chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician who reported that 90-100 patients were inadvertently administered 5 vaccines from December 2013 to March 2014 that had been improperly stored. This report refers to unknown number of these patients who were vaccinated with ROTATEQ had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician who reported that 90-100 patients were inadvertently administered 5 vaccines for prophylaxis from December 2013 to March 2014 that had been improperly stored. This report refers to unknown number of these patients who were vaccinated with VAQTA had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer (customer of the patient) refers to a female patient of unknown age. On an unknown date, the patient reported that "her/his hair dresser" was vaccinated with ZOSTAVAX (dose, duration and route were not reported). On an unknown date, the patient experienced shingles and the reporter could not get her/his hair done because her/his did not want to get shingles. The outcome of had shingles was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician who reported that 90-100 patients were inadvertently administered 5 vaccines for prophylaxis from December 2013 to March 2014 that had been improperly stored. This report refers to unknown number of these patients who were vaccinated with VARIVAX that had been improperly stored. No adverse effects reported. This is one of several reports received 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 as received from a physician who reported that 90-100 patients were inadvertently administered vaccines from December 2013 to March 2014 that had been improperly stored. This report refers to unknown number of these patients who were vaccinated with GARDASIL that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain where injection was given.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Redness and swelling 8x8cm induration to right arm. 3x4 cm induration to left.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm with one 1.5 cm round area of erythema, warm, raised. Another 2.5 cm round area of erythema, warm, raised slightly, tender but no drainage.
Age: 1.04
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Dyspnoea
Clinical narrative: 30 seconds after giving PEDIARIX child started crying then she was unable to breath approximately 45 seconds. Then child started sleeping. She opens eye when she wakes up. Patient was sent to Emergency room for further evaluation.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2014US019229 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519089) website on 17 Feb 2014 with a follow-up received on 24 Apr 2014. This report refers to a 27-year-old female patient. Her concurrent condition included flu. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307901) intramuscularly into left arm on 16 Sep 2013. On 14 Oct 2013, 28 days after vaccination, she experienced GBS (Guillain-Barre syndrome). She had a visit to emergency room due to this event. She was hospitalized for 12 days following this event. Outcome of the event was reported as condition unchanged as of 13 Jan 2014. Causality of the event was not reported. Follow-up received from the vaccine adverse event reporting system (VAERS reference number: 519089) web site on 24 Apr 2014: Updated trade name, batch number, site and route of administration of the suspect vaccine and information on hospitalization. Following an internal review on 06 May 2014 of the data received on 24 Apr 2014, it was identified that the suspect vaccine batch number was captured wrongly as 122105 in the previous follow up and hence it was now corrected to 1307901.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blindness unilateral, C-reactive protein increased, Differential white blood cell count, Full blood count, Optic neuritis
Clinical narrative: Case number PHHY2014US043040 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519590) website on 08 Apr 2014 with a follow up information received from the quality assurance department (QA reference number: 294015) on 01 May 2014. This report refers to a 60-year-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13423P, expiry date: 30 Apr 2014) intramuscularly into right arm on 14 Oct 2013. On 02 Jan 2014, 81 days after vaccination, she experienced sudden vision loss (L) eye and optic neuritis / papillitis (L) eye. She had a visit to an emergency room due to these events. She underwent many vision tests, complete blood count (CBC) and differential white blood cell count for which results were not reported; C-reactive protein (CRP) was 1.6 and erythrocyte sedimentation rate (ESR) was 8. The events were reported as serious (permanent disability). Outcome of the events was reported as condition unchanged as of 16 Jan 2014. Causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 294015), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 01 May 2014: Expiry date and batch summary updated.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Papillitis, Red blood cell sedimentation rate normal, Sudden visual loss, Visual acuity tests
Clinical narrative: Case number PHHY2014US043040 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519590) website on 08 Apr 2014 with a follow up information received from the quality assurance department (QA reference number: 294015) on 01 May 2014. This report refers to a 60-year-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13423P, expiry date: 30 Apr 2014) intramuscularly into right arm on 14 Oct 2013. On 02 Jan 2014, 81 days after vaccination, she experienced sudden vision loss (L) eye and optic neuritis / papillitis (L) eye. She had a visit to an emergency room due to these events. She underwent many vision tests, complete blood count (CBC) and differential white blood cell count for which results were not reported; C-reactive protein (CRP) was 1.6 and erythrocyte sedimentation rate (ESR) was 8. The events were reported as serious (permanent disability). Outcome of the events was reported as condition unchanged as of 16 Jan 2014. Causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 294015), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 01 May 2014: Expiry date and batch summary updated.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein increased, Differential white blood cell count, Full blood count, Optic neuritis, Red blood cell sedimentation rate normal
Clinical narrative: Case number PHHY2014US043040 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519590) website on 08 Apr 2014 with a follow up information received from the quality assurance department (QA reference number: 294015) on 01 May 2014. This report refers to a 60-year-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13423P, expiry date: 30 Apr 2014) intramuscularly into right arm on 14 Oct 2013. On 02 Jan 2014, 81 days after vaccination, she experienced sudden vision loss (L) eye and optic neuritis / papillitis (L) eye. She had a visit to an emergency room due to these events. She underwent many vision tests, complete blood count (CBC) and differential white blood cell count for which results were not reported; C-reactive protein (CRP) was 1.6 and erythrocyte sedimentation rate (ESR) was 8. The events were reported as serious (permanent disability). Outcome of the events was reported as condition unchanged as of 16 Jan 2014. Causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 294015), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 01 May 2014: Expiry date and batch summary updated.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sudden visual loss, Visual acuity tests
Clinical narrative: Case number PHHY2014US043040 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519590) website on 08 Apr 2014 with a follow up information received from the quality assurance department (QA reference number: 294015) on 01 May 2014. This report refers to a 60-year-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13423P, expiry date: 30 Apr 2014) intramuscularly into right arm on 14 Oct 2013. On 02 Jan 2014, 81 days after vaccination, she experienced sudden vision loss (L) eye and optic neuritis / papillitis (L) eye. She had a visit to an emergency room due to these events. She underwent many vision tests, complete blood count (CBC) and differential white blood cell count for which results were not reported; C-reactive protein (CRP) was 1.6 and erythrocyte sedimentation rate (ESR) was 8. The events were reported as serious (permanent disability). Outcome of the events was reported as condition unchanged as of 16 Jan 2014. Causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 294015), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 01 May 2014: Expiry date and batch summary updated.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US043074 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 519743) website on 08 Apr 2014, and with a follow up batch review report (QA reference: 294011) received from quality assurance department on 01 May 2014. This report refers to a 56-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: 13461P) intramuscularly into left arm on 11 Jan 2014. The patient claimed that the Bell's palsy on the right side of his face appeared on the morning for 13 Jan 2014 when he woke up. He assumed that it was from the flu vaccine that he got from the pharmacy. The patient had a visit to emergency room due to this event. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. Outcome and causality of the event were not reported. Based on the document review, it was stated that the concerned FLUVIRIN batch number 13461P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up batch review report (QA reference: 294011) received from quality assurance department on 01 May 2014. Updated batch review report.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, HPV4
Symptoms: Injection site reaction, Rash macular
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 years old male patient. No pertinent medical history and drug reactions/allergies were reported. On 14-JAN-2014, the patient was vaccinated with GARDASIL lot # H021608, expiry date 13-AUG-2015, 0.5 ml, intramuscularly, for prevention HPV. Other suspect therapy was included MENACTRA, administered same day (14-JAN-2014), subcutaneously on same arm. On 16-JAN-2014, the patient developed swelling and blotches on the arm after receiving GARDASIL. Patient did not seek medical attention. BENADRYL was given as treatment for adverse events. No lab diagnostics studies were performed. Action taken with respect to GARDASIL and MENACTRA was not applicable. No product quality complaint was involved. The outcome of events was unknown. Causality was not provided. No further information was provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, HPV4
Symptoms: Local swelling, Rash macular
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 years old male patient. No pertinent medical history and drug reactions/allergies were reported. On 14-JAN-2014, the patient was vaccinated with GARDASIL lot # H021608, expiry date 13-AUG-2015, 0.5 ml, intramuscularly, for prevention HPV. Other suspect therapy was included MENACTRA, administered same day (14-JAN-2014), subcutaneously on same arm. On 16-JAN-2014, the patient developed swelling and blotches on the arm after receiving GARDASIL. Patient did not seek medical attention. BENADRYL was given as treatment for adverse events. No lab diagnostics studies were performed. Action taken with respect to GARDASIL and MENACTRA was not applicable. No product quality complaint was involved. The outcome of events was unknown. Causality was not provided. No further information was provided. Additional information has been requested.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13, DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site abscess, Ultrasound scan
Clinical narrative: On 04/04/2014 the patient came back with a abscess on the sight where he get the shots. Dr. prescribed clindamycin. 04/24/2014 came back clindamycin did not work and the abscess was still there referred to a surgeon. 04/25/2014 there was a cystic lesis 1.5* 1.5cm, referred to surgeon.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13, DTAP, HEPA, HIBV, PNC13
Symptoms: Cyst, Injection site abscess
Clinical narrative: On 04/04/2014 the patient came back with a abscess on the sight where he get the shots. Dr. prescribed clindamycin. 04/24/2014 came back clindamycin did not work and the abscess was still there referred to a surgeon. 04/25/2014 there was a cystic lesis 1.5* 1.5cm, referred to surgeon.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Necrotising colitis, Pneumatosis intestinalis, Portal venous gas, Vomiting projectile
Clinical narrative: Patient developing necrotizing enterocolitis. Admitted 4/3/14 for projectile vomiting, dehydration, partial venous system air (admitted 4/3-5/2014). Readmitted 4/6-20/2014. Dx: NEC.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: Patient developing necrotizing enterocolitis. Admitted 4/3/14 for projectile vomiting, dehydration, partial venous system air (admitted 4/3-5/2014). Readmitted 4/6-20/2014. Dx: NEC.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Hip fracture
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 90 year old male patient. The patient's pertinent medical history included dementia. On 30-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency unknown) (lot number, expiry date was unknown) in the right deltoid. Concomitant therapies included PERCOCET (unspecified medication) for dementia. On 30-APR-2014, the patient fell and broke his hip (hospitalization, life threatening, disability and medically significant) after he received ZOSTAVAX. It was reported that the patient lived at home with his daughter and he was brought to hospital by ambulance. It was reported that the patient would be admitted to the hospital and the doctor was scheduling to do a bi-polar right hip replacement on the patient. The outcome of the event was unknown. Reporter's causality assessment was not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Local swelling, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a approximately 70 year old female patient. On 08-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J011826 dose 1, .65 ml, subcutaneous injection. No concomitant medication was reported. On an unspecified date in 2014 the patient experienced bruising at the injection site (medically significant), swelling from the elbow to the lymph nodes of the patient's neck (medically significant). Physician was contacted to sought medical attention. It was reported that patient was seen by unspecified physician a few days later approximately in 2014 who gave a prednisone injection. The outcome of were reported as resolving. The relatedness between the ZOSTAVAX and event was not reported. Upon internal review the event swelling from the elbow to the lymph nodes of the patient's neck and bruising at the injection site was considered medically significant. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Bursitis, Musculoskeletal pain
Clinical narrative: Subacromial bursitis, shoulder pain on active and passive ROM. No warmth redness or erythema.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: After receiving vaccines, patient was sitting in her chair, slumped over, and passed out. The Rapid Response team was called and patient was lowered to the floor, evaluated by MD, and given oxygen 2 liters per nasal cannula. Symptoms resolved and patient was alert and oriented within 2 minutes.
Age: 17.0
Sex: M
Vaccine: HEP, HPV4, IPV, TTOX, VARCEL
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Rash on neck going down right arm vesicules noted. Patient c/o itching. No fever noted by parent or patient.
Age: 23.0
Sex: F
Vaccine: IPV, YF
Symptoms: Hypersensitivity, Palpitations, Pruritus, Swollen tongue
Clinical narrative: Seen at Emergency Room for swelling of tongue, palpitations and pruritis. Diagnosed as allergic reaction.
Sex: U
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Convulsion, Otitis media, Pyrexia
Clinical narrative: Initial case retrieved via a search of the scientific literature on 24 April 2014. ABSTRACT OBJECTIVE: Live vaccines are generally contraindicated in patients with DiGeorge syndrome (DGS), a congenital disorder characterized by cellular immune deficiency. Vaccine utilization and safety in this population are not well described. This study examined vaccination patterns and adverse events following live immunization (AEFLI) in these individuals. METHODS: A multicenter retrospective cohort study was conducted in subjects with DGS confirmed by fluorescence in situ hybridization assay (chromosome 22q11.2 microdeletion). Live vaccine-preventable illnesses, vaccination coverage and timeliness, and AEFLIs in the 56-day window after live vaccination were examined. Bivariate and multivariable analyses assessed the impact of demographics medical history, timing of diagnostic confirmation, and preceding immune function on vaccination patterns and AEFLIs. RESULTS: Of 194 subjects, 77% and 75% received measles-mumps-rubella (MMR) and varicella vaccines, respectively; 58% completed recommended vaccinations by age 19 to 35 months. Adverse events occurred after 14% and 20% of MMR and varicella vaccine doses, respectively. Most events were minor, few were serious, and no deaths were reported in post-live vaccination windows. Although early diagnostic confirmation negatively affected live vaccination coverage and timeliness (P < .001), baseline CD4% did not differ between subjects who did or did not receive live vaccines by 12 to 18 months. Among varicella vaccine recipients, those with a subsequent adverse event had a lower preceding CD4% (24.8% + or - 7.3%) than those without (35.5% + or - 11.7%) (P < .05); no CD4% differences were observed with MMR vaccination. Fourteen unvaccinated subjects experienced live vaccine-preventable illnesses. CONCLUSIONS: Live vaccines were frequently given and generally well tolerated among patients with DGS with mild-to-moderate immunosuppression. A patient (gender and age not reported) with a history of DiGeorge syndrome received the following vaccines on an unspecified date: DTaP vaccine  (manufacturer not reported), HIB vaccine (manufacturer not reported), MMR vaccine (other manufacturer) and Varicella vaccine (Live) (other manufacturer). Five days post-vaccination, the patient experienced seizure and a fever and was seen in the emergency department. Five days later, i.e. 10 days post-vaccination, the patient was seen again in the emergency department with a fever and was diagnosed with otitis media. Outcome was not reported. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash
Clinical narrative: Tingling in feet and scalp followed by rash on back. Started w/in 24 h and continues to now (approximately 2 months). Patient self-treated by doubling acyclovir.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 8 week old patient of unknown gender. On 25-APR-2014 the patient was vaccinated with ROTATEQ lot # H013164, expiry date 01-MAR-2014, dose 1, 2 ml, oral. No adverse events were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site swelling
Clinical narrative: 5 cm diameter swelling surrounding site of injection from MCV4 (R) deltoid area - cold compresses.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Fever, chills, body aches, sore arm, pink bicep, warm to touch, grapefruit size area of redness, injection site sore.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Fever, chills, body aches, sore arm, pink bicep, warm to touch, grapefruit size area of redness, injection site sore.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Product name confusion, Product quality issue, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. On 29-APR-2014 the patient who was vaccinated with a dose of MMR II (strength, dose, route, lot # not reported) additionally received a dose PROQUAD (Merck) (strength, dose, route, lot # not reported) inadvertently instead of dose of VARIVAX (Merck) (strength, dose, route, lot # not reported) due to product confusion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referred to three unspecified patients of unknown ages and genders. On an unknown dates the three patients were vaccinated with VARIVAX (Lot# unspecified), 0.5 ml, subcutaneous (frequency and indication unspecified). The registered nurse reported that three unspecified patients received improperly stored VARIVAX, exposed to -13 C for 10 minutes. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with third dose of GARDASIL, dose (unknown) and route of administration (unknown), for unknown indication, that was exposed to temperatures between 32F and 367F for a cumulative time of 2 hours. No concomitant Medications were reported. The patient, who received the improperly stored dose of GARDASIL had not reported any adverse effects. Action taken with respect to GARDASIL was not applicable. No product quality complaint was involved. The outcome of events was unknown. No additional information was provided. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Biopsy skin, Blood immunoglobulin G decreased, Pain, Papule
Clinical narrative: This spontaneous report as received from a physician refers to a 38 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 16-APR-2014 the patient was vaccinated with the first 0.5ml dose of VARIVAX (lot# unspecified) (subcutaneous, location unspecified) for "by lab patient was susceptible to varicella". Concomitant therapies included ENPRESSE for birth control. The reporter stated that on an unspecified date in April 2014 after the administration of VARIVAX the patient felt achy (described by physician "as a little bit of a prodrome") and on the next day on an unspecified date in April 2014 she had a lesion on her right wrist. On an unspecified date in April 2014 the patient then developed lesions on her left upper chest, stomach and legs which were itchy since an unspecified date. Patient had sought medical attention with a dermatologist on an unspecified date in April after the administration of VARIVAX. Dermatologist described lesions to physician, as papular and not vesicular which could possible be spider bites. Result of IGG (Blood immunoglobulin G) prior to administration of VARIVAX on 14-MAR-2014 was "less than 0.91". Dermatologist obtained a biopsy of one of the lesions on 30-APR-2014. Result of biopsy was not available. Treatment for lesions since an unspecified date was BENADRYL and ADVIL. Physician described patient as recovering and "back to work" since an unspecified date. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to a 38 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 16-APR-2014 the patient was vaccinated with the first 0.5ml dose of VARIVAX (lot# unspecified) (subcutaneous, location unspecified) for "by lab patient was susceptible to varicella". Concomitant therapies included ENPRESSE for birth control. The reporter stated that on an unspecified date in April 2014 after the administration of VARIVAX the patient felt achy (described by physician "as a little bit of a prodrome") and on the next day on an unspecified date in April 2014 she had a lesion on her right wrist. On an unspecified date in April 2014 the patient then developed lesions on her left upper chest, stomach and legs which were itchy since an unspecified date. Patient had sought medical attention with a dermatologist on an unspecified date in April after the administration of VARIVAX. Dermatologist described lesions to physician, as papular and not vesicular which could possible be spider bites. Result of IGG (Blood immunoglobulin G) prior to administration of VARIVAX on 14-MAR-2014 was "less than 0.91". Dermatologist obtained a biopsy of one of the lesions on 30-APR-2014. Result of biopsy was not available. Treatment for lesions since an unspecified date was BENADRYL and ADVIL. Physician described patient as recovering and "back to work" since an unspecified date. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL. No concomitant medication was reported. On an unknown date medication error was reported that patient may have received an expired dose of GARDASIL and no adverse effects reported. She stated that the dose could have been administered up to ten days after expiry. She stated that she is unsure if it was given, and she stated that she had no specific information. The outcome of the medication error was unknown. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner via a field representative refers to a 17 year old male patient. He had no pertinent medical history. On 10-APR-2014, the patient was vaccinated with the first dose of GARDASIL lot # J012212. No co-suspected or concomitant medications were reported. Two to three seconds after the vaccination, the patient fainted. He woke up 20 seconds later, and it took him another 2-3 minutes to become fully functional again. He received no treatment for the event. He afterwards admitted that he had not been eating or drinking anything for a long time before receiving the vaccination. Routine blood work was performed (results were not reported). This was his first dose of GARDASIL, and he will not be received the next two. A causality assessment was not provided. 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 unspecified number of patients of unknown demographics. On an unknown date the patient was vaccinated with MMR II, injection (dose regimen unspecified). No concomitant medication was reported. On an unknown date medication error was reported that MMR II was exposed to 10 C (celsius) for 10 hours, and was administered to unspecified number of patients on unspecified dates. Reporter stated that she does not, nor will she ever have any patient specific information. She stated that she does not want to be contacted at all by our safety department. There was no product quality complaint involved. The outcome of the medication error is unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an office manager via field representative refers to an approximately 12 months old female patient. Pertinent medical history was reported as none. On 23-APR-2014, the patient was vaccinated with VARIVAX, lot # J009167, 1 single shot, subcutaneously for the prevention of varicella. Other suspect therapies included PREVNAR received on 23-APR-2014 and ACTHIB received on 23-APR-2014. On approximately 01-MAY-2014 (also reported as eight days after administration of VARIVAX), the patient was diagnosed with herpes zoster. Patient sought medical attention and visited the physician. Action taken with respect to VARIVAX, PRENAR, ACTHIB was not applicable. No product quality complaint was involved. The outcome of herpes zoster was unknown. Causality was not provided. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple 1 to 4 year old patients. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. Multiple unidentified patients received (Oka/Merck) VARIVAX doses (0.5 ml, intramuscular) (unspecified in series) between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects reported. The lots affected include "private stock and VFC stock" with lots and expiration dates: private: Lot J006695 expiry 30-MAY-2015 and Lot J012210 expiry 28-SEP-2015. No outcome reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper thigh red warm slight swelling. No fever this AM.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to one patient of unknown age and gender. Patient's medical history was not reported. On an unspecified date in December 2013 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, anatomical location, lot#, expiration date not provided). VARIVAX (Oka/Merck) was exposed to 10.5 Fahrenheit (F) since October 2013. No adverse symptoms reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Neuritis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. The physician reported an adverse event involving ZOSTAVAX. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced post injection neuritis. The outcome of the event was unknown. The relatedness between the ZOSTAVAX and the event was not reported. The physician stated the patient let his friends know that he developed these problems and was discouraging others from receiving ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 76 year old patient. The patient's gender was not reported. No information regarding the patient's medical history was provided. On 01-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, 0.5 ml once, lot # J004156, subcutaneously. It was reported that the patient inadvertently received a dose of VARIVAX instead of ZOSTAVAX. No adverse effects were reported. No outcome was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash on chest and back; Treatment cool compress and topical nystatin.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Culture wound, Induration, Injection site erosion, Injection site vesicles, Pruritus
Clinical narrative: Administered vaccine on 4/21/14. Pt reported tenderness, itching and hardened area. On 5/4 pt stated she developed blisters which opened into a 3 cm x 2.4 cm erosion (R) deltoid.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Tenderness
Clinical narrative: Administered vaccine on 4/21/14. Pt reported tenderness, itching and hardened area. On 5/4 pt stated she developed blisters which opened into a 3 cm x 2.4 cm erosion (R) deltoid.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a county health nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients may had been vaccinated with improperly stored GARDASIL (dose, route, lot numbers and expiration dates were not provided). Excursions began on 08-JAN-2014. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a county health nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On unknown dates, the patients may had been vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, lot numbers and expiration dates were not provided). Excursions occurred on 17-JAN-2014 and 18-JAN-2014; 04-MAR-2014 through 08-MAR-2014. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a county health nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients may had been vaccinated with improperly stored PEDVAX HIB (dose, route, lot numbers and expiration dates were not provided), Excursions began on 08-JAN-2014. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. The patient historical drug included unspecified PNEUMOVAX 23. On 2-APR-2014, the patient was vaccinated with expired PNEUMOVAX 23 lot # H018380 (Expiry: 12-MAR-2014), 0.5 ml, intramuscular. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Carotid artery stenosis, Cerebral infarction, Cerebrovascular accident, Computerised tomogram head abnormal, Headache
Clinical narrative: 11/26/12: treated with MEDROL DOSEPAK for asthma; by 02/11/13 on ADVAIR, but consulting neurologist recorded she was also using methylprednisolone as of 02/13/13. 02/11/13: Received ZOSTAVAX vaccination (apparently in setting of methylprednisolone use). 02/13/13: Headache that afternoon, followed by right hemiparesis from left hemispheric CVA Question possible VZV vasculitis after ZOSTAVAX as precipitant on background atherosclerosis? See PMR case. Also, case reports on retinal necrosis post VZV vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hemiparesis, Ultrasound Doppler abnormal
Clinical narrative: 11/26/12: treated with MEDROL DOSEPAK for asthma; by 02/11/13 on ADVAIR, but consulting neurologist recorded she was also using methylprednisolone as of 02/13/13. 02/11/13: Received ZOSTAVAX vaccination (apparently in setting of methylprednisolone use). 02/13/13: Headache that afternoon, followed by right hemiparesis from left hemispheric CVA Question possible VZV vasculitis after ZOSTAVAX as precipitant on background atherosclerosis? See PMR case. Also, case reports on retinal necrosis post VZV vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Pruritic indurated and redness at vaccine site 24 and 48 hours later.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Injected limb mobility decreased, Local swelling, Rash
Clinical narrative: Red/swelling of arm, underneath armpit to rt breast also rash. Rt arm sore hardly able to move arm for 2 days. She also felt "foggy" in the head. Treatment - alternating heat and ice taking BENADRYL - MOTRIN.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Flushing, Rash macular, Swollen tongue
Clinical narrative: Flushed, swollen tongue, red blotchy skin within 60 seconds of receiving vaccine. Administered Epi pen right thigh. EMS was called. EMS checked patient. Patient signed EMS declination for further observation.
Age: 0.14
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blood culture, Blood test normal, Breath holding, Culture urine, Differential white blood cell count
Clinical narrative: One hour after vaccines began with fussiness. By two hours inconsolable, breath holding, spitting up. Seen at hospital - noted tachycardia and fever. Evaluation with blood work completed (WNL). Symptomatic care provided.
Age: 0.14
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Emotional distress, Full blood count, Infantile spitting up, Irritability, Pyrexia
Clinical narrative: One hour after vaccines began with fussiness. By two hours inconsolable, breath holding, spitting up. Seen at hospital - noted tachycardia and fever. Evaluation with blood work completed (WNL). Symptomatic care provided.
Age: 0.14
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Tachycardia, Urine analysis
Clinical narrative: One hour after vaccines began with fussiness. By two hours inconsolable, breath holding, spitting up. Seen at hospital - noted tachycardia and fever. Evaluation with blood work completed (WNL). Symptomatic care provided.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Oedema, Pain in extremity, Pyrexia
Clinical narrative: Patient was vaccinated at 2:00 pm on Friday (04/09/14). This night she experienced pain at her left arm. On Saturday she presented pain, edema, fever and erythema on her left arm. She decided to go to emergency department and Dr. diagnosed her with cellulitis on Monday. Medication list: Levaquin 750 mg (1 tab x 7 days) and Sulmdec 200mg (1 tab every 12 hours).
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Agitation, Anaemia, Anaphylactic reaction, Angina pectoris, Angioedema
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Arthralgia, Blood creatinine increased, Blood urea increased, Bradycardia, Cerebrovascular accident
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Confusional state, Constipation, Convulsion, Cough, Death
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Depression, Diarrhoea, Dizziness, Erythema multiforme, Gastric haemorrhage
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Haemorrhage, Haemorrhage intracranial, Hallucination, Headache, Hepatic enzyme increased
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Hyperglycaemia, Hypertension, Hypoglycaemia, Hypotension, International normalised ratio abnormal
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.