chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker referring to an 18 year old female patient who was not pregnant and had no pertinent medical history or drug allergies. On 28-JUN-2015, VARIVAX (Merck) (Lot# L006385, expiration date 25-FEB-2017) was improperly stored at an unspecified "high" temperature for an unspecified length of time. On 02-JUL-2015 the patient was vaccinated with this improperly stored dose of VARIVAX (Merck) (dose and frequency not reported), subcutaneously. Then on an unknown date in July 2015 the patient developed swelling at the injection site and pain in the arm in which the VARIVAX (Merck) was injected. No treatment was given for the events and no lab diagnostics studies were performed. The patient recovered from the swelling at the injection and pain in the arm on unknown dates in July 2015. Causality assessment was not provided. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Left arm at injection site very sore.  Condition has not improved since then.  Arm still sore.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vomiting
Clinical narrative: Severe headache and vomiting lasting 7 hours.
Age: 1.28
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Swelling of entire leg.  Happened in late morning / early afternoon and still continues to be swollen on 7/10/15. No treatment.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of MMR II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected, since there is no consent to contact the physician to follow up.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Cold sweat, Lethargy, Vomiting
Clinical narrative: Mom called the office on 7/9/15 stating shortly after arriving home child "seemed lethargic and lazy". Mom reported he did not eat dinner and went to bed at 6:30pm. Mom checked on him at 9:30pm and found he had possible two separate events of vomiting, felt clammy to the touch. Mom did not check his temp. Child is home with parent today and doing well no events of vomiting.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Pt had PREVNAR 13 on 6/30/15. That evening he developed fist size area of injection site. Raised, red, not hot to touch. The next day hives developed around bicep. No drainage, pain or itching noted.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 12-OCT-2011 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# were not reported). On 12-DEC-2011 the patient was vaccinated with the second dose of GARDASIL (dose, route and lot# were not reported). The patient has not yet received the third dose of GARDASIL at the time of this report. The patient did not report any adverse experiences. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. On 17-NOV-2008, the patient was vaccinated with the first dose of GARDASIL (route of administration, dose, lot number and expiry date were not reported), on 19-JUN-2013, with the second dose of GARDASIL (route of administration, dose, lot number and expiry date were not reported) and on 29-SEP-2014, with the third dose of GARDASIL (route of administration, dose, lot number and expiry date were not reported). On 06-JUL-2015, today, the patient received a dose of GARDASIL 9 (route of administration, dose, lot number and expiry date were not reported). No adverse effect was reported for GARDASIL or GARDASIL 9. 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 an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL (0.5 ml, lot # K006960 (expiration dates, route and site of administrations were not reported)) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. The health care professional explained that the shipment was received on 29-APR-2015, therefore went under only one excursion of 63 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 19-MAY-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot # K018961; expiry: 15-OCT-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site streaking, Injection site swelling, Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient with drug hypersensitivity. The patient was allergic to penicillin. On 22-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 0.5 ml/1 dose (lot # K020795 and expiry date of 19-MAR-2016), intramuscular in the left deltoid. On 23-JUN-2015, 2 days after onset of therapy the patient experienced rash and swelling at injection site and had a red streak running from the injection site and around the back of the arm and into the armpit. The patient sought medical attention and called the pharmacist and was advised to "seek medical attention if he feels he needs to". No treatment was received in response to the events. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. No concurrent conditions, medical history and drug allergies reported. On 18-JUN-2015 the patients were vaccinated with improperly stored PROQUAD (Merck) (lot number L005297 and expiry date 17-AUG-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with PROQUAD (Merck) was unknown. The outcome of the events to the therapy with PROQUAD (Merck) was unknown. The relatedness of the events to the therapy with PROQUAD (Merck) was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with MMR II (dose and route of administration no provided). No concomitant therapy was reported. The physician reported that nursing students were required to have titers done for MMR II prior to working in the hospital and physician had seen may students who received this vaccine as part of their childhood vaccines, showing low titers for MMR components. The patients sought medical attention. Booster dose was administered as a treatment. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. 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 unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, since 12-JUN-2015, the unspecified number of patients were administered an unspecified number of improperly stored doses of PEDVAXHIB (lot #K025002, expiration date 20-JUL-2017) (dose, frequency, route of administration and indication 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: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with VARIVAX (Merck), (0.5 ml, subcutaneous). No concomitant therapy was reported. It was reported that improperly stored VARIVAX (Merck) doses had been administered (Incorrect Product Storage). No adverse effects was reported. The outcome of the event was unknown. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 07-JUL-2015 the patient was inadvertently vaccinated with an expired dose of M-M-R II, lot # J007929 with expiry date 28-JUN-2015 (dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history or drug allergies were not reported. On unknown dates, multiple unspecified patients received improperly stored GARDASIL (lot#, expiration date, strength, dose, frequency and route were unknown). The patients' concomitant medication was not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 year old male patient with a medical history of unspecified allergic reaction to penicillin in 2006. On an unknown date, the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (dose was not reported, lot # K021485, expiry date 03-NOV-2016). Concomitant medications included CONCERTA and PROZAC. On 07-JUL-2015, after being vaccinated, the patient experienced grand mal seizure. The patient sought medical attention in July 2015, but no treatment was given and no lab diagnostics studies were performed. The patient recovered on 07-JUL-2015. The relatedness between the event of grand mal seizure and VARIVAX (Merck) was not reported. Upon internal review, the event of grand mal seizure was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number L001325 and expiry date 13-JAN-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with vaccinated with (Oka/Merck) VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with vaccinated with (Oka/Merck) VARIVAX was unknown. There was no product quality issue reported. This is one of the many reports from the same source. 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 pharmacist refers to a 10 patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 24-JUN-2015, 10 plastic syringes were pre-filled with GARDASIL and then were refrigerated. On 25-JUN-2015, the 10 patients was vaccinated with GARDASIL intramuscular (dose, lot # and expiration date were not reported). The patient received a doses of GARDASIL that was stored improperly. No known adverse effects. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Mass, Pain
Clinical narrative: This spontaneous report as received from a physician refers to her/his 16 year old female daughter. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported) and concomitantly with a dose of MENACTRA (dose, route of administration, lot # and expiration date were not reported). It was reported that approximately 3 weeks later, the patient developed an "unresolving mass" which the reporter was sure was an abscess. IT was also reported that the patient was in extreme pain. No treatment was given for the adverse events. The outcome of the adverse events was unknown. The relatedness between the adverse events and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # K021485, expiration date 03-NOV-2016, through an unspecified route. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 28 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. Approximately on an unknown dates when the patient was 26 years or younger, she was vaccinated with first and the second dose of GARDASIL series intramuscularly. On 26-JUN-2015 (reported as today), the patient was in the office to receive her third dose of GARDASIL and now she was 28 years old. No adverse effect was reported. Action taken was not applicable. The outcome of Inappropriate schedule of drug administration and No adverse effect was unknown. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Blood electrolytes normal, Chest X-ray normal, Febrile convulsion, Full blood count normal
Clinical narrative: Child had a febrile seizure on 6/16/15-had PREVNAR, Hepatitis A and Hib vaccines on 6/15/15.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old female patient. On 09-JUN-2015 the patient was subcutaneously vaccinated against chickenpox with single dose of (Oka/Merck) VARIVAX (dose: 0.5 ml, lot # K008822 with expiration date: 19-JUN-2016. Concomitant therapies included MYCOSTATIN. On 21-JUN-2015, 11 days post vaccination, the patient experienced rash on her face, mouth and trunk. No treatment was given for adverse event. No lab diagnostic studies were performed. The patient sought medical attention by visiting unspecified urgent care facility. The outcome of rash was reported as recovered/resolved on 22-JUN-2015. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myasthenia gravis, Systemic lupus erythematosus
Clinical narrative: Information has been received from the customer concerning a female subject of unknown age enrolled in an unknown study. On an unknown date the subject was vaccinated with GARDASIL. As per the subject self-reported, she did not know if she finished all the doses of GARDASIL during the study period. The subject wanted to report that she was diagnosed with systemic lupus erythematous and myasthenia gravis after she participated in the study. No further information about the adverse events was provided. The reporter was inquiring about the records from the study that the subject participated back 10 to 12 years ago. No subject number, site number or investigator's name was reported. It was attempted to reach the subject to not avail to get her full demographics. Both events were considered medically significant. Relatedness between the event and the study therapy was not reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored Oral, ROTATEQ (Lot #, dose and route were not reported). No symptoms were reported. This is one of the several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 (Lot #, dose and route were reported). No symptoms were reported. This one of the several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (Lot #, dose and route were not reported). No symptoms were reported. This is one of the several reports 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 was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARADSIL (Lot #, dose and route were not reported). No symptoms were reported. This is one of the several cases from same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (Lot #, dose and route were not reported). No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Myalgia. Severe joint pain.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a registered nurse and refers to an unspecified number of patients of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K008334, expiration date 09-JUN-2016, through an unspecified route. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reprots received from the same source. 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 registered nurse and refers to an unspecified number of patients of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017, through an unspecified route. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. Pertinent medical history was unspecified by reporter. Drug reactions/allergies were none. Concomitant therapies included COREG and lisinopril (manufacturer unknown). On 24-JUN-2015, the patient was vaccinated with ZOSTAVAX, lot # K015310, expiry date 17-DEC-2015, 1 shot (DF), subcutaneously, for prevention of shingles. On 26-JUN-2015, the patient experienced a painful knot at injection site and also redness around the area as well as feeling a little woozy after administration of ZOSTAVAX. The patient was seen by the pharmacist where meclinzine and ibuprofen were administered as well as ice put on the area for medical attention. Lab diagnostics studies performed were reported as none. The outcome of the events were recovering. Causality was not provided. Patient sought medical attention. No product quality complaint (PQC) was involved. No further adverse event information reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of VAQTA lot # K005958, expiration date 09-FEB-2017, through an unspecified route. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous reprot as received from a medical assistant and physician via company representative refers to an 84 year old male patient. Medical history and concurrent conditions were not reported. On an unknown date in 2015 at the beginning of an unspecified week, the patient was vaccinated in another medical center with a dose of ZOSTAVAX vial. Concomitant medications was unknown. On an unknown date in 2015 by the end of the same week of vaccination, the patient experienced shingles (herpes zoster). The patient's shingles were so bad that the patient had called the clinic (sought medical attention) crying in pain and asking for pain mediations (pain). The patient was treated with acyclovir. The patient had an appointment in the medical center where he was vaccinated. Action taken was not applicable. The outcome of herpes zoster and pain was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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. No concurrent conditions, medical history and drug allergies reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with vaccinated with (Oka/Merck) VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with vaccinated with (Oka/Merck) VARIVAX was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K003407 and expiry date of 06-MAR-2016 and lot # L000453 with expiry date of 06-JAN-2017) subcutaneous. The nurse did not know which lot of VARIVAX (Merck) the patient received. Concomitant medications were not reported. There were no adverse effects. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Blood test abnormal, Chills, Endoscopy normal, Headache, Inflammatory marker increased
Clinical narrative: Uncontrollable shaking, teeth chattering, seizuring, debilitating headache just several hours after receiving DTaP and flu shot.
Age: 35.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Seizure, Tremor, White blood cell count decreased
Clinical narrative: Uncontrollable shaking, teeth chattering, seizuring, debilitating headache just several hours after receiving DTaP and flu shot.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Pain, Swelling
Clinical narrative: Swelling, redness, pain, headache.
Age: 0.69
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood test, Computerised tomogram, Culture urine, Cyanosis, Electroencephalogram
Clinical narrative: Woke up screaming in pain, I thought she had a fever but didn't have a chance to take her temperature. She went unresposive within 4 or 5 mins of waking. Eyes stuck in downward gaze and she stiffened and turned blue around lips. I called 911 immediately and she was rushed to the hospital via ambulance to a nearby city. She was having a seizure and unresponsive to pain and everything and it lasted a little over an hour until 2 differrent seizure medications were administered at the hospital.
Age: 0.69
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Gaze palsy, Lumbar puncture, Musculoskeletal stiffness, Pain, Screaming
Clinical narrative: Woke up screaming in pain, I thought she had a fever but didn't have a chance to take her temperature. She went unresposive within 4 or 5 mins of waking. Eyes stuck in downward gaze and she stiffened and turned blue around lips. I called 911 immediately and she was rushed to the hospital via ambulance to a nearby city. She was having a seizure and unresponsive to pain and everything and it lasted a little over an hour until 2 differrent seizure medications were administered at the hospital.
Age: 0.69
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Seizure, Skin warm, Unresponsive to stimuli
Clinical narrative: Woke up screaming in pain, I thought she had a fever but didn't have a chance to take her temperature. She went unresposive within 4 or 5 mins of waking. Eyes stuck in downward gaze and she stiffened and turned blue around lips. I called 911 immediately and she was rushed to the hospital via ambulance to a nearby city. She was having a seizure and unresponsive to pain and everything and it lasted a little over an hour until 2 differrent seizure medications were administered at the hospital.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Injection site reaction, Muscle twitching
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to a 31 year old male patient. No relevant medical history or concurrent conditions were reported. The patient was vaccinated with two pediatric doses of RECOMBIVAX HB (dose not reported), on 28-MAY-2015 (lot #010535, expiration date not reported) and 28-JUN-2015 (lot# K020216, expiration date not reported) respectively, intramuscularly in the left deltoid. On an unknown date in 2015, the patient experienced muscle twitching in the left deltoid. The patient sought medical attention by reporting the event to the reporter's department. The outcome of muscle twitching was unknown. Causality between muscle twitching and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 unspecified patients of unknown age and gender. Medical history concurrent conditions and concomitant medications were not reported. On unspecified dates, the 2 patients were vaccinated with a dose of ZOSTAVAX (lot # L000449, expiry date: 08-MAR-2016) which were exposed to temperatures outside of the recommended range. No adverse effect was reported. Action taken was not applicable. The outcome of incorrect product storage and no adverse effect was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 08-JUL-2015, the patient was vaccinated with VARIVAX (lot # J007680, dose and route of administration not provided). No concomitant therapy was reported. It was reported that the patient was inadvertently administered a vaccine which had expired on 13-JUN-2015. No adverse effects was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The consumer obtained the information from a website through e-mail with a link to an article on-line. The patient's current conditions and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL (unknown route and strength). Concomitant medications were not reported. It was reported that the patient experienced adverse event while on GARDASIL (unknown date). The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient experienced unspecified injection site reaction. The outcome of injection site reaction was unknown. Causality assessment was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HIBV, PPV
Symptoms: Ear infection, Eye infection, Gene mutation identification test, Pyrexia, Rash generalised
Clinical narrative: Fever started and lasted for 4 days. The peak (tested) was 104.4.  Took to a different doc. and learned she also got an ear infection, something she doesn't get. Doc said they OFTEN SEE IT IN THOSE WITH THE PCV13 Shot! This turn into a double eye infection and she also got a full body rash and return of fever.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Feeling hot, Flushing, Throat irritation
Clinical narrative: Face flushed and hot, especially cheeks, continual clearing of throat, changing voice.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, 0.5 ml, intramuscular. No adverse effects was reported. Action taken was not applicable. The outcome of incorrect product storage and no adverse effect was unknown. Additional information has been requested.
Sex: F
Vaccine: MEN
Symptoms: Hypoacusis, Meningitis meningococcal
Clinical narrative: Initial unsolicited report received from a health care professional on 30 June 2015. A female patient, whose medical history and concomitant medications were not reported, had received twice Meningococcal vaccine (batch number, route of administration, site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, the patient experienced meningococcal meningitis and lost some hearing. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient was recovering from meningococcal meningitis and outcome of lost some hearing was unknown. Upon medical review, the case was considered as serious due to important medical event: meningococcal meningitis. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Differential white blood cell count, Erythema, Full blood count, Local swelling
Clinical narrative: PREVNAR was given on 7-7-15 next morning developed chills, fever, and local redness and swelling. Burning pain an warm to touch pt treated with prednisone x 5 days apt made for recheck in 2 days in office.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia, Skin warm
Clinical narrative: PREVNAR was given on 7-7-15 next morning developed chills, fever, and local redness and swelling. Burning pain an warm to touch pt treated with prednisone x 5 days apt made for recheck in 2 days in office.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Localized circular rash at injection site, itchy.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Injection site became a red swollen knot that was warm to the touch for 5-6 days.  Days 2-3 were also characterized by fatigue/flu-like symptoms.  After 5-6 days the red knot transitioned to a red rash that covered majority of the upper arm.  The rash was warm to the touch and extremely itchy.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became a red swollen knot that was warm to the touch for 5-6 days.  Days 2-3 were also characterized by fatigue/flu-like symptoms.  After 5-6 days the red knot transitioned to a red rash that covered majority of the upper arm.  The rash was warm to the touch and extremely itchy.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: 6-24-15 13:10 vaccine administered. 1830-fever 99.8. 6-25-15 12:30 localized redness, itching (mild) measures 1 1/2 inches x 1 1/2 inches. Left arm. 6-26-15 temp decreased 98.1-redness continues. Itching 1325. No treatment resolved-06/30/15.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swollen 13 x 9 round at left side. Loratadine, BENADRYL, heat and ice packs.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site swelling, Rash vesicular
Clinical narrative: Reported some chicken pox-like spots, swelling at injection site (approximately 1-2"), and periodic headache. Recommended BENADRYL and hydrocortisone. Pt. already taking ibuprofen.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Raised red warm, itchy 2 in area around site of VAR given. Treated with ice, Ibuprofen PRN, vitals, monitor youth.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, induration, warmth to 7 cm at site of injection.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Nodule, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: The day after the shot arm swelled, knots on arm, 102 degree fever and vomiting.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Patient presented to clinic 2 days post injection. C/O pain 8/10 at injection site. Palpable "lump" 1" in circumference with red area noted to be 1 3/4" round. Warm painful to touch.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Low grade fever, redness, heat 2 1/2 x 3 in.
Age: 76.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling, erythema, redness. MEDROL pak, BENADRYL provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient complained of redness, itching, and soreness at injection site starting 3 days after vaccination. Patient also complained of headaches. These symptoms resolved by 6/22/15.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt had a Tdap vaccine (L) upper arm on 7/10/14 that resulted in severe upper arm pain for > 3 mos. No evidence of infection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Burning sensation, Chills, Dizziness
Clinical narrative: 1 1/2" x 3" long fiery red blistered area. Larger-almost complete circle on my arm (around arm) in swollen pink area and itchy. Burning on arm, dizzy-weak fever up and down chills, nausea. Arm was so swollen it was very heavy and throbbed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Local swelling, Nausea, Pain in extremity
Clinical narrative: 1 1/2" x 3" long fiery red blistered area. Larger-almost complete circle on my arm (around arm) in swollen pink area and itchy. Burning on arm, dizzy-weak fever up and down chills, nausea. Arm was so swollen it was very heavy and throbbed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: 1 1/2" x 3" long fiery red blistered area. Larger-almost complete circle on my arm (around arm) in swollen pink area and itchy. Burning on arm, dizzy-weak fever up and down chills, nausea. Arm was so swollen it was very heavy and throbbed.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 18 year old female patient with no pertinent medical history or concurrent conditions. On 24-JUN-2015 the patient was vaccinated with a fourth dose of GARDASIL. No adverse effects were reported. The outcome of extra dose administered was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and referred to an unspecified number of patients of unknown age and sex. On an unknown date, the unspecified number of patients may have received improperly stored PROQUAD (Merck) (lot #, expiration date, strength, dose and frequency were not reported). No adverse effects were reported. This is one of four reports from the same source. 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 worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with MMR II (lot # K010319, dose and route of administration not provided) that may have been improperly stored for the month of June 2015. No adverse symptoms was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from same reporter link (1507USA004579). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Vocational Nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was delayed in receiving the scheduled second dose of GARDASIL, (Lot # and exp. date not provided) intramuscular injection, 0.5 ml. No adverse effects were reported. Product quality complaint (PQC) was not 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 registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-JUL-2015, the patient was inadvertently vaccinated with an expired dose of (Oka/Merck) VARIVAX (dose: 0.5 ml, route of administration: subcutaneous, lot# reported as J005690, expiry date 07-MAY-2015). There were no concomitant therapies reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients received either one or two doses of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). In order to complete the HPV vaccination series, for a total of three HPV vaccine doses per patient, the patients were vaccinated with either one or two doses of GARDASIL 9, (dose, route of administration, injection site, lot number and expiration date were not reported) on unspecified dates. According to the reporting physician, each of these unspecified patients experienced pain at the injection site with each dose of GARDASIL 9 on unspecified dates. The outcome of the events was unknown at the time of the report. The relatedness between the events and GARDASIL 9 and GARDASIL was not reported. Additional information is not expected, because the reporter did not wish to be contacted.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old male patient. Medical history and concurrent conditions were none. Drug reactions or allergies was none. On an unspecified dates, the patient received the first and the second dose of GARDASIL 0.5 ml intramuscular. On 24-JUN-2015, the patient received the third dose of GARDASIL 9 (Lot# was reported as K026247, expiry date was 29-JAN-2017), intramuscular. On 24-JUN-2015, the patient experienced low grade fever after receiving GARDASIL 9. Patient sought medical attention (had called physician). None of the laboratory tests were performed. Patient was treated with TYLENOL for the low grade fever. Action taken was not applicable. The outcome of pyrexia was reported as not recovered/not resolved. The outcome of wrong drug administered was unknown. The causality for the event pyrexia was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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. No concurrent conditions, medical history and drug allergies reported. On an unknown date the patients were vaccinated with improperly stored vaccinated with VARIVAX (Merck) (lot number K021484 and expiry date 03-NOV-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with vaccinated with VARIVAX (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with vaccinated with VARIVAX (Merck) was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a 19 year old male patient. No pertinent medical history was reported. On an unknown date (also reported recently) the patient was vaccinated with PROQUAD (Merck) (dose, route, lot number and expiration date were not reported). They were unaware of the recommended age limit of 12 for PROQUAD (Merck) at the time of administration. No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.