chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Constipation, Gastroenteritis viral, Insomnia, Retching, Urine analysis normal
Clinical narrative: 7/20/12 Woke up vomiting.  Complained of stomach pain.  Took her to the doctor's.  x-ray was taken.  Was diagnosed with stomach flu and constipation.  7/21/12 still vomiting 60-90 minutes after eating, complaining of severe stomach pain, could not sleep, could not walk, took her to the ER.  Urine sample was taken, blood work was done on her organs.  Everything appeared to be in normal range.  7/22/12 woke up with stomach pain, ate and then vomited 70 minutes later, now 4 small blisters are on her hands.  Took her to facility, diagnosed with a stomach virus and was advised to watch the blisters to see if they get bigger, was informed that they were not large enough to be chicken pox, came home, ate, vomited 90 mins later. Had difficulty sleeping again woke up dry heaving on 7/23/12 and still complaining of upset stomach and abdominal pain.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vomiting, X-ray
Clinical narrative: 7/20/12 Woke up vomiting.  Complained of stomach pain.  Took her to the doctor's.  x-ray was taken.  Was diagnosed with stomach flu and constipation.  7/21/12 still vomiting 60-90 minutes after eating, complaining of severe stomach pain, could not sleep, could not walk, took her to the ER.  Urine sample was taken, blood work was done on her organs.  Everything appeared to be in normal range.  7/22/12 woke up with stomach pain, ate and then vomited 70 minutes later, now 4 small blisters are on her hands.  Took her to facility, diagnosed with a stomach virus and was advised to watch the blisters to see if they get bigger, was informed that they were not large enough to be chicken pox, came home, ate, vomited 90 mins later. Had difficulty sleeping again woke up dry heaving on 7/23/12 and still complaining of upset stomach and abdominal pain.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abasia, Abdominal pain, Asthenia, Axillary pain, Blister
Clinical narrative: 7/20/12 Woke up vomiting.  Complained of stomach pain.  Took her to the doctor's.  x-ray was taken.  Was diagnosed with stomach flu and constipation.  7/21/12 still vomiting 60-90 minutes after eating, complaining of severe stomach pain, could not sleep, could not walk, took her to the ER.  Urine sample was taken, blood work was done on her organs.  Everything appeared to be in normal range.  7/22/12 woke up with stomach pain, ate and then vomited 70 minutes later, now 4 small blisters are on her hands.  Took her to facility, diagnosed with a stomach virus and was advised to watch the blisters to see if they get bigger, was informed that they were not large enough to be chicken pox, came home, ate, vomited 90 mins later. Had difficulty sleeping again woke up dry heaving on 7/23/12 and still complaining of upset stomach and abdominal pain.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Body temperature decreased, Chest pain, Constipation, Dark circles under eyes, Decreased appetite
Clinical narrative: 7/20/12 Woke up vomiting.  Complained of stomach pain.  Took her to the doctor's.  x-ray was taken.  Was diagnosed with stomach flu and constipation.  7/21/12 still vomiting 60-90 minutes after eating, complaining of severe stomach pain, could not sleep, could not walk, took her to the ER.  Urine sample was taken, blood work was done on her organs.  Everything appeared to be in normal range.  7/22/12 woke up with stomach pain, ate and then vomited 70 minutes later, now 4 small blisters are on her hands.  Took her to facility, diagnosed with a stomach virus and was advised to watch the blisters to see if they get bigger, was informed that they were not large enough to be chicken pox, came home, ate, vomited 90 mins later. Had difficulty sleeping again woke up dry heaving on 7/23/12 and still complaining of upset stomach and abdominal pain.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dehydration, Emotional distress, Epstein-Barr virus test positive, Gastroenteritis viral, Hand-foot-and-mouth disease
Clinical narrative: 7/20/12 Woke up vomiting.  Complained of stomach pain.  Took her to the doctor's.  x-ray was taken.  Was diagnosed with stomach flu and constipation.  7/21/12 still vomiting 60-90 minutes after eating, complaining of severe stomach pain, could not sleep, could not walk, took her to the ER.  Urine sample was taken, blood work was done on her organs.  Everything appeared to be in normal range.  7/22/12 woke up with stomach pain, ate and then vomited 70 minutes later, now 4 small blisters are on her hands.  Took her to facility, diagnosed with a stomach virus and was advised to watch the blisters to see if they get bigger, was informed that they were not large enough to be chicken pox, came home, ate, vomited 90 mins later. Had difficulty sleeping again woke up dry heaving on 7/23/12 and still complaining of upset stomach and abdominal pain.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Heart rate increased, Hunger, Hypersomnia, Influenza, Injection site swelling
Clinical narrative: 7/20/12 Woke up vomiting.  Complained of stomach pain.  Took her to the doctor's.  x-ray was taken.  Was diagnosed with stomach flu and constipation.  7/21/12 still vomiting 60-90 minutes after eating, complaining of severe stomach pain, could not sleep, could not walk, took her to the ER.  Urine sample was taken, blood work was done on her organs.  Everything appeared to be in normal range.  7/22/12 woke up with stomach pain, ate and then vomited 70 minutes later, now 4 small blisters are on her hands.  Took her to facility, diagnosed with a stomach virus and was advised to watch the blisters to see if they get bigger, was informed that they were not large enough to be chicken pox, came home, ate, vomited 90 mins later. Had difficulty sleeping again woke up dry heaving on 7/23/12 and still complaining of upset stomach and abdominal pain.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Insomnia, Irritable bowel syndrome, Laboratory test, Lethargy, Musculoskeletal chest pain
Clinical narrative: 7/20/12 Woke up vomiting.  Complained of stomach pain.  Took her to the doctor's.  x-ray was taken.  Was diagnosed with stomach flu and constipation.  7/21/12 still vomiting 60-90 minutes after eating, complaining of severe stomach pain, could not sleep, could not walk, took her to the ER.  Urine sample was taken, blood work was done on her organs.  Everything appeared to be in normal range.  7/22/12 woke up with stomach pain, ate and then vomited 70 minutes later, now 4 small blisters are on her hands.  Took her to facility, diagnosed with a stomach virus and was advised to watch the blisters to see if they get bigger, was informed that they were not large enough to be chicken pox, came home, ate, vomited 90 mins later. Had difficulty sleeping again woke up dry heaving on 7/23/12 and still complaining of upset stomach and abdominal pain.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vomiting, Weight decreased, Weight gain poor, X-ray
Clinical narrative: 7/20/12 Woke up vomiting.  Complained of stomach pain.  Took her to the doctor's.  x-ray was taken.  Was diagnosed with stomach flu and constipation.  7/21/12 still vomiting 60-90 minutes after eating, complaining of severe stomach pain, could not sleep, could not walk, took her to the ER.  Urine sample was taken, blood work was done on her organs.  Everything appeared to be in normal range.  7/22/12 woke up with stomach pain, ate and then vomited 70 minutes later, now 4 small blisters are on her hands.  Took her to facility, diagnosed with a stomach virus and was advised to watch the blisters to see if they get bigger, was informed that they were not large enough to be chicken pox, came home, ate, vomited 90 mins later. Had difficulty sleeping again woke up dry heaving on 7/23/12 and still complaining of upset stomach and abdominal pain.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea
Clinical narrative: Severe Nausea. Pain at sight for 3 days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anger, Aura, Disorientation, Dyskinesia, Dyspnoea
Clinical narrative: Approx 4 to 5 minutes after rcving the Gardasil shot (2nd dose) my daughter was seated on the exam table undergoing the rest of her physical. She suddenly became unresponsive to the dr she made a moaning sound, her eyes rolled back in her head she began to slide sideways down the wall. As I caught her her upper body became rigid and her arms made some jerky movements and her neck tensed up so she did not faint limply but actually tensed some of her muscles unlike normal fainting and more like siezure. Her color went out of her and she looked yellow. She came around in 20 to 30 seconds very upset and disoriented. She complained it was difficult to breathe at that point, she complained of neck pain, she complained of a tingling and painful sensation running up the arm the immunization was given in and into her neck. Dr checked her vitals and observed her prior to release from his office. Later in the day she complained of visual aura, was extremely fatigued and complained of discomfort moving the arm and strange tingling feeling in the arm and fingers for several hours which dissipated within 24 hours.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Gaze palsy, Injection site pain, Limb discomfort, Moaning
Clinical narrative: Approx 4 to 5 minutes after rcving the Gardasil shot (2nd dose) my daughter was seated on the exam table undergoing the rest of her physical. She suddenly became unresponsive to the dr she made a moaning sound, her eyes rolled back in her head she began to slide sideways down the wall. As I caught her her upper body became rigid and her arms made some jerky movements and her neck tensed up so she did not faint limply but actually tensed some of her muscles unlike normal fainting and more like siezure. Her color went out of her and she looked yellow. She came around in 20 to 30 seconds very upset and disoriented. She complained it was difficult to breathe at that point, she complained of neck pain, she complained of a tingling and painful sensation running up the arm the immunization was given in and into her neck. Dr checked her vitals and observed her prior to release from his office. Later in the day she complained of visual aura, was extremely fatigued and complained of discomfort moving the arm and strange tingling feeling in the arm and fingers for several hours which dissipated within 24 hours.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle rigidity, Muscle tightness, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Approx 4 to 5 minutes after rcving the Gardasil shot (2nd dose) my daughter was seated on the exam table undergoing the rest of her physical. She suddenly became unresponsive to the dr she made a moaning sound, her eyes rolled back in her head she began to slide sideways down the wall. As I caught her her upper body became rigid and her arms made some jerky movements and her neck tensed up so she did not faint limply but actually tensed some of her muscles unlike normal fainting and more like siezure. Her color went out of her and she looked yellow. She came around in 20 to 30 seconds very upset and disoriented. She complained it was difficult to breathe at that point, she complained of neck pain, she complained of a tingling and painful sensation running up the arm the immunization was given in and into her neck. Dr checked her vitals and observed her prior to release from his office. Later in the day she complained of visual aura, was extremely fatigued and complained of discomfort moving the arm and strange tingling feeling in the arm and fingers for several hours which dissipated within 24 hours.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena, Unresponsive to stimuli, Yellow skin
Clinical narrative: Approx 4 to 5 minutes after rcving the Gardasil shot (2nd dose) my daughter was seated on the exam table undergoing the rest of her physical. She suddenly became unresponsive to the dr she made a moaning sound, her eyes rolled back in her head she began to slide sideways down the wall. As I caught her her upper body became rigid and her arms made some jerky movements and her neck tensed up so she did not faint limply but actually tensed some of her muscles unlike normal fainting and more like siezure. Her color went out of her and she looked yellow. She came around in 20 to 30 seconds very upset and disoriented. She complained it was difficult to breathe at that point, she complained of neck pain, she complained of a tingling and painful sensation running up the arm the immunization was given in and into her neck. Dr checked her vitals and observed her prior to release from his office. Later in the day she complained of visual aura, was extremely fatigued and complained of discomfort moving the arm and strange tingling feeling in the arm and fingers for several hours which dissipated within 24 hours.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Human chorionic gonadotropin positive, Maternal exposure during pregnancy
Clinical narrative: No event. Pt had negative pregnancy test 17JUL when test given and returns today 24JUL with positive test. Pt was pregnant at time of vaccine anthrax but B HCG was negative.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Pyrexia, Screaming, Sleep disorder, Somnolence
Clinical narrative: Fever, Screaming/crying, sleepiness/changed sleep pattern. Administered acetaminophen at 3:30PM and 7:30 PM.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, Throat tightness
Clinical narrative: Initial report was received from a consumer, who was the patient's daughter, on 13 July 2012, which also involved a case of misuse (vaccine administered at inappropriate site). A 53-year-old female patient had received a dose one intramuscular injection at the gluteal site for post-exposure of IMOVAX Rabies, sanofi pasteur SA (lot number unknown) on 11 July 2012. Within minutes, the patient experienced tightening of throat. The patient was treated with BENADRYL in the emergency room (ER). No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Injection site discolouration, Injection site reaction
Clinical narrative: Pt. came to our office (we are PCP) due to concern about discoloration and dry skin at site of zoster vaccine.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Influenza like illness, Pyrexia, Swelling
Clinical narrative: Initial report was received from a health care professional through another manufacturer under reference number S2012US03633 on 11 July 2012. A 15-year-old male patient had received an injection of DIPHTHERIA AND TETANUS TOXOIDS (manufacturer, lot number, route and site not reported) on 28 July 2009. On 28 July 2009, severe swelling began. On 29 July 2009, fever and flu-like symptoms began which lasted for 3 days. Past medical history and concomitant medications were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: Vaccination rec'd Thursday AM 7/19/12 and began with fever late Thursday afternoon until Saturday 7/21/12 night. Left upper arm red, hot, swollen. Today 7/23/12 pt. seen in office upon her calling to report s/s, arm less red, and swollen per pt. States feels itchy/prickly in (L) arm (upper) Rx BENADRYL & cold compress.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Oedema peripheral
Clinical narrative: Left arm swollen & red at injection site.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Discomfort, Erythema, Induration, Local swelling
Clinical narrative: Localized swelling, redness, induration & discomfort.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure systolic decreased, Heart rate decreased, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Nausea & vomiting, pallor, sweating, about decreased SBPA1 (from baseline one teens systolic) & decreased HR 40's - improved w/in about 10 min.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Nausea & vomiting, pallor, sweating, about decreased SBPA1 (from baseline one teens systolic) & decreased HR 40's - improved w/in about 10 min.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Allergy to vaccine, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has pain, redness and swelling on injection site of left arm for 4 days. Allergic to Tdap.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Dr. ordered ZOSTAVAX, Pt took script to pharmacy, pharmacy filled Rx, brought back to Dr. office, injection given. No adverse reaction noted.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Full blood count normal, Metabolic function test normal, Pallor
Clinical narrative: Few minutes after (IM) shots - felt dizzy, became pale. Normal respiration, conscious coherent. HR strong 72 BP (NL) offered supine position. Gradually recovered - up next 15 - 30 min. No complaints total time observe 30 min after recovery.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Syncope 30 secs after injection and vomiting about 15 min. after injection.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Urticaria
Clinical narrative: Red, edema, hives.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 68 years old female patient with high cholesterol and allergies to PROTONIX, PRILOSEC and BETADINE. The patient was vaccinated with a dose of ZOSTAVAX on 23-OCT-2011. No other co-suspects were reported. Concomitant medications included: MEVACOR TABLET. The physician reported that on 19-JUN-2012 the patient developed shingles. Initially the patient experienced abdominal pain that went from the epigastric region to her back on one side (unspecified side). The following day the patient developed a rash in the same area. The patient's lesions currently had crusted over but she had postherpetic neuralgia. The physician did not keep ZOSTAVAX in her office and she did not administer the vaccine so she thought the patient might had received it from a pharmacy. The patient sought medical attention by office visit. Treatment included VALTREX, NEURONTIN, acetaminophen, VICODIN, ELAVIL and LIDODERM. No lab diagnostics studies were performed. The outcome of shingles and postherpetic neuralgia was reported as not recovered/not resolved. Shingles and postherpetic neuralgia was considered to be disabling by the reporter because the patient had incapacity pain. This is one of two reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: This spontaneous report as received from a physician refers to a 68 years old female patient with high cholesterol and allergies to PROTONIX, PRILOSEC and BETADINE. The patient was vaccinated with a dose of ZOSTAVAX on 23-OCT-2011. No other co-suspects were reported. Concomitant medications included: MEVACOR TABLET. The physician reported that on 19-JUN-2012 the patient developed shingles. Initially the patient experienced abdominal pain that went from the epigastric region to her back on one side (unspecified side). The following day the patient developed a rash in the same area. The patient's lesions currently had crusted over but she had postherpetic neuralgia. The physician did not keep ZOSTAVAX in her office and she did not administer the vaccine so she thought the patient might had received it from a pharmacy. The patient sought medical attention by office visit. Treatment included VALTREX, NEURONTIN, acetaminophen, VICODIN, ELAVIL and LIDODERM. No lab diagnostics studies were performed. The outcome of shingles and postherpetic neuralgia was reported as not recovered/not resolved. Shingles and postherpetic neuralgia was considered to be disabling by the reporter because the patient had incapacity pain. This is one of two reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gaze palsy, Head injury, Loss of consciousness, Tremor
Clinical narrative: Information has been received from a Registered Nurse concerning a 16 year old female patient with chronic fatigue who on 30-MAY-2012 was vaccinated intramuscularly with a dose of GARDASIL, (dose not reported), (Lot#669795/1317AA, exp date 13-OCT-2012). On 30-MAY-2012 the patient experienced dizziness. The patient went to ER and was given unspecified treatment. The patient underwent MRI test (results not reported). The outcome was not reported. Follow-up information has been received from a Registered Nurse concerning a female patient, a student with no known allergies who on 30-MAY-2012 at 12:02 PM, was vaccinated with a second dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The Registered Nurse reported that on 30-MAY-2012 at 12:10, the patient passed out 8 min after she received second dose of GARDASIL - apparently hit her head on frame door, has "twitching" movements for about 20 seconds. The patient came to her and went to ER for evaluation. No treatment information was reported. Computer tomography of head was performed - no acute disease, electroencephalogram - negative. The patient recovered on 30-MAY-2012. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head normal, Dizziness, Electroencephalogram normal, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a Registered Nurse concerning a 16 year old female patient with chronic fatigue who on 30-MAY-2012 was vaccinated intramuscularly with a dose of GARDASIL, (dose not reported), (Lot#669795/1317AA, exp date 13-OCT-2012). On 30-MAY-2012 the patient experienced dizziness. The patient went to ER and was given unspecified treatment. The patient underwent MRI test (results not reported). The outcome was not reported. Follow-up information has been received from a Registered Nurse concerning a female patient, a student with no known allergies who on 30-MAY-2012 at 12:02 PM, was vaccinated with a second dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The Registered Nurse reported that on 30-MAY-2012 at 12:10, the patient passed out 8 min after she received second dose of GARDASIL - apparently hit her head on frame door, has "twitching" movements for about 20 seconds. The patient came to her and went to ER for evaluation. No treatment information was reported. Computer tomography of head was performed - no acute disease, electroencephalogram - negative. The patient recovered on 30-MAY-2012. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a Registered Nurse concerning a 16 year old female patient with chronic fatigue who on 30-MAY-2012 was vaccinated intramuscularly with a dose of GARDASIL, (dose not reported), (Lot#669795/1317AA, exp date 13-OCT-2012). On 30-MAY-2012 the patient experienced dizziness. The patient went to ER and was given unspecified treatment. The patient underwent MRI test (results not reported). The outcome was not reported. Follow-up information has been received from a Registered Nurse concerning a female patient, a student with no known allergies who on 30-MAY-2012 at 12:02 PM, was vaccinated with a second dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The Registered Nurse reported that on 30-MAY-2012 at 12:10, the patient passed out 8 min after she received second dose of GARDASIL - apparently hit her head on frame door, has "twitching" movements for about 20 seconds. The patient came to her and went to ER for evaluation. No treatment information was reported. Computer tomography of head was performed - no acute disease, electroencephalogram - negative. The patient recovered on 30-MAY-2012. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from registered nurse concerning an 83 year old female patient who on 06-JUL-2012, was vaccinated SQ in the left deltoid area with 0.65 ml dose of ZOSTAVAX (lot# 0257AE, exp 15-MAR-2013). The pharmacist stated that the following day, on 07-JUL-2012, the patient noticed that the injection site was red. On the day of reporting, 10-JUL-2012, the patient was till experiencing redness at the injection site "about the size of a quarter", but the patient stated that there was no evidence of rash. The patient declined receipt of the VZVIP Packet for HCPs. The patient went to the physician and was diagnosed with a mild case of shingles on 10-JUL-2012. The pharmacist also reported that the patient's husband also had shingles at the time of the report "right now". It was unclear if the patient's husband received ZOSTAVAX. At the time of the report, the patient had not recovered. She sought medical attention by visiting physician's office. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema
Clinical narrative: This spontaneous report as received from registered nurse concerning an 83 year old female patient who on 06-JUL-2012, was vaccinated SQ in the left deltoid area with 0.65 ml dose of ZOSTAVAX (lot# 0257AE, exp 15-MAR-2013). The pharmacist stated that the following day, on 07-JUL-2012, the patient noticed that the injection site was red. On the day of reporting, 10-JUL-2012, the patient was till experiencing redness at the injection site "about the size of a quarter", but the patient stated that there was no evidence of rash. The patient declined receipt of the VZVIP Packet for HCPs. The patient went to the physician and was diagnosed with a mild case of shingles on 10-JUL-2012. The pharmacist also reported that the patient's husband also had shingles at the time of the report "right now". It was unclear if the patient's husband received ZOSTAVAX. At the time of the report, the patient had not recovered. She sought medical attention by visiting physician's office. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Diarrhoea, Dizziness, Erythema, Induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female with allergy to tramadol hydrochloride, niacin and ALDARA and no pertinent medical history. The patient was vaccinated subcutaneously with a dose of (lot # 0255AE; exp date 16-MAR-2013), ZOSTAVAX on 07-JUL-2012 (dose not reported). No other co-suspects and no concomitant medications were reported. On 08-JUL-2012 the patient developed fever, runny nose, nausea, diarrhea, light headedness, chest pain, and hard lump at the injection site. The hard lump area was about 1 and 1/2 inches by 3 and 1/2 inches on 08-JUL-2012, but at the time of the report it was 6 by 5 inches. The site was itchy at the beginning but at the time of the report it was painful. The patient sought medical attention by seeing the pharmacist. No treatment was given for the reported events and no lab diagnostic tests were performed. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female with allergy to tramadol hydrochloride, niacin and ALDARA and no pertinent medical history. The patient was vaccinated subcutaneously with a dose of (lot # 0255AE; exp date 16-MAR-2013), ZOSTAVAX on 07-JUL-2012 (dose not reported). No other co-suspects and no concomitant medications were reported. On 08-JUL-2012 the patient developed fever, runny nose, nausea, diarrhea, light headedness, chest pain, and hard lump at the injection site. The hard lump area was about 1 and 1/2 inches by 3 and 1/2 inches on 08-JUL-2012, but at the time of the report it was 6 by 5 inches. The site was itchy at the beginning but at the time of the report it was painful. The patient sought medical attention by seeing the pharmacist. No treatment was given for the reported events and no lab diagnostic tests were performed. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Diarrhoea, Dizziness, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female with allergy to tramadol hydrochloride, niacin and ALDARA and no pertinent medical history. The patient was vaccinated subcutaneously with a dose of (lot # 0255AE; exp date 16-MAR-2013), ZOSTAVAX on 07-JUL-2012 (dose not reported). No other co-suspects and no concomitant medications were reported. On 08-JUL-2012 the patient developed fever, runny nose, nausea, diarrhea, light headedness, chest pain, and hard lump at the injection site. The hard lump area was about 1 and 1/2 inches by 3 and 1/2 inches on 08-JUL-2012, but at the time of the report it was 6 by 5 inches. The site was itchy at the beginning but at the time of the report it was painful. The patient sought medical attention by seeing the pharmacist. No treatment was given for the reported events and no lab diagnostic tests were performed. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female with allergy to tramadol hydrochloride, niacin and ALDARA and no pertinent medical history. The patient was vaccinated subcutaneously with a dose of (lot # 0255AE; exp date 16-MAR-2013), ZOSTAVAX on 07-JUL-2012 (dose not reported). No other co-suspects and no concomitant medications were reported. On 08-JUL-2012 the patient developed fever, runny nose, nausea, diarrhea, light headedness, chest pain, and hard lump at the injection site. The hard lump area was about 1 and 1/2 inches by 3 and 1/2 inches on 08-JUL-2012, but at the time of the report it was 6 by 5 inches. The site was itchy at the beginning but at the time of the report it was painful. The patient sought medical attention by seeing the pharmacist. No treatment was given for the reported events and no lab diagnostic tests were performed. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous report as received from a Pharmacy Intern (also reported as a healthcare student) refers to a 65 years old female patient with no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot # 671901/0421AE, expiration date 21-MAR-2013) (route and site unspecified) on 10-JUL-2012. No other co-suspects were reported. Concomitant medications included gabapentin, ofloxacin, HCTZ, levothyroxine, metoprolol and tramadol. Patient experienced redness and firmness around the injection site after receiving ZOSTAVAX. Patient started noticing symptoms on 11-JUL-2012 and redness spread down to her elbow area and the size of the firm area around the injection site was about 2 half dollar coins. Patient also reported some itching around the injection site area and the area was warm and painful to touch. The patient had sought medical attention via office visit. No treatment was given. The outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a Pharmacy Intern (also reported as a healthcare student) refers to a 65 years old female patient with no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot # 671901/0421AE, expiration date 21-MAR-2013) (route and site unspecified) on 10-JUL-2012. No other co-suspects were reported. Concomitant medications included gabapentin, ofloxacin, HCTZ, levothyroxine, metoprolol and tramadol. Patient experienced redness and firmness around the injection site after receiving ZOSTAVAX. Patient started noticing symptoms on 11-JUL-2012 and redness spread down to her elbow area and the size of the firm area around the injection site was about 2 half dollar coins. Patient also reported some itching around the injection site area and the area was warm and painful to touch. The patient had sought medical attention via office visit. No treatment was given. The outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a Pharmacy Intern (also reported as a healthcare student) refers to a 65 years old female patient with no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot # 671901/0421AE, expiration date 21-MAR-2013) (route and site unspecified) on 10-JUL-2012. No other co-suspects were reported. Concomitant medications included gabapentin, ofloxacin, HCTZ, levothyroxine, metoprolol and tramadol. Patient experienced redness and firmness around the injection site after receiving ZOSTAVAX. Patient started noticing symptoms on 11-JUL-2012 and redness spread down to her elbow area and the size of the firm area around the injection site was about 2 half dollar coins. Patient also reported some itching around the injection site area and the area was warm and painful to touch. The patient had sought medical attention via office visit. No treatment was given. The outcome was unknown. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Urticarial rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Local swelling, Rash
Clinical narrative: Given ZOSTAVAX 7/6 in (L) arm. Developed swelling & rash under axilla on breast & (L) side of back. Seen 7/18 with shingles. I examined her- classic shingles along T4 dermatome.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pharyngeal oedema, Rash
Clinical narrative: Developed rash later that day. Felt throat swelling, rash on legs.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Left arm with local reaction - swelling, erythema, mild warmth. Hydroxyzine HCl 25 mg TID prn. Treatment: KEFLEX 500 mg BID x 10 days, prednisone 20 mg TID x 2 days.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Rash, Swelling
Clinical narrative: RASH, RAISED AREA IN CENTER.
Age: 27.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Anxiety, Asthenia, Dizziness, Dyspnoea
Clinical narrative: Patient described weakness, dizziness and a feeling of anxiety/shortness of breath within a few minutes of the vaccine. After several more minutes these subsided and he left the pharmacy (he didn't want medical treatment).
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Injection site swelling, Nausea
Clinical narrative: Pt woke up morning after vaccination with h/a, nausea, temp 101 and swelling at site. Pt. stated she was fine when she called on 7/20/12.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Mobility decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Service member received a Tdap vaccine. Woke up in middle of night vomiting, has pain at injection site, stiff neck, headache and is running a fever. Still vomiting about every 30 minutes: Taking TYLENOL and ALEVE for pain. Unable to move arm. Going to be seen by PCP.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Service member received a Tdap vaccine. Woke up in middle of night vomiting, has pain at injection site, stiff neck, headache and is running a fever. Still vomiting about every 30 minutes: Taking TYLENOL and ALEVE for pain. Unable to move arm. Going to be seen by PCP.
Age: 0.87
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Dyskinesia, Gaze palsy, Posture abnormal
Clinical narrative: Head tilted to side; arms jerked; eyes rolled; Mom historian; episode lasted several seconds.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 79 year old female patient with none pertinent medical history and none drug reactions/allergies who on 11-JUN-2012, was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (Merck), (Lot # not reported). There was no concomitant medication. On 11-JUN-2012 (patient returned on 12-JUN-2012 to the pharmacy) the patient developed redness, tenderness, itching and warmth at the injection site several hours following the vaccination. The patient received "cold pack" to the affected area. No lab diagnostic test were performed. At the time of the report the patient's status was not recovered. The relationship between the events and (Merck) ZOSTAVAX was unknown. No further information is available.
Age: 0.3
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered Nurse (R.N.) concerning her 12 weeks old daughter, who approximately on 24-JAN-2011, was vaccinated SC with a 0.5ml dose of VARIVAX (Merck) (lot# not reported). No adverse effects reported. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, TYP
Symptoms: Throat tightness
Clinical narrative: Patient described "throat closing". Got diphenhydramine. Patient recovered in 15-30 minutes.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Abasia, Educational problem, Fine motor delay, Motor dysfunction, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with MMR II (lot#, route and dose were unspecified) on approximately August-1974, "15 months old" and for 5 years didn't walk. No concomitant medications were reported. On approximately 1974, "the next day" after given MMR II the patient was shaking and then 3 days later stopped walking. The patient couldn't sit up and lost motor control. The consumer stated her daughter was a perfectly healthy child until the MMR II was given. Consumer states her daughter couldn't read for a long time and when her daughter started school, she was 3 years behind. Consumer stated treatment with "ACTH shots" for 3 months then her daughter would start walking again but if her daughter had a fever, her daughter would stop walking and needed "ACTH shots". This occurred for 5 years. Consumer states to this day, her daughter's fine motor skills were not 100%. Consumer mentioned her daughter would run high fevers with most vaccines but not with MMR II. Consumer could only remember DTAP (manufacturer unknown). The patient sought medical attention via office visits, and was hospitalized every 3 to 4 years. Lab diagnostic studies included brain scans and kidney tests. Lab diagnostics results were not reported. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Reading disorder, Renal function test, Scan brain, Tremor
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with MMR II (lot#, route and dose were unspecified) on approximately August-1974, "15 months old" and for 5 years didn't walk. No concomitant medications were reported. On approximately 1974, "the next day" after given MMR II the patient was shaking and then 3 days later stopped walking. The patient couldn't sit up and lost motor control. The consumer stated her daughter was a perfectly healthy child until the MMR II was given. Consumer states her daughter couldn't read for a long time and when her daughter started school, she was 3 years behind. Consumer stated treatment with "ACTH shots" for 3 months then her daughter would start walking again but if her daughter had a fever, her daughter would stop walking and needed "ACTH shots". This occurred for 5 years. Consumer states to this day, her daughter's fine motor skills were not 100%. Consumer mentioned her daughter would run high fevers with most vaccines but not with MMR II. Consumer could only remember DTAP (manufacturer unknown). The patient sought medical attention via office visits, and was hospitalized every 3 to 4 years. Lab diagnostic studies included brain scans and kidney tests. Lab diagnostics results were not reported. Additional information is not expected.
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Death neonatal, Maternal exposure during pregnancy, Neonatal disorder, Ultrasound antenatal screen normal
Clinical narrative: This retrospective pregnancy case was reported by a consumer and described the occurrence of death nos in a female neonate subject who was exposed to BOOSTRIX (GlaxoSmithKline), ADACEL (non-gsk) during pregnancy. A physician or other health care professional has not verified this report. On 6 September 2011, the 31-year-old mother of the subject received unspecified dose of BOOSTRIX (.5 ml, transplacentary) and unspecified dose of ADACEL (transplacentary). The mother's last menstrual period was on an unknown date and estimated date the delivery was 01 May 2012. The neonate was exposed to BOOSTRIX during an unknown trimester. Examination results of an "ultrasound 7" showed no evidence of a defect. On 1 May 2012, at an unspecified gestation age, the neonate was delivered by unknown method and weight 3.9 kilograms. Apgar score was not provided. The neonate was diagnosed with pulmonary hypertension and arterial venous malformation. The neonate remained hospitalized and died on 17 May 2012, cause of death was not provided. It was unknown whether an autopsy was performed. The outcome of pulmonary hypertension and arterial venous malformation were not specified. Please see report A0984491A for details regarding the mother case. Follow-up information received via the consumer on 17 July 2012 indicated the lot number for BOOSTRIX as C3947BA with expiration date 03 February 2014.
Sex: F
Vaccine: TDAP, TDAP, TDAP, TDAP
Symptoms: Arteriovenous malformation, Death neonatal, Foetal exposure during pregnancy, Neonatal disorder, Pulmonary hypertension
Clinical narrative: This retrospective pregnancy case was reported by a consumer and described the occurrence of death nos in a female neonate subject who was exposed to BOOSTRIX (GlaxoSmithKline), ADACEL (non-gsk) during pregnancy. A physician or other health care professional has not verified this report. On 6 September 2011, the 31-year-old mother of the subject received unspecified dose of BOOSTRIX (.5 ml, transplacentary) and unspecified dose of ADACEL (transplacentary). The mother's last menstrual period was on an unknown date and estimated date the delivery was 01 May 2012. The neonate was exposed to BOOSTRIX during an unknown trimester. Examination results of an "ultrasound 7" showed no evidence of a defect. On 1 May 2012, at an unspecified gestation age, the neonate was delivered by unknown method and weight 3.9 kilograms. Apgar score was not provided. The neonate was diagnosed with pulmonary hypertension and arterial venous malformation. The neonate remained hospitalized and died on 17 May 2012, cause of death was not provided. It was unknown whether an autopsy was performed. The outcome of pulmonary hypertension and arterial venous malformation were not specified. Please see report A0984491A for details regarding the mother case. Follow-up information received via the consumer on 17 July 2012 indicated the lot number for BOOSTRIX as C3947BA with expiration date 03 February 2014.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Herpes zoster, Muscular weakness, Pain in extremity, Pyrexia, Rash
Clinical narrative: Rec'd HPV #1 on 7-9-12, c/o arm pain since. Developed rash x 5 days with arm weakness and worse pain starting on about 7-13-12. Fever 101 on 7-18-12 (Date of o.v.). Rash was c/w Zoster along majority of C-7 dermatome.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a currently 81 years old female patient with no drug reactions or allergies. The patient was vaccinated subcutaneously with a premeasured dose of lot # (671663/1159AA; exp date 18-Oct-2012) ZOSTAVAX on 15-JUN-2012 (dose not provided). No other co-suspects were reported. Concomitant medications included amlodipine, LASIX, PLAQUENIL, SPIRIVA, fluticasone propionate, ADVAIR, ZOCOR and DHEA. On an unknown date the patient had fever, malaise and chills. The patient visited the pharmacy and no treatment was given for the reported events. The outcome of fever, malaise and chills was reported as recovered (date unknown). The relatedness for fever, malaise and chills was not provided for ZOSTAVAX.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash, Urticaria
Clinical narrative: Rash on body 2 days after vaccine was given, urticarial rash primarily on torso as described by mom.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received form a registered nurse concerning a 27 month old male patient with no pertinent medical history or drug reactions/allergies who on 02-MAR-2011 was vaccinated SQ with 0.5 mL of VARIVAX (Merck) (lot # 668431/0996Z, expiration date on 28-JUL-2012). There was no concomitant medication. The nurse reported that on 25-MAY-2012, the patient developed 14-20 pox lesions on his back and trunk. The patient was treated with calamine lotion and BENADRYL by mouth as needed. No laboratory test was performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow up information has been received from the registered nurse who reported that the patient has recovered from the chickenpox and no further appointment with the office was required. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cardiac arrest
Clinical narrative: 6/28 - Pt. rushed to ER in cardiac arrest.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Decreased appetite, Dyspnoea, Emotional distress, Respiratory disorder
Clinical narrative: Starting at around 6:00 PM and lasting until around 9:30 PM patient screamed and nothing would help him calm down.  He had no appetite.  He started zoning out and staring at one spot and wouldn't respond to voices or loud noises.  Then at around 9:30, on the way to the hospital, his breathing became very irregular and he was gasping for breaths.  Everything seemed to straighten itself out on it's own though.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming, Staring, Unresponsive to stimuli
Clinical narrative: Starting at around 6:00 PM and lasting until around 9:30 PM patient screamed and nothing would help him calm down.  He had no appetite.  He started zoning out and staring at one spot and wouldn't respond to voices or loud noises.  Then at around 9:30, on the way to the hospital, his breathing became very irregular and he was gasping for breaths.  Everything seemed to straighten itself out on it's own though.