chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.22
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired drug administered, No adverse event
Clinical narrative: None on adverse events - no signs & symptoms. Expired vaccine administered. Mother of pt informed; she would prefer to repeat dose after few mos. Pt in good condition before leaving facility.
Age: 29.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Excoriation, Head injury, Neck injury, Syncope
Clinical narrative: Fainted & hit & neck, abrasions to neck, paramedics assessed. Refused further medical care.
Age: 0.17
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, Feeling abnormal, Nodule, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 8 week old son with no pertinent medical history and no drug reaction or allergies on 24-MAR-2011 was vaccinated subcutaneously with a 0.5ml dose of MMR II (Lot# 669200/1346Z, expired date October 2012). There was no concomitant medication. On 24-MAR-2011 the patient experienced fever, a knot in the leg and seemed spaced out. The reporter reported this to the doctor who advised the reporter to give her son TYLENOL and wait. No lab diagnostics studies performed. The reporter stated she was concerned that MMR II was given at a young age. The reporter planned to follow up with her health care provider. At the time of this report, the status of the patient was not known. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Sensation of pressure
Clinical narrative: Initial report received from healthcare professional on 30 April 2012. An 18-year-old female patient, whose medical history included history of allergy to tree nuts and not to eggs and concomitant medications were not reported, had received subcutaneous dose of YF-VAX (batch number UH277AA), at left arm on 23 April 2012. On 30 April 2012 i.e. 7 days after the vaccination, the patient experienced pressure in her "axillary" area and under her breast. She also had redness around the area of vaccination. The lab details and corrective treatment details were not reported. The outcome of event was not reported. Documents held by sender: None.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Constipation, Lethargy
Clinical narrative: A 10-weeks-old female patient had received an intramuscular (IM) injection of PENTACEL (lot number and site of administration not reported) on 16 January 2012. On an unspecified date after the vaccine, the patient was constipated for six days. She also developed increased lethargy and was advice by the physician to take her to the emergency room (ER). No further informational was available at the time of this report. The patient outcome was reported as unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Pruritus, Rash generalised
Clinical narrative: Initial report was received on 12 November 2011 from a health care professional. A 57-year-old male patient with an allergy to sunflower seeds had received TYPHIM Vi (lot number, route, site and date of administration not reported), YF VAX (lot number, route, site and date of administration not reported) and HAVRIX (manufacturer, lot number, route, site and date of administration not reported) and eight to ten hours after vaccination while he was sleeping, experienced itching and a rash from armpits to waist and posteriorly down to the back of his knees. The patient reported it was "not hives". According to the reporter, they were not sure if the events could be attributed to vaccination at all, either on specific vaccine or a combination of the vaccines. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: None.
Sex: F
Vaccine: YF
Symptoms: Influenza like illness, Pain
Clinical narrative: Initial report was received from a health care professional on 30 November 2011. A female patient had received a subcutaneous injection of YF VAX, sanofi pasteur Inc., (lot number, site and exact date of administration not reported) in September 2011. At 2:00 AM following the vaccination, the patient felt a little achy all over and felt as if they had flu-like symptoms. The patient felt fine later that morning. The patient had no illness at the time of vaccination. It was unknown if the patient took any concomitant medications or had any relevant past medical history. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Dysgeusia, Nausea, Vomiting
Clinical narrative: Initial report was received from a health care professional on 10 January 2012. A female patient (age and date of birth not reported) had received an injection of YF VAX (lot number, route and site of administration not reported) on 06 January 2011. On the same day twenty minutes after vaccination, the patient developed a metallic taste in her mouth. On 07 January 2011, she got nauseated and vomited and went to the emergency room (ER). No further information was available at the time of the report. The patient outcome was unknown. Follow-up information was received from a health care professional on 27 February 2012. The lot number for YF VAX was UH140AA. The patient received the injection subcutaneously in the left deltoid on 05 January 2012 (previously reported as 06 January 2011). The patient went to a rapid care facility and was treated with intramuscular phenergan and oral ciprofloxacin and promethazine. The patient's concomitant medications included Combi Patch 50/140. The patient's outcome was recovered. Documents held by sender: None. Follow up information received on 11 and 14 May 2012: It was reported that the events recovered within a couple of days and the date of vaccination was confirmed as 05 January 2012 and onset date was confirmed as 06 January 2012. Documents held by sender: None.
Age: 51.0
Sex: M
Vaccine: YF
Symptoms: Eye pain, Lymph node pain, Lymphadenopathy, Pyrexia, Sinus headache
Clinical narrative: Initial report was received from a health care professional on 01 August 2011. A 51 year-old male patient who is a smoker with no other significant past medical history had received a Yellow Fever Vaccine (manufacturer, lot number, route, site and date of administration not reported) and 21 days later, he experienced pain behind his right eye, postnasal drip, tactile fever and a swollen lymph node in his right neck. He was evaluated by a physician. During physical exam the patient was found to have sinus pressure and tender lymphadenopathy. The physician treated the patient for a sinus infection. According to the physician, the patient's "history was complicated by having received the vaccine". No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 06 September 2011. The patient's birth date was reported. The patient received a right deltoid injection of YF VAX, sanofi pasteur Inc. lot number UF805AA, on 13 July 2011 at 5:55 PM. The outcome was reported as recovered. Documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: YF
Symptoms: Sinusitis, Upper-airway cough syndrome
Clinical narrative: Initial report was received from a health care professional on 01 August 2011. A 51 year-old male patient who is a smoker with no other significant past medical history had received a Yellow Fever Vaccine (manufacturer, lot number, route, site and date of administration not reported) and 21 days later, he experienced pain behind his right eye, postnasal drip, tactile fever and a swollen lymph node in his right neck. He was evaluated by a physician. During physical exam the patient was found to have sinus pressure and tender lymphadenopathy. The physician treated the patient for a sinus infection. According to the physician, the patient's "history was complicated by having received the vaccine". No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 06 September 2011. The patient's birth date was reported. The patient received a right deltoid injection of YF VAX, sanofi pasteur Inc. lot number UF805AA, on 13 July 2011 at 5:55 PM. The outcome was reported as recovered. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination error
Clinical narrative: Initial report was received on 22 July 2011 from a health care professional which involved a case of misuse. A five year-old male patient with no reported past medical history and no reported adverse events following prior vaccinations had received on 21 July 2011 a fifth dose subcutaneous left upper inner thigh injection of PENTACEL, lot number C3664AA (also reported C3553AA) and the next day experienced left leg tenderness, warmth, pain in upper thigh and a red spot at the injection site. The patient was evaluated by a physician. Treatments were not reported. The patient's previous vaccination history included four DTaP, three ACTHIB and three IPOL but no previous PENTACEL injections. No further information was available at the time of the report. The patient's  outcome was not recovered. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site discolouration
Clinical narrative: A female infant, who was five months of age at the time of the report, had received a first dose injection of PENTACEL (lot number, route, site and date of administration not reported) "months ago", and an unspecified amount of time later, she experienced persistent crying and a blackish-blue discoloration at the site. Outcome was not reported. It was not reported if the patient had any concurrent illness, past medical history or concomitant medications usage at the time of the event. Outcome was not reported. This patient subsequently experienced this same event after receiving ACTHIB, which has been captured in case number 2011-02903. Documents held by sender: None.
Age: 1.53
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site induration, Injection site papule
Clinical narrative: Initial report received on 23 March 2012 from a health care professional on 23 March 2012. An 18 month old patient (gender not reported) with unknown medical history had received a dose of PENTACEL on 20 March 2012 and 2 days later, the patient's mother reported to the physician that the patient had a 5 cm area of erythema and induration at the injection site that was warm to touch. The patient was treated with MOTRIN and BENADRYL. The following day, the patient was evaluated by the physician and on examination only had a purple area left at the injection site, but had fine red papules that surrounded the site. Later that day, the patient developed fine, red papules covering the trunk of the body, from the knees to the mid back. A strep test was negative. The reporter did not have time to provide any further information. At the time of this report the patient had not recovered. Documents held by sender: None.
Age: 1.53
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth, Papule, Streptococcus test negative
Clinical narrative: Initial report received on 23 March 2012 from a health care professional on 23 March 2012. An 18 month old patient (gender not reported) with unknown medical history had received a dose of PENTACEL on 20 March 2012 and 2 days later, the patient's mother reported to the physician that the patient had a 5 cm area of erythema and induration at the injection site that was warm to touch. The patient was treated with MOTRIN and BENADRYL. The following day, the patient was evaluated by the physician and on examination only had a purple area left at the injection site, but had fine red papules that surrounded the site. Later that day, the patient developed fine, red papules covering the trunk of the body, from the knees to the mid back. A strep test was negative. The reporter did not have time to provide any further information. At the time of this report the patient had not recovered. Documents held by sender: None.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial report received from a consumer's parent on 25 August 2011. A healthy 15 month-old male patient who was in for a well child visit on 23 August 2011 received a 4th left thigh dose of DTAP vaccine and a dose of HIB vaccine. The manufacturer names and lot numbers were unknown for both vaccines. The following day after vaccination, the patient was found to have redness, swelling, and hardness at the injection site; and she felt warm, her temperature at the time was unknown. The patient did not require medical evaluation, and the parent administered the patient TRIAMINIC and Ibuprofen. Recovery status was not reported. Follow-up information was received from a health care professional on 24 February 2012. The reporter clarified that the patient received a dose 4 injection in the left thigh of PENTACEL, sanofi pasteur Ltd. lot number C3912AA. The patient's outcome was unknown. Documents held by sender: None. Follow up information received on 03 May 2012: The patient received PENTAXIM vaccine via intramuscular route.
Age: 1.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial report received from a Healthcare professional on 26 April 2012. MIS/VIS number: 12-0248. This case is linked with AER n# 2012-04562 case received under same MIS/VIS number by same reporter and similar adverse events occurred after administration of PENTACEL lot number C4163AA. A 15-months-old patient, whose medical history and concomitant therapy were not reported, had received a dose of PENTACEL (lot number C4163AA, route and anatomical site of administration was not reported) around a month ago on unspecified date. On an unspecified date the patient was developed leg swelling and redness. The lab details and corrective treatment details were not provided. The outcome of event was not reported. List of document held by sender: none.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Dehydration, Urinary tract infection, Vomiting
Clinical narrative: Initial report was received on 29 September 2011 from a health care professional. A two-month-old male patient, had received on 24 September 2011 an intramuscular left thigh injection of PENTACEL, lot number C3853AA and an intramuscular right thigh injection of PREVNAR13, Pfizer lot number 916304 and two hours later, the patient began vomiting profusely and vomiting with each feeding. The patient was taken to the ER (emergency room) and was diagnosed with mild dehydration. She was treated with an "IV" (intravenous) not otherwise specified. The patient had not experienced any adverse events following prior vaccinations. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Follow-up information was received on 27 December 2011 from health care professional. The patient was diagnosed with a UTI (urinary tract infection). According to the reporter, there was no adverse RXN (reaction). Documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial report received from a Healthcare professional on 26 April 2012. MIS/VIS number: 12-0248. This case is linked with AER n# 2012-04721 case received under same MIS/VIS number by same reporter and similar adverse events occurred after administration of PENTACEL lot number C4163AA. A 04-months-old patient, whose medical history and concomitant therapy were not reported, had received 2nd dose of PENTACEL (lot number C4163AA, route and anatomical site of administration was not reported) on unspecified date. On an unspecified date the patient was developed leg swelling and redness. The lab details and corrective treatment details were not provided. The outcome of event was not reported. List of document held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal distension, Body temperature increased, Irritability, Muscle rigidity, Screaming
Clinical narrative: Initial report was received from a healthcare professional on 11 November 2011. A currently 12-month-old male patient had received at 2-months-old an Intramuscular (IM) injection of PENTACEL (lot number C3640BA invalid) in left thigh, PREVNAR in right thigh and ROTATEQ oral on 09 December 2010. On the same day of the injection, the patient experienced screaming for two hours, abdominal distention, rigidity day, temperature "102" and fussiness for several days. The patient had no bowel obstruction; however he had a minor cold symptom at the time of vaccination. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Follow-up information was received from a health care professional on 12 March 2012. It was the patient's first dose of PENTACEL, PREVNAR and ROTATEQ. The patient recovered on 10 December 2010. No additional information was available at the time of the report. Documents held by sender: None.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Crying, Ecchymosis, Erythema, Irritability, Swelling
Clinical narrative: A two-month-old patient (gender not reported) had received an injection of PENTACEL, sanofi pasteur Ltd. (lot number, date, route and site not reported) and an unspecified amount of time later experienced redness, swelling, ecchymosis, irritability and crying for several hours. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: HEPA, SMALL, YF
Symptoms: Culture, Injection site pruritus, Rash papular, Vaccination site pustule, Vaccination site reaction
Clinical narrative: This case was received on 27 September 2011 via a third part query tool search on the VAERS database, under reference number 427842. A 28 year-old female patient had received on 16 June 2011 a left arm injection of ACAM2000 (lot number VV04003A), a subcutaneous right arm injection of YF VAX (lot number UH272AA) and an intramuscular right arm injection HAVRIX (lot number AHAVB459BB) and 30 days later on 16 July 2011, the patient noticed three papular bumps around the smallpox vaccination site that were intensely itchy and progresses into pustular lesions. A culture was conducted to confirm if the smallpox was the causative agent however results were not reported. Current illnesses and history were reported as none. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Rash
Clinical narrative: Presented to office with a red, raised vesicular rash on (R) flank, on 6-5-12. Appearance of shingles like rash.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Presented to office with a red, raised vesicular rash on (R) flank, on 6-5-12. Appearance of shingles like rash.
Age: 1.16
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: Low grade fever reaching 103 at highest - lasted for 5 days followed by extreme fussiness that still persists- called nurse who thinks it is a reaction gave infant Tylenol to reduce fever.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Disturbance in attention, Headache, Thinking abnormal
Clinical narrative: Headache that intensified through the evening.  Focus in activities was diminished; thinking was dulled.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Nasal congestion, Nasopharyngitis, Pain
Clinical narrative: The most serious event was a fever of about 99.5 degrees 12 hours or so after having received the shot. This fever persisted through the night/early morning, relented the next day, then returned the following night. It was also accompanied by moderately severe chills and body aches--enough to be shivering slightly and to make me use a personal heater the second night despite it being summer--and in my personal experience, were more severe than I would normally expect from a fever of only 99.5 degrees. While the fever and chills went away for good after the second night, the body aches persisted through the third day, although they were much milder by that point. Also, curiously, for the first three or four days or so after the shot, my nose felt as if I were recovering from a cold (yet I haven't had a cold in over a year). Specifically, it was like my nasal mucous wasn't thin enough for me to have a runny nose, yet wasn't of normal thickness either. Accordingly, I had very mild nasal congestion upon laying down, and for the few days, did not produce hardly any dried nasal mucous. Finally, as would be expected, I had mild pain in my arm where the shot was administered. This pain was again mild and only when I moved my arm in certain directions, and it subsided after three or four days or so as well.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: The most serious event was a fever of about 99.5 degrees 12 hours or so after having received the shot. This fever persisted through the night/early morning, relented the next day, then returned the following night. It was also accompanied by moderately severe chills and body aches--enough to be shivering slightly and to make me use a personal heater the second night despite it being summer--and in my personal experience, were more severe than I would normally expect from a fever of only 99.5 degrees. While the fever and chills went away for good after the second night, the body aches persisted through the third day, although they were much milder by that point. Also, curiously, for the first three or four days or so after the shot, my nose felt as if I were recovering from a cold (yet I haven't had a cold in over a year). Specifically, it was like my nasal mucous wasn't thin enough for me to have a runny nose, yet wasn't of normal thickness either. Accordingly, I had very mild nasal congestion upon laying down, and for the few days, did not produce hardly any dried nasal mucous. Finally, as would be expected, I had mild pain in my arm where the shot was administered. This pain was again mild and only when I moved my arm in certain directions, and it subsided after three or four days or so as well.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Abdominal pain upper, Back pain, Blindness, Blood culture, Blood test
Clinical narrative: Patient had symptoms start within two weeks of her shots. I took her to the ER & they sent her home symptoms grew worse and more presented so she was sent to hospital. Fever, lesions, back pain, stomach pain, stiff neck, loss of vision & use of legs.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Computerised tomogram, Lumbar puncture, Mobility decreased, Musculoskeletal stiffness, Nuclear magnetic resonance imaging
Clinical narrative: Patient had symptoms start within two weeks of her shots. I took her to the ER & they sent her home symptoms grew worse and more presented so she was sent to hospital. Fever, lesions, back pain, stomach pain, stiff neck, loss of vision & use of legs.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Pyrexia, Skin lesion
Clinical narrative: Patient had symptoms start within two weeks of her shots. I took her to the ER & they sent her home symptoms grew worse and more presented so she was sent to hospital. Fever, lesions, back pain, stomach pain, stiff neck, loss of vision & use of legs.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Pyrexia, Skin warm
Clinical narrative: Information has been received from a physician concerning 2 patients who on unknown dates, were vaccinated with a dose of VARIVAX (Merck) (lot number 670992/0822AA, expiration date June 2013) (dose and route not reported). It was reported that the physician had two patients who experienced swelling on the leg, fever, it became red, itchy and warm to the touch (dates unspecified). The patients were given BACTRIM and KEFLEX as treatment for the adverse events. The patients sought unspecified medical attention. At the time of the report, the patient's outcome were recovering. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a health care professional who stated that she was not familiar with the two patients who were vaccinated with the VARIVAX (Merck) (lot number 670992/0822AA, expiration date June 2013) and experienced the above adverse events. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, date of event and recovery status. This is one of the two reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes simplex, Immediate post-injection reaction, Syncope
Clinical narrative: Case was received from the Health Authorities on 27-JUN-2012 (reference number PEI2012020019). Case was medically confirmed. A 13 year old female patient, received a first dose of GARDASIL (lot number NN08930 batch G004210) IM into the upper arm who on 01-JUN-2012. Immediately after vaccination she developed a syncope for 30 seconds. After elevating legs and oral administration of fluids, the patient recovered. Unspecified time later, she presented with herpes simplex infection. Duration and outcome was not reported. Case was assessed as serious by Health Authorities, as other important medical event. Other business partner numbers include E2012-04192. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a several unspecified patients, who on unknown dates were vaccinated with a dose of VARIVAX (Merck) (lot #, doses and routes were not reported). Physician reported that the patients developed shingles years after receiving VARIVAX (Merck). Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abasia, Blister, Infection, Skin exfoliation
Clinical narrative: He had the shingles shot. Got blisters on left foot which broke open and spread all the top layer of flesh came off. Looked like a burn. Bad infection, can't walk on. Dr's don't know what to do. Haven't really done anything yet. May have to amputate foot.
Age: 0.15
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Irritability, Pyrexia, Tachycardia
Clinical narrative: Information was obtained on a request by the Company from the agency via a Public Case Detail form (local reference # AUS/12/1356, OPR#300172) concerning a 56 days male patient who on 02-MAY-2012 was vaccinated in the morning with a dose of ROTATEQ oral, 1 dose unspecified, 1 time (batch and lot number not reported). Secondary suspect vaccine given on the same day (in the morning) included a dose of PREVNAR 13, 1 dose unspecified, 1 time (route, batch and lot number not reported) and a dose of INFANRIX HEXA, intramuscular, dose unspecified, 1 time (batch and lot number not reported). On 02-MAY-2012, the patient presented to the emergency department with fever and tachycardia and was irritable at home. Temperature measurement was of 38.1C. The child was admitted. Overnight he was afebrile and was discharged. The patient was seen by a general practitioner. Subsequently, on an unknown date the patient recovered from the events. The agency felt that fever, tachycardia and irritable were possibly related to therapy with ROTATEQ, PREVNAR 13 and INFANRIX HEXA. The original reporting source was not provided. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old male with allergy to penicillin, Macrolides and niacin who on 05-JUN-2012 was vaccinated with one dose of ZOSTAVAX (Merck) subcutaneously (lot number 671453/1057AA, expiration date 05-OCT-2012). Concomitant therapy included simvastatin (manufacturer unknown). Subsequently, the patient developed a rash at the injection site at some point in time by 09-JUN-2012. The patient called pharmacist for medical attention, no treatment was given for the adverse event. No lab test performed. The patient present status was unknown. Follow up information was received from the pharmacist concerning the retired patient with hypercholesterolaemia, allergy to penicillin, Macrolides and niacin and no illness at the time of vaccination who on 06-JUN-2012 (at 2:34 pm) (also reported 05-JUN-2012 previously) was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 671453/1057AA) subcutaneously in left arm. On 07-JUN-2012, a small rash developed at the injection site. Per the patient there were no vesicles, no open sores or broken skin, only a warm patch of red skin at the injection site. Subsequently, the patient was recovered on 09-JUN-2012. There were no relevant diagnostic tests and laboratory data. No adverse event followed prior vaccination. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Accidental exposure, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 19-JUN-2012 was inadvertently administered with a dose of ROTATEQ (dose and route not reported) (lot number 1463AA - in validation, Exp: 30-JUN-2013). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.72
Sex: F
Vaccine: VARCEL
Symptoms: Decreased activity, Decreased appetite, Rash generalised, Varicella
Clinical narrative: Information has been received from a physician concerning a 20 month old patient with no drug reaction, no allergies, and no pertinent medical history who on 09-APR-2012 was vaccinated subcutaneously with a 5.0ml dose of VARIVAX (Merck) (LOT# 671126/1062AA, exp. date 05-Jul-2013). There was no concomitant medication. The physician mentioned on 21-APR-2012 the patient developed chicken pox. The child had 10 lesions and no fever. The patient had visited office to sought medical attention. At the time of this report, the patient had not recovered. Follow up information has been received from a physician who reported that the 20 month child female patient with no illness at the time of vaccination, no pre-existing allergies, birth defects and medical conditions was vaccinated with a first dose of VARIVAX (Merck) (671126/1062AA), IM, (previously reported as SQ) at 18:00. The physician described that on 24-APR-2012 at 18:00 (previously reported as 21-APR-2012) the patient experienced chickenpox, rash that had grown from leg to "over all body", decreased appetite and activity. There were no labs performed. At the time of reporting, the patient's outcome from rash that had grown from leg to "over all body", decreased appetite and activity was unknown. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Inflammation, Rash papular, Skin oedema, Tenderness
Clinical narrative: 11 days post vaccination numerous papulovesicles, 2-4 mm size are present about the dorsal hands, favoring joint surfaces, similar appearing papulovesicles are also present about the palmar surfaces and extensor elbows. Few are also scattered about the extensor forearms. Areas mildly tender to palpate. Symptoms: Rash, other nonspecific skin eruption.
Age: 31.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: "High fever with body aches and chills fever 103 degrees, uncontrolled shivering swollen/painful glands."
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Oedema
Clinical narrative: Edema, erythema, pain to Left deltoid and difficulty with abduction of arm.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Smallpox satellite lesions.
Age: 22.0
Sex: M
Vaccine: ANTH, HEP, SMALL, UNK
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Oedema peripheral, Tenderness
Clinical narrative: Small pox immunization, developed local satellite lesions with swelling erythema and tenderness of surrounding upper arm with axillary lymph node involvement.  Treated with oral Keflex.  Given Lamisil for ringworm infection on face.
Age: 22.0
Sex: M
Vaccine: ANTH, HEP, SMALL, UNK
Symptoms: Tinea infection, Vaccination complication
Clinical narrative: Small pox immunization, developed local satellite lesions with swelling erythema and tenderness of surrounding upper arm with axillary lymph node involvement.  Treated with oral Keflex.  Given Lamisil for ringworm infection on face.
Age: 9.0
Sex: M
Vaccine: MMRV
Symptoms: Fatigue, Pyrexia, Vertigo
Clinical narrative: Felt run down, running a slight fever which got higher over the next 3 days to 103.1, vertigo.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood glucose, Computerised tomogram, Febrile convulsion
Clinical narrative: Complex Febrile Seizure lasting 40 minutes.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Feeling hot, Muscular weakness, Paraesthesia
Clinical narrative: Felt hot in the face then I started having difficulty breathing then my hands and feet started tingling. When I stood up my legs felt very weak.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with no drug reactions or allergies and with high blood pressure who on an unknown date, was intramuscularly vaccinated with a dose of ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included BYSTOLIC and over the counter supplements. On an unknown date, the patient experienced a welt at the injection site and it was painful. The welt looked like a "bug bite" that was red, raised and painful. The ZOSTAVAX (Merck) was given by another pharmacist. The patient sought medical attention-pharmacy visit. No lab diagnostic studies were performed. There was no treatment given for AE. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: PNC13
Symptoms: Eye pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Imm given on 6/21 - no complaints. 6/22 - arm not observed by parents. 6/23 - Felt nauseous - eye pain - arm site "popping out" - warm - went to ER 7:30 pm.
Age: 1.55
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Pyrexia, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 18 month old female patient, who on 01-JUN-2012 was vaccinated with a dose of VARIVAX (Merck) (lot number 670992/0822AA, expiration date June 2013) (dose and route and not reported). It was reported that on 12-JUN-2012, the patient experienced swelling on the leg, fever, leg became itchy, leg became red and leg became warm to the touch. At the time of the report, the patient had recovered (date not provided). It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 59 year old female consumer with arthritis, hypertension, diabetes, thyroid problems and several allergies to a lot of medications (unspecified) who on 27-JUN-2012 was vaccinated SQ with a dose of 0.65 mL of ZOSTAVAX (Merck) (lot # 672608/1715AA, expiration date on 02-FEB-2012). The pharmacist stated that after vaccination with the ZOSTAVAX (Merck) the consumer developed red and swelling at the injection site. The pharmacist indicated that the consumer presented to the pharmacy on 29-JUN-2012 with red, 2 inch round swollen area at the injection site that was warm to the touch. No treatment was given for the events and no laboratory tests were performed. The pharmacist stated the consumer tried to contact her doctor but the physician was not in the office. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a health registered nurse, for GARDASIL a Pregnancy Registry product, concerning a 15 year old female patient with no drug reactions/allergies and no pertinent medical history, who on 29-JUN-2012 was vaccinated with the third dose of GARDASIL (dose and route not reported) (lot number 672232/1495AA, Exp: 22-AUG-2014) and also found out on the same day that she was pregnant. Concomitant therapy included loratadine, CELEXA and "PRO AIR". Her second dose of GARDASIL (dose and route not reported) (lot number 668051/0178AA, Exp: 09-MAR-2012) was administered on 30-JUN-2011 and date for the first dose of unspecified. The patient's last menstrual period was 02-MAY-2012 and estimated delivery date would be on 06-FEB-2013. No treatment was given for the AE. Laboratory diagnostic study was performed: pregnancy test. The patient sought medical attention - office visit. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Maternal exposure before pregnancy
Clinical narrative: Initial and follow-up information has been received from a physician and a licensed vocational nurse (LVN), for GARDASIL, a pregnancy registry product, concerning a female baby. A 19 year old female on 26-SEP-2007, was vaccinated with her first dose of GARDASIL (Lot # 0530U). The patient's last menstrual period (LMP) was 02-OCT-2007, with an estimated delivery date of 09-JUL-2008. On 02-JUL-2008, 39 weeks from LMP, the patient delivered a normal female infant with apgar score 9/9, weight 3,062 grams. Pediatric medical records were received and reviewed and the following experiences were identified: On 07-JUL-2008 the baby was seen for well child visit. The weight was 6lbs 7.4 ozs, height 18.75 in, temperature 98.5, pulse 146, and respiration 30. The baby had total bilirubin (TBIL) of 17.09 mg/dL. The baby had unspecified neonatal jaundice. On 09-JUL-2008 a family history of alcohol problem, epilepsy, seizure (father), and tobacco use and high blood pressure (maternal grandfather) was noted. On 14-JUL-2008 the baby underwent an upper gastrointestinal (GI) series indicated for gastroesophageal reflux disease (GERD), and persistent emesis. Fluoroscopic evaluation of the upper GI tract was performed with multiple spot films. Impression was gastroesophageal reflux, nasopharyngeal reflux noted as well. There was no evidence of pyloric stenosis or small bowel malrotation. On 16-JUL_2008 the patient had a 2 week well child visit and recheck of GERD, status post UGI. Feeding difficulties including spitting up while feeding. Weight: 6lbs 14.08 oz, height: 19 inches, temperature: 98.5, pulse: 132, respiration: 34. A recheck total bilirubin was 10.94 mg/dL. Physical exam showed skin with slight jaundice. Assessment was unspecified neonatal jaundice, GERD and constipation. On 29-JUL-2008, at 3 weeks old, the baby was seen by the physician and presented with complaint of GERD. The physician's assessment indicated that the baby was doing well on Enfamil AR and no longer jaundiced. Weight was 8lbs 4.96 ozs. Temperature: 98/3, pulse: 128, respirations: 26. Assessment was GERD. This is an amended report. The baby's birth weight now reads 3,062 grams instead of 3.062 grams. The mother's experience has been captured in WAES0711USA06548. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Purpura, Tooth extraction
Clinical narrative: Information has been received from a 62 year old consumer with penicillin allergy and chronic obstructive pulmonary disease (COPD) reporting on himself who on approximately 18-MAY-2012 (reported as "6 weeks ago"), was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included AVODART, vitamin D (unspecified), gabapentin, ibuprofen, montelukast sodium (MSD), tamsulosin hydrochloride, fiber (unspecified), pantoprazole, ABILIFY, SPIRIVA, ADVAIR, trazodone HCl, pravastatin Na, "morandine", "spotipozon", "zopavin" and MINOCIN. It was reported that the patient received ZOSTAVAX (Merck) vaccine and went to see his dentist and had a tooth pulled the following day. On 21-JUN-2012, as a result of the medications given by the dentist the consumer had a rash he believed was Schaumburg purpura, the patient was experiencing a rash at the site of injection. The patient did not seek the medical attention. There was no treatment given for AE. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a female patient (age not reported) who on 30-MAY-2012, was vaccinated with an expired dose of ZOSTAVAX (Merck) (lot# 669189/1389Z; exp. date 19-JAN-2012) (dose and route not reported). No adverse event was reported. Follow up information was received from the registered nurse concerning a 74 year old retired female patient who on 30-MAY-2012 before midday was vaccinated intramuscularly with the first dose of ZOSTAVAX (Merck) (lot# 669189/1389Z), which expired on 19-JAN-2012. The patient had no adverse reaction. No further is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a physician assistant (PA) concerning a 19 year old female patient with no known drug reaction/allergies and no other pertinent medical history, who on 13-JAN-2012 was vaccinated with her second dose of GARDASIL into the left deltoid (route, dose and lot number not reported). The date of the first vaccination was unspecified. Concomitant therapy included ACCUTANE. The PA reported that a couple of hours after the second dose GARDASIL, the patient developed an injection site reaction. The injection site reaction was described as a large red erythematous area at injection site (left deltoid) about 10 cm in diameter. The injection site reaction resolved after an unspecified time period with treatment with ice and unspecified anti-inflammatories. The patient contacted the office for medical attention. No lab diagnostic studies were performed. At the time of the report, the patient had recovered. Injection site reaction and large red erythematous area at injection site were considered to be disabling by the reporter, since the patient had an inability to perform unspecified activities associated with daily living. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Ear infection, Fatigue, Oropharyngeal pain, Pharyngitis, Pyrexia
Clinical narrative: 1st Hep B 5/22/12 Sq tired with T - 100.5 2 hours post vaccine 2nd Hep B 6/25/12 by Tues. evening developed T 104.5 sore throat fever reduced to 101 with antipyretic tonsil swollen. Saw MD on 6/28/12 Dx Ear Infection & Pharyngitis Not Strep. Tx with 2000mg. Amoxicillin BID x 10 days. Practitioner, mother, & patient feel symptoms were related to vaccine especially the extreme tiredness.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: 1st Hep B 5/22/12 Sq tired with T - 100.5 2 hours post vaccine 2nd Hep B 6/25/12 by Tues. evening developed T 104.5 sore throat fever reduced to 101 with antipyretic tonsil swollen. Saw MD on 6/28/12 Dx Ear Infection & Pharyngitis Not Strep. Tx with 2000mg. Amoxicillin BID x 10 days. Practitioner, mother, & patient feel symptoms were related to vaccine especially the extreme tiredness.
Age: 49.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Arthralgia, Body temperature increased, Pain
Clinical narrative: Patient reported onset of joint pain and general body aches with temperature rise of 5 degrees, resting pulse 98 degrees. At 2:00 am temperature increase to 102.3 degress; 0800 temp drop to 100.3 dregrees; took Motrin 200mg/4hrs.
Age: 49.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Arthralgia, Body temperature increased, Heart rate increased, Pain
Clinical narrative: Patient reported onset of joint pain and general body aches with temperature rise of 5 degrees, resting pulse 98 degrees. At 2:00 am temperature increase to 102.3 degress; 0800 temp drop to 100.3 dregrees; took Motrin 200mg/4hrs.
Age: 49.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Arthralgia, Body temperature increased, Pain
Clinical narrative: Injection at 1400. 2200 - onset of joint pain & general body aches w/ temperature raise of 3 degrees, resting pulse 98 0200 - Temp increase to & 40 (102.3) 0800 - Temp drop to +2 degrees. MOTRIN 200mg / 4 hrs. Next night (07/07/12) temp was still elevated, returned to normal 07/08/12 around 0800.
Age: 49.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Arthralgia, Body temperature increased, Heart rate increased, Pain
Clinical narrative: Injection at 1400. 2200 - onset of joint pain & general body aches w/ temperature raise of 3 degrees, resting pulse 98 0200 - Temp increase to & 40 (102.3) 0800 - Temp drop to +2 degrees. MOTRIN 200mg / 4 hrs. Next night (07/07/12) temp was still elevated, returned to normal 07/08/12 around 0800.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Sensation of foreign body
Clinical narrative: Itching at site of injection & Phlegm like feeling in throat. Took BENADRYL & felt fine.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches. Fever of 103 degrees.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Injection site bruised very sore. Swelling and redness at injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Joint swelling
Clinical narrative: On 6-27-12 she said she got a vaccine - shingle, 2 days later knees became swollen & then got better.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Per note in computer nurse whom saw client: "Shoulder area above right deltoid is swollen and warm to touch and painful to touch".
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Blood glucose, Gaze palsy, Musculoskeletal stiffness, Tremor
Clinical narrative: Eyes "shook", arms stiffened, body trembled lasted 10 seconds, urinary incontinence, abdominal pain, vomiting.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: Eyes "shook", arms stiffened, body trembled lasted 10 seconds, urinary incontinence, abdominal pain, vomiting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Pt has developed a blister at the vaccine administration site with an area of redness surrounding the blister.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Soreness at site within the hour of administration. After 3 days, increased soreness and swelling, pain down arm and in shoulder.