chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of an unknown gender and age. Medical history and current conditions were not reported. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (dose, dose number and route were not reported)with lot numbers reported as J013066 expiration date 16-OCT-2015, J013068 expiration date 16-OCT-2015, K007785 expiration date 28-MAY2016, and K005182 expiration date 10-APR-2016, that were improperly stored. No adverse effects were reported. Additional information has been requested. This is one (1) of two (2) reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with expired dose of VARIVAX (Merck) (lot # H020671, exp. date: 14-NOV-2014) (dose, strength not reported). The reporter did not report any adverse experiences. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received ENGERIX B (batch number unknown, expiry date 24th January 2015). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Pharmacist was not sure but she thinks that an expired dose of the vaccine was administered. She did not have any patient information. The only information she has was the expiry date: 1/24/15.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. On an unknown date at unspecified number of patients received the doses of VARIVAX (Merck) (dose, route, anatomical location, lot#, expiration date were not reported) that underwent a supported temperature excursion. No adverse experiences were reported. Concomitant therapies were not reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. The reporter stated that he personally knew people who have had side effects after they were vaccinated with M-M-R II (dose, route, lot number and expiation date were not provided). The caller also reported that an unspecified physician told him that some patients had developed measles after receiving M-M-R II (dose, route, lot number and expiration date were not provided). The reporter did not gave any concrete information about patients, side effects or dates of vaccinations or onset dates of events. Additional information is not expected, as there is no contact information to follow up.
Age: 1.14
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient was given KINRIX on accident. Patient was supposed to get DTaP and Hib instead.
Sex: U
Vaccine: MMR
Symptoms: Abnormal behaviour
Clinical narrative: This spontaneous report as received from a Registered Nurse, refers to patient of unknown age and gender. Medical history and concurrent conditions were not reported. The reporting nurse stated that a celebrity noted a "change" in her child after her child was vaccinated with a dose of M-M-R II (dose, route, lot number and expiration date were not provided). No concomitant medication was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 62 year old male patient. On an unknown date, the patient inadvertently received a dose of pediatric RECOMBIVAX HB 2.5 mcg/0.5 ml (lot #, batch #, dose and route of administration were not provided) as his first dose of the series. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-JAN-2015 an expired ZOSTAVAX (lot # J005849, expiration date 17-AUG-2014, dose and frequency not reported) was administered to patient. Potency supported. No adverse effects reported. No additional information provided. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified patients of unknown age and unknown gender. The nurse reported that frequency unspecified patients returned to the office to complete GARDASIL (dose, frequency, route and lot # were not reported) series on alternate dose schedule. Nurse stated sometimes the second dose of GARDASIL was given to unspecified patients on the fifth month after the first dose of GARDASIL. No adverse effects were reported. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: This case was reported by a physician and described the occurrence of vaccine underdose in a adult patient who received ENGERIX B pediatric. On an unknown date, the patient received ENGERIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information received: HCP reported ENGERIX vaccine for pediatrics was given to adults. It is unknown at this time how many adults received the pediatric dose and on what day. Patient information is also unknown at this point.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a 59 year old female patient. Patient's concurrent conditions included high cholesterol, hyperthyroidism, asthma, depression, diabetes and gastrooesophageal reflux disease (GERD). Patient's medical history included following drug reactions: stomach upset after taking LEVAQUIN, sulfa and ampicillin; hyperactivity after SUDAFED; face swelling after dextromethorphan and MUCINEX; fever and unspecified severe local reaction after tetanus toxoid and unspecified reaction after taking lidocaine and iodine. On 19-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX via the intramuscular route in error (dose: 0.65 ml, lot # K011002, expiration date: 07-NOV-2015) in the left arm. Concomitant therapies included aspirin, EXCEDRIN MIGRAINE, simvastatin (manufacturer unknown), SINGULAIR, ranitidine, metformin, fluticasone propionate, levothyroxine sodium (manufacturer unknown), vitamin DC, budesonide, ipratropium bromide (manufacturer unknown), WELLBUTRIN, benzonatate, bupropion hydrochloride and ADVIL. The patient also used One Touch Ultra Test Strips, as directed, daily. On 20-JAN-2015, the patient experienced red, swollen, painful rash on the left upper arm (the same arm, where ZOSTAVAX had been injected). The patient sought medical attention-called the healthcare worker. BENADRYL was recommended by the healthcare worker, but was not started yet. The patient recovered on 24-JAN-2015. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain in jaw
Clinical narrative: This spontaneous report was received from a consumer refers to a 60 year old male patient concerning himself. The patient did not have any medical history and drug reactions/allergies or concurrent conditions. Approximately 15-JAN, about a week and half ago, the patient was vaccinated with ZOSTAVAX "one single shot" (dose number, lot# and expiration date were not reported). On an unspecified date in January 2015, the patient developed nasopharyngitis and jaw pain. The outcome of developed nasopharyngitis and jaw pain was reported as not recovered/not resolved. The patient received treatment with ibuprofen (dose, frequency unknown). Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Information was received on 11 August 2014 from a consumer who is the patient. A 21 year old male patient had received the following vaccine on 01 August 2014: ACAM2000, (lot number, route and site not reported). On 10 August 2014, the patient experienced a rash with multiple blisters, 3 inches around the injection site. The patient had the vaccine administered on 11 August 2014. He did not have his own healthcare provider and was going to go to the nearest hospital emergency room for evaluation and treatment as needed. The patient's medical history and concomitant medications were not reported. Laboratory tests were not reported. The patient outcome was unknown. Documents held by sender: None.
Sex: U
Vaccine: SMALL
Symptoms: Rash, Rash pustular, Vaccination complication
Clinical narrative: Initial report was received on 20 December 2013 from another manufacturer national service center (service request number 1-962816342), who received the report from a health care professional. A patient had received a Smallpox vaccine (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a rash with pustules. According to the reporter, he believed that it was not an allergic reaction, but a reaction to the vaccine itself. No further information was provided. The patient's outcome was not reported. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Bacterial test, Biopsy skin, Fatigue, Headache, Hypersensitivity
Clinical narrative: Initial report received via a search of the scientific literature on 11 March 2014. The literature article provides information for two patients who experienced similar events after receiving smallpox vaccine. This case pertains to one of the two patients; information for the other patient is captured in case number 2014SA033350. Abstract: "Post-vaccinial non-viral folliculitis has been recognized in the past decade as a new adverse cutaneous reaction to smallpox vaccination. Contrary to more serious smallpox vaccine reactions, post-vaccinial non-viral folliculitis has a benign course and resolves spontaneously within approximately 7 days. We describe additional histopathologic findings associated with post-vaccinial non-viral folliculitis, which has only been described once previously. New findings include the presence of a neutrophilic or lymphohistiocytic infiltrate that is concentrated around the hair follicles. We compare our findings to the follicular nature of varicella and herpes zoster infections, generating the hypothesis of deposition of vaccinia protein within folliculosebaceous units as a potential pathophysiologic mechanism behind post-vaccinial non-viral folliculitis." A 21-year-old male, with a remote childhood history of eczema, received a left arm injection of ACAM2000 (lot number and date of vaccination not reported). Eleven days post-vaccination he presented to dermatology clinic with complaints of a rash, fatigue, malaise, flu-like symptoms, headache (treated with acetaminophen), pain at injection site, and left axilla lymphadenopathy. The rash was described as approximately 50 3-4mm pink papules on an erythematous base across the chest and upper back, some with a central pinpoint white pustule. Bacterial culture of the pustules was sterile. Skin biopsy of a papule revealed the following: a neutrophilic infiltrate within and surrounding a hair follicle with rupture of the follicular epithelium. Scattered lymphocytes were present adjacent to the follicle in the superficial dermis, the majority labeled with CD3; CD4, CD8, and TIA-1 were also noted to be present. No fungal organisms were seen, and viral cytopathic changes were not seen. The patient was determined to have post-vaccinial non-viral folliculitis. According to the authors, the event was possibly "a pustular hypersensitivity reaction". Outcome was not reported. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Influenza like illness, Injection site pain, Lymphadenopathy, Malaise, Papule
Clinical narrative: Initial report received via a search of the scientific literature on 11 March 2014. The literature article provides information for two patients who experienced similar events after receiving smallpox vaccine. This case pertains to one of the two patients; information for the other patient is captured in case number 2014SA033350. Abstract: "Post-vaccinial non-viral folliculitis has been recognized in the past decade as a new adverse cutaneous reaction to smallpox vaccination. Contrary to more serious smallpox vaccine reactions, post-vaccinial non-viral folliculitis has a benign course and resolves spontaneously within approximately 7 days. We describe additional histopathologic findings associated with post-vaccinial non-viral folliculitis, which has only been described once previously. New findings include the presence of a neutrophilic or lymphohistiocytic infiltrate that is concentrated around the hair follicles. We compare our findings to the follicular nature of varicella and herpes zoster infections, generating the hypothesis of deposition of vaccinia protein within folliculosebaceous units as a potential pathophysiologic mechanism behind post-vaccinial non-viral folliculitis." A 21-year-old male, with a remote childhood history of eczema, received a left arm injection of ACAM2000 (lot number and date of vaccination not reported). Eleven days post-vaccination he presented to dermatology clinic with complaints of a rash, fatigue, malaise, flu-like symptoms, headache (treated with acetaminophen), pain at injection site, and left axilla lymphadenopathy. The rash was described as approximately 50 3-4mm pink papules on an erythematous base across the chest and upper back, some with a central pinpoint white pustule. Bacterial culture of the pustules was sterile. Skin biopsy of a papule revealed the following: a neutrophilic infiltrate within and surrounding a hair follicle with rupture of the follicular epithelium. Scattered lymphocytes were present adjacent to the follicle in the superficial dermis, the majority labeled with CD3; CD4, CD8, and TIA-1 were also noted to be present. No fungal organisms were seen, and viral cytopathic changes were not seen. The patient was determined to have post-vaccinial non-viral folliculitis. According to the authors, the event was possibly "a pustular hypersensitivity reaction". Outcome was not reported. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash erythematous, Rash pustular
Clinical narrative: Initial report received via a search of the scientific literature on 11 March 2014. The literature article provides information for two patients who experienced similar events after receiving smallpox vaccine. This case pertains to one of the two patients; information for the other patient is captured in case number 2014SA033350. Abstract: "Post-vaccinial non-viral folliculitis has been recognized in the past decade as a new adverse cutaneous reaction to smallpox vaccination. Contrary to more serious smallpox vaccine reactions, post-vaccinial non-viral folliculitis has a benign course and resolves spontaneously within approximately 7 days. We describe additional histopathologic findings associated with post-vaccinial non-viral folliculitis, which has only been described once previously. New findings include the presence of a neutrophilic or lymphohistiocytic infiltrate that is concentrated around the hair follicles. We compare our findings to the follicular nature of varicella and herpes zoster infections, generating the hypothesis of deposition of vaccinia protein within folliculosebaceous units as a potential pathophysiologic mechanism behind post-vaccinial non-viral folliculitis." A 21-year-old male, with a remote childhood history of eczema, received a left arm injection of ACAM2000 (lot number and date of vaccination not reported). Eleven days post-vaccination he presented to dermatology clinic with complaints of a rash, fatigue, malaise, flu-like symptoms, headache (treated with acetaminophen), pain at injection site, and left axilla lymphadenopathy. The rash was described as approximately 50 3-4mm pink papules on an erythematous base across the chest and upper back, some with a central pinpoint white pustule. Bacterial culture of the pustules was sterile. Skin biopsy of a papule revealed the following: a neutrophilic infiltrate within and surrounding a hair follicle with rupture of the follicular epithelium. Scattered lymphocytes were present adjacent to the follicle in the superficial dermis, the majority labeled with CD3; CD4, CD8, and TIA-1 were also noted to be present. No fungal organisms were seen, and viral cytopathic changes were not seen. The patient was determined to have post-vaccinial non-viral folliculitis. According to the authors, the event was possibly "a pustular hypersensitivity reaction". Outcome was not reported. Documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Biopsy skin abnormal, Folliculitis, Papule, Pruritus, Rash papular
Clinical narrative: Initial report received via a search of the scientific literature on 11 March 2014. The literature article provides information for two patients who experienced similar events after receiving smallpox vaccine. This case pertains to one of the two patients; information for the other patient is captured in case number 2014SA033333. Abstract: "Post-vaccinial non-viral folliculitis has been recognized in the past decade as a new adverse cutaneous reaction to smallpox vaccination. Contrary to more serious smallpox vaccine reactions, post-vaccinial non-viral folliculitis has a benign course and resolves spontaneously within approximately 7 days. We describe additional histopathologic findings associated with post-vaccinial non-viral folliculitis, which has only been described once previously. New findings include the presence of a neutrophilic or lymphohistiocytic infiltrate that is concentrated around the hair follicles. We compare our findings to the follicular nature of varicella and herpes zoster infections, generating the hypothesis of deposition of vaccinia protein within folliculosebaceous units as a potential pathophysiologic mechanism behind post-vaccinial non-viral folliculitis." A previously healthy 43-year-old male received a left arm injection of ACAM2000 (lot number and date of vaccination not reported). Seven days post-vaccination he noted the appearance of pruritic lesions. Ten days post-vaccination he presented to the local emergency room, where he was noted to have over one hundred pink papules and papulovesicles on the trunk and upper extremities. Skin biopsy of a papulovesicle revealed the following: a mixed inflammatory infiltrate with abundant lymphocytes and histiocytes in a perifollicular distribution, with exocytosis of lymphocytes into the follicular epithelium with follicular spongiosis. No fungal organisms, follicular mucin, or vial cytopathic changes were seen. Immunohistochemical stains showed a predominance of CD3-positive cells, with CD4, CD8, and scattered CD68-positive cells. The patient was determined to have post-vaccinal non-viral folliculitis. According to the authors, the event was possibly as "classic lymphocytic hypersensitivity reaction". Outcome was not reported. Follow-up information received on 20 June 2014: The patient's outcome is recovered. Documents held by sender: None.
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion
Clinical narrative: Initial report received via a search of the scientific literature on 11 March 2014. The literature article provides information for two patients who experienced similar events after receiving smallpox vaccine. This case pertains to one of the two patients; information for the other patient is captured in case number 2014SA033333. Abstract: "Post-vaccinial non-viral folliculitis has been recognized in the past decade as a new adverse cutaneous reaction to smallpox vaccination. Contrary to more serious smallpox vaccine reactions, post-vaccinial non-viral folliculitis has a benign course and resolves spontaneously within approximately 7 days. We describe additional histopathologic findings associated with post-vaccinial non-viral folliculitis, which has only been described once previously. New findings include the presence of a neutrophilic or lymphohistiocytic infiltrate that is concentrated around the hair follicles. We compare our findings to the follicular nature of varicella and herpes zoster infections, generating the hypothesis of deposition of vaccinia protein within folliculosebaceous units as a potential pathophysiologic mechanism behind post-vaccinial non-viral folliculitis." A previously healthy 43-year-old male received a left arm injection of ACAM2000 (lot number and date of vaccination not reported). Seven days post-vaccination he noted the appearance of pruritic lesions. Ten days post-vaccination he presented to the local emergency room, where he was noted to have over one hundred pink papules and papulovesicles on the trunk and upper extremities. Skin biopsy of a papulovesicle revealed the following: a mixed inflammatory infiltrate with abundant lymphocytes and histiocytes in a perifollicular distribution, with exocytosis of lymphocytes into the follicular epithelium with follicular spongiosis. No fungal organisms, follicular mucin, or vial cytopathic changes were seen. Immunohistochemical stains showed a predominance of CD3-positive cells, with CD4, CD8, and scattered CD68-positive cells. The patient was determined to have post-vaccinal non-viral folliculitis. According to the authors, the event was possibly as "classic lymphocytic hypersensitivity reaction". Outcome was not reported. Follow-up information received on 20 June 2014: The patient's outcome is recovered. Documents held by sender: None.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Asthenia, Hormone level abnormal, Infertility female, Menorrhagia
Clinical narrative: This spontaneous report was received from a licensed practical nurse who was reporting regarding her 25 year old daughter. Patient's concurrent conditions included drug reactions/allergies to amoxicillin and penicillin. The patient's medical history included hypothyroidism. On an unknown date (reported as in 2005 or 2006) the patient was vaccinated with GARDASIL (lot number, dose and frequency unspecified) (all three shots of the series according to the normal dosing schedule) (route: injection) for routine vaccination. Concomitant medications were not reported. The reporter stated that the patient began experiencing adverse effects (adverse event) right away after receiving GARDASIL when the patient was 14 or 15 years of age in 2005 or 2006. On unspecified dates, the patient experienced hormones which were out of balance, menstrual cycle irregularities, fainting at school, having no cramps but instead huge blood clots during menstrual bleeding, hemorrhagic, losing so much blood during menstrual bleeding, anemia, low energy level, and suspected sterility. The patient also has psychological side effects because of the adverse effects and the possible sterility. The reporter stated that the patient always dreamt of having children and cries as she now may not be able to. The side effects appear to be severe and long term. The patient's first sexual intercourse was at age 21. The patient experienced various different unspecified side effects which had onsets in the years following vaccination including at age 15, 16, 17, 18, and 19 years. The patient switched physicians from the time of having received GARDASIL. The patient had the same unspecified physician from birth through the time of having been recommended GARDASIL and receiving GARDASIL. The patient has to have unspecified long-term medical treatments for complex adverse effect issues. The patient has undergone many unspecified lab tests of which none were reported. The patient sought medical attention by visiting many physicians. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Mental disorder, Syncope
Clinical narrative: This spontaneous report was received from a licensed practical nurse who was reporting regarding her 25 year old daughter. Patient's concurrent conditions included drug reactions/allergies to amoxicillin and penicillin. The patient's medical history included hypothyroidism. On an unknown date (reported as in 2005 or 2006) the patient was vaccinated with GARDASIL (lot number, dose and frequency unspecified) (all three shots of the series according to the normal dosing schedule) (route: injection) for routine vaccination. Concomitant medications were not reported. The reporter stated that the patient began experiencing adverse effects (adverse event) right away after receiving GARDASIL when the patient was 14 or 15 years of age in 2005 or 2006. On unspecified dates, the patient experienced hormones which were out of balance, menstrual cycle irregularities, fainting at school, having no cramps but instead huge blood clots during menstrual bleeding, hemorrhagic, losing so much blood during menstrual bleeding, anemia, low energy level, and suspected sterility. The patient also has psychological side effects because of the adverse effects and the possible sterility. The reporter stated that the patient always dreamt of having children and cries as she now may not be able to. The side effects appear to be severe and long term. The patient's first sexual intercourse was at age 21. The patient experienced various different unspecified side effects which had onsets in the years following vaccination including at age 15, 16, 17, 18, and 19 years. The patient switched physicians from the time of having received GARDASIL. The patient had the same unspecified physician from birth through the time of having been recommended GARDASIL and receiving GARDASIL. The patient has to have unspecified long-term medical treatments for complex adverse effect issues. The patient has undergone many unspecified lab tests of which none were reported. The patient sought medical attention by visiting many physicians. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a Registered Nurse, refers to an unspecified number of patients of unknown age and gender. Medical histories and concurrent conditions were not reported. The reporting nurse stated that she was informed by some of her friends and colleagues, that an unspecified number of their children developed beginning signs of autism (some of them noted differences with eye contact and smiling with their children), on unknown dates after receiving M-M-R II (dose, route, lot numbers and expiration dates were not provided). No concomitant medications were reported. The reporter stated that some of her friends and colleagues decided not to continue with a second dose of M-M-R II, and that some of those parents noticed that their children "snapped right back". This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Influenza virus test negative, Meningitis, Posturing, Pyrexia, Streptococcus test negative
Clinical narrative: Patient sent to ED 2/4/2015 for evaluation of fever of unknown origin with abnormal posturing involving back and neck, concern for meningitis, adverse reaction to vaccine. Fever max 104F 2/3/15.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Patient sent to ED 2/4/2015 for evaluation of fever of unknown origin with abnormal posturing involving back and neck, concern for meningitis, adverse reaction to vaccine. Fever max 104F 2/3/15.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Pt was given an immunization of ZOSTAVAX, at 4:30 pm on 2/2/15. Pt reported feeling dizziness/nausea, patient put head down and took deep breaths, dizziness/nausea subsides after approx 15 min. Pt given some water and orange juice (pt. request).
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. On 12-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose 1, 0.65 ml, subcutaneous, lot # not provided). On 14-JAN-2015, the patient inadvertently received second dose of ZOSTAVAX (dose, route and lot # not provided) (extra dose administered). No adverse effects reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: On 1-13-15 around 6pm left arm at injection site became sore, red and hot about size of 50 cent piece. The next day size got 3x larger, fever was at 99.3. This lasted one week. Today 1-27-15 site has a faint red color - no other symptoms.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection-(L) deltoid and down upper arm to elbow-left. Treatment supportive.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Back of patient's arm is red and hot to the touch and swollen. There is a large red area that is 10 inches long by 6 inches wide with a smaller dark red circle in the middle that is 4 inches long and 3 inches wide.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, warmth, swelling at injection site that spread to below elbow. Treated with ice. Felt to have developed into cellulitis. Started on KEFLEX 2/3/15.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Redness, pain, warmth, swelling at injection site that spread to below elbow. Treated with ice. Felt to have developed into cellulitis. Started on KEFLEX 2/3/15.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Discomfort, Headache, Tremor
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to a 15 year old female patient of unspecified ethnicity (nurse niece). On 19-JAN-2015, the patient was vaccinated with her first dose of GARDASIL (lot #, batch #, expiration date, dose, route of administration and indication were not provided) in the pediatrician's office. In the evening of 19-JAN-2015, the patient experienced shakiness, headaches and "uncomfortable reaction". The patient sought medical attention. The pediatrician was contacted on the following day, 20-JAN-2015. No treatment was given to the patient, however, the pediatrician stated that the patient should not receive any further doses of GARDASIL in the future. Action taken with GARDASIL was not reported. The outcome of the events was not reported. Relatedness between GARDASIL and the events was not provided. Additional information is not expected. It was reported that the physician could not be contacted.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Feeling hot
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to a 15 year old female patient of unspecified ethnicity (nurse niece). On 19-JAN-2015, the patient was vaccinated with her first dose of GARDASIL (lot #, batch #, expiration date, dose, route of administration and indication were not provided) in the pediatrician's office. In the evening of 19-JAN-2015, the patient experienced shakiness, headaches and "uncomfortable reaction". The patient sought medical attention. The pediatrician was contacted on the following day, 20-JAN-2015. No treatment was given to the patient, however, the pediatrician stated that the patient should not receive any further doses of GARDASIL in the future. Action taken with GARDASIL was not reported. The outcome of the events was not reported. Relatedness between GARDASIL and the events was not provided. Additional information is not expected. It was reported that the physician could not be contacted.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry throat, Injection site erythema, Injection site pruritus, Injection site swelling, Sensation of foreign body
Clinical narrative: Patient felt a slight dryness in back of throat after a few moments admin and as if there was a small pill stuck in throat. Also felt some itching sensation at injection site. Upon examining site, some slight redness and swelling was present. Patient drank some H2O and said felt same or slightly better and itching was minimal. Upon questioning, patient had no other sx such as SOB, lightheaded dizzy etc. Called MD said go to ER, patient refused, took BENADRYL and went home. Called 2 hrs later and said was fine.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Chest X-ray normal, Culture throat, Influenza A virus test negative, Influenza virus test negative, Pyrexia
Clinical narrative: On 2/3/15 at 6:00 AM patient seen in ER reporting fever 104.9 degrees after receiving vaccines 12 hours prior and vomited ibuprofen. ER dept recorded 99.9 degree temp rectally. Child was discharged with TYLENOL and ZOFRAN.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: On 2/3/15 at 6:00 AM patient seen in ER reporting fever 104.9 degrees after receiving vaccines 12 hours prior and vomited ibuprofen. ER dept recorded 99.9 degree temp rectally. Child was discharged with TYLENOL and ZOFRAN.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to incorrect product storage due to on 02-FEB-2015 unknown number of patients of unknown ages and genders were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, lot #, expiration dates and route were not reported). No adverse effects reported. This one of several reports from the same source. Additional information is not expected because we cannot contact the physician.
Age: 83.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Unevaluable event
Clinical narrative: See attached sheet.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Site of immunization swelling and pain, diffuse myalgias.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Electromyogram, Hypoaesthesia, Injected limb mobility decreased, Laboratory test
Clinical narrative: Approx 2 days after immunization pt experienced (R) arm pain, numbness, decreased movt/strength. Seen for this 1/7 - worsened symptoms so then admitted x 2-3 days to medical center. Followed by neurology there, EMG and other testing done, given splint, receiving occupat therapy needs f/u with neurology.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Neurological examination, Pain in extremity, Splint application
Clinical narrative: Approx 2 days after immunization pt experienced (R) arm pain, numbness, decreased movt/strength. Seen for this 1/7 - worsened symptoms so then admitted x 2-3 days to medical center. Followed by neurology there, EMG and other testing done, given splint, receiving occupat therapy needs f/u with neurology.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 28-year-old female subject was enrolled in a study. The subject received BOOSTRIX (injection) .5 ml on 3rd February 2015. Concurrent medical conditions included hypertension. The subject's last menstrual period was on 26th May 2014 and estimated date of delivery was 21st March 2015. The subject received BOOSTRIX at week 36 of the pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Age: 0.48
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 08 July 2013. A patient (demographical details were not reported) had received an intramuscular dose of ACT-HIB (batch number, dose number and site of administration not reported), and an intramuscular dose of PREVNAR-13 (other manufacturer, batch number, dose number and site of administration were not reported), both on 11 April 2013. The patient had no illness at the time of vaccination and pre-existing physician-diagnosed allergies, birth defects and medical conditions were not reported. The patient's concomitant medications were not reported. On 11 April 2013, i.e. on the same day after vaccination, the patient experienced fever for two days. The patient did not experience any other symptoms. Temperature was 104 (units not reported). No laboratory tests were performed. Corrective treatment details were not reported. On an unspecified date, the patient had recovered. Follow up information received from a healthcare professional on 09 August 2013: A 5-month-old male patient had received second dose of ACTHIB vaccine (lot number- UH769AA) in the right thigh and second dose of PREVNAR (PCV13) vaccine from Wyeth (lot number- F64401) in the left thigh. The patient's pre-existing physician diagnosed drug allergies, birth defects, medical conditions were reported as "NA". On 12 April 2013, 1 day after vaccination, the patient experienced fever of 104 degrees. List of documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MNQ, RV5
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: Initial report received from a healthcare professional on 11 June 2013. A 3-month-19 day-old female patient, had received second dose of ACT HIB (lot number UH767AA), MENACTRA (lot number U4413AC, dose number was not reported), second dose of PEDIARIX from GSK (Lot number AC21B408CA/ AC21B40814) and second dose of ROTATEQ from Merck (lot number H012981) ( route and anatomical site of vaccination was not reported for all vaccines), all on 10 June 2013. Patient had no illness at the time of vaccination. Patient's physician diagnosed allergies, birth defects and medical conditions were unknown. On 10 June 2013, the patient received MENACTRA vaccine in error instead of PREVNAR thus the patient received wrong vaccine. On 10 June 2013, after vaccinations, the patient developed fever. Laboratory investigations were not reported. It was reported that the patient was doing well with fever. The patient received TYLENOL as corrective treatment on unspecified dates. At the time of this report the outcome of event was not reported. Follow-up information received from a healthcare professional on 22 July 2013. The birth weight of the patient was reported as 8 pounds 6 oz. The patient had received all vaccines on 10 June 2013 at 3.15 pm approx. The patient had received ACTHIB intramuscularly in right vastus lateralis, MENACTRA intramuscularly in left Vastus lateralis and PEDIARIX intramuscularly in right Vastus lateralis. ROTATEQ was given orally. No laboratory investigations were performed. On an unspecified date, the patient had recovered from adverse event. List of documents held by sender: none.
Age: 0.34
Sex: F
Vaccine: HIBV
Symptoms: Crying, Dermatitis diaper, Diarrhoea, Erythema, Frequent bowel movements
Clinical narrative: Initial report received from a non-healthcare professional on 7 October 2013. A 4-month-old female patient who had no medical history, illness at the time of vaccination and concomitant medication were not reported, had received a second dose of ACTHIB vaccine (lot number: UH738AA, route and anatomical site of administration were not reported) on 25 September 2013. On 26 September 2013, next day the patient was irritable, fussy, has excessive crying. On 27 September 2013, the patient had increased number of stools which were loose stools. Patient had continued to have loose stools of 7-8 per day and also now has red "diaper rash". Laboratory investigations and corrective medications were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: None.
Age: 0.34
Sex: F
Vaccine: HIBV
Symptoms: Irritability
Clinical narrative: Initial report received from a non-healthcare professional on 7 October 2013. A 4-month-old female patient who had no medical history, illness at the time of vaccination and concomitant medication were not reported, had received a second dose of ACTHIB vaccine (lot number: UH738AA, route and anatomical site of administration were not reported) on 25 September 2013. On 26 September 2013, next day the patient was irritable, fussy, has excessive crying. On 27 September 2013, the patient had increased number of stools which were loose stools. Patient had continued to have loose stools of 7-8 per day and also now has red "diaper rash". Laboratory investigations and corrective medications were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised, Rash pruritic, White blood cell count increased
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database, under reference number 522978. A 22 year-old male patient with no known history had received on 09 January 2014 a dose of ACAM2000 (lot number and site not reported) and 29 days later on 07 February 2014, developed a widespread pruritic rash over chest, abdomen, back, scalp, forehead and then arms and legs sparing the palms and soles. The patient had an emergency visit four days later and was treated with prednisone with improvement. Lab data included WBC 14. Other medication: "Information is limited and listed above. Learned of patient via telemedicine. In the end, the consensus was that the rash was not related to the smallpox vaccine." Current illnesses were none and prior vaccinations were not reported. The patient outcome was unknown. Document held by sender: none.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, HIBV, PNC
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Initial case received from a healthcare professional on 21 October 2013. A 2-month-old male patient with no medical history had received a dose of ACTHIB (batch number: UH857AA, intramuscularly in the right thigh) and PREVNAR (other MFR) (batch number: G63300, intramuscularly in right thigh) on 23 August 2013. On 23 August 2013, 2 hours after vaccination, the patient developed symptoms below the injection site. Swelling, skin discoloration and experienced discomfort. As corrective treatment TYLENOL was administered. No lab investigations were performed. At the time of this report, the patient had recovered. Document held by sender: none.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, HIBV, PNC
Symptoms: Injection site discolouration, Injection site discomfort, Injection site swelling
Clinical narrative: Initial case received from a healthcare professional on 21 October 2013. A 2-month-old male patient with no medical history had received a dose of ACTHIB (batch number: UH857AA, intramuscularly in the right thigh) and PREVNAR (other MFR) (batch number: G63300, intramuscularly in right thigh) on 23 August 2013. On 23 August 2013, 2 hours after vaccination, the patient developed symptoms below the injection site. Swelling, skin discoloration and experienced discomfort. As corrective treatment TYLENOL was administered. No lab investigations were performed. At the time of this report, the patient had recovered. Document held by sender: none.
Age: 0.61
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Crying, Emotional distress, Hypersensitivity, Restlessness, Urticaria
Clinical narrative: Prior to 2/1 my daughter began showing extreme restlessness and an overall discontented state. Prior to this, she rarely cried and was as close to perfect as you can get in a baby. Beginning 2/1 she began breaking out in hives all over her body, non-stop throughout each day since. She cries constantly, is rarely comforted by virtually anything possible to try. Today, 2/4 she was taken to her pediatrician and it was confirmed to be hives due to an allergic reaction and to give her Benadryl during outbreaks (which are, since onset, 24/7) and to make an appointment with an allergist if they persist beyond a week. My daughter has not been introduced to any new foods/fabric cleaners/baby hygiene items. My sweet baby who was so happy all the time has, in the past two weeks been inconsolable, discontent and unhappy. Its breaking my heart and I don't know what to do.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Woke up day after immunization noticed redness around injection site. Area is red, warm to touch, and tender. 24 hours after onset, area of redness has spread.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal distension, Activities of daily living impaired, Blood calcium normal, Blood follicle stimulating hormone normal, Blood glucose fluctuation
Clinical narrative: ITCHY RIGHT AWAY  -Today is 2-5-15. On Jan 17 to now. Dry painful eyes, severe stiffness in back and stomach and bloat. Shoulder pain, muscle tremors and muscle spasms in legs move to arms stomach back and neck. My BP up and down as well as sugar -BP low as 100/50. Always cold but low temp. No blood work has been conclusive of what is the issue. I have never had these issues -I work out every day. This has halted me to a stop for 2 weeks. My muscle hurt so bad in groin legs and back stomach when even attempting one hour of cardio and no weights.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Blood oestrogen normal, Blood pressure fluctuation, Blood thyroid stimulating hormone normal, Borrelia test negative, Dry eye
Clinical narrative: ITCHY RIGHT AWAY  -Today is 2-5-15. On Jan 17 to now. Dry painful eyes, severe stiffness in back and stomach and bloat. Shoulder pain, muscle tremors and muscle spasms in legs move to arms stomach back and neck. My BP up and down as well as sugar -BP low as 100/50. Always cold but low temp. No blood work has been conclusive of what is the issue. I have never had these issues -I work out every day. This has halted me to a stop for 2 weeks. My muscle hurt so bad in groin legs and back stomach when even attempting one hour of cardio and no weights.