chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 68 year old female patient. No demographics were provided for the patient involved. In August or September of 2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot# unknown). No other co-suspects were reported. No concomitant medications were reported. "A week ago, on approximately 22-APR-2013 the patient experienced a mild case of shingles in the upper shoulder area. The patient had sought medical attention by doctor's visit. The outcome of a mild case of shingles on the upper shoulder area was reported as not recovered/not resolved. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Headache
Clinical narrative: Mild headaches and dizziness during schedule and up to present.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site discolouration, Malaise
Clinical narrative: This spontaneous report as received from a 60 year old female patient with allergies and without drug reactions/allergies refers to herself. On 11-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX in the left arm (dose, route and lot # unspecified). On 12-APR-2013 the patient started to feel mild flu like symptoms which lasted a week (stopped on approximately 18-APR-2013), feel tired and just not feel well. The patient also mentioned she noticed a light pink spot around the injection site. The outcome of not feeling well, a light pink spot around the injection site and feeling tired was unknown. No lab diagnostics studies were performed. The patient did not seek medical attention. The relatedness of the events for ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect dose administered, Local swelling
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 4 year old male patient. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Lot number, expiry date, route and dose were not reported). Concomitantly the patient also received KINRIX at the same visit. On an unknown date, the patient developed very large localized swelling that required a second visit to the doctor. The outcome of the event localized swelling was unknown. This is one of the two assistant received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a female patient of unknown age. On a January 2012, the patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot# and expiration date not reported) intramuscularly. On an unknown date in March 2013, the patient was vaccinated with dose 2, 0.5 ml GARDASIL (lot# and expiration date not reported) intramuscularly. No adverse effects reported. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No adverse event, No therapeutic response
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 35 year old female patient. The patient had a complete series of RECOMBIVAX HB at an unspecified time in 2006. On an unknown date in 2007, the patient was vaccinated with a second series RECOMBIVAX HB (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient has had titers drawn at an unspecified time and the results "don't show high enough titers" yet reports no other adverse effects. The reporter stated that the patient may be attempting to attend nursing school and was in need of vaccination. The outcome of don't show high enough titers was unknown. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Feeling of body temperature change, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 40 year old female patient with colitis, urinary urgency and latex allergy (causes skin irritation). On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) by an unspecified healthcare provider with no problems. Approximately on 18-MAR-2012 (reported as 2 weeks prior to 02-APR-2012), the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified) by an unspecified healthcare provider. The patient was seen by nurse on 18-APR-2013 questioning whether a third dose of GARDASIL should be given. It was unknown if the third of GARDASIL was given on 18-APR-2013. Concomitant therapies included RITALIN, ergocalciferol (reported as Vitamin D2), acetaminophen, dichloralphenazone, MIDRIN and polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, COLYTE. On 02-APR-2012, the patient experienced hot and cold sensations. The patient did not seek any medical attention. No treatment was given to the patient. No lab tests were performed. The nurse referred the patient back to the primary healthcare provider of the patient. The patient recovered from the event on an unknown date. The relatedness for the event was unknown for GARDASIL. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter, a 19 year old female patient with no reported medical history. On unspecified date in 1998 the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (route, dose, frequency and lot number unknown). No other suspect therapy or concomitant medication was reported. The nurse reports that her daughter received an unspecified varicella vaccine (that may or may not have been VARIVAX) on a unspecified date when she was 11 years old. Nurse assistant that her daughter since then has had shingles 3 times; once when she was 19 years old (on unspecified date in 2006), then when she 24 years old (on unspecified date in 2011), and the nurse assistant that she believes her daughter has the shingles again now (21-APR-2013) but with no rash present when she was 26 years old. No treatment information was reported. The outcome of shingles when she was 19 years old, shingles when she was 24 years old and shingles with no rash present when she was 26 years old is unknown. The reporters relatedness of shingles when she was 19 years old, shingles when she was 24 years old and shingles with no rash present when she was 26 years old to varicella virus vaccine live (manufacturer unknown) is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 03-APR-2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 05-JUL-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 30-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 4 year old male patient. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (Lot number, expiry date, route and doses were not reported). Concomitant therapies included KINRIX. On an unknown date, the patient developed cellulitis after receiving the PROQUAD (Merck). The outcome of developed cellulitis was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. The physician reported that on unspecified dates, an unspecified number of patients may have received improperly stored MMR II (lot number, expiry not reported) that were exposed to 36F for 13 hours. The physician was unable to provide any additional information or details about whether or not patients received this improperly stored MMR II. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-APR-2013 the patient was vaccinated with MMR II (lot number 669840/0446AA, expiry date 28-MAR-2013). No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. Since an unknown date in November 2012, the patient's were vaccinated with a dose of improperly stored PNEUNOVAX 23 (lot#, expiration date and route not reported). No adverse event reported. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified healthcare worker from a pharmacy via a company representative concerning two patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of ZOSTAVAX (lot number reported as J00444, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patients experienced unspecified adverse experience. Patients sought medical attention (both the patients were hospitalized with an unspecified length of stay at an unspecified hospital). It was unspecified if any treatment was given or if any lab tests were performed. The outcome of unspecified adverse experience was unknown. The relatedness for unspecified adverse experience was unknown for ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Influenza, Pain, Pyrexia
Clinical narrative: Case number PHEH2013US005583 is an initial spontaneous report received from a consumer on 06 Mar 2013 with the follow-up received from Quality Assurance Department (reference number: 215380) on 09 Apr 2013: This report refers to a 64-year-old male patient. His current condition, medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on an undetermined date in Oct 2012. On 02 Jan 2013, he was diagnosed with flu. He had fever, diarrhea and body aches. His doctor prescribed him TAMIFLU and he felt better within four to five days. The events abated on 07 Jan 2013. No further information about causality and seriousness was provided. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the complaint production, testing and supply processes for FLUVIRIN. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow-up received from Quality Assurance Department on 09 Apr 2013: Updated batch review report.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. Since an unknown date in November 2012, the patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (lot#, expiration date and route not reported). No adverse event reported. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. Since an unknown date in November 2012, the patients were vaccinated with a dose of improperly stored GARDASIL (lot #, expiration date and route not reported). No adverse event reported. This is one of the several reports from the same source. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 65 year old female patient with drug allergy to codeine, niacin and penicillin. The patient had no pertinent medical history. On 18-APR-2013 the patient was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX23 (lot # H018608, exp. 21-JUL-2014 also reported as 02-JUL-2014). No co-suspect therapy was reported. There was no concomitant therapy. The patient called the office and reported that she had experienced an unspecified allergic reaction to PNEUMOVAX23. The patient had been evaluated by an unspecified physician in her hometown. The outcome of the event of an unspecified allergic reaction to PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a pharmacist regarding a 64 year old male patient. Patient's medical history was not provided. There was no drug reactions or allergies. On 26-APR-2013, the patient was vaccinated with 0.5 mL dose of ZOSTAVAX, subcutaneous (Lot number reported as J000427, expiration date 10-APR-2014). On an unknown date, the patient who is a dentist, received a dose of ZOSTAVAX and developed an injection site reaction. The affected area was red and rashy. Treatment was not received for the adverse event. Laboratory test was not performed. The patient sought medical attention, he visited pharmacist on 30-APR-2013. At the time of the report, the patient had not recovered. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient claims arm numbness.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Rash erythematous, Skin warm
Clinical narrative: This spontaneous report as received from a physician refers to a 73 year old (age at the time of the report) female patient with diabetes, gastroparesis, hypertension and gastritis and no drug reactions/allergies who on an unknown date was hospitalized due to Gastroparesis. On 16-APR-2013, while in the hospital, the patient was vaccinated intramuscularly in the deltoid muscle on her right arm with 0.5 mL of PNEUMOVAX23 (lot # H014653, expiration date on 19-APR-2014) as a routine hospital vaccination. Concomitant therapies included LOVENOX, ERYTHROMYCIN, MIRALAX, NIFEDIPINE, TYLENOL, ZOFRAN, PHENERGAN  and TEMAZEPAM. After receiving the PNEUMOVAX23, the patient experienced pain and a rash at the injection site, AE onset date was reported as 17-APR-2013. The physician stated that less than 24 hours later, the rash doubled in size and was measuring 2.5 by 4 to 5 centimeters. The rash was blanchable, erythematous and her right upper extremity was warm. The physician reported that the patient had a good pulse, good right arm motion, there was no pus or collection and no systemic fever. No treatment was given for the events. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The causal relationship between the events and PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 84 year old male patient. On 07-JUL-2011 the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, strength and lot number were not reported). No concomitant medications were reported. On an unspecified date in March 2013 the patient was diagnosed with shingles during an office visit. The outcome of shingles is unknown. The patient sought unspecified medical attention. The relationship between the event and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13, VARCEL, DTAPIPV, MMRV, PNC13, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse manager refers to a patient of unknown age. On 29-APR-2013 the patient was vaccinated with VARIVAX (Merck). Other suspect therapies included PROQUAD (Merck). Dosing information was not provided. The patient received a dose of VARIVAX (Merck) and a dose of PROQUAD (Merck) administered during the same visit (Overdose). No symptoms reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13, VARCEL, DTAPIPV, MMRV, PNC13, VARCEL
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a nurse manager refers to a patient of unknown age. On 29-APR-2013 the patient was vaccinated with VARIVAX (Merck). Other suspect therapies included PROQUAD (Merck). Dosing information was not provided. The patient received a dose of VARIVAX (Merck) and a dose of PROQUAD (Merck) administered during the same visit (Overdose). No symptoms reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Rash, Skin warm, Swelling
Clinical narrative: On left thigh, erythema with central "bruising: surrounding KINRIX injection; erythema marked with marker earlier today by caregiver. No advancing margin; and warmth and swollen; Non-tender, non-streaking, rash noted. Tx: OTC remedies and monitor.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Cough, Cyanosis, Diet refusal, Pallor, Pharyngeal oedema
Clinical narrative: Initial case was received from a healthcare professional on 26 April 2013. A two-month-old female patient received an intramuscular injection of PENTACEL, sanofi pasteur Ltd., (lot number, site, side and dose in series not reported); Hep B, other manufacturer; PREVNAR, other manufacturer; and ROTARIX, other manufacturer (lot numbers, routes, sites, sides and dose in series not reported) on an unspecified date. By evening of vaccination (unspecified date), the two-month-old would not take her bottle and was coughing. Mom thought the infant's throat was swelling. The infant became pale and blue around the lips and was taken to the emergency room (ER). The patient's past medical history was not reported and illness at time of vaccination was reported as none. Laboratory and diagnostic tests were reported as unknown. Treatments were not reported. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: none.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. Since an unknown date in November 2012, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot#, expiration date and route not reported). No adverse event reported. This is one of several reports from the same source. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: TYP, YF
Symptoms: Urticaria
Clinical narrative: Hives, 12.5 mL BENADRYL given, DECADRON 0.6 mL.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Asthenia, Hypotonia, Myoclonus, Poor sucking reflex
Clinical narrative: 45 minutes of being weak, limp, not sucking well 3 hours after vaccines, breathing OK no seizure. Had a few myoclonic jerks. Color good. After 45 minutes was perfect.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 48 hours after immunizations mother noted (L) deltoid, swollen, red and warm, area the size of a baseball. Pt does not c/o discomfort.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Chills, Dizziness, Injection site induration, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist (healthcare student) refers to a new 66 year old female patient with no known drug reactions or allergie. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapies included LEVAQUIN, doxycycline and vancomycin. The pharmacist reported the patient developed induration and urticaria at the injection site "that had rapidly progressed" after receiving PNEUMOVAX 23. The pharmacist also mentioned the patient stated she experienced "chills, increased dizziness, fever, body aches and pain" after receiving PNEUMOVAX 23. The patient contacted pharmacy. TICK panel and blood cultures were performed but the results were unknown. The outcome of increased dizziness, fever, chills, induration and urticaria at the injection site and body aches and pain was reported as not recovered. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist (healthcare student) refers to a new 66 year old female patient with no known drug reactions or allergie. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapies included LEVAQUIN, doxycycline and vancomycin. The pharmacist reported the patient developed induration and urticaria at the injection site "that had rapidly progressed" after receiving PNEUMOVAX 23. The pharmacist also mentioned the patient stated she experienced "chills, increased dizziness, fever, body aches and pain" after receiving PNEUMOVAX 23. The patient contacted pharmacy. TICK panel and blood cultures were performed but the results were unknown. The outcome of increased dizziness, fever, chills, induration and urticaria at the injection site and body aches and pain was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was reported. On an unknown date in April 2013 (reported as within the last month), the patient was vaccinated with dose 1 of ROTATEQ (lot #, expiry not reported) orally. No concomitant medications were reported. On an unknown date in April 2013, the patient experienced diarrhea the day after the patient received ROTATEQ. It was unspecified as to how long the patient had diarrhea. The patient sought medical attention (called the physician). The outcome of diarrhea was unknown. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Arthralgia, Lymph node pain
Clinical narrative: 1 week ago pt started having lymph node tenderness. Currently progressing to joint pain in both knees. Advised to see physician.
Age: 0.44
Sex: F
Vaccine: PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea since 4-29-13 date of admin. Vomited
Age: 71.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Pruritis and erythema that spread distally.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash vesicular
Clinical narrative: Redness at injection site. Chicken pox like bumps all over the body.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Convulsion, Pyrexia, Urinary tract infection
Clinical narrative: This case was reported by a physician via a market research company and described the occurrence of convulsion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included cold. Per the physician, the subject had a cold when they went to the emergency room. Concurrent vaccination included PEDIARIX (GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject received 2nd dose of PEDIARIX for primary series ("standard dose", unknown details). Within 48 hours to 72 hours after vaccination with PEDIARIX, the subject experienced fever, convulsion, and urinary tract infection (U.T.I.). Per the physician, the subject had "fever and then develop[ed] short-term convulsion." The subject was "diagnosed with U.T.I.". This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. Report received from a physician during market research. The physician reported another case with PEDIARIX. See case A1021890A for details on the other case.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Large local reaction at injection site warm and swollen shoulder to elbow.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Convulsion, Otitis media, Pyrexia
Clinical narrative: This case was reported by a physician via market research and described the occurrence of convulsion in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on an unspecified dates for dose 1 and 2. On an unspecified date the subject received 3rd dose of PEDIARIX for primary series ("standard dose", unknown details). Within 48 to 72 hours after vaccination with PEDIARIX, the subject experienced fever and convulsion. At an unknown time after vaccination with PEDIARIX, the subject experienced otitis media. Per the physician, the subject had "fever and then develop[ed] short-term convulsion." This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. Report was received from a physician during market research. The physician reported another case with PEDIARIX. See case A1021881A for details on the other case.
Age: 25.0
Sex: F
Vaccine: JEVX
Symptoms: Feeling abnormal, Headache, Heart rate increased
Clinical narrative: Pt received Japanese Encephalitis on 4/25/13 approx 3 minutes after receiving vaccine pt told nurse she felt funny - head hurting - and c/o rapid heart rate - pulse rate 90/ B/P 100/60 - pt denies itching or breathing issue - monitor pt for 30 minutes pulse rate down - left with father stable and alert. Spoke with pt on 4/26/13 no additional problems.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Autism
Clinical narrative: This case was reported by a physician and described the occurrence of autism in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates in August 2006 and in 2006 the subject received three unspecified doses of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced autism. The physician, who is also the subject's father, had inquired about the amount of Thimerosal in PEDIARIX vaccines. He reported the subject was vaccinated with PEDIARIX in 2006 and was diagnosed with autism. the subject was vaccinated with lots AC21B074CA expiration November 2008, AC21B073AA expiration November 2008 and AC21B084CA expiration February 2009. The physician declined to provide any further details but was open to follow-up. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unresolved.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender who on 30-APR-2013, was vaccinated with an expired dose of GARDASIL (lot # 1397AA, expiration date, 09-APR-2013) this was the 2nd. The first dose was administered on 19-MAR-2013. No adverse effect reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Patient reported having little red, itchy bumps all over his body lasting nearly one month. Treated with topical OTC steroid creams and anti itch creams.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth, Local swelling
Clinical narrative: 2 days after injection right arm injection site was hot itchy! Painful and hard. No improvement until started prednisone taper 04/27/13 and doxycycline BID x 10 days. Neck swelling on right side noted as well.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Case with red, swollen, warm, hard areas on both upper arms. Area on left arm larger than right arm. Case stated his right hand was tingling. Case to FNP this a.m. reporting some shortness of breath.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: Case with red, swollen, warm, hard areas on both upper arms. Area on left arm larger than right arm. Case stated his right hand was tingling. Case to FNP this a.m. reporting some shortness of breath.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site urticaria, Pain
Clinical narrative: Child woke up on the morning of 5/2/13 with redness over the injection site of varicella given on the left thigh.  Looked like a small hive per mom.  Was observe and throughout the day seem to be getting a little bigger.  This morning are was more firm and red.  Maybe a little painful.  No fever.  In office found to have firm area beneath skin.  With superficial erythema and tenderness.  Still no fever.  As a precaution treated with cephalexin for possible cellulitis.  No vesicles present.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Tenderness
Clinical narrative: Child woke up on the morning of 5/2/13 with redness over the injection site of varicella given on the left thigh.  Looked like a small hive per mom.  Was observe and throughout the day seem to be getting a little bigger.  This morning are was more firm and red.  Maybe a little painful.  No fever.  In office found to have firm area beneath skin.  With superficial erythema and tenderness.  Still no fever.  As a precaution treated with cephalexin for possible cellulitis.  No vesicles present.
Age: 33.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, White blood cell count increased
Clinical narrative: Erythema, edema, 8/10 pain of left upper arm.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Feeling hot, Formication, Hyperaemia, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Per MD note: "18-yr-old with Type 1 VWD received Hepatitis B reimmunization dose #3 of second series. Upon leaving clinic and reaching elevator stated he had deltoid and finger numbness. On questioning stated he had experienced immediate paresthesiae with sensation of a "furry caterpillar crawling from deltoid down arm". Numbness of dorsal surface of four fingers excluding thumb, also reported increased warmth in right hand compared to left. Objectively there was no significant bleeding at injection site. There was hyperemeia of the affected distal upper limb. Motor examination was completely normal." Given Benadryl 25mg po, observed in clinic. Injection site was 9 cm from acromion and in appropriate location with 1 inch needle. Upper arm circumferences was equal at 33cm. Eventual discharge from clinic around 5.50 pm."
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Per MD note: "18-yr-old with Type 1 VWD received Hepatitis B reimmunization dose #3 of second series. Upon leaving clinic and reaching elevator stated he had deltoid and finger numbness. On questioning stated he had experienced immediate paresthesiae with sensation of a "furry caterpillar crawling from deltoid down arm". Numbness of dorsal surface of four fingers excluding thumb, also reported increased warmth in right hand compared to left. Objectively there was no significant bleeding at injection site. There was hyperemeia of the affected distal upper limb. Motor examination was completely normal." Given Benadryl 25mg po, observed in clinic. Injection site was 9 cm from acromion and in appropriate location with 1 inch needle. Upper arm circumferences was equal at 33cm. Eventual discharge from clinic around 5.50 pm."
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Grand mal convulsion
Clinical narrative: Grand mal seizure, duration 15 minutes.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Convulsion, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Pt. was seen convulsing briefly after the injection while waiting in the chair.  Pt. also fainted and came to shortly after 1 minute.  A&O x 3, BP slightly lower than baseline, pt. was clammy, sweating, very pale.  Provider assessed the pt. and advised that she be seen at hospital due to the adverse reaction.  Pt. was taken by ambulance to the hospital.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pt. was seen convulsing briefly after the injection while waiting in the chair.  Pt. also fainted and came to shortly after 1 minute.  A&O x 3, BP slightly lower than baseline, pt. was clammy, sweating, very pale.  Provider assessed the pt. and advised that she be seen at hospital due to the adverse reaction.  Pt. was taken by ambulance to the hospital.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Cough, Dyspnoea, Injection site mass, Rash, Throat irritation
Clinical narrative: Itchy throat, cough, shortness of breath, rash across chest, large lump upper right arm.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Serum sickness, Vaccination complication
Clinical narrative: Ot serum react d/t vacc on 2013-04-09.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Hard red rash on left arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain
Clinical narrative: 48 hrs after vaccine had pain, induration, erythema 3 cm 2.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Local itch, redness at site of vaccine. Started 24 hrs after shot.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: 4 pox like lesions, 12 days after VARIVAX #1,
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: 5/2/13 Mom called to report 4" area of redness and warmth. 5/3/13 per mom, school nurse said it is no longer swollen, child says it feels better.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Client states that 2-3 days following his flu vaccine that he developed a deep aching pain where flu shot was given. Client stated Ibuprofen would help some. Went to visit his physician. Was prescribed physical therapy for 2 weeks. Some improvement with ROM. No swelling or discoloration at injection site. Still has pain, but not as bad now as it was.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphemia
Clinical narrative: The morning after patient received the Hepatitis A vaccine he developed stuttering which progressed over 2 months and then gradually resolved.  He had excellent language skills prior to the vaccine and now is back to his usual state.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Aggression, Expressive language disorder, Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE AS WELL AS MOTHER STATES "FLYING OFF THE HANDLE". DESCRIBES SYMPTOMS AS SPITTING, URINATING, AND DEFECATING ON HIMSELF. LANGUAGE ABILITIES DIMINISHED, NOT VERBALIZING HIMSELF CLEARLY COMPARED TO PRE-VACCINATION. DENIES FEVER AT THIS TIME. STATES HAD SAME SYMPTOMS FOLLOWING 07/14/2011 IMMS. DID NOT REPORT SYMTOMS AT THAT TIME TO PROVIDER BUT DID TAKE TO HOSPITAL FOR EVALUATION
Age: 19.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash generalised, Urticaria
Clinical narrative: PT developed a RASH over the entire body the day after vaccination which worsened with time. Treated with Solu-medrol 125mg and Prednisone 10mg. PT is improving and is stable. Diagnosed as URTICARIA.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Cognitive disorder, Convulsion, Crying, Developmental delay, Electroencephalogram abnormal
Clinical narrative: Being fussy, non-stop crying day and night. Event get worse and worse, in early September, reported to the doctor, doctor said that it might be teething, parents have to live through it.  We reported it a second time to the doctor, as soon as we could get an appointment in October. We get an EEG done in hospital, said that she had a significant abnormal EEG. Doctor said that she has seizure.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Irritability, Speech disorder developmental
Clinical narrative: Being fussy, non-stop crying day and night. Event get worse and worse, in early September, reported to the doctor, doctor said that it might be teething, parents have to live through it.  We reported it a second time to the doctor, as soon as we could get an appointment in October. We get an EEG done in hospital, said that she had a significant abnormal EEG. Doctor said that she has seizure.
Age: 35.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema
Clinical narrative: Student noticed pink flare 10-18mm x 40mm on left arm at site of Yellow Fever vaccination. Went back to clinic on 5/3 to show nurse. Denied pain, discomfort. Afebrile. Not raised, just pink.
Age: 0.51
Sex: F
Vaccine: HIBV
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Insomnia, Vomiting
Clinical narrative: 5/2/13 - abnormally tired. 5/3/13 - Vomiting, diarrhea, loss of appetite, couldn't sleep.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: Not even 10 minutes after the vaccine injection I felt cloudy headed but I thought it was my anxiety, I am not sure of the exact time it was maybe around 3:45. By approximately 4:00, I felt my ear go numb, and the right side of my face was tingling and my right eyelid went numb, I could feel the numbness spreading down my face on the right side. I immediately took a Benadryl, knowing the feeling from a previous vaccine reaction. I left the health department around 4:40 although I did not feel right but knowing that I had taken a Benadryl, I would hopefully be okay to make it home. By 7:15pm I felt I was having minor trouble breathing. So I took another Benadryl, and it did not seem to help by 7:40 approximately I took another Benadryl because I felt like I was suffocating and having to gasp for air and I was getting really light headed and felt like I was going to faint. My mother took me to hospital. I arrived there at approximately 8:00pm. Approximately 15-20 minutes after arriving I felt the Benadryl start working and breathing was not such a hard task. The doctor gave me a steroid pill 10mgs. (Not sure what kind, because it is not listed on my discharge paper) I was also given a 20mg Pepcid AC, I was told to take Pepcid AC if needed and to get help if the problem re-occurred and I was discharge with the diagnosis of vaccine reaction. Today 5/03/2013 I approximately 7:30 I felt I was starting to have breathing difficulty again and I took a Pepcid AC, and seem to be okay for now.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Suffocation feeling, Vaccination complication
Clinical narrative: Not even 10 minutes after the vaccine injection I felt cloudy headed but I thought it was my anxiety, I am not sure of the exact time it was maybe around 3:45. By approximately 4:00, I felt my ear go numb, and the right side of my face was tingling and my right eyelid went numb, I could feel the numbness spreading down my face on the right side. I immediately took a Benadryl, knowing the feeling from a previous vaccine reaction. I left the health department around 4:40 although I did not feel right but knowing that I had taken a Benadryl, I would hopefully be okay to make it home. By 7:15pm I felt I was having minor trouble breathing. So I took another Benadryl, and it did not seem to help by 7:40 approximately I took another Benadryl because I felt like I was suffocating and having to gasp for air and I was getting really light headed and felt like I was going to faint. My mother took me to hospital. I arrived there at approximately 8:00pm. Approximately 15-20 minutes after arriving I felt the Benadryl start working and breathing was not such a hard task. The doctor gave me a steroid pill 10mgs. (Not sure what kind, because it is not listed on my discharge paper) I was also given a 20mg Pepcid AC, I was told to take Pepcid AC if needed and to get help if the problem re-occurred and I was discharge with the diagnosis of vaccine reaction. Today 5/03/2013 I approximately 7:30 I felt I was starting to have breathing difficulty again and I took a Pepcid AC, and seem to be okay for now.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Decreased appetite
Clinical narrative: Loss of appetite and severe abdominal pain.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Loss of consciousness, Pain
Clinical narrative: I was on break at work and I went to a friends house. I was sitting on the bed and ended up blacking out and having a full blown seizure. I do not remember anything from it. I don't remember feeling weird. I woke up to my friend grabbing my shoulders and asking if I was okay. I ended up biting my tongue really bad and my body was hurting really bad the next few days. I went to the doctor the following day and I am seeing neurologist now.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Tongue biting
Clinical narrative: I was on break at work and I went to a friends house. I was sitting on the bed and ended up blacking out and having a full blown seizure. I do not remember anything from it. I don't remember feeling weird. I woke up to my friend grabbing my shoulders and asking if I was okay. I ended up biting my tongue really bad and my body was hurting really bad the next few days. I went to the doctor the following day and I am seeing neurologist now.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient developed stiff neck with slight headache and muscle aches.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in with redness swelling warm, at site of injection.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: 2 1/2 x 2 inch area of warmth and erythema starting day of vaccine then progressing treated with KEFLEX (250/5) 5 ml po q6 hours x 10 days.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Pallor, Syncope, Vomiting
Clinical narrative: 5 minutes after vaccines pt standing and became pale and fainted. Vomited x 2. Patient laid down elevated feet drank 8 oz carbonated soda. Waited 20 minutes Dr checked pulse which was normal.
Age: 1.99
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Patient had a fever on and off for 10 days, also had a rash after vaccine on cheeks and body that lasted for 3 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came in office on 4/25/13 and returned on 5/3/13 with c/o swelling and redness at injection site. Pt had fading purplish pink erythema about 4 cm.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site rash
Clinical narrative: Pt had a rash on both arms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 60 year old female patient. On 26-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # not reported) (one shot, strength and total daily dose not reported) (in the arm). It was reported that the patient developed an "injection-site reaction" on 26-APR-2013 after receiving ZOSTAVAX. The patient appeared to have a "large ball on her arm" at the injection site on 26-APR-2013 and sought medical attention on 26-APR-2013 at an unspecified emergency room, where she was treated with unspecified antibiotics and then released at an unspecified time on an unspecified date. The patient returned to the unspecified emergency room on 29-APR-2013 and was treated with unspecified intravenous and oral steroids before being released at an unspecified time on an unspecified date. The patient saw the pharmacist on 30-APR-2013 to show him her remaining injection-site reaction. The remaining reaction appeared to be minor and only "a little injection-site reaction" with no cause for concern. The injection-site reaction was reported to "look like cellulitis" on 30-APR-2013. The patient's unspecified medications were evaluated to not have caused any kind of immunosuppressed state. The patient was not yet fully recovered. The outcome was reported as recovering. The causality between the adverse event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a male patient of unknown age. On 20-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The student reported that "recently" on an unspecified date in 2013, the patient experienced severe headaches. The outcome of severe headaches was reported as not recovered/not resolved. Additional information is not expected.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Crying, Insomnia, Irritability, Opisthotonus, Pain
Clinical narrative: A high fever around 5am 5/2/2013. Behavior that is associated with infant pain (the type of crying heard, arching back, irritability, restlessness, difficulty sleeping). Round the clock pain and fever relievers given but were not completely effective for pain.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Pyrexia, Restlessness
Clinical narrative: A high fever around 5am 5/2/2013. Behavior that is associated with infant pain (the type of crying heard, arching back, irritability, restlessness, difficulty sleeping). Round the clock pain and fever relievers given but were not completely effective for pain.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site haematoma, Vaccination site warmth
Clinical narrative: Bilateral erythema/warmth at vaccine sites, right hematoma, fever.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: VOMITING (SEVERAL TIMES).
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram, Injection site pain, Loss of consciousness, Mobility decreased, Nausea
Clinical narrative: First, pain at injection site. Then, increasing pain radiating throughout entire arm.  Swelling of entire arm and inability to move fingers wrist etc.  Excruciating pain ("worse than childbirth").  Shaky, near blackout several times, nausea, vomiting mucous. Fever.   Night sweats continue (night of May 3). Pain entirely resolved by May 3. No evidence of lasting disability at this time.