chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Gait disturbance, Injection site pain, Wrong drug administered
Clinical narrative: This spontaneous report was received from a consumer refers to his 5 year old male son with food allergy to cinnamon. On 30-JUL-2014 the patient was vaccinated with a dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported). Concomitant therapies included poliovirus vaccine inactivated (unspecified) and varicella virus vaccine live (manufacturer unknown). The parent stated his son was seen today (30-JUL-2014) in the physician's office and was accidentally given the GARDASIL vaccine by a Nurse Practitioner (anonymous male) instead of a vaccine. The patient experienced "injection site pain" and had "trouble with his legs while walking to the car". The patient was not observed for the fifteen minutes after receiving the injection as stated in the prescribing information. Instead, the patient walked to his car about five minutes after receiving the injection. While in the office, the patient also received a vaccine injection to prevent chicken pox, varicella virus vaccine live (manufacturer unknown). At the time of the report the outcome was unknown. Patient did not received medical attention or treatment for the adverse event. No lab diagnostics studies were performed. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination site reaction
Clinical narrative: Patient developed herpes zoster at the site of shingles vaccination.
Sex: M
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. Approximately on an unknown date in August 2010 (reported as 4 years ago), the patient was vaccinated with first dose of M-M-R II (dose unspecified) and experienced a seizure after administration of first dose. Concomitant medications were not reported. The outcome of seizure was unknown. The causality of the event with M-M-R II was not reported. Upon internal review, seizure was determined to be medically significant. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a healthcare worker (who was also an office manager) via company representative refers to an unspecified patient of unknown age and gender. The healthcare worker heard from a friend that on an unknown date, the patient was vaccinated with a dose of GARDASIL, injection (lot#, expiration date, dose, strength and route not reported). The an unspecified patient experienced a seizure, on an unspecified date, after receipt of GARDASIL. The patient was not a patient of the office manager's facility. The outcome of seizure was unknown. It was unspecified if the patient sought medical attention. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a 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 those patients were administered with a doses of PNEUMOVAX23 (doses, routes of administration, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2013 that had been improperly stored. 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.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The pharmacist reported that these unspecified patients may had received improperly stored M-M-R II (lot #, dose, route not reported) and sterile diluent on an unknown date. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 54 year old male patient who was a Merck employee with no pertinent medical history and drug reactions/allergies. On 31-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX vial lot # J013450, Exp date: 24-JAN-2015, (0.65 ml, as per prescribing information, dose# and strength unspecified), subcutaneous. No concomitant medication was taken. On 01-AUG-2014 the patient experienced rash. The patient did not seek medical attention and no treatment was given for the event. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered. Additional information is not expected as the physician did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Diarrhoea, Fatigue, Pyrexia, Varicella
Clinical narrative: This spontaneous report as received from a physician via company representative refers to three anonymous patients of unknown age and gender with no medical history no allergies or reactions to the drugs. On an unkonwn date, the patients were vaccinated with VARIVAX (Merck) (dose, frequency and anatomical location: not reported, subcutaneous) (lot #, exp date: unknown). There was no concomitant medications. On an unknown date, the patients experienced chicken pox, diarrhea, fatigue and low grade fever. No laboratory diagnostic studies were performed. The patients sought medical attention (office visit on unspecified dates). The outcome of fatigue, low grade fever, chicken pox and diarrhea was unknown. Relatedness between fatigue, low grade fever, chicken pox and diarrhea and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that PROQUAD (Merck) reached temperatures that were outside the prescribing information. No adverse effects reported. Follow up information has been received from the clinical manager. The clinical manager stated, she did not have any patient identifiers or dates of vaccine administration, but provided lot number: K002037 valid for V221 expiration date: 10-AUG-2015 and lot number: J006162 expiration date: 30-NOV-2014 and for PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
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 with Merck.   Follow up information has been received from the registered nurse who provided patient details. This report refers to a 2 years old child patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a does of LIQUID PEDVAXHIB (dose and route were 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: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unkonwn demographics. No relevant medical history of the patient was reported. On 06-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J006242, expiration date: 03-AUG-2014), 0.5 ml, intramuscular. There were no concomitant medications reported. On 06-AUG-2013 the patient received a dose of PNEUMOVAX 23 3 days after the expiry (03-AUG-2014). The patient experienced no adverse effects. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown dates, multiple unspecified patients were administered PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not provided) that was stored improperly. No adverse effects were reported. Additional information has been requested.
Age: 1.77
Sex: M
Vaccine: MEA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old male patient. The patient was administered ATTENUVAX (Enders-Edmonston) on 02-APR-2008, then administered MUMPSVAX (dose number, units, route of administration, anatomical location, lot number were not reported), then RUBELLA on 07-MAY-2008, then the patient was revaccinated with M-M-R II (dose number, units, route of administration, anatomical location, lot number were not reported) on 11-AUG-2011. No adverse effects reported. Additional information is not expected because the reporter do not wish to be contacted.
Age: 13.0
Sex: F
Vaccine: DTPIPV, HEP, HPV4, MMR
Symptoms: Concussion, Confusional state, Convulsion, Eye movement disorder, Fall
Clinical narrative: Immediately following immunizations we were walked out of room by nurse to the front desk to schedule a follow up appointment. With in 1-2 minutes of standing at the desk I heard a loud bang! I turned around to see what it was and my daughter was laying flat on her back, her eyes were rolling and she was seizuring. My daughter fainted while standing, fell back and slammed her head off the tile floor. She was unresponsive and very confused.  911 was called and she was taken by ambulance to the hospital. My daughter did indeed have a concussion. Since the fall she is experiencing severe headaches and neck pain started today.
Age: 13.0
Sex: F
Vaccine: DTPIPV, HEP, HPV4, MMR
Symptoms: Head injury, Headache, Neck pain, Syncope, Unresponsive to stimuli
Clinical narrative: Immediately following immunizations we were walked out of room by nurse to the front desk to schedule a follow up appointment. With in 1-2 minutes of standing at the desk I heard a loud bang! I turned around to see what it was and my daughter was laying flat on her back, her eyes were rolling and she was seizuring. My daughter fainted while standing, fell back and slammed her head off the tile floor. She was unresponsive and very confused.  911 was called and she was taken by ambulance to the hospital. My daughter did indeed have a concussion. Since the fall she is experiencing severe headaches and neck pain started today.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: No signs or symptoms noted. No treatment needed. No Adverse reactions.
Age: 0.09
Sex: M
Vaccine: DTAPHEPBIP, RVX
Symptoms: Allergy test positive, Allergy to animal, Blood immunoglobulin E, Eczema, Food allergy
Clinical narrative: Projectile vomiting for days. Went away within a week. Right before he turned 1 month old, he developed eczema. Right before he turned 3 months old, he started to throw up after every time I breast fed him. I spent weeks doing elimination diets. At 4 months old, I figured out he was allergic to wheat, dairy, eggs, peanuts, and tree nuts. We had his blood tested by an allergist. He was allergic to wheat, dairy, eggs, peanuts, tree nuts, soy, corn, and dogs. By 5 months old, he still wasn't well, he never got clear skin and never stopped puking. I was still breastfeeding and thought he was allergic to banana, coconut, sunflower seeds, oats, flax seeds, and oats. We had blood tests drawn and he was in fact allergic to all of those allergens. I had him tested for protein and veggies, and he tested negative for those. I only ate those, and he developed more allergies to the point we had to put him on Neocate. By 6 months old, he had fallen to the 5th%, was still showing signs of being allergic to something, so we put him on Neocate.
Age: 0.09
Sex: M
Vaccine: DTAPHEPBIP, RVX
Symptoms: General physical health deterioration, Milk allergy, Skin disorder, Vomiting, Vomiting projectile
Clinical narrative: Projectile vomiting for days. Went away within a week. Right before he turned 1 month old, he developed eczema. Right before he turned 3 months old, he started to throw up after every time I breast fed him. I spent weeks doing elimination diets. At 4 months old, I figured out he was allergic to wheat, dairy, eggs, peanuts, and tree nuts. We had his blood tested by an allergist. He was allergic to wheat, dairy, eggs, peanuts, tree nuts, soy, corn, and dogs. By 5 months old, he still wasn't well, he never got clear skin and never stopped puking. I was still breastfeeding and thought he was allergic to banana, coconut, sunflower seeds, oats, flax seeds, and oats. We had blood tests drawn and he was in fact allergic to all of those allergens. I had him tested for protein and veggies, and he tested negative for those. I only ate those, and he developed more allergies to the point we had to put him on Neocate. By 6 months old, he had fallen to the 5th%, was still showing signs of being allergic to something, so we put him on Neocate.
Age: 2.0
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 2 years old child patient of unknown gender. On 13-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse refers to a 42 year old male patient with hyperlipidemia and cephalosporins allergy. On 18-JUL-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) subcutaneous, 0.5 ml dose, lot # K004419 and expiration date 31-MAR-2016. Concomitant therapies included LIPITOR. On 01-AUG-2014, the patient was diagnosed with chicken pox. The patient had isolated vesicular lesions on his chest, back, left arm and left hip. The patient sought medical attention by an office visit and no medical treatment was prescribed. No laboratory diagnostic studies were performed. At the time of the report the outcome the event was reported as not recovered. Additional information has been requested.
Age: 2.0
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 with Merck. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 2 years old child patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 06-AUG-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB 5/0.5 mcg/ml, 0.5ml administered intramuscularly; lot # 0737AE, expiration date 18-APR-2014; site of administration unkonwn. This was patient's third dose of RECOMBIVAX HB; dates of the two previous vaccinations were not reported. The patient experienced no adverse effects. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a 18 month old patient of unknown gender. There was no information on pertinent medical history and drug reactions or allergies. The patient was vaccinated with a dose of RECOMBIVAX HB strength 5/0.5 MCRG/ML (microgram/millilitre)(route, product lot#, Expiry date not reported) on 29-JAN-2013 and on 01-APR-2013. On 05-AUG-2014, the patient received 2 doses of pediatric RECOMBIVAX HB. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Fatigue, Influenza like illness, Injection site erythema, Injection site irritation
Clinical narrative: This spontaneous report was received from a 46 year old female patient, regarding herself. The patient had codeine allergy and acid reflux disorder. The patient has no medical history. The patient was non pregnant at the time of reporting. On 02-AUG-2014 the patient was vaccinated with PNEUMOVAX23 in the left arm. Concomitant therapies included ZYRTEC-D and a medication for acid reflux gurd (details unknown). On 02-AUG-2014, the patient began with redness and irritation at the injection site. On 03-AUG-2014 (reported as the next day) she began to experience fatigue and exhibit "flu-like" symptoms. The patient also stated her arm was beginning to swell on 03-AUG-2014. On 04-AUG-2014 (reported as the third day after the injection) she began to experience body aches and her arm was completely swollen, burning and painful and she could not move her arm. During this period prior to going to the physician's office the patient self-administered ALEVE, TYLENOL, Ibuprofen (manufacturer and dose unspecified). No product quality complaint was filed.  On an unknown date in August 2014, the patient went to the physician's office (medical attention) and was prescribed an antibiotic (dose and manufacturer unspecified). No intervention initiated to prevent serious criteria as there were none. The action taken was assessed as not applicable. The outcome of events was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 46 year old female patient, regarding herself. The patient had codeine allergy and acid reflux disorder. The patient has no medical history. The patient was non pregnant at the time of reporting. On 02-AUG-2014 the patient was vaccinated with PNEUMOVAX23 in the left arm. Concomitant therapies included ZYRTEC-D and a medication for acid reflux gurd (details unknown). On 02-AUG-2014, the patient began with redness and irritation at the injection site. On 03-AUG-2014 (reported as the next day) she began to experience fatigue and exhibit "flu-like" symptoms. The patient also stated her arm was beginning to swell on 03-AUG-2014. On 04-AUG-2014 (reported as the third day after the injection) she began to experience body aches and her arm was completely swollen, burning and painful and she could not move her arm. During this period prior to going to the physician's office the patient self-administered ALEVE, TYLENOL, Ibuprofen (manufacturer and dose unspecified). No product quality complaint was filed.  On an unknown date in August 2014, the patient went to the physician's office (medical attention) and was prescribed an antibiotic (dose and manufacturer unspecified). No intervention initiated to prevent serious criteria as there were none. The action taken was assessed as not applicable. The outcome of events was reported as not recovered. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 05-AUG-2014 the patient was vaccinated with PNEUMOVAX 23, (strength and lot number were not reported, expiration date: 20-JUL-2014) intramuscular. There were no concomitant medications reported. It was reported that on 05-AUG-2014, the patient was inadvertently administered with PNEUMOVAX 23, which expired on 20-JUL-2014. This was supported and the patient experienced no adverse effects. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
Age: 1.77
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Pruritus, Rash, Rash generalised, Swelling face, Urticaria
Clinical narrative: Rash on body and face. Swollen cheeks. Itchy. Hives 1 hour after vaccines. Spread over groin. Went to face, trunk, arms, legs within 3 hours. Treated with BENADRYL and calamine lotion.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a consumer regarding her daughter refers to a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 22-JUL-2014 the patient was vaccinated with MMR II and (Oka/Merck) VARIVAX (strength, route were not reported) at her well baby visit. The reporter also mentioned that the vaccines administered were well with in expiry. On 30-JUL-2014 evening, the patient felt warm and temperature rectally was measured with a result of 104.1 F. The patient was given with a dose of MOTRIN to bring it down. The reporter stated that fever had decreased to around 100F next day morning and was given additional MOTRIN dose the same morning. The outcome of high fever was reported as Recovering/Resolving. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a company representative refers to a patient of unknown age who was administered GARDASIL. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patient experienced inappropriate schedule of vaccine that was administered. The outcome of inappropriate schedule of vaccine administered is unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local swelling, Pain, Pruritus, Skin lesion
Clinical narrative: Red bump (L) arm. Dx R/O IMZ reaction. C/O itchy and pain. 8/3/14 1:24 PM. 8/1/14 Dx (L) arm lesion Rx ATARAX 25 mg TID PRN itching, BACTRIM DS BID x 10 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram head normal, Seizure like phenomena, Vomiting
Clinical narrative: Patient began vomiting around midnight, 8/2/14, around 9:30 am pt had first seizure like episode and was taken to ER. Patient continues with seizure like episodes per mother.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Enterovirus test positive, Pyrexia, Rash, Rash generalised
Clinical narrative: Was being treated for possible Lyme disease before 12 mo well check. Rash had resolved and pt was afebrile when shots given but also on AMOXIL shots on 7/11/14. 7/18/14 went to urgent care b/c of rash on face and body and also had fever of 101 that day. Stopped AMOXIL 7/15. Took one dose of cefuroxime 7/19. No abx since 7/19. Was seen by Pedi ID for possible tick borne dz. Also tested for enterovirus which was (+).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning a female patient in her early 60's (age). On an unknown date, the patient was vaccinated with ZOSTAVAX  (injection site unspecified) lot#J011339, expiry date: 13-DEC-2014. No concomitant therapy was reported. On an unknown date, the patient experienced redness and swelling, approximately 2.5 centimeters in diameter, at injection site. It was reported that, injection site reaction occurred 3 to 5 days after ZOSTAVAX was administered. No product quality complaint was filed. No intervention initiated to prevent serious criteria as there were none. The action taken was assessed as not applicable. The outcome of event was reported as recovered on an unknown date. The causality was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Feer 101 degrees F for 2 days, rash around injection site, no treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with initial dose of ZOSTAVAX (dosage and indication were not reported). On an unknown date, two years after first dose, patient possibly received a second dose of ZOSTAVAX. No symptoms reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Local reaction, Local swelling, Oedema peripheral
Clinical narrative: Severe local reaction. Redness, pain & swelling from top of left shoulder to 4" above elbow - swelling is all around the arm into the armpit area.  Fingers on left hand tingling and numb (on & Off)
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Severe local reaction. Redness, pain & swelling from top of left shoulder to 4" above elbow - swelling is all around the arm into the armpit area.  Fingers on left hand tingling and numb (on & Off)
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a patient of unknown age immunized with GARDASIL, and another patient of unknown age immunized with MMR II. On an unknown date in MAY 2014, that one patient was vaccinated with GARDASIL. Another patient vaccinated with MMR II, both reported to be stored improperly. The outcome of incorrect product storage and patients receiving improperly stored MMR and GARDASIL is unknown. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning a female patient in her early 60's (age). On an unknown date, the patient was vaccinated with ZOSTAVAX (injection site unspecified) lot # J011339, expiry date: 13-DEC-2014. No concomitant therapy was reported. On an unknown date, the patient experienced redness and swelling at injection site. No product quality complaint was filed. No interventioned initiated to prevent serious criteria as there were none. The action taken was assessed as not applicable. The outcome of event was reported as recovered on an unknown date. The causality was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 42 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 30-JUL-2014 the patient was vaccinated with an expired dose of M-M-R II lot # H012572, expiration date 29-JUN-2014 (strength, dose and route were not reported). The reporter stated that this was patient's first dose of M-M-R II series. No adverse effect reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 dose 2 (strength, route, lot number and expiration date were not reported). There were no concomitant therapies reported. It was reported that the patient received a second dose of PNEUMOVAX 23 six weeks after receiving the first dose. There were no adverse effects reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Burning sensation, Hordeolum, Pruritus, Rash, Rash erythematous
Clinical narrative: Started as itchy right wrist, then became red itchy burning rash on lower right torso, then eye sty and mouth sore
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Rash pruritic, Stomatitis
Clinical narrative: Started as itchy right wrist, then became red itchy burning rash on lower right torso, then eye sty and mouth sore
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Drug eruption, Histology abnormal, Hypersensitivity, Rash pruritic
Clinical narrative: Case number PHHY2014US093799 is an initial literature report received on 26 Jul 2014. The author discussed about lichenoid drug reaction following influenza vaccination in an HIV (human immunodeficiency virus) positive patient. This report refers to a 46-year-old female patient. Her medical history included treatment for HIV disease. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. One day after vaccination she developed a diffuse, pruritic rash. Physical exam and histopathology were consistent with a lichenoid drug eruption. The author concluded that the patient's underlying HIV disease, known to be a risk factor for both cutaneous drug reactions and more severe manifestations of lichen planus and likely predisposed her to this generalized hypersensitivity phenomenon. The final outcome and seriousness of the events were not reported. It was reported this was only the fifth reported case of lichenoid drug reaction and only the second generalized case, following influenza vaccination.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram, Fall, Pallor
Clinical narrative: Patient left the exam room about 630 pm as she was leaving thru the waiting area she fell down, was very pale. She was laid flat on carpeted floor legs raised, after few seconds color was back radial pulse was 90/minute BP stable. She stood up walked after taking lollipop.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Mobility decreased, Syncope, Unresponsive to stimuli
Clinical narrative: Shortly after administration of HPV vac. pt. collapsed from a sitting to supine position. She was motionless, non responsive but breathing on own with no change in HR O2 sat, BP of 80/42/ M49/nl BS. Taken to ED after ox 45 in/IVF given in office.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. Patient had a history of unspecified reactions to sulfa/sulfur medications (unspecified), salicylates (unspecified) and tetracycline (unspecified). On 28-JUL-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm (strength, dose number, lot number and expiration date were not reported). Concomitant therapies included ZYRTEC. On 29-JUL-2014, 2 days after onset of therapy, the patient experienced rash at injection site. Rash grown larger and covered an area approximately 3 inches from injection site on patient's left arm. No treatment was given for the adverse event. None laboratory diagnostic studies were performed. The patient did not sought medical attention. The outcome of rash was reported as not recovered. The relationship between ZOSTAVAX and the rash was not reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to an 83 year old female patient. No relevant medical history of the patient was reported. It was reported that the patient was vaccinated with 3 doses of PNEUMOVAX 23 (strength, lot number and expiration date were not reported), over an unspecified time frame. There were no concomitant therapies reported. There were no adverse effects reported. There was no product quality complaint (PQC) involved. The outcome of received 3 doses of PNEUNOVAX 23 over an unspecified time frame was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Guttate psoriasis, Injection site reaction, Local reaction
Clinical narrative: Received immunization 3/8/2014: Flare of guttate psoriasis. Initially with local rxn (possibly vesicular at site of shingles vaccine but has subsequently over past 4 months had same guttate psoriasis. (Locations: Both arms/lower back, scalp, b/l thighs.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Decreased activity, Pruritus, Urticaria
Clinical narrative: Mother calls health department today (7-28-14) at 10:00 am. States child started having hives the day after shots and started swelling at area of hives because she was itching them. Stated, "I do not know if she had a fever or not but she did lay down most of the day yesterday." Has not been evaluated by MD yet but instructed to do so.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of entire left arm and shoulder with slight redness and warmth. Mother applying cool compress to area and giving child BENADRYL po. Instructed to continue treatment. Instructed to seek medical treatment if swelling increases or breathing difficulty occurs.
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Injection site urticaria
Clinical narrative: Child received MMR on 7/7/14. After receiving vaccine had small welt at site of injection. Child was not complaining or having any itching, breathing problems. Applied ice for a couple of minutes. Area became larger - child was given 12.5 mg of BENADRYL. V/S remained stable - child was monitored for one hour. Left clinic with parent stable condition. Area didn't get any larger but did remain present.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Upper left arm from crease/elbow to shoulder, swollen welt, red, hot painful, itching, dr prescribed doxycycline, BENADRYL, ZYRTEC prescribed by dr.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Upper left arm from crease/elbow to shoulder, swollen welt, red, hot painful, itching, dr prescribed doxycycline, BENADRYL, ZYRTEC prescribed by dr.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Varicella vaccination was administered via route intramuscularly instead of sub-1. Mother notified.
Age: 29.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Injection site pain, Swelling face
Clinical narrative: The patient reported facial swelling, soreness at injection site (left deltoid).
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Myalgia, Pain, Petechiae, Pruritus
Clinical narrative: 4-5 CM OF ERYTHEMA, ITCHING, FOCAL SORENESS. PATIENT ALSO COMPLAINED OF MYALGIAS. SYMPTOMS IMPROVED AFTER 3 DAYS WITH RESOLUTION OF SYMPTOMS.  RESIDUAL FOCAL PETECHIAE OCCUPYING A 1.5 CM AREA REMAINED.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, soreness, warmth at the injection site.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Chest discomfort, Cough, Eye swelling, Fatigue, Headache
Clinical narrative: Client left health dept and in car about 10 mins started sneezing and coughing. Went to restaurant and ate outside but continued sneezing and coughing with eyes watery. Got home about 2:45-3pm and took 20 minute nap. Woke up and chest was tight, throat was tight, eyes swollen, face and ears itchy. Father was home with her. Called health dept and closed, called PCP office and instructed to go to ER. Drove to ER in about 10 minutes and arrived about 4-4:30pm. Seen immediately. Given IV Benadryl, Epi Pen x1. States she felt better immediately. Observed x 2hours. Discharged home with Benadryl OTC to take on 8/8/14 and prescription for Prednisone 20 mg 3 tabs daily for 3 days, Epi Pen for use as needed. Today she feels fine but little tired from Benadryl. Had HA when first work up today but since gone.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Lacrimation increased, Pruritus, Sneezing, Throat tightness
Clinical narrative: Client left health dept and in car about 10 mins started sneezing and coughing. Went to restaurant and ate outside but continued sneezing and coughing with eyes watery. Got home about 2:45-3pm and took 20 minute nap. Woke up and chest was tight, throat was tight, eyes swollen, face and ears itchy. Father was home with her. Called health dept and closed, called PCP office and instructed to go to ER. Drove to ER in about 10 minutes and arrived about 4-4:30pm. Seen immediately. Given IV Benadryl, Epi Pen x1. States she felt better immediately. Observed x 2hours. Discharged home with Benadryl OTC to take on 8/8/14 and prescription for Prednisone 20 mg 3 tabs daily for 3 days, Epi Pen for use as needed. Today she feels fine but little tired from Benadryl. Had HA when first work up today but since gone.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chest pain, Chills, Computerised tomogram head abnormal, Concussion
Clinical narrative: Arm in area of injection started aching, muscles started aching throughout body, light headaches increased daily, light fever, had stomach ache, body chills, throat glands started swelling, ears started aching, developed tiredness, now have pink eye, developed post nasal drip, chest pain, dizziness.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Conjunctivitis infective, Dizziness, Ear pain, Fatigue, Head injury
Clinical narrative: Arm in area of injection started aching, muscles started aching throughout body, light headaches increased daily, light fever, had stomach ache, body chills, throat glands started swelling, ears started aching, developed tiredness, now have pink eye, developed post nasal drip, chest pain, dizziness.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Arm in area of injection started aching, muscles started aching throughout body, light headaches increased daily, light fever, had stomach ache, body chills, throat glands started swelling, ears started aching, developed tiredness, now have pink eye, developed post nasal drip, chest pain, dizziness.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Upper-airway cough syndrome
Clinical narrative: Arm in area of injection started aching, muscles started aching throughout body, light headaches increased daily, light fever, had stomach ache, body chills, throat glands started swelling, ears started aching, developed tiredness, now have pink eye, developed post nasal drip, chest pain, dizziness.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Headache, Migraine, Pyrexia
Clinical narrative: Fever, chills, headache, migraine.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Right and left arm edema and redness.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: Patient noticed big red area where injection was give (round area with a circumference of 2-3"; A little sore happened 2 days after injection.  Patient does not have fever.  Will use cold compresses and Benadryl and was told to use APAP if was painful.  Patient was instructed to seek medical treatment if area worsensed or fever developed.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Walk-in patient reports left upper arm pain that stated late in the evening on 8/6/14 and have continued to get worse each day. He reports he was unable to sleep last night due to the pain, shivering & night sweats. He received a Tdap vaccine on 8/6/14. Currently the pain is in the arm & radiates throughout the left arm into his upper chest & antecubital area. Left upper arm is red, firm to palpation & slightly swollen. Explained to patient that to treat with ibuprofen & ice, but also the option of ER precaution is available for treatment to help with symptoms. Records provided to patient if he desires to go to ER.  Patient verbalized understanding.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Insomnia, Night sweats, Pain in extremity
Clinical narrative: Walk-in patient reports left upper arm pain that stated late in the evening on 8/6/14 and have continued to get worse each day. He reports he was unable to sleep last night due to the pain, shivering & night sweats. He received a Tdap vaccine on 8/6/14. Currently the pain is in the arm & radiates throughout the left arm into his upper chest & antecubital area. Left upper arm is red, firm to palpation & slightly swollen. Explained to patient that to treat with ibuprofen & ice, but also the option of ER precaution is available for treatment to help with symptoms. Records provided to patient if he desires to go to ER.  Patient verbalized understanding.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local swelling, Pain, Skin warm
Clinical narrative: Localized swelling, warmth and pain. Cefdinir-300mg.-2 caps. po daily x 10 days.
Age: 42.0
Sex: M
Vaccine: HEPAB, IPV, MMR, MNQ
Symptoms: Arthralgia, Asthenia, Myalgia, Pyrexia
Clinical narrative: Fever (below 100 F), muscle/joint aches, weakness.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Pallor, Somnolence
Clinical narrative: About 3 minutes after vaccination with Tdap (LD), Hep A (LD), MCV4 (RD) and HPV (RD), client stated she was filling dizzy and did not feel good. She slumped over to her side and appeared to have a syncopal episode; she be came very diaphoretic and pale. when she awoke, she was groggy but A&Ox4. BP- 100/70 P- 80's. cold pack was applied to nape of neck and forehead.  Client was assisted to floor without difficulty. Allowed to rest. Once she started to feel less dizzy (approximately 10 minutes) she was assisted to a seated position and offered juice and crackers as tolerated. All symptoms and signs resolved within 15 minutes.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: About 3 minutes after vaccination with Tdap (LD), Hep A (LD), MCV4 (RD) and HPV (RD), client stated she was filling dizzy and did not feel good. She slumped over to her side and appeared to have a syncopal episode; she be came very diaphoretic and pale. when she awoke, she was groggy but A&Ox4. BP- 100/70 P- 80's. cold pack was applied to nape of neck and forehead.  Client was assisted to floor without difficulty. Allowed to rest. Once she started to feel less dizzy (approximately 10 minutes) she was assisted to a seated position and offered juice and crackers as tolerated. All symptoms and signs resolved within 15 minutes.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea, Vision blurred
Clinical narrative: After vaccination reported feeling nauseous and vision was "blurry". Denied shortness of breath, did not lose consciousness.  Educated on when to seek emergency care. Pt given juice and observed 15 minutes. Pt reported she was nervous and did not eat today.  Pt left with guardian, walked out of immunization clinic.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Fall, Hyperhidrosis, Pallor, Somnolence
Clinical narrative: About 5 minutes after vaccination with Tdap (LD) and MCV4 (RD), client was talking with RN and then appeared to have a syncopal episode; she be came very diaphoretic and pale, slumped to her side. RN lowered ct to the floor. When she awoke approximately 20 sec later, she was groggy but A&Ox4; was very upset and unsure why she was on the floor. BP- 130/90 P- 80's. cold pack was applied to nape of neck and forehead.  Client was allowed to rest. Once she started to feel less dizzy (approximately 10 minutes) she was assisted to a seated position and offered juice and crackers as tolerated. She began to feel dizzy again and was assisted to a supine position. After about 10 more minutes of rest, she was able to sit up and eventually stood up and sat in a chair. All symptoms and signs resolved and ct was escorted to her car with her mother.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: About 5 minutes after vaccination with Tdap (LD) and MCV4 (RD), client was talking with RN and then appeared to have a syncopal episode; she be came very diaphoretic and pale, slumped to her side. RN lowered ct to the floor. When she awoke approximately 20 sec later, she was groggy but A&Ox4; was very upset and unsure why she was on the floor. BP- 130/90 P- 80's. cold pack was applied to nape of neck and forehead.  Client was allowed to rest. Once she started to feel less dizzy (approximately 10 minutes) she was assisted to a seated position and offered juice and crackers as tolerated. She began to feel dizzy again and was assisted to a supine position. After about 10 more minutes of rest, she was able to sit up and eventually stood up and sat in a chair. All symptoms and signs resolved and ct was escorted to her car with her mother.