chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of deltoid pain in an 27-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  Concurrent medications included Ibuprofen (Advil), Paracetamol (Tylenol) and Cold medication.  Following previous influenza vaccinations (unknown manufacturer), the subject's arm felt tingly but it went away 4-5 hours after the shot was administered.  Subject also experienced minor soreness for a couple of days.  See GSK case A0698837A for details.  On 26 October 2007 the subject received 1st dose of Flulaval (.5 ml, left arm).  On 26 October 2007, within 2 hours after vaccination with Flulaval, the subject experienced pain to movement in deltoid.  That same day she also experienced pain in arm on lifting heavy objects and pain when moving arm above her or behind her.  The following day she experienced arm stiffness in the morning.  At an unspecified time during the week of 18 November 2007, she experienced a cold.  The subject did consult with a physician regarding the events.  At the time of reporting the arm stiffness, pain lifting heavy objects and pain when moving arm above or behind her had improved.  The pain in the deltoid area was unresolved.  The outcome of the cold was unspecified.  The facility received two lots of vaccine and they were not certain which lot number this Flulaval came from.  The two lot numbers are AFLLA0533AA and AFL1A0075AA.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a physician to a vaccine distributor and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  Information regarding previous immunization with influenza virus vaccine was not provided.  On an unspecified date on or before 14 November 2007, the subject received unspecified dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject experienced rash.  At the time of reporting the outcome of the event was unspecified.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  No other vaccinations were administered on the date of Flulaval administration.  The subject had received influenza virus vaccine in previous years with no subsequent adverse events.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site pain and product complaint.  The subject returned to the clinic for further evaluation.  The healthcare professional considered the events were disabling.  The clinic used a 1 inch, 30 gauge needle to administer the vaccinations.  The office is very concerned about using additional doses of this vaccine and believe there is a quality issue associated with it.  The healthcare professional reported that the injection site pain lasted greater than two weeks.  The outcome of the events was unspecified.  Follow-up information received on 27 November 2007 indicated that the subject was a 39 year old female.  The event of left arm pain was documented and the date of the earliest sign or symptom onset was recorded as 17 October 2007.  The events were reportedly improved and considered by the reporter to be related to treatment with Flulaval.  The events were initially reported as disabling and on follow-up, indicated to not be disabling.  No other details were reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  No other vaccinations were administered on the date of Flulaval administration.  The subject had received Flulaval in previous years with no subsequent adverse events.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  At an unspecified time after vaccination with Flulaval, the subject experienced injection site pain and product complaint.  The subject returned to the clinic for further evaluation.  The healthcare professional considered the events were disabling.  The clinic used a 1 inch, 30 gauge needle to administer the vaccinations.  The office is very concerned about using additional doses of this vaccine and believe there is a quality issue associated with it.  The healthcare professional reported that the injection site pain lasted greater than two weeks and the outcome of the events was unspecified. Follow-up received on 22 January 2008 via the healthcare professional and it was reported that she was not aware of any other reactions at this time.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. The subject's medical history. Concurrent conditions, and concurrent medications were not reported. No other vaccinations were administered on the date of Flulaval administration. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm). At an unspecified time after vaccination with Flulaval, the subject experienced injection site pain and product complaint. The subject returned to the clinic for further evaluation. The healthcare considered the events were disabling. The clinic used a 1 inch needle, 30 gauge needle to administer the vaccinations. The office is very concerned about using additional doses of this vaccine and believe there is a quality issue associated with it. The healthcare professional reported that the injection site pain lasted greater than two weeks and the outcome of the events was unspecified.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of arm soreness in a 69-year-old female subject who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included sulfa allergy. Concurrent medications included Toprol XL, Aspirin, Multivitamins, Calcium salt and Glucosamine. On 15 October 2007 at 16:15 the subject received unspecified dose of Flulaval (unknown, left arm). The subject was not able to specify which vaccine she received. On 15 October 2007, less than one day after vaccination with Flulaval, the subject experienced arm soreness. Two hours after vaccination the subject developed hives that spread to her whole torso. By day five, the subject's torso was covered mainly in the front and stopped under the arms and under the breasts; it was not on her neck. The hives were also no her calves. The subject was treated with Benadryl and Poison ivy lotion. Six weeks later, in November 2007, the events were resolved. This case was reported by a consumer, and subsequently confirmed by a physician, that described the occurrence of arm soreness in q 69-year-old female subject who was vaccinated with FLULAVAL (Glaxosmithkline). On 15 October 2007 at 16:15 the subject received unspecified dose of FLUVAL (unknown, lef arm). The subject was not able to speciy which vaccine she received. On 15 October 2007, less than one day after vaccination with FLULAVAL, the subject experienced arm soreness. Two hours after vaccination the subject developed hives that spread to her whole torso. By day five, the subject's torso was covered mainly in the front and stopped under the arms and under the breasts; it was not on her neck. The hives were also in her calves. The subject was treated with BENADRYL and POISON IVY lotion, Six weeks later, in November 2007, the events were resolved. Follow-up information was received on 30 January 2008 via a physician, which conflicted with the original report, According to the physician, the arm soreness, hives, and itching occurred on 20 October 2007, five days after the subject was vaccinated with FLULAVAL. As of 22 October 2007, the events were resolved. The reportinf physician considered the events to be related to FLULAVAL vaccination.
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unspecified event in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (unknown0.  At an unspecified time after vaccination with Flulaval, the subject experienced unspecified event.  The reporter declined to provide any other information.  At the time of reporting the outcome of the event was unspecified.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac flutter, Skin warm, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of wrong drug administered in a 61-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history included atrial fibrillation.  Concurrent medical conditions included allergy to dye and hypertension.  Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; left arm given on 14 November 2007.  Concurrent medications included Coumadin, Crestor, Altace, digoxin, Synthroid, Nexium and Periostat.  On 14 December 2007 at 08:30 the subject received unspecified dose of Flulaval (.5 unknown, left arm) and experienced wrong vaccine administered.  The subject was supposed to receive a pneumonia vaccine and inadvertently was given Flulaval.  A follow-up call from the consumer was received later on 14 December 2007.  She reported that she inadvertently received a second influenza vaccine (Flulaval) instead of her pneumonia vaccine.  Additional information was provided by the subject and this information has not been medically confirmed by a physician or healthcare professional.  The subject reported at an unspecified time on the same day as vaccination in her left arm with Flulaval, she reported that her left arm felt hot.  Approximately three hours after vaccination with Flulaval, the subject reported that she feels like she is about to have an episode of atrial fibrillation.  She clarified the statement and noted that she feels "heart flutters like she has had before previous episodes of atrial fibrillation."  The consumer also reported that she received influenza virus vaccine (unknown manufacturer) on 14 November 2007.  At an unspecified time after vaccination she experienced in the left arm where the vaccine was injected, a sensation of her arm feeling hot which later resolved on an unspecified date.  At the time of reporting the consumer reported that the sense of heat occurrence in the left arm had improved and the feeling of heart flutters was unresolved.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified. Follow up information was received on 04 April 2008 via a nurse, who reported that the subject  was a 70-year-old female, who received her FLULAVAL vaccination in her left arm. The nurse reported that the onset date of the adverse events was 11 December 2007, and the events were resovled as of 15 December 2007. The reporting healthcre professional considered the events to be related to vaccination with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly subject of unspecified gender who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown). Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch. At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly patient of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bicep tendonitis in a 50-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 26 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  At an unspecified time (shortly) after vaccination with Flulaval, the subject experienced bicep tendonitis.  At the time of reporting the event was unresolved.  Follow-up information received on 11 January 2008 indicated that bicep tendonitis began on the same day that Flulaval was administered to the subject, 26 October 2007.  At the time of follow-up, the outcome of the event was unknown, but had previously been unresolved.  In the reporter's opinion, the event was not related to treatment with Flulaval.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Endoscopy, Gastrooesophageal reflux disease, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of difficulty swallowing in a 62-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  Subject was healthy and had not experienced any adverse events following previous influenza vaccinations.  On 4 December 2007 at 17:30 the subject received 1st dose of Flulaval (unknown, left arm).  On 12 December 2007, 8 days after vaccination with Flulaval, the subject experienced difficulty swallowing, headache, chills, fever, queasiness and acid reflux.  The subject was seen at a walk in clinic on 16 December 2007.  On 17 December 2007, he was seen by his regular physician.  An upper GI series was done on 18 or 19 December 2007.  An endoscopy was done on 26 December 2007.  Results were not reported.  At the time of reporting the outcome of the events were unspecified.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, X-ray with contrast upper gastrointestinal tract
Clinical narrative: This case was reported by a consumer and described the occurrence of difficulty swallowing in a 62-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  Subject was healthy and had not experienced any adverse events following previous influenza vaccinations.  On 4 December 2007 at 17:30 the subject received 1st dose of Flulaval (unknown, left arm).  On 12 December 2007, 8 days after vaccination with Flulaval, the subject experienced difficulty swallowing, headache, chills, fever, queasiness and acid reflux.  The subject was seen at a walk in clinic on 16 December 2007.  On 17 December 2007, he was seen by his regular physician.  An upper GI series was done on 18 or 19 December 2007.  An endoscopy was done on 26 December 2007.  Results were not reported.  At the time of reporting the outcome of the events were unspecified.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Bacillus infection, Blood culture positive, Influenza serology negative, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: Information has been received from an agency concerning an 8 week old male who was vaccinated with a dose of PEDVAXHIB (lot# 657177/0500U). Concomitant therapy included a dose of Rotateq, a dose of PREVNAR and a dose of PEDIARIX (dates not specified). Thirty days after vaccination on 05-JAN-2008, a blood culture that was collected as an outpatient grew Bacillus cereus which was confirmed by the Department of Health Laboratory. It was also reported that the patient had severe febrile respiratory illness diagnosed as respiratory syncytial virus infection (RSV) which required hospitalization. It was reported that an older sibling had RSV pneumonia in December. On 06-JAN-2008, a repeat blood culture was performed and was negative (while on antibiotics). Specimens collected for RSV were positive. It was also reported that influenza testing was negative. Subsequently, the infant recovered completely. The agency felt that Bacillus cereus was related to therapy with PEDVAXHIB. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Sick relative, Virus serology test
Clinical narrative: Information has been received from an agency concerning an 8 week old male who was vaccinated with a dose of PEDVAXHIB (lot# 657177/0500U). Concomitant therapy included a dose of Rotateq, a dose of PREVNAR and a dose of PEDIARIX (dates not specified). Thirty days after vaccination on 05-JAN-2008, a blood culture that was collected as an outpatient grew Bacillus cereus which was confirmed by the Department of Health Laboratory. It was also reported that the patient had severe febrile respiratory illness diagnosed as respiratory syncytial virus infection (RSV) which required hospitalization. It was reported that an older sibling had RSV pneumonia in December. On 06-JAN-2008, a repeat blood culture was performed and was negative (while on antibiotics). Specimens collected for RSV were positive. It was also reported that influenza testing was negative. Subsequently, the infant recovered completely. The agency felt that Bacillus cereus was related to therapy with PEDVAXHIB. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory tract infection, Sick relative, Virus serology test
Clinical narrative: Information has been received from an agency concerning an 8 week old male who was vaccinated with a dose of PEDVAXHIB (lot# 657177/0500U). Concomitant therapy included a dose of Rotateq, a dose of PREVNAR and a dose of PEDIARIX (dates not specified). Thirty days after vaccination on 05-JAN-2008, a blood culture that was collected as an outpatient grew Bacillus cereus which was confirmed by the Department of Health Laboratory. It was also reported that the patient had severe febrile respiratory illness diagnosed as respiratory syncytial virus infection (RSV) which required hospitalization. It was reported that an older sibling had RSV pneumonia in December. On 06-JAN-2008, a repeat blood culture was performed and was negative (while on antibiotics). Specimens collected for RSV were positive. It was also reported that influenza testing was negative. Subsequently, the infant recovered completely. The agency felt that Bacillus cereus was related to therapy with PEDVAXHIB. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. Additional information has been requested.
Age: 0.47
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site rash
Clinical narrative: Fine, raised, non-red, bilateral rash on upper thighs lasted 4 days.  ER visit.
Age: 0.77
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising
Clinical narrative: Bruising and swelling at injection site.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Discomfort, Injection site erythema, Swelling, Urticaria
Clinical narrative: Patient was given the vaccine on Monday 1/21/07.  Her twin brother was given the same and had a more severe adverse reaction.  Unlike her twin brother, patient's reaction did not surface until Monday evening, Jan. 28, 2008.  There was a red welt at the sight of the shot.  Some discomfort and swelling.  I took her to Dr. and she gave us a prescription for Cephalexin, like her twin brother.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Axillary mass, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 1/16/08 Patient reports wideapread joint and muscle pain.  Upper left arm was swollen, with a red rash and warm to touch. Entire left arm was painful. 1/17/08 Left arm continued to swell and swelling spread into axilla. Pain in joints and muscles continued and patient generally did not feel well. 1/18/08 General aches and pain was less. Left arm rash continued to spread to above left shoulder and extended to above elbow. A firm lump the size of a "golf ball" developed in the left axilla. The swelling continued into the left breast. The left arm remained very painful. 1/19/08 The swelling and rash started to diminish.  1/22/08 Almost completely resolved.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Malaise, Myalgia
Clinical narrative: 1/16/08 Patient reports wideapread joint and muscle pain.  Upper left arm was swollen, with a red rash and warm to touch. Entire left arm was painful. 1/17/08 Left arm continued to swell and swelling spread into axilla. Pain in joints and muscles continued and patient generally did not feel well. 1/18/08 General aches and pain was less. Left arm rash continued to spread to above left shoulder and extended to above elbow. A firm lump the size of a "golf ball" developed in the left axilla. The swelling continued into the left breast. The left arm remained very painful. 1/19/08 The swelling and rash started to diminish.  1/22/08 Almost completely resolved.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity
Clinical narrative: 1/16/08 Patient reports wideapread joint and muscle pain.  Upper left arm was swollen, with a red rash and warm to touch. Entire left arm was painful. 1/17/08 Left arm continued to swell and swelling spread into axilla. Pain in joints and muscles continued and patient generally did not feel well. 1/18/08 General aches and pain was less. Left arm rash continued to spread to above left shoulder and extended to above elbow. A firm lump the size of a "golf ball" developed in the left axilla. The swelling continued into the left breast. The left arm remained very painful. 1/19/08 The swelling and rash started to diminish.  1/22/08 Almost completely resolved.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Condition aggravated, Petit mal epilepsy
Clinical narrative: PATIENT HAD A ABSENCE SEIZURE IN HOME ON 01/27/2008.  PATIENT HAS HISTORY OF SEIZURES DIS-ORDER.  NO RECENT ILLNESS OR FEVERS.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a health professional, for the Pregnancy Registry for Gardasil, concerning a 26 year old female who on 03-APR-2007 was vaccinated with a first dose of Gardasil (lot number unknown) IM. On 06-JUN-2007 the patient returned for a second dose of Gardasil and a beta-human chorionic gonadotropin test (unspecified) was conducted and the results were positive. The patient received her second dose of Gardasil. Patient returned on 26-JUN-2007 and received a second dose of Gardasil at that time and the patient was no longer pregnant. No further information was available. The date of the last menstrual period and the estimated time of delivery is unknown. Follow-up information was received. The patient had no pertinent medical history or drug reactions/allergies. The patient had a spontaneous abortion "4/07" from LMP. It was unknown if the products of conception were examined. The fetus was not normal. In May 2007 a diagnostic laboratory test was performed during pregnancy. No further information was available. Upon internal review spontaneous abortion was considered to be an other important medical event (OME). Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, UNK
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: My daughter broke out in hives about 5 hours after receiving her vaccinations.  She received DTaP, Polio, Chicken Pox and MMR.  She had two shots in each leg.  This completes her immunizations, and she never reacted before.  She ended up getting a prescription for Prednisone from a clinic the next evening.
Age: 9.0
Sex: M
Vaccine: FLUN3, HEPA, TD, VARCEL
Symptoms: Blood pressure, Dizziness, Dysstasia, Heart rate decreased, Lethargy
Clinical narrative: Received vaccinations at 10:00 on 01/29/2008, and immediately reported dizziness and exhibited palor. After lying down pulse was 40, resp 8. Following juice administration pallor improved and B/P was 78/40, pulse 42.  By 10:25 B/P was 98/70, pulse was 60.  Patient reported itching on face above eyebrow and lips.  No visible hives were noted.  Benadryl (30mg) administered as appropriate for weight.  By 11:00 B/P was 92/68, pulse 68, itching did not progress, but patient did report continued lethargy, dizziness and inability to stand unassisted.  Patient referred to primary care and transferred in private vehicle by parent.  On 1/29/2008 received a message from child's physician stating episode was probable syncopal episode.
Age: 9.0
Sex: M
Vaccine: FLUN3, HEPA, TD, VARCEL
Symptoms: Pallor, Pruritus, Syncope
Clinical narrative: Received vaccinations at 10:00 on 01/29/2008, and immediately reported dizziness and exhibited palor. After lying down pulse was 40, resp 8. Following juice administration pallor improved and B/P was 78/40, pulse 42.  By 10:25 B/P was 98/70, pulse was 60.  Patient reported itching on face above eyebrow and lips.  No visible hives were noted.  Benadryl (30mg) administered as appropriate for weight.  By 11:00 B/P was 92/68, pulse 68, itching did not progress, but patient did report continued lethargy, dizziness and inability to stand unassisted.  Patient referred to primary care and transferred in private vehicle by parent.  On 1/29/2008 received a message from child's physician stating episode was probable syncopal episode.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness, redness, heat, and swelling at the site injection that was given approximately 24hrs. ago.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Rash, Fever, Vomiting.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Oedema peripheral, Pruritus, Pyrexia, Skin warm
Clinical narrative: Local Right upper outer arm; red swollen, hot and itching; aprox 12cm x 8cm x 5 days.  Low grade fever.  Symptoms less on day 6.  No official treatment required, used NSAID for symptom management. SHINGLES VACCINE
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Headache, Lymphadenopathy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Lymph node swelling in left arm - arm of injection. Fever 100 - 102. Headache. Stiffness in neck. Joint Pain.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Apnoea, Blood caffeine increased, Cyanosis, Gastrointestinal tube insertion, Haemoglobin decreased
Clinical narrative: Approximately at 6:30 pm on 1-8-08, parent note child looking pale, blue lips, apnea monitor alarmed continuously. On 1-9-08, ~7:00am infant stopped breathing. EMS called, CPR given, infant resumed breathing on own. Lifeflighted to hospital, put on ventilator, feeding tube inserted. 2 blood transfusions. Caffeine levels were high, Hbg decreased, DC'd from hospital 1-15-08. 2/11/08-records received for DOS 1/9-1/15/08- DC DX: Apnea. AnemiaPresented with decreased appetite, increased apneas. Afebrile. PE: coarse rhonchi. Elective intubation and mechanical ventilation for support.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Mechanical ventilation, Oxygen supplementation, Pallor, Respiratory arrest, Resuscitation
Clinical narrative: Approximately at 6:30 pm on 1-8-08, parent note child looking pale, blue lips, apnea monitor alarmed continuously. On 1-9-08, ~7:00am infant stopped breathing. EMS called, CPR given, infant resumed breathing on own. Lifeflighted to hospital, put on ventilator, feeding tube inserted. 2 blood transfusions. Caffeine levels were high, Hbg decreased, DC'd from hospital 1-15-08. 2/11/08-records received for DOS 1/9-1/15/08- DC DX: Apnea. AnemiaPresented with decreased appetite, increased apneas. Afebrile. PE: coarse rhonchi. Elective intubation and mechanical ventilation for support.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Transfusion
Clinical narrative: Approximately at 6:30 pm on 1-8-08, parent note child looking pale, blue lips, apnea monitor alarmed continuously. On 1-9-08, ~7:00am infant stopped breathing. EMS called, CPR given, infant resumed breathing on own. Lifeflighted to hospital, put on ventilator, feeding tube inserted. 2 blood transfusions. Caffeine levels were high, Hbg decreased, DC'd from hospital 1-15-08. 2/11/08-records received for DOS 1/9-1/15/08- DC DX: Apnea. AnemiaPresented with decreased appetite, increased apneas. Afebrile. PE: coarse rhonchi. Elective intubation and mechanical ventilation for support.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood electrolytes normal, CSF test normal, Computerised tomogram normal, Depressed level of consciousness, Echocardiogram normal
Clinical narrative: ~24 hours after vaccine administered, the patient became acutely obtunded/lethargic after eating breakfast.  No preceding illness, no fever, no trauma, no ingestion.  Nml behavior before Sx onset.  Lasted ~12 hours.  No response to Narcan. 4/4/08-records received for DOS 1/22-1/27/08- DC DX: Change in mental status secondary to adverse reaction to vaccine administered 1 day prior to symptom onset. Became lethargic, very drowsy. Difficult to arouse.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Electroencephalogram normal, Influenza serology negative, Laboratory test, Lethargy, Liver function test normal
Clinical narrative: ~24 hours after vaccine administered, the patient became acutely obtunded/lethargic after eating breakfast.  No preceding illness, no fever, no trauma, no ingestion.  Nml behavior before Sx onset.  Lasted ~12 hours.  No response to Narcan. 4/4/08-records received for DOS 1/22-1/27/08- DC DX: Change in mental status secondary to adverse reaction to vaccine administered 1 day prior to symptom onset. Became lethargic, very drowsy. Difficult to arouse.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Sinus bradycardia, Virus serology test
Clinical narrative: ~24 hours after vaccine administered, the patient became acutely obtunded/lethargic after eating breakfast.  No preceding illness, no fever, no trauma, no ingestion.  Nml behavior before Sx onset.  Lasted ~12 hours.  No response to Narcan. 4/4/08-records received for DOS 1/22-1/27/08- DC DX: Change in mental status secondary to adverse reaction to vaccine administered 1 day prior to symptom onset. Became lethargic, very drowsy. Difficult to arouse.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Convulsion, Febrile convulsion, Pyrexia, Tremor, Urinary tract infection
Clinical narrative: Pt a period of 4h shaking, 7 AM, 01-12-08. 3 mild seizures with fever. 1st one afterward seen by paramedics. He felt it was febrile seizure. Seen at ER; found to have UTI infection.
Age: 15.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Erythema, Varicella
Clinical narrative: Dx; Varicella. Stomach, chest, red bumps vesicle. Vaccine breakthrough per doctor.
Age: 1.2
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash to face and chest.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Break-through chicken pox - mild - back, chest, axillae. Noted at clinic on 1/23/08.
Age: 15.0
Sex: F
Vaccine: DT, MMR, VARCEL
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Pt came in for catch-up immunizations.  She required a tetanus booster and was inadvertently given DT instead of Td.  She was followed up for 4 days with phone calls.  She did not report any adverse effects of the DT.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site urticaria, Pain, Pyrexia
Clinical narrative: 24 hours after receiving the Pneumonia vaccine she developed hives at the injection site & redness that traveled down to her elbow.  She also developed fever, chills & body aches.
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Cold sweat, Nausea, Pallor, Physiotherapy, Vertigo
Clinical narrative: PATIENT PRESENTED WITH SUDDEN VERTIGO, NAUSEA, VOMITED 2X IN AM, PALLOR AND COLD/CLAMMY IN CLINIC. BACKGROUND - PRESENTED ON THE 10 JAN 08 WITH ODD LS-S1 OF THE THE L SPINE. HE RECEIVED EPIDURAL STEROID INJECTION OF 100MG DEPOMEDROL. PATIENT ALSO HAD A PHYSICAL THERAPY SESSION ON THE 11 JAN 08.
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: PATIENT PRESENTED WITH SUDDEN VERTIGO, NAUSEA, VOMITED 2X IN AM, PALLOR AND COLD/CLAMMY IN CLINIC. BACKGROUND - PRESENTED ON THE 10 JAN 08 WITH ODD LS-S1 OF THE THE L SPINE. HE RECEIVED EPIDURAL STEROID INJECTION OF 100MG DEPOMEDROL. PATIENT ALSO HAD A PHYSICAL THERAPY SESSION ON THE 11 JAN 08.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Scab, Skin lesion
Clinical narrative: Vaccine administered on 1/4/08. Employee developed a varicella like rash with 5 lesions on torso and arms on 1/19/08. Rash reported to employee health on 1/23/08 - lesions at that time were scabbed.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Vomiting
Clinical narrative: 60 hours after 2nd Hep A vaccine patient had a severe grand mal seizure lasting about 3-4 minutes.  No fever,  SHe did vomit.  Happened about 20 minutes after falling asleep. Rushed to Hospital 911
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Swollen, red sore arm, large hard area on left upper arm. Fever reported as 99.9 in pm thru the night.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity, Pain
Clinical narrative: Client was admin. TST with 0.1 cc ID Left F/A. She later called and stated that within 30 minutes she had "shooting pain in left elbow from outer bone to inner arm". She was referred to her MD and her MD diagnosed the reaction as an allergic reaction to PPD solution. No meds that would have C/I the TST, pt states she has "health issues and many allergies". Appeared stable and alert immed. following the TST.
Age: 8.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Pruritus, Rash papular, Skin warm, Swelling
Clinical narrative: Pt received VARIVAX and INFLUENZA vaccines 2 days ago.  Yesterday she noted swelling, redness and pruritus on right deltoid area.  She came today; on exam the area was a round papule, reddened, swollen and hot of 2 inches diameter.  She was treated with BENADRYL and sent to school.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: PATIENT HAD SIGNIFICANT UNILATERAL SUB-CENTIMETER LEFT ANTERIOR CHAIN AND ONE CENTIMETER LEFT LOWER CHAIN AND SUPRACLAVICULAR LYMPHADENOPATHY THREE DAYS AFTER VACCINATION IN THE LEFT DELTOID MUSCLE.  THESE WERE FULLY MOBILE NODES WITHOUT MATTING.  LYMPHADENOPATHY RESOLVED WITHIN 17 DAYS OF VACCINATION.
Age: 7.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt came home from school on 1/29 c/o pain @ injection site.  Pt had swelling, 1" long by 1/2" wide.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site reaction
Clinical narrative: Localized redness and erythema at injection site (left deltoid) after receiving a Pneumovax Vaccine on Jan 23, 2008. Further investigation proved pt had received a previous vaccine 1 year ago on 1/2/08 which was not documented. The cellulitis was an immune reaction.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site pain, Nausea, Presyncope
Clinical narrative: Severe nausea with near vomiting; lightheadedness, near loss of consciousness, localized pain at injection site. Recommended NSAIDS with GI protection, Claritin QAM X 3 days+ prn; Benadryl QPM X 3 nights + prn.
Age: 61.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: c/o pain upon injection.  By the evening, pain from shoulder to elbow.  Unable to raise arm. No rednes or swelling at site.
Age: 0.52
Sex: M
Vaccine: DTAP, IPV
Symptoms: Crying, Insomnia, Sleep disorder
Clinical narrative: Cried on and off for four days, did not sleep for 13 hours day after vaccines were administered, and when he did sleep, he woke up screaming.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Chills, Muscle spasms, Presyncope
Clinical narrative: Almost fainted after having Gardasil vaccination.  In the 5-6 hours following vaccination had 100 + temperature as well as chilling and muscle cramps.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Gaze palsy, Laboratory test, Muscle twitching, Nausea
Clinical narrative: Pt's mother presented at clinic reporting possible reaction to Gardasil. States daughter got the Gardasil Friday afternoon. Sat "about 24 hours later" pt was at a dress fitting, states pt hadn't eaten was standing x 20 min and got nauseous and light headed then fainted. States she was out for several minutes and had "some twitching" and "her eyes rolled back". States called emergency line and then went to ER where they spent several hrs, test run there were negative, but they have been advised to get a neuro work up and pt is not to drive. Mother reports no F/H of seizures and the only thing that was different in pt's life was the Gardasil. States she went online and fainting is one of the side effects listed for Gardasil. States doesn't want to have unnecessary testing done if this was caused by the Gardasil. Mother states she is not sure she wants pt to get another Gardasil injection.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological examination, Syncope
Clinical narrative: Pt's mother presented at clinic reporting possible reaction to Gardasil. States daughter got the Gardasil Friday afternoon. Sat "about 24 hours later" pt was at a dress fitting, states pt hadn't eaten was standing x 20 min and got nauseous and light headed then fainted. States she was out for several minutes and had "some twitching" and "her eyes rolled back". States called emergency line and then went to ER where they spent several hrs, test run there were negative, but they have been advised to get a neuro work up and pt is not to drive. Mother reports no F/H of seizures and the only thing that was different in pt's life was the Gardasil. States she went online and fainting is one of the side effects listed for Gardasil. States doesn't want to have unnecessary testing done if this was caused by the Gardasil. Mother states she is not sure she wants pt to get another Gardasil injection.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Irritability, Tremor, Vomiting
Clinical narrative: Patient was given vaccine, later that evening patient became sick. Symptoms Include shaking, vomiting, irritable, continued for several days. Patient Lipids was if centered on bladder and bowel 4dys later. Seen in clinic. given injection of Phenergan and cortisone.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site induration, Injection site papule
Clinical narrative: Developed red papules multiple on B/L thighs with induration, no streaking, no warmth.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Induration, Rash, Skin nodule
Clinical narrative: Developed a hard lump under skin with slightly red rash.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Paraesthesia, Skin tightness
Clinical narrative: Pt woke the next day after receiving inj with symptom of swelling in L hand + also L foot.  Fell skin was tight, ring tight on L hand.  Top of L foot felt tight.  Sl. tingling in toes/fingers - no numbness.  Reports symptom was gone by next day.  This was pt 1st Gardasil injection, pt came into clinic for 2nd inj and reported above incident.  2nd dose was not given.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen area/lump at site of vaccine, (L) UE, warm to touch. About 1 cm mass with exam. Pt said it had been slightly larger.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Blood glucose, Convulsion, Pyrexia
Clinical narrative: 7 days after receiving MMRV, DTaP, HIB, PCV-7, and flu, had fever to 102.9. Soon after had seizure lasting approx. 4 minutes. Presumed related to MMR.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Infection
Clinical narrative: L axillary redness with approximately 10 cm red streaky cephalad L anterior shoulder.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Woke up AM with vaccination. Lg. red swollen area at site of inj. (? Varicella) Developed nausea/vomiting, fever increased to 104.6 (oral) Mom contacted MD. Fever cont'd for 48 hrs up to 102. (Info Rec'vd from pt's mother)
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Cough, Eye pain, Full blood count, Headache
Clinical narrative: Eye pain, tingling fingers, shakiness, dry cough, chills, headache.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Laboratory test, Paraesthesia, Tremor
Clinical narrative: Eye pain, tingling fingers, shakiness, dry cough, chills, headache.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Otitis media, Skin lesion
Clinical narrative: Started breaking out 1-23-2008. Has 50-60 lesions - mouth, on face and torso.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: The arm became painful to move for several days. Then became red and painful to the touch.
Age: 80.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Within 24hs of vaccine -> redness at site of injection Developed. Then redness Down the left arm and itching.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Local reaction, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Local erythema & swelling on back of R arm.  Swelling measured approx 7 cm x 6 cm in diameter.  Started 1-29-08, symptoms have improved since yesterday (site warm & tender).  Swelling decreasing per mother.  Site examined by Dr.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Dyspnoea, Fatigue, Gastrooesophageal reflux disease, Pain in extremity
Clinical narrative: Patient complained of tiredness and exhaustion. Also low grade temp, slight shortness of breath, post nasal drip and s/s of GERD. Patient also complained of right foot pain between 3 and 4th toes.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Postnasal drip
Clinical narrative: Patient complained of tiredness and exhaustion. Also low grade temp, slight shortness of breath, post nasal drip and s/s of GERD. Patient also complained of right foot pain between 3 and 4th toes.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Erythema multiforme, Joint swelling, Urticaria
Clinical narrative: 4h after vaccine administered child developed generalized urticaria. Also joint pain and swelling over subsequent 3-4d. 1 week later, still with erythema multiforme.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain in extremity, Pruritus, Skin warm
Clinical narrative: 1/19/08 at 3:00PM noticed soreness, redness of back of arm, induration of about 5 cm.  On 1/20/08 induration increased to about 10 cm, is very sore and hot.  On 1/23/08 still has induration of about 4 cm, with itching.
Age: 1.3
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Skin lesion
Clinical narrative: Started breaking out on 1-25-08, 0-50 lesions.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Hives treated with antihistamine.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Cough, Full blood count, Headache, Influenza like illness
Clinical narrative: 4x7cm Redness, warmth and swelling of injection site 2days with vaccine. Flu-like symptoms - cough, chills, HA.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 4x7cm Redness, warmth and swelling of injection site 2days with vaccine. Flu-like symptoms - cough, chills, HA.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: On 1/21/08 patient recieved Varivax and Prevnar vaccines.  Woke up morning of 1/30/08 with right thigh redness, and itching.  Seen at our office and diagnosed with ? vaccine releated cellullitis.  Treated with Augmentin.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site cellulitis, Injection site haematoma, Injection site induration
Clinical narrative: Patient recieved Varivax, Prevnar and Hepatitis A on 1/17/08.  On 1/20/08 mom noticed hard lumps under skin where injections were give.  Brought in to office on 1/29/08 and diagnosed wirh cellulitis/localized (hematoma).  Treated with Omnicef.