chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP, ANTH, TDAP, TYP
Symptoms: Maternal exposure during pregnancy, Meconium in amniotic fluid, Ultrasound antenatal screen normal
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), typhoid vaccine (non-gsk) and anthrax vaccine (non-gsk). Concurrent medical conditions included seasonal allergy. Concurrent medications included ZYRTEC and SINGULAIR. On 20 July 2011 the subject received a dose of BOOSTRIX (details unknown), 1st dose of typhoid vaccine (Non-GSK) (details unknown), 2nd dose of anthrax (Non-GSK) (details unknown), and experienced vaccine exposure during pregnancy. The subject was approximately 30 days pregnant at the time of vaccination. Date of last menstrual period was not provided. Estimated delivery date was 02 March 2012. No other adverse events were reported. Follow-up information was received on 10 January 2012 via healthcare professional. Concurrent medical conditions included allergy to pet dander, asthma, hyperemesis gravidarum, pollen allergy and seasonal allergy. Additional co-suspect medications included ZOFRAN, albuterol and FLOVENT. On 20 July 2011 the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown), 1st dose of typhoid vaccine (Non-GSK) (.5 ml, intramuscular, unknown), 2nd dose of anthrax vaccine (.5 ml, intramuscular, unknown). The subject's last menstrual period was on 27 June 2011 and estimated date of delivery is 05 April 2012 (previously reported as 02 March 2012). The pregnancy was by normal conception and consisted of one fetus. Relevant test results included: On 01 August 2011, Qualitative human chorionic gonadotropin (hCG) serum positive and hCG quantitative, serum 1072. On 16 August 2011, hCG quantitative, serum 44747. On 20 September 2011, OB ultrasound showed 1) Live single intrauterine gestation demonstrating NL interval growth and grossly normal anatomy. 2) Overall decreased echotexture and size of the previously noted subchronic hemorrhage compatible with interval maturation. No new hemorrhage identified. Hyperemesis gravidarum. On 12 December 2011, OB ultrasound showed fetal measurement consistent with dating. No evidence of major fetal abnormalities. At the time of the report the outcome of the pregnancy was ongoing. Follow-up information was received on 10 April 2012. It was reported that the subject delivered a live, full term, baby boy on 05 April 2012 via spontaneous vaginal birth. The neonate weighed 3.7 kg and had APGAR scores of 9.0 and 9.0 at 1 and 5 minutes following delivery. The delivery was complicated by moderate meconium. There was artificial rupture of membranes and spontaneous crying of the baby at the perianum at the time of delivery. No other events were noted or reported.
Age: 30.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included FLUZONE (Sanofi) given on 25 August 2011. There were no concurrent medications. On 25 August 2011 at 16:52 the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. It was reported that two days after vaccination with BOOSTRIX, 27 August 2011, the subject experienced fever. The fever resolved two days later. Injection site pain and numb feeling in the left arm were noted to have begun 7 days after vaccination with BOOSTRIX, on 01 September 2011. Pain in the arm itself was also reported. Injection site pain and numb feeling in the left arm were unresolved at the time of reporting. Outcome and attribution of arm pain to BOOSTRIX was not known. In the reporter's opinion, injection site pain, numb feeling in the left arm and fever were probably related to BOOSTRIX administration.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Feeling hot, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 28 years old female patient with rheumatoid arthritis and gastrooesophageal reflux disease (GERD). The patient's medical history included fatigue. The patient had no history of drug reactions/allergies. The patient was vaccinated once, with 0.5 ml PNEUMOVAX 23 intramuscularly on 05-SEP-2012. Lot number was reported as 0653AE with expiry date of 10-FEB-2014. No other co-suspects were reported. Concomitant medications included methotrexate, prednisone, folic acid, LOW-OGESTREL, vitamins (unspecified), vitamin D (unspecified), calcium (unspecified) and ACTEMRA. On 07-SEP-2012 the patient developed cellulitis after receiving a dose of PNEUMOVAX 23. The patient developed 8 by 9 inches of warmth and redness at the injection site along with neck stiffness, headaches, leukocytosis, and fever of 101.8 F. The patient went to an emergency room. Complete blood count and basic metabolic panel were taken. Treatment with vancomycin, ROCEPHIN and doxycycline was given. The patient was released after the treatment. At the time of report the patient was recovering. The relatedness per reporter for cellulitis is unknown for PNEUMOVAX 23. This is 1 of 2 reports from the same source (other MARRS # 1209USA011196). Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Full blood count abnormal, Headache, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 28 years old female patient with rheumatoid arthritis and gastrooesophageal reflux disease (GERD). The patient's medical history included fatigue. The patient had no history of drug reactions/allergies. The patient was vaccinated once, with 0.5 ml PNEUMOVAX 23 intramuscularly on 05-SEP-2012. Lot number was reported as 0653AE with expiry date of 10-FEB-2014. No other co-suspects were reported. Concomitant medications included methotrexate, prednisone, folic acid, LOW-OGESTREL, vitamins (unspecified), vitamin D (unspecified), calcium (unspecified) and ACTEMRA. On 07-SEP-2012 the patient developed cellulitis after receiving a dose of PNEUMOVAX 23. The patient developed 8 by 9 inches of warmth and redness at the injection site along with neck stiffness, headaches, leukocytosis, and fever of 101.8 F. The patient went to an emergency room. Complete blood count and basic metabolic panel were taken. Treatment with vancomycin, ROCEPHIN and doxycycline was given. The patient was released after the treatment. At the time of report the patient was recovering. The relatedness per reporter for cellulitis is unknown for PNEUMOVAX 23. This is 1 of 2 reports from the same source (other MARRS # 1209USA011196). Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Leukocytosis, Musculoskeletal stiffness, Pyrexia, White blood cell count normal
Clinical narrative: This spontaneous report as received from a nurse refers to a 28 years old female patient with rheumatoid arthritis and gastrooesophageal reflux disease (GERD). The patient's medical history included fatigue. The patient had no history of drug reactions/allergies. The patient was vaccinated once, with 0.5 ml PNEUMOVAX 23 intramuscularly on 05-SEP-2012. Lot number was reported as 0653AE with expiry date of 10-FEB-2014. No other co-suspects were reported. Concomitant medications included methotrexate, prednisone, folic acid, LOW-OGESTREL, vitamins (unspecified), vitamin D (unspecified), calcium (unspecified) and ACTEMRA. On 07-SEP-2012 the patient developed cellulitis after receiving a dose of PNEUMOVAX 23. The patient developed 8 by 9 inches of warmth and redness at the injection site along with neck stiffness, headaches, leukocytosis, and fever of 101.8 F. The patient went to an emergency room. Complete blood count and basic metabolic panel were taken. Treatment with vancomycin, ROCEPHIN and doxycycline was given. The patient was released after the treatment. At the time of report the patient was recovering. The relatedness per reporter for cellulitis is unknown for PNEUMOVAX 23. This is 1 of 2 reports from the same source (other MARRS # 1209USA011196). Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Initial report received from a health care professional on 20 September 2012. A 30-year-old female patient, with no significant medical history, received a dose of MENACTRA (Lot number: U4397AD, site of vaccination not reported) intramuscularly on 17 September 2012. The patient was taking BCP (Birth Control Pills) as concomitant medication. On 17 September 2012, 2 hours after the vaccination, the patient developed fever, headache and exhaustion. Laboratory investigations and corrective medications were not reported. The patient had recovered from the events on after 24 to 30 hours on an unspecified date. Documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old male patient with diabetes. The patient's medical history included pneumonia, abdominal bloating as a reaction to simvastatin (manufacturer unknown) (MARRS case # 2010USA007512) in 2006 and a unspecified drug reaction/allergy to cholestyramine resin. On 03-OCT-2012 the patient was vaccinated intramuscularly with PNEUMOVAX23 (Lot # reported as H010661, exp date 02-FEB-2014). No other co-suspects were reported. Concomitant medications included unspecified medications. The pharmacist reports that the patient developed a cellulitis at the injection site and was hospitalized. The cellulitis was described as leukocytosis, a high C-reactive protein and a fever. The pharmacist reported that the exact development of the cellulitis at the PNEUMOVAX 23 injection site was unspecified, but 3 days after vaccination with PNEUMOVAX23 the patient went to the emergency room and was admitted to the hospital. The patient was treated with intravenous vancomycin. Unspecified urine and blood tests were performed, results were not reported. The pharmacist reported that the patient was discharged (date of discharge unspecified) and is recovering. The pharmacist asked for a lot check. This case is linked to 1210USA005747 by same reporter link and to 2010USA007512 by same patient link. Additional information has been requested. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test, C-reactive protein increased, Injection site cellulitis, Leukocytosis, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old male patient with diabetes. The patient's medical history included pneumonia, abdominal bloating as a reaction to simvastatin (manufacturer unknown) (MARRS case # 2010USA007512) in 2006 and a unspecified drug reaction/allergy to cholestyramine resin. On 03-OCT-2012 the patient was vaccinated intramuscularly with PNEUMOVAX23 (Lot # reported as H010661, exp date 02-FEB-2014). No other co-suspects were reported. Concomitant medications included unspecified medications. The pharmacist reports that the patient developed a cellulitis at the injection site and was hospitalized. The cellulitis was described as leukocytosis, a high C-reactive protein and a fever. The pharmacist reported that the exact development of the cellulitis at the PNEUMOVAX 23 injection site was unspecified, but 3 days after vaccination with PNEUMOVAX23 the patient went to the emergency room and was admitted to the hospital. The patient was treated with intravenous vancomycin. Unspecified urine and blood tests were performed, results were not reported. The pharmacist reported that the patient was discharged (date of discharge unspecified) and is recovering. The pharmacist asked for a lot check. This case is linked to 1210USA005747 by same reporter link and to 2010USA007512 by same patient link. Additional information has been requested. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Urine analysis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old male patient with diabetes. The patient's medical history included pneumonia, abdominal bloating as a reaction to simvastatin (manufacturer unknown) (MARRS case # 2010USA007512) in 2006 and a unspecified drug reaction/allergy to cholestyramine resin. On 03-OCT-2012 the patient was vaccinated intramuscularly with PNEUMOVAX23 (Lot # reported as H010661, exp date 02-FEB-2014). No other co-suspects were reported. Concomitant medications included unspecified medications. The pharmacist reports that the patient developed a cellulitis at the injection site and was hospitalized. The cellulitis was described as leukocytosis, a high C-reactive protein and a fever. The pharmacist reported that the exact development of the cellulitis at the PNEUMOVAX 23 injection site was unspecified, but 3 days after vaccination with PNEUMOVAX23 the patient went to the emergency room and was admitted to the hospital. The patient was treated with intravenous vancomycin. Unspecified urine and blood tests were performed, results were not reported. The pharmacist reported that the patient was discharged (date of discharge unspecified) and is recovering. The pharmacist asked for a lot check. This case is linked to 1210USA005747 by same reporter link and to 2010USA007512 by same patient link. Additional information has been requested. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rubella antibody test
Clinical narrative: This spontaneous report has been received from a 55 years old female registered nurse regarding herself. She reported no pre-existing physician- diagnosed allergies, no birth defects, no medical conditions and no illness at the time of vaccination. The patient was vaccinated with first dose of MMR II on 09-DEC-1982, dose and route unknown. No other co-suspects were reported. No concomitant medications were reported. On 25-SEP-2012 a titre was drawn to check immunity, and it was equivocal for rubella, 10884 days after onset of therapy. The patient did not seek medical attention. No treatment information was reported. The outcome of immunity was equivocal for rubella was reported as recovered/resolved. The relatedness for immunity was equivocal for rubella was not reported for MMR II. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report has been received from a 55 years old female registered nurse regarding herself. She reported no pre-existing physician- diagnosed allergies, no birth defects, no medical conditions and no illness at the time of vaccination. The patient was vaccinated with first dose of MMR II on 09-DEC-1982, dose and route unknown. No other co-suspects were reported. No concomitant medications were reported. On 25-SEP-2012 a titre was drawn to check immunity, and it was equivocal for rubella, 10884 days after onset of therapy. The patient did not seek medical attention. No treatment information was reported. The outcome of immunity was equivocal for rubella was reported as recovered/resolved. The relatedness for immunity was equivocal for rubella was not reported for MMR II. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, FLUN3, MNQ
Symptoms: Emotional distress, Erythema, Flushing, Headache, Injection site erythema
Clinical narrative: Initial report received from a health care professional on 28 September 2012. An 11-year-old female patient, with no reported medical history and concomitant medication, received dose of MENACTRA (route, site and side not reported) (Lot unknown) on an unspecified date. It was reported that the patient experienced syncope episode and instantly out of it. She also had developed huge patch of redness at the injection site and which extended to the arm on an unspecified date. She also experienced hives and severe headache on an unspecified date. Corrective medications and lab details were not reported. At the time of report the outcome of the event was unknown. List of documents held by the sender: None.
Age: 11.0
Sex: F
Vaccine: MNQ, FLUN3, MNQ
Symptoms: Injection site swelling, Neurological examination normal, Presyncope
Clinical narrative: Initial report received from a health care professional on 28 September 2012. An 11-year-old female patient, with no reported medical history and concomitant medication, received dose of MENACTRA (route, site and side not reported) (Lot unknown) on an unspecified date. It was reported that the patient experienced syncope episode and instantly out of it. She also had developed huge patch of redness at the injection site and which extended to the arm on an unspecified date. She also experienced hives and severe headache on an unspecified date. Corrective medications and lab details were not reported. At the time of report the outcome of the event was unknown. List of documents held by the sender: None.
Age: 11.0
Sex: F
Vaccine: MNQ, FLUN3, MNQ
Symptoms: Headache, Injection site erythema, Syncope, Urticaria
Clinical narrative: Initial report received from a health care professional on 28 September 2012. An 11-year-old female patient, with no reported medical history and concomitant medication, received dose of MENACTRA (route, site and side not reported) (Lot unknown) on an unspecified date. It was reported that the patient experienced syncope episode and instantly out of it. She also had developed huge patch of redness at the injection site and which extended to the arm on an unspecified date. She also experienced hives and severe headache on an unspecified date. Corrective medications and lab details were not reported. At the time of report the outcome of the event was unknown. List of documents held by the sender: None.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Eye pain, Fatigue, Full blood count, Headache
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 13 years old female patient with bees and wasps allergy and no pertinent medical history. The patient was vaccinated with 0.5 ml GARDASIL intramuscularly on 05-OCT-2012. Lot# was unspecified. No other co-suspects were reported. Concomitant medications included vitamin B and vitamin D. On 05-OCT-2012, the patient received GARDASIL and 2-3 hours after the vaccination had diarrhea. In the days following the vaccination the patient had malaise, fatigue, headache, low grade temperature and pain behind both eyes. The patient might be admitted to hospital. No treatment was given for the events. The patient did a complete blood count (CBC) and basic metabolic profile at outside facility. The reporter was waiting for the information from the other facility and no lab resulted was provided at reporting time. The patient was not recovered. The patient also visited primary care physician and visit to emergency room to seek medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Metabolic function test, Pyrexia
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 13 years old female patient with bees and wasps allergy and no pertinent medical history. The patient was vaccinated with 0.5 ml GARDASIL intramuscularly on 05-OCT-2012. Lot# was unspecified. No other co-suspects were reported. Concomitant medications included vitamin B and vitamin D. On 05-OCT-2012, the patient received GARDASIL and 2-3 hours after the vaccination had diarrhea. In the days following the vaccination the patient had malaise, fatigue, headache, low grade temperature and pain behind both eyes. The patient might be admitted to hospital. No treatment was given for the events. The patient did a complete blood count (CBC) and basic metabolic profile at outside facility. The reporter was waiting for the information from the other facility and no lab resulted was provided at reporting time. The patient was not recovered. The patient also visited primary care physician and visit to emergency room to seek medical attention. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Chills, Nausea, Pain, Vomiting
Clinical narrative: Body aches. Chills. Stomach pains/cramps. Nausea/vomiting - tx with ZOFRAN by primary MD.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Malaise, Pain in extremity, Throat tightness
Clinical narrative: This consumer report was received on 02 October 2012 and involves a female patient. A female patient (date of birth not provided) had received a flu vaccine (manufacturer unknown) on 02 October 2012 around 2:30 pm, and the same day experienced pain in her arm, headache, and feeling of thickness in her throat as if the throat was swollen. The patient stated she did not feel well at all and had someone with her and was going to the emergency room. Medical history was no provided. Outcome was unknown. Documents held by sender: None.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Acanthosis, Biopsy skin abnormal, Blister, Dermatitis, Eczema
Clinical narrative: Initial report was received from the scientific literature on 02 October 2012. The following is verbatim from the aforementioned article: "A 19-month-old boy presented to the emergency department with asymmetrically distributed skin lesions that developed 2 days after immunization with MMR through the right thigh and the VARIVAX (Merck) and DTaP administered through the left thigh. He developed a fever to 39 degrees C the night of the immunizations but then remained afebrile. He had no preceding respiratory or gastrointestinal symptoms. Initially, pink papules were noted at and around the site of the injection of the left thigh, which then coalesced into larger plaques. Pink papules, many of which coalesce into larger plaques, on the left thigh. Pink macules and edematous papules developed later on the pinna, face, trunk, and right leg. A punch biopsy from the left thigh showed interface dermatitis with perivascular lymphocytes and histiocytes and rare neutrophils and eosinophils. These findings were read as consistent with GCS. A punch biopsy from the left leg demonstrated acanthosis, mild spongiosis, and spongiotic microvesicles containing few lymphocytes. There is prominent basal vacuolization, exocytosis of lymphocytes into the lower epidermis, and edema of the papillary dermis. There is a brisk perivascular infiltrate of mostly lymphocytes and histiocytes with rare neutrophils and eosinophils. These findings support the diagnosis of Glanotti-Crosti syndrome. Because the major site of involvement was at the site of the injection on the left thigh, we suspected that the DTaP or the VARIVAX was responsible for precipitating the skin eruption. Although GCS was initially described in association with anicteric hepatitis caused by hepatitis B, it has been more commonly associated with other viruses in the country. In addition to viral infections, GCS has been reported to occur after immunizations with live, killed and recombinant vaccines. Some authors have suggested that combined vaccinations carry a higher risk for precipitating GCS lesions. Other authors have suggested that the risk of developing GCS is greater when an active viral infection is present at the time of vaccination. It has been suggested that high T-cell reactivity due to preceding infection or preceding vaccination greatly increased the likelihood of developing GCS. Our patient had a history of fever immediately after the vaccination but no fever or other viral symptoms before or at the time of the vaccination. As the number of childhood immunizations increased and more combination vaccines are available, perhaps we will see further reports of this postimmunization phenomenon." The patient's outcome was not reported. Documents held by sender: None.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Gianotti-Crosti syndrome, Injection site papule, Injection site reaction, Lymphocytic infiltration, Lymphohistiocytosis
Clinical narrative: Initial report was received from the scientific literature on 02 October 2012. The following is verbatim from the aforementioned article: "A 19-month-old boy presented to the emergency department with asymmetrically distributed skin lesions that developed 2 days after immunization with MMR through the right thigh and the VARIVAX (Merck) and DTaP administered through the left thigh. He developed a fever to 39 degrees C the night of the immunizations but then remained afebrile. He had no preceding respiratory or gastrointestinal symptoms. Initially, pink papules were noted at and around the site of the injection of the left thigh, which then coalesced into larger plaques. Pink papules, many of which coalesce into larger plaques, on the left thigh. Pink macules and edematous papules developed later on the pinna, face, trunk, and right leg. A punch biopsy from the left thigh showed interface dermatitis with perivascular lymphocytes and histiocytes and rare neutrophils and eosinophils. These findings were read as consistent with GCS. A punch biopsy from the left leg demonstrated acanthosis, mild spongiosis, and spongiotic microvesicles containing few lymphocytes. There is prominent basal vacuolization, exocytosis of lymphocytes into the lower epidermis, and edema of the papillary dermis. There is a brisk perivascular infiltrate of mostly lymphocytes and histiocytes with rare neutrophils and eosinophils. These findings support the diagnosis of Glanotti-Crosti syndrome. Because the major site of involvement was at the site of the injection on the left thigh, we suspected that the DTaP or the VARIVAX was responsible for precipitating the skin eruption. Although GCS was initially described in association with anicteric hepatitis caused by hepatitis B, it has been more commonly associated with other viruses in the country. In addition to viral infections, GCS has been reported to occur after immunizations with live, killed and recombinant vaccines. Some authors have suggested that combined vaccinations carry a higher risk for precipitating GCS lesions. Other authors have suggested that the risk of developing GCS is greater when an active viral infection is present at the time of vaccination. It has been suggested that high T-cell reactivity due to preceding infection or preceding vaccination greatly increased the likelihood of developing GCS. Our patient had a history of fever immediately after the vaccination but no fever or other viral symptoms before or at the time of the vaccination. As the number of childhood immunizations increased and more combination vaccines are available, perhaps we will see further reports of this postimmunization phenomenon." The patient's outcome was not reported. Documents held by sender: None.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Macule, Papule, Perivascular dermatitis, Pyrexia, Rash
Clinical narrative: Initial report was received from the scientific literature on 02 October 2012. The following is verbatim from the aforementioned article: "A 19-month-old boy presented to the emergency department with asymmetrically distributed skin lesions that developed 2 days after immunization with MMR through the right thigh and the VARIVAX (Merck) and DTaP administered through the left thigh. He developed a fever to 39 degrees C the night of the immunizations but then remained afebrile. He had no preceding respiratory or gastrointestinal symptoms. Initially, pink papules were noted at and around the site of the injection of the left thigh, which then coalesced into larger plaques. Pink papules, many of which coalesce into larger plaques, on the left thigh. Pink macules and edematous papules developed later on the pinna, face, trunk, and right leg. A punch biopsy from the left thigh showed interface dermatitis with perivascular lymphocytes and histiocytes and rare neutrophils and eosinophils. These findings were read as consistent with GCS. A punch biopsy from the left leg demonstrated acanthosis, mild spongiosis, and spongiotic microvesicles containing few lymphocytes. There is prominent basal vacuolization, exocytosis of lymphocytes into the lower epidermis, and edema of the papillary dermis. There is a brisk perivascular infiltrate of mostly lymphocytes and histiocytes with rare neutrophils and eosinophils. These findings support the diagnosis of Glanotti-Crosti syndrome. Because the major site of involvement was at the site of the injection on the left thigh, we suspected that the DTaP or the VARIVAX was responsible for precipitating the skin eruption. Although GCS was initially described in association with anicteric hepatitis caused by hepatitis B, it has been more commonly associated with other viruses in the country. In addition to viral infections, GCS has been reported to occur after immunizations with live, killed and recombinant vaccines. Some authors have suggested that combined vaccinations carry a higher risk for precipitating GCS lesions. Other authors have suggested that the risk of developing GCS is greater when an active viral infection is present at the time of vaccination. It has been suggested that high T-cell reactivity due to preceding infection or preceding vaccination greatly increased the likelihood of developing GCS. Our patient had a history of fever immediately after the vaccination but no fever or other viral symptoms before or at the time of the vaccination. As the number of childhood immunizations increased and more combination vaccines are available, perhaps we will see further reports of this postimmunization phenomenon." The patient's outcome was not reported. Documents held by sender: None.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Skin lesion, Skin oedema, Skin plaque
Clinical narrative: Initial report was received from the scientific literature on 02 October 2012. The following is verbatim from the aforementioned article: "A 19-month-old boy presented to the emergency department with asymmetrically distributed skin lesions that developed 2 days after immunization with MMR through the right thigh and the VARIVAX (Merck) and DTaP administered through the left thigh. He developed a fever to 39 degrees C the night of the immunizations but then remained afebrile. He had no preceding respiratory or gastrointestinal symptoms. Initially, pink papules were noted at and around the site of the injection of the left thigh, which then coalesced into larger plaques. Pink papules, many of which coalesce into larger plaques, on the left thigh. Pink macules and edematous papules developed later on the pinna, face, trunk, and right leg. A punch biopsy from the left thigh showed interface dermatitis with perivascular lymphocytes and histiocytes and rare neutrophils and eosinophils. These findings were read as consistent with GCS. A punch biopsy from the left leg demonstrated acanthosis, mild spongiosis, and spongiotic microvesicles containing few lymphocytes. There is prominent basal vacuolization, exocytosis of lymphocytes into the lower epidermis, and edema of the papillary dermis. There is a brisk perivascular infiltrate of mostly lymphocytes and histiocytes with rare neutrophils and eosinophils. These findings support the diagnosis of Glanotti-Crosti syndrome. Because the major site of involvement was at the site of the injection on the left thigh, we suspected that the DTaP or the VARIVAX was responsible for precipitating the skin eruption. Although GCS was initially described in association with anicteric hepatitis caused by hepatitis B, it has been more commonly associated with other viruses in the country. In addition to viral infections, GCS has been reported to occur after immunizations with live, killed and recombinant vaccines. Some authors have suggested that combined vaccinations carry a higher risk for precipitating GCS lesions. Other authors have suggested that the risk of developing GCS is greater when an active viral infection is present at the time of vaccination. It has been suggested that high T-cell reactivity due to preceding infection or preceding vaccination greatly increased the likelihood of developing GCS. Our patient had a history of fever immediately after the vaccination but no fever or other viral symptoms before or at the time of the vaccination. As the number of childhood immunizations increased and more combination vaccines are available, perhaps we will see further reports of this postimmunization phenomenon." The patient's outcome was not reported. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Throat tightness, Wheezing
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 08 October 2012. A 47-year-old female patient had received an intramuscular injection in the deltoid of FLUZONE, lot number UH752AA, on 04 October 2012 and experienced wheezing, cough, tight throat and temperature of 38.8 degrees Celsius (100 degrees Fahrenheit). The patient self treated the events with PULMICORT inhaler, cough syrup with codeine and ADVIL. The symptoms resolved. The patient was not acutely ill at the time of vaccination. The patient had a past medical history of gastroesophageal reflux disease (GERD), high cholesterol and pneumonia. The patient received an influenza vaccine 15 years ago. The patient's outcome was recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: MNQ, TDAP, TYP
Symptoms: Angiotensin converting enzyme, Anterior chamber inflammation, Antineutrophil cytoplasmic antibody positive, Antinuclear antibody, Back pain
Clinical narrative: Previously healthy 34-year old M was in his usual state of good health in JUL 2012. On 6 AUG 2012, patient received MGC, Typhoid and Tdap vaccinations. Prior to being immunized that day, patient sought evaluation for a 1-day history of right eye irritation with discharge noted that morning. He was evaluated by an optometrist and diagnosed with bacterial conjunctivitis. While waiting for his prescriptions, he received his vaccinations. Pt does not recall any significant and/or persistent local reactions at the vaccination sites. Within 12 hours of vaccine receipt, patient developed viral-type symptoms including generalized aching, including area of lower back, malaise, mild headaches and fevers. He self treated with NSAIDS. He measured his temperatures at home and noted elevations x 8 days, with the highest reading being 103. Patient sought evaluation for these symptoms but no additional recommendations were made. He continued follow up for his conjunctivitis and was seen by a ophthalmologist on 13 AUG, when he diagnosed with bilateral uveitis. At the time of his initial ophthalmological exam. Patient was not experiencing any discharge, pain or itching of his eyes, but did report a hazy glaze over his vision. His vision was not affected. Patient had been using TOBRADEX as prescribed on 6 AUG, but it did not help his symptoms. On 8 AUG, the TOBRADEX was discontinued and erythromycin drops were initiated and on 13 AUG, he was changed to 1% prednisolone acetate every 2 hours and homatropline 5% three times daily and ACULAR LS four time per day. Additional lab studies were completed, and patient was found to be HLA-B27 positive. Other than his ocular symptoms, patient was feeling well on the day of vaccine receipt. He denies any recent infections, including upper respiratory, gastrointestinal or genitourinary infections. He denies a history of previous eye conditions, except he was diagnosed with a stye in his right eye in APR 2012. He denies a history of chronic back pain, chronic skin conditions or chronic gastrointestinal symptoms. IMPRESSION AND PLAN per dr on 13 AUG 2012: Nongranulomatous anterior uveitis OU. We discussed this diagnosis at length and a complete review of systems was obtained. He does have a history of stray cat exposure approximately a year to a year and half ago..., we obtained extensive blood work and he will try to obtain that as soon as possible. For now, I prescribed DUREZOL four times q.i.d. OU to help quiet his anterior inflammation. Given the fact that he has had multiple flare-ups indicative of his coreneal endo-pigment and posterior synechiae, a thorough work up is indicated. Patient was referred for a rheumatology evaluation and imaging studies, which are pending.
Age: 34.0
Sex: M
Vaccine: MNQ, TDAP, TYP
Symptoms: Blood immunoglobulin G decreased, Borrelia test negative, Corneal pigmentation, HLA marker study positive, Headache
Clinical narrative: Previously healthy 34-year old M was in his usual state of good health in JUL 2012. On 6 AUG 2012, patient received MGC, Typhoid and Tdap vaccinations. Prior to being immunized that day, patient sought evaluation for a 1-day history of right eye irritation with discharge noted that morning. He was evaluated by an optometrist and diagnosed with bacterial conjunctivitis. While waiting for his prescriptions, he received his vaccinations. Pt does not recall any significant and/or persistent local reactions at the vaccination sites. Within 12 hours of vaccine receipt, patient developed viral-type symptoms including generalized aching, including area of lower back, malaise, mild headaches and fevers. He self treated with NSAIDS. He measured his temperatures at home and noted elevations x 8 days, with the highest reading being 103. Patient sought evaluation for these symptoms but no additional recommendations were made. He continued follow up for his conjunctivitis and was seen by a ophthalmologist on 13 AUG, when he diagnosed with bilateral uveitis. At the time of his initial ophthalmological exam. Patient was not experiencing any discharge, pain or itching of his eyes, but did report a hazy glaze over his vision. His vision was not affected. Patient had been using TOBRADEX as prescribed on 6 AUG, but it did not help his symptoms. On 8 AUG, the TOBRADEX was discontinued and erythromycin drops were initiated and on 13 AUG, he was changed to 1% prednisolone acetate every 2 hours and homatropline 5% three times daily and ACULAR LS four time per day. Additional lab studies were completed, and patient was found to be HLA-B27 positive. Other than his ocular symptoms, patient was feeling well on the day of vaccine receipt. He denies any recent infections, including upper respiratory, gastrointestinal or genitourinary infections. He denies a history of previous eye conditions, except he was diagnosed with a stye in his right eye in APR 2012. He denies a history of chronic back pain, chronic skin conditions or chronic gastrointestinal symptoms. IMPRESSION AND PLAN per dr on 13 AUG 2012: Nongranulomatous anterior uveitis OU. We discussed this diagnosis at length and a complete review of systems was obtained. He does have a history of stray cat exposure approximately a year to a year and half ago..., we obtained extensive blood work and he will try to obtain that as soon as possible. For now, I prescribed DUREZOL four times q.i.d. OU to help quiet his anterior inflammation. Given the fact that he has had multiple flare-ups indicative of his coreneal endo-pigment and posterior synechiae, a thorough work up is indicated. Patient was referred for a rheumatology evaluation and imaging studies, which are pending.
Age: 34.0
Sex: M
Vaccine: MNQ, TDAP, TYP
Symptoms: Iridocyclitis, Iris adhesions, Laboratory test normal, Malaise, Pain
Clinical narrative: Previously healthy 34-year old M was in his usual state of good health in JUL 2012. On 6 AUG 2012, patient received MGC, Typhoid and Tdap vaccinations. Prior to being immunized that day, patient sought evaluation for a 1-day history of right eye irritation with discharge noted that morning. He was evaluated by an optometrist and diagnosed with bacterial conjunctivitis. While waiting for his prescriptions, he received his vaccinations. Pt does not recall any significant and/or persistent local reactions at the vaccination sites. Within 12 hours of vaccine receipt, patient developed viral-type symptoms including generalized aching, including area of lower back, malaise, mild headaches and fevers. He self treated with NSAIDS. He measured his temperatures at home and noted elevations x 8 days, with the highest reading being 103. Patient sought evaluation for these symptoms but no additional recommendations were made. He continued follow up for his conjunctivitis and was seen by a ophthalmologist on 13 AUG, when he diagnosed with bilateral uveitis. At the time of his initial ophthalmological exam. Patient was not experiencing any discharge, pain or itching of his eyes, but did report a hazy glaze over his vision. His vision was not affected. Patient had been using TOBRADEX as prescribed on 6 AUG, but it did not help his symptoms. On 8 AUG, the TOBRADEX was discontinued and erythromycin drops were initiated and on 13 AUG, he was changed to 1% prednisolone acetate every 2 hours and homatropline 5% three times daily and ACULAR LS four time per day. Additional lab studies were completed, and patient was found to be HLA-B27 positive. Other than his ocular symptoms, patient was feeling well on the day of vaccine receipt. He denies any recent infections, including upper respiratory, gastrointestinal or genitourinary infections. He denies a history of previous eye conditions, except he was diagnosed with a stye in his right eye in APR 2012. He denies a history of chronic back pain, chronic skin conditions or chronic gastrointestinal symptoms. IMPRESSION AND PLAN per dr on 13 AUG 2012: Nongranulomatous anterior uveitis OU. We discussed this diagnosis at length and a complete review of systems was obtained. He does have a history of stray cat exposure approximately a year to a year and half ago..., we obtained extensive blood work and he will try to obtain that as soon as possible. For now, I prescribed DUREZOL four times q.i.d. OU to help quiet his anterior inflammation. Given the fact that he has had multiple flare-ups indicative of his coreneal endo-pigment and posterior synechiae, a thorough work up is indicated. Patient was referred for a rheumatology evaluation and imaging studies, which are pending.
Age: 34.0
Sex: M
Vaccine: MNQ, TDAP, TYP
Symptoms: Pyrexia, Toxoplasma serology negative, Treponema test negative, Viral infection, Vision blurred
Clinical narrative: Previously healthy 34-year old M was in his usual state of good health in JUL 2012. On 6 AUG 2012, patient received MGC, Typhoid and Tdap vaccinations. Prior to being immunized that day, patient sought evaluation for a 1-day history of right eye irritation with discharge noted that morning. He was evaluated by an optometrist and diagnosed with bacterial conjunctivitis. While waiting for his prescriptions, he received his vaccinations. Pt does not recall any significant and/or persistent local reactions at the vaccination sites. Within 12 hours of vaccine receipt, patient developed viral-type symptoms including generalized aching, including area of lower back, malaise, mild headaches and fevers. He self treated with NSAIDS. He measured his temperatures at home and noted elevations x 8 days, with the highest reading being 103. Patient sought evaluation for these symptoms but no additional recommendations were made. He continued follow up for his conjunctivitis and was seen by a ophthalmologist on 13 AUG, when he diagnosed with bilateral uveitis. At the time of his initial ophthalmological exam. Patient was not experiencing any discharge, pain or itching of his eyes, but did report a hazy glaze over his vision. His vision was not affected. Patient had been using TOBRADEX as prescribed on 6 AUG, but it did not help his symptoms. On 8 AUG, the TOBRADEX was discontinued and erythromycin drops were initiated and on 13 AUG, he was changed to 1% prednisolone acetate every 2 hours and homatropline 5% three times daily and ACULAR LS four time per day. Additional lab studies were completed, and patient was found to be HLA-B27 positive. Other than his ocular symptoms, patient was feeling well on the day of vaccine receipt. He denies any recent infections, including upper respiratory, gastrointestinal or genitourinary infections. He denies a history of previous eye conditions, except he was diagnosed with a stye in his right eye in APR 2012. He denies a history of chronic back pain, chronic skin conditions or chronic gastrointestinal symptoms. IMPRESSION AND PLAN per dr on 13 AUG 2012: Nongranulomatous anterior uveitis OU. We discussed this diagnosis at length and a complete review of systems was obtained. He does have a history of stray cat exposure approximately a year to a year and half ago..., we obtained extensive blood work and he will try to obtain that as soon as possible. For now, I prescribed DUREZOL four times q.i.d. OU to help quiet his anterior inflammation. Given the fact that he has had multiple flare-ups indicative of his coreneal endo-pigment and posterior synechiae, a thorough work up is indicated. Patient was referred for a rheumatology evaluation and imaging studies, which are pending.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count abnormal, Pyrexia, White blood cell count increased
Clinical narrative: Fever 103.7.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Pain is at a 7/10 right arm, shoulder to elbow. Wakes her up at night. Advised to see physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram, Haemorrhagic stroke
Clinical narrative: Hemorrhagic stroke.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, TYP
Symptoms: Activities of daily living impaired, Decreased appetite, Fatigue, Feeling cold, Headache
Clinical narrative: Left shoulder still sore, rash near injection site, head ache, fatigue, and was very cold. Had to leave early from work and go home. Wasnt able to get home until 1430 due to train schedule. Took a shower, and went to sleep. Woke up about 1930 covered in sweat, and still tired. Went back to sleep until 0200, and had to get out of bed because I was cold. Took another shower, and changed into dry clothes. Slept until 0630, but did not feel well. Headache was worse, but I wasnt cold anymore. Slept through most of day, 16 Oct, and was able to eat a little for breakfast and lunch, and drank water and orange juice. Did not eat dinner on 15 or 16 Oct. Went to work on 17 Oct.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, TYP
Symptoms: Hyperhidrosis, Hypersomnia, Injection site rash, Malaise, Musculoskeletal pain
Clinical narrative: Left shoulder still sore, rash near injection site, head ache, fatigue, and was very cold. Had to leave early from work and go home. Wasnt able to get home until 1430 due to train schedule. Took a shower, and went to sleep. Woke up about 1930 covered in sweat, and still tired. Went back to sleep until 0200, and had to get out of bed because I was cold. Took another shower, and changed into dry clothes. Slept until 0630, but did not feel well. Headache was worse, but I wasnt cold anymore. Slept through most of day, 16 Oct, and was able to eat a little for breakfast and lunch, and drank water and orange juice. Did not eat dinner on 15 or 16 Oct. Went to work on 17 Oct.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives near injection site and under arm. Advised to call PCP and to take Benadryl.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria
Clinical narrative: Hives over body, throat tightened. Was given two Benadryl and observed. Mother picked up.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: 10/13/2012 @ 14:00:  redness, swelling at injections site Left Deltoid, dulling pain in L Shoulder day of injection.  10/16/2012 @ 0500: swelling at front left neck where it meets shoulder.  Appears to be a node. Size of a walnut.