chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Dry skin, Eczema, Erythema, Skin exfoliation, Vaccination complication
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 09 May 2012. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of Sanofi Pasteur. Additional information was on 11 May 2012 and 14 May 2012. A male patient had received two injections consisting of (Hepatitis B, DTaP, IPOL and Hib) on 04 April 2012 (combinations, lot numbers, routes and site not reported). The next day, the patient turned all red and the doctor confirmed the patient had a reaction to the vaccination. An unspecified amount of time after the vaccinations, the patient developed dry scaly skin all over his body. The patient's mother reported the event to the doctor's office and was instructed to apply hydrocortisone cream. The event did not resolve. The patient was seen at the doctor's office and was told the patient had eczema probably due to vaccination. The patient subsequently received pneumonia vaccine and rotavirus on 18 April 2012. The patient previously received a first dose of Hepatitis B vaccine at birth on 03 February 2012. The event of eczema was not recovered. The doctor's office was not aware of the adverse event. The patient's outcome was not recovered. Follow-up information received from consumer, who is also the patient's parent (RN) on 16 July 2012: The patient received a combination of (DTaP, Ipol and Hib)- "PENTACEL vaccine" (lot number: C4131AA, route: intramuscular and site: left thigh); and also received Hepatitis B vaccine ("MFR GSK", lot number: AHBVC093AA, route: intramuscular, site: right thigh). It was reported the patient's family had a strong history of eczema and food allergies. The patient had no ongoing illness at the time of vaccination. It was reported by the physician that the symptoms were due to the family medical history of allergy and eczema and not because of vaccines administered. The parents have continued to vaccinate the children on a divided schedule and there were no contraindication to the vaccine. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Mass, Rash
Clinical narrative: Initial report received from a consumer who is also patient's husband on 07 May 2012 in mailbox under the inquiry no. 1-376625441. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of Tdap vaccine on an unspecified date, (Manufacturer unknown, lot number, site and route of administration were not reported). The patient's husband had called and reported that his wife had broken out in clusters and had lumps on her head. The patient's outcome was not reported. Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: TDAP
Symptoms: Crying, Pyrexia
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent on 15 February 2012. A two-month-old female patient had received an intramuscular injection of DTAP (manufacturer, lot number and site of administration unknown) on 19 February 2010 and cried for 12 hours straight and developed a fever. The patient had no known allergies (NKA), denied any illness at the time of vaccination, denied any other vaccinations within 4 weeks of DTaP and weighed 5 pounds 4 ounces at birth. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None. Follow up information received on 7 May 2012. The patient had no illness at the time of vaccination. On an unknown date the patient had recovered from the events.
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: Initial report was received from a health care professional on 06 February 2012. An unidentified patient had received a full series of DTAP (manufacturer, lot number, route, site and dates of administration not reported) and an unspecified amount of time later tested positive for Bordetella Pertussis. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Initial information received on 20 December 2012 from the FDA under the Freedom of Information (FOI) Act. This information was initially request by a consumer and forwarded to the Company. The following information is verbatim from the listings provided by the health authority. Patient felt syncopal and nauseated. List of documents held by sender: None.
Sex: F
Vaccine: DTAP
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 03 January 2013. A female patient, whose demographic details, medical history and concomitant medications were not reported, had received a dose of Tdap vaccine manufacturer unknown (lot number, site and route of administration, dosage and number in series were not reported) on an unspecified date. It was reported that, the patient had a reaction after vaccine administration. Laboratory date and corrective treatment were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Initial report received from a consumer who is also the patient, on 10 October 2012. A 35-year-old female patient had received a dose of intramuscular Tdap (Manufacturer unknown, Lot number unknown) in deltoid on 08 October 2012. Patient denied any illness at the time of the vaccination. The patient had no past medical history. Patient is allergic to Amoxicillin. The patient had received Tdap in 2004. The concomitant medication included iron supplement and TYLENOL. The patient had menses at the time of vaccination. On 08 October 2012 after 8 hours of vaccination, the patient had headache, body aches, chills, nausea nad sweats. Temperature was not recorded. The patient had received Tdap in 2004 but was informed that Tdap was not licensed until 2005. Corrective treatment was not reported. Laboratory investigations were none as per reporter. The reporter stated that the symptoms were resolving. The patient's outcome was unknown. List of documents held by the sender: None.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Mood altered, Pain in extremity, Skin test negative
Clinical narrative: Initial report was received on 30 July 2012 from a health care professional which involves a case of misuse. A two-year-old male had received on 22 May 2012 the second half of "1/2 dose (2.5ml)" of DTaP (manufacturer, lot number, route and site of administration not reported) and was observed for 1/2 hour without adverse effect. The patient had a history of reactive airway disease with wheezing, bronchiolitis with wheezing, respiratory distress, chest tightness and fever following the third dose of TRIPEDIA on 10 January 2012. The patient had experienced increased fussiness following dose one of IPV at three months. The patient was evaluated by an allergist where a prick skin test with DTaP was negative at 15 minutes and histamine control was 2+. The patient was given the first 1/2 dose DTaP (manufacturer, lot number and date of administration not reported) IM (intramuscularly) in the left quad (date not reported) and was observed for one hour without adverse effect. Follow-up information was received from a health care professional on 20 August 2012. The patient received the first 1/2 dose (0.25cc) of DAPTACEL, lot number C4002AA, via the intramuscular route in the left vastus lateralis on 16 May 2012 and was observed for about one hour without adverse effect. The patient received the second 1/2 dose (0.25cc) of DAPTACEL, lot number C4050AA, via the intramuscular route in the right vastus lateralis on 22 May 2012 and was observed for 1/2 hour without adverse effect. The patient has additional events captured in cases 2012-05165 and 2012-05169. Documents held by sender: none. Follow-up information received on 4 September 2012: On an unspecified date after vaccination, the patient developed pain in leg (unsure of which leg, both legs). Patient also seemed more tired and grumpy post Dtap vaccine. Outcome of the events was not reported.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Immediate post-injection reaction, Injection site erythema, Urticaria
Clinical narrative: Initial report received from a healthcare professional on 11 July 2012. A 4-year-old male patient with no reported concomitant medications and no medical history, had received fifth dose of intramuscular DAPTACEL in left thigh (batch number: C4186AA) and Hepatitis B vaccination (lot number, route, dose, was not reported) in the right thigh on 3 July 2012. It was reported that, the patient received DAPTACEL vaccination on an 3 July 2012 and immediately following vaccination she developed 4 small hives lateral to injection site and small area of redness at injection site of thigh. It was reported that 20 minutes after vaccination the 4 small hives formed in to one large hive and red area became larger which was 3 x3 cm in size area at injection site with one large hive. The patient received ibuprofen as treatment and her mother administered BENADRYL at home 1 hour later. After 8 hours the patients mother reported that the injection site looked same no large. Details of laboratory investigations were not reported. The outcome of the event was recovered on an unspecified date. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster ophthalmic
Clinical narrative: This spontaneous report as received from a physician via a representative refers to a 70 year old female patient. The patient's medical history included mild lupus disease. On 17-OCT-2012 the patient was vaccinated with ZOSTAVAX, subcutaneous. The physician reported to the representative that the patient went blind with "herpes zoster" in her eyes after being vaccinated with ZOSTAVAX. The patient had an office visit on an unspecified date for medical attention. At time of reporting, the outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Blood aluminium increased, Injection site erythema, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: Initial report received from scientific literature on 28 August 2012. The reporter for this case is the same as case number 2012-07952. The following is verbatim from the article: "An 11-year-old girl presented 6 months after influenza vaccination and 14 months after a DTaP vaccination for evaluation of pruritic eruptions after vaccine administration, partially relieved by oral antihistamines. Past medical history was notable for von Willebrand disease, with no known allergy to eggs." Family history included hay fever and atopic dermatitis. The child received an injection of DTaP vaccine, 14 months before the adverse event, and an injection of INFLUENZA VACCINE, 6 months before the adverse event, (for both vaccines, manufacturer was unknown; lot number route, site, and dose in series were not reported) on unspecified dates. Symptoms included "swelling, erythema, and pruritus at the injection site" and "concurrent pruritic, erythematous eruption of arms and legs." The patient had a positive patch test with reaction results (2+) Aluminum chloride hexahydrate on an unspecified date. The patient's outcome was not reported. Follow-up information was received from the scientific literature on 07 November 2012. No additional information was provided in the article. The patient's outcome remained not reported. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Rash pruritic, Skin test positive
Clinical narrative: Initial report received from scientific literature on 28 August 2012. The reporter for this case is the same as case number 2012-07952. The following is verbatim from the article: "An 11-year-old girl presented 6 months after influenza vaccination and 14 months after a DTaP vaccination for evaluation of pruritic eruptions after vaccine administration, partially relieved by oral antihistamines. Past medical history was notable for von Willebrand disease, with no known allergy to eggs." Family history included hay fever and atopic dermatitis. The child received an injection of DTaP vaccine, 14 months before the adverse event, and an injection of INFLUENZA VACCINE, 6 months before the adverse event, (for both vaccines, manufacturer was unknown; lot number route, site, and dose in series were not reported) on unspecified dates. Symptoms included "swelling, erythema, and pruritus at the injection site" and "concurrent pruritic, erythematous eruption of arms and legs." The patient had a positive patch test with reaction results (2+) Aluminum chloride hexahydrate on an unspecified date. The patient's outcome was not reported. Follow-up information was received from the scientific literature on 07 November 2012. No additional information was provided in the article. The patient's outcome remained not reported. Documents held by sender: None.
Sex: F
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Crying, Pyrexia, Staring
Clinical narrative: Initial report received from a physician on 24 July 2012. A 04-months old female patient with no reported concomitant medications and medical history, received a dose of DTAP vaccine (mfr unknown, route and site of administration, dose, batch number were not reported), rotavirus vaccine (mfr unknown, route and site of administration, dose, batch number were not reported), polio vaccine (mfr unknown, route and site of administration, dose, batch number were not reported) and HIB vaccine (mfr unknown, route and site of administration, dose, batch number were not reported) on an unknown date. It was reported that, following vaccination the patient presented crying, wild eye staring and fever on an unknown date. Details of corrective treatment and laboratory investigations were not reported. On an unspecified date, after 5 days the patient recovered from the events. Documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (gender and ages not reported). On unspecified dates the patients were vaccinated with the second dose of GARDASIL, intramuscularly (Lot number and dose not reported). It was reported that the patients received the "vaccination series late". No adverse effects were reported. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Initial report was received from a consumer, who was also the patient's parents on 06 February 2012. This reporter also reported another adverse event, which is captured in case 2011-01544. The cases involved the same reporter. A 4-month-old male patient had received the second dose injection of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (manufacturer, lot number, route, site and date not reported) and an unspecified amount of time later experienced unusual crying, lasting several hours. Medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Follow-up information was received on 27 February 2012 from a consumer, who was also the patient's parent. The reporter clarified that the patient was a four-month-old female at the time of the event, which occurred in 1985. No further information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper
Clinical narrative: Initial report received from non-healthcare professional who is also a patient on 11 December 2012. A 56-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of Tdap or ADACEL vaccine Sanofi Pasteur (Lot number was unknown, dose number, route and site were not reported) on 11 December 2012. The patient was not sure if she received ADACEL or Tdap vaccine. The same day i.e. on 11 December 2012 after vaccination, the patient experienced stomach pain. Relevant diagnostic tests and corrective treatments were not reported. At the time of this report patient had not recovered from the events. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Unevaluable event
Clinical narrative: Initial report received from a consumer who is also patient mother, on 01 May 2012.
Age: 0.2
Sex: U
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 06 February 2012. A 2-month-old patient (gender not reported) had received a dose 1 injection of DAPTACEL, Sanofi Pasteur Ltd. (lot number, route, date and site of administration unknown). The patient cried for more than three hours after the vaccination. It was unknown if the patient had any illness at the time of vaccination, had any medical history or took any concomitant medications. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Papular skin rashes, noticed the day after vacc. on both anterior thighs.
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case linked with AER # 2012-11732 belongs for same patient event occurred after the ADACEL vaccine. Initial report received from a healthcare professional on 19 February 2013. A less than 2 year old female patient, who had no illness at the time of vaccination and unknown medical history and concomitant medications were not reported, had received a dose of Tdap (lot number, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date, patient had experienced swelling in arm. Corrective treatments and relevant diagnostic tests were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Abscess sterile, Injection site swelling
Clinical narrative: This case is linked to case number 2012-06158. Initial report received from a healthcare professional on 27 April 2012. A 02-year-old male patient without any medical history or known allergies and whose concomitant medication were not reported, had received intramuscularly first dose of DAPTACEL (lot number: C4006AA) in the left thigh on 15 February 2012. It was reported that 15 February 2012, the patient developed sterile abscess and swelling about the size of a baseball at the injection site. The reporter denies any redness at the site. The patient did not visit the physician for evaluation. Corrective treatment was not reported. The patient's outcome was not recovered. List of documents held by sender: None.
Age: 0.39
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Initial report received from a consumer on 28 August 2012. A 4-month-old male patient, whose medical history and concomitant medications were reported as none, received intramuscular dose of PENTACEL vaccine in left thigh (lot number: C4127AA) on 07 June 2012. The reporter stated that on the day of vaccination i.e. 07 June 2012 child's thigh was swollen and covered in a raised rash, but not itchy. The boarder of the rash was a darker red than the rest of the rash. The Patient's history of adverse event to previous vaccination and corrective treatments were not reported. Laboratory details were none. The outcome of the event was recovered on unspecified date. List of documents held by sender: none. Follow up information received on 31 October 2012. The patient had no illness at the time of vaccination and had no vaccinations within 4 weeks of 07 June 2012. The patient had received 1 dose of DAPTACEL vaccine on an unspecified date. The patient (birth weight reported as 6 lb and 3 oz) received an intramuscular dose 2 of DAPTACEL (batch number: C4127AA) on left thigh on 07 June 2012 (previously reported as PENTACEL). The patient was referred to an allergist.
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: This case is a cluster of three patients who experienced adverse reactions following administration to DAPTACEL, lot number C4006AA. The other two patients were captured in cases 2012-03354 and 2012-03355. Initial report was received from a health care professional on 23 March 2012. A female patient (age and date of birth unknown) had received a dose four intramuscular injection in the leg of DAPTACEL, lot number C4006AA on an unknown date and an unspecified amount of time later had a "bad reaction" at the injection site. Medical history, concomitant medications, illness at the time of vaccination and any other vaccinations within four weeks of DAPTACEL were not reported. The patient's outcome was unknown. Documents held by sender: None.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Local swelling
Clinical narrative: Initial information received from a healthcare professional on 19 July 2012. A patient (age and gender not reported) whose medical history and concomitant medications were not reported received DAPTACEL and POL on unspecified date (lot number, dose number, route and anatomical site of injection were not reported. On an unspecified date, the patient experienced swelling in arm, 2 days post vaccination. Laboratory details and corrective treatment were not reported. The patient's outcome was not reported. Documents held by sender: None
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Summary narrative including initial information received from healthcare professional on 14 June 2012 and follow-up information received on 17 September 2012. A 4-month-old male patient with no reported medical history and concomitant medications received intramuscular DAPTACEL (batch number: unk) in the right thigh on an unspecified date (1 month ago). On an unspecified date, the patient developed injection site redness. The treatment medications were not reported. The lab investigations were none. The event of injection site redness resolved in 2 days. Documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Abscess sterile, Injection site swelling
Clinical narrative: Initial report received from a Healthcare professional on 27 April 2012. This case is linked to the case number 2012-04702. Several patients (age, gender and number of the patient not reported), whose medical history and concomitant medication were not reported, had received a dose of DAPTACEL on an unspecified date (lot number, route and site of administration was not reported). It was reported that several patients had developed sterile abscess and swelling about the size of a baseball at the injection site after the administration of the DAPTACEL vaccine. Outcome of the event was not reported. List of documents held by sender: none.
Age: 0.7
Sex: U
Vaccine: DTAP
Symptoms: Lethargy, Somnolence
Clinical narrative: Initial report was received from a health care professional on 08 February 2012. An 8-month-old patient (gender not reported) had received dose three of DAPTACEL (lot number, route, site and date of administration not reported) and the "next day", the patient's mom reported the patient was lethargic and slept for six hours. The patient's medical history, concomitant medications, illnesses at the time of vaccination and adverse event following prior vaccinations were not reported. The reporter declined to provide further information or contact information. No further information to provide. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: This case is cluster of 2 cases and is linked to case number 2013-01999 (same reporter, same events after administration of DAPTACEL and IPOL). Initial report received from a healthcare professional on 4 February 2013. A 5-year-old patient whose gender, date of birth, medical history and concomitant medications were not reported, had received a dose of DAPTACEL from Sanofi Pasteur (lot number: C4310BA, expiry date: 03-15-2015, number in series not reported) and a dose of IPOL from Sanofi Pasteur (lot number: H1354-2, expiry date 07-08-2014, number in series not reported) intramuscularly on the left thigh on an unspecified date. The patient had also received a dose of MMR (manufacturer: unknown, lot number, number in series and route of administration were not reported) and a dose of varicella (manufacturer:unknown, lot number, number in series and route of administration were not reported) on the right thigh on an unspecified date. On an unspecified date after vaccination, the patient experienced local site reactions of red, hot, induration at left thigh injection site which varied in size of redness and induration. Relevant laboratory data and corrective treatment details were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: This case pertains to 1 of a cluster of 2 patients who experienced adverse events following administration of DAPTACEL (lot number C4310BA) and IPOL vaccine (H1354-2). Other patient is captured in case number 2013-02000 (same reporter, same events after administration of DAPTACEL (lot number C4310BA0 and IPOL vaccine (H1354-2). Initial report received from a healthcare professional on 4 February 2013. A 4-year-old patient whose gender, medical history and concomitant medications were not reported, had received a dose of DAPTACEL vaccine from Sanofi Pasteur (lot number: C4310BA, expiry date: 03-15-2015, number in series were not reported) and a dose of IPOL vaccine from Sanofi Pasteur (lot number: H1354-2, expiry date: 07/08/2014, number in series were not reported) intramuscularly in left thigh on an unspecified date. The patient had also received a dose of MMR vaccine (manufacturer: unknown, lot number, number in series and route of administration were not reported) and a dose of Varicella vaccine (manufacturer: unknown, lot number, number in series and route of administration were not reported) in right thigh on an unspecified date. On an unspecified date after vaccination, the patient experienced local site reactions of red, hot, induration at left thigh injection site which varied in size of redness and induration. Relevant laboratory data and corrective treatment details were not reported. The patient's outcome was unknown. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Glossodynia, Tongue disorder
Clinical narrative: Initial report received from non-healthcare professional on 16 October 2012. A 04 year old male patient whose medical history include sclera derma and allergic to amoxicillin and concomitant medications were not reported had received intramuscular DAPTACEL (batch number, site of administration, dose, dose number not reported) on 12 October 2012. It was reported that, 2 days after vaccination on 14 October 2012, the patient complained that his tongue burns which was seen by his MD who felt tongue was little red and might be irritated by food. The patients mother stated that whenever he eats even cold food the patient claims his tongue burns. The patients tongue was not blistered or swollen. The patient received vaccine due to laceration on his foot. Details of corrective treatments and laboratory investigations were none. The outcome of the event was not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 02 January 2013. The patient had received DAPTACEL vaccine with Lot no: C4154BA in left leg.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case is a cluster of three patients who experienced adverse reactions following administration to DAPTACEL, lot number C4006AA. The other two patients were captured in cases 2012-03354 and 2012-03356. Initial report was received from a health care professional on 23 March 2012. A female patient had received a dose four intramuscular injection in the right arm of DAPTACEL, lot number C4006AA on an unknown date and the second day after the vaccine the patient experienced swelling, tenderness and redness of 5-10cm at the injection site. Medical history, concomitant medications, illness at the time of vaccination and any other vaccinations within four weeks of DAPTACEL were not reported. The patient's sister experienced the same adverse reaction to DAPTACEL where she experienced swelling, tenderness and redness of 5-10cm at the injection site, which was captured in case 2012-03354. The patient's outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case is a cluster of three patients who experienced adverse reactions following administration to DAPTACEL, lot number C4006AA. The other two patients were captured in cases 2012-03355 and 2012-03356. Initial report was received from a health care professional on 23 March 2012. A female patient had received a dose four intramuscular injection in the right arm of DAPTACEL, lot number C4006AA on an unknown date and the second day after the vaccine the patient experienced swelling, tenderness and redness of 5-10cm at the injection site. Medical history, concomitant medications, illness at the time of vaccination and any other vaccinations within four weeks of DAPTACEL were not reported. The patient's sister experienced the same adverse reaction to DAPTACEL where she experienced swelling, tenderness and redness of 5-10cm at the injection site, which was captured in case 2012-03355. The patient's outcome was not recovered. Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV5
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Initial report was received on 01 March 2012 from a health care professional. A two-month-old female with no reported past medical history and no illness at the time of vaccination had received on 17 March 2012 the following vaccines: an intramuscular left thigh injection of ACTHIB, lot number UH622AA (sanofi pasteur SA lot number G1371-1); an intramuscular left thigh injection of DAPTACEL, lot number C4022AA; an intramuscular right thigh injection of IPOL, lot number G1500-1; an intramuscular right thigh injection of PREVNAR 13, Pfizer lot number F611177; an intramuscular right thigh injection of HEPATITIS B VACCINE, lot number B1455AA and ROTATEQ, lot number 1036AA (route and site of administration not reported). On 18 February 2012, the patent experienced a rash and urticaria that started on the face, moved to the extremities, arms and more on the legs. The rash was also noted on the chest and trunk. The urticaria was a red, raised rash however the patient did not "seem to be itchy". The patient was evaluated by a physician. Treatments were not reported. Concomitant medications and adverse events following prior vaccinations were reported as none. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 0.3
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Unevaluable event
Clinical narrative: This non-serious listed case involves one of a cluster of two, (identical twins) out of two vaccinees who had received DAPTACEL, lot number C4050AA. Information regarding the other patient is captured in non-serious case number 2012-05755. Documents held by sender: None. Follow up information received on 28 June 2012: It was reported that the patient had no known drug allergy and had apnea of prematurity. The weight of the patient at the time of report was reported as 4 pounds and 14. ounces. The time of vaccination of dose one of DAPTACEL was reported as 3: 19 pm. The patient had received subcutaneous dose of IPV (lot number: H1305, on right thigh on 18 May 2012 and intramuscular dose of PREVANR 13 vaccine (Mfr Wyeth) (lot number: F88044, on left thigh on 25 May 2012. the patient's concomitant medication included caffeine citrate.
Age: 0.3
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Unevaluable event
Clinical narrative: This non-serious listed case involves use of a cluster of two, (identical twins) out of two vaccinees who had received DAPTACEL, lot number C4050AA. Information regarding the other patient is captured in non-serious case number 2012-06012. Documents held by sender: None. Follow up information received on 28 June 2012: It was reported that the patient had no known drug allergy and had apnea of prematurity. The weight of the patient at the time of report was reported as 4 pounds and 5 ounces. The time of vaccination of dose one of DAPTACEL was reported as 3:18 pm. The patient had received subcutaneous dose of IPOL (lot number: H1305, on right thigh on 18 May 2012 and intramuscular dose of PREVNAR 13 (lot number: F88044, on left thigh on 25 May 2012. The patient's concomitant medications included caffeine citrate.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, MMR, VARCEL
Symptoms: Injection site erythema, Skin lesion, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt began having redness, pain, and swelling at vaccination site about 2 days after injection. Pt advised on using antihistamine and ice and lesion resolved in 2-3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pruritus, Pyrexia, Swelling
Clinical narrative: Swelling itching, fever, possible infection of injection site, sweats, chills, Tx Antibiotic given, patient doesn't know the name of it.
Age: 21.0
Sex: U
Vaccine: HEP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site oedema, Swelling, Throat irritation
Clinical narrative: Presented to health dept with redness and edema (Lt) arm at Varicella vaccine injection site. States noticed "redness and swelling in the evening of 5-17-13." Started taking BENADRYL. Today throat" itchy and feels tight" referral to ER for evaluation Hx of seasonal allergies. No acute resp. distress.
Age: 21.0
Sex: U
Vaccine: HEP, VARCEL
Symptoms: Throat tightness
Clinical narrative: Presented to health dept with redness and edema (Lt) arm at Varicella vaccine injection site. States noticed "redness and swelling in the evening of 5-17-13." Started taking BENADRYL. Today throat" itchy and feels tight" referral to ER for evaluation Hx of seasonal allergies. No acute resp. distress.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: 3 cm redness and warmth to rt arm.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Erythema, swelling, pain.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H014561, expiration date 21-MAR-2014) 0.3 ml (route and anatomical location unspecified). The Registered Nurse reported that a PQC was filed for possibly underfilled PNEUMOVAX23 vial. No adverse effect reported. Additional infiormation has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Anxiety, Asthenia, Autoimmune thyroiditis, Blood thyroid stimulating hormone
Clinical narrative: This spontaneous report as received from a nurse refers to a patient with unknown age and gender. For many years, since high school, the patient had suffered with constipation and abdominal "issues", which she had gone to many doctors for (2 primary care docs and 2 GI (gastrointestinal) specialists, and had a colonoscopy), to no avail. It was reported that the patient had been in a old study that's been closed for about 10 years and was vaccinated with GARDASIL (dose, route , lot # were not reported) or placebo on an unspecified date. The patient discovered she had Hashimoto's in March 2013. She was diagnosed with hypothyroidism at age 23 and have been on SYNTHROID. In the last couple years these GI problems had become more uncomfortable, including heartburn, nausea, and gas after eating anything. These symptoms interfered with the patient's well-being, sex life/relationship, travel, daily activities, social life, etc. Since conventional medicine and approaches have not helped with the patient's stomach, the patient went to see a Naturopath. The Naturopath advised the patient went on the GAPS diet, which was a ketogenic diet. The patient had been on this diet for about 6 week. A lot of her GI problems have improved, which was good. But, the patient felt like crap from not getting enough carbohydrate. The patient had chronic headaches, weakness. The Naturopath says this was due to a "die-off reaction" from the "bad bacteria" dying. The Naturopath upped the dose of SYNTHROID once discovering the patient had Hashimoto's and that the patient was still hypothyroid. She took the patient from the 75 mcg the patient had been on for years all the way up to 125 mcg on approximately 19-MAR-2013. After 6 weeks on this higher dose, the patient had blood drawn Tuesday, on 30-APR-2013, and was now hyperthyroid, with a TSH (thyroid stimulating hormone) of 0.5. The patient had been having a lot of anxiety the past 2 weeks, from approximately 19-APR-2013 and she thought she was going nuts. At the time of reporting, the patient's outcome was unknown. This is one of several cases with the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dyspepsia, Flatulence, Headache, Hyperthyroidism, Hypothyroidism
Clinical narrative: This spontaneous report as received from a nurse refers to a patient with unknown age and gender. For many years, since high school, the patient had suffered with constipation and abdominal "issues", which she had gone to many doctors for (2 primary care docs and 2 GI (gastrointestinal) specialists, and had a colonoscopy), to no avail. It was reported that the patient had been in a old study that's been closed for about 10 years and was vaccinated with GARDASIL (dose, route , lot # were not reported) or placebo on an unspecified date. The patient discovered she had Hashimoto's in March 2013. She was diagnosed with hypothyroidism at age 23 and have been on SYNTHROID. In the last couple years these GI problems had become more uncomfortable, including heartburn, nausea, and gas after eating anything. These symptoms interfered with the patient's well-being, sex life/relationship, travel, daily activities, social life, etc. Since conventional medicine and approaches have not helped with the patient's stomach, the patient went to see a Naturopath. The Naturopath advised the patient went on the GAPS diet, which was a ketogenic diet. The patient had been on this diet for about 6 week. A lot of her GI problems have improved, which was good. But, the patient felt like crap from not getting enough carbohydrate. The patient had chronic headaches, weakness. The Naturopath says this was due to a "die-off reaction" from the "bad bacteria" dying. The Naturopath upped the dose of SYNTHROID once discovering the patient had Hashimoto's and that the patient was still hypothyroid. She took the patient from the 75 mcg the patient had been on for years all the way up to 125 mcg on approximately 19-MAR-2013. After 6 weeks on this higher dose, the patient had blood drawn Tuesday, on 30-APR-2013, and was now hyperthyroid, with a TSH (thyroid stimulating hormone) of 0.5. The patient had been having a lot of anxiety the past 2 weeks, from approximately 19-APR-2013 and she thought she was going nuts. At the time of reporting, the patient's outcome was unknown. This is one of several cases with the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Malaise, Mental disorder, Nausea
Clinical narrative: This spontaneous report as received from a nurse refers to a patient with unknown age and gender. For many years, since high school, the patient had suffered with constipation and abdominal "issues", which she had gone to many doctors for (2 primary care docs and 2 GI (gastrointestinal) specialists, and had a colonoscopy), to no avail. It was reported that the patient had been in a old study that's been closed for about 10 years and was vaccinated with GARDASIL (dose, route , lot # were not reported) or placebo on an unspecified date. The patient discovered she had Hashimoto's in March 2013. She was diagnosed with hypothyroidism at age 23 and have been on SYNTHROID. In the last couple years these GI problems had become more uncomfortable, including heartburn, nausea, and gas after eating anything. These symptoms interfered with the patient's well-being, sex life/relationship, travel, daily activities, social life, etc. Since conventional medicine and approaches have not helped with the patient's stomach, the patient went to see a Naturopath. The Naturopath advised the patient went on the GAPS diet, which was a ketogenic diet. The patient had been on this diet for about 6 week. A lot of her GI problems have improved, which was good. But, the patient felt like crap from not getting enough carbohydrate. The patient had chronic headaches, weakness. The Naturopath says this was due to a "die-off reaction" from the "bad bacteria" dying. The Naturopath upped the dose of SYNTHROID once discovering the patient had Hashimoto's and that the patient was still hypothyroid. She took the patient from the 75 mcg the patient had been on for years all the way up to 125 mcg on approximately 19-MAR-2013. After 6 weeks on this higher dose, the patient had blood drawn Tuesday, on 30-APR-2013, and was now hyperthyroid, with a TSH (thyroid stimulating hormone) of 0.5. The patient had been having a lot of anxiety the past 2 weeks, from approximately 19-APR-2013 and she thought she was going nuts. At the time of reporting, the patient's outcome was unknown. This is one of several cases with the same reporter. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Computerised tomogram, Dyspnoea, Headache, Laboratory test normal
Clinical narrative: Within 24hr dyspnea, temps to 100, WBC 15K, myalgias, and headache. Prior to shot no symptoms. Arms without reaction locally. ER labs meningitis negative.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Lumbar puncture, Myalgia, White blood cell count increased
Clinical narrative: Within 24hr dyspnea, temps to 100, WBC 15K, myalgias, and headache. Prior to shot no symptoms. Arms without reaction locally. ER labs meningitis negative.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Irritability, Pyrexia
Clinical narrative: Fevers, irritable, head bobbing.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Facial rash.
Age: 0.15
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV5
Symptoms: Crying, Decreased appetite, Insomnia, Irritability
Clinical narrative: Fussy, intermittently, inconsolable baby, not sleeping, decreased feeding even after day 5 since vaccines given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Swelling
Clinical narrative: 24 hours after shot red, swelling size of grapefruit blister dime size x 3 days. Tx-ice, BENADRYL, ADVIL.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Condition aggravated, Decreased appetite, Diabetes mellitus inadequate control, Fatigue
Clinical narrative: Extreme weakness, tiredness (lasted months), lack of appetite, uncontrolled blood sugars, shaky legs and pain.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Neurological examination, Nuclear magnetic resonance imaging, Pain, Tremor
Clinical narrative: Extreme weakness, tiredness (lasted months), lack of appetite, uncontrolled blood sugars, shaky legs and pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash morbilliform
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 28-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose not reported, subcutaneous route). Concomitant therapy was not reported. It was reported that a couple days later, approximately 30-MAR-2013, after the patient received the ZOSTAVAX, the patient experienced measles like rash on upper arm. The patient then had a follow-up appointment with an unspecified physician and was diagnosed with shingles. The patient then received an unspecified medication from her pharmacist and the symptoms resolved and the patient made a full recovery on an unspecified date. Additional information has been recovery.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 18 year old female patient. On an unknown date the patient was vaccinated with the second dose of GARDASIL (lot # not reported) (dose not reported, route reported as injection). Concomitant therapy was not reported. On an unspecified date the patient experienced swelling of the throat after receiving her second dose of GARDASIL. The patient went to see the doctor. At the time of the report the patient' outcome was recovering. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 month old patient. On an unknown date in approximately 2013 (reported as within the past few days) the patient was vaccinated with a dose of GARDASIL (dose, route and lot number were not reported). No other concomitant medications were reported. It was reported that the patient was inadvertently administered GARDASIL instead of PEDVAXHIB at an outside clinic. No adverse effects were noted. Staff error only. The patient did not seek medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from an unknown age, male physician, who is also the consumer, reporting on himself with a history of shingles that goes back 20 years (unspecified date) and no known allergies. In January of 2006 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route unspecified) for vaccination, no other suspect therapies or concomitant medications were reported. The patient reported that approximately in July 2007 (reported as "about a year and a half later" he developed a case of shingles that continues to present with short periods of remission. The patient reported that during a period of remission in early 2011, he received another dose of ZOSTAVAX, but the shingles outbreaks were now worse (lasted longer and did not respond to treatments). The patient reported that he had been taking Acyclovir ointment (manufacturer unspecified) and Acyclovir orally (manufacturer unspecified) as treatment for the shingles outbreaks. The patient reported that his current outbreak had lasted for about 3 months without remission. The outcome for the shingles outbreak has been reported as not recovered. The reporting physician did not assess the relatedness between ZOSTAVAX and the shingles outbreak. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Information has been received from a healthcare professional, concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose shingles vaccine zoster vaccine live (manufacturer unknown) (dose, route and frequency were not reported) (Lot # was not reported). On an unknown date, the patient developed a lump under skin at the injection site. At the time of the report, the patient's outcome of lump under skin at injection site was unknown. Additional information is not expected.