chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not reported. On an unknown date, the patients were vaccinated with improperly stored (OKA/MERCK) VARIVAX injection (dose, frequency, route and lot number were not provided). No adverse events were reported. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTP, PPV, RVX
Symptoms: Abdominal distension, Constipation, Decreased appetite, Faeces discoloured, Irritability
Clinical narrative: Constipation, green sticky poop that is much drier then previous bowel movements, very gassy and irritable.  Lack of appetite.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia, Somnolence, Speech disorder
Clinical narrative: He fell asleep at 3:30 pm went to wake him up a couple of times all he did was mumble. I called medical center. They told me it sound like a stroke to call 911. I did he was for two days there.
Age: 1.43
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: High fever, moderate swelling of nodules between jaw and ear.
Age: 0.52
Sex: F
Vaccine: DTAP, RVX
Symptoms: Pain, Respiration abnormal, Screaming, Skin warm
Clinical narrative: Friday At about 3PM I laid patient down for a nap. I looked at her often and she seemed fine. It wasn't until around 7PM when I noticed she was sleeping too long for a nap. When I woke her up for a feeding, her skin was HOT! She seemed very lethargic. She was panting as if in pain.  I gave her Motrin, removed her clothes and gave her a luke-warm bath.   After the bath, I tried to feed her, but she refused to eat. She was very fussy and wobbly. She was not herself. I figured the symptoms would be gone by Saturday. That night when she went to sleep she kept making strong jerking movements and panting in her sleep. It startled me. I took her temperature at about 1AM Saturday morning and it was 103.8! I gave her more medicine and did my best to cool her off. Saturday morning at about 8AM I took her temperature again and it was 103. I gave her Tylenol and called the Pediatrician. The nurse seemed to brush it off, told me to keep doing what Im doing and if her temp gets higher than 104 than take her to the ER. Her lack of concern angered me. All day Saturday my poor baby cried and screamed uncontrollably. Nothing comforted her. My daughter hardly EVER cries... if she needs something she whines like "mmmmmmmmm". Her brother and sister always make her smile, or distract her. No smiles, no babbling, no interest. Nothing. Saturday she would hardly look at them. As if her eyes wouldn't focus. She had a sleepy, lazy demeanor about her during the short periods when she wasnt crying Saturday. She was also staring in space for several minutes and making strange jerking movements.  Her fever would continuously rise between medicine doses. I kept giving her baths. I was only able to get her to eat 6oz of milk ALL DAY saturday. I recorded video of her non stop crying at 3Pm and 9Pm. I also recorded video of the date and time from google that day for video proof. Saturday night she was jerking in her sleep again. At 5AM Sunday, I took her Temperature rectally and it was 105.8!!!!!!!! I gave her medicine, got a cold rag on her head and I quickly got her to the nearest ER in her diaper only. When she arrived, her rectal temp there was 105.2. After she got blood drawn and received an IV and nose swabs. She was frightened by everyone that entered the room. One of the nurses also inserted the thermometer too far in her rectum, she screamed and cried. My sweet poor 6 month old angel should not have to be scared and put through this pain. I am so hurt by this, and I just want my daughter back to normal. I want my BABY back! I am battling her fever and she is not behaving as she did before. Everything from the hospital is documented if proof is required. Also, Friday right before receiving vaccines, I asked the doctor (a different doctor) if she knew about the previous event at her last vaccines. She looked at her chart and said, "no I don't see anything". WHY WOULD THEY NOT ADD IN THE NOTES, OR REPORT HOW SHE NEARLY PASSED OUT IN THEIR OFFICE AT 4 MONTHS WITHIN MINUTES OF RECEIVING DTAP!!! I am very hurt and angry. I just want my baby back.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient was experiencing stinging at the injection site a few days after she got the vaccine.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to male patient (her husband) of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On 05-DEC-2006, patient was vaccinated with first dose of PNEUMOVAX 23 (dose, frequency and route of administration were not reported). Then on 10-MAR-2010, the patient was vaccinated with second dose of PNEUMOVAX 23 (dose, frequency and route of administration were not reported). No adverse effects reported. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 11-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.27
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 3 month old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. The patient received oral, ROTATEQ (lot#, expiration date and dose not provided) on 16-MAR-2015, 19-MAR-2015, and 18-MAY-2015 (Inappropriate schedule of vaccine administration). No adverse effects had been observed or reported. Additional information is not expected because the physician asked not to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 30-APR-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 30-APR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reproted). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Bruxism, Chills, Feeling cold, Influenza
Clinical narrative: This medically confirmed spontaneous report (initial receipt 11-May-2015) concerns a 32 year-old male patient who had no known medical conditions and did not take any concomitant medications. The patient received FLUMIST in Jan-2005 and felt like he had the flu for four months which included the flu symptoms of a runny nose and malaise until Apr-2005 (self-resolved). He previously also received 'split influenza vaccine from bioCSL' (batch number 084911A) in 2009 with no issues. On 29-Sep-2010 at 1:30pm in the afternoon, the patient received intramuscular AFLURIA injection (batch number 0994911B) 0.5mL annually in the unspecified arm. The patient did not receive any other immunisations/injections that day. On 29-Sep-2010, at around 8-9pm, the patient felt increasing coldness. The patient felt extremely cold and his teeth were clattering so hard he thought they were going to break. The patient was shivering and every muscle in his body was tense. The patient's jaw was clenched but the patient's body was shaking uncontrollably. The patient's wife was concerned and wanted to take the patient to hospital but the patient refused. The patient's measured temperature was 100-101 degrees Fahrenheit. The symptoms slowly dissipated after 45 minutes. After one hour, the patient had minor shivers. The patient also had malaise and chills. On the next day, the patient felt achy like he was beat up. The patient was fine today (at the time of reporting). Antipyretic was not given. The outcome was recovered. Reporter's comments: The reporter stated that he had received flu vaccine before and this was the first time he had this reaction. The patient was exempt from receiving the flu vaccine.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Muscle tightness, Pain, Rhinorrhoea
Clinical narrative: This medically confirmed spontaneous report (initial receipt 11-May-2015) concerns a 32 year-old male patient who had no known medical conditions and did not take any concomitant medications. The patient received FLUMIST in Jan-2005 and felt like he had the flu for four months which included the flu symptoms of a runny nose and malaise until Apr-2005 (self-resolved). He previously also received 'split influenza vaccine from bioCSL' (batch number 084911A) in 2009 with no issues. On 29-Sep-2010 at 1:30pm in the afternoon, the patient received intramuscular AFLURIA injection (batch number 0994911B) 0.5mL annually in the unspecified arm. The patient did not receive any other immunisations/injections that day. On 29-Sep-2010, at around 8-9pm, the patient felt increasing coldness. The patient felt extremely cold and his teeth were clattering so hard he thought they were going to break. The patient was shivering and every muscle in his body was tense. The patient's jaw was clenched but the patient's body was shaking uncontrollably. The patient's wife was concerned and wanted to take the patient to hospital but the patient refused. The patient's measured temperature was 100-101 degrees Fahrenheit. The symptoms slowly dissipated after 45 minutes. After one hour, the patient had minor shivers. The patient also had malaise and chills. On the next day, the patient felt achy like he was beat up. The patient was fine today (at the time of reporting). Antipyretic was not given. The outcome was recovered. Reporter's comments: The reporter stated that he had received flu vaccine before and this was the first time he had this reaction. The patient was exempt from receiving the flu vaccine.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Joint range of motion decreased, Pain, X-ray
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 26 year-old male patient who had no known current illness, no concomitant medications, and no medical history. On 07-Oct-2014, the patient received AFLURIA injection (batch number T57305) via the intramuscular route in the right arm. On an unspecified date following the AFLURIA injection, the patient experienced the normal pain of injection which never stopped. The inflammation continued through February 2015 which limited arm motion, raising his hand, reaching his back, and across his chest. X-ray was performed. Physical therapy was prescribed for three times a week for four weeks. The outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the symptom of 'X-ray', and reported the patient presented at the Emergency Room. The authority reported symptom was 'pain'.
Age: 26.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Injection site pain, Mobility decreased, X-ray
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 26 year-old male patient who had no known current illness, no concomitant medications, and no medical history. On 07-Oct-2014, the patient received AFLURIA injection (batch number T57305) via the intramuscular route in the right arm. On an unspecified date following the AFLURIA injection, the patient experienced the normal pain of injection which never stopped. The inflammation continued through February 2015 which limited arm motion, raising his hand, reaching his back, and across his chest. X-ray was performed. Physical therapy was prescribed for three times a week for four weeks. The outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the symptom of 'X-ray', and reported the patient presented at the Emergency Room. The authority reported symptom was 'pain'.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Haematoma, Herpes zoster, Musculoskeletal pain, Pain
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). Other suspect therapies included influenza virus vaccine. There was not concomitant therapy reported. On 25-FEB-2015, the patient experienced a serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area to filled with blood and turned red". On 04-APR-2015, the patient was admitted to the hospital experienced with severe pain in her shoulder and injury area. On 06-APR-2015, the patient was found to have herpes zoster. The patient stated that she was in the 7th week of herpes zoster and the patient was still in pain and the symptoms were not subsided despite she was taking gabapentin. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of road traffic accident, pain in shoulder and pain injury area and hematoma were unknown. Additional information has been requested.    This spontaneous report as received from a female consumer of unknown age reporting on herself with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). Other suspect therapies included influenza virus vaccine. There was not concomitant therapy reported. On 25-FEB-2015, the patient experienced a serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area to filled with blood and turned red". On 04-APR-2015, the patient was admitted to the hospital experienced with severe pain in her shoulder and injury area. On 06-APR-2015, the patient was found to have herpes zoster. The patient stated that she was in the 7th week of herpes zoster and the patient was still in pain and the symptoms were not subsided despite she was taking gabapentin. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of road traffic accident, pain in shoulder and pain in injury area and hematoma were unknown. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Road traffic accident
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). Other suspect therapies included influenza virus vaccine. There was not concomitant therapy reported. On 25-FEB-2015, the patient experienced a serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area to filled with blood and turned red". On 04-APR-2015, the patient was admitted to the hospital experienced with severe pain in her shoulder and injury area. On 06-APR-2015, the patient was found to have herpes zoster. The patient stated that she was in the 7th week of herpes zoster and the patient was still in pain and the symptoms were not subsided despite she was taking gabapentin. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of road traffic accident, pain in shoulder and pain injury area and hematoma were unknown. Additional information has been requested.    This spontaneous report as received from a female consumer of unknown age reporting on herself with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). Other suspect therapies included influenza virus vaccine. There was not concomitant therapy reported. On 25-FEB-2015, the patient experienced a serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area to filled with blood and turned red". On 04-APR-2015, the patient was admitted to the hospital experienced with severe pain in her shoulder and injury area. On 06-APR-2015, the patient was found to have herpes zoster. The patient stated that she was in the 7th week of herpes zoster and the patient was still in pain and the symptoms were not subsided despite she was taking gabapentin. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of road traffic accident, pain in shoulder and pain in injury area and hematoma were unknown. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Haematoma, Herpes zoster, Injury, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). Other suspect therapies included influenza virus vaccine. There was not concomitant therapy reported. On 25-FEB-2015, the patient experienced a serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area to filled with blood and turned red". On 04-APR-2015, the patient was admitted to the hospital experienced with severe pain in her shoulder and injury area. On 06-APR-2015, the patient was found to have herpes zoster. The patient stated that she was in the 7th week of herpes zoster and the patient was still in pain and the symptoms were not subsided despite she was taking gabapentin. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of road traffic accident, pain in shoulder and pain injury area and hematoma were unknown. Additional information has been requested.    This spontaneous report as received from a female consumer of unknown age reporting on herself with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). Other suspect therapies included influenza virus vaccine. There was not concomitant therapy reported. On 25-FEB-2015, the patient experienced a serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area to filled with blood and turned red". On 04-APR-2015, the patient was admitted to the hospital experienced with severe pain in her shoulder and injury area. On 06-APR-2015, the patient was found to have herpes zoster. The patient stated that she was in the 7th week of herpes zoster and the patient was still in pain and the symptoms were not subsided despite she was taking gabapentin. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of road traffic accident, pain in shoulder and pain in injury area and hematoma were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated first and second doses of GARDASIL (dose, route not reported). The patient would be administered the third dose of GARDASIL 2 months late. The patient had not been administered this third dose of GARDASIL yet. No adverse effect reported. Additional information has been requested.
Age: 93.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Pruritus, Skin discolouration
Clinical narrative: This spontaneous report as received from a 93 years old male patient refers to himself. The patient's pertinent medical history was not provided. He had no drug reactions/allergies and was taking unspecified concomitant medications. In approximately 2014 (reported as "last year"), the patient was vaccinated with a dose of ZOSTAVAX (vial) (dose, route of administration, expiration date and lot # not reported). On approximately 24-APR-2015 (reproted as "2 to 3 weeks ago"), the patient began to experience itching on his breast, back and neck area. His left arm down to his elbow was red, and then there were the blue patch areas. The redness and blue patches had dissipated. He went to see his physician, and the physician stated it was allergy. Skin test was done and the patient was prescribed with CLARITIN. The itching continued and the patient went to see an unspecified allergist, who prescribed prednisone (manufacturer unknown) tablets. The physician didn't diagnose the patient with "shingles", but the patient felt he had "shingles" since an unspecified date in 2015. Neither treatment with CLAIRITIN nor prednisone (manufacturer unknown) had been effective for the itching (captured in MARRS# 1505USA010597 and MARRS # 1505USA010598). The patient sought medical attention via office visit. The outcome of adverse events was reported as not recovered at the time of the report. The relatedness between adverse events and ZOSTAVAX was unkonwn. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site swelling, Pain
Clinical narrative: C/O onset of symptoms the day after PREVNAR 13 vaccination. Stated increased temp to 102, chills, generalized body aches; "confined to bed"; c/o (L) arm (upper) swollen and red; follow up with PMD on 5/26/2015.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. Since an excursion in February 2015, unspecified number of patients, on unspecified date, were vaccinated with doses of GARDASIL (lot # J006850, expiration date 31-MAR-2015) (route not reported), which have been exposed to temperatures outside of recommended range allso reported as improperly stored vaccines. No concomitant medications were reported. No adverse effect (AE) had been observed or reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65 ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-May-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 05-MAY-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 15-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated by the medical assistant that on 11-MAY-2015, the adult patient was vaccinated with a pediatric dose of VAQTA 0.5 ml, intramuscular (lot #, dose and frequency were not reported), instead of the adult dose of 1.0 ml of VAQTA. Concomitant therapies were not reported. At the time of the report no adverse effects were reported. Additional information is not expected since there was not consent from the reporter to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age. The patient's medical history was not reported. On 20-MAY-2015, the patient was inadvertently administered a dose of PNEUMOVAX 23 lot # J011045, expiration date 15-MAY-2015, 0.5 ml, intramuscular. No adverse effects were reported. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 40 year old patient. Patient medical history and current condition was not reported. On an unknown date the 40 year old patient was vaccinated with GARDASIL series (dose and unspecified) (Inappropriate schedule of drug administration). Product quality complaint was not reported. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient received an improperly stored dose of GARDASIL (Lot number, expiration date, dose and route were not reported). There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to multiple unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown date the patients were vaccinated with GARDASIL (Lot# K007828, expiry: 02-MAR-2017 and lot# K007264, expiry: 02-MAR-2017) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 01-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Concurrent conditions or medical history were not reported. On 20-MAY-2015, the patient was inadvertently administered one dose of expired MMR II (Batch # J006140, lot # 1720AA, expiration date 17-APR-2015) (route unspecified). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a Company Representative referring to unknown number of patients of unknown age and gender. Many patients had unspecified medical histories. On an unknown date in 2012, these patients were vaccinated with ZOSTAVAX (lot#, expiration date, dose, frequency and route were not reported). Concomitant therapies included influenza virus vaccine (unspecified). The reporting pharmacist reported that these patients experienced shingles on an unknown date in 2012 after receiving ZOSTAVAX and influenza virus vaccine (unspecified) concomitantly or within two 2 weeks of each other. Outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. The patient received the first dose of GARDASIL (lot#, expiration date and dose not reported, intramuscular) on 19-DEC-2014 and administered the second dose of it (lot#, expiration date and dose not reported, intramuscular) on 21-MAY-2015 (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. On an unknown date, a dose of improperly stored PNEUMOVAX 23 lot# K007262, expiry date: 25-NOV-2015, which went below the temperature excursion over a 10 day span was administered. No adverse event reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65 ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 21-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unkonwn age and gender. Information regarding the patients' relevant medical history and concomitant medications was not reported. On unknown dates, the patients were vaccinated with a dose of ROTATEQ (oral, dose, lot# and expiration date were not reported) that was stored improperly. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, an expired sterile diluent (dose, frequency, route of administration, lot# and expiration date were not reported) was used to reconstitute (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported) and was inadvertently administered to a patient. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-MAY-2015, the patient was vaccinated with an expired dose of ROTATEQ (oral, the first dose in series, dose unknown, lot # J010966, expiration date 20-MAR-2015). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 30-APR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates approximately in 2015 (reported as since 20-FEB-2015), the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported), which were exposed to a temperature outside of the recommended range on 20-FEB-2015. No adverse experience had been observed or reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates approximately in 2015 (reported as since 20-FEB-2015), the patients were vaccinated with doses of PEDVAXHIB (dose, frequency, route of administration, lot# and expiration date were not reported), which were exposed to a temperature outside of the recommended range on 20-FEB-2015. No adverse experience had been observed or reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 42 year old patient. Patient medical history and current condition was not reported. On 19-MAY-2015 the patient was inadvertently vaccinated with ZOSTAVAX of dose 0.65 ml, once via subcutaneous route (Inappropriate schedule of vaccine administered). No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with a doses of improperly stored VAQTA (adult doses) (dose, frequency, route of administration, lot # and expiration date unknown). No adverse effects were reported. It was unspecified if the patients sought medical attention. Follow up information has been received on 29-APR-2015 from a healthcare worker. It was reported that more unspecified patients (unspecified number) received doses of improperly stored VAQTA (adult doses) (dose, frequency, route of administration, lot # and expiration dates unknown). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested. General details and analysis were updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with one dose of improperly stored GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017, dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 23-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 19-MAY-2015 the patient was vaccinated with one dose of improperly stored VAQTA vial 25/0.5, (lot#, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same reporter. Additional informatino has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 (lot, dose, route of administration not reported) as either second or third doses after previously receiving GARDASIL (lot, dose, route of administration not reported) as a first dose. No adverse symptoms were reported. The relatedness between the adverse event and suspect therapies was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (also the mother of the patients) via a company representative refers to two female patients of unknown age. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013 (reported as "unspecified date 2 years ago") the two patients were vaccinated with their first doses of GARDASIL (1 single shot, dose, route and lot number not reported). On an unknown date in 2013 (reported as "unspecified date 2 years ago") after receiving the vaccines, the patients fainted in the office. The patients sought unspecified medical attention. Therapy with GARDASIL was discontinued and was not reintroduced. The outcome of the events was reported as recovered on an unspecified date. The causality between the events and GARDASIL was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Swelling face
Clinical narrative: This spontaneous report as received from a registered nurse via other company Pfizer refers to a 73 year old female patient. Medical history and current condition of the patient was unknown. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose and route unknown). Concomitant medication was unknown. On an unknown date, the patient experienced facial swelling. The outcome of facial swelling was unknown. There was no product complaint reported. The registered nurse requested for medical information that since the patient experienced facial swelling in the past with a PNEUMOVAX23, vaccine, would it be contraindicated to give her the PREVNAR 13 vaccine. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to multiple unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown date the patients were vaccinated with ROTATEQ (Lot# K013411, expiry: 19-MAR-2016, lot# K006457, expiry: 09-MAR-2016 and lot# K016275, expiry: 20-APR-2016) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 21-MAY-2015 the patient was inadvertently administered an expired dose of PNEUMOVAX23 (lot # K005957, expiration date: 08-MAR-2015, 0.5 ml, once, intramuscular) (expired product administered). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to multiple unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown date the patients were vaccinated with M-M-R II (Lot# J014873, expiry: 21-NOV-2015, Lot# J004949, expiry 04-APR-2016 and lot # J000738, expiry 16-JAN-2016) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to a 1 year old patient. Pertinent medical history and reactions/allergies were unspecified. On 13-MAY-2015 the patient received PROQUAD (Merck), .5 ml, subcutaneous and VARIVAX (Merck) (inappropriate schedule of drug administration). Nurse also reported that the patient received PROQUAD (Merck), when he/she should have received M-M-R II (wrong drug administered). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 1993 the patient was vaccinated with a three dose series of hepatitis B vaccine (manufacturer unknown), and may have also received an extra dose, (dose, schedule, route, anatomical location, lot number and expiration date were unspecified) at that time. Concomitant therapies were not reported. Since an unknown date and at the moment of this report, the patient experienced hepatitis B antibody negative. The related between hepatitis B antibody negative and Hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.