chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Blood test, Computerised tomogram, Guillain-Barre syndrome, Hypoaesthesia, Loss of control of legs
Clinical narrative: Inintially, numbness and tingling in hands, developed to loss of control of arms and legs and later full paralysis. Diagnosis is Guillian Barre syndrome.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Lumbar puncture, Movement disorder, Nuclear magnetic resonance imaging, Paraesthesia, Paralysis
Clinical narrative: Inintially, numbness and tingling in hands, developed to loss of control of arms and legs and later full paralysis. Diagnosis is Guillian Barre syndrome.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intestinal ischaemia, Intestinal resection, Intussusception, Surgery
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 22-MAR-2010, a 6 month old female with no medical history and no preexisting illness was vaccinated with the third dose of ROTATEQ (lot # 664881/1521Y). Secondary suspect therapy on 22-MAR-2010 included a third dose of PENTACEL (lot # C3297AA), a third dose of ENGERIX-B (lot # AHBVB818AA) and a third dose of PREVNAR (lot # D93211). There were no other concomitant medications. 13 days after the vaccination, on 04-APR-2010 the patient experienced intestinal ischaemia. On 06-APR-2010 intussusception was diagnosed and 10 cm ischemic bowel was removed. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. On unspecified dates, the patient recovered. No further information is available. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The original reporting source was not provided. The VAERS ID # is 385742. This report was filed with the FDA. the VAERS ID is 385742.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intestinal ischaemia, Intestinal resection, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 22-MAR-2010, a 6 month old female with no medical history and no preexisting illness was vaccinated with the third dose of ROTATEQ (lot # 664881/1521Y). Secondary suspect therapy on 22-MAR-2010 included a third dose of PENTACEL (lot # C3297AA), a third dose of ENGERIX-B (lot # AHBVB818AA) and a third dose of PREVNAR (lot # D93211). There were no other concomitant medications. 13 days after the vaccination, on 04-APR-2010 the patient experienced intestinal ischaemia. On 06-APR-2010 intussusception was diagnosed and 10 cm ischemic bowel was removed. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. On unspecified dates, the patient recovered. No further information is available. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The original reporting source was not provided. The VAERS ID # is 385742. This report was filed with the FDA. the VAERS ID is 385742.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, RV1, PNC13
Symptoms: Coagulation test, Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3 hours after receiving PENTACEL in (L) thigh and PCV-13 in (R) thigh, pt. developed purpura in (R) lower leg; and fever to 101 degrees. Went to ER and had blood drawn from (R) arm - Petechiae below elbow.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, RV1, PNC13
Symptoms: Metabolic function test, Petechiae, Purpura, Pyrexia
Clinical narrative: 3 hours after receiving PENTACEL in (L) thigh and PCV-13 in (R) thigh, pt. developed purpura in (R) lower leg; and fever to 101 degrees. Went to ER and had blood drawn from (R) arm - Petechiae below elbow.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, RV1, PNC13
Symptoms: Injection site rash, Petechiae, Purpura, Pyrexia
Clinical narrative: 3 hours after receiving PENTACEL in (L) thigh and PCV-13 in (R) thigh, pt. developed purpura in (R) lower leg; and fever to 101 degrees. Went to ER and had blood drawn from (R) arm - Petechiae below elbow.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, RV1, PNC13
Symptoms: Body temperature increased, Injection site reaction, Purpura, Pyrexia
Clinical narrative: 3 hours after receiving PENTACEL in (L) thigh and PCV-13 in (R) thigh, pt. developed purpura in (R) lower leg; and fever to 101 degrees. Went to ER and had blood drawn from (R) arm - Petechiae below elbow.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Brain neoplasm, Inappropriate schedule of drug administration
Clinical narrative: Report called in to agency by mother: Child received a dose of MMR vaccine and a dose of mumps vaccine 2-3 weeks apart (both given 11/2003); one dose given in one foreign country and the other in another foreign country. Child diagnosed with brain tumor (anaplastic arthrocytoma grade 3) on 5/2009. Mother believes brain tumor may be associated with receipt of 2 doses of MMR vaccine at an interval of <28 days. Child is still alive.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Varicella vaccine on 6/8/10 - began to itch and swell on 6/9/10 - Now 6/10/ with redness, swelling, itching upper R arm.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Varicella vaccine on 6/8/10 - began to itch and swell on 6/9/10 - Now 6/10/ with redness, swelling, itching upper R arm.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia, Skin warm
Clinical narrative: "PT RECEIVED THE PNEUMONIA VACCINE YESTERDAY IN HIS LEFT DELTOID, LAST EVENING IT BECAME PAINFUL, (SCALE OF 1-10: 10), SWOLLEN AND RED. THE PAIN TRAVELS DOWN HIS ARM, THE REDNESS AND SWELLING IS STARTING TO GO AWAY, HE DOESN'T SEE RED OR BLUE STREAKING IN THE ARM, THERE ISN'T A RASH. HE'S ABLE TO BEND AT THE ELBOW, HIS FINGERS FEEL "A LITTLE " TINGLY. HE DOESN'T HAVE FACIAL OR TONGUE SWELLING, NO  SHORTNESS OF BREATH, SWEATING, JAW OR CHEST PAIN, NO CHILLS. HIS VOICE ISN'T HOARSE, HE DOESN'T HAVE A HEADACHE, NO NECK STIFFNESS. HE'S NOT HAVING NAUSEA, VOMITING, OR DIARRHEA. HIS WIFE FELT THE ARM COMPARING IT TO THE OTHER, IT FEELS HOT. HE DOESN'T HAVE ANY ALLERGIES THAT HE KNOWS OF, "I'VE HAD ALL KINDS OF SHOTS AND NEVER HAD A REACTION." PT WILL REPORT TO URGENT CARE THIS AFTERNOON."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Red swollen warm to the touch at injection site and on back of neck.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Red swollen warm to the touch at injection site and on back of neck.
Age: 1.8
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Erythema, Injection site scab
Clinical narrative: 2 1/2 x 3 1/2 localized patch of erythema with increased thickness. Non tender to touch site on (L) upper thigh. Puncture site with scab and non-draining to Lt leg.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Site with mild erythema swelling this am. Appears to be increased in size later this pm. Left thigh with moderate raised red firm nodule. non-tender.
Age: 4.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Wrong drug administered
Clinical narrative: A KINRIX was ordered by CPNP. Tdap was given instead of KINRIX by MA.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Gammopathy, Protein urine present, Proteinuria, Swelling
Clinical narrative: Received three doses of AVA from 4 Jun- 18 Jul 07 prior to deployment on 23 Jul 07. He did have an episode of bilateral leg edema around the time of his first vaccination; cannot be sure if it was just prior to or after vaccination. The edema persisted for 1-2 days and then subsided. He did not seek medical attention. During his trip overseas he had a recurrent episode of swelling that persisted. He sought medical attention on 13 Aug when it was noted he had elevated urine protein. During his workup it was noted that he had monoclonal gammopathy and by mid September he was diagnosed as having Multiple Myeloma. He denies family history and agricultural exposure. His first four years of service included working around diesel and jet fuels on the flight line.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site discolouration, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Information has been received from a nurse manager concerning a 77 year old female patient who on 03-MAY-2010 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# 664964/1338Y). Subsequently the patient felt weak and ill the next day (on 04-MAY-2010) as well as the patient's arm was slightly pink at the injection site. The patient sought unspecified medical attention and was advised to use ibuprofen and TYLENOL (manufacturers unspecified) as needed. On an unknown date, the patient had recovered. Follow-up information has been received from the nurse manager concerning the 77 year old retired female with no definite allergies but "some antibiotics caused dizziness and nausea" who was vaccinated IM with the first dose of PNEUMOVAX 23 into her right deltoid at approximately 4:00 PM on 03-MAY-2010. On 4-MAY-2010, the patient complained of general ill feeling and felt weak at 10:35 AM. The patient was advised to use TYLENOL, ibuprofen, or phenergan (25mg, PO) as needed. On 05-MAY-2010, the patient complained of warmth and swelling of injection site. On 05-MAY-2010, the patient, who had refused to be seen on 04-MAY-2010, was seen by a physician. The patient was to use ibuprofen, TYLENOL and ice to the injection site and to follow-up for problems per doctor's instruction. The physician reported that the patient was diagnosed with of pulmonary embolism/infarction on 10-MAY-2010 and the pulmonary embolism/infarction was not related to PNEUMOVAX 23. The symptoms of warmth and swelling of the site noted on 05-MAY-2010 at the time of an office were addressed. No further follow-up occurred related to the complaint of ill feeling or symptoms of localized reactions. Upon internal review, "pulmonary embolism" was determined to be an other important medical event. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pulmonary embolism, Pulmonary infarction
Clinical narrative: Information has been received from a nurse manager concerning a 77 year old female patient who on 03-MAY-2010 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# 664964/1338Y). Subsequently the patient felt weak and ill the next day (on 04-MAY-2010) as well as the patient's arm was slightly pink at the injection site. The patient sought unspecified medical attention and was advised to use ibuprofen and TYLENOL (manufacturers unspecified) as needed. On an unknown date, the patient had recovered. Follow-up information has been received from the nurse manager concerning the 77 year old retired female with no definite allergies but "some antibiotics caused dizziness and nausea" who was vaccinated IM with the first dose of PNEUMOVAX 23 into her right deltoid at approximately 4:00 PM on 03-MAY-2010. On 4-MAY-2010, the patient complained of general ill feeling and felt weak at 10:35 AM. The patient was advised to use TYLENOL, ibuprofen, or phenergan (25mg, PO) as needed. On 05-MAY-2010, the patient complained of warmth and swelling of injection site. On 05-MAY-2010, the patient, who had refused to be seen on 04-MAY-2010, was seen by a physician. The patient was to use ibuprofen, TYLENOL and ice to the injection site and to follow-up for problems per doctor's instruction. The physician reported that the patient was diagnosed with of pulmonary embolism/infarction on 10-MAY-2010 and the pulmonary embolism/infarction was not related to PNEUMOVAX 23. The symptoms of warmth and swelling of the site noted on 05-MAY-2010 at the time of an office were addressed. No further follow-up occurred related to the complaint of ill feeling or symptoms of localized reactions. Upon internal review, "pulmonary embolism" was determined to be an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Hypersensitivity, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Information has been received from a physician assistant concerning a 13 year old female with no pertinent medical history, who on 17-MAR-2010 was vaccinated with the first dose of GARDSIL (IM, lot # 662299/1099Y). On 17-MAY-2010, she received her second dose (IM, lot #663558/0819Y). The physician assistant confirmed that the patient did not receive concomitant vaccinations when the first and second dose of GARDASIL were administered. After the first dose the patient developed "painful rash-like symptoms on her belly." For this rash, BACTRIM and steroids. The patient was treated approximately 6 weeks earlier with antibiotics and steroids for rash which patient's mother was attributing to dose 1 of GARDASIL. The rash resolved. On 31-MAY-2010, she reported to the emergency room with anaphylaxis, transient nausea/vomiting, site of injection redness/swelling, and painful rashes. It was reported that the patient's rash (unknown type) occurred 2 weeks following dose 2 of GARDASIL. Rash was evaluated in the ER after dose 2 and the term anaphylaxis was reported to the reporter from ER report. The patient was diagnosed with an allergic reaction and an urticarial reaction. The P.A. stated that there was post-allergic reaction, the patient developed lesions under her left arm. The patient had been treated with a 5 day course of steroids and topical ointment. Everything was resolved, except some painful "lesions" under the left arm. Rash was evaluated yesterday (02-JUN-2010) in office-"axilla skin erosion" was described by reporter. She was recovering. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Rash, Skin erosion, Skin lesion, Urticaria
Clinical narrative: Information has been received from a physician assistant concerning a 13 year old female with no pertinent medical history, who on 17-MAR-2010 was vaccinated with the first dose of GARDSIL (IM, lot # 662299/1099Y). On 17-MAY-2010, she received her second dose (IM, lot #663558/0819Y). The physician assistant confirmed that the patient did not receive concomitant vaccinations when the first and second dose of GARDASIL were administered. After the first dose the patient developed "painful rash-like symptoms on her belly." For this rash, BACTRIM and steroids. The patient was treated approximately 6 weeks earlier with antibiotics and steroids for rash which patient's mother was attributing to dose 1 of GARDASIL. The rash resolved. On 31-MAY-2010, she reported to the emergency room with anaphylaxis, transient nausea/vomiting, site of injection redness/swelling, and painful rashes. It was reported that the patient's rash (unknown type) occurred 2 weeks following dose 2 of GARDASIL. Rash was evaluated in the ER after dose 2 and the term anaphylaxis was reported to the reporter from ER report. The patient was diagnosed with an allergic reaction and an urticarial reaction. The P.A. stated that there was post-allergic reaction, the patient developed lesions under her left arm. The patient had been treated with a 5 day course of steroids and topical ointment. Everything was resolved, except some painful "lesions" under the left arm. Rash was evaluated yesterday (02-JUN-2010) in office-"axilla skin erosion" was described by reporter. She was recovering. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician assistant concerning a 13 year old female with no pertinent medical history, who on 17-MAR-2010 was vaccinated with the first dose of GARDSIL (IM, lot # 662299/1099Y). On 17-MAY-2010, she received her second dose (IM, lot #663558/0819Y). The physician assistant confirmed that the patient did not receive concomitant vaccinations when the first and second dose of GARDASIL were administered. After the first dose the patient developed "painful rash-like symptoms on her belly." For this rash, BACTRIM and steroids. The patient was treated approximately 6 weeks earlier with antibiotics and steroids for rash which patient's mother was attributing to dose 1 of GARDASIL. The rash resolved. On 31-MAY-2010, she reported to the emergency room with anaphylaxis, transient nausea/vomiting, site of injection redness/swelling, and painful rashes. It was reported that the patient's rash (unknown type) occurred 2 weeks following dose 2 of GARDASIL. Rash was evaluated in the ER after dose 2 and the term anaphylaxis was reported to the reporter from ER report. The patient was diagnosed with an allergic reaction and an urticarial reaction. The P.A. stated that there was post-allergic reaction, the patient developed lesions under her left arm. The patient had been treated with a 5 day course of steroids and topical ointment. Everything was resolved, except some painful "lesions" under the left arm. Rash was evaluated yesterday (02-JUN-2010) in office-"axilla skin erosion" was described by reporter. She was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Influenza like illness, Loss of consciousness, Malaise, Pain
Clinical narrative: An online magazine reported that a consumer said that on an unspecified date her daughter was vaccinated with all 3 injections of GARDASIL and after each one she got sicker and sicker. At the time, the patient's mother had no idea that it was the shots doing it to her. After the first shot, she had flu like symptoms, would pass out and had seizures. The second shot left her with vision problems and a lot of pain. She was so sick to that she was hospitalized, but it was not possible to find what was wrong. The physician declared: "you have one sick daughter, but we don't know why". At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Upon internal review, seizure was considered to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: An online magazine reported that a consumer said that on an unspecified date her daughter was vaccinated with all 3 injections of GARDASIL and after each one she got sicker and sicker. At the time, the patient's mother had no idea that it was the shots doing it to her. After the first shot, she had flu like symptoms, would pass out and had seizures. The second shot left her with vision problems and a lot of pain. She was so sick to that she was hospitalized, but it was not possible to find what was wrong. The physician declared: "you have one sick daughter, but we don't know why". At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Upon internal review, seizure was considered to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Adrenal disorder, Arrhythmia, Bedridden, Convulsion, Decreased activity
Clinical narrative: Information was received from an online magazine who reported that a consumer said that on an unspecified date her daughter was vaccinated with GARDASIL. It was reported that late June 2007, her daughter's life changed after GARDASIL. The patient went from a vibrant, active college student, to a bedridden, chronically ill, young woman with seizures, GI tract problems, constant migraines, blurred vision, abnormal pupil reaction, loss of feeling in both legs, heart arrhythmia, TIAs, eye sensitivity, exhausted adrenals and the list just kept growing. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Seizures was considered to be an other important medical event and bedridden was considered to be disabling. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Malaise, Migraine, Photophobia, Pupillary disorder
Clinical narrative: Information was received from an online magazine who reported that a consumer said that on an unspecified date her daughter was vaccinated with GARDASIL. It was reported that late June 2007, her daughter's life changed after GARDASIL. The patient went from a vibrant, active college student, to a bedridden, chronically ill, young woman with seizures, GI tract problems, constant migraines, blurred vision, abnormal pupil reaction, loss of feeling in both legs, heart arrhythmia, TIAs, eye sensitivity, exhausted adrenals and the list just kept growing. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Seizures was considered to be an other important medical event and bedridden was considered to be disabling. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Sensory loss, Transient ischaemic attack, Vision blurred
Clinical narrative: Information was received from an online magazine who reported that a consumer said that on an unspecified date her daughter was vaccinated with GARDASIL. It was reported that late June 2007, her daughter's life changed after GARDASIL. The patient went from a vibrant, active college student, to a bedridden, chronically ill, young woman with seizures, GI tract problems, constant migraines, blurred vision, abnormal pupil reaction, loss of feeling in both legs, heart arrhythmia, TIAs, eye sensitivity, exhausted adrenals and the list just kept growing. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Seizures was considered to be an other important medical event and bedridden was considered to be disabling. No further information is available.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Agitation, Dyspnoea, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: Information has been received from a pharmacist concerning a female with Down's Syndrome and no drug allergies, who on 23-MAR-2010 was inadvertently vaccinated with a dose of PNEUMOVAX 23 vaccine, 0.5ml, IV (lot # 664537/1193Y). On 23-MAR-2010 the patient became agitated and diaphoretic. The patient received medical attention. The physician gave the patient PHENERGAN and SOLU-MEDROL for the treatment. There were no labs or diagnostic tests performed. The patient recovered on 24-MAR-2010. Follow up information received from a pharmacist concerning a 38 year old female with Down's Syndrome and pneumonia at time of vaccination who on 23-MAR-2010 at 5:00 pm was vaccinated with a dose of PNEUMOVAX 23 vaccine, IV, (Lot # 664537/1193Y). On 23-MAR-2010 at 5:04 pm the patient became agitated, short of breath, hypotensive and loss of consciousness for 1 minute. The patient was given BENADRYL and SOLU-MEDROL. The patient recovered quickly after initial problem. Agitated, short of breath, hypotensive and loss of consciousness for 1 minute were considered to be other important medical events by the physician. No further information is available.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a female with Down's Syndrome and no drug allergies, who on 23-MAR-2010 was inadvertently vaccinated with a dose of PNEUMOVAX 23 vaccine, 0.5ml, IV (lot # 664537/1193Y). On 23-MAR-2010 the patient became agitated and diaphoretic. The patient received medical attention. The physician gave the patient PHENERGAN and SOLU-MEDROL for the treatment. There were no labs or diagnostic tests performed. The patient recovered on 24-MAR-2010. Follow up information received from a pharmacist concerning a 38 year old female with Down's Syndrome and pneumonia at time of vaccination who on 23-MAR-2010 at 5:00 pm was vaccinated with a dose of PNEUMOVAX 23 vaccine, IV, (Lot # 664537/1193Y). On 23-MAR-2010 at 5:04 pm the patient became agitated, short of breath, hypotensive and loss of consciousness for 1 minute. The patient was given BENADRYL and SOLU-MEDROL. The patient recovered quickly after initial problem. Agitated, short of breath, hypotensive and loss of consciousness for 1 minute were considered to be other important medical events by the physician. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fatigue, Underdose
Clinical narrative: Information has been received from a physician and medical assistant concerning a female patient with seizures who on 03-JUN-2010 was vaccinated with a dose of GARDASIL in her arm which was not fully injected. The patient most likely got a drop, if that, of GARDASIL when all the sudden the patient had a seizure and the medical assistant pulled out the shot immediately. The patient had a seizure a couple of months ago while at a dentist office. The patient called a neurologist and her primary care physician to be seen. The patient felt exhausted after her seizure. The patient was in the process of trying to become pregnant. The office kept the vial of GARDASIL to show that most of the dose was still in the vial. At the time of the report, the patient's status was unknown. Upon internal review, "seizure" was determined to be an other important medical event. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability
Clinical narrative: Information has been received from an approximately 58 year old male with high blood pressure and high cholesterol and with no drug reaction/allergies, who in 2006 was vaccinated subcutaneously with ZOSTAVAX (Merck) (lot # not provided). Concomitant therapy included simvastatin (manufacturer unknown) and metoprolol tartrate ER. In 2007 the patient developed shingles and on 3 other occasions after that. The outbreaks were on the pubic area, stomach area and on the ear. He was unable to go to work. Unspecified medical attention was sought and "perhaps" some lab tests were performed. He received acyclovir, gabapentin, and ZOVIRAX ointment as treatment. The first experience of shingles was recovered in 2007. He was also recovered from each shingles episode after that. The shingles were considered to be disabling and other important medical events by the consumer. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTP, HIBV, PNC13
Symptoms: Full blood count normal, Rash, Rash generalised, Red blood cell sedimentation rate normal, Skin exfoliation
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old male patient who experienced rash on abdomen spreading to generalized rash all over body and skin peeling, knees, hands and feet. At 15 months of age, the patient received the first dose on 12-MAY-2010. The patient also received the third dose of DPT (manufacturer unknown) and the third dose of HIB (manufacturer unknown) on 12-MAY-2010. On 13-May-2010, on or about 0600, the patient experienced a rash on his abdomen spreading to a generalized rash all over his body. On 14-May-2010, he was evaluated by a physician. Treatment was not reported. On an unspecified date in May he recovered from the rash. On 16-May-2010, on or about 1400, the patient experienced skin peeling on the knees followed by skin peeling on his hands on 20-May-2010 and in May-2010 from his feet. On 21 and 28-May-2010, the patient evaluated at a physician's office for the event of skin peeling. A complete blood count and sedimentation rate were performed and found to be "normal". A "strep" culture was negative. No treatment was reported. As of 01-Jun-2010, the event of skin peeling had not recovered.
Age: 1.25
Sex: M
Vaccine: DTP, HIBV, PNC13
Symptoms: Streptococcus test negative
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old male patient who experienced rash on abdomen spreading to generalized rash all over body and skin peeling, knees, hands and feet. At 15 months of age, the patient received the first dose on 12-MAY-2010. The patient also received the third dose of DPT (manufacturer unknown) and the third dose of HIB (manufacturer unknown) on 12-MAY-2010. On 13-May-2010, on or about 0600, the patient experienced a rash on his abdomen spreading to a generalized rash all over his body. On 14-May-2010, he was evaluated by a physician. Treatment was not reported. On an unspecified date in May he recovered from the rash. On 16-May-2010, on or about 1400, the patient experienced skin peeling on the knees followed by skin peeling on his hands on 20-May-2010 and in May-2010 from his feet. On 21 and 28-May-2010, the patient evaluated at a physician's office for the event of skin peeling. A complete blood count and sedimentation rate were performed and found to be "normal". A "strep" culture was negative. No treatment was reported. As of 01-Jun-2010, the event of skin peeling had not recovered.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count normal, Hypophagia, Intussusception, Urine analysis normal, Vomiting
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-month-old female patient who experienced intussusception, poor intake and persistent vomiting. The patient received a dose on 18-May-2010. The patient also received a dose of ROTARIX (GlaxoSmithKline) and a dose of PENTACEL (Aventis-Pasteur) on 18-May-2010. On 22-May-2010, the patient had persistent vomiting and poor intake for 24 hours. On 23-May-2010, the physician sent the patient to the emergency room and intussusception was diagnosed. The patient was given intravenous fluids and was still vomiting at each feeding. The patient was transferred to another hospital. On 27-May-2010, the issues had resolved; however the patient experienced the symptoms again. The outcome of the events is unknown at this time. No additional information was available at the time of this report.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Barium double contrast, Intussusception, Irritability, Vomiting
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-month-old female patient who experienced intussusception, poor intake and persistent vomiting. The patient received a dose on 18-May-2010. The patient also received a dose of ROTARIX (GlaxoSmithKline) and a dose of PENTACEL (Aventis-Pasteur) on 18-May-2010. On 22-May-2010, the patient had persistent vomiting and poor intake for 24 hours. On 23-May-2010, the physician sent the patient to the emergency room and intussusception was diagnosed. The patient was given intravenous fluids and was still vomiting at each feeding. The patient was transferred to another hospital. On 27-May-2010, the issues had resolved; however the patient experienced the symptoms again. The outcome of the events is unknown at this time. No additional information was available at the time of this report.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count normal, Hypophagia, Intussusception, Urine analysis normal, Vomiting
Clinical narrative: Intussusception diagnosed on 5/23/10. Vomiting and fussiness started 5/21/10.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Barium double contrast, Intussusception, Irritability, Vomiting
Clinical narrative: Intussusception diagnosed on 5/23/10. Vomiting and fussiness started 5/21/10.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray, Dizziness, Electrocardiogram, Feeling abnormal, Pain in extremity
Clinical narrative: 06-08-10 Arm sore within 1 hour of getting vaccine-Next day 06-09-10 came home from work at 9AM with fever 102.5 and called HD. Left arm sore-hot-swollen the whole upper arm- at 500 went to ER due to dizzy and fever 102.5 and felt bad all over. ER did EKG and CXR, labs with thyroid-gave IV fluids, ibuprofen and was told was from shot at HD and Strep test neg. 06-10-10 went to work with fever.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm, Streptococcus test negative, Swelling
Clinical narrative: 06-08-10 Arm sore within 1 hour of getting vaccine-Next day 06-09-10 came home from work at 9AM with fever 102.5 and called HD. Left arm sore-hot-swollen the whole upper arm- at 500 went to ER due to dizzy and fever 102.5 and felt bad all over. ER did EKG and CXR, labs with thyroid-gave IV fluids, ibuprofen and was told was from shot at HD and Strep test neg. 06-10-10 went to work with fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain
Clinical narrative: L arm - able to raise arm normally.  No weakness.  Greatest area of erythema is around site of DTaP.  Varicella site below & behind main area of redness.  Eryth from top of shoulder to elbow.  Feels sl. warm not indurated.  Does c/o pain on palpitation.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: ( L ) arm 6x9 cm erythema, indurated on upper arm middle is at site of DTaP imm. Varicella site is at border of area. Has FRO arm, tender to palp, uses without apparent pn.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3, HEP, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash, Scab
Clinical narrative: Fever x 3 days, treated with TYLENOL 10 little dots all over body, became fluid filled, then crusted over.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Computerised tomogram, Fatigue, Malaise, Nausea
Clinical narrative: On 10/31 started not feeling good. Had nausea, tiredness, achy. Went to many Drs. & hospital. Had dry heaves bad. Went to hospital emergency 4 times. Finally in April found out I had strep through my body. Put on medicine for 8 weeks.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nuclear magnetic resonance imaging, Pain, Retching, Streptococcal bacteraemia
Clinical narrative: On 10/31 started not feeling good. Had nausea, tiredness, achy. Went to many Drs. & hospital. Had dry heaves bad. Went to hospital emergency 4 times. Finally in April found out I had strep through my body. Put on medicine for 8 weeks.
Age: 30.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Presyncope, Syncope
Clinical narrative: Pt had vaso-vagal reaction. Came to and was okay.
Age: 14.0
Sex: F
Vaccine: HPV4, TD
Symptoms: Dizziness, Hypoacusis, Nausea, Pallor
Clinical narrative: Nauseated, hearing deficit, pale, light-headed, dizzy. Had patient lie down for 20 minutes.
Age: 79.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Decreased appetite, Dizziness, Hypotension, Pruritus, Urticaria
Clinical narrative: Pt. rec'd IM injection in rt arm on 11/11/09. Reports experiencing upper body itchiness, dizziness, loss of appetite, low bp 2 days later. No soreness at injection site. Rec'd seasonal vaccination 1 wk later in left arm. Consulted doctor by phone approximately 2 wks later, who recommended BENADRYL cream. Dizziness had diminished by April, 2010. Visited doctor June 1st for continued itching. Dr. prescribed CORTISONE cream. Itchiness on upper body w/ rashy welt areas continues.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at vaccine administration sites (L) SQ 4cm swelling - thigh, (R) SQ 5cm swelling - thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Had DTAP in right arm on 5/24/10, 3 days ago.  Noted some eryth & swelling 2nd day, getting more over last 24 hrs.  No fevers, does c/o some pn, but able to use arm normally.  No prior vaccine RXNS.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site erythema, Injection site haematoma, Skin warm, Swelling
Clinical narrative: Pneumococcal vaccine given on 05/19/10 IM on left arm deltoid.  Several hours later she got redness and bruising around injection site.  Two days later she came in and there is some redness and swelling extends to proximal elbow.  Feels warm and burns a bit.  Was given CEPHALEXIN 500 mg and take BENADRYL.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling left thigh.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Pain in extremity
Clinical narrative: Tdap given between 4-7 PM at clinic, RA - Woke up with headache, soreness right arm.  Temp 99 degrees at school - per parent ok - acetaminophen given at 7:55 AM back to school nurse at 12:05 P.M.  Headache temp 103 degrees.  No reaction at injection site.  Advised MD follow up.
Age: 23.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: A few days after I received vaccination a lymph node in my under arm became swollen and sore.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Adverse reaction, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: No fever, area of vaccine administration with local erythema & warmth, size of cantaloupe, raised and tender, superficial -> developed 2 days after given -> steroids & abx given for reaction & cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site warmth
Clinical narrative: No fever, area of vaccine administration with local erythema & warmth, size of cantaloupe, raised and tender, superficial -> developed 2 days after given -> steroids & abx given for reaction & cellulitis.
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left shoulder/arm started with pain and progressively got worse to the point of almost no use of arm w/out severe pain. Waited one week and made a Dr. apt. Look more like a nerve may have been hit. No really much progress as of today 6-11-2010 been on MOBIC since 6-3 notified Dr office today - 6-11-2010.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis around injection site Rt outer thigh. Started on KEFLEX.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Gaze palsy, Hypotonia, Influenza like illness, Irritability, Loss of consciousness
Clinical narrative: 1am pt went to moms room and vomited and lost color in face and was feverish. Mom gave ibuprofen fever went down, then at 6am pt was fussy and his face was really pale and he told mom that he had to vomit and when she was about to take him to the bathroom he passed out for 10sec. His eyes rolled back and then he came out of it. Mom said he got shots and this may be a reaction to the DTaP.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Nausea, Pallor, Pyrexia, Syncope, Vomiting
Clinical narrative: 1am pt went to moms room and vomited and lost color in face and was feverish. Mom gave ibuprofen fever went down, then at 6am pt was fussy and his face was really pale and he told mom that he had to vomit and when she was about to take him to the bathroom he passed out for 10sec. His eyes rolled back and then he came out of it. Mom said he got shots and this may be a reaction to the DTaP.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site mass
Clinical narrative: Inconsolable crying X 30 - 45 mins with in 2 hours of administration.  3 cm left thigh lump.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Deep vein thrombosis, Lumbar puncture abnormal, Muscular weakness, Rhabdomyolysis
Clinical narrative: Acute onset lower extremity weakness 30Apr10, with diagnosis of, rhabdomyolysis, right leg deep vein thrombosis, and possible GUILLAIN BARRE SYNDROME. Required renal dialysis and is currently in a rehabilitation hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling and redness on (L) thigh.
Age: 11.0
Sex: M
Vaccine: FLU3, IPV, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Patient sated that he felt "faint" and experienced syncope while sitting in a chair. Was responding verbally after about 2 minutes.  However the patient remained "lightheaded".  Was placed in a lying position and vital signs were monitored.  By 12:30 patient had no symptoms of syncope, was ambulating without discomfort, Vital signs remained stable, patient was eating and drinking, awake, alert and oriented.
Age: 0.29
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased appetite, Diarrhoea, Irritability, Rash erythematous, Skin warm
Clinical narrative: Infant developed watery diarrhea, fussiness and poor appetite around 6pm on 6/10/2010.  Sometime during night, infant developed diffuse, red, raised rash over face, trunk, and extremities. Mom states infant is "hot to touch" but does not have any fever. Infant has "puffiness" of face but does not have any difficulty breathing. Infant is a paternal twin. Twin does not present with any symptoms but did receive same vaccines at same time.
Age: 0.29
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Swelling face
Clinical narrative: Infant developed watery diarrhea, fussiness and poor appetite around 6pm on 6/10/2010.  Sometime during night, infant developed diffuse, red, raised rash over face, trunk, and extremities. Mom states infant is "hot to touch" but does not have any fever. Infant has "puffiness" of face but does not have any difficulty breathing. Infant is a paternal twin. Twin does not present with any symptoms but did receive same vaccines at same time.
Age: 40.0
Sex: M
Vaccine: ANTH, FLUX, TDAP, TYP
Symptoms: Joint swelling, Musculoskeletal discomfort
Clinical narrative: shoulder discomfort and swelling for approximately 4 weeks; mild improvement with Tylenol;
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Application site odour, Injection site pain, Injection site pustule
Clinical narrative: Sore left shoulder, green, pus-filled area at site of vaccine, foul odor.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Fatigue, Muscular weakness, Tremor
Clinical narrative: Weakness to right leg and right arm, general fatigue, shakiness/tremors to all extremities and neck.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Client c/o dizziness.
Age: 21.0
Sex: F
Vaccine: JEV1
Symptoms: Chest X-ray normal, Chest pain, Dizziness, Dyspnoea, Laboratory test normal
Clinical narrative: Next day-chest pain, shortness of breath, paleness, dizziness, nausea, vomiting, fever. ER ran labs and CXR and physician said everything looked fine and released her.
Age: 21.0
Sex: F
Vaccine: JEV1
Symptoms: Nausea, Pallor, Pyrexia, Vomiting
Clinical narrative: Next day-chest pain, shortness of breath, paleness, dizziness, nausea, vomiting, fever. ER ran labs and CXR and physician said everything looked fine and released her.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at site of injection (deltoid).
Age: 18.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Head injury, Heart rate decreased, Loss of consciousness, Muscle twitching, Pulse abnormal
Clinical narrative: Patient passed out and hit his head following vaccines.  Patient responsive almost immediately following incident.  Within moments pt became unresponsive with facial and forearm muscle twitching.  Pulse slow and thready.  Paramedics arrived on site and transported.  Patient conscious and alert at time of transport.
Age: 18.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient passed out and hit his head following vaccines.  Patient responsive almost immediately following incident.  Within moments pt became unresponsive with facial and forearm muscle twitching.  Pulse slow and thready.  Paramedics arrived on site and transported.  Patient conscious and alert at time of transport.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Complained of dizziness, nausea.  Became pale, diaphoretic.  B/P 110/50, pulse 98.  Positioned in supine position with leges elevated. Symptoms subsided after 40 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: CHILD HAD SWELLING, REDNESS ON L UPPER ARM.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site joint pain, Injection site swelling
Clinical narrative: Local swell, erythema, joint pain.  Localized to area of injection, erythema about 8 inches diameter.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient woke up with warmth, redness, and swelling of the right thigh at the vaccine site.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Decreased appetite, Depressed level of consciousness, Mental status changes, Pyrexia
Clinical narrative: 105. fever, seizure complex, over two hours long, decrease level consciousness, loss of appetite night prior to seizure, decrease in mental status.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site pain
Clinical narrative: Pain and edema at injection site, worsening edema and pain over next 3 days not relieved with over the counter analgesics, decreased range of motion of upper extremity.
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain
Clinical narrative: Wed. 6/9/10 mild discomfort at injection site (left deltoid), Thurs. 6/10/10 became painful to touch and limited range of motion, pain increases when left arm is abducted away from the body, 6/11/10 Fri. experiencing more intense pain, rates pain 7 on pain scale.
Age: 21.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Dizziness, Pallor, Palpitations, Paraesthesia
Clinical narrative: After client received vaccines he became lightheaded. Client was laid down on exam table and given juice and a fruit and grain bar.  After 10 minutes client sat up at edge of table, but within 3-4 minutes began to feel dizzy, became very pale and stated that his hands were tingling and his heart was racing.  Client was laid back down on exam table and given 5L of O2 per non re-breather mask.  Vital signs were taken.  After 10 minutes O2 was removed and client sat up and was given more juice and crackers.  Client stated that he felt better after sitting for 5 minutes and was release to go home.