chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Information regarding Flu Shield was received from a consumer, a 49 year old female patient who experienced injection site reaction, the site was big, red, hot. At 49 years of age, the patient received a dose in 1999. The patient's concurrent illness includes hypothyroidism. Indication for Flu Shield was prophylaxis. Product was administered in 1999. Dose regimen was 1 dose per 1 time per day (IM). Concomitant therapy included Synthroid. In 1999, the patient developed an injection site reaction. The patient described the site as being big, red, hot. The event resolved with rubbing and massage. No additional information was available at the time of this report.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Information regarding Flu Shield was received from a consumer, a 48 year old female patient who experienced injection site reaction, the site was big, red, hot. At 48 years of age, the patient received a dose in 1998. The patient's concurrent illness included hypothyroidism. Indication for Flu Shield was prophylaxis. Product was administered in 1998. Dose regimen was 1 dose 1 times per 1 day (IM). Concomitant therapy included Synthroid. In 1998, the patient developed an injection site reaction. The patient described the site as being big, red, hot. The event resolved with rubbing and massage. No additional information was available at the time of this report.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Pruritus, Throat tightness
Clinical narrative: Follow-up information received 15-AUG-2003 provided medical history, event onset date, treatment medications, and outcome. A physician reported that a 44-year-old female received an injection of influenza virus vaccine (manufacturer unknown) on 16-NOV-1994. The patient's medical history included an allergy to cats, hypertension, migraine headaches, and low thyroid. That same day, she was seen in the ER for an anaphylactic reaction characterized by generalized erythema, pruritis, throat tightness, and SOB. She was treated with SC epinephrine, IV and oral Benadryl (diphenhydramine), physician reported that the pt ate chicken and potatoes 1-2 hours prior to onset of symptoms. This event was considered medically important (OMIC).
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Information was received from a 64 year old male patient who is a health care professional, who, 10 years ago, at the age of 54, received a dose of influenza virus vaccine trivalent, types A &B, Flu Shield. Ten days following administration of the vaccine, he experienced pain and numbness on the right side of his face. The symptoms lasted for 6 weeks. No treatment was prescribed. No further information was available at the time of this report.
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Information regarding influenza virus vaccine was received from a 60 year old male consumer who received a dose in 1993. The patient's concurrent illnesses include syncope vasovagal, anxiety, allergy to animal, hypersensitivity, and food allergy. Indication for Flu Shield was immunization. Product was administered in 1993. Dose regimen was not provided. Concomitant therapy included Clonazepam. The patient reported that he developed an injection site reaction, injection site arm redness, injection site arm hot, and injection site arm itching in 1993. All events resolved within 24 hours, without treatment. No additional information was available at the time of this report.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information regarding influenza virus vaccine, trivalent, A&B, was received from a consumer regarding a 24 year old male patient who experienced red striations out from injection site and injection site reaction. At 10 years of age, the patient received a dose on an unspecified date. No allergies to eggs. Indication for influenza virus vaccine, trivalent, A&B was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Patient was not taking concomitant therapy. On an unspecified date, sometime during 1988-1989, at the age of 10 years, the patient received a dose of influenza virus vaccine and developed an injection site reaction of the arm characterized by red striations radiating out from the injection site. The reaction lasted for a day or so and resolved with an unknown dose of Benadryl. No additional information was available at the time of this report.
Age: 60.0
Sex: F
Vaccine: YF
Symptoms: Fatigue, Nausea, Pain, Vomiting
Clinical narrative: From initial information received on 2/25/03 from a nurse regarding an adverse event occurring in the USA, it was reported that a 60 year old female patient received her first dose of YF-VAX, lot number UB234AA, administered SC in the left arm on 1/22/03. on 2/2/03,. 11 days post vaccination, the patient reported having moderate to severe pain in her left arm and generalized aches, fatigue, nausea and vomiting. The patient declined an appointment with the physician at the facility and was seen by her primary care physician, date of doctor visit was not reported. The patient was taking PULMICORT and MAXAIR at time of vaccination for silent asthma. Reportedly, it is unknown if the patient recovered from the events.
Age: 12.0
Sex: M
Vaccine: RAB, YF
Symptoms: Chills, Pyrexia
Clinical narrative: From initial information received on 3/12/03 from a registered nurse, it was reported that a 12 year old male child was vaccinated with IMOVAX RABIES, lot number U0595, given IM/site not reported and YF-VAX on 3/10/03. The lot number and route/site were not reported for YF-VAX. A few hours later, on the same day, the patient experienced a fever and chills lasting until noon the next day. Recovery status of the patient was not reported.
Age: 53.0
Sex: F
Vaccine: HEP, RAB, YF
Symptoms: Chills, Pyrexia, Vaccine positive rechallenge
Clinical narrative: From initial info received on 3/12/03 from a registered nurse regarding an adverse event, it was reported that a 53 year old female pt received a second dose of Imovax Rabies vaccine, lot U0595, a dose of YF-Vax vaccine, lot unknown, and the third dose of hep B vaccine, manuf. unknown on 3/10/03. A few hours later, the pt experienced fever and chills lasting until noon the next day. THe pt's recovery status was not reported.
Age: 29.0
Sex: M
Vaccine: HEP, YF
Symptoms: Dysphagia, Headache, Nausea, Pharyngolaryngeal pain
Clinical narrative: From initial info received on 4/16/03 from a nurse regarding an adverse event, it was reported that a 29 year old male pt received his first dose of YF-VAX, and second dose of hep B vaccine on 4/16/03. The pt also received his first dose of hep B vaccine given IM in his right deltoid and his first dose of Pneumovax given IM in his left deltoid on 3/21/03. Upon receiving his second dose of hep B and first dose of YF-VAX, the pt developed difficulty swallowing, and irritated throat, nausea and a headache. The pt was transferred to the ER via ambulance and given 50mg of Benadryl. Reportedly, the pt recovered from these events.
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain lower, Diarrhoea, Dizziness
Clinical narrative: From initial info received on 4/21/03 from a health professional regarding an adverse event, it was reported that a 34 year old female pt received her second dose of YF-VAX on 4/21/03. Within seven to eight minutes after vaccination, the pt felt light headed, lower abdominal cramping and had diarrhea. Reportedly, the pt received her first dose of YF-VAX 10 years ago. The pt was taking Paxil and Desogen at the time of vaccination. Reportedly, the pt recovered from these evnets.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: It was reported that a 22 year old femlae received a dose of Yellow fever vaccine on 6/12/02. The pt compalined of intense localized aching to left upper injection site on 6/13/02 which lasted over 24 hrs. At 2.5mm erythematous induration noted to the left upper arm. The pt was seen by a physician on 6/14/02. Her temp was 97.8 deg F and blood pressure was 101/61. She recovered from the event.
Age: 41.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Pain, Polyarthritis, Sleep disorder
Clinical narrative: Pain from elbow to shoulder severe enough to cause difficulty sleeping.  Following morning had erythema of upper arm from deltoid to elbow with striations.  He had polyarthritis for 48 hours.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Hemiparesis, Joint range of motion decreased, Oedema peripheral, Pain
Clinical narrative: 0.5ml Td vaccine given IM to Left deltoid on 2/12/04 after patient revealed she had not had Td booster since 1985. Pt seen again 2/18/04 stating she was having a "reaction" to Td injection. Pt c/o increasing pain,arm swelling, weakness to L arm from shoulder to elbow which began 2/15/04 and has continued to worsen resulting in L arm abduction restricted to 90 degrees due to pain. On exam L arm was without obvious swelling, no redness or warmth, tender to touch, abduction > 90 degrees caused pain. Strength to bil arms was weak but equal. Pt states she had taken ES tylenol without relief.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Bronchiolitis, Cough, Dyspnoea, Eructation, Infection
Clinical narrative: RESPITORY WEIGHT LOSS BREATHING DIFFICULTY ETC. The discharge summary received on 3/23/04 states RSV, bronchiolitis, tachypnea, gas and spitting up. The hospital records received on 3/30/04 states listlessness, tachypnea, vomiting, head contusion, coughing, oral thrush and URI. Listless, decreased responsiveness, fever, decreased appetite. Soon in ER x3, then admitted X2. Treated with IV antibiotics, xopenex and pulmacort. Diagnosis was viral infection. After discharge home, pt treated with Robitussin and recovered. Did not receive pneuovax. Fever, malaise, dyspnea developed one day after vaccinations. Seen by MD. Treated with Xopenex, Pulmarcort, Tylenol. A few ounces of wt loss noted. Pt has recovered except for slight nasal conjestion. Review of additional hospital d/c summary confirms diagnosis of fever (FEVER) and r/o sepsis. Sepsis was subsequently ruled out. Final diagnosis was probable viral illness (infect). Facial rash (RASH) was also noted. Child received Synagis on 12/11/03, 5 days prior to vaccination.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injury, Listless, Malaise, Oral candidiasis, Pharyngitis
Clinical narrative: RESPITORY WEIGHT LOSS BREATHING DIFFICULTY ETC. The discharge summary received on 3/23/04 states RSV, bronchiolitis, tachypnea, gas and spitting up. The hospital records received on 3/30/04 states listlessness, tachypnea, vomiting, head contusion, coughing, oral thrush and URI. Listless, decreased responsiveness, fever, decreased appetite. Soon in ER x3, then admitted X2. Treated with IV antibiotics, xopenex and pulmacort. Diagnosis was viral infection. After discharge home, pt treated with Robitussin and recovered. Did not receive pneuovax. Fever, malaise, dyspnea developed one day after vaccinations. Seen by MD. Treated with Xopenex, Pulmarcort, Tylenol. A few ounces of wt loss noted. Pt has recovered except for slight nasal conjestion. Review of additional hospital d/c summary confirms diagnosis of fever (FEVER) and r/o sepsis. Sepsis was subsequently ruled out. Final diagnosis was probable viral illness (infect). Facial rash (RASH) was also noted. Child received Synagis on 12/11/03, 5 days prior to vaccination.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Rash, Respiratory syncytial virus infection, Tachypnoea, Vomiting
Clinical narrative: RESPITORY WEIGHT LOSS BREATHING DIFFICULTY ETC. The discharge summary received on 3/23/04 states RSV, bronchiolitis, tachypnea, gas and spitting up. The hospital records received on 3/30/04 states listlessness, tachypnea, vomiting, head contusion, coughing, oral thrush and URI. Listless, decreased responsiveness, fever, decreased appetite. Soon in ER x3, then admitted X2. Treated with IV antibiotics, xopenex and pulmacort. Diagnosis was viral infection. After discharge home, pt treated with Robitussin and recovered. Did not receive pneuovax. Fever, malaise, dyspnea developed one day after vaccinations. Seen by MD. Treated with Xopenex, Pulmarcort, Tylenol. A few ounces of wt loss noted. Pt has recovered except for slight nasal conjestion. Review of additional hospital d/c summary confirms diagnosis of fever (FEVER) and r/o sepsis. Sepsis was subsequently ruled out. Final diagnosis was probable viral illness (infect). Facial rash (RASH) was also noted. Child received Synagis on 12/11/03, 5 days prior to vaccination.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Weight decreased
Clinical narrative: RESPITORY WEIGHT LOSS BREATHING DIFFICULTY ETC. The discharge summary received on 3/23/04 states RSV, bronchiolitis, tachypnea, gas and spitting up. The hospital records received on 3/30/04 states listlessness, tachypnea, vomiting, head contusion, coughing, oral thrush and URI. Listless, decreased responsiveness, fever, decreased appetite. Soon in ER x3, then admitted X2. Treated with IV antibiotics, xopenex and pulmacort. Diagnosis was viral infection. After discharge home, pt treated with Robitussin and recovered. Did not receive pneuovax. Fever, malaise, dyspnea developed one day after vaccinations. Seen by MD. Treated with Xopenex, Pulmarcort, Tylenol. A few ounces of wt loss noted. Pt has recovered except for slight nasal conjestion. Review of additional hospital d/c summary confirms diagnosis of fever (FEVER) and r/o sepsis. Sepsis was subsequently ruled out. Final diagnosis was probable viral illness (infect). Facial rash (RASH) was also noted. Child received Synagis on 12/11/03, 5 days prior to vaccination.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Arthropathy, Bursitis, Fibromyalgia, Laboratory test abnormal, Nerve injury
Clinical narrative: Flu shot given to me on 10/14/2003 by the nurse. My arm turned red and puffy. I called in and was told it would be fine. I also told them I was having severe pain and she stated it was my fibromyalgia acting up. So then I told her again later about it getting worse and she said to tell the doctor about it when I seen her. Doctor said that I should go back because she didn't specialize in it. So the doctor did ordered an xray at my request. It was normal. So she referred me. He stated it was fluid on my shoulder and gave me bextra to take for ten days and suggested therapy. I went to therapy and the lady said she couldn't do much to help me. I then told the doctor it was getting worse and she referred me to another doctor who stated it was tendonitis and brusitis and gave me a shot and told me to continue therapy. But yet the therapist contacted the rehab clinic to get a script for therapy and he never replied and or never sent them one either. So our insurance changed at the first of the year so I went to a new doctor. He said I have a frozen shoulder and sent me to another clinic. One doctor is the bone doctor. He told me to do therapy for eight weeks. That was it. The lady that does my therapy said she didn't know what he expected her to do. I went twice and then the neurologist said to do my therapy at home and gave me some pills for nerve damage and said he is sure the flu shot caused the problems. The pain management doctor gave me Daypro for the swelling and a tens unit. The daypro made some of the swelling go down but the tens unit made it worse. So she told me she is sure the flu shot caused the problem and that I needed to get me another opinion from a bone doctor. So I went to another doctor. Finally someone that could help with the pain. I am now having to pay for therapy three times a week, a membership for a gym, medicine and doctor bills all from getting a flu shot. And the worst of it all is I have only been getting an hour or two of sleep and I am left handed and she gave me the shot in my left arm. I had been looking for work and have had to turn down several jobs because of my arm not working and the severe pain I live with day in and day out. Ratterman did give me some pills for the pain and a shot to help. I finally got some sleep last night. Before today I couldn't even type.  Medical Record received on 4/7/2004 includes tenderness, shoulder capsulitis, and impingment syndrome.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Neuropathy, Pain, Swelling, Tenderness, Tendonitis
Clinical narrative: Flu shot given to me on 10/14/2003 by the nurse. My arm turned red and puffy. I called in and was told it would be fine. I also told them I was having severe pain and she stated it was my fibromyalgia acting up. So then I told her again later about it getting worse and she said to tell the doctor about it when I seen her. Doctor said that I should go back because she didn't specialize in it. So the doctor did ordered an xray at my request. It was normal. So she referred me. He stated it was fluid on my shoulder and gave me bextra to take for ten days and suggested therapy. I went to therapy and the lady said she couldn't do much to help me. I then told the doctor it was getting worse and she referred me to another doctor who stated it was tendonitis and brusitis and gave me a shot and told me to continue therapy. But yet the therapist contacted the rehab clinic to get a script for therapy and he never replied and or never sent them one either. So our insurance changed at the first of the year so I went to a new doctor. He said I have a frozen shoulder and sent me to another clinic. One doctor is the bone doctor. He told me to do therapy for eight weeks. That was it. The lady that does my therapy said she didn't know what he expected her to do. I went twice and then the neurologist said to do my therapy at home and gave me some pills for nerve damage and said he is sure the flu shot caused the problems. The pain management doctor gave me Daypro for the swelling and a tens unit. The daypro made some of the swelling go down but the tens unit made it worse. So she told me she is sure the flu shot caused the problem and that I needed to get me another opinion from a bone doctor. So I went to another doctor. Finally someone that could help with the pain. I am now having to pay for therapy three times a week, a membership for a gym, medicine and doctor bills all from getting a flu shot. And the worst of it all is I have only been getting an hour or two of sleep and I am left handed and she gave me the shot in my left arm. I had been looking for work and have had to turn down several jobs because of my arm not working and the severe pain I live with day in and day out. Ratterman did give me some pills for the pain and a shot to help. I finally got some sleep last night. Before today I couldn't even type.  Medical Record received on 4/7/2004 includes tenderness, shoulder capsulitis, and impingment syndrome.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Pain
Clinical narrative: DEVELOPED RT. SCIATIC PAIN/RT. RADICULOPATHY-SYMPTOMS ON SAME DAY AS AS SHE HAD THE TD
Age: 10.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Vaccine Failure - Rubella 02-05-2004
Age: 51.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Periorbital oedema, Rash
Clinical narrative: No symptoms immediately following administration of vaccine. Rash erupted on trunk and arms approx. 48 hours following injection. Onset of moderate-severe periorbital edema 6 days after administration of vaccine.
Age: 51.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Periorbital oedema, Rash, Respiratory distress
Clinical narrative: No symptoms immediately following administration of vaccine. Rash erupted on trunk and arms approx. 48 hours following injection. Onset of moderate-severe periorbital edema 6 days after administration of vaccine.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: This child received the varicella vaccine on June 5, 2000.  She was reported by the daycare as having Chicken Pox.
Age: 26.0
Sex: M
Vaccine: HEPA, TD, TYP
Symptoms: Hypoaesthesia, Oedema peripheral, Skin discolouration
Clinical narrative: PT RECEIVED VACCINES FOR TRAVEL AT 9:30AM. AT APPROX. 2:00PM, PT CALLED THE HEALTH DEPT. AND SPOKE WITH IMMUNIZATION NURSE. PT C/O SWELLING TO ENTIRE RIGHT ARM DOWN INTO HAND AND FINGERS. PT STATED HIS ARM WAS CHANGING COLORS. STATED IT LOOKED PURPLE IN COLOR. PT C/O NUMBNESS. PT DENIED ANY OTHER S&S. PT WAS REFERRED TO ED. NO TREATMENT GIVEN PER PT. INSTRUCTED TO MONITOR FOR FURTHER SWELLING OR PROBLEMS.
Age: 44.0
Sex: M
Vaccine: MEN, TD, TYP
Symptoms: Injection site hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: From initial information received on 5/14/03 from a nurse, regarding an adverse event occurring in the USA, it was reported that a 44 year old male patient received TYPHIM Vi, lot number W1366, administered in the right deltoid, MENOMUNE, lot number UB425AA, administered in the right upper arm and TD AS ADULT, lot number U0836AA, administered in the left deltoid, on 5/9/03. About 22 hours later, the patient began itching at the site of the TYPHIM Vi vaccination and developed a rash and welts, which progressed down to his wrist and to the left arm. He was medicated with topical Benadryl and took oral Benadryl 25mg at bedtime that night. The patient reportedly recovered from this event within 72 hours. From additional information received on 11/20/03 through a telephone call to the reporter, it was reported that MENOMUNE was administered SC, TD ADS ADULT IM, and TYPHIM Vi IM. The patient had not previously received any of the vaccines. The patient was on no other medications at the time of vaccination and had no illnesses. No allergy testing was ordered. Reportedly, the patient fully recovered. No further information is anticipated, this case is considered closed.
Age: 55.0
Sex: F
Vaccine: HEPA, IPV, PPV, TYP, YF
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: From initial information received on 8/14/03 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 55 year old female patient received her first doses of YF-VAX, lot number UB363AA, administered SC in the left upper outer arm, IPOL, lot number W0906, administered SC in the left upper outer arm, TYPHIM Vi, lot number U1203, administered IM in the deltoid, PNEUMOCOCCAL VACCINE, lot number 1212M, administered IM in the right upper outer arm and HEPATITIS A VACCINE, lot number 0980M, administered IM in the right deltoid at 6:00 PM on 8/12/03. Approximately 18 hours later, the patient developed a mild fever, flu-like symptoms and a sore arm where vaccine was administered. The patient also received TETANUS in another physician's office on an unspecified date with the four week time frame of the other vaccinations. During the evening of 8/13/03, the patient's symptoms at the injection site worsened and she experienced redness, swelling and warmth measuring the size of a half dollar. She was seen by a physician for different check up on 8/14/03. The physician thought the patient had a mild cellulitis and Keflex was prescribed. The patient's recovery status is unknown. From additional information received on 10/6/03 from a registered nurse, the patient developed the local symptoms in the left arm (upper outer aspect). Initially the area under the arm, from arm pit to elbow became reddened, warm and sensitive to the touch. The patient also had a fever up to 102 degrees F three to four days after the injections were given. The patient was seen by a physician and was prescribed Keflex four times a day for seven days and completed this treatment two weeks post-injection. The symptoms resolved completely after two weeks and the patient recovered. No further information is anticipated, this case is closed.
Age: 55.0
Sex: F
Vaccine: HEPA, IPV, PPV, TYP, YF
Symptoms: Pyrexia
Clinical narrative: From initial information received on 8/14/03 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 55 year old female patient received her first doses of YF-VAX, lot number UB363AA, administered SC in the left upper outer arm, IPOL, lot number W0906, administered SC in the left upper outer arm, TYPHIM Vi, lot number U1203, administered IM in the deltoid, PNEUMOCOCCAL VACCINE, lot number 1212M, administered IM in the right upper outer arm and HEPATITIS A VACCINE, lot number 0980M, administered IM in the right deltoid at 6:00 PM on 8/12/03. Approximately 18 hours later, the patient developed a mild fever, flu-like symptoms and a sore arm where vaccine was administered. The patient also received TETANUS in another physician's office on an unspecified date with the four week time frame of the other vaccinations. During the evening of 8/13/03, the patient's symptoms at the injection site worsened and she experienced redness, swelling and warmth measuring the size of a half dollar. She was seen by a physician for different check up on 8/14/03. The physician thought the patient had a mild cellulitis and Keflex was prescribed. The patient's recovery status is unknown. From additional information received on 10/6/03 from a registered nurse, the patient developed the local symptoms in the left arm (upper outer aspect). Initially the area under the arm, from arm pit to elbow became reddened, warm and sensitive to the touch. The patient also had a fever up to 102 degrees F three to four days after the injections were given. The patient was seen by a physician and was prescribed Keflex four times a day for seven days and completed this treatment two weeks post-injection. The symptoms resolved completely after two weeks and the patient recovered. No further information is anticipated, this case is closed.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Disorientation, Fatigue, Pallor, Syncope, Tachycardia
Clinical narrative: It was reported that an 18 year old male pt received a 0.5ml dose of Menomune on 8/11/03 at 9am. One to two seconds after the vaccine was administered, the pt became pale and tachycardic. Syncope occurred and the pt was placed on the floor and regained consciousness, but was disoriented. It took approx. 20 mins before the pt was able to sit up without dizziness. The pt was observed for a total of 45 mins with no other problems. Vital signs were reported as nomal and the tp denied any anxiety or nervousness. The pt was called later that evening by the physician's office and he stated that he only felt tired, with improving symptoms of fatigue. The pt recovered from these events.
Age: 22.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Hearing impaired, Photophobia, Vision blurred
Clinical narrative: It was reported that a 22 year old female pt received a first dose of Menomune on 8/12/03 during a routine physical for college. One day later, on 8/13/03, the pt developed a headache with sensitivity to light and sound. The headache remained constant since that time. On 8/23/03, the pt developed blurry vision with headache, as well as fatigue. A CAT scan of the head was negative. The pt had not recovered from these events at the time of this report.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Injection site pain, Injection site rash, Vomiting
Clinical narrative: From initial information received on 10/14/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 year old male pt received a dose of Meningococcal vaccine, Lot # UB487AA, administered SC, multidose vial, in the left arm on 09/15/03.  That evening, the pt developed rash at the injection site.  The pt's mother stated that her son complained of a very sore arm one week after receiving the vaccine.  The pt had an onset of two severe headaches in the last 10 days and a sudden onset of vomiting.  Pt needed to stay in bed.  A strep test completed at a health clinic was negative.  The pt's recovery status is currently unknown.
Age: 18.0
Sex: M
Vaccine: HEP, MEN, HEP, MEN
Symptoms: Dizziness, Medication error
Clinical narrative: It was reported that an 18 year old male pt received Menomune and a third dose of Engerix B on 7/29/03. The nurse did not realize the pt had already received a second injection of Engerix B one week earlier. The pt's mother telephoned the physician that the pt experienced lightheadedness foru to five hrs post immunization on 7/29/03. The lightheadedness resolved by the morning of 7/30/03 and the pt recovered.
Age: 18.0
Sex: M
Vaccine: HEP, MEN, HEP, MEN
Symptoms: Dizziness
Clinical narrative: It was reported that an 18 year old male pt received Menomune and a third dose of Engerix B on 7/29/03. The nurse did not realize the pt had already received a second injection of Engerix B one week earlier. The pt's mother telephoned the physician that the pt experienced lightheadedness foru to five hrs post immunization on 7/29/03. The lightheadedness resolved by the morning of 7/30/03 and the pt recovered.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Aspiration, Bursitis, Cardiac arrest, Cellulitis, Choking
Clinical narrative: This is a 71 year old female died after a respiratory arrest secondary to aspiration while enrolled in RSV 11 vaccine study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/17/02. The subject died 374 days post immunization on 10/26/03 after choking on some food and aspirating. She was intubated, but did not recover. The aspiration and respiratory arrest were reported by the investigator as unrelated to the study vaccine. Additional information received on 2/13/04. After several attempts, the investigator is unable to obtain a death certificate. The ER record received on 2/26/04 states syncope and cardiac arrest. The discharge summary received on 2/26/04 states cellulitis of R elbow, infected bursitis, and severe COPD.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoxia, Lung disorder, Respiratory arrest, Syncope
Clinical narrative: This is a 71 year old female died after a respiratory arrest secondary to aspiration while enrolled in RSV 11 vaccine study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/17/02. The subject died 374 days post immunization on 10/26/03 after choking on some food and aspirating. She was intubated, but did not recover. The aspiration and respiratory arrest were reported by the investigator as unrelated to the study vaccine. Additional information received on 2/13/04. After several attempts, the investigator is unable to obtain a death certificate. The ER record received on 2/26/04 states syncope and cardiac arrest. The discharge summary received on 2/26/04 states cellulitis of R elbow, infected bursitis, and severe COPD.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Atelectasis, Autopsy, Blood caffeine, Cardiac arrest, Cyanosis
Clinical narrative: Child was laughing and playing; nothing abnormal. Went down to nap and approximately 1.5 hours later he was found unresponsive in his crib. Was taken to ER and pronounced dead. Autopsy report on 04/28/04 states: SIDS. This report was received from the Centers for Disease Control (CDC) in response to a Freedom-of-Information request by GSK. This case was reported by the Centers for Disease Control and described the occurrence of sudden death infant death syndrome in a 3-month-old female patient who had received PEDIARIX. The Centers for Disease received the report from the Department of Health (Ref. No. CT 2004-03). There was no relevant medical history. On 09 January 2004, the patient received the first dose of PEDIARIX (GlaxoSmithKline lot number 21895A2). Co-administered vaccinations on that dat included ACTHIB (Aventis Pasteur) and PREVNAR (Lederle Laboratories). On 13 January 2004, four days after vaccination, the child was laughing and playing. Nothing abnormal was noticed. The child was put down for a nap. One and one-half hours later, the child was found unresponsive in the crib. The child was taken to the emergency room and upon arrival she was cold, cyanotic, pulseless, and asystolic. She was not breathing. Despite resuscitation attempts (cardiopulmonary resuscitation, advanced cardiac life support, bilateral needle thoracotomy), she was pronounced dead at 1746. Causality was not reported. An autopsy report stated there was no evidence of trauma or significant natural disease processes. Gas chromatography of brain tissue revealed the presence of caffeine. The report identified Sudden Infant Death syndrome as the cause of death.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Peripheral coldness, Pulse absent, Respiratory arrest, Resuscitation, Sudden infant death syndrome
Clinical narrative: Child was laughing and playing; nothing abnormal. Went down to nap and approximately 1.5 hours later he was found unresponsive in his crib. Was taken to ER and pronounced dead. Autopsy report on 04/28/04 states: SIDS. This report was received from the Centers for Disease Control (CDC) in response to a Freedom-of-Information request by GSK. This case was reported by the Centers for Disease Control and described the occurrence of sudden death infant death syndrome in a 3-month-old female patient who had received PEDIARIX. The Centers for Disease received the report from the Department of Health (Ref. No. CT 2004-03). There was no relevant medical history. On 09 January 2004, the patient received the first dose of PEDIARIX (GlaxoSmithKline lot number 21895A2). Co-administered vaccinations on that dat included ACTHIB (Aventis Pasteur) and PREVNAR (Lederle Laboratories). On 13 January 2004, four days after vaccination, the child was laughing and playing. Nothing abnormal was noticed. The child was put down for a nap. One and one-half hours later, the child was found unresponsive in the crib. The child was taken to the emergency room and upon arrival she was cold, cyanotic, pulseless, and asystolic. She was not breathing. Despite resuscitation attempts (cardiopulmonary resuscitation, advanced cardiac life support, bilateral needle thoracotomy), she was pronounced dead at 1746. Causality was not reported. An autopsy report stated there was no evidence of trauma or significant natural disease processes. Gas chromatography of brain tissue revealed the presence of caffeine. The report identified Sudden Infant Death syndrome as the cause of death.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Tracheal haemorrhage, Unresponsive to stimuli
Clinical narrative: Child was laughing and playing; nothing abnormal. Went down to nap and approximately 1.5 hours later he was found unresponsive in his crib. Was taken to ER and pronounced dead. Autopsy report on 04/28/04 states: SIDS. This report was received from the Centers for Disease Control (CDC) in response to a Freedom-of-Information request by GSK. This case was reported by the Centers for Disease Control and described the occurrence of sudden death infant death syndrome in a 3-month-old female patient who had received PEDIARIX. The Centers for Disease received the report from the Department of Health (Ref. No. CT 2004-03). There was no relevant medical history. On 09 January 2004, the patient received the first dose of PEDIARIX (GlaxoSmithKline lot number 21895A2). Co-administered vaccinations on that dat included ACTHIB (Aventis Pasteur) and PREVNAR (Lederle Laboratories). On 13 January 2004, four days after vaccination, the child was laughing and playing. Nothing abnormal was noticed. The child was put down for a nap. One and one-half hours later, the child was found unresponsive in the crib. The child was taken to the emergency room and upon arrival she was cold, cyanotic, pulseless, and asystolic. She was not breathing. Despite resuscitation attempts (cardiopulmonary resuscitation, advanced cardiac life support, bilateral needle thoracotomy), she was pronounced dead at 1746. Causality was not reported. An autopsy report stated there was no evidence of trauma or significant natural disease processes. Gas chromatography of brain tissue revealed the presence of caffeine. The report identified Sudden Infant Death syndrome as the cause of death.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coma, Convulsion, Respiratory rate decreased, Similar reaction on previous exposure to drug, Staring
Clinical narrative: Infant received immunizations 2/17/04. Baby fainted this morning, staring and unresponsive with slow breathing. Recovered then slept deeply. Stated this happened before after shots but did not inform us until now. Discharge summary on 04/28/04 states: Patient had 4 seizures 2/19/04. Admitted to hospital 2/19/04. Has neurologic evaluation 3/12/04 and was diagnoed with benign familial infantile seizures disorder. She receives Phenoberab BID.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Syncope
Clinical narrative: Infant received immunizations 2/17/04. Baby fainted this morning, staring and unresponsive with slow breathing. Recovered then slept deeply. Stated this happened before after shots but did not inform us until now. Discharge summary on 04/28/04 states: Patient had 4 seizures 2/19/04. Admitted to hospital 2/19/04. Has neurologic evaluation 3/12/04 and was diagnoed with benign familial infantile seizures disorder. She receives Phenoberab BID.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Pharyngolaryngeal pain, Rash
Clinical narrative: Pt presented to MD with reddened throat, sore throat, and rash on back, hips and groin.  Pt also experiencing fatigue.  Symptoms have not resolved.  Pt never had a flu shot previously.
Age: 1.3
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Four hours after vaccine, patient developed fever. Next morning, developed seizure lasted 3 minutes;hospitalized.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Syncope vasovagal
Clinical narrative: Vasovagal, syncopal episode post Anthrax vaccination (24 hours later).
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Myalgia
Clinical narrative: Muscle pain, myalgia following "recent" Anthrax and Smallpox vaccinations.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Rash
Clinical narrative: Swelling, redness to right arm from deltoid to elbow and to shoulder area with redness to deltoid and pinpoint rash to upper arm area.
Sex: F
Vaccine: HEPA, TD
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Tetanus site at deltoid reddened and swollen 8x8.5cm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: Localized vaccine reaction with warmth, edema left upper arm less than 24 hours with concurrent MMR, IPV, DTAP.  Arm swollen shoulder-elbow.  No systemic urticaria or respiratory distress.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Erythema, Oedema
Clinical narrative: Erythema; edema on right deltoid 2 days post vaccination.
Age: 1.25
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Coordination abnormal, Dizziness, Gait disturbance
Clinical narrative: Dizzy, ataxic gait (wobbly) normal hand control. Deep tendon reflex's upper extremity lower extremity 2+ & equal. Symptoms started 2/15/04 until 2/16/04-quick recovery, same day.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Lethargy, Otitis media, Pyrexia, Urticaria
Clinical narrative: 1 day after, lethargy & irritability. 1 1/2 days later, fever, urticaria (OM also). Tylenol Benadryl Amsxil.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis from shoulder to elbow. Left arm being treated with Augmentin.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Hypersensitivity, Pyrexia, Viral infection
Clinical narrative: Viral Illness with pleuretic chest pain very sensitive reaction to Smallpox Vaccine.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Sinus bradycardia
Clinical narrative: Substernal chest pain
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Asthma, Malaise
Clinical narrative: Malaise post vaccinations plus reactive airway.
Sex: F
Vaccine: HEPA
Symptoms: Bronchospasm, Pruritus
Clinical narrative: Bronchospasm (mild) and pruritis without rash peuse.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: DTAP given left thigh on 02/11/04, pt seen 12/13 with 6x6cm warm, red induration at vaccination site.  No fever, no limping.  Treated with Augmenting for cellulitis.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Lymphadenopathy, Malaise, Skin striae, Swelling
Clinical narrative: Smallpox vaccine administered 02/04/04; red on day 7 major reaction with mild erythema, day 9 complained of increased swelling, redness, streaking, malaise (+) lymphed.  Prescribed Z-pack #1 on day 9.  Re-eval on 12/16/04 (day 12), decreased swelling, erythema faint, slight streaking still visible, no LA, no fever.
Age: 27.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Flushing, Heart rate increased, Hyperventilation, Pallor
Clinical narrative: Flushed then pale, weak, brief period of feeling rapid heart rate, hyperventilating.  Administered Epinepherine 0.3mg x2.  Benadryl 50mg IM, O2 3L/NC.  Pt recovered and discharged in stable condition.
Age: 46.0
Sex: F
Vaccine: JEV, TYP
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: From initial information received on 6/11/03 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 46 year old female patient received her third dose of JE-VAX, lot number EJN210B, administered SC, in the left arm and a dose of TYPHIM Vi, lot number U1511-2, administered IM in the right arm on 6/6/03. The next day the patient developed flu-like symptoms, including fever, diarrhea and fatigue. It was reported that the patient had also experienced these same symptoms following the second dose of JE-VAX (lot number EJN210B) which was administered on 5/30/03. The patient had also received Hepatitis B vaccine (lot number ENG5338B6) on 5/23/03. Concomitant medications included Adipex-P daily, Topomax twice a day and Wellbutrin twice daily for depression. At the time of this report, it was noted that the fatigue still persists and the patient's recovery status is unknown. From additional information received on 11/21/03 through a telephone call to the primary reporter, it was reported that the patient travels a lot and never returned or called back to this medical office. The reporter stated that she would place a call to the patient for additional information. A follow up phone call was made on 11/24/03 to the primary reporter, who stated that she did place a call to the patient on 11/21/03 and left a voice message to return her call regarding follow up. She has received no response back. No further information is anticipated, this case is considered closed.
Age: 42.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Neck pain, Pain
Clinical narrative: It was reported that a 42 year old female pt received a 0.5ml booster dose of Typhim Vi and hep A vaccine on 9/11/03. Within 24 hrs of receiving the vaccine, the pt developed sharp pain on the right side of the neck behind the ear, which at times shot down through the arm to her hand. The pt was seen by a doctor, who prescribed cyclobenzaprine 10mg for three days and ibuprofen 800mg for three days. No tests were performed. The pt's past medical history includes asthma, which was diagnose in 2002, as well as allergies to amoxicillin, grasses, mites and dust. The pt's recovery status was not reported. From additional info received on 11/21/03 from telephone contact with the reporter, it was stated that "this individual is a business person and travels frequently and might be hard to contact for follow-up." She also added that "this individual is just fine." An additional phone contact on 11/24/03 yielded no new info. No further info is anticipated, this case is considered closed. From additional info received on 11/26/03 from the reporter, the pt's address, birth weight, number of brothers and sisters, illness at time of vaccination and other medications were reported. No other info was provided.
Age: 40.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Dry throat, Face oedema
Clinical narrative: It was reported that a 40 year old male pt received a dose of Typhim Vi and a dose of hep A in the deltoid on 10/28/03. The following day, the pt developed facial swelling and a dry throat. Treatment included Benadryl and Medrol dose-pack. The pt's recovery status is currently unknown.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Asthma, Chest discomfort, Malaise
Clinical narrative: It was reported that an 18 year old female pt received a Menomune on 5/29/03. Five hrs later, the pt experienced chest tightness, an asthma-like reaction and malaise. The pt used an inhaler, and was reported as "doing fine" at the time of this report. It was reported that the pt recovered from these events.
Age: 43.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Discomfort, Hypoaesthesia, Muscular weakness, Paraesthesia, Renal pain
Clinical narrative: It was reported that a 43 year old male pt received a Menomune vaccination, and Td vaccination on 7/17/03. Two days later at 8:00 am in the morning, the pt developed numbness and tingling in the left arm, weakness in the left hand, and bilateral kidney aching and discomfort. The recovery status of the pt was reported as unknown.
Age: 43.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Arthralgia, Discomfort, Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: It was reported that a 43 year old male pt received a Menomune vaccination, and Td vaccination on 7/17/03. Two days later at 8:00 am in the morning, the pt developed numbness and tingling in the left arm, weakness in the left hand, and bilateral kidney aching and discomfort. The recovery status of the pt was reported as unknown.
Age: 43.0
Sex: M
Vaccine: MEN, TD, MEN, TD
Symptoms: Paraesthesia
Clinical narrative: It was reported that a 43 year old male pt received a Menomune vaccination, and Td vaccination on 7/17/03. Two days later at 8:00 am in the morning, the pt developed numbness and tingling in the left arm, weakness in the left hand, and bilateral kidney aching and discomfort. The recovery status of the pt was reported as unknown.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: It was reported that an 18 year old female pt received Menomune on 7/15/03. Three days later, the pt developed a fever of 102 deg, chills, body aches and headache. The pt took antipyretics. She was evaluated by her physician on 7/19/03. The pt's recovery status was not reported.
Age: 18.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: It was reported that an 18 year old female pt received a dose of Menomune and a dose of hep A on 8/1/03. Approximately 28 hrs post vaccination, the pt had a headache, general malaise and felt fatigued. On an unspecified date, the pt was seen by a physician. Reportedly, the pt had a tonsillectomy three weeks ago. The pt has not recovered from the events.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site urticaria, Pruritus
Clinical narrative: It was reported that a 17 year old female pt received Menomune and aplisol on 6/23/03. Two days later, the pt experienced a half dollar size swelling with redness, itching and a hive at the injection site. The pt was treated with Benadryl 25milligrams given orally. She fully recovered within 24 hrs.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: It was reported that an 18 year old male pt inadvertently received a second dose of Meningitis vaccine on an unspecified date. Reportedly, the doctor did not realize that the pt had received the same injection, either the same day or very shortly before. The doctor did not give any other info. By the next day, the pt experienced a severe headache, fever and stiff neck. Reportedly, the pt has since recovered from these events.