chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fall, Head injury, Hydrocephalus, Loss of consciousness
Clinical narrative: Patient received both vaccines at the pharmacy around 10:30am on 10/2/14 and indicated that she has not had her pneumonia vaccine in the past. Patient came back in around 2:30pm the same day to pick up a prescription unrelated to the vaccines. She did not complain of any adverse events at this time.  Patient's daughter came in on 10/4/14 reporting the patient became dizzy around 7pm on 10/2/14 while walking to the bathroom, fell down, hit her head and became unconscious. The patient's daughter reported that the doctors at the hospital said the patient had a small amount of "water on the brain" and they gave her a presciption for meclizine which her daughter picked up for her on 10/4/14. Her daughter said the patient spent 1 night in the hospital and the doctors were not sure if the vaccines could have caused her dizziness.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: Severe muscle aches, temp 102.3, localized swelling of right deltoid region, approximately 8cm diameter red area with 2 other 1cm small  areas, lymph node swelling under right arm.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: Achy everywhere, then chills, nausea and vomiting, headache.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Patient received influenza and Pneumovax. Influenza was tolerated well with no bleeding in left arm. Upon receipt of Pneumovax in right arm, significant bleeding occurred, and patient's tissue at site of injection almost had the texture of becoming fibrous and hard on palpitation. Patient was asked to stay in the pharmacy for 15 more minutes, at which time the swelling and fibrous nature of the site resolved significantly.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Patient called about 2 hours after receiving the vaccination and complained of headache and sharp shooting pains down the arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling cold, Hyperhidrosis, Injection site erythema
Clinical narrative: slight fever,light heated (almost fainted) profuse sweating then coldness, blood pressure was 81 over 53 weakness @ 2:30 AM  on Oct. 3 hot & redness soreness at injection site on Oct. 4 2014
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: slight fever,light heated (almost fainted) profuse sweating then coldness, blood pressure was 81 over 53 weakness @ 2:30 AM  on Oct. 3 hot & redness soreness at injection site on Oct. 4 2014
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nausea, Pain, Tremor
Clinical narrative: Patient reports today, from 10/1/14 to 10/3/14 she felt achy, nauseous, and shaky and her legs were weak.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Eye swelling, Fatigue, Pallor, Pyrexia
Clinical narrative: Swollen Eyes, Fever, Fatigue, Pale.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain in left shoulder and limited mobility, shooting pains down arm for 5 nights.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis, X-ray limb
Clinical narrative: Pain in left shoulder and limited mobility, shooting pains down arm for 5 nights.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Extreme dizziness, nausea.
Age: 32.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Local swelling, Pain
Clinical narrative: Swollen arm, redness at site, body aches, limited use of right limb.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Dyspnoea, Fatigue, Malaise
Clinical narrative: Difficulty taking deep breath. Fatigue. Dizziness/feeling of faint upon standing. Malaise.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Patient informed us of swelling and redness the following day. Went to MD and started antibiotics. Did not improve so pt was hospitalized for IV antibiotics. Left arm only.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 68  year old male patient with no medical history and no drug allergy. On 12-SEP-2014 the patient was vaccinated with ZOSTAVAX (reported as vial 19400 PFU, lot # K000726 expiry date: 09-JAN-2015, dose: 0.65 ml, route of administration: subcutaneous, arm). There was no concomitant medication. In approximately September 2014, after receiving the injection the patient experienced very swollen arm after receiving the injection/injection site was very swollen. No lab diagnostic was performed and no treatment was provided. The outcome of very swollen arm after receiving the injection/injection site was very swollen was not reported. The relatedness between ZOSTAVAX and very swollen arm after receiving the injection/injection site was very swollen was not reported. This one of several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug dose omission, No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report as received from a healthcare worker (medical supplier), calling on behalf of an unspecified client, refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. It was reported that, on an unknown date, 5 dose vial of PNEUMOVAX23 was under filled. On an unknown date, the patient missed a dose of PNEUMOVAX23 injection (dose, frequency, route of administration, indication, lot # and expiry date unspecified). No concomitant medications were reported. No adverse event was reported. 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 registered nurse refers to a patient of unknown age and gender.  Patient's concurrent conditions and relevant medical history was unknown. On 26-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot number, dose and route unspecified) that was exposed to temperatures outside of the proper storage range. Concomitant medications were unknown. No adverse event was reported. The outcome of the events was unknown. The causality of the events with (Oka/Merck) VARIVAX was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's relevant medical history and relevant past drug history were unknown. On 18-SEP-2014 (also reported as unknown date), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency unknown) lot # K009105, Expiration Date 21-JAN-2016, intramuscular in the left deltoid (indication reported as unknown). Concomitant therapies included FLUZONE every year, last dose of "FLUZONE" given on 18-SEP-2014 in the left deltoid intramuscularly. On 19Sep2014, the patient began experiencing fever, swelling and redness from elbow to shoulder pain, warmth, and tenderness in her arm. The patient went to see her doctor and was told that he did not know what it was. He was afraid that it might be cellulitis but said it was too soon to tell. The patient was started on KEFLEX. There was no relevant lab data. As of 20-SEP-2014, it is unknown if the patient was still on PNEUMOVAX 23 and the swelling, redness, fever, warmth, tenderness and pain were improving. The causality was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's relevant medical history and relevant past drug history were unknown. On 18-SEP-2014 (also reported as unknown date), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency unknown) lot # K009105, Expiration Date 21-JAN-2016, intramuscular in the left deltoid (indication reported as unknown). Concomitant therapies included FLUZONE every year, last dose of "FLUZONE" given on 18-SEP-2014 in the left deltoid intramuscularly. On 19Sep2014, the patient began experiencing fever, swelling and redness from elbow to shoulder pain, warmth, and tenderness in her arm. The patient went to see her doctor and was told that he did not know what it was. He was afraid that it might be cellulitis but said it was too soon to tell. The patient was started on KEFLEX. There was no relevant lab data. As of 20-SEP-2014, it is unknown if the patient was still on PNEUMOVAX 23 and the swelling, redness, fever, warmth, tenderness and pain were improving. The causality was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22 years old female patient. On 20-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot# J015378, expiry date: 09-APR-2016, dose, dose number, route of administration were not reported) that was improperly stored on 08-AUG-2014. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient's relevant medical history relevant concomitant medications, and relevant past drug history were unknown. On 20-SEP-2014 the patient was inadvertently vaccinated with PNEUNOVAX23 (dose and frequency unknown) lot # J004080, expired date 22-AUG-2014, intramuscular in the left deltoid. It was unknown if there was relevant lab data. The patient did not report any problems after receiving expired PNEUMOVAX23. As of 20-SEP-2014, it was unknown if the patient was still on PNEUMOVAX and the outcome of received expired PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: This spontaneous report was received from a 74 year old female patient with diabetes, codeine allergy, hypertension, thyroid issues and sulfa allergy, who was reporting on herself. On an unspecified date in 2014, reported as about "3-6 months ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, lot number and route of administration were not reported). Concomitant medications included the medications the patient took to treat her diabetes, hypertension and thyroid issues (the patient stated that she didn't know the exact names of her concomitant medications). In approximately August 2014, reported as "about a month ago", the patient experienced burning, tingling, and numbness in her left groin and hip after being administered ZOSTAVAX. The patient also reported that "her symptoms were constantly there and that sometimes he pain was worse than others". No treatment was given for the events. No lab diagnostic studies were performed. The patient did not seek medical attention. 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: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to two patients of unknown age and gender. On an unknown date in 2014 (reported as sometimes in the last two months) the patients were vaccinated with PNEUMOVAX23 (dose, strength not reported) (lot # K004148, exp date: 10-MAY-2014). The reporter stated that on an unknown date in 2014 the patients experienced extreme injection site reactions including swelling and redness. The outcome of events was unknown. The relatedness between events and PNEUMOVAX23 was not reported. No Product Quality Complaint (PQC) reported. The reporter stated that at least three patient's (two described in this report and one described in report #1409YSA013405) returned to the pharmacy with complaint about having bad reactions after vaccination with PNEUMOVAX23 with this lot #. The reporter requested lot check and would like to return the remaining vaccines with this lot and get replacements depending on the results of the lot check. This is one of several reports from the same reporter (other MARRS # 1409USA013405). 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 pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that an unknown number of doses of RECOMBIVAX HB, in (lot # and expiration date not provided) (dose  not reported) that were exposed to temperatures below 36 degrees F had been administered (dates unspecified). In the past 3 months the temperature in the refrigerator dropped below 36 degrees F, 8 different times, for a period of 30 minutes each time. The coldest temperature was 34.1 F, for a total time of 4 hours. No adverse effect reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 49 year old female patient. On 22-SEP-2014 (reported as today), the patient was vaccinated with an expired dose of RECOMBIVAX HB (dose number not reported) lot # J014312, expiration date 07-SEP-2014, 1 ml dose, intramuscular injection the right arm. No adverse effects were reported. No product quality complaint (PQC) involved. Additional information is not expected as no consent for contact was given.
Age: 1.54
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 18 month old patient of unknown gender. No concurrent conditions or medical history were provided. Approximately in May 2014, the patient was vaccinated with the first dose of VAQTA 25/05 (units not provided) injection, 0.5 ml injected intramuscularly (lot# and expiry date unspecified). On 30-SEP-2014, four months after the first dose, the patient was vaccinated with the second dose of VAQTA 25/05 (units not provided) injection, 0.5 ml injected intramuscularly (lot # K008254 with expiry date: 12-NOV-2015 (reported as: 11-DEC-2015). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 years old male patient. On 02-SEP-2014, the patient was vaccinated with a dose of GARDASIL (lot#: H012643, expiry date: 30-MAR-2015, dose, dose number, route of administration, date were not reported) that was improperly stored on 08-AUG-2014. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age. On an unknown date in 2014 (reported as sometimes in the last two months) the patient was vaccinated with PNEUMOVAX 23 (dose, strength not reported) (lot # K004148, exp. Date: 10-MAY-2014). The reporter stated that on an unknown date in 2014 the patient experienced swelling and redness on one whole side of the body. This patient was treated by her physician and given steroids and an antibiotic. The outcome of was swollen and red on one whole side of her body was unknown. The relatedness between events and PNEUMOVAX 23 was not reported. No Product Quality Complaint (PQC) reported. The reporter requested lot check and would like to return the remaining vaccines with this lot and get replacements depending on the results of the lot check. This is one of several reports from the same reporter (other MARRS # 1410USA001868). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient with no medical history and no drug allergy. It was reported that the patient was not pregnant. On 12-SEP-2014 the patient was vaccinated with ZOSTAVAX (reported as vial 19400PFU, lot # K000726, expiry date: 09-JAN-2015, dose: 0.65 ml, route of administration: subcutaneous, arm). There was no concomitant medication. In approximately September 2014, after receiving the injection the patient experienced very swollen arm/injection site was very swollen. The patient was seen by a physician and was treated with penicillin. No lab diagnostic was performed. The outcome of very swollen arms after receiving the injection/injection site was very swollen was unknown. The relatedness between ZOSTAVAX and very swollen arms after receiving the injection/injection site was very swollen was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood test, Diarrhoea, Dyspnoea, Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a female (not pregnant) patient who currently would have 22 years old (age at the AE onset unknown). No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route of administration, lot# and expiry date unspecified) in her unspecified gynecologist's office. No concomitant medications were reported. It was reported that the patient felt different on the night after receiving the injection (exact date unknown). She was nauseated and developed diarrhea and abdominal cramping with myalgia and shortness of breath on an unspecified date. She had no fever and there was no injection site reaction. The patient sought medical attention via visiting the physician on 22-SEP-2014. The patient was still having significant nausea. The physician had blood work drawn on the patient on an unspecified date. No results have been received at the time of report (25-SEP-2014). The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a physician refers to a female (not pregnant) patient who currently would have 22 years old (age at the AE onset unknown). No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route of administration, lot# and expiry date unspecified) in her unspecified gynecologist's office. No concomitant medications were reported. It was reported that the patient felt different on the night after receiving the injection (exact date unknown). She was nauseated and developed diarrhea and abdominal cramping with myalgia and shortness of breath on an unspecified date. She had no fever and there was no injection site reaction. The patient sought medical attention via visiting the physician on 22-SEP-2014. The patient was still having significant nausea. The physician had blood work drawn on the patient on an unspecified date. No results have been received at the time of report (25-SEP-2014). The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. Medical history and drug reactions or allergies were not specified. On 30-SEP-2014, also reported as yesterday, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot number and anatomical location were not reported). No adverse effects were reported. Concomitant medications were not specified. Additional information is not expected because consent for contact was not obtained.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On 29-SEP-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # H014196, expiration date 19-MAR-2014 (dose strength, route not reported). No adverse events were reported. The outcome of events reported is unknown. No product quality complaint was involved. 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 registered nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown dates in September 2014, those patient were vaccinated with doses of PROQUAD injections (lot # K006217 with expiry date: 29-OCT-2015 or lot # K007797 with expiry date: 29-NOV-2015; doses, routes of administration and indication unspecified), that underwent a temperature excursion, on unspecified dates between 03-SEP-2014 - 30-SEP-2014. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 20 years old female patient. On 28-AUG-2014 the patient was vaccinated with a dose of GARDASIL (lot# J015378, expiry date: 09-APR-2016, dose, dose number, route of administration were not reported) that was improperly stored on 08-AUG-2014. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from medical assistant refers to her daughter, a 13 year old female patient. Patient's concurrent conditions and relevant medical history was none. Patient had drug reactions/allergies to penicillin and amoxicillin. When the patient was ready for the kindergarten, she received M-M-R II (lot number, dose and route unspecified) on an unknown date. Concomitant medications was reported as none. The patient has been seen in an unspecified emergency room on an unspecified date. The patient sought medical attention but was not admitted to the unspecified hospital. After receiving M-M-R II the patient's arm swelled. The outcome of the event was reported as not recovered/not resolved. The causality of the event with M-M-R II was not reported. Product quality issue was not involved. This is one of the two reports regarding the same patient. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: Small blisters near area vaccine given. Could have been reaction to adhesive on Band-Aid.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The reporter stated that a dose of RECOMBIVAX HB, inj (lot# not provided) (dose not reported), that expired on 07-SEP-2014, was administered to a patient today (reported as on 18-SEP-2014), for prophylaxis. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. On an unknown date, the patient were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported) oral route. Co-suspect and concomitant therapies were not reported. The medical assistant reported dose of ROTATEQ that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports 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 was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. On an unknown date, the patients were vaccinated with dose of RECOMBIVAX HB (dose, dose number, lot number, expiration date and route were reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported doses of RECOMBIVAX HB that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unkonwn number of patients of an unknown gender and age. On an unknown date, the patients were vaccinated with a dose PEDVAXHIB (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported doses of PEDVAXHIB that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
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. Medical history and concurrent conditions were not reported. On 25-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 0.5, intramuscular, lot # J009827, expiration date 10-AUG-2014. Secondary and concomitant therapies were not reported. Pharmacist reported that patient was inadvertently administered PNEUMOVAX 23 that expired on 10-AUG-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, lot#, expiration date, anatomical location, route of administration not reported) that was improperly stored. Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Malaise
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 64 year old female patient. Current condition included drug allergy DEMEROL. The patient's medical history included, chicken pox as a child, developed shingles on an unknown date approximately in 2010 (four years ago), thyroid storm, appendix removal on an unspecified date approximately in 1979 (35 years ago) and unspecified knee surgery on an unknown date approximately in January 2014 (9 months ago). On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX, (dose unknown) (lot number not specified), subcutaneously. Concomitant therapies included ATIVAN. On 30-SEP-2014 (also reported as this morning) the patient wasn't feeling well at all, upon speaking with her doctor was informed that she developed shingles again (vaccination failure). No treatment was given. Patient sought medical attention by visiting the doctor this morning. The outcome was reported as not recovered. The causality was unknown. No product quality complaint was reported. This is one of several reports from the same source (1410USA000805-same patient). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 75 year-old female patient. In 2012, the patient was vaccinated with a second dose of ZOSTAVAX (dose, lot/batch number, expiration date and route were not reported). It was reported that the patient was vaccinated with the first dose of ZOSTAVAX (dose, lot/batch number, expiration date and route were not reported). On an unknown date, the patient developed shingles after receiving the second dose of ZOSTAVAX. No product quality complaint (PQC) involved. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 1 year old female patient with no pertinent medical history. On an unknown date, reported as second week of September (year not reported), the patient was vaccinated with a dose of M-M-R II (dose reported as required dosing, route and lot number were not reported) as a state required vaccine. Concomitant medications were not specified. On an unkonwn date, the patient experienced fever, red bumpy rash on the trunk of her body, vomited and fussiness while using M-M-R II. The patient sought medical attention. Treatment (unspecified) was given for the adverse events. The outcome of fever, red bumpy rash on the trunk of her body, vomited and fussiness was unknown. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to currently 63 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous single injection. Concomitant therapies included influenza virus vaccine (unspecified). On an unknown date, a couple years ago the patient experienced shingles. The patient reported he is not sure if he experienced shingles before or after ZOSTAVAX was administered. The patinet sought medical attention and visited a doctor. The outcome of shingles was unknown. The causality between the shingles and vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with asthma. On 16-SEP-2013, the patient was vaccinated with PNEUMOVAX 23 lot number H009826, expiration date 11-FEB-2014 (dose, strength and route were not reported. On 24-SEP-2014, the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular, lot number reported as K009809, expiration date 16-SEP-2015. Pharmacist reported that a patient received a dose of PNEUMOVAX 23 and then informed the pharmacist after she received a dose that she received a dose of PNEUMOVAX in 16-SEP-2013 (reported as "last year"). The patient had not experienced or demonstrated any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date in September 2014, the patient were vaccinated with doses of (Oka/Merck) VARIVAX injections (lot# J004160 with expiry date: 05-APR-2015; doses, routes of administration and indication unspecified), that underwent a temperature excursion, on unspecified dates between 03-SEP-2014 -30-SEP-2014. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 66 years old female patient. No information about medical history, concurrent conditions were reported. On 23-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (25/0.5y) (lot # K007773, expiration date- 01-MAY-2015) (dose strength, route not reported) in the left arm (also reported as left deltoid) 01-MAY-2015. The concomitant medications included unspecified seasonal allergy medications. The reporter stated that the patient, returned to the office on 24-SEP-2014 because she experienced redness, swelling and pain at the PNEUMOVAX 23 injection site on her left deltoid which developed approximately on an unknown date in September 2014. No lab diagnostic studies were performed. The physician suggested the patient to take Oral BENADRYL, LOTRISONE and Ibuprofen to address the symptoms and the patient symptoms subsided. The outcome events was reported as recovered/resolved approximately on an unknown date in September 2014. Product quality complaint was involved. The physician also stated that, does not want to use the other vaccines in the office with this same lot number as this result has recently happened to another patient in the office. This case is linked to the case 1409USA014229 via same reporter link. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of inj.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oral herpes
Clinical narrative: Pt's lower lip started swelling 1.5hrs after vaccine administration. MD diagnosed on 10/2/14 as fever blisters and patient has never had them before. Swelling has subsided as of 10/3/14.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Local swelling
Clinical narrative: Pt came into pharmacy on 10/3/14, she had swelling (blister like), shining, over entire outside of outer arm about the size of hand. She went to urgent care clinic and was given 2 antibiotics on 10/4/14.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left arm mild swelling and pain (on shoulder area of injection).
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Injection went in shoulder joint, severe pain and inability to use arm. We sent her to doctor, she received steroid, antibiotic, muscle relaxer.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Neuralgia
Clinical narrative: Muscle/nerve pain both arms.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Electrocardiogram normal, Laboratory test, Myalgia, Pain in extremity
Clinical narrative: Muscle/nerve pain both arms.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 19 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The register nurse reported that two patients (MARRS 1409USA012034) received improperly stored GARDASIL, exposed to 1C for 24 hours, on an unknown date.  Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register  nurse concerning a 13 year old patient. Medical history and concurrent conditions were not reported. On an unknown date, the patient ws vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The register nurse reported that two patients (MARRS 1409USA012031) received improperly stored dose GARDASIL, exposed to 1C for 24 hours. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Pt received flu vaccine (FLUZONE Quad) and PNEUMOVAX 23 both same day same arm (1" apart) 4 days later still had red mark, sore arm, slight raised area.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. On an unknown date, the patients were vaccinated with VAQTA (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported doses of VAQTA that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) 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 was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported doses of GARDASIL that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports from the same source. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 25 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date of 2010 (at age 23 years old), patient received the first dose of GARDASIL 0.5 ml, intramuscular (lot number and expiration date were not reported. On an unknown date of 2012 (at age 25 years old), the patient was vaccinated with second dose of GARDASIL 0.5 ml, intramuscular (lot number and expiration date were not reported). Medical assistant stated that patient received first dose of GARDASIL near the 23.5 year old (approximately in 2010), then the second dose of GARDASIL at 25 years old and the patient wanted to complete GARDASIL series and now she was 27 years old. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. Co-suspect and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, dose number and route were not reported) lot number K004204, expiration date 12-JAN-2017, expiration. Co-suspect and concomitant therapies were not reported. The medical assistant reported seven (7) doses of GARDASIL that were exposed to temperatures as low as 33 F since 18-AUG-2014, were administered to unspecified patients on unspecified dates. This temperature excursion was not supported. No adverse experience has been reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: Severe pain near the injection site. Became so severe (10) by 8:30 PM I contacted my doctor and the man at the store who gave me the vaccine. I took pain pills and the pain began to subside the following morning at 9:00 AM.  I was unable to leave my bed for 2 days and still I have pain at the site.  Not always and not as severe.  I just want to know what happened.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Oropharyngeal pain, Sinus congestion
Clinical narrative: Sinus Congestion, Sore Throat, Coughing, Hoarseness - Continued symptoms as of today 10/5/2014.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: Face swollen on both sides.  So bad on right side entire eye swollen shut almost completely.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Nausea
Clinical narrative: Sudden onset of dizziness and nausea, feeling weak and faint. Lasted approximately 15 minutes. Then had chills for additional 10 minutes. Then felt basically normal again.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Axillary pain, Injection site pain, Neck pain
Clinical narrative: Injection site right arm pain radiating to and into anterior, medial and posterior shoulder joint, including arm pit, elbow and right neck.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Blood pressure increased, Blood test, Computerised tomogram, Dysstasia
Clinical narrative: Could not stand or walk. Blood pressure and heart rate soared.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Heart rate increased, Neurological examination
Clinical narrative: Could not stand or walk. Blood pressure and heart rate soared.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Dysstasia
Clinical narrative: Could not stand or walk. Blood pressure and heart rate soared.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site joint pain, Injection site pain, Pyrexia, Restlessness
Clinical narrative: Fever lasting 2 weeks, but most importantly leg/joint pain a day after shots. Child began kicking legs and becoming restless at night complaining of leg pain, could not pinpoint exact spot but rather and all over pain in both legs (top/bottom). It is now October and child has complained every single night since her immunizations took place.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Headache, Nausea, Pain
Clinical narrative: Woke at 12 AM with cold sweats, dizziness, 101 fever, nausea, body aches, headache. Treated with fluids and 500 mg of Tylenol for fever/symptoms. Fever and symptoms sustained through 10/5/2014.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Woke at 12 AM with cold sweats, dizziness, 101 fever, nausea, body aches, headache. Treated with fluids and 500 mg of Tylenol for fever/symptoms. Fever and symptoms sustained through 10/5/2014.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Left arm pain for > 3 days after injection.  She experiences sporadic pain since injection in left arm.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations, Pyrexia
Clinical narrative: Patient reported racing heart (100 bpm) at rest and fever. He was encouraged to seek medical attention but did not. He reported the event 10/04/2014 about 9 am. A care call in the afternoon revealed that he was feeling much better.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Malaise, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Fever of 100.8 to 101.8 and still 101.8.  Pain in entire shoulder with blotches of red.  Headache, muscle pain entire body, malaise still continues 10/5/2014 at 12:40 PM. Tylenol and ibuprofen alternating does not reduce fever below 100.8. Pharmacist used multidose vial.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash macular
Clinical narrative: Fever of 100.8 to 101.8 and still 101.8.  Pain in entire shoulder with blotches of red.  Headache, muscle pain entire body, malaise still continues 10/5/2014 at 12:40 PM. Tylenol and ibuprofen alternating does not reduce fever below 100.8. Pharmacist used multidose vial.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Joint stiffness, Musculoskeletal pain
Clinical narrative: Shoulder area sore and stiff around injection site which never occurred with regular flu shot, similar to tetanus shot.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Malaise, Rhinorrhoea
Clinical narrative: Started with a runny nose; progressed during the night to include cough, headache, malaise and fatigue. Tylenol severe cold liquid helped, however I was sick for 4 days!
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Fatigue, Headache, Nasal congestion, Photophobia
Clinical narrative: After receiving flu vaccine on 10/2/14. 2 days later; extreme exhaustion, headache, nasal congestion, eye pain, sensitivity to light.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Inflammation, Injected limb mobility decreased
Clinical narrative: Patient had extreme soreness that began at the site of injection of the deltoid of her arm, extend down her arm to her wrist, over her shoulder, down her back, and along her ribcage.  She is in terrible pain and cannot reach her arm up over her head.  It is not getting better even though she has taken some naproxen to help with the inflammation. The pain is starting to interfere with her working her job.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal chest pain
Clinical narrative: Patient had extreme soreness that began at the site of injection of the deltoid of her arm, extend down her arm to her wrist, over her shoulder, down her back, and along her ribcage.  She is in terrible pain and cannot reach her arm up over her head.  It is not getting better even though she has taken some naproxen to help with the inflammation. The pain is starting to interfere with her working her job.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Fatigue, Glucose urine absent, Poor quality sleep, Urine ketone body absent
Clinical narrative: During evening of 10/04/2014. Pt stated he had persistent elevated blood sugar after receiving flu injection requiring more than usual insulin injections. Pt was fatigued from poor sleep, but showed no lasting effects. He reported to clinic A+Ox3 with no significant clinical findings. Pt was sent home to convalesce.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Varicella-like rash.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Delirium, Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: First very sore upper arm and shoulder only got worse through the night- High fever all night and following day- Nausea-delirium.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Unsure if infection or allergic reaction. Left arm became red, swollen, and painful. Redness and swelling covered majority of the back of the upper arm. Pt experienced fever and chills as well.