3, HEP, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness, Upper extremity mass
Clinical narrative: Red, tender, swollen lump in (L) arm. Pt advised to apply warm compress and return if symptom worsens.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest pain, Discomfort, Injection site pain
Clinical narrative: Client returned to clinic on 12-13-12 for read of TB test. Client stated she had onset of left arm pain at site of injection, deltoid area, that extended to the shoulder, traveling down to left front chest and then down to left upper back that evening and through the next day. Discomfort dissipating. Referred her to see a doctor. Site of injection without signs of reaction.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Pyrexia
Clinical narrative: 45 min. post vaccine experienced - fever, cough, headache & chills x4 days. Cough persisted x16+ days; symptoms worsen with each vaccine. Will no longer do annual flu vaccines.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, erythema and warmth approx 8x15 cm area of (R) upper arm occurring 1 day after vaccine given. Treated with ice and NSAIDS.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Mobility decreased, Oedema peripheral, Pain, Skin discolouration
Clinical narrative: Vaccine administered 12/13 and patient reports was hurting & hot by the time he got home. Saw Dr 12/14 & put on prednisone. Patient still having pain & cannot raise arm independently on 12/18/12 arm had swollen & turned blackish & is still discolored today 12/18/12.