chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Viral test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 70 years old female patient with a pacemaker for her heart condition and drug reaction/allergy to BETADINE. The patient's medical history included shingles and cancer. The patient was vaccinated with single dose, 0.65 ml ZOSTAVAX, product circular # 9989115, vaccination date reported as 21-SEP-2012. No other co-suspects were reported. Concomitant medications included COUMADIN, METOPROLOL and FLECAINIDE ACETATE. After vaccination (also reported as on 20-SEP-2012) the patient experienced she developed flu-like symptoms, fever, malaise, headache, diarrhea and extreme fatigue. The patient's husband felt the patient should not have received ZOSTAVAX, as she is a cancer survivor who has had chemotherapy and also has already had shingles. He also stated the patients symptoms have not improved and have actually become worse. The patient did visit an urgent care center where they did a viral swab of the nose which came back negative. The patient was provided a treatment of TYLENOL WITH CODEINE and PROMETHAZINE. The physician reported that the extreme fatigue, malaise and fever are still present at the time of the call, but the diarrhea (described as 5 or 7 occurrences, dates unspecified) has resolved as of 30-SEP-2012. The patient's husband reported that his wife is continuing to have problems following vaccination with the ZOSTAVAX. The patient's husband stated that his wife is in "dire straits" and continues to have a fever. The fever resolved at 05-OCT-2012 and on an unknown date the patient had pink eye in both eyes and immune problems. The patient's husband reports that the patient developed a circular, red rash on her chest and back on 05-OCT-2012. She was admitted to hospital on 05-OCT-2012 and treated with "unspecified antibiotics" and "hydration therapy". The patient was discharged from the hospital on 07-OCT-2012. She was prescribed a 5 day course of CEFPODOXIME 200 mg twice per day and an "unspecified topical ointment" for the rash. The outcome of circular, red rash on her chest and back, she developed flu-like symptoms, malaise, headache, is in "dire straits", pink eye in both eyes, immune problems and extreme fatigue was reported as not recovered/not resolved. The outcome of diarrhea and fever was reported as recovered/resolved. The relatedness for circular, red rash on her chest and back, she developed flu-like symptoms, fever, malaise, headache, diarrhea, is in "dire straits", pink eye in both eyes, immune problems and extreme fatigue was not reported for ZOSTAVAX. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Altered state of consciousness, Chest discomfort, Crying, Dizziness, Dyskinesia
Clinical narrative: This 31 year old male report receipt of first AVA on 11/10/2008 to left upper arm subcutaneously. He advised approximately 2 min after leaving facility he began to feel dizzy "as if drunk". He returned to medical (estimates about 10-15 min since given vaccination) and placed flat. He recalled while speaking to medical staff he felt strange, had chest tightness, difficulty breathing with sensation of a rapid heart rate, and was crying for no reason. He advised tensing of hand-knees muscles then tensing and jerking of legs. His vision would fade in and out. This cycle came and went. He stated when his vision would fade in and out he would awaken with medical officer rubbing his chest or pinching arms. His medical  records note heart rate of 98 to 59 (vital signs: 10:06 am 168/95, heart rate 98 bpm; 10:09 am 167/92, HR 61 bpm; 10:12 am 140/91 HR 59 bpm; and 10:23 am 163/92, HR 87 bpm, 1027-1049 am BP 144-157/82-90, HR 69-90 bpm; Temperature 99 degree F, and respiratory rate not recorded, O2 sats 100% room air). His pulse was steady. His provider's exam documented "fluctuating consciousness being responsive to voice alternating with tactile stimuli only"; otherwise his exam was unremarkable. He was transported by EMS to ER where he reported being observed for a few hours and released. An ER discharge summary lists diagnosis of "reaction to immunization-resolved". Attempts to locate actual ER records at medical center have been unsuccessful by two providers. Patient  reported full recovery without relapse as of 11/21/2008. Pt recalls he ate a donut that morning and did not exercise. He denied any use of energy drinks that day but did use "stacker 2" supplements in workouts. Patient denied any use of other supplemental vitamins or medications. He denied any head injury, illness or health issues prior to vaccination (preparing for 2009 trip). He does not wear glasses. He did go go in Jan 2009 for 10 months without problems. Patient is concerned this syncopal event was an adverse reaction from the AVA vaccine. A review of limited medical records documented receipt of AVA vaccinations on 11/10/2008 (FAV168), 11/28/2008 (FAV196), 12/20/2008 (FAV196) and 3/27/2011 (unknown); however he denied receiving AVA 2, 3 or 4. Other vaccines given included FLUMIST on 11/24/2008 and SPV on 12/28/2008. He remembers no unexpected reactions from these two vaccinations or any since.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Feeling abnormal, Feeling drunk, Heart rate increased, Muscle tightness
Clinical narrative: This 31 year old male report receipt of first AVA on 11/10/2008 to left upper arm subcutaneously. He advised approximately 2 min after leaving facility he began to feel dizzy "as if drunk". He returned to medical (estimates about 10-15 min since given vaccination) and placed flat. He recalled while speaking to medical staff he felt strange, had chest tightness, difficulty breathing with sensation of a rapid heart rate, and was crying for no reason. He advised tensing of hand-knees muscles then tensing and jerking of legs. His vision would fade in and out. This cycle came and went. He stated when his vision would fade in and out he would awaken with medical officer rubbing his chest or pinching arms. His medical  records note heart rate of 98 to 59 (vital signs: 10:06 am 168/95, heart rate 98 bpm; 10:09 am 167/92, HR 61 bpm; 10:12 am 140/91 HR 59 bpm; and 10:23 am 163/92, HR 87 bpm, 1027-1049 am BP 144-157/82-90, HR 69-90 bpm; Temperature 99 degree F, and respiratory rate not recorded, O2 sats 100% room air). His pulse was steady. His provider's exam documented "fluctuating consciousness being responsive to voice alternating with tactile stimuli only"; otherwise his exam was unremarkable. He was transported by EMS to ER where he reported being observed for a few hours and released. An ER discharge summary lists diagnosis of "reaction to immunization-resolved". Attempts to locate actual ER records at medical center have been unsuccessful by two providers. Patient  reported full recovery without relapse as of 11/21/2008. Pt recalls he ate a donut that morning and did not exercise. He denied any use of energy drinks that day but did use "stacker 2" supplements in workouts. Patient denied any use of other supplemental vitamins or medications. He denied any head injury, illness or health issues prior to vaccination (preparing for 2009 trip). He does not wear glasses. He did go go in Jan 2009 for 10 months without problems. Patient is concerned this syncopal event was an adverse reaction from the AVA vaccine. A review of limited medical records documented receipt of AVA vaccinations on 11/10/2008 (FAV168), 11/28/2008 (FAV196), 12/20/2008 (FAV196) and 3/27/2011 (unknown); however he denied receiving AVA 2, 3 or 4. Other vaccines given included FLUMIST on 11/24/2008 and SPV on 12/28/2008. He remembers no unexpected reactions from these two vaccinations or any since.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Visual impairment
Clinical narrative: This 31 year old male report receipt of first AVA on 11/10/2008 to left upper arm subcutaneously. He advised approximately 2 min after leaving facility he began to feel dizzy "as if drunk". He returned to medical (estimates about 10-15 min since given vaccination) and placed flat. He recalled while speaking to medical staff he felt strange, had chest tightness, difficulty breathing with sensation of a rapid heart rate, and was crying for no reason. He advised tensing of hand-knees muscles then tensing and jerking of legs. His vision would fade in and out. This cycle came and went. He stated when his vision would fade in and out he would awaken with medical officer rubbing his chest or pinching arms. His medical  records note heart rate of 98 to 59 (vital signs: 10:06 am 168/95, heart rate 98 bpm; 10:09 am 167/92, HR 61 bpm; 10:12 am 140/91 HR 59 bpm; and 10:23 am 163/92, HR 87 bpm, 1027-1049 am BP 144-157/82-90, HR 69-90 bpm; Temperature 99 degree F, and respiratory rate not recorded, O2 sats 100% room air). His pulse was steady. His provider's exam documented "fluctuating consciousness being responsive to voice alternating with tactile stimuli only"; otherwise his exam was unremarkable. He was transported by EMS to ER where he reported being observed for a few hours and released. An ER discharge summary lists diagnosis of "reaction to immunization-resolved". Attempts to locate actual ER records at medical center have been unsuccessful by two providers. Patient  reported full recovery without relapse as of 11/21/2008. Pt recalls he ate a donut that morning and did not exercise. He denied any use of energy drinks that day but did use "stacker 2" supplements in workouts. Patient denied any use of other supplemental vitamins or medications. He denied any head injury, illness or health issues prior to vaccination (preparing for 2009 trip). He does not wear glasses. He did go go in Jan 2009 for 10 months without problems. Patient is concerned this syncopal event was an adverse reaction from the AVA vaccine. A review of limited medical records documented receipt of AVA vaccinations on 11/10/2008 (FAV168), 11/28/2008 (FAV196), 12/20/2008 (FAV196) and 3/27/2011 (unknown); however he denied receiving AVA 2, 3 or 4. Other vaccines given included FLUMIST on 11/24/2008 and SPV on 12/28/2008. He remembers no unexpected reactions from these two vaccinations or any since.
Age: 20.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Feeling hot, Rash
Clinical narrative: Client tolerated procedure well. Did not state any concerns with vaccine. During waiting period became dizzy hot and rashy area appeared on opposite arm from flu shot and around neck. Face became reddened. Pt recovered with rest, cool compress and laying down x 30min. BP 128/76 WNL.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Dyspnoea, Heart rate increased, Hypertension, Liver function test normal
Clinical narrative: Developed itchy hands, neck and head, then all over. Dyspnea and SOB; red rash on arms, neck, face. Tongue red and swollen, throat red and swollen. B.P. and P. high. Had flu shot at 820AM. Took BENADRYL at 1:20PM. Seen in flu clinic at 1:30PM - given BENADRYL and called 911.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal erythema, Pharyngeal oedema, Pruritus generalised, Rash, Rash erythematous
Clinical narrative: Developed itchy hands, neck and head, then all over. Dyspnea and SOB; red rash on arms, neck, face. Tongue red and swollen, throat red and swollen. B.P. and P. high. Had flu shot at 820AM. Took BENADRYL at 1:20PM. Seen in flu clinic at 1:30PM - given BENADRYL and called 911.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Tongue disorder
Clinical narrative: Developed itchy hands, neck and head, then all over. Dyspnea and SOB; red rash on arms, neck, face. Tongue red and swollen, throat red and swollen. B.P. and P. high. Had flu shot at 820AM. Took BENADRYL at 1:20PM. Seen in flu clinic at 1:30PM - given BENADRYL and called 911.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Balance disorder, Feeling hot, Gait disturbance, Headache
Clinical narrative: Today woke up sweating that pajamas and bed sheets were soaked. Temperature above 102 severe headache on back head upper neck weakness, trouble walking, wobbly. Site of injection swelling and redness 3 inches in diameter. By 4am fever broken down to 100. Right now on the warm side, sweaty, a bit of weakness. Did not receive Flu on same facility.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Today woke up sweating that pajamas and bed sheets were soaked. Temperature above 102 severe headache on back head upper neck weakness, trouble walking, wobbly. Site of injection swelling and redness 3 inches in diameter. By 4am fever broken down to 100. Right now on the warm side, sweaty, a bit of weakness. Did not receive Flu on same facility.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Discomfort, Malaise, Mobility decreased, Muscle spasms
Clinical narrative: My wife and I each had flu vaccinations at the same time, on the same date, and at the same facility. My wife is a life-long asthmatic and, as such, decided to take the pneumonia vaccine. The vaccinations were obtained on Monday, October 8, 2012. The first day, she experienced only very mild "serum sickness" symptoms of temperature of 99 degrees, generalized muscle aches, and mild malaise. The second day, there was the onset of more-severe muscle pain which was localized to the neck, shoulders, and upper trunk. The pain was present at rest but became much greater with motion, simulating the severe muscle cramps that occur with athletic endeavors. By the late afternoon, she was extremely uncomfortable with the muscle pains which had begun to limit any activity related to motion of the neck and arms. There was no headache, the temperature remained only slightly elevated, but the muscle pains continued to increase in severity. I took it upon myself to start her on a 4 mg MEDROL dose pack in order to block the pain. She also was given one ROBAXIN tablet and one-half of a 7.5 mg VICODIN so that she could sleep. The third day was the worst with the muscle pain. The same muscle groups were involved with constant but increasing pain at rest with very severe (crying out) pain with the slightest motion. Movement of only millimeters triggered intense muscle spasm that continued until the muscles were again released and placed at rest, with the pain not disappearing but returning to the "baseline." In all my years in medicine, the closest clinical picture to that which I was witnessing was a full-blown case of Tetanus when I was a sophomore medical student in 1952. She remained as motionless as possible, out of bed only with great pain and a large amount of help for trips to the bathroom. I continued the oral steroids, ROBAXIN in larger doses, and a small amount of VICODIN for help with sleep. Due to a missed communication, I was unable to report to the Minor Emergency facility where she had received the injections. Beginning with the fourth day, all of the symptoms began to subside to the point that she remained in a great deal of muscle pain, but could, with help move about and show some very minimal improvement. The only significant change was that, as the pain improved in the upper part of the body, it began to involve the trunk, pelvis, and legs. In subsequent days, all of the symptoms have improved but, even at this time (10th day), she remains symptomatic with pain in the pelvis, legs, and strap muscles of the neck. She saw our local internist yesterday, and he believes that this pattern was and is a reaction to the flu vaccine and warned her to not take another, and he will give her TAMIFLU should she become exposed or symptomatic in the future.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain, Serum sickness
Clinical narrative: My wife and I each had flu vaccinations at the same time, on the same date, and at the same facility. My wife is a life-long asthmatic and, as such, decided to take the pneumonia vaccine. The vaccinations were obtained on Monday, October 8, 2012. The first day, she experienced only very mild "serum sickness" symptoms of temperature of 99 degrees, generalized muscle aches, and mild malaise. The second day, there was the onset of more-severe muscle pain which was localized to the neck, shoulders, and upper trunk. The pain was present at rest but became much greater with motion, simulating the severe muscle cramps that occur with athletic endeavors. By the late afternoon, she was extremely uncomfortable with the muscle pains which had begun to limit any activity related to motion of the neck and arms. There was no headache, the temperature remained only slightly elevated, but the muscle pains continued to increase in severity. I took it upon myself to start her on a 4 mg MEDROL dose pack in order to block the pain. She also was given one ROBAXIN tablet and one-half of a 7.5 mg VICODIN so that she could sleep. The third day was the worst with the muscle pain. The same muscle groups were involved with constant but increasing pain at rest with very severe (crying out) pain with the slightest motion. Movement of only millimeters triggered intense muscle spasm that continued until the muscles were again released and placed at rest, with the pain not disappearing but returning to the "baseline." In all my years in medicine, the closest clinical picture to that which I was witnessing was a full-blown case of Tetanus when I was a sophomore medical student in 1952. She remained as motionless as possible, out of bed only with great pain and a large amount of help for trips to the bathroom. I continued the oral steroids, ROBAXIN in larger doses, and a small amount of VICODIN for help with sleep. Due to a missed communication, I was unable to report to the Minor Emergency facility where she had received the injections. Beginning with the fourth day, all of the symptoms began to subside to the point that she remained in a great deal of muscle pain, but could, with help move about and show some very minimal improvement. The only significant change was that, as the pain improved in the upper part of the body, it began to involve the trunk, pelvis, and legs. In subsequent days, all of the symptoms have improved but, even at this time (10th day), she remains symptomatic with pain in the pelvis, legs, and strap muscles of the neck. She saw our local internist yesterday, and he believes that this pattern was and is a reaction to the flu vaccine and warned her to not take another, and he will give her TAMIFLU should she become exposed or symptomatic in the future.
Sex: M
Vaccine: FLUX, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site pain in a male subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; manufacturer unspecified; unknown; unknown given on 13 February 2012; meningococcal acwy vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 13 February 2012. On 13 February 2012 the subject received a dose of BOOSTRIX (unknown route, left arm). On 13 February 2012, immediately after vaccination with BOOSTRIX, the subject experienced injection site pain and facial hives. The subject was given BOOSTRIX and immediately after the vaccination he developed hives on his face and complained of pain at the injection site. The subject was treated with BENADRYL and after 30 minutes he was "fine". The lot number provided for the BOOSTRIX was not in the correct batch numbering system for BOOSTRIX, but attempts to clarify with the reporter were unsuccessful. The healthcare professional considered the events were clinically significant (or requiring intervention). At that time of reporting the facial hives were improved and the injection site pain was resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow up information received from the healthcare professional on 21 February 2012. The healthcare professional reported that the correct lot number for the BOOSTRIX is AC52B073CA. No further detail was provided.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Swollen tongue
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of anaphylactic reaction in a 37-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) and FLULAVAL. A physician or other health care professional has not verified this report. Concurrent medical conditions included latex allergy and possible allergy to penicillin. Concurrent medications included SYNTHROID and Oral contraceptive. On 12 January 2012 at 14:00 the subject received a dose of BOOSTRIX (unknown route, left arm) and FLULAVAL (unknown route, right arm). On 13 January 2012, approximately 15 minutes after vaccination with BOOSTRIX and FLULAVAL, the subject experienced anaphylactic reaction, swollen tongue and swollen throat. This case was assessed as medically serious by GSK. The subject was treated in an emergency room with Epinephrine, prednisone and BENADRYL. At the time of reporting the events were improved.
Age: 30.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bumps around injection site in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included FLUZONE (Sanofi) given in the right arm on 3 March 2012. Concurrent medications included PERCOCET and MOTRIN. On 3 March 2012 at 14:43, two days post normal delivery of a newborn, the subject received a dose of BOOSTRIX in the left arm. On 3 March 2012, 47 minutes after vaccination with BOOSTRIX, the subject experienced bumps around injection site and injection site redness as well as injection site hives. The subject was treated with BENADRYL. On 3 March 2012, 63 minutes following event onset, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. Based on the subject's reaction, it was noted that she would not receive further vaccinations with BOOSTRIX. Follow up information received from the subject's pharmacist on 11 June 2012. The pharmacist reported that the subject received BOOSTRIX 0.5 ml dose. She noted that BOOSTRIX ("Tdap") was the suspect vaccine and that she did not consider the events serious. The pharmacist marked that no action was taken with the BOOSTRIX and that immunization series was discontinued. The pharmacist confirmed that the events were started and resolved on 03 March 2012.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Eyelid oedema, Respiratory distress, Vomiting
Clinical narrative: Respiratory system, (lungs) distress, eyes swollen shut, vomiting.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site pain, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site lump in a 57-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to morphine, ROCEPHIN allergy and metal plate in arm. Concurrent vaccination included seasonal influenza vaccine (non-gsk); Sanofi Pasteur; unknown; left arm given on 27 January 2012. Concurrent medications included Simvastatin, DIOVAN, Metformin, Metoprolol, TRILIPIX, Glimepiride, Venlafaxine and aspirin. On 27 January 2012 between 09:50 and 10:00, the subject received a dose of BOOSTRIX (.5 cc, unknown route, right arm). On 29 January 2012, 2 days after vaccination with BOOSTRIX, the subject experienced lump or knot at injection site, extreme pain at injection site, "injection more painful with movement" and redness at injection site. It was reported that the subject has a metal plate in his arm in the area where the BOOSTRIX vaccine was administered. It was noted that the flu vaccine was administered in the opposite arm. The subject was treated with ibuprofen. At the time of the reporting, all the events were unresolved. The healthcare professional considered all the events were probably related to vaccination with BOOSTRIX.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling at site (right arm) pain. Hot packs, BENADRYL, SEPTRA DS bid x 7 days.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Cough, Dyspnoea, Heart rate increased, Hypersensitivity
Clinical narrative: Approx. 2 hrs. aft. rec. flu shot c/o itching, cough, SOB; increased HR, increased B/P, eyes red- went to Hosp. ER - Dx - Allergic react. Rx. Albuterol and Prednisone.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pruritus
Clinical narrative: Approx. 2 hrs. aft. rec. flu shot c/o itching, cough, SOB; increased HR, increased B/P, eyes red- went to Hosp. ER - Dx - Allergic react. Rx. Albuterol and Prednisone.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Oedema peripheral, Sensation of foreign body
Clinical narrative: Patient was given BOOSTRIX (Tdap) in LD around 11:30 10-16-12. She states she ran errands & then went home to take a nap. When she woke up around 1600 on 10-16-12, she noticed swelling bilaterally in all 4 extremities & she felt like she had something in her throat. She called her primary Dr. office & was Rx liquid BENADRYL. Spoke with patient this AM & she states only swelling noted to (L) ankle.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Injection site erythema
Clinical narrative: Pt. c/o feeling SOB in nasal passage et c/o red area over injection site.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Pt presents to office 1 day after injection in (L) deltoid. 5.5 x 7 cm red, warm whelp at site. C/o soreness at site. No red streaking. No wheezing or facial swelling. I put TOPICORT ointment (steroid) on site. Drew a line around it so mom can call back if worse after treatment. Advised mom to give 2 tsp BENADRYL and MOTRIN every 6 hours. Ice the area the rest of afternoon.
Age: 11.0
Sex: U
Vaccine: FLU3, HPV4, TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness at inj. site (L) deltoid.
Age: 1.34
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt. rec'd vac DTaP on 10/15/12 at OV. Mom called 10/17/12 and stated quarter size red raised hard area at site of vacc. inj. - mom advised cool compress 10 min at time, MOTRIN if needed, 1% hydrocortisone cr for itching.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Patient presented with left arm swelling, redness, and warmth. Advised to apply cool compresses and take TYLENOL for pain. PCP prescribed BENADRYL and Prednisone for swelling.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Lymphadenopathy, Pyrexia
Clinical narrative: Pt. w/ noted on (L) arm at site of inoculation a 8cm x 6cm ovoid area of erythema and induration. Diffuse axillary adenopathy. Subjective fever and headache reported.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Cellulitis
Clinical narrative: (L) arm cellulitis 10/12/12. Tx with BACTRIM and KEFLEX and TYL #3.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope, Tongue biting, Tooth fracture
Clinical narrative: Pt fainted in waiting room breaking her tooth and bite her tongue. We took pt to dental then the ambulance came to pick pt up.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Hyperhidrosis, Inflammation, Oedema peripheral, Pyrexia
Clinical narrative: Arm became swollen (bicep) 1-2 days after injection. Pt. contacted MD and was told to get to OTC BENADRYL treatment. Spoke w/ pt. 10-1-2012 he had recovered. Arm was red/discolored/inflamed. Pt. had sweats/fever. Inj. 9-24-12. Treatment 9-26-2012.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin discolouration
Clinical narrative: Arm became swollen (bicep) 1-2 days after injection. Pt. contacted MD and was told to get to OTC BENADRYL treatment. Spoke w/ pt. 10-1-2012 he had recovered. Arm was red/discolored/inflamed. Pt. had sweats/fever. Inj. 9-24-12. Treatment 9-26-2012.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient had immediate swelling/redness at injection site. By evening, she had redness down to elbow and intense itchiness. After taking BENADRYL every 4-6 hours, it is now only red/swollen at injection site and itching has resolved.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Chapped lips, Lip pain
Clinical narrative: Vaccine administered on 09/25/12, patient woke up on 09/27/12 w/ chapped lips, pain, and cracking. Patient came into our clinic today to be seen for above symptoms.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 6 inch area of swelling at site with redness, warm, pruritus. ZOSTAVAX was given.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient stated he has low-grade pain (2-3/10, pain scale) since he had vaccine on 9/8/12. He denied any other sx such as fever, redness/inflammation on injection site. Patient called his doctor and he was told to take TYLENOL for pain. He still complains about low-grade pain.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Flu shot given 10/10/12. Pt returned 10/17/12 and reported she still had hives from the vaccine.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Contusion, Erythema, Feeling abnormal
Clinical narrative: Feeling cold, chills, sore, upset stomach at night. On Saturday, upset stomach, red, hot and itchy, felt terrible, didn't do much. On Sunday red migrating down arm. Sore and itchy. Today is almost above elbow like a bruise. Part of it under arm. This morning had sweats.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis, Pain in extremity, Pruritus
Clinical narrative: Feeling cold, chills, sore, upset stomach at night. On Saturday, upset stomach, red, hot and itchy, felt terrible, didn't do much. On Sunday red migrating down arm. Sore and itchy. Today is almost above elbow like a bruise. Part of it under arm. This morning had sweats.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Nausea, Vomiting
Clinical narrative: Patient's daughter called on 10/15 and advised her father received shot earlier during day. That night he was vomiting and reported loss of appetite. Patient did not seek medical care. Pharmacy called and checked on patient following day - pt felt better but still nauseated.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Pt states went home after receiving vaccine had headache, fever, muscle pain. Felt better after 1 hour.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Asthenia, Headache, Pain
Clinical narrative: Patient experienced body weakness, headache, soreness, used ibuprofen to relieve symptoms.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site swelling, Rash
Clinical narrative: Rash on left arm with moderate swelling at injection site, BENADRYL relieved symptoms within 2 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Pruritus
Clinical narrative: About 5 minutes after receiving vaccine pt said she had intense itchiness and her chest was heavy and she was having a little difficulty breathing. RPh gave 50mg of liquid diphenhydramine for reaction. Patient rested about 20 min and felt better.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Poor quality sleep
Clinical narrative: Vaccine given 9-25-12. On 10-16-12 pt. reported painful shoulder, possibly in joint for 3 weeks after injection. Pain is waking her up at night. She is thinking about going to the Dr. in a few days if it does not improve.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Muscular weakness, Rash
Clinical narrative: Patient reports soreness and muscle weakness in PNEUMOVAX injected arm (left side). There was a bump that developed days later in shoulder area. Her doctor was notified and she will follow-up with an appointment.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Client came to my pharmacy 14 days after flu shot was given and stated he was experiencing a rash on his left side of neck and left arm. Same arm shot given.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Tightness in chest and throat 4-5 hours following injections. In ER; nebulizer tmt given and cortisone. Rx for Prednisone 20 mg 2 QD x 3 days.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: 10/1/12 AM KINRIX given (L) arm. 10/3/12 AM mom brought child in - arm erythematous, hard, swollen - 6 3/4 inches - 4 1/2 inches form shoulder to above elbow. 10/4/12 PMD Rx'd prednisone & cephalexin. 10/11/12 arm back to normal.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Discomfort, Pain, Paralysis
Clinical narrative: Ptat complains of pain, discomfort and as her note said "paralyzed" (note attached). MD evaluation noted bruising & discomfort.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states he can barely move arm, nor can he lift it above his head. He states that he was fine the day of the shot and a couple days after, but then his arm began to ache and this morning he can barely move it.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Myalgia, Pain of skin
Clinical narrative: After patient received the HIGH-DOSE FLUZONE vaccine, she complained of terrible muscle ache all over her body lasted for approximately 30 hrs. She is now feeling a lot better. She is also said that her scalp and hair is painful to the touch. Local site reaction.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient said right after the shot, the area was swollen and solid red circle (about 2") and pain down to her whole arm. When patient came in and report on 10/10/12, not red anymore, but still swollen. She started LEVAQUIN for sinus infection 2 days after the shot. Nurse think patient got infection from shot. Recommend to check with her Dr. Dr. couldn't conclude what caused it.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis
Clinical narrative: Patient said right after the shot, the area was swollen and solid red circle (about 2") and pain down to her whole arm. When patient came in and report on 10/10/12, not red anymore, but still swollen. She started LEVAQUIN for sinus infection 2 days after the shot. Nurse think patient got infection from shot. Recommend to check with her Dr. Dr. couldn't conclude what caused it.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Rash generalised
Clinical narrative: Pt. received both a ZOSTAVAX vaccine subcutaneously and a FLUVIRIN vaccine IM; both in right arm. Within about 1/2 hour pt. felt dizzy and area of ZOSTAVAX became very red, hot and swollen, and rash appeared over most of body. Swelling of arm resolved, rash resolving. ER Dr. put her on prednisone and hydroxyzine.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Full blood count normal, Metabolic function test normal, Pallor, Skin warm
Clinical narrative: After shots and done waiting in office - WCL d/c. While in parking lot she felt dizzy and facing pale so father brought her back to office. Looking pale with HR 79 strong no distress alert warm to touch pink nail bed - observation done with fully recovered.
Age: 50.0
Sex: M
Vaccine: HEPAB, JEV1, PPV, TYP, YF
Symptoms: Chills, Dyspnoea, Erythema, Fatigue, Malaise
Clinical narrative: Fever 101 degrees, chills. Body aches. Malaise. Severe fatigue. SOB with movement/walking. Scratchy throat. (L) arm warm, red, swollen like a baseball size x4 days after vaccines. 10/15 - advised to apply ice, take ibuprofen, see PCP.
Age: 50.0
Sex: M
Vaccine: HEPAB, JEV1, PPV, TYP, YF
Symptoms: Oedema peripheral, Pain, Pyrexia, Skin warm, Throat irritation
Clinical narrative: Fever 101 degrees, chills. Body aches. Malaise. Severe fatigue. SOB with movement/walking. Scratchy throat. (L) arm warm, red, swollen like a baseball size x4 days after vaccines. 10/15 - advised to apply ice, take ibuprofen, see PCP.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection in right deltoid, pt states she has redness swelling and pain at site. Advised to ice for 24h then heat and use ibuprofen.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: 3 days after injection, patient had a generalized rash not explained by anything else. Patient took BENADRYL to help treat.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Febrile convulsion, Otitis media
Clinical narrative: Patient experienced a brief simple febrile seizure 48 hrs after immunization. Seen in ER diagnosed with feb. seizure & OM.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Oedema peripheral
Clinical narrative: C/O redness and itching from injection site to elbow the 1/2 the circumference of the arm - arm edematous.
Age: 56.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site infection, Pyrexia, Tenderness
Clinical narrative: Pt got both Flu/Pneumo vaccine in same arm on 10/7/12 flu shot on front Pneumo 2 inches behind. Pt felt feverish and arm tenderness for 2 days after vaccination. Has taken TYLENOL/MOTRIN and iced arm. Fever has improved but redness on flu site lingers MD prescribed BACTRIM said had a skin infection.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Influenza like illness, Injection site anaesthesia, Injection site haematoma, Injection site mass
Clinical narrative: States initial flu like symptoms, lasting less than 24 hours. She states bruising at site and continued pain. She states numbness and tingling from shoulder to fingers from administration site (left arm) began 10/05/2012. Immunization was given 09/14/2012. States she was seen at Occ. Health on 09/26/2012, provider stated they felt a small bump at site.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Pain, Paraesthesia
Clinical narrative: States initial flu like symptoms, lasting less than 24 hours. She states bruising at site and continued pain. She states numbness and tingling from shoulder to fingers from administration site (left arm) began 10/05/2012. Immunization was given 09/14/2012. States she was seen at Occ. Health on 09/26/2012, provider stated they felt a small bump at site.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Injection site oedema, Scab, Secretion discharge
Clinical narrative: Returned to clinic 11 days after vaccine rec'd with dermatologic reaction on forehead above (R) eye. Clear, weeping vesicles as well as crusted, dry vesicles present, approximately 2 sq in. on forehead. Denies itching, pain, or fever. Slight edema also noted at site. Agreed to contact primary care physician immediately to be evaluated.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Returned to clinic 11 days after vaccine rec'd with dermatologic reaction on forehead above (R) eye. Clear, weeping vesicles as well as crusted, dry vesicles present, approximately 2 sq in. on forehead. Denies itching, pain, or fever. Slight edema also noted at site. Agreed to contact primary care physician immediately to be evaluated.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a registered nurse refers to a patient of unknown age. The patient received expired GARDASIL (lot# 1130X exp date 13-MAR-2011, dose and route unspecified) on 20-SEP-2012. No adverse event reported. At the time of reporting, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a registered nurse refers to a patient of unknown age. The patient received expired GARDASIL (lot# 1130X exp date 13-MAR-2011, dose and route unspecified) on 21-SEP-2012. No adverse event reported. At the time of reporting, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patient. The patient was vaccinated with the first and second doses of GARDASIL (lot number, dose, route not reported) about one year ago. No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient was in the office to get the third dose. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: This spontaneous report was received from a healthcare worker concerning to a 23 years old female patient with penicillin allergy. The patient was vaccinated with the first dose 0.5 ml GARDASIL (lot not provided) approximately in October 2006 (6 yeas ago) when the patient was 17 years old. No other co-suspects were reported. No concomitant medications were reported. The caller reported that the patient was vaccinated IM with the second dose of 0.5 ml GARDASIL (lot number H011350 exp. Date: 21-FEB-2015) on 02-OCT-2012 and had a reaction. Next day on 03-OCT-2012, the patient developed hives on her back and her chest, and a rash on her body. The patient called the doctor office on the night of 03-OCT-2012 and the treatment recommended was over the counter BENADRYL. On follow up call to the patient the next day, the patient told the healthcare worker that when she took BENADRYL the hives/rash disappeared. The reporter stated that the patient when was vaccinated with the first dose of 0.5 ml GARDASIL she had no adverse effects after that first dose. At the time of the report the patient was recovering from the events. The relatedness for hives on her back and her chest and patient developed "rash on her body" is unknown for GARDASIL. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a female consumer refers to her 19-year-old son with no pertinent medical history. On 17-JUN-2010, the patient was vaccinated with the first dose of GARDASIL under the skin in the arm (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient had only received 1 out of 3 doses of GARDASIL to date. Additional information has been requested.
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. The patient was vaccinated with dose 1 and 2 of GARDASIL IM, on 31-OCT-2011 and 01-AUG-2012 respectively (dose and lot number not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age, unknown gender. The patient was vaccinated intramuscularly with first and second doses of GARDASIL (lot number not reported) on 17-JAN-2007 and 07-DEC-2007 respectively. No other co-suspects were reported. No concomitant medications were reported. The patient would be administered the third dose in the vaccination schedule on 15-OCT-2012. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an immunization nurse refers to 3 female patients of unknown age. The patients were vaccinated with first doses of GARDASIL (lot number unspecified) on an unknown date. But for their second dose, the 3 patients were administered CERVARIX (GSK, lot number unspecified). No concomitant medications were reported. No adverse reaction reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was received 3 doses of GARDASIL (route, dose and lot # were unknown) in the past, started "about a year ago" (in 2011). Specific dates of administration for the GARDASIL were unavailable. No other co-suspects were reported. No concomitant medications were reported. Now the patient had a positive pap smear test. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.