chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Blood culture negative, C-reactive protein increased, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included hiv vaccine (Sanofi), ROTARIX (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 16 April 2012. There were no concurrent medications. On 16 April 2012 at about 13:00 the subject received 2nd dose of PEDIARIX at 0. ml in the left thigh. On the evening of 16 April 2012, within hours of vaccination with PEDIARIX, the subject experienced fever (to 102 and 103 degrees), a couple episodes of vomiting, injection site redness and swelling at injection site. On 24 April 2012, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX. Follow-up information was received on 15 May 2012 via healthcare professional who clarified the subject did not received an HIV vaccine (Sanofi) but received a Haemophilus influenzae type b vaccine (Non-GSK) (Sanofi). The subject previously received PEDIARIX, vaccination details not provided, but it was noted the subject did not experience adverse events following previous vaccinations. The subject had a white blood cell count (WBC count) of 25, 500 and c-reactive protein value of 47 on 20 April 2012. On 24 April 2012 the WBC count decreased to 11, 500 and the c-reactive protein decreased to 6. The healthcare professional reported the immunization series with PEDIARIX was delayed. The healthcare professional considered the events of fever, vomiting, injection site redness and swelling at injection site to be associated with an undetected infectious process. The reported healthcare professional also considered the events jeopardizing to the subject and/ or required intervention.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included hiv vaccine (Sanofi), ROTARIX (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 16 April 2012. There were no concurrent medications. On 16 April 2012 at about 13:00 the subject received 2nd dose of PEDIARIX at 0. ml in the left thigh. On the evening of 16 April 2012, within hours of vaccination with PEDIARIX, the subject experienced fever (to 102 and 103 degrees), a couple episodes of vomiting, injection site redness and swelling at injection site. On 24 April 2012, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX. Follow-up information was received on 15 May 2012 via healthcare professional who clarified the subject did not received an HIV vaccine (Sanofi) but received a Haemophilus influenzae type b vaccine (Non-GSK) (Sanofi). The subject previously received PEDIARIX, vaccination details not provided, but it was noted the subject did not experience adverse events following previous vaccinations. The subject had a white blood cell count (WBC count) of 25, 500 and c-reactive protein value of 47 on 20 April 2012. On 24 April 2012 the WBC count decreased to 11, 500 and the c-reactive protein decreased to 6. The healthcare professional reported the immunization series with PEDIARIX was delayed. The healthcare professional considered the events of fever, vomiting, injection site redness and swelling at injection site to be associated with an undetected infectious process. The reported healthcare professional also considered the events jeopardizing to the subject and/ or required intervention.
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash, Myalgia
Clinical narrative: Myalgia. Rash at the injection site.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction (described as hives).
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Major allergic reaction. Fever. Hives. Sweling.
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Extreme pain at the injection site.
Age: 59.0
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 05-Oct-2012) concerns a 59-year-old male patient. On an unknown date the patient received flu vaccine (manufacturer, brand name and batch number were not provided). Concomitantly he also received PNEUMOVAX (batch number: H010515) and Tdap. After vaccinations, the patient developed swelling at the injection site. The event outcome was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX, TDAP, VARCEL
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous consumer report (initial receipt: 19-Oct-2012) concerns a female pregnant patient, who had no pertinent medical history or drug allergy. On 25-Sep-2012 the patient received an unspecified flu vaccine (manufacturer, brand name and batch number were not provided). On the same day she also received VARIVAX injection and TDAP (diphtheria, pertussis and tetanus vaccine). The patient received these 3 vaccines while she was pregnant. At the time when he received these vaccines she did not know that she was pregnant. It was only last week when she found out she was 2 months pregnant. No lab diagnostic study was performed. The patient spoke to her physician. The event outcome was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 05-Oct-2012) concerns a 52-year-old female patient. On 26-Sep-2012 the patient received flu vaccine (manufacturer, brand name and batch number were not provided). Concomitantly she also received PNEUMOVAX (batch number: H010515) intramuscularly. After vaccinations, the patient developed swelling at the injection site and a fever of 102 F (Fahrenheit), which was not controlled by ADVIL at home. She was evaluated at an Emergency room and 'treated for the swelling'. The event outcome was not reported.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Burning sensation, Erythema, Facial pain, Rosacea
Clinical narrative: This consumer report (initial receipt 08-Jun-2012) concerns a female patient, who had a medical history of drug reaction/allergy to penicillin, mushrooms and chocolate. 2 years ago in 2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. 2 days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. The patient sought medical attention. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Burning sensation, Capillary fragility, Cataract, Cataract operation, Diagnostic procedure
Clinical narrative: This consumer report (initial receipt 08-Jun-2012) concerns a female patient, who had a medical history of drug reaction/allergy to penicillin, mushrooms and chocolate. 2 years ago in 2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. 2 days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. The patient sought medical attention. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Erythema, Facial pain, Headache, Laboratory test, Malaise
Clinical narrative: This consumer report (initial receipt 08-Jun-2012) concerns a female patient, who had a medical history of drug reaction/allergy to penicillin, mushrooms and chocolate. 2 years ago in 2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. 2 days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. The patient sought medical attention. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Neck pain, Rash, Rosacea
Clinical narrative: This consumer report (initial receipt 08-Jun-2012) concerns a female patient, who had a medical history of drug reaction/allergy to penicillin, mushrooms and chocolate. 2 years ago in 2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. 2 days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. The patient sought medical attention. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: Description of Event or Problem: This medically confirmed spontaneous report (initial receipt 13-Oct-2011) concerns a female patient who had a history of fibromyalgia, COPD (Chronic pulmonary obstructive disease), high blood pressure, GERD (Gastroesophageal reflux disease), penicillin allergies and SULFA allergies. Concomitant medications included salbutamol and anti-hypertensives. Upon follow up it was reported that the patient had no other illness at time of vaccination, pre-existing allergies, birth defects or medical conditions. On 20-Sep-2011 at 19:30 the patient received AFLURIA (batch number: N55105) injection intramuscularly into her left arm at a dose of 0.5 mL. On 13-Oct-2011 the patient called the pharmacist stating she has experienced arm pain, had difficulty/decreased range of motion of her left arm and had difficulty sleeping due to the pain after receiving AFLURIA. She also reported injection site reaction resulting in sore arm and shoulder. It hurt to move arm and raise above her head. The event outcome was recovered on 20-Oct-2011. The reporter considered events as non serious. Follow up (01-May-2012) : time of vaccination, lot number, additional AE terms, event outcome, medical history, reporter's causality assessment. Follow-up (17-Jul-2012) : further adverse events detail and recovery date.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Description of Event or Problem: This medically confirmed spontaneous report (initial receipt 13-Oct-2011) concerns a female patient who had a history of fibromyalgia, COPD (Chronic pulmonary obstructive disease), high blood pressure, GERD (Gastroesophageal reflux disease), penicillin allergies and SULFA allergies. Concomitant medications included salbutamol and anti-hypertensives. Upon follow up it was reported that the patient had no other illness at time of vaccination, pre-existing allergies, birth defects or medical conditions. On 20-Sep-2011 at 19:30 the patient received AFLURIA (batch number: N55105) injection intramuscularly into her left arm at a dose of 0.5 mL. On 13-Oct-2011 the patient called the pharmacist stating she has experienced arm pain, had difficulty/decreased range of motion of her left arm and had difficulty sleeping due to the pain after receiving AFLURIA. She also reported injection site reaction resulting in sore arm and shoulder. It hurt to move arm and raise above her head. The event outcome was recovered on 20-Oct-2011. The reporter considered events as non serious. Follow up (01-May-2012) : time of vaccination, lot number, additional AE terms, event outcome, medical history, reporter's causality assessment. Follow-up (17-Jul-2012) : further adverse events detail and recovery date.
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 02-Nov-2011) concerns a pregnant female patient. On 30-Oct-2011, the patient received a partial dose of AFLURIA. No adverse effect was reported. In the absence of a reported date of last menstrual period (LMP) or estimated date of delivery (EDD), CSL has approximated the EDD to be 27-Jun-2012, using the CSL receipt date of this initial report to be the date of six week gestation.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction with hives in a 6-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), Rotavirus vaccine. Approximately three and half years prior to this report, on an unspecified date the subject received 3rd dose of PEDIARIX (unknown), unspecified dose of Rotavirus vaccine (unknown). At an unspecified time after vaccination with Rotavirus vaccine and PEDIARIX, the subject experienced allergic reaction with hives. At 6-months old the subject was vaccinated with PEDIARIX and Rotavirus and had an allergic reaction (hives). The subject received PEDIARIX at 2 months and 4 months of age without any allergic reaction. The subject is currently 4-years old. At the time of the report no additional information was available. At the time of reporting the outcome of the allergic reaction with hives was unspecified.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Irritability, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crying in a 2-month old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk). Concurrent vaccination included PREVNAR (non-gsk); Pfizer; unknown given on 2 May 2012. There were no concurrent medications. On 2 May 2012 at 11:30 the subject received 1st dose of PEDIARIX (unknown, left thigh). On 2 May 2012 the subject received the 1st dose of ACTHIB (Non-GSK) (unknown). On 2 May 2012, 1 hour after vaccination with ACTHIB (Non-GSK) and PEDIARIX, the subject experienced crying, irritability and pharmaceutical product complaint. At the time of reporting, the crying was resolved. The outcome of the irritability was unspecified. The healthcare professional considered the events were probably related to vaccination with PEDIARIX and ACTHIB (Non-GSK). The healthcare professional reported another case see A0976319A. Follow-up information was received on 23 May 2012 via healthcare professional who reported the events of crying and irritability resolved on 02 May 2012. Action taken with PEDIARIX was withdrawn, the symptoms resolved. The immunization series was not discontinued but it was noted that the subject will receive "Ped dt in the future". The healthcare professional indicated the haemophilus influenzae type b vaccine (non-gsk) vaccine was "not given". Quality Assurance (QA) results received on 05 June 2012. The nurse reported an undetermined quality concern with this box of PEDIARIX vaccine (lot AC21B323AA, expiration 31 October 2013) that resulted in two separate adverse events for two subjects, reported separately (see case A0976319A for details regarding other subject). The responsible physician would not allow the use of the remaining syringes and wished to have this investigated. Based on the fact that no precise technical problem was reported and the conforming test results, no technical investigation was performed. GlaxoSmithKline Biologicals considered the complaint as unsubstantiated.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Emotional distress, Irritability
Clinical narrative: This case was reported by a physician and described the occurrence of inconsolable crying in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 26 April 2012; PREVNAR (non-gsk); non-GSK manufacturer; unknown; unknown given on 26 April 2012; ROTATEQ (non-gsk); non-GSK manufacturer; unknown given on 26 April 2012. There were no concurrent medications. On 26 April 2012 the subject received 1st dose of PEDIARIX (.5 ml, unknown, right thigh). On 26 April 2012, 4 hours after vaccination with PEDIARIX, the subject experienced inconsolable crying, fussy and inconsolable. The 2-month old subject received PEDIARIX during a well child examination. Four hours later the mother called and stated the subject was very fussy and could not be consoled. The subject was treated with TYLENOL and MOTRIN without any effect. Approximately six hours later on 26 April 2012, the events were resolved. Follow-up information was received on 24 August 2012 via physician who reported discrepant onset date of 27 June 2012 and outcome date of 28 June 2012; previously reported as 26 April 2012 and 26 April 2012. The outcome of the events were resolved. The reporting physician considered the events probably related to vaccination with PEDIARIX.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age, Injection site nodule, Subcutaneous nodule
Clinical narrative: This case was reported by a physician and described the occurrence of nodule injection site in an approximately 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), PEDIARIX, Hib and PREVNAR 13. On 27 March 2012 and 20 January 2012 the subject received 2nd dose and 1st dose of ROTARIX (unknown), unspecified dose of PEDIARIX (unknown), unspecified dose of Hib (unknown), unspecified dose of PREVNAR 13 (unknown) and on 27 March 2012, the subject experienced inappropriate age at vaccine administration with the ROTARIX vaccination. The subject was older than the indicated age for ROTARIX. ROTARIX is indicated to be administered prior to 24 weeks of age and at the second dose of ROTARIX, the subject was 7 months old. On 20 January 2012, less than one day after vaccination with Hib, PEDIARIX, PREVNAR 13, the subject experienced nodule injection site and subcutaneous nodule and less than a day after vaccination with ROTARIX the subject experienced subcutaneous nodule. The events occurred with rechallenge. On 27 March 2012, less than a day after vaccination with Hib, PEDIARIX, PREVNAR 13, the subject experienced nodule injection site and subcutaneous nodule and less than a day after vaccination with ROTARIX the subject experienced subcutaneous nodule. The subject was being evaluated by an allergist because she "is exhibiting subcutaneous nodules. This happened on 20 January 2012 and on 27 March 2012." At the time of reporting the outcome of the events was unspecified. Clarification of the original report was received from GlaxoSmithKline Medical Information and the case was corrected on 16 August 2012. ROTARIX should not have been reported as a suspect medication. This was a report for PEDIARIX. ROTARIX was considered concomitant on 20 January 2012 and was not administered on 27 March 2012 as previously reported. Thus, the inappropriate age at vaccine administration was deleted since ROTARIX was not administered on 27 March 2012. The subcutaneous nodule occurred at an injection site, but the healthcare provider did not specify that it was the PEDIARIX injection site. The subject also received the Hib vaccine and PREVNAR 13 when the PEDIARIX was administered. The event of subcutaneous nodule indicating a systemic reaction was removed, since ROTARIX was not suspect and the nodule only occurred at the injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX on 31-DEC-2012 (Monday). No other co-suspects were reported. No concomitant medications were reported. The patient reported that he still had some tenderness at the injection site. This is one of several reports received from the patient. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a consumer refers to his wife. The female patient was vaccinated with a dose of ZOSTAVAX on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient had some redness after she received the ZOSTAVAX vaccine. The outcome of redness was unknown. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information has been received from a registered nurse concerning an adult with an unspecified age, pertinent medical history or drug reactions/allergies who was not on dialysis. On an unspecified date, the patient was vaccinated with the first dose of RECOMBIVAX HB and it was the adult formulation, (lot number and exp date were not reported). On an unspecified date, the patient was vaccinated intramuscularly with second dose, dialysis dose, of RECOMBIVAX HB (lot #0276AE and exp date 27-MAR-2013) 40 micrograms. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. The patient's outcome was unknown. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Sneezing
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old male patient with no medical history and no drug reaction/allergies. The patient was vaccinated with a dose of ZOSTAVAX in October 2012 (about two months ago). No other co-suspects were reported. There was no concomitant medication. The pharmacist noted the patient presented (on 26-DEC-2012) with a prescription for a three-day course of prednisone for some sneezing and coughing the patient had been experiencing. The date this sneezing and coughing began was unknown. There was no laboratory studies performed. The patient was prescribed prednisone by a physician. The outcome of sneezing and coughing was reported as not recovered/not resolved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: This spontaneous consumer report (initial receipt 08-Oct-2012) concerns a 52 year old female patient with a medical history of allergy to sulfur drugs. On 06-Oct-2012, the patient received 0.5 ml of AFLURIA (batch no. unspecified) via intramuscular injection. Several hours later the patient developed soreness and tenderness at the injection site. It hurt to lift her arm. She also developed fever, headache, dizziness and fatigue. The adverse effects of headache and fatigue ebbs and wanes in severity. The patient was still experiencing symptoms on 08-Oct-2012. The patient was treated with paracetamol and ibuprofen. The event outcome was not yet recovered.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This spontaneous consumer report (initial receipt 08-Oct-2012) concerns a 52 year old female patient with a medical history of allergy to sulfur drugs. On 06-Oct-2012, the patient received 0.5 ml of AFLURIA (batch no. unspecified) via intramuscular injection. Several hours later the patient developed soreness and tenderness at the injection site. It hurt to lift her arm. She also developed fever, headache, dizziness and fatigue. The adverse effects of headache and fatigue ebbs and wanes in severity. The patient was still experiencing symptoms on 08-Oct-2012. The patient was treated with paracetamol and ibuprofen. The event outcome was not yet recovered.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal distension, Abdominal mass, Abdominal pain, Abdominal tenderness, Anion gap increased
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. A 0.5 year old male patient with medical history of RAD and without previous vaccine illness treated with a dose of ROTATEQ (lot # reported as 170922) on 09-APR-2012. Concomitant medications included PENTACEL (IM with the second dose, Lot #: C412822) and PREVNAR 13 (IM with the second dose, Lot #: F80383). The patient developed intussusception and had surgery on 11-APR-2012. The patient was still hospitalized currently. The patient presented intermittent fussiness, abdominal pain, bloody stools. The PE included: abdominal distension and tenderness, palpable mass across entire upper abdomen. Ileocolic intussusception was showed on ultra-sound. Air enema was unsuccessful. Exploratory laparotomy, reduction of intussusception performed. The patient did well post-op, and discharged home with care and follow-up instructions. The lab data included: Barium enema, US abdomen abnormal. Blood test: WBC 18.55 K/mcl (H), Plt 512 K/mcl (H), neutros 73.1% and 13.58 K/mcl (H), lymphs 14.1% (L), monos 12% and 2.2 K/mcl (H), CRP 3.6 mg/dl (H), BUN <2 mg/dl, (L), creatinine <0.17 mg/dl (L), CO2 17 mmol/l (L), agap 22 mmol/l (H), glucose 143 mg/dl (H). The listing indicated that one or more of the events was hospitalization and required ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453935-1. Follow-up information received which indicated that lot # 170922 is not a valid lot # for ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema abnormal, Blood creatinine decreased, Blood glucose increased, Blood urea decreased, C-reactive protein increased
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. A 0.5 year old male patient with medical history of RAD and without previous vaccine illness treated with a dose of ROTATEQ (lot # reported as 170922) on 09-APR-2012. Concomitant medications included PENTACEL (IM with the second dose, Lot #: C412822) and PREVNAR 13 (IM with the second dose, Lot #: F80383). The patient developed intussusception and had surgery on 11-APR-2012. The patient was still hospitalized currently. The patient presented intermittent fussiness, abdominal pain, bloody stools. The PE included: abdominal distension and tenderness, palpable mass across entire upper abdomen. Ileocolic intussusception was showed on ultra-sound. Air enema was unsuccessful. Exploratory laparotomy, reduction of intussusception performed. The patient did well post-op, and discharged home with care and follow-up instructions. The lab data included: Barium enema, US abdomen abnormal. Blood test: WBC 18.55 K/mcl (H), Plt 512 K/mcl (H), neutros 73.1% and 13.58 K/mcl (H), lymphs 14.1% (L), monos 12% and 2.2 K/mcl (H), CRP 3.6 mg/dl (H), BUN <2 mg/dl, (L), creatinine <0.17 mg/dl (L), CO2 17 mmol/l (L), agap 22 mmol/l (H), glucose 143 mg/dl (H). The listing indicated that one or more of the events was hospitalization and required ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453935-1. Follow-up information received which indicated that lot # 170922 is not a valid lot # for ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Carbon dioxide decreased, Enema administration, Explorative laparotomy, Haematochezia, 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. A 0.5 year old male patient with medical history of RAD and without previous vaccine illness treated with a dose of ROTATEQ (lot # reported as 170922) on 09-APR-2012. Concomitant medications included PENTACEL (IM with the second dose, Lot #: C412822) and PREVNAR 13 (IM with the second dose, Lot #: F80383). The patient developed intussusception and had surgery on 11-APR-2012. The patient was still hospitalized currently. The patient presented intermittent fussiness, abdominal pain, bloody stools. The PE included: abdominal distension and tenderness, palpable mass across entire upper abdomen. Ileocolic intussusception was showed on ultra-sound. Air enema was unsuccessful. Exploratory laparotomy, reduction of intussusception performed. The patient did well post-op, and discharged home with care and follow-up instructions. The lab data included: Barium enema, US abdomen abnormal. Blood test: WBC 18.55 K/mcl (H), Plt 512 K/mcl (H), neutros 73.1% and 13.58 K/mcl (H), lymphs 14.1% (L), monos 12% and 2.2 K/mcl (H), CRP 3.6 mg/dl (H), BUN <2 mg/dl, (L), creatinine <0.17 mg/dl (L), CO2 17 mmol/l (L), agap 22 mmol/l (H), glucose 143 mg/dl (H). The listing indicated that one or more of the events was hospitalization and required ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453935-1. Follow-up information received which indicated that lot # 170922 is not a valid lot # for ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Lymphocyte percentage decreased, Monocyte count increased, Monocyte percentage increased, Neutrophil count increased
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. A 0.5 year old male patient with medical history of RAD and without previous vaccine illness treated with a dose of ROTATEQ (lot # reported as 170922) on 09-APR-2012. Concomitant medications included PENTACEL (IM with the second dose, Lot #: C412822) and PREVNAR 13 (IM with the second dose, Lot #: F80383). The patient developed intussusception and had surgery on 11-APR-2012. The patient was still hospitalized currently. The patient presented intermittent fussiness, abdominal pain, bloody stools. The PE included: abdominal distension and tenderness, palpable mass across entire upper abdomen. Ileocolic intussusception was showed on ultra-sound. Air enema was unsuccessful. Exploratory laparotomy, reduction of intussusception performed. The patient did well post-op, and discharged home with care and follow-up instructions. The lab data included: Barium enema, US abdomen abnormal. Blood test: WBC 18.55 K/mcl (H), Plt 512 K/mcl (H), neutros 73.1% and 13.58 K/mcl (H), lymphs 14.1% (L), monos 12% and 2.2 K/mcl (H), CRP 3.6 mg/dl (H), BUN <2 mg/dl, (L), creatinine <0.17 mg/dl (L), CO2 17 mmol/l (L), agap 22 mmol/l (H), glucose 143 mg/dl (H). The listing indicated that one or more of the events was hospitalization and required ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453935-1. Follow-up information received which indicated that lot # 170922 is not a valid lot # for ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Neutrophil percentage increased, Platelet count increased, Surgery, Ultrasound abdomen abnormal, White blood cell count increased
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. A 0.5 year old male patient with medical history of RAD and without previous vaccine illness treated with a dose of ROTATEQ (lot # reported as 170922) on 09-APR-2012. Concomitant medications included PENTACEL (IM with the second dose, Lot #: C412822) and PREVNAR 13 (IM with the second dose, Lot #: F80383). The patient developed intussusception and had surgery on 11-APR-2012. The patient was still hospitalized currently. The patient presented intermittent fussiness, abdominal pain, bloody stools. The PE included: abdominal distension and tenderness, palpable mass across entire upper abdomen. Ileocolic intussusception was showed on ultra-sound. Air enema was unsuccessful. Exploratory laparotomy, reduction of intussusception performed. The patient did well post-op, and discharged home with care and follow-up instructions. The lab data included: Barium enema, US abdomen abnormal. Blood test: WBC 18.55 K/mcl (H), Plt 512 K/mcl (H), neutros 73.1% and 13.58 K/mcl (H), lymphs 14.1% (L), monos 12% and 2.2 K/mcl (H), CRP 3.6 mg/dl (H), BUN <2 mg/dl, (L), creatinine <0.17 mg/dl (L), CO2 17 mmol/l (L), agap 22 mmol/l (H), glucose 143 mg/dl (H). The listing indicated that one or more of the events was hospitalization and required ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453935-1. Follow-up information received which indicated that lot # 170922 is not a valid lot # for ROTATEQ. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Antibody test normal, Biopsy site unspecified abnormal, C-reactive protein normal, Complement factor C3, Complement factor C4
Clinical narrative: Patient with persistent dermatitis for several months following vaccination. Biopsy in Nov2012 was consistent with urticarial vasculitis associated with NORMAL complement levels, normal ESR, and no evidence of systemic disease.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Complement factor normal, Dermatitis, Full blood count normal, Laboratory test normal, Leukocytoclastic vasculitis
Clinical narrative: Patient with persistent dermatitis for several months following vaccination. Biopsy in Nov2012 was consistent with urticarial vasculitis associated with NORMAL complement levels, normal ESR, and no evidence of systemic disease.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Red blood cell sedimentation rate normal, Thiopurine methyltransferase
Clinical narrative: Patient with persistent dermatitis for several months following vaccination. Biopsy in Nov2012 was consistent with urticarial vasculitis associated with NORMAL complement levels, normal ESR, and no evidence of systemic disease.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Sensory disturbance, Urticaria
Clinical narrative: This spontaneous report was received from a 68 years old female consumer reporting on herself with active tetanus vaccine allergy who on 25-MAY-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant medications included hydrochlorothiazide, MAXZIDE, enalapril (manufacturer unknown) and lovastatin. The consumer reported that on an unknown date, she had the shingles. The consumer stated that she had a spot under the hairline the size of a silver dollar and it felt like bugs were biting her. The consumer described the area welts. No treatment was given for the experience. Blood work was done in October 2012 (results not provided). At the time of the report, the patient had not recovered. The patient did not seek medical attention. The relatedness for consumer stated that she had the shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Gave injection approximately 1 inch below the acromion. Patient returned about one week later complaining of extreme pain in her deltoid and radiating down her arm. Patient claimed injection was given too high.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Foreign body sensation in eyes, Rash
Clinical narrative: This spontaneous report was received from a 70 years old female consumer reporting on herself with no pertinent medical history and allergy to CIPRO, morphine, codeine and sulfa who on 29-DEC-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 31-DEC-2012, she began to feel like something was in the right eye. On 02-JAN-2013, she developed a rash on the entire right side of her face. The patient started valcyclovir on 04-JAN-2013. No lab diagnostics studies were performed. At the time of the report, the consumer had not recovered. The consumer went to see the physician assistant and also an unspecified ophthalmologist. The relatedness for patient began to feel like something was in the right eye and developed a rash on the entire right side of her face was unknown for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Foreign body sensation in eyes, Rash
Clinical narrative: This spontaneous report was received from a 70 years old female consumer reporting on herself with no pertinent medical history and allergy to CIPRO, morphine, codeine and sulfa who on 29-DEC-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 31-DEC-2012, she began to feel like something was in the right eye. On 02-JAN-2013, she developed a rash on the entire right side of her face. The patient started valcyclovir on 04-JAN-2013. No lab diagnostics studies were performed. At the time of the report, the consumer had not recovered. The consumer went to see the physician assistant and also an unspecified ophthalmologist. The relatedness for patient began to feel like something was in the right eye and developed a rash on the entire right side of her face was unknown for ZOSTAVAX. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in shoulder/arm at site of administration and into distal arm.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever, vomiting.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Pain, Skin warm
Clinical narrative: Pain, redness at sight. Now worsening pain, swelling, and warm on leg. Trouble walking.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Pain, redness at sight. Now worsening pain, swelling, and warm on leg. Trouble walking.
Age: 17.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Influenza Vaccine given 01/07/2013 PM, Low grade fever 99-100 01/08/2013, elevated to high fever 102.8 01/10/2013 and today.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Fall, Loss of consciousness, Nervousness
Clinical narrative: PATIENT RECEIVED HIS VARICELLA #2 VACCINE, WAS NERVOUS BUT RESPONSIVE AFTER THE SHOT AND APPROXIMATELY 1-2 MINUTES AFTER THE VACCINE HE PASSED OUT AND FELL OUT OF THE CHAIR HE WAS SITTING IN. HE WOKE QUICKLY AND SAID HE WAS FINE BUT WE CALLED THE DOCTOR IN TO EXAMINE HIM AND HAD HIM DRINK JUICE AND SIT WITH AN ICE PACK ON HIS NECK FOR ABOUT 15 MINUTES. HIS VITALS WERE STABLE SO HE WAS ABLE TO GO HOME.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Abdominal pain, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: PATIENT STATED THAT APPROXIMATELY 6 HOURS AFTER RECEIVING HIS SECOND (IN THE SERIES) ANTHRAX VACCINATION OVER HIS RIGHT DELTOID, HE BEGAN TO EXPERIENCE HEADACHE, NAUSEA, MILD ABDOMINAL PAIN, LOW-GRADE FEVER, AND FATIGUE. HE SELF-MEDICATED WITH OVER-THE-COUNTER ALEVE, WHICH HE STATED DID HELP SOMEWHAT TO RELIEVE HIS SYMPTOMS. HE PRESENTED TO THIS CLINIC ON JANUARY 8TH, 2013, 2 DAYS POST-VACCINATION, WITH AN APPROXIMATELY 2" x 2.5" AREA OF ERYTHEMATOUS, DRY-APPEARING RASH THAT WAS NOT SOLID. PATIENT STATED HE WAS STILL EXPERIENCING THE OTHER SYMPTOMS AS WELL. HE STATED THAT THE RASH WAS NOT ITCHY, BUT WAS RATHER VERY PAINFUL TO TOUCH. PATIENT VITAL SIGNS WERE OBTAINED AND WERE AS FOLLOWS: BP 114/76, P52, R14, T98.0F ORALLY. PATIENT OTHERWISE STABLE WITH NO FURTHER COMPLAINTS. THIS CLINIC SENT PATIENT TO A LOCAL WALK-IN CLINIC FOR FURTHER EVALUATION BY A PHYSICIAN. MEDICAL DOCUMENTATION FROM VISIT WAS OBTAINED, AND PATIENT IS SCHEDULED TO FOLLOW-UP WITH ONE OF THIS CLINIC'S PHYSICIANS ON FEBRUARY 9TH, 2013. SINCE JANUARY 8, 2013, THREE ATTEMPTS TO CONTACT MEMBER FOR FOLLOW-UP BY PHONE HAVE BEEN UNSUCCESSFUL. MESSAGES LEFT FOR PATIENT TO RETURN CALLS THREE TIMES. WILL CONTINUE TO CALL AND LEAVE MESSAGES IF NECESSARY.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Tenderness
Clinical narrative: PATIENT STATED THAT APPROXIMATELY 6 HOURS AFTER RECEIVING HIS SECOND (IN THE SERIES) ANTHRAX VACCINATION OVER HIS RIGHT DELTOID, HE BEGAN TO EXPERIENCE HEADACHE, NAUSEA, MILD ABDOMINAL PAIN, LOW-GRADE FEVER, AND FATIGUE. HE SELF-MEDICATED WITH OVER-THE-COUNTER ALEVE, WHICH HE STATED DID HELP SOMEWHAT TO RELIEVE HIS SYMPTOMS. HE PRESENTED TO THIS CLINIC ON JANUARY 8TH, 2013, 2 DAYS POST-VACCINATION, WITH AN APPROXIMATELY 2" x 2.5" AREA OF ERYTHEMATOUS, DRY-APPEARING RASH THAT WAS NOT SOLID. PATIENT STATED HE WAS STILL EXPERIENCING THE OTHER SYMPTOMS AS WELL. HE STATED THAT THE RASH WAS NOT ITCHY, BUT WAS RATHER VERY PAINFUL TO TOUCH. PATIENT VITAL SIGNS WERE OBTAINED AND WERE AS FOLLOWS: BP 114/76, P52, R14, T98.0F ORALLY. PATIENT OTHERWISE STABLE WITH NO FURTHER COMPLAINTS. THIS CLINIC SENT PATIENT TO A LOCAL WALK-IN CLINIC FOR FURTHER EVALUATION BY A PHYSICIAN. MEDICAL DOCUMENTATION FROM VISIT WAS OBTAINED, AND PATIENT IS SCHEDULED TO FOLLOW-UP WITH ONE OF THIS CLINIC'S PHYSICIANS ON FEBRUARY 9TH, 2013. SINCE JANUARY 8, 2013, THREE ATTEMPTS TO CONTACT MEMBER FOR FOLLOW-UP BY PHONE HAVE BEEN UNSUCCESSFUL. MESSAGES LEFT FOR PATIENT TO RETURN CALLS THREE TIMES. WILL CONTINUE TO CALL AND LEAVE MESSAGES IF NECESSARY.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Pyrexia, Rash
Clinical narrative: Fever & rash on one side of buttocks.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Pyrexia, Throat irritation, Vision blurred
Clinical narrative: Scratchy throat, hard to breathe, blurry vision, fever, chills.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Hypoperfusion, Immediate post-injection reaction, Lethargy, Lip swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old male patient. Patient had no pertinent medical history. Patient received separate doses of M-M-R and VARIVAX previously in January 2009 without difficulty. Patient has allergy to red dye. The patient was vaccinated with dose 1 PROQUAD (merck), subcutaneously, on 03-JAN-2013. Dosing information was not provided. Two lot number were provided: H019918 and H01577 (1 lot number for PROQUAD and lot number for the sterile diluent for PROQUAD); expiry date: February 2014. No other co-suspects were reported. No concomitant medications were reported. Immediately after first dose the patient experienced tight, wheezing cough, lethargy, low oxygen saturation, poor perfusion and dusky color in his fingers and toes, paleness in his face and swelling of lips and face. The events were assessed to be lifethreatening and disabling. Patient was treated with 2 nebulizer treatments, oral BENADRYL (manufacturer unknown), which the patient coughed up, followed by an intramuscular administration of BENADRYL and an EPIPEN JUNIOR (manufacturer unknown). Patient was transported from the office to the hospital where he was admitted. The nurse mentioned that the twin brother of the patient received a dose of PROQUAD (merck) from the same lot number/expiration date and no adverse symptoms were reported. The outcome of the events was reported as recovering/resolving. The relatedness for the events for PROQUAD (Merck) was not provided. Merck considered the events to be medically significant, as these are hypersensitivity symptoms treated with epinephrine. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Oxygen saturation decreased, Pallor, Skin discolouration, Swelling face, Wheezing
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old male patient. Patient had no pertinent medical history. Patient received separate doses of M-M-R and VARIVAX previously in January 2009 without difficulty. Patient has allergy to red dye. The patient was vaccinated with dose 1 PROQUAD (merck), subcutaneously, on 03-JAN-2013. Dosing information was not provided. Two lot number were provided: H019918 and H01577 (1 lot number for PROQUAD and lot number for the sterile diluent for PROQUAD); expiry date: February 2014. No other co-suspects were reported. No concomitant medications were reported. Immediately after first dose the patient experienced tight, wheezing cough, lethargy, low oxygen saturation, poor perfusion and dusky color in his fingers and toes, paleness in his face and swelling of lips and face. The events were assessed to be lifethreatening and disabling. Patient was treated with 2 nebulizer treatments, oral BENADRYL (manufacturer unknown), which the patient coughed up, followed by an intramuscular administration of BENADRYL and an EPIPEN JUNIOR (manufacturer unknown). Patient was transported from the office to the hospital where he was admitted. The nurse mentioned that the twin brother of the patient received a dose of PROQUAD (merck) from the same lot number/expiration date and no adverse symptoms were reported. The outcome of the events was reported as recovering/resolving. The relatedness for the events for PROQUAD (Merck) was not provided. Merck considered the events to be medically significant, as these are hypersensitivity symptoms treated with epinephrine. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: Injection site painful. No obvious infection. No edema nor erythema. Patient to use local warm heat and TYLENOL or ADVIL for pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness in left upper arm starting at injection site & down arm continuing below elbow. Pain radiated up to shoulder & to finger tips. Red area hot to touch & swollen. Initially I couldn't touch my face or head with affected arm. 9 am on 12/13/12 I saw my doctor who immediately put me on a 10 day regimen of cephalexin 500 mg #40. Redness started to clear on day 3; & by day 5 there was only a slight discoloration. Doctor checked my arm for next 2 days in his office. No fever.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Oedema peripheral, Pain in extremity, Skin discolouration, Skin warm
Clinical narrative: Redness in left upper arm starting at injection site & down arm continuing below elbow. Pain radiated up to shoulder & to finger tips. Red area hot to touch & swollen. Initially I couldn't touch my face or head with affected arm. 9 am on 12/13/12 I saw my doctor who immediately put me on a 10 day regimen of cephalexin 500 mg #40. Redness started to clear on day 3; & by day 5 there was only a slight discoloration. Doctor checked my arm for next 2 days in his office. No fever.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: 1/2/13 Shortly after Tdap vaccine about 2 hours, developed severe HA, low grade fever (997), generalized malaise & fatigue, joint aches, chills & swollen glands (per pt) & diarrhea. Taking FIORCET for HA, ibuprofen for body aches & BENADRYL at NOC for sleep. 1/4/13. All sx resolved except fatigue.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: 1/2/13 Shortly after Tdap vaccine about 2 hours, developed severe HA, low grade fever (997), generalized malaise & fatigue, joint aches, chills & swollen glands (per pt) & diarrhea. Taking FIORCET for HA, ibuprofen for body aches & BENADRYL at NOC for sleep. 1/4/13. All sx resolved except fatigue.