chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Platelet count normal, Protein urine absent, Red blood cell count normal, Red blood cell sedimentation rate normal, Red blood cells urine negative
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Red cell distribution width normal, Specific gravity urine normal, Tachycardia, Tachyphrenia, Tremor
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin T normal, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: pH urine normal
Clinical narrative: 25 year old male who received his primary smallpox vaccination (SPV) on 08 MAR. He had no preceding illness or complaint. He was well until the evening of 13MAR when while at work in the PICU, he noted a very brief sense of anxiousness (lasting seconds) without any other feelings/sensations. Approximately 4-5 hours later he was awakened at 0500 from sleep with "rigors"--he c/o a stiff/clenched jaw; bilateral upper extremities "shaking" and bilat. lower extremities "twitching" for 30 mins. The UE and LE sxs were relieved by "walking around". Although the shivering/shaking (rigors) ceased, a sense of anxiety (feeling of doom) and difficulty falling asleep due to 'his mind racing' remained. He was evaluated in the ER at which time VS, PE, and EKG were normal. While he had no chest pain, he did complain of mild dyspnea and tachycardia. While initially his anxiety was pervasive, over the past 3 days he feels it has lessened somewhat (from 100% to now 70%) and is intermittent rather than continuous. He still has difficulty falling asleep, ruminating about both the nature of this reaction and his upcoming deployment. There is no past personal or family history of anxiety disorders, depression, dysthymia, etc. His only medication is the Valium prescribed for sleep until two days ago. Once he falls asleep, he is able to sleep for hours. There are no intrusive thoughts or dreams. His SPV site is progressing as expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia, Rash, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 50 year old female patient. The medical history of the patient included internal shingles on her right side approximately in 2011 (last 2 years) for 6 weeks, neuralgia pain (for 9 months after). The patient had an allergic reaction to an unnamed flu shot when she was a baby and nearly died and she could not take any flu shots. On 29-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously. Concomitant medications included PREMARIN (reported as PRIMERIN), cholestyramine resin (reported as cholestremine), SYNTHROID and an unspecified medication of sleep drug. On an unknown date, approximately in 2013, the patient experienced rash on arm like 2 silver dollars, a fever in her arm and a low grade fever. On an unknown date, approximately in 2013, the patient broke out into a rash on her side, her legs and arms, backside and under her breasts. She called the healthcare professional (HCP) the next Monday and the HCP did not diagnose her with Shingles. It was reported that, it was going on for approximately forty-five days. It was reported that taking an unnamed prescription of sleep drug and scratching herself until she was bleeding. The patient sought an unspecified medical attention. She was treated with VALTREX (2 rounds). Silver sulfadiazine, Nyspapin, triamcinolone acetonide cream. No lab tests were performed. The outcome of itchy rash was reported as not resolved as the patient still had itchy rash all over the body below her neck at the time of reporting. The outcome of fever in her arm and low grade fever was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 50 year old female patient. The medical history of the patient included internal shingles on her right side approximately in 2011 (last 2 years) for 6 weeks, neuralgia pain (for 9 months after). The patient had an allergic reaction to an unnamed flu shot when she was a baby and nearly died and she could not take any flu shots. On 29-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously. Concomitant medications included PREMARIN (reported as PRIMERIN), cholestyramine resin (reported as cholestremine), SYNTHROID and an unspecified medication of sleep drug. On an unknown date, approximately in 2013, the patient experienced rash on arm like 2 silver dollars, a fever in her arm and a low grade fever. On an unknown date, approximately in 2013, the patient broke out into a rash on her side, her legs and arms, backside and under her breasts. She called the healthcare professional (HCP) the next Monday and the HCP did not diagnose her with Shingles. It was reported that, it was going on for approximately forty-five days. It was reported that taking an unnamed prescription of sleep drug and scratching herself until she was bleeding. The patient sought an unspecified medical attention. She was treated with VALTREX (2 rounds). Silver sulfadiazine, Nyspapin, triamcinolone acetonide cream. No lab tests were performed. The outcome of itchy rash was reported as not resolved as the patient still had itchy rash all over the body below her neck at the time of reporting. The outcome of fever in her arm and low grade fever was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old female patient. On 05-MAR-2013 the patient was vaccinated with her first dose of ROTATEQ (oral, Lot#, dose/frequency and duration were unspecified). On 08-MAR-2013, patient suffered intussusception. Patient was seen at Hospital for an unspecified length of time. Therapy with ROTATEQ, oral was discontinued. The patient was now recovered. The causality between intussusception to ROTATEQ, Oral was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Bone disorder, Drug administered at inappropriate site, Gastrointestinal tube insertion, Injection site joint movement impairment
Clinical narrative: This spontaneous report as received from a 70 year old female registered nurse concerning herself. The patient had arthritis, depression, unspecified digestive problems, asthma, osteoporosis, precancerous esophagus, hypothyroidism and allergic to penicillin. The patient's medical history included bowel obstruction. The nurse stated that she had previously received a dose of PNEUMOVAX23 (lot number, dose, route and injection site were not reported) about 5 years ago (in approximately March 2008) with no adverse reactions. On 31-JAN-2013 the patient was vaccinated with PNEUMOVAX23 (lot number was not reported) (0.5 ml in the left arm) by unknown route. Concomitant therapies included SYNTHROID. On 31-JAN-2013, 5 hrs after receiving a dose of PNEUMOVAX23 the patient experienced severe pain in her left shoulder. At 3:00 AM, on 01-FEB-2013 the patient woke up with all of her joints swollen and very painful. The patient was evaluated in the emergency room of the Hospital and admitted. The PNEUMOVAX23 injection was administered "high" on her left arm, and "did not go into muscle" but was not administered subcutaneously. She could not provide a definite route of administration. A Magnetic resonance imaging (MRI) showed a "hole" in her left, upper, arm bone, and that she had very little range of motion in her left shoulder. The patient also stated that a few days after receiving PNEUMOVAX23 she was diagnosed with a bowel obstruction and a nasogastric (NG) tube was inserted. The patient stated that she had a history of bowel obstruction. Treatment extra strength TYLENOL and CELEBREX were given for adverse events. Lab diagnostics studies X-ray and MRI of left shoulder were performed. The outcome was reported as recovering. Action taken and causality were not provided at the time of report. The patient had a phone call to physician then visited to emergency room. Adverse events were considered serious as significant disability or incapacity, and the patient was hospitalized. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site joint pain, Intestinal obstruction, Joint swelling, Laboratory test, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous report as received from a 70 year old female registered nurse concerning herself. The patient had arthritis, depression, unspecified digestive problems, asthma, osteoporosis, precancerous esophagus, hypothyroidism and allergic to penicillin. The patient's medical history included bowel obstruction. The nurse stated that she had previously received a dose of PNEUMOVAX23 (lot number, dose, route and injection site were not reported) about 5 years ago (in approximately March 2008) with no adverse reactions. On 31-JAN-2013 the patient was vaccinated with PNEUMOVAX23 (lot number was not reported) (0.5 ml in the left arm) by unknown route. Concomitant therapies included SYNTHROID. On 31-JAN-2013, 5 hrs after receiving a dose of PNEUMOVAX23 the patient experienced severe pain in her left shoulder. At 3:00 AM, on 01-FEB-2013 the patient woke up with all of her joints swollen and very painful. The patient was evaluated in the emergency room of the Hospital and admitted. The PNEUMOVAX23 injection was administered "high" on her left arm, and "did not go into muscle" but was not administered subcutaneously. She could not provide a definite route of administration. A Magnetic resonance imaging (MRI) showed a "hole" in her left, upper, arm bone, and that she had very little range of motion in her left shoulder. The patient also stated that a few days after receiving PNEUMOVAX23 she was diagnosed with a bowel obstruction and a nasogastric (NG) tube was inserted. The patient stated that she had a history of bowel obstruction. Treatment extra strength TYLENOL and CELEBREX were given for adverse events. Lab diagnostics studies X-ray and MRI of left shoulder were performed. The outcome was reported as recovering. Action taken and causality were not provided at the time of report. The patient had a phone call to physician then visited to emergency room. Adverse events were considered serious as significant disability or incapacity, and the patient was hospitalized. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: X-ray limb
Clinical narrative: This spontaneous report as received from a 70 year old female registered nurse concerning herself. The patient had arthritis, depression, unspecified digestive problems, asthma, osteoporosis, precancerous esophagus, hypothyroidism and allergic to penicillin. The patient's medical history included bowel obstruction. The nurse stated that she had previously received a dose of PNEUMOVAX23 (lot number, dose, route and injection site were not reported) about 5 years ago (in approximately March 2008) with no adverse reactions. On 31-JAN-2013 the patient was vaccinated with PNEUMOVAX23 (lot number was not reported) (0.5 ml in the left arm) by unknown route. Concomitant therapies included SYNTHROID. On 31-JAN-2013, 5 hrs after receiving a dose of PNEUMOVAX23 the patient experienced severe pain in her left shoulder. At 3:00 AM, on 01-FEB-2013 the patient woke up with all of her joints swollen and very painful. The patient was evaluated in the emergency room of the Hospital and admitted. The PNEUMOVAX23 injection was administered "high" on her left arm, and "did not go into muscle" but was not administered subcutaneously. She could not provide a definite route of administration. A Magnetic resonance imaging (MRI) showed a "hole" in her left, upper, arm bone, and that she had very little range of motion in her left shoulder. The patient also stated that a few days after receiving PNEUMOVAX23 she was diagnosed with a bowel obstruction and a nasogastric (NG) tube was inserted. The patient stated that she had a history of bowel obstruction. Treatment extra strength TYLENOL and CELEBREX were given for adverse events. Lab diagnostics studies X-ray and MRI of left shoulder were performed. The outcome was reported as recovering. Action taken and causality were not provided at the time of report. The patient had a phone call to physician then visited to emergency room. Adverse events were considered serious as significant disability or incapacity, and the patient was hospitalized. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Rash/redness occurred 2 days ago on (R) deltoid. Rash was red, swollen and warm to the touch. Redness was the width of his arm. Sensitivity to touch and itching were noted. No other symptoms noted. Swelling noted today (3/15/13).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Swelling, Tenderness
Clinical narrative: Rash/redness occurred 2 days ago on (R) deltoid. Rash was red, swollen and warm to the touch. Redness was the width of his arm. Sensitivity to touch and itching were noted. No other symptoms noted. Swelling noted today (3/15/13).
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.03
Sex: F
Vaccine: HIBV, IPV, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Pt had 3 imms at WCE on 2/29/13. Today at 11:00 am mom called because of rash on (L) thigh, arm & back. "Hive like". Denies RD, V & D, fever. Resolved by 3/10. Per patient's mom - 3/18/13.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dehydration, Diarrhoea, Pyrexia, Rash, Vomiting
Clinical narrative: Fever, projectile vomiting, diarrhea, rash in hair & all over torso, back, arms, legs & between toes, dehydration. Diarrhea for 3 days, vomiting x1. Rash x3.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Vomiting projectile
Clinical narrative: Fever, projectile vomiting, diarrhea, rash in hair & all over torso, back, arms, legs & between toes, dehydration. Diarrhea for 3 days, vomiting x1. Rash x3.
Age: 9.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Seen in ED for rash on 2-12-13. Dx'd with varicella. Flat rash began on face to back and neck. Did not appear on arms or legs. No fever, cough, or runny nose. Rash gone next AM.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age, reporting on herself. On an unknown date the patient was vaccinated with ZOSTAVAX injection, 1 shot (lot # and exp date unspecified) (dose unspecified), right arm. The consumer stated that on an unknown date she experienced pain in her right arm at the ZOSTAVAX injection site and received the flu shot in the same arm within a couple of weeks of receiving ZOSTAVAX vaccination. At the time of the report the outcome of pain in right arm at the ZOSTAVAX injection site was unknown. It was unknown if the patient sought medical attention. There was no treatment given for the pain in right arm. Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient of unknown gender. On an unknown date the patient was inadvertently vaccinated with M-M-R II (lot number not reported), (Merck) VARIVAX (lot number not reported) and VAQTA (lot number not reported). No adverse event was reported. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Chills, Diarrhoea, Pyrexia, Tonsillar disorder, Tremor
Clinical narrative: Fever (tympanic) to 104.7 on 3/4/13 with chills, reported by parents to be "shaking, eyes almost rolling" but awake and alert during event. Found to have white patches or erythematous tonsils but otherwise unremarkable exam. Vigorous and well appearing and playful in no acute distress. Had one loose bowel movement.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea
Clinical narrative: Patient given MENACTRA & ADACEL on 3-8-13. Mom reports 20 hrs after vaccine child had brief episode of trouble breathing. Mom gave BENADRYL, felt better.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: Fever.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Injection site rash, Rash
Clinical narrative: Rash all over the arm around the injection site. Very weak unavailable to perform general activity for 2 days.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site redndess, warm to touch & painful.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Headache
Clinical narrative: Headache developed the day after vaccines given (in the morning). TYLENOL and ibuprofen given without benefit.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Chest pain, Diplopia
Clinical narrative: Headache developed the day after vaccines given (in the morning). TYLENOL and ibuprofen given without benefit.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Dyspnoea, Electrocardiogram, Headache, Hemiparesis, Migraine
Clinical narrative: Headache developed the day after vaccines given (in the morning). TYLENOL and ibuprofen given without benefit.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Musculoskeletal stiffness, Mydriasis, Nausea
Clinical narrative: Headache developed the day after vaccines given (in the morning). TYLENOL and ibuprofen given without benefit.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPV4, MEN
Symptoms: Neurological examination, Pain in extremity, Ultrasound scan, Vomiting
Clinical narrative: Headache developed the day after vaccines given (in the morning). TYLENOL and ibuprofen given without benefit.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Patient's wife called early next morning, he was very itchy. By approximately 6AM lips & tongue swelling, then patient broke out in hives. Told patient to take 2 BENADRYL and go to ER right away. Patient received prednisone taper, Hydrocortisone ointment and Hydroxyzine HCl.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Vaccine administered in the morning 03/02/2013, reaction started in the later afternoon. Patient reports 36 hrs of symptoms: local pain in deltoid, chills, fever, body aches, weakness/fatigue. Patient treated herself with ADVIL as needed, which states was effective.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Nausea, Pain, Pruritus, Pyrexia
Clinical narrative: Fever, chills, body aches, lesion on left chin, nausea, itching upper back (no lesions). 3/6/13 noon - report to clinic with above s/s went home. 3/6/13 saw MD - RTW 3/11/13 ? steroid shot.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Fever, chills, body aches, lesion on left chin, nausea, itching upper back (no lesions). 3/6/13 noon - report to clinic with above s/s went home. 3/6/13 saw MD - RTW 3/11/13 ? steroid shot.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Aggression, Body temperature increased, Crying, Dyskinesia, Screaming
Clinical narrative: Patient awoke screaming/crying, eyes tightly closed with brief jerking of upper arms, then flailing of arms and hitting parents. Seen in our ER where above description noted with eyes squeezed shut and crying and hitting parents. Vitals stable, afebrile. Crying lasted 4 hours. Recovery complete.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Lethargy, Vomiting
Clinical narrative: 3/16/13 - 7:25 pm mother notified physician on call that child vomited a few times that day, is lethargic & has blood mixed with stool. Advised to go to ER for eval. of possible intussusception. Parents stated they would go but didn't - physician received call 3/17/13 at 3:45 pm now taking pt to ER.
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Influenza, Pyrexia, Vomiting
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 07 March 2013. A female patient (age and date of birth not reported) had received an INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) in January 2013. On 14 February 2013, the patient experienced low grade fever, vomiting, diarrhea for which she was admitted to the hospital. Treatment included IV fluids. She was diagnosed with "the flu" when in the hospital. By 15 February 2013, the patient started to "keep food down". On 16 February 2013, the patient was discharged. Symptoms completely resolved and has had no further problems. The patient had no illness at the time of vaccination and a history of MS. Outcome was recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Patient starting getting lightheaded and dizzy 10 mins after vaccination. Patient also had numbness in both legs from feet to knees. Patient was taken to ER and received Valcyclovir and Zofran.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Blood pressure increased, Electrocardiogram normal, Fatigue, Hyperhidrosis, Muscular weakness
Clinical narrative: Sudden onset tachycardia, diaphoresis, near syncope, extreme muscle weakness, extreme fatigue, low grade fever, elevated BP; paramedics evaluated. Sx improved without intervention.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Presyncope, Pyrexia, Tachycardia
Clinical narrative: Sudden onset tachycardia, diaphoresis, near syncope, extreme muscle weakness, extreme fatigue, low grade fever, elevated BP; paramedics evaluated. Sx improved without intervention.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Patient began severe itching with redness to left arm, across chest and going up neck. Mom administered Benadryl 50mg po at 10:06 AM. Child presents back to health department.  Benadryl 25mg po at 10:25 AM.  Red rash to neck, arms, chest, abdomen and back. No whelps or difficulty breathing noted.
Age: 45.0
Sex: F
Vaccine: HPV4
Symptoms: Microvascular coronary artery disease, Migraine, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Electrical shock up arm.. tingling in hand and fingers still to this day.  Electric tingling on half of face.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pain in extremity, Swelling
Clinical narrative: Right arm pain and swelling developed in middle of night after getting injection. Arm is sore with sharp pain and throbbing in the deltoid area & also throughout upper arm, radiating to forearm & shoulder. Hurts to move the shoulder. No fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Lip swelling, Local swelling
Clinical narrative: Local swelling 5 inches long inch wide, lips swelling, eyes swollen, took 3 doses of 25 mg Benadryl helped with face but not with site reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Redness, swelling, induration, pain.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Same day reaction - red circle from injection site, throbbing, sore to touch, shower spray hurts hitting spot, sore to lay on injection site side. Doxycycline started 2/25 & 1 wk course. Starting BACTRIM DS 3/6/13.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Evening of vaccination had fever 101.7 for 24 hrs. Painful at injection site, reddened, swelling.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Pain in extremity, VIIth nerve paralysis
Clinical narrative: I have numbness & pain in hands & feet. Face became paralyzed also. Acquired Guillain-Barre around Sept. 2012.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: (R) thigh - erythematous, hot to the touch, firm lump 5cm x 5 cm.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Fatigue, Tremor
Clinical narrative: Initial report was received from a consumer, who is also the patient's grandmother, on 08 March 2013. A four-year-old male patient had received an fifth dose of DTaP (manufacturer, lot number, route and site unknown) in January 2013 (seven weeks ago on a Thursday). Forty eight hours post-vaccination, the patient experienced "neuro problems" of shaking but not seizures. Uncontrollable intermittent shaking started two days post-vaccination after he complained of loss of appetite and being very tired. The patient was taken to an urgent care clinic since symptoms were off and on. One minute the patient is fine and the next he is shaking his head and upper and lower extremities. An MRI could not be performed due to the shaking. The reporter denied any illness at the time of vaccination and history. Outcome was not reported. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling, soreness around injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral disorder, Oral pain
Clinical narrative: This spontaneous report as received from a dentist refers to his wife who was a 66 year old female patient with none Pertinent Medical History. On an unknown date in the end of September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # was not reported). The concomitant medicines included estrogen supplement. On an unknown date in October 2012 the patient experienced painful oral lesion resembling mucoceles on the tip of her tongue and cheeks after vaccination with ZOSTAVAX. The lesions had a yellow center and last only about 3 hours. The patient contacted the dentist for medial attention and no treatment was given to the adverse event. The outcome of the adverse event was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On an unknown date, sometime in 2010, the patient was vaccinated with dose 1 of GARDASIL (lot number, expiry date, dose and route unspecified). On 12-MAR-2013, the patient was vaccinated with dose 2 of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt noticed swelling, pain, and redness around vaccination site that progressively worsened following injection. Pt went to ED and received pain meds and symptoms resolved after discussion with patient/parents.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration, Injection site pain, Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via field representative referred to a 40 year old female patient. The patient's medical history included severe chicken pox outbreak as a child. On 02-MAR-2013 the patient was vaccinated with ZOSTAVAX (1 injection, lot#, dose/frequency were unspecified). A few days after injection in March 2013 the patient developed in a 3-4 inch around the injection site with vesicular moist lesions that were painful. It had since spread to her neck and chin. Physician reported that he did not administer the injection. The injection was administered at pharmacy. Physician believes that the injection was not given in the deltoid region, that it was in fact given in the mid triceps area. Patient had sought medical attention via speaking with physician. No lab diagnostics studies were performed. BENADRYL (manufacturer unspecified) and VALTREX (manufacturer unspecified) were given as treatment for the events. The outcome was reported as not recovered. The causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). On an unknown date the patient experienced swelling, redness and pain at the injection site and also experienced vomiting. It was not reported whether the patient  was sought medical attention. The outcome of the adverse events was reported as recovered/resolved on an unspecified date. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Incorrect route of drug administration, Induration, Skin warm, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible cellulitis in a 58-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergic to ACE inhibitors, allergy to NSAIDs and high blood pressure. Concurrent medications included verapamil, CRESTOR, ADVAIR, SPIRIVA and AVALIDE. On 11 March 2013 at 18:54 the subject received unspecified dose of BOOSTRIX (.5 unknown, subcutaneous, left arm). On 11 March 2013, 16 minutes after vaccination with BOOSTRIX, the subject experienced possible cellulitis, large local red welt and intramuscular formulation administered by other route. Healthcare professional from an employee health department reported the subject, who is also an employee there, received BOOSTRIX subcutaneously instead of intramuscularly. The subject reported that a huge warm hard welt that looked like cellulitis appeared approximately 15-20 minutes after receiving the injection. She was treated in the employee health department on 13 March 2013. This case was assessed as medically serious by GSK. At the time of reporting the welt and cellulitis were unresolved.
Age: 36.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Pt reported to clinic with hx of recent Yellow fever vaccine (3-8-13.) She had the injection on (R) post. deltoid that area is now very swollen, red, measuring 140 mm x 110 mm. Also with axillary node involvement (R). CDC contacted, Pt sent to local ER for evaluation. Given sulfate Rx. Will follow her 3-22-13.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Blood culture, Culture urine, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Pt received PEDIARIX, rotavirus PCV next am mom c/o red rash head to toe & fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Patients arm on 03/18/2013 was swollen, red and bruised.  Bruising look as if was residing.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Eye swelling, Rhinorrhoea, Sneezing
Clinical narrative: Eye swelling; Profuse rhinorrhea; Sneezing; Coughing.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, Herpes zoster, Neck pain, Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 72 year old male patient with hypertension, Coronary Artery Disease (CAD) and hyperlipidemia. The patient had no allergies. The patients medical history included bladder cancer. On 07-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H021712, expiry date and the dose was not reported) in the left arm(deltoid). Concomitant therapies included atenolol, simvastatin, amlodipine, lisinopril and tamsulosin hydrochloride(reported as tamsulosin). The reporter stated that 48 hours post vaccination (09-MAR-2013), the patient woke up with pain on backside on his neck. The patient sought medical attention for the same and on 12-MAR-2013 was seen at the doctors office and was diagnosed with shingles where he experienced the pain of his neck. The physician also stated that the patient had dermatomal rash from neck to back of his skull with one sided pain. The patient was put on antiviral and pain medication. The dermatomes involved were C3, C4 and C5. The patient maximum temperature was 100.6 (units unspecified). VZVIP (Varicella Zoster Virus Identification Program) sample of the vesicle/lesion was obtained on 14-MAR-2013. The outcome of all the reported events was reported as not recovered/not resolved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Culture, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 72 year old male patient with hypertension, Coronary Artery Disease (CAD) and hyperlipidemia. The patient had no allergies. The patients medical history included bladder cancer. On 07-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H021712, expiry date and the dose was not reported) in the left arm(deltoid). Concomitant therapies included atenolol, simvastatin, amlodipine, lisinopril and tamsulosin hydrochloride(reported as tamsulosin). The reporter stated that 48 hours post vaccination (09-MAR-2013), the patient woke up with pain on backside on his neck. The patient sought medical attention for the same and on 12-MAR-2013 was seen at the doctors office and was diagnosed with shingles where he experienced the pain of his neck. The physician also stated that the patient had dermatomal rash from neck to back of his skull with one sided pain. The patient was put on antiviral and pain medication. The dermatomes involved were C3, C4 and C5. The patient maximum temperature was 100.6 (units unspecified). VZVIP (Varicella Zoster Virus Identification Program) sample of the vesicle/lesion was obtained on 14-MAR-2013. The outcome of all the reported events was reported as not recovered/not resolved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 72 year old male patient with hypertension, Coronary Artery Disease (CAD) and hyperlipidemia. The patient had no allergies. The patients medical history included bladder cancer. On 07-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H021712, expiry date and the dose was not reported) in the left arm(deltoid). Concomitant therapies included atenolol, simvastatin, amlodipine, lisinopril and tamsulosin hydrochloride(reported as tamsulosin). The reporter stated that 48 hours post vaccination (09-MAR-2013), the patient woke up with pain on backside on his neck. The patient sought medical attention for the same and on 12-MAR-2013 was seen at the doctors office and was diagnosed with shingles where he experienced the pain of his neck. The physician also stated that the patient had dermatomal rash from neck to back of his skull with one sided pain. The patient was put on antiviral and pain medication. The dermatomes involved were C3, C4 and C5. The patient maximum temperature was 100.6 (units unspecified). VZVIP (Varicella Zoster Virus Identification Program) sample of the vesicle/lesion was obtained on 14-MAR-2013. The outcome of all the reported events was reported as not recovered/not resolved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Gradually enlarging area of erythema, induration, warmth & tenderness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Cellulitis vs local vaccine reaction (L) femoral lateral. Rx cephalexin x 10 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Muscle pain in arm where injection took place occurs with certain arm movements. After 9 months it is not getting better.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a 76 year old female patient with high blood pressure regarding herself. The patient had no drug reactions or allergies. On 11-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, and dose were not reported) in the left arm subcutaneously. Approximately on an unspecified date in March 2013, the patient developed a red dot at the vaccine site, left arm, that was about 2 inches x 3 inches. The patient sought no medical attention. No laboratory test was performed and no treatment was given. The reporter stated that it had subsided to about a 50 cent piece. The outcome of the event was reported as recovering/resolving. The reporter wanted to know how long it would last. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Tourette's disorder
Clinical narrative: This spontaneous report was received from a grandfather regarding his grandson (who the patient) of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was unknown). On an unknown date, the patient developed a reaction that started with fever and typical swelling and redness around the injection site. The patient the developed autism like symptoms that evolved into a Tourette syndrome. The outcome of the reported events were unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Sx 4.5 red tender site in (R) lateral femoral area warm. Cellulitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Raised approximately 3" circle surrounding vaccine site. Red & hot to touch & itchy.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Secondary transmission, Vaccination complication
Clinical narrative: Patient received smallpox vaccination on 01 Mar 2013. Adverse reaction occurred with wife on 01 Mar 13 on left eye lid. (accidental inoculation).
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blister, Polymerase chain reaction, Viral test negative
Clinical narrative: Patient received smallpox vaccination on 01 Mar 2013. Adverse reaction occurred with wife on 01 Mar 13 on left eye lid. (accidental inoculation).
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Crying over 12 hours after immunizations.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: Complains of right deltoid pain, apparent tenderness. Treatment take TYLENOL or MOTRIN for pain & warm compresses as needed.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Loss of consciousness, Syncope
Clinical narrative: "Fainted" 1635 unconscious about 1 minute, couple of "jerky" arm movements. 98/64 BP HRR 64. Lowered to floor & elevated legs. 1647 Sitting up, drank water BP 92/68 HRR 60.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Skin lesion
Clinical narrative: This spontaneous report was received from a physician refers to a 60 year old female patient. On an unknown date(reported as in last 3 months), the patient was vaccinated with ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, after 3 or 4 days the patient experienced pain at injection site and a reaction described as egg shaped lesion like after tetanus vaccination. The outcome of the events were reported as recovering. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practiced nurse refers to a 57 year old male patient. On 05-FEB-2013, the patient was vaccinated with first dose of RECOMBIOVAX HB, (lot number, expiry date and route was not reported). On 06-MAR-2013, the patient was vaccinated with second dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 13-MAR-2013 the patient was vaccinated with GARDASIL dose 3 (lot no not provided). Route of administration was not reported. On 13-MAR-2013 the patient was administered dose 3, which was received late. Dose 1 and 2 were administered sometime in 2011. No symptoms were reported. The outcome of dose 3 was received late and no adverse event is unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from two health professional (N.P. (nurse practitioner) and R.N.P (registered nurse practitioner)) refer to a 21 years old female patient. The registered nurse practitioner stated patient received doses of HPV vaccine;the nurse practitioner stated the vaccine was unspecified between GARDASIL or CERVARIX. The registered nurse practitioner reported that the patient received first dose of in July 2012, second dose in November 2012 and third dose in December 2012. The registered nurse practitioner and the nurse practitioner stated an additional dose was administered today, 11-MAR-2013, 0.5 ml, intramuscular. N.P. stated not all doses administered in OB/GYN office; office had another section for pediatrics where earlier doses may have been administered. No adverse effect reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction, Rash erythematous, Rash vesicular, Viral test
Clinical narrative: Vaccinated 3/12/13. Developed red vesicular rash (R) T8-10 dermatome 3/15/13. (Shingles).