chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB.  No adverse symptoms reported. At the time of the report the action taken was not reported.  All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 09-JUL-2014 at 10:58 AM, the patient was vaccinated with an improperly the first dose of RECOMBIVAX HB (Thimerosal Free) intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 04-JUL-2014 at 11:39 AM, the patient received the RECOMBIVAX HB stored to 0-1 degree of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were within 2-8 degrees. The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordantly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was  identified and was not been used after 21-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected because all follow up information was received.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB.  No adverse symptoms reported. At the time of the report the action taken was not reported.  All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 18-JUN-2014 at 20:47, the patient was vaccinated with an improperly the first dose of RECOMBIVAX HB (Thimerosal Free) intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 09-JUL-2014 at 10:58 AM, the patient received the RECOMBIVAX HB stored to 0-1 degree of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were within 2-8 degrees. The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordantly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was  identified and was not been used after 21-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected because all follow up information was received.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Convulsion, Febrile convulsion
Clinical narrative: After 4 mo vaccine, baby had ? fever with seizures which were under control. After 6 mol; she again had febrile sz after vaccinated and went to ER.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Cough, Reaction to food additive, Urticaria
Clinical narrative: Generalized hives and persistent cough started within 5 minutes of immunizations given. All resolved after IM Epinephrine given.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from the registered nurse regarding 1 day old female patient who on 18-JUN-2014 at 15:49 P. M was vaccinated with improperly stored fist dose of RECOMBIVAX HB (thimerosal Free) (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, on unspecified dates (between May 14 and July 21) vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degree. Additional information is not expected because all follow up information was received.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anaphylactic reaction, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Rt upper arm redness, warmth, pain, and mild edema. S/s developed evening of vaccine administration per patient report. Tx - continue to monitor and if worsening seek f/u care - Emergent if needed with s/s of severe oraphylaxis educ. provided.
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patients pertinent medical history, drug reactions/allergies were not provided.  On 30-SEP-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23, Lot # J004332, expiration date on 26-SEP-2014. No adverse effects reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Palpitations
Clinical narrative: Patient came back an hour after the shot complaining of dizziness, heart racing. Did a BP check was 160/80. Patient said she usually has low BP. Caregiver took her to hospital. Patient was so dizzy they went to emergency room.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Head injury, Presyncope, Syncope
Clinical narrative: Fainted after leaving exam room, hit head on floor in waiting room, rested approx 1/2 hr in office. Evaluated by MD prior to leaving had snack here in office. No breakfast most likely due to vaso vagal episode.
Age: 8.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 8 year old male patient. On 20-SEP-2014 the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Patient reported redness, swelling, paiin, and fever after getting a flu and pneumonia shot in the left arm.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eye pruritus, Local swelling, Skin warm, Tenderness
Clinical narrative: 10/02/14 Received a call from patient's mother, that patient had received her flu vaccine on 9/20/14 and on Wednesday evening she had a 4 inch welt on her arm that was warm to touch, swollen, and painful to the touch and she had itchy eyes. Mom says they had applied warm compress's to her arm and the swelling has gone down, still some redness. She is wondering if this should be documented as a reaction, and maybe get FLUMIST in the future. She will have her continue to do warm compresses's and she is picking up BENADRYL for her as well. Any other recommendations, please advise, thanks.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: 10/02/14 Received a call from patient's mother, that patient had received her flu vaccine on 9/20/14 and on Wednesday evening she had a 4 inch welt on her arm that was warm to touch, swollen, and painful to the touch and she had itchy eyes. Mom says they had applied warm compress's to her arm and the swelling has gone down, still some redness. She is wondering if this should be documented as a reaction, and maybe get FLUMIST in the future. She will have her continue to do warm compresses's and she is picking up BENADRYL for her as well. Any other recommendations, please advise, thanks.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse regarding 1 day old female patient who on 28-JUN-2014 at 02:38 AM was vaccinated with improperly stored first dose of RECOMBIVAX HB (Thimerosal Free) (lot # J012520, expiration date 30-JAN-2016) dose not reported, intramuscularly. The reporting nurse stated that there were no adverse events (reported as zero) after the vaccination. The reporter stated that, on unspecified dates (between May 14 and July 21), vaccine storage temperature dropped to 0-1 degree in 18  different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degrees. This is one of several reports from the same source. Additional information is not expected because all follow up information was received.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to an 86 year old female patient. On 01-DEC-2011 the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration not reported). On 03-SEP-2014 the patient experienced shingles on the forehead and eye area. The patient started an unspecified antiviral medicine on unknown date. She went to see her physician on unknown date. The outcome of the event was reported as recovered/resolved on unknown date in September 2014. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Paralysis, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from nurse refers to a 23 year old male patient. The patient's medical history included chicken pox and had no drug reactions/allergies. On 11-SEP-2014 the patient was vaccinated with VARIVAX (Merck) 1350U (lot # K002922, expiry date: 26-FEB-2016) (dose, route, frequency not provided). Concomitant therapy included TORADOL and doxycycline. Nurse reported patient experienced paralysis and was diagnosed with Bell's Palsy (medically significant) on 13-SEP-2014. As treatment, patient was given 1000mg VALTREX one tablet by mouth for 3 times a day for 7 days and 10mg prednisone taper (manufacturer unknown) for 6 tablets daily for 5 days, 5 tablets daily for 5 days, 4 tablets daily for 5 days, 3 tablets daily for 5 days, 2 tablets daily for 5 days and 1 tablet daily for 5 days. Lab diagnostics studies were not performed. Patient did not recover from the reported event. Patient sought medical attention and went to see a doctor. Causality of the event was unknown. There was no product quality complaint. Upon internal review the event of Bell's palsy was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty Band-Aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received 25 September 2014: QUAL number updated.
Age: 39.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Antinuclear antibody negative, Blood thyroid stimulating hormone normal, Electromyogram normal, Hypoaesthesia, Immunoglobulins normal
Clinical narrative: This case was reported by a nurse (subject herself) and described the occurrence of paresthesia in a 39-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 July 2014, the subject received unspecified dose of FLUARIX (unknown route, injection site and batch number not reported). On 18 July 2014, 3 days after vaccination with FLUARIX, the subject experienced prickling, tingling in both feet. The subject also experienced numbness in both feet along with muscle weakness, severe muscle pain and muscle twitching. The subject visited doctor and reported that she still had the tingling sensation, pins and needles, along with muscle weakness and muscle pain. The subject also visited a neurologist and was currently querying for Guillain-Barre syndrome. At the time of reporting, the events were unresolved. Follow-up information received by a physician on 26 September 2014: The case was considered as serious (clinically significant) by the reporter. The batch number for FLUARIX was reported as AFLUA825AB but expiry date was not provided. Co-suspect products included AVAXIM (batch number H0227-03, expiry date unknown). Concurrent medical conditions included penicillin allergy and allergic reaction to antibiotics (Cephalexin). Regarding her alcohol abuse, the subject used to drink very little and seldom. The reporter considered the paresthesia, numbness in feet, muscle cramp, muscle twitching, muscle weakness and muscle pain to be possibly related to FLUARIX. Few lab tests were done (MRI, nerve conduction test, EMG, blood tests) and nothing abnormal was detected. Guillain Barre syndrome was not suspected.
Age: 39.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Liver function test normal, Muscle twitching, Muscular weakness, Myalgia, Nerve conduction studies normal
Clinical narrative: This case was reported by a nurse (subject herself) and described the occurrence of paresthesia in a 39-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 July 2014, the subject received unspecified dose of FLUARIX (unknown route, injection site and batch number not reported). On 18 July 2014, 3 days after vaccination with FLUARIX, the subject experienced prickling, tingling in both feet. The subject also experienced numbness in both feet along with muscle weakness, severe muscle pain and muscle twitching. The subject visited doctor and reported that she still had the tingling sensation, pins and needles, along with muscle weakness and muscle pain. The subject also visited a neurologist and was currently querying for Guillain-Barre syndrome. At the time of reporting, the events were unresolved. Follow-up information received by a physician on 26 September 2014: The case was considered as serious (clinically significant) by the reporter. The batch number for FLUARIX was reported as AFLUA825AB but expiry date was not provided. Co-suspect products included AVAXIM (batch number H0227-03, expiry date unknown). Concurrent medical conditions included penicillin allergy and allergic reaction to antibiotics (Cephalexin). Regarding her alcohol abuse, the subject used to drink very little and seldom. The reporter considered the paresthesia, numbness in feet, muscle cramp, muscle twitching, muscle weakness and muscle pain to be possibly related to FLUARIX. Few lab tests were done (MRI, nerve conduction test, EMG, blood tests) and nothing abnormal was detected. Guillain Barre syndrome was not suspected.
Age: 39.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Nuclear magnetic resonance imaging normal, Paraesthesia, Rheumatoid factor negative
Clinical narrative: This case was reported by a nurse (subject herself) and described the occurrence of paresthesia in a 39-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 July 2014, the subject received unspecified dose of FLUARIX (unknown route, injection site and batch number not reported). On 18 July 2014, 3 days after vaccination with FLUARIX, the subject experienced prickling, tingling in both feet. The subject also experienced numbness in both feet along with muscle weakness, severe muscle pain and muscle twitching. The subject visited doctor and reported that she still had the tingling sensation, pins and needles, along with muscle weakness and muscle pain. The subject also visited a neurologist and was currently querying for Guillain-Barre syndrome. At the time of reporting, the events were unresolved. Follow-up information received by a physician on 26 September 2014: The case was considered as serious (clinically significant) by the reporter. The batch number for FLUARIX was reported as AFLUA825AB but expiry date was not provided. Co-suspect products included AVAXIM (batch number H0227-03, expiry date unknown). Concurrent medical conditions included penicillin allergy and allergic reaction to antibiotics (Cephalexin). Regarding her alcohol abuse, the subject used to drink very little and seldom. The reporter considered the paresthesia, numbness in feet, muscle cramp, muscle twitching, muscle weakness and muscle pain to be possibly related to FLUARIX. Few lab tests were done (MRI, nerve conduction test, EMG, blood tests) and nothing abnormal was detected. Guillain Barre syndrome was not suspected.
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness and bump, all at the injection site. The subject didn't use a heavy duty Band-Aid. At the time of reporting, the events were still unresolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated.
Sex: U
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 Sep 2014, the subject received unspecified dose of FLUARIX (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty ban-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX injections and they had seen a higher number of injection site reactions. This is one of 7 cases reported by the same reported for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated.
Sex: U
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject didn't use a heavy duty Band-Aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated.
Sex: U
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty band-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated.
Age: 1.0
Sex: F
Vaccine: DTP, HEP, IPV, MMR, PPV, RV5, VARCEL
Symptoms: Abdominal distension, Adenoidal hypertrophy, Blood iron decreased, Developmental delay, Growth retardation
Clinical narrative: This case was reported by a consumer and described the occurrence of stopped growing in a 5-year-old female patient who received Hib vaccine. Co-suspect products included DTP (A or W not known), IPV, HepB, Pneumo, ROTATEQ, MMR and Varicella. The patient's past medical history included ear infection. Previously administered products included antibiotics, steroids, DTP, IPV, HepB, PCV-7, ROTATEQ (Batch number 0411F, expiry date 07 Dec 2007), DTP, IPV, HepB, PCV7, ROTATEQ, DTP, IPV, HepB, PCV7 and ROTATEQ. On an unknown date, the patient received Hib at an unknown dose. On 24th June 2007, the patient received DTP, IPV, HepB, Pneumo, ROTATEQ, MMR and Varicella. On 12th March 2011, unknown after receiving Hib and 3 years and 262 days after receiving Hib, DTP and HepB, the patient experienced stopped growing (serious criteria GSK medically significant) and stop developing. In July 2011, the patient experienced weight gain. In August 2011, the patient experienced learning issue. In October 2011, the patient experienced headache, In June 2014, the patient experienced sleep apnea, large tonsil and large adenoid. On an unknown date, the outcome of stopped growing, stop developing, learning issue and weight gain were not recovered/not resolved and the outcome of the sleep apnea and headache were unknown and the outcome of the large tonsil and large adenoid were recovered/resolved. It was not reported if the reporter considered the stopped growing, stop developing, sleep apnea, large tonsil, large adenoid, learning issue, weight gain and headache to be related to Hib, DTP and HepB. Additional details received from the reporter (patient's mother): her daughter was in 2 clinical studies. The patient received 3 injections but she did not know which vaccine the child received. The reporter believed that her daughter received Hib 3 times through clinical studies and 4 times through routine childhood vaccine administration. Unspecified time after pre-kindergarten shots the patient stopped moving forward with schooling and stopped developing. She was supposed to be in 3rd grade but she was testing on a 1st grade level. She acted like when was 4-5 years old. On 05 February 2014, the patient experienced weight gain in abdomen. The outcome of weight gain in abdomen was not recovered.
Age: 1.0
Sex: F
Vaccine: DTP, HEP, IPV, MMR, PPV, RV5, VARCEL
Symptoms: Headache, Learning disability, Sleep apnoea syndrome, Tonsillar hypertrophy, Weight increased
Clinical narrative: This case was reported by a consumer and described the occurrence of stopped growing in a 5-year-old female patient who received Hib vaccine. Co-suspect products included DTP (A or W not known), IPV, HepB, Pneumo, ROTATEQ, MMR and Varicella. The patient's past medical history included ear infection. Previously administered products included antibiotics, steroids, DTP, IPV, HepB, PCV-7, ROTATEQ (Batch number 0411F, expiry date 07 Dec 2007), DTP, IPV, HepB, PCV7, ROTATEQ, DTP, IPV, HepB, PCV7 and ROTATEQ. On an unknown date, the patient received Hib at an unknown dose. On 24th June 2007, the patient received DTP, IPV, HepB, Pneumo, ROTATEQ, MMR and Varicella. On 12th March 2011, unknown after receiving Hib and 3 years and 262 days after receiving Hib, DTP and HepB, the patient experienced stopped growing (serious criteria GSK medically significant) and stop developing. In July 2011, the patient experienced weight gain. In August 2011, the patient experienced learning issue. In October 2011, the patient experienced headache, In June 2014, the patient experienced sleep apnea, large tonsil and large adenoid. On an unknown date, the outcome of stopped growing, stop developing, learning issue and weight gain were not recovered/not resolved and the outcome of the sleep apnea and headache were unknown and the outcome of the large tonsil and large adenoid were recovered/resolved. It was not reported if the reporter considered the stopped growing, stop developing, sleep apnea, large tonsil, large adenoid, learning issue, weight gain and headache to be related to Hib, DTP and HepB. Additional details received from the reporter (patient's mother): her daughter was in 2 clinical studies. The patient received 3 injections but she did not know which vaccine the child received. The reporter believed that her daughter received Hib 3 times through clinical studies and 4 times through routine childhood vaccine administration. Unspecified time after pre-kindergarten shots the patient stopped moving forward with schooling and stopped developing. She was supposed to be in 3rd grade but she was testing on a 1st grade level. She acted like when was 4-5 years old. On 05 February 2014, the patient experienced weight gain in abdomen. The outcome of weight gain in abdomen was not recovered.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosages were not reported)  which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported.  Follow up information has been received from a pharmacist refers to a 66 years old male patient with peripheral neuropathy.  On 05-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (lot # J016257, expiration date: 20-FEB-2015) in the left arm (circle one). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient with diabetes. On 06-SEP-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (strength: 0.65 ml, route unknown lot J003805) that had an expiration date of 03-JUL-2014 (also reported as an unknown indication). The patient's concomitant medications and relevant past drug history were unknown. It was unknown was there relevant lab data. As of 06-SEP-2014, it was unknown if the patient was still on ZOSTAVAX and the outcome of receiving expired ZOSTAVAX was unknown. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosages were not reported) which was improperly exposed to defrost cycling up to 7F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No know adverse effects were reported.   Follow up information has been received from a pharmacist refers to a 71 years old patient of unknown gender. On 25-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, in the left arm (circle one). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Balance disorder, Crying, Eating disorder, Gait disturbance, Insomnia
Clinical narrative: This spontaneous report as received from a consumer refers to her 1 year old daughter. On an unknown date in August 2014, the patient was vaccinated with one shot of M-M-R II (lot# and strength unknown), 1 shot, injection for vaccine. On the same day, the patient also received a shot of TDAP (unspecified)  (lot #, strength, dosage and route unknown). The same day the M-M-R II was administered, the patient had a severe reaction . The patient's "equilibrium (reported as equillbrim) was off" and was constantly crying uncontrollably, ran a fever of 103 for 5 days, was taken to the emergency room (ER) twice, broke out in a rash and had inflamed lymph nodes all over her body. She did not want to walk, wasn't sleeping or eating. And according to an unspecified HCP, the patient might have caught a cold as well. The reporter stated these symptoms occurred all through August 2014. Treatment of being given fluids and an unspecified steroid had been give and blood work had been performed on unspecified date (result unspecified). The outcome of the events was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Lymphadenitis, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to her 1 year old daughter. On an unknown date in August 2014, the patient was vaccinated with one shot of M-M-R II (lot# and strength unknown), 1 shot, injection for vaccine. On the same day, the patient also received a shot of TDAP (unspecified)  (lot #, strength, dosage and route unknown). The same day the M-M-R II was administered, the patient had a severe reaction . The patient's "equilibrium (reported as equillbrim) was off" and was constantly crying uncontrollably, ran a fever of 103 for 5 days, was taken to the emergency room (ER) twice, broke out in a rash and had inflamed lymph nodes all over her body. She did not want to walk, wasn't sleeping or eating. And according to an unspecified HCP, the patient might have caught a cold as well. The reporter stated these symptoms occurred all through August 2014. Treatment of being given fluids and an unspecified steroid had been give and blood work had been performed on unspecified date (result unspecified). The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-SEP-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # J005848, strength and dose unknown) that had expired on 17-AUG-2014, subcutaneous. Other suspect therapies included PNEUMOVAX23 (strength, dose, route and lot# unknown) started on 16-SEP-2014. The ZOSTAVAX had also been improperly stored. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to 2 girl young patients of unknown age. On an unspecified date at an unspecified time, the patient was vaccinated with a dose of GARDASIL injection, 0.5 ml, once, intramuscular (lot # and expired date were not reported). Concomitant therapy was not reported. The 2 girl patients waited 30 minutes in office post vaccination then went to a local restaurant nearby (unspecified) where each girl fainted. An ambulance was called by restaurant personnel, the girl patients were determined to be "fine" and did not go to emergency department. A report of incident was made to an unspecified source. The patient present status was reported as "doing fine". The relationship  between adverse event and GARDASIL 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 as received from a nurse who refers to an unspecified group of patients of unknown age and gender. Patients' medical histories were not provided. On an unknown date the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency, route of administration and indication were not provided) (lot # reported as K008871, exp date: 19-DEC-2015). Concomitant medication was not reported. Firstly it was reported that the PROQUAD was stored at 75 F. The reporting nurse subsequently called back and corrected temperature range in which the PROQUAD was improperly stored at 14.5F. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Follow up information has been received from a pharmacist refers to a 69 years old female patient with knee problems. On 28-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (lot#K000994, expiration date: 06-MAR-2015) in the left arm. Concomitant therapy included influenza virus vaccine (unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients who received LIQUID PEDVAXHIB (lot#, dose, frequency and route unspecified) between 09-AUG-2014 and 06-SEP-2014. healthcare worker stated LIQUID PEDVAXHIB had been improperly stored with a low temperature of 33.6F for 6 hours. No adverse effects reported. Healthcare worker stated currently no patient data available.  This is one of several 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: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients who received GARDASIL (lot#, dose and frequency unspecified, intramuscular) between 09-AUG-2014 and 06-SEP-2014. Healthcare worker stated GARDASIL had been improperly stored with a low temperature of 33.6F for 6 hours. No adverse effects reported. Healthcare worker stated currently no patient data available. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 73 year old female consumer with blood pressure abnormal and cholesterol abnormal refers to herself. The patient had no drug allergies. On 17-SEP-2014 the patient was vaccinated with ZOSTAVAX (strength, dose, and lot # not reported), one single shot, subcutaneous injection. Concomitant therapies include "unspecified blood pressure and cholesterol medication". On 17-SEP-2014, the patient experienced redness and itching at the injection site. No treatment was given. No lab was performed. The patient did not sought medical attention. The outcome of redness and itching at the injection site was reported as not recovered/not resolved. Additional information is not expected because no reporter's contact information provided.
Age: 90.0
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Follow up information has been received from a pharmacist refers to a 90 years old patient of unknown gender. The patient's concurrent condition included scoliosis. The patient's medical history included heart attack. On 28-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (lot#K000994, expiration date: 06-MAR-2015) in the right arm (circle one). Concomitant therapy included Influenza virus vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Hyperhidrosis, Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a 56 year old male patient refers to himself. The patient was unsure if he had ever had chickenpox in the past. On 25-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route and lot # not reported). The patient's physician prescribed him the vaccine since the patient's wife was diagnosed with shingles the same date. The patient reported the first week after receiving the vaccine he felt fine. On 01-SEP-2014 (estimated date, reported as "the Monday following receiving the vaccine"), the patient reported he began "feeling poorly with a fever". The patient also reported he developed an injection site reaction around the same time as he began to feel poorly in which the place of the injection became red with "small red dots circling the injection site." On an unknown date in September 2014 ("later in the week"), he began experiencing "a low grade fever, feeling crappy, and sweating". The patient sought medical attention by visiting his physician on 03-SEP-2014, his physician reported to the patient he was experiencing "an injection reaction". The patient and his wife went traveling on 05-SEP-2014. On 06-SEP-2014, he woke up with hives all over his face and neck, which the patient reported was "full blown chickenpox". On the same day, 06-SEP-2014, he went to a hospital (hospital unspecified and it unspecified if he was admitted to the hospital). The patient reported he spent four hours in the unspecified hospital where he had his blood taken  placed (result not provided). The patient reported he was treated with VALTREX which the patient reported he took one gram three times a day for seven days. The patient also reported he was treated with an unspecified topical oil which he places all over his face and body. The patient reported he was currently feeling "fine" by the time of this report. The patient recovered on an unknown date in 2014. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia, Urticaria, Varicella
Clinical narrative: This spontaneous report as received from a 56 year old male patient refers to himself. The patient was unsure if he had ever had chickenpox in the past. On 25-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route and lot # not reported). The patient's physician prescribed him the vaccine since the patient's wife was diagnosed with shingles the same date. The patient reported the first week after receiving the vaccine he felt fine. On 01-SEP-2014 (estimated date, reported as "the Monday following receiving the vaccine"), the patient reported he began "feeling poorly with a fever". The patient also reported he developed an injection site reaction around the same time as he began to feel poorly in which the place of the injection became red with "small red dots circling the injection site." On an unknown date in September 2014 ("later in the week"), he began experiencing "a low grade fever, feeling crappy, and sweating". The patient sought medical attention by visiting his physician on 03-SEP-2014, his physician reported to the patient he was experiencing "an injection reaction". The patient and his wife went traveling on 05-SEP-2014. On 06-SEP-2014, he woke up with hives all over his face and neck, which the patient reported was "full blown chickenpox". On the same day, 06-SEP-2014, he went to a hospital (hospital unspecified and it unspecified if he was admitted to the hospital). The patient reported he spent four hours in the unspecified hospital where he had his blood taken  placed (result not provided). The patient reported he was treated with VALTREX which the patient reported he took one gram three times a day for seven days. The patient also reported he was treated with an unspecified topical oil which he places all over his face and body. The patient reported he was currently feeling "fine" by the time of this report. The patient recovered on an unknown date in 2014. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to unspecified patients of unknown age and gender. Medical assistant reported that an unspecified number of patients have received improperly stored (Oka/Merck) VARIVAX (dose, route of administration, lot numbers and expiration dates were not provided) during the past 11 days. No symptoms reported. This is one of several reports from the same source. Additional information is not expected, because there was no consent to contact physician.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to an unspecified number of patients. On an unknown date the patients were vaccinated with the third dose of 0.5 ml GARDASIL (strength and lot# unknown) intramuscularly (also reported as immunization). An unspecified number of patients reported an increased severity of pain with the third injection of GARDASIL, compared with the first and second doses on an unknown date. None of treatment was given for adverse event. The field representative confirmed with physician that these doses were administered correctly. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site vesicles, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 51 year old female patient with allergy to codeine. No other pertinent medical history was reported. On 17-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose: 0.65 ml, frequency and lot # were not provided). No concomitant medication was reported. On 17-SEP-2014, the patient experienced a small red area at the injection site. On 19-SEP-2014 also reported as "today", the patient sought medical attention, since she visited the nurse practitioner. On 19-SEP-2014 the patient had a vesicular rash at injection site, with the area directly around injection site, approximately 5 cm in diameter, displaying round, erythematous vesicles. The reporter stated that the surrounding affected tissue measures 17 cm by 7 cm of erythema. The patient was experiencing a lot of pain in the arm and at injection site (onset date of an unknown date in September 2014). No treatment was give for adverse event. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse refers to a 51 year old female patient with allergy to codeine. No other pertinent medical history was reported. On 17-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose: 0.65 ml, frequency and lot # were not provided). No concomitant medication was reported. On 17-SEP-2014, the patient experienced a small red area at the injection site. On 19-SEP-2014 also reported as "today", the patient sought medical attention, since she visited the nurse practitioner. On 19-SEP-2014 the patient had a vesicular rash at injection site, with the area directly around injection site, approximately 5 cm in diameter, displaying round, erythematous vesicles. The reporter stated that the surrounding affected tissue measures 17 cm by 7 cm of erythema. The patient was experiencing a lot of pain in the arm and at injection site (onset date of an unknown date in September 2014). No treatment was give for adverse event. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history was not provided. On 19-SEP-2014, the patient was vaccinated with expired dose of ZOSTAVAX (frequency and route of administration were not provided) (lot # J006156, exp date: 30-AUG-2014). Concomitant medication was not reported. No adverse effects were reported. Additional information is not expected, as there was no consent to follow up.