chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMRV, FLUN4
Symptoms: Salivary gland enlargement
Clinical narrative: A report has been received from a physician concerning a 5 year old male patient. Medical history of the patient was not reported. Concomitant medications included diphtheria toxoid, pertussis vaccine acellular, tetanus toxoid and poliomyelitis vaccine inactivated. The patient had received nasal FLUMIST quadrivalent started on 11-SEP-2013. The reporter stated that the patient was seen at ER on the early hours of 19-DEC-2013 as parents noticed submandibular swelling but was not hospitalized. The reporter stated that the patient had croup infection which started on 16-DEC-2013, fever and cough. Patient was tested positive for influenza A and was prescribed TAMIFLU and steroids for his symptoms. Action taken with FLUMIST was not reported. Patient recovered from the event of flu A, croup and submandibular swelling on 20-DEC-2013. The company physician considered the events flu A, croup and submandibular swelling to be serious due to important medical event.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) regarding a patient of an unknown age and gender who on 25-JUL-2013 and 22-OCT-2013 was vaccinated with an improperly stored dose of GARDASIL exposed to 20F and 30 F. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) regarding a patient of an unknown age and gender who on 30-JUL-2013 was vaccinated with an improperly stored dose of GARDASIL exposed to 20F and 30 F. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.75
Sex: F
Vaccine: DTAP, FLUX, HIBV
Symptoms: Crying, Hyperhidrosis, Injection site pain, Insomnia, Pyrexia
Clinical narrative: Woke from sleep screaming around 11pm-12am, and wouldn't fall back to sleep. Pain at injection sites, trouble standing (injections in upper legs), inconsolable crying for 3+ hours, legs shaking, unable to sleep (even with Tylenol), vomiting, fever, sweating.
Age: 1.75
Sex: F
Vaccine: DTAP, FLUX, HIBV
Symptoms: Screaming, Tremor, Vomiting
Clinical narrative: Woke from sleep screaming around 11pm-12am, and wouldn't fall back to sleep. Pain at injection sites, trouble standing (injections in upper legs), inconsolable crying for 3+ hours, legs shaking, unable to sleep (even with Tylenol), vomiting, fever, sweating.
Age: 38.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Back pain, Eye pain, Injection site swelling, Lethargy, Migraine
Clinical narrative: Skin swelling around left deltoid area; shooting migraine headache causing pain around his left eye and pain runs down on his spine down to lower back; feels lethargic, but doesn't hinder his daily activities.
Age: 38.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Spinal pain
Clinical narrative: Skin swelling around left deltoid area; shooting migraine headache causing pain around his left eye and pain runs down on his spine down to lower back; feels lethargic, but doesn't hinder his daily activities.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid infection, Herpes zoster, Mass, Nerve injury, Rash erythematous
Clinical narrative: Pt had diagnosed shingles that caused nerve damage in forehead thus 2 doctors including her neurologist recommended that she receives the shingles vaccine. After vaccine she continued to get shingles episodes but this time the shingles are different, they are big red spots and lumps and it is very itchy. It was diagnosed as shingles by the doctor. Shingles episodes have continued and have to see ophthalmologist periodically of infections in eyelids. Doctor asked patient to continue with usual treatment, no changes were made.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Pt had diagnosed shingles that caused nerve damage in forehead thus 2 doctors including her neurologist recommended that she receives the shingles vaccine. After vaccine she continued to get shingles episodes but this time the shingles are different, they are big red spots and lumps and it is very itchy. It was diagnosed as shingles by the doctor. Shingles episodes have continued and have to see ophthalmologist periodically of infections in eyelids. Doctor asked patient to continue with usual treatment, no changes were made.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Arthralgia, Asthenia, Chills, Cough
Clinical narrative: This is first flu shot pt received in her life. Pt had fasted because had blood work appointment before flu shot. Pt has no egg allergies. Started with cough which then subsided. Then layed down and noticed heart was racing (83 beats/minute). White of eyes turned red like if had pink eye. There was sticky residue. Felt bloatness in stomach. Then chills started. Called doctor who directed her to ER. By then every single joint in body hurting/aching. Felt weak, light headed. Was given oxygen. They swabbed nose to test for influenza and was negative. Was given MOTRIN (6) and doctor ordered TAMIFLU and amoxicillin. Had 102 fever but resolved with TYLENOL. Continue taking TAMIFLU and amoxicillin. By Thursday eyes itched a bit but were better.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye discharge, Eye pruritus, Influenza virus test negative, Ocular hyperaemia
Clinical narrative: This is first flu shot pt received in her life. Pt had fasted because had blood work appointment before flu shot. Pt has no egg allergies. Started with cough which then subsided. Then layed down and noticed heart was racing (83 beats/minute). White of eyes turned red like if had pink eye. There was sticky residue. Felt bloatness in stomach. Then chills started. Called doctor who directed her to ER. By then every single joint in body hurting/aching. Felt weak, light headed. Was given oxygen. They swabbed nose to test for influenza and was negative. Was given MOTRIN (6) and doctor ordered TAMIFLU and amoxicillin. Had 102 fever but resolved with TYLENOL. Continue taking TAMIFLU and amoxicillin. By Thursday eyes itched a bit but were better.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Pyrexia
Clinical narrative: This is first flu shot pt received in her life. Pt had fasted because had blood work appointment before flu shot. Pt has no egg allergies. Started with cough which then subsided. Then layed down and noticed heart was racing (83 beats/minute). White of eyes turned red like if had pink eye. There was sticky residue. Felt bloatness in stomach. Then chills started. Called doctor who directed her to ER. By then every single joint in body hurting/aching. Felt weak, light headed. Was given oxygen. They swabbed nose to test for influenza and was negative. Was given MOTRIN (6) and doctor ordered TAMIFLU and amoxicillin. Had 102 fever but resolved with TYLENOL. Continue taking TAMIFLU and amoxicillin. By Thursday eyes itched a bit but were better.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 12-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOStAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOStAVAX lot # H)19999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 19-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. 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 physician refers to an unspecified number of patients. On an unknown date the patients might have been vaccinated with GARDASIL (lot #, expiration date, route and dose unspecified) that was exposed to temperature conditions that Merck cannot support. NO PQC. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Lichenoid keratosis, Lip dry, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a 70 years old female Licensed Practical Nurse refers herself with diabetes. On 16-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J004268, expiry date: 12-JUL-2014) (dose, location unspecified) ("one single shot" as reported), route as injection as reported for the prevention of shingles. The nurse stated that she was also using many other "unspecified medications" (names/dosages/frequencies/manufacturers unknown). On an unspecified date she developed "rash like bumps all over her body" after the ZOSTAVAX vaccine, she stated that "it did not itch at first". She stated that the rash had become progressively worse, and it now itches. It had spread to cover almost her entire trunk, her lower extremities, and her buttocks. She stated that when the rash itches and she scratches it, it developed a "whitish scaly appearance", and occasionally the lesions ooze and crust-over. She had only consulted her physician about her rash one time, and biopsy results indicated that she might have lichenoid dermatitis. She also stated that her lips were very dry, and she put an unspecified ointment on her lips often throughout the day. She stated that she would be consulting her physician on 15-JAN-2014. She stated that no steroids or antivirals had bene prescribed, and she was agreeable to submitting to a VZVIP test. Routine blood work was performed and no result was performed. At the time of report, the outcome of the events was not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin exfoliation, Skin lesion, Wound secretion
Clinical narrative: This spontaneous report as received from a 70 years old female Licensed Practical Nurse refers herself with diabetes. On 16-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J004268, expiry date: 12-JUL-2014) (dose, location unspecified) ("one single shot" as reported), route as injection as reported for the prevention of shingles. The nurse stated that she was also using many other "unspecified medications" (names/dosages/frequencies/manufacturers unknown). On an unspecified date she developed "rash like bumps all over her body" after the ZOSTAVAX vaccine, she stated that "it did not itch at first". She stated that the rash had become progressively worse, and it now itches. It had spread to cover almost her entire trunk, her lower extremities, and her buttocks. She stated that when the rash itches and she scratches it, it developed a "whitish scaly appearance", and occasionally the lesions ooze and crust-over. She had only consulted her physician about her rash one time, and biopsy results indicated that she might have lichenoid dermatitis. She also stated that her lips were very dry, and she put an unspecified ointment on her lips often throughout the day. She stated that she would be consulting her physician on 15-JAN-2014. She stated that no steroids or antivirals had bene prescribed, and she was agreeable to submitting to a VZVIP test. Routine blood work was performed and no result was performed. At the time of report, the outcome of the events was not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient of unknown gender. The pharmacist reported that on 16-JAN-2014, the patient received a dose of ZOSTAVAX (lot # J007857, expiration date: 28-SEP-2014) (0.6 ml, once, subcutaneously left deltoid). The patient received a dose of ZOSTAVAX that had been reconstituted with Sanofi Pasteur saline diluent. She (the pharmacist) stated that she was "busy", and she grabbed a diluent for a yellow fever vaccine; she stated, "The labels of Merck diluent and the Sanofi diluent were so similar, I didn't notice until I was documenting the vaccination after it was administered." The diluent that was used was NDC# 49281-912-01, lot # UH380AB, expiration date 15-MAR, and the volume was "between 0.5 and 0.6 mL" of 0.9% saline solution. The patient had not any adverse effect. 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 medical assistant refers to unspecified number of patients of unknown age. From 07-OCT-2013 to 16-DEC-2013, the unspecified number of patients might have vaccinated with doses of GARDASIL (lot number unspecified) (dose, route unspecified) that were exposed to temperature outside of the prescribed information which were not supported. No adverse effects were reported. It was unknown if the patient had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
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. On an unknown date the patients might have been vaccinated with RECOMBIVAX HB (lot 3, expiration date, route and route unspecified) that was exposed to temperature conditions that Merck cannot support. NO PQC. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age. From 07-OCT-2013 to 16-DEC-2013, the unspecified number of patients might have vaccinated with doses of RECOMBIVAX HB (lot number unspecified) (dose, route unspecified) that were exposed to temperature outside of the prescribed information which were not supported. No adverse effects were reported. It was unknown if the patient had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-APR-2011, the patient was administered with a dose of VARIVAX (Lot # 1004Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Age: 0.05
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a poison center refers to a 2 week old female patient. The patient's medical history included neonatal jaundice. On 20-JAN-2014 the patient was vaccinated with a dose of VAQTA one dose, injection route, once by accidental (lot number and expiration date were not reported). There was no concomitant medication or past drugs. The vaccine was not supposed to be provided to the patient. She had not received any other vaccines. No adverse reactions were observed 20 minutes post injection. No laboratory date was available. As of 20-JAN-2014 the patient would not continue to be given VAQTA accidentally. The outcome was unknown but was without adverse reactions at the time of the report. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-JUL-2011, the patient was administered with a dose of VARIVAX (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 27-JUL-2011, the patient was administered with a dose of VARIVAX (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 29-JUL-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 15-APR-2013 (lot number, dose, frequency and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 30-JUL-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 16-APR-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-SEP-2011, the patient was administered with a dose of VARIVAX (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Physician Assistant refers to a 3 week old patient of unknown gender. On an unknown date the patient was vaccinated with HepA vaccine (manufacturer unknown) (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The physician assistant stated that an unspecified Physician Medical Assistant had accidentally administered an unspecified HepA vaccine to a 3 weeks old patient on an unspecified date. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 10-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 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 was received from a health care worker (clinical assistant) refers to unspecified number of patients. On an unknown date the patient was vaccinated with MMR II injection, lot # J003623; expiry: 22-MAR-2015. On an unknown date clinical assistant stated that an unspecified number of unspecified patients may have been administered improperly stored MMR II on unspecified dates. No adverse effect reported. Outcome of the medication error was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 04-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site swelling, Skin reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23. No concomitant medications were reported. The pharmacist was informed by the patient that she had an allergic reaction PNEUMOVAX 23 on an unknown date. The allergic reaction was described as a local skin reaction at the injection site that was swollen. The outcome was reported as recovered. The patient sought medical attention by contacting the pharmacist and physician. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 28-JUL-2011, the patient was administered with a dose of VARIVAX (oka/merck) (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to 3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 09-APR-2013 (lot number: H031350; exp date: 21-FEB-2015) (dose, frequency and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 29-JUL-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Injection site erythema, Pain, Swelling
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB. On an unknown date the patient experienced flu-like symptoms, pain, swelling and injection site redness. The outcome of swelling, injection site redness, pain and flu-like symptoms was unknown. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site pustule
Clinical narrative: This spontaneous report as received from a pharmacist refers to his mother, a 78 year old female patient with allergy to CIPRO and allergy to DARVON. On 31-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, indication not reported) 0.65 ml, subcutaneous at left arm. On 12-JAN-2014 ("12 days after receiving") the patient developed 3 or 4 itchy pustules, the size of an eraser on a pencil, on her left arm at the injection site. The outcome of the events was reported as not recovered/not resolved. This is the one two cases received from the same reporter (related case # 1401USA009539). Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 13-JAN-2014 the patient was vaccinated with one dose of ROTATEQ (dose not reported, lot # J003813, expired date: 10-AUG-2014) (unspecified in series) that were improperly stored with exposure to 9C for up to 64 hours. They were not standard doses. No adverse effects reported. This is one of several reports from the same reporter. 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 a patient of unknown age. ON 13-JAN-2014 the patient was vaccinated with one dose of M-M-R II (dose not reported, lot # reported as J003005, expired date: 14-MAR-2014) (unspecified in series) that was improperly stored with exposure to 9C for up to 64 hours. They were not standard doses. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12 C for an estimated total time out of range of 10.5 hours. On 28-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 year old female patient. On 14-JAN-2014 the patient was vaccinated with VARIVAX (Merck), .5 ml, subcutaneous. Other suspect therapy included PROQUAD (Merck). On 14-JAN-2014, the patient received PROQUAD (lot number J007202/ exp. date 20-DEC-2014) 0.5 ml subcutaneously and then received VARIVAX (lotJ006806/ exp. date 30-MAY-2015) 0.5 ml subcutaneously. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 15-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estiamted total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 01-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months old patient of unknown gender. The patient's current conditions or medical history were not reported. On 09-JAN-2014, the patient was vaccinated with a dose of VAQTA route, lot and expiration date were not reported. No adverse effects reported. At the time of the report the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total tie out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00 ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time ou of range of 10.5 hours. On 01-APR-2013, the patient was vaccinated with an out of rang dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 16-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 05-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 22-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time to of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 04-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 08-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 03-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 01-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H01999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H01999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14c for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for estimated total time out of range of 10.5 hours. On 10-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 24-MAY-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCt-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCt-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 04-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of  9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H01999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 11-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 0.81
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria; Hives legs, buttocks, face.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: The patient was up by the front of the store with her husband and passed out. The manager on duty called 911. The paramedic came and took vitals and BP. Pt was deemed ok and she left with her husband. Did not go to hospital with paramedic.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 12-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 04-NOV-2013, the patient was vaccinated with an out of range doe of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H013576 is an invalid lot number for (Zoster Vaccine Live)). (Dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 05-SEP-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL on 05-SEP-2013, (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.