chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
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. No concurrent conditions or medical history were provided. On 09-JUL-2014, the patient was vaccinated with an expired dose of ROTATEQ oral fluid, 2 ml orally (lot# J003464, expiry dose: 08-JUL-2014; indication unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The medical assistant reported that hose patients were administered with a doses of VAQTA that had been improperly stored (doses, routes of administration, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2014. no concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additonal information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, and diarrhea. Flu-like symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pustular, Secondary transmission
Clinical narrative: This spontaneous report was received from a nurse referring to herself as approximately 60 year old female patient No pertinent medical history and concurrent conditions reported. On 16-JUN-2014 the patient's husband was vaccinated with ZOSTAVAX, subcutaneous (dose not reported). No other concomitant therapies reported. The reporter suspects that she has contracted shingles from her husband. On 07-JUL-2014 the reporter developed pustules which spread to her forehead, her ear, her thigh and currently she is beginning to developed pustules on trunk region. The patient had secondary transmission. The patient did not sought medical attention. The patient also stated that her husband did not develop rash nor he experienced any adverse effects after receiving ZOSTAVAX. The outcome of the events was unknown. The causality of the events was unspecified. No PQC reported. The reporter accepted VZVIP to be faxed to her physician. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assisted refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The medical assistant reported that those patients were administered with a dose of GARDASIL that had been improperly stored (doses, route of administration, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2013. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 years old patient of unknown gender. On 10-JUL-2014 the patient was vaccinated with (Oka-Merck) PROQUAD (second dose in series, 0.5 ml once, subcutaneously, lot# K004713, expiry date: 02-OCT-2015) which was exposed to 1.5C for 1 hour, 15 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Pallor, Thirst
Clinical narrative: Received Gardasil LD and Hep A RD.  Walked out to waiting room where mother was waiting and sat in chair.  Approx 3 mins after vaccine was given pt turned pale and passed out for approx 3 secs. Aroused and stated he was thirsty and bottled cold water was provided. Sat in chair and became talkative and laughing.  After 15 mins stated he was well enough to leave with mother, and walked out of facility.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 29-JUL-2014 the patient was vaccinated with an expired dose of M-M-R II rHA (dose not reported), batch #J008882, lot#0293AA, expiration date 27-JUL-2014, subcutaneously. No known adverse effects were reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 year old female patient. On 10-FEB-2010 the patient ws vaccinated with a third dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, in an unspecified site). Previous dates of vaccinations were not reported. The reporter stated that his error occurred when they were converting their paper charts to electronic records. No adverse effect experienced. This is one of several reports from the same reporter. Additional information is not expected because the reporter does not want to be contacted.
Age: 1.41
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old child patient of unknown gender. On 13-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J011121, expiration date 04-JUN-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to a 2 years old patient of unknown gender. On 10-JUL-2014 the patient was vaccinated with PROQUAD (merck) (first dose in series, 0.5 ml once, subcutaneous, lot #K002997, expiry date: 27-AUG-2015, also reported as 27-SEP-2015) which was exposed to 1.5C for 1 hour, 15 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from 51 year old male patient (the pharmacist) who reported on himself. On 24-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot # J011882, expiration date 04-JAN-2015). On an unknown date in 2014 the patient developed redness and pain, soreness at the injection site. The patient stated that the symptoms lasted for over a week. The patient was fully recovered as of 11-JUL-2014. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients ("kids") of unknown age. On an unknown date these patients was vaccinated with a dose of GARDASIL (lot#, expiration date, dose not reported) intramuscular. On an unknown date these patients experienced the injection was extremely painful. The outcome of the event was reported as recovered. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old non-pregnant female patient with no known allergies. IT was reported that the patient had an unspecified reaction to a flu shot, could not rule out ALFURIA, administered on an unspecified date in 2013 (also reported as "last year"). On 08-JUL-2014 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose not reported, lot # J011882, expiration date 04-JAN-2015). On 09-JUL-2014 (also reported as "the following day") the patient complained of swelling, redness and pain at the injection site. On 09-JUL-2014 the patient visited an unspecified physician and was diagnosed with cellulitis. The patient was prescribed doxycycline for 7 days as well as an unspecified cream. The patient was not recovered as of 11-JUL-2014. The relatedness between ZOSTAVAX and the events was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Breast mass, Ultrasound scan
Clinical narrative: This spontaneous report as received from a female consumer refers to her 23 year old daughter with allergy to amoxicillin. On 04-APR-2014, the patient was vaccinated with the first dose of GARDASIL. On 05-JUN-3024 the patient was vaccinated with the second dose of GARDASIL (lot # J013277, expiration date:06-AUG-2014, strength unknown, 1 single shot, intramuscular). Concomitant therapies included ZYPREXA and CELEXA (dosage/frequency/manufacturer unknown). In approximately 19-JUN-2014, reported as "2-3 weeks after", the patient discovered lumps in her breasts. The patient sought unspecified medical attentions, two ultrasounds and a biopsy were performed and they were awaiting the results. No adverse effects were reported with the 1st shot of GARDASIL. The outcome of the event was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy breast abnormal, Breast mass, Fibroadenoma of breast, Mammogram, Pathology test
Clinical narrative: This spontaneous report as received from a female consumer refers to her 23 year old daughter with allergy to amoxicillin. On 04-APR-2014, the patient was vaccinated with the first dose of GARDASIL. On 05-JUN-3024 the patient was vaccinated with the second dose of GARDASIL (lot # J013277, expiration date:06-AUG-2014, strength unknown, 1 single shot, intramuscular). Concomitant therapies included ZYPREXA and CELEXA (dosage/frequency/manufacturer unknown). In approximately 19-JUN-2014, reported as "2-3 weeks after", the patient discovered lumps in her breasts. The patient sought unspecified medical attentions, two ultrasounds and a biopsy were performed and they were awaiting the results. No adverse effects were reported with the 1st shot of GARDASIL. The outcome of the event was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound scan
Clinical narrative: This spontaneous report as received from a female consumer refers to her 23 year old daughter with allergy to amoxicillin. On 04-APR-2014, the patient was vaccinated with the first dose of GARDASIL. On 05-JUN-3024 the patient was vaccinated with the second dose of GARDASIL (lot # J013277, expiration date:06-AUG-2014, strength unknown, 1 single shot, intramuscular). Concomitant therapies included ZYPREXA and CELEXA (dosage/frequency/manufacturer unknown). In approximately 19-JUN-2014, reported as "2-3 weeks after", the patient discovered lumps in her breasts. The patient sought unspecified medical attentions, two ultrasounds and a biopsy were performed and they were awaiting the results. No adverse effects were reported with the 1st shot of GARDASIL. The outcome of the event was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered medical assistant, refers to a 5 year old male patient. On 23-JUL-2014, the patient was vaccinated with an unspecified dose of VARIVAX (Merck) in the series, lot # J014228 (expiration date 08-NOV-2015) (route of administration was not reported). Concomitant therapies included IPV (unspecified), M-M-R II and DTaP. On 23-JUL-2014, later that evening, the patient's unspecified parent called the office to report that the patient developed a chicken-pox-like rash around his face. The reporter stated that the patient was then brought into the office on 24-JUL-2014, and the rash had spread to the patient's stomach and back. The patient was being treated with cooling lotion (unspecified) every 6 hours applied to the rash. Lab diagnostics studies were not performed. The outcome of event was reported as not recovered/not resolved. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Faecal incontinence, Fall, Increased upper airway secretion, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Client given vaccines below, informed client to stay seated while entering vaccines in computer. After 305 minutes client started leaning to the right towards the floor. Client's dad caught him before hitting the floor. Client was unresponsive breathing with heartbeat. Gurgling sounds started and clients hands started to draw up, small amount of movement noted for less than a minute, during this time, client was placed on a cushioned mat in the immunization room and cold wet towel was put on face. Ice to underarms and legs up on the chair. Client was out 1-2 minutes. After client was on floor 5-10 minutes, client set up and had coke and crackers, stated did not eat this AM, client aware of his surroundings. States has passed out before but just after immunizations. Client had a bowel movement while unresponsive, After sit up, client stood up with help to the chair and then dad accompanied client to the bathroom. Dad wanted to go to store for change of clothes. Informed someone now here could go get change of clothes so dad could stay here. Instead towel was given to client and client walked out with dad with towel around his waist. Informed dad, I would call and check on client tomorrow by phone. Encouraged dad to take client to pediatrician for workup. Physical and informed meds well check yearly with pediatrician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse reported that on 23-JUN-2014 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot# reported as H019447, expiration date: 25-OCT-2014 (route and dose were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to two unspecified patients or unknown age and gender. The nurse reported that on 26-JUN-2014 the patients were vaccinated with improperly stored ZOSTAVAX (route and dose were not provided) lot # J014811, expiration date: 21-FEB-2015. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Dermatitis contact, Erythema, Herpes zoster, Polymerase chain reaction
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an 8 year old male child. On 18-SEP-2007 the patient ws vaccinated with (Oka/Merck) VARIVAX. On 07-JUL-2014, the patient was diagnosed with Contact Dermatitis and given Triamcinolone. On 08-JUL-2014 the patient developed "red streaking and swelling on the left mid back", AUGMENTION was started on 08-JUL-2014, "a PCR test was performed which was Negative for VZV". On 09-JUL-2014, vesicles developed on the left mid back. On 15-JUL-2014, the patient ws seen by an unspecified Dermatologist who diagnosed the patient with Shingles. Acyclovir was started on 16-JULY-2014. The patient has not recovered. All listed data confirmed by the reporter, no further information was provided. Outcome is patient has not recovered. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Swelling, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an 8 year old male child. On 18-SEP-2007 the patient ws vaccinated with (Oka/Merck) VARIVAX. On 07-JUL-2014, the patient was diagnosed with Contact Dermatitis and given Triamcinolone. On 08-JUL-2014 the patient developed "red streaking and swelling on the left mid back", AUGMENTION was started on 08-JUL-2014, "a PCR test was performed which was Negative for VZV". On 09-JUL-2014, vesicles developed on the left mid back. On 15-JUL-2014, the patient ws seen by an unspecified Dermatologist who diagnosed the patient with Shingles. Acyclovir was started on 16-JULY-2014. The patient has not recovered. All listed data confirmed by the reporter, no further information was provided. Outcome is patient has not recovered. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitional nurse refers to one unspecified patient of unknown age and gender. The nurse reported that on 24-JUN-2014 the patient was vaccinated with improperly stored ZOSTAVAX (route and dose were not provided) lot # J014811, expiration date: 21-FEB-2015. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitional nurse refers to one unspecified patient of unknown age and gender. The nurse reported that on 30-JUN-2014 the patient was vaccinated with improperly stored ZOSTAVAX (route and dose were not provided) lot # J014811, expiration date: 21-FEB-2015. No adverse events were reported. This is one of several reports from the same source. 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 Nurse Practitioner concerning 2 patients of unknown age. On an unknown date, two unspecified patients were vaccinated with VARIVAX  (lot number and other details unspecified), that were stored improperly again. No concomitant therapy was reported. However, no adverse effects were reported. No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to the therapy with VARIVAX. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received from a consumer, the aunt of the patient, refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot # were not reported). The patient was pregnant when she received GARDASIL. The patient LMP (last menstrual period) and EDD (estimated day of delivery) was not reported. The outcome of pregnant when she received the GARDASIL vaccine was unknown. Additional information is not expected because no reporter details were provided.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Petechiae, Rash pruritic
Clinical narrative: Received Tdap, MENACTRA and Hep A on 7-30-14. Per pt, broke out in itchy rash along bra line/chest. Petechiae observed in that area. Hydroxyzine was rx'd.
Age: 1.34
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Vaccines were given on 7/25/14 in AM on 7/26/14 mom called clinic and reported child had woken up with fine non raised rash all over body,not itching. Seen in clinic and assessed by FNP on 7/26/14. No distress, temp up to 101 resolved w TYLENOL.
Age: 1.65
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 19 months old child patient of unknown gender. On 13-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a company representative refers to a patient of unknown age with shingles. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced shingles. The outcome of shingles was reported as recovering/resolving. Additional information is not expected.
Age: 1.49
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, 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 genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 17 months old child patient of unknown gender. On 26-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Child woke up at 0800 on 7/31/14; mom noticed a small rash on chin area. By the afternoon, rash moved to face, neck, trunk and legs. Rash associated with itching. No fever. Child given BENADRYL orally.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Patient received Hep B vac. on 7/30/14 - Did not notify provider she had allergy to wheat. On 7/31/14 she developed a rash with n/v that progressed requiring treatment at urgent care. It was not until after I contacted her again today to f/u with her that she remembered she was allergic to wheat.
Age: 57.0
Sex: F
Vaccine: IPV
Symptoms: Abdominal pain upper, Pruritus, Rash erythematous
Clinical narrative: Itching right thigh and complain of stomach ache, small redness rashes. Tx Benadryl 50 Mg @ 0950 Po. Observed for 1 hour. Discharge about 1120 back to clinic.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Began with fever (lasting 1 day), myalgia, joint pain, lymphadenopathy and fatigue progressively lessening. Rash began on day on 8-4: face chest, back, and stomach.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Began with fever (lasting 1 day), myalgia, joint pain, lymphadenopathy and fatigue progressively lessening. Rash began on day on 8-4: face chest, back, and stomach.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus generalised, Rash
Clinical narrative: On 8/4/14 pt received Kinrix. That afternoon/evening he experienced full body itching with minimal development of rash. On 8/5/15, pt experienced swelling, warmth, redness, and fullness at injection site (left deltoid). We saw him in the office 8/6/14 and gave him Benadryl and Keflex. We will see him back in 2 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: The site was sore as I left the pharmacy. The left arm was painful to touch for 4-5 months - event to have clothes touch the arm when getting dressed. Arm muscles very sore, currently tricep muscle has caved in - atophied ? - and pain is also in forearm.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Pain/tenderness in arm. Unable to lift arm above waist.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (dose, route and lot numbers were not reported). No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patients medical history and current condition are not reported. IT was reported that on 04-AUG-2014 the patient ws vaccinated with expired M-M-R II of unknown strength, dose and frequency (lot # 0287AE and Expiry date 01-FEB-2014). Also reported that the M-M-R II did not have any previous temperature excursions. No adverse events reported. There is no product quality complaint. The outcome of the event is unknown.  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 registered nurse refers to an unspecified number of patients (demographics unknown). On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX 0.5 ml subcutaneous (dose number and lot numbers were not reported). No adverse effects reported. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 0.59
Sex: M
Vaccine: HIBV, PPV
Symptoms: Constipation, Faeces hard
Clinical narrative: Constipation. Normally baby pooped at least one big poop daily, and has only had small harder bowel movements since the vaccines.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Skin reaction
Clinical narrative: Skin reaction - 5x3 cm hard, sore, raised, red area at injection site.  Cleared on its own.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: We were getting ice cream and she was saying the flavors she wanted and she had her hands in her lap while standing.  I asked her if she had to pee and she said yes and then she collapsed.  She lost consciousness for a second, but enough to fall and hit the ground, I think she might have hit her head.  I picked her up and ran out of the store and ran to her Dr.s office, which is very close, and we just ran out.  The saw her at the Dr.s office and gave her juice and graham crackers until she was steady on her feet.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, Exposure via direct contact, Ocular hyperaemia
Clinical narrative: Temporary redness in eye.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Fatigue, Injection site hypersensitivity, Injection site swelling
Clinical narrative: VERY SWOLLEN ARM, IT FEELS LIKE A BIG BUMP AND AN ALLERGIC REACTION IN THE INJECTION SITE, FEVER, A LOT OF CHILLS, BODY ACHES, TIREDNESS. IN GENERAL I AM VERY SICK, TODAY IS MY 3RD DAY AFTER ADMINISTRATION OF VACCINE AND STILL UNABLE TO GO TO WORK AND DO MY REGULAR AND DAILY ACTIVITIES.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Pain, Pyrexia, White blood cell count
Clinical narrative: VERY SWOLLEN ARM, IT FEELS LIKE A BIG BUMP AND AN ALLERGIC REACTION IN THE INJECTION SITE, FEVER, A LOT OF CHILLS, BODY ACHES, TIREDNESS. IN GENERAL I AM VERY SICK, TODAY IS MY 3RD DAY AFTER ADMINISTRATION OF VACCINE AND STILL UNABLE TO GO TO WORK AND DO MY REGULAR AND DAILY ACTIVITIES.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rt. deltoid area where injection was given became extremely swollen (the entire deltoid area up to the shoulder and down towards to the elbow. Hot to touch and very painful.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chest discomfort, Dyspnoea, Pruritus generalised, Throat tightness
Clinical narrative: 7/24/2014 at 5pm at EOH c/o "itchy" all over (no rash) - feels like her throat is tight with normal speech. BENADRYL taken by employee TX: (1)CLARITIN and PEPCID (2) prednisone 60 mg x 5 days (1 dose given). 7/25/2014 SOB (shortness of breath) chest tightness at ED. Temp 97.8.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. On 13-JAN-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB 1 ml, intramuscular. On 12-FEB-2014, the patient was vaccinated with the second dose of RECOMBIVAX HB 1 ml, intramuscular. On 20-MAR-2014, the patient was vaccinated with the third dose of RECOMBIVAX HB, 1 ml, intramuscular. On 20-MAR-2014, the patient received their dose of RECOMBIVAX HB "too early". No adverse effect reported. The outcome of the patient received their dose of RECOMBIVAX "too early" was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report was received from a consumer via field employee refers to a 17 year old male patient. On an unknown date, the patient was vaccinated with GARDASIL 1 injection, intramuscular for prevention of HPV (human papillomavirus). On an unknown date, the patient fainted and fell to the side after being administered GARDASIL. No treatment was given for the adverse event. The outcome of fainted and fell to the side after being administered GARDASIL was unknown. Additional information is not expected because no reporter details were provided.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Headache, Presyncope
Clinical narrative: C/O headache, lightheaded near fainting. Headache persisted till next day.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitional nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on unknown dates unspecified number of patients were vaccinated with improperly stored PROQUAD (route, dose, lot number and expiration date were not provided. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Patient reports Bells Palsy 4 days after injection.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Vomiting
Clinical narrative: Headache and vomiting that started about one hour after receiving MENACTRA which resolved with no need for any meds after about 2 hours.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Apnoea, Disorientation, Injection site pain, Unresponsive to stimuli, Vertigo
Clinical narrative: 0931 pt c/o vertigo and pain at injection site, became unresponsive. BLE elevated periods of apnea. Opened eyes after sternal rub. BP 70/30. EMS arrived. Disoriented to name, place, and time. Transported to ER.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Vascular purpura
Clinical narrative: Vascular purpura. Prednisone.
Age: 4.0
Sex: F
Vaccine: DT
Symptoms: Body temperature increased, Convulsion, Decreased interest, Headache, Irritability
Clinical narrative: 11-24-11 complained of head pain before bed. Went to check on her after she fell asleep. Had seizure during sleep. I woke her right away. Temp 100.5 degrees, Gave her TYLENOL. Watched her closely all night. Next 3 days complained of headache. Was "clingy" for following 2 months. Not interested in usual activities. Eventually recovered.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Condition aggravated, Culture wound negative, Dermatitis, Dermatitis bullous, Dry skin
Clinical narrative: The child received her 6 month vaccinations on 28 March 2014. This included PEDIARIX #3 left thigh and PREVNAR 13 right thigh. At the time of vaccination the child had had a cough and runny nose for 2 weeks. According to the mother the infant had a low grade fever (at 100.0 rectal). On 3/31/14 the mother noted a rash on her legs and arms. At that time it appeared as a papulopustular dermatitis mostly with clusters on the extremities with some involvement of the trunk and neck--it spared the palms/soles/mouth. It did not appear to cause the infant any discomfort and was dx as a viral exanthema. On 4/1/14 the infant was referred to Dermatology due to worsening of the rash--the infant was fussy and not sleeping well; the mother reported that the infant was scratching. On exam the child had numerous 0.2-1.5cm erythematous papules on the forearms, dorsal hands and buttocks; 3 targetoid lesions with central dusty appearance and peripheral lightening; and numerous 0.3-1.0 papules and papulovesicles. The differential diagnosis included Erythema Multiforme (EM), Urticaria Multiforme and Cutaneous Bullous Multiforme. The infant was prescribed Hydroxyzine and Fluocinolone topical ointment and was referred to the Allergy Clinic. When the infant was seen by in the Dermatology Clinic on 4/4/14 all previous papulovesicles were crusted over and there was no evidence of new lesions. The mother was noted to have vesicopapules of the palms, soles and vesicles of the soft palate; thought to be Hand-Foot-Mouth Disease (HFMD--current outbreak at the childcare institution where the child is cared for). At this time the infant was diagnosed with HFMD (atypical). Of note, the father of the child was diagnosed with HFMD on 4/5/14. The infant was seen by Pediatrics on 4/8/14 for ongoing URI symptoms. At her visit with Dermatology on 4/11/14 it was noted that the rash "was much improved since the last visit". On 4/21/14 the infant had a 1cm abnormal dry patch on her left upper cheek, numerous 3mm-1.5cm erythematous papules and plaques with central clearing on her arms, legs and dorsum of her hands/feet. Additionally, peeling was noted on the pad of the left little toe and right great toe. The mother reports that the rash completely resolved at 2-3 weeks later. Of note the child received Hib-PRP-T on 6/11/14 without adverse event.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Erythema multiforme, Hand-foot-and-mouth disease, Irritability, Papule, Poor quality sleep
Clinical narrative: The child received her 6 month vaccinations on 28 March 2014. This included PEDIARIX #3 left thigh and PREVNAR 13 right thigh. At the time of vaccination the child had had a cough and runny nose for 2 weeks. According to the mother the infant had a low grade fever (at 100.0 rectal). On 3/31/14 the mother noted a rash on her legs and arms. At that time it appeared as a papulopustular dermatitis mostly with clusters on the extremities with some involvement of the trunk and neck--it spared the palms/soles/mouth. It did not appear to cause the infant any discomfort and was dx as a viral exanthema. On 4/1/14 the infant was referred to Dermatology due to worsening of the rash--the infant was fussy and not sleeping well; the mother reported that the infant was scratching. On exam the child had numerous 0.2-1.5cm erythematous papules on the forearms, dorsal hands and buttocks; 3 targetoid lesions with central dusty appearance and peripheral lightening; and numerous 0.3-1.0 papules and papulovesicles. The differential diagnosis included Erythema Multiforme (EM), Urticaria Multiforme and Cutaneous Bullous Multiforme. The infant was prescribed Hydroxyzine and Fluocinolone topical ointment and was referred to the Allergy Clinic. When the infant was seen by in the Dermatology Clinic on 4/4/14 all previous papulovesicles were crusted over and there was no evidence of new lesions. The mother was noted to have vesicopapules of the palms, soles and vesicles of the soft palate; thought to be Hand-Foot-Mouth Disease (HFMD--current outbreak at the childcare institution where the child is cared for). At this time the infant was diagnosed with HFMD (atypical). Of note, the father of the child was diagnosed with HFMD on 4/5/14. The infant was seen by Pediatrics on 4/8/14 for ongoing URI symptoms. At her visit with Dermatology on 4/11/14 it was noted that the rash "was much improved since the last visit". On 4/21/14 the infant had a 1cm abnormal dry patch on her left upper cheek, numerous 3mm-1.5cm erythematous papules and plaques with central clearing on her arms, legs and dorsum of her hands/feet. Additionally, peeling was noted on the pad of the left little toe and right great toe. The mother reports that the rash completely resolved at 2-3 weeks later. Of note the child received Hib-PRP-T on 6/11/14 without adverse event.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Rash, Rash papular, Rash pustular, Scab
Clinical narrative: The child received her 6 month vaccinations on 28 March 2014. This included PEDIARIX #3 left thigh and PREVNAR 13 right thigh. At the time of vaccination the child had had a cough and runny nose for 2 weeks. According to the mother the infant had a low grade fever (at 100.0 rectal). On 3/31/14 the mother noted a rash on her legs and arms. At that time it appeared as a papulopustular dermatitis mostly with clusters on the extremities with some involvement of the trunk and neck--it spared the palms/soles/mouth. It did not appear to cause the infant any discomfort and was dx as a viral exanthema. On 4/1/14 the infant was referred to Dermatology due to worsening of the rash--the infant was fussy and not sleeping well; the mother reported that the infant was scratching. On exam the child had numerous 0.2-1.5cm erythematous papules on the forearms, dorsal hands and buttocks; 3 targetoid lesions with central dusty appearance and peripheral lightening; and numerous 0.3-1.0 papules and papulovesicles. The differential diagnosis included Erythema Multiforme (EM), Urticaria Multiforme and Cutaneous Bullous Multiforme. The infant was prescribed Hydroxyzine and Fluocinolone topical ointment and was referred to the Allergy Clinic. When the infant was seen by in the Dermatology Clinic on 4/4/14 all previous papulovesicles were crusted over and there was no evidence of new lesions. The mother was noted to have vesicopapules of the palms, soles and vesicles of the soft palate; thought to be Hand-Foot-Mouth Disease (HFMD--current outbreak at the childcare institution where the child is cared for). At this time the infant was diagnosed with HFMD (atypical). Of note, the father of the child was diagnosed with HFMD on 4/5/14. The infant was seen by Pediatrics on 4/8/14 for ongoing URI symptoms. At her visit with Dermatology on 4/11/14 it was noted that the rash "was much improved since the last visit". On 4/21/14 the infant had a 1cm abnormal dry patch on her left upper cheek, numerous 3mm-1.5cm erythematous papules and plaques with central clearing on her arms, legs and dorsum of her hands/feet. Additionally, peeling was noted on the pad of the left little toe and right great toe. The mother reports that the rash completely resolved at 2-3 weeks later. Of note the child received Hib-PRP-T on 6/11/14 without adverse event.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Skin discolouration, Skin exfoliation, Skin lesion, Skin plaque, Upper respiratory tract infection
Clinical narrative: The child received her 6 month vaccinations on 28 March 2014. This included PEDIARIX #3 left thigh and PREVNAR 13 right thigh. At the time of vaccination the child had had a cough and runny nose for 2 weeks. According to the mother the infant had a low grade fever (at 100.0 rectal). On 3/31/14 the mother noted a rash on her legs and arms. At that time it appeared as a papulopustular dermatitis mostly with clusters on the extremities with some involvement of the trunk and neck--it spared the palms/soles/mouth. It did not appear to cause the infant any discomfort and was dx as a viral exanthema. On 4/1/14 the infant was referred to Dermatology due to worsening of the rash--the infant was fussy and not sleeping well; the mother reported that the infant was scratching. On exam the child had numerous 0.2-1.5cm erythematous papules on the forearms, dorsal hands and buttocks; 3 targetoid lesions with central dusty appearance and peripheral lightening; and numerous 0.3-1.0 papules and papulovesicles. The differential diagnosis included Erythema Multiforme (EM), Urticaria Multiforme and Cutaneous Bullous Multiforme. The infant was prescribed Hydroxyzine and Fluocinolone topical ointment and was referred to the Allergy Clinic. When the infant was seen by in the Dermatology Clinic on 4/4/14 all previous papulovesicles were crusted over and there was no evidence of new lesions. The mother was noted to have vesicopapules of the palms, soles and vesicles of the soft palate; thought to be Hand-Foot-Mouth Disease (HFMD--current outbreak at the childcare institution where the child is cared for). At this time the infant was diagnosed with HFMD (atypical). Of note, the father of the child was diagnosed with HFMD on 4/5/14. The infant was seen by Pediatrics on 4/8/14 for ongoing URI symptoms. At her visit with Dermatology on 4/11/14 it was noted that the rash "was much improved since the last visit". On 4/21/14 the infant had a 1cm abnormal dry patch on her left upper cheek, numerous 3mm-1.5cm erythematous papules and plaques with central clearing on her arms, legs and dorsum of her hands/feet. Additionally, peeling was noted on the pad of the left little toe and right great toe. The mother reports that the rash completely resolved at 2-3 weeks later. Of note the child received Hib-PRP-T on 6/11/14 without adverse event.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Urticaria, Viral rash
Clinical narrative: The child received her 6 month vaccinations on 28 March 2014. This included PEDIARIX #3 left thigh and PREVNAR 13 right thigh. At the time of vaccination the child had had a cough and runny nose for 2 weeks. According to the mother the infant had a low grade fever (at 100.0 rectal). On 3/31/14 the mother noted a rash on her legs and arms. At that time it appeared as a papulopustular dermatitis mostly with clusters on the extremities with some involvement of the trunk and neck--it spared the palms/soles/mouth. It did not appear to cause the infant any discomfort and was dx as a viral exanthema. On 4/1/14 the infant was referred to Dermatology due to worsening of the rash--the infant was fussy and not sleeping well; the mother reported that the infant was scratching. On exam the child had numerous 0.2-1.5cm erythematous papules on the forearms, dorsal hands and buttocks; 3 targetoid lesions with central dusty appearance and peripheral lightening; and numerous 0.3-1.0 papules and papulovesicles. The differential diagnosis included Erythema Multiforme (EM), Urticaria Multiforme and Cutaneous Bullous Multiforme. The infant was prescribed Hydroxyzine and Fluocinolone topical ointment and was referred to the Allergy Clinic. When the infant was seen by in the Dermatology Clinic on 4/4/14 all previous papulovesicles were crusted over and there was no evidence of new lesions. The mother was noted to have vesicopapules of the palms, soles and vesicles of the soft palate; thought to be Hand-Foot-Mouth Disease (HFMD--current outbreak at the childcare institution where the child is cared for). At this time the infant was diagnosed with HFMD (atypical). Of note, the father of the child was diagnosed with HFMD on 4/5/14. The infant was seen by Pediatrics on 4/8/14 for ongoing URI symptoms. At her visit with Dermatology on 4/11/14 it was noted that the rash "was much improved since the last visit". On 4/21/14 the infant had a 1cm abnormal dry patch on her left upper cheek, numerous 3mm-1.5cm erythematous papules and plaques with central clearing on her arms, legs and dorsum of her hands/feet. Additionally, peeling was noted on the pad of the left little toe and right great toe. The mother reports that the rash completely resolved at 2-3 weeks later. Of note the child received Hib-PRP-T on 6/11/14 without adverse event.
Age: 1.79
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient was given vaccine for the first time and skin/injection site appeared normal after 10 minutes elapsed and patient's mom noticed injected site was warm to touch and a quarter size bump had appeared.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Chills, Erythema, Influenza like illness, Local swelling, Myalgia
Clinical narrative: Large swollen red area pt. had fever, chills and generalized myalgia - state felt like flu symptoms.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Large swollen red area pt. had fever, chills and generalized myalgia - state felt like flu symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a female consumer of unkonwn age with penicillin allergy and KEFLEX allergy. The patient's medical history included thyroid. On 30-JUL-2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant therapies included SYNTHROID. On an unknown date, the patient experienced redness, but no rash, at the injection site after receiving ZOSTAVAX. The patient did not receive treatment. No lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected because the consumer declined to provide demographics for her physician.