chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain
Clinical narrative: This solicited report has been received from a pharmacist and refers to a female patient of unknown age enrolled in a patient support program. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot number, expiration date, dose and route of administration were not reported) into the deltoid region of her arm. However, the patient stated that it was very painful having the vaccine injected, and then later (date unspecified) she developed cellulitis that then spread underneath her arm. The patient sought medical attention by visiting a physician and she was also given unspecified treatment for the events. The outcome of both events was not reported. The reporter did not provide causal relationship between the events and PNEUMOVAX23. Upon internal review, the event of cellulitis that then spread underneath her arm was considered to be medically significant. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the investigational therapy and the reported events cannot be established. Cellulitis is an infection and there's lack of information if the patient had a skin lesion predisposing to this event. The non-serious event of injection site pain was also reported. Company Comment- No changes to the investigational product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the investigational product.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, Product label confusion
Clinical narrative: This spontaneous report was received from nurse. She reported that she inadvertently placed PROQUAD, which had lot # M031945 with expiry: 27-DEC-2017, in the refrigerator thinking it was M-M-R II because they were almost exactly identical each other. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a currently 22 years old non-pregnant female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient was vaccinated with GARDASIL, dose 1 on an unknown date in November 2009, dose 2 on an unknown date in January 2010 and a 3rd dose on an unknown date in April 2010. On 20-DEC-2016, the patient was seen in office for a colposcopy for an abnormal pap smear/ atypical cells. No treatment was given for the event. The patient sought medical attention by visiting the office. Patient's present status was reported as "doing fine". Causality of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 3 patients of unknown age and gender. On unknown dates, the patients were vaccinated with 3 doses of improperly stored PNEUMOVAX23 (lot # L014458, expiration date 11-FEB-2017) for prophylaxis. No adverse effects were reported. The outcome of events was unknown. Previous excursion: Temperature: 51F. Time frame: 13 hours and 30 minutes. Present excursion: Temperature: 62F. Time frame: 11 hours. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The nurse reported that multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot number and expiration date were not reported) on multiple unspecified dates. The nurse did not have temperature excursion information as RECOMBIVAX HB was being stored in the pockets of the administering nurses uniform. No adverse effects had been reported in any patients. No other information was available. Additional information is not expected since the reporter did not consent for further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to an unspecified number of patients of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, these unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX, (lot # M015926, expiration date 28-JUN-2017) for prophylaxis. No adverse effects were reported. The vaccines were exposed to the temperature of 13.9 degree Fahrenheit for a time frame of one hour, which was recorded by a data logger. No previous temperature excursions were reported. No product quality complaint was involved. 09-DEC-2016, it was reported that no patients' were affected. Merck's temperature and stability data indicated that the affected vaccines were viable and not compromised. This is one of the two reports from the same reporter.   Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA002560.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Influenza virus test negative, Nasal congestion
Clinical narrative: Initial unsolicited case received from a consumer (Patient herself) on 12 Dec 2016. This case involves a 62 year old female patient who was vaccinated with a dose of FLU SHOT (INFLUENZA VACCINE) (Batch number, expiry date, route and site of administration was not reported) on an unknown date, and the patient was prescribed an Study medication possibly ALIROCUMAB (PRALUENT) (Batch number, expiry date, route and dose was not reported) injects q 2 weeks for over a year ago on an unknown date. The patient medical history includes high cholesterol. The patient concomitant medications were not reported. On an unknown date after the vaccination the patient developed experiencing mild flu or flu-like symptoms/ tests for the flu were negative. It was reported as the patient started experiencing mild flu or flu-like symptoms on Wednesday 07 Dec 2016 which became full blown on Friday 09 Dec 2016 and it was reported as the patient said she had to go to the hospital for a morphine shot on Friday 09 Dec 2016 and again yesterday 11 Dec 2016 and the patient told that the physician in the hospital said that the tests for the flu were negative, and the patient got her flus shot 6 weeks ago and it was reported as the patient had nasal congestion since she started the study medication but she can tolerate it and She was advised to contact her healthcare provider about her symptoms. She said she will contact the nurse about her symptoms before she takes her next injection of the study medication. The patient any other lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Condition aggravated, Vitiligo
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 13 December 2016. This case involves a 16-year-old female patient who was vaccinated with booster doses of Menactra (batch number, expiry date, dose, route and anatomical site of administration were not reported) in an unknown site on an unknown date. Patient's medical history was reported as vitiligo which was also mostly resolved in the past 4-5 years. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified time following the vaccination, the patient had developed new patches around her eyes. Laboratory investigations were not reported. Corrective treatment was reported as unknown. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, diarrhea.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates, the patients was each vaccinated with an improperly stored dose of GARDASIL 9 (lot # M018810 with expiration date 28-MAY-2018, dosage and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion (temperature: 51.3 degrees Fahrenheit, time frame: 1 hour) because of data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports from the same reporter. Follow up information has been received from the nurse on 03-NOV-2016. Product information and narrative were updated. All telephone attempts on 22-DEC-2016 to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1611USA000902:Original Case : 1611USA000845, US-009507513-1611USA000903:Original Case : 1611USA000845, US-009507513-1611USA000901:Original Case : 1611USA000845, MERCK 1611USA000845:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (incorrect product storage) (lot # L038503, expiry date: 18-DEC-2017) (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported. The administered vaccine underwent a temperature excursion at 1.3 degrees (C) for a time frame of 12 minutes. Previous temperature excursions reported occurred on 06-JUL-2016 at a temperature of 2.2 C (low), 10.7 (high) for a time frame of 3 hours and 9 minutes and on 15-AUG-2016 at a temperature of 1.2 C for a time frame of 48 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: MERCK 1611USA003118:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to 4 unspecified patients of unknown age and gender. There was no information about patients' medical history, concurrent condition and concomitant therapy. The patients were vaccinated with GARDASIL 9 (lot L043213, expiration date 28-AUG-2017) via unknown route of administration for prophylaxis (dose not provided). It was reported that GARDASIL 9 was improperly stored before vaccination. The storage temperature was 50 F and time frame was 1440 hours. No adverse effect was reported. This case is linked with 1612USA012285 (same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1612USA012285.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information on patient's pertinent medical history and concurrent condition was not reported. The medical assistant reported that on 19-DEC-2016, a patient was vaccinated with VAQTA lot # L036300 (route and dose not reported) and later discovered that the product had expired on 04-NOV-2016. No adverse effect was reported in the patient. No other information was available. 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 medical assistant and office manager and refers to patient of unknown age and gender. The was no information about patient's medical history, concurrent condition and concomitant therapy. The patient was vaccinated with M-M-R II (lot # L028273, expiration date 28-JUL-2017) via unknown route of administration for prophylaxis (dose not provided). It was reported that M-M-R II was improperly stored before vaccination. The storage temperature was 50 F and time frame was 1440 hours. No adverse effect was reported. This case is linked with 1612USA004760 (same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1612USA004760.
Age: 70.0
Sex: F
Vaccine: PNC
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fatigue, headache, muscle pain, joint pain, decreased appetite, chills.
Age: 70.0
Sex: F
Vaccine: PNC
Symptoms: Myalgia
Clinical narrative: Fatigue, headache, muscle pain, joint pain, decreased appetite, chills.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Two Dtap-Hep B-Polio (Pediarix) were given at the same time.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Myalgia, Pruritus, Swelling
Clinical narrative: Redness, swelling, itchness, myalgia.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Blood glucose decreased, Feeling cold, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Immediate onset of feeling of burning pain, then whole body going cold. Feeling of weakness in body, stiffness. Had normal vital signs, blood sugar 70. Symptoms started to improve with cold water, eating, but were not fully resolved by the time he left the office. He was neurologically able to move all extremities equally and with adequate strength.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Immediate onset of feeling of burning pain, then whole body going cold. Feeling of weakness in body, stiffness. Had normal vital signs, blood sugar 70. Symptoms started to improve with cold water, eating, but were not fully resolved by the time he left the office. He was neurologically able to move all extremities equally and with adequate strength.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Lethargy
Clinical narrative: Patient reported: difficulty breathing, headache, fatigue, lethargy, and left side chest/rib pain when breathing.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal chest pain, Painful respiration
Clinical narrative: Patient reported: difficulty breathing, headache, fatigue, lethargy, and left side chest/rib pain when breathing.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Swelling LUE warm to touch with area of erythema 12cm x 10 cm. No breathing issues. No other areas of involvement. Excessive localized reaction.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash and redness at injection site wrapping around to under arm, warm to touch and painful.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Pyrexia, Tenderness
Clinical narrative: Patient presented two days after receiving vaccine complaining that she had a fever of 103, pain and arm redness that was sensitive to touch.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient states that following the flu shot, he has had continued pain in his shoulder above where the flu shot was given. It required MD visit and physical therapy.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Cytogenetic analysis, Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen
Clinical narrative: This spontaneous report was received from a nurse midwife, referring to a 37 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. No information about her concomitant medications was reported. On 06-AUG-2016, the patient had her last menstrual period. On 10-AUG-2016, the patient was vaccinated with a dose of VARIVAX (expiration date 07-JUL-2017, lot #, dose and route of administration were not reported) as a routine vaccination. On an unknown date in 2016 (reported as "soon after vaccination"), the patient had a positive pregnancy test. The patient also underwent an ultrasound and a genetic screening on unknown dates in 2016 but the results were pending at the time of reporting. The estimated conception date was 20-AUG-2016 and estimated delivery date was 13-MAY-2017. The pregnancy outcome was pending and fetal outcome was unknown. Exposure to VARIVAX occurred in the patient's first trimester. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a the patient's sister-in-low and refers to a female patient of an unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, after receiving the dose of ZOSTAVAX the patient developed shingles. The outcome of the event and causality between development of shingles and ZOSTAVAX were not reported. Additional information is not expected, as there was no consent for further contact.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. The reporter stated that her coworkers often give PNEUMOVAX23 on the same day as ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA005475: US-009507513-1612USA005476: US-009507513-1612USA004758: US-009507513-1612USA005474:
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. The reporter stated that her coworkers re-administer PNEUMOVAX 23 to the  patients every 5 years regardless of how many previous doses of PNEUMOVAX 23 those patients have received or at what ages those previous doses were received. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA005475: US-009507513-1612USA005476: US-009507513-1612USA005473: US-009507513-1612USA004758.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patients were vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. The reporter stated that on an unspecified dates, the patients experienced "winced" at the vaccination time (pain). The outcome of pain was not provided. The reporter did not assess the relatedness between the event and suspect therapy. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA005475: US-009507513-1612USA004758: US-009507513-1612USA005473: US-009507513-1612USA005474.
Sex: F
Vaccine: HPVX
Symptoms: Ovarian disorder
Clinical narrative: This spontaneous report was received from a physician assistant referring to an unspecified female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. It was reported that on unknown date, the patient was taking GARDASIL or GARDASIL 9 (dosage scheduled, lot #, route of administration and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced ovarian dysfunction. At the reporting time the outcome of ovarian dysfunction was unknown. The causality between the event and GARDASIL or GARDASIL 9 was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an adult male patient of unknown age. Information on patient's pertinent medical history and concurrent condition was not reported.  On an unspecified date in December 2016 (reported as this past week), the patient was vaccinated with properly stored ZOSTAVAX (dose, route and lot number not specified) and later it was discovered that the patient had received a dose of properly stored ZOSTAVAX (lot number and expiration date not reported) approximately sixteen months ago (unspecified date in September 2015). No adverse effect was reported. No additional information was available. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history and concurrent condition was not reported. On an unspecified date of 2016 after 19-NOV-2016, the patient was vaccinated with improperly stored GARDASIL 9 (dose and route not reported). The reporting nurse was not sure about which lot was administered, if L019297 expiry date 18-AUG-2017 or M007764 expiry date 30-JAN-2018 was involved. There was no previous excursion reported. Temperature/Time: 31.3F for 64 hours.  Digital data logger was used. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps, Vaccination failure
Clinical narrative: This spontaneous report was received from a consumer via social media and refers to six unspecified patients of unknown age and gender. The patients' concurrent conditions and medical histories were not reported. On an unknown date, the patients were vaccinated with unspecified doses of M-M-R II (concentration, route, dose and anatomical place of vaccination were not provided), for prophylaxis. Information regarding concomitant therapies was not reported. On an unspecified date in 2016 reported as " so far in 2016",  the patients experienced mumps and the reporter stated that strength of M-M-R II vaccine was questioned (vaccination failure). At the time of reporting, the outcome of vaccination failure was unknown. The reporter did not provide a causality assessment between M-M-R II and vaccination failure.  Additional information is not expected, as no contact details were provided.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: CSF test normal, Deafness, Delusion, Lethargy, Pharyngitis streptococcal
Clinical narrative: Started with a fever. Fevers gradually increased until Tuesday he was having fevers in the 106 range. He lost most of his hearing and when taken to the doctor we were told he had strep. After 24 hours on antibiotics his fever spiked to 107.3 and he was extremely lethargic (slightly delusional) so we brought him back to the doctor and then the ER . He had an unidentifiable rash all over his body and on fever reducing medication had a fever of 104.5. He was checked for all sorts of infections, including having a spinal tap done for meningitis, which all came back negative. I kept asking the doctors if it could have anything to do with vaccination and they continued to say there was no possibility. With no answers for his three day hospitalization and research I just did when looking up vaccines for my babies, I am confident he was hospitalized for a negative reaction to the vaccine.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash generalised, Streptococcus test positive
Clinical narrative: Started with a fever. Fevers gradually increased until Tuesday he was having fevers in the 106 range. He lost most of his hearing and when taken to the doctor we were told he had strep. After 24 hours on antibiotics his fever spiked to 107.3 and he was extremely lethargic (slightly delusional) so we brought him back to the doctor and then the ER . He had an unidentifiable rash all over his body and on fever reducing medication had a fever of 104.5. He was checked for all sorts of infections, including having a spinal tap done for meningitis, which all came back negative. I kept asking the doctors if it could have anything to do with vaccination and they continued to say there was no possibility. With no answers for his three day hospitalization and research I just did when looking up vaccines for my babies, I am confident he was hospitalized for a negative reaction to the vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent conditions, concomitant medications and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011117, expiration date 07-DEC-2017) (dose and unit unknown) for prophylaxis. The vaccine was exposed to 47.8F for 1.5 hours. No previous temperature excursion. Data logger was involved.  No adverse effects reported. As of 22-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1611USA001000: Mfr number.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaise
Clinical narrative: Information has been received from the patient's mother referring to her daughter of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 30-NOV-2016, the patient was vaccinated with her first dose of GARDASIL (lot# and expiration date were unknown) intramuscularly for prevention of human papillomavirus (HPV). In approximately 2016, since the administration, the patient experienced malaise, overall not feeling well and headache. The outcome of the events was reported as not recovered. Causality was not provided. Additional information is not expected as it is not permitted to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medications were not specified. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ (lot # M025565, expiry date: 06-NOV-2017) (dosing regimen and frequency unknown) for prophylaxis (incorrect product storage). No adverse effects were reported. On an unspecified date between 03-SEP-2016 and 10-OCT-2016, the vaccine was exposed to temperature of 49.5 Fahrenheit (F) for 10 hours. No further information was provided. No product quality complaint (PQC) was reported. This case is linked to case number 1612USA006604 via same reporter link. Additional information has been requested.; Sender's Comments: US-009507513-1612USA006604:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medications were not specified. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (lot # M018810, expiry date: 28-MAY-2018) (dosing regimen and frequency unknown) for prophylaxis (incorrect product storage). No adverse effects were reported. On an unspecified date between 03-SEP-2016 and 10-OCT-2016, the vaccine was exposed to temperature of 49.5 Fahrenheit (F) for 10 hours. No further information was provided. No product quality complaint (PQC) was reported. This case is linked to case number 1612USA012436 via same reporter link. Additional information has been requested. Sender's Comments:  US-009507513-1612USA012436.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Redness, swelling discomfort.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Back pain, Chills, Injected limb mobility decreased, Injection site abscess
Clinical narrative: Woke up to site of injection swollen, red, and warm, muscles stiff, unable to lift or move arm without severe pain/blacking out.  Lower back pain later in the day, followed by joint pain, aches, chills and fever.  Non-responsive to NSAIDs.  By the next day, on 12//23/2016, no improvement at injection site, and non-itchy rash had developed over entire chest region.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Woke up to site of injection swollen, red, and warm, muscles stiff, unable to lift or move arm without severe pain/blacking out.  Lower back pain later in the day, followed by joint pain, aches, chills and fever.  Non-responsive to NSAIDs.  By the next day, on 12//23/2016, no improvement at injection site, and non-itchy rash had developed over entire chest region.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Woke up to site of injection swollen, red, and warm, muscles stiff, unable to lift or move arm without severe pain/blacking out.  Lower back pain later in the day, followed by joint pain, aches, chills and fever.  Non-responsive to NSAIDs.  By the next day, on 12//23/2016, no improvement at injection site, and non-itchy rash had developed over entire chest region.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: States she felt soreness in her arm from the shot around 3 pm however late night around 1am 12/23/2016 she started to feel hot and achy, experienced chills and a headache and had a fever of 101. Upon waking up around 7am this morning, she states her fever broke. She reported the event to me today at 2pm after most of her symptoms resolved and after taking her temperature at 2:10pm, her temperature is now 97.8. She states she still feels a little weak and achy today.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Skin warm
Clinical narrative: States she felt soreness in her arm from the shot around 3 pm however late night around 1am 12/23/2016 she started to feel hot and achy, experienced chills and a headache and had a fever of 101. Upon waking up around 7am this morning, she states her fever broke. She reported the event to me today at 2pm after most of her symptoms resolved and after taking her temperature at 2:10pm, her temperature is now 97.8. She states she still feels a little weak and achy today.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Abscess drainage, Abscess limb, Abscess sterile, Chills, Induration
Clinical narrative: Developed abscess in right arm slightly posterior in the upper arm with induration and welling, with associated fever, chills and rigors. Presented to ED with extremely large, tangerine sized abscess in her right upper arm, admitted for sepsis, placed on cefepime and vanco. Sterile abscess was incised and drained, with ongoing inflammation with unknown cause.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Inflammation, Pyrexia, Sepsis, Swelling
Clinical narrative: Developed abscess in right arm slightly posterior in the upper arm with induration and welling, with associated fever, chills and rigors. Presented to ED with extremely large, tangerine sized abscess in her right upper arm, admitted for sepsis, placed on cefepime and vanco. Sterile abscess was incised and drained, with ongoing inflammation with unknown cause.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified patients of unknown age and gender.  Information about the patients' medical history, concurrent conditions and concomitant medication was not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 dose: 0.5 ml, intramuscularly (lot # M017983, expiration 30-MAY-2018) (dosage schedule and frequency were not provided) for prophylaxis. The vaccine had a temperature excursion of 31.9 Fahrenheit degrees in a time frame of 19 days and 12 hours. The temperatures were logged with a data logger and there were no previous excursions. No adverse effects were noted. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 06-DEC-2016, the patient was vaccinated with M-M-R II, via intramuscular for prophylaxis (dose, lot# and expiration date were not reported) (Inappropriate route of vaccination). No adverse effects were reported and a product quality complaint was not involved.  Additional information is not expected as there is not consent to follow-up.
Sex: F
Vaccine: HPVX
Symptoms: Ovarian disorder
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative referring to a female patient of unknown age. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL or GARDASIL 9 for prophylaxis (dose, frequency, route, lot number and expiration date were not provided). On an unknown date, the patient experienced ovarian dysfunction (ovarian disorder). No product quality complaint (PQC) was involved. At the time of reporting, the outcome of ovarian disorder was unknown. The primary reporter did not provide the causal relationship between GARDASIL and GARDASIL 9 and  ovarian disorder. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not informed. On unknown dates, the patients were administered improperly stored doses of M-M-R II, lots # M014902 and L047133 with expiration dates 22-MAR-2018 and 24-NOV-2017 respectively, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. Exposure temperature, time frame and prior excursions were not reported. A data logger was not used to track the temperature. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012452:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored VARIVAX (dose and route of administration were not reported) for prophylaxis. Data Logger was involved. No adverse effects reported. A product quality complaint was not involved. The following lot number and temperatures were reported: M005972 expiration date 02/FEB/18 -14.9C for 15 minutes -14.6C for 15 minutes -14.3C for 05 minutes -14.7C for 05 minutes -14.7C for 05 minutes -14.6C for 05 minutes -14.6C for 05 minutes -14.7C for 15 minutes -14.8C for 15 minutes -14.9C for 15 minutes -14.1C for 07 minutes -14.5C for 15 minutes -14.8C for 15 minutes -10.7C for 10 minutes - 9.4C for 01 minute -14.5C for 15 minutes - 9.4C for 11 minutes -10.3C for 03 minutes -14.8C for 15 minutes - 9.6C for 01 minute -13.0C for 14 minutes -14.9C for 05 minutes -14.6C for 05 minutes.This is one of the two cases reported for the same contact.  Additional information has been requested.; Sender's Comments:  US-009507513-1612USA005638:Original Case : 1612USA005638.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not informed. On unknown dates, the patients were administered improperly stored doses of GARDASIL 9, lots # M024261 and M018810 with expiration dates 30-JUL-2018 and 28-MAY-2018 respectively, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. Exposure temperature, time frame and prior excursions were not reported. A data logger was not used to track the temperature. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-09507513-1612USA005776.
Age: 34.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient received two vaccines in same arm, Tdap first then flu. No apparent issues after first vaccine, after administering second, patient passed out for approximately 10-15 seconds. Patient then came back to consciousness and was speaking normally after 1 to 2 minutes. He stated after the event that this happened to him around the age of 10 after a vaccine that he could not recall. He was given some water and remained seated until EMS could arrive. Patient then left the store with them.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Paraesthesia oral
Clinical narrative: PATIENT WITHIN 15 MINUTES OF INJECTION BEGAN TO HAVE TIGLING OF THE MOUTH. HE WAS THEN GIVEN 25MG OF BENADRIL AND ASK TO REMAIN IN THE WAITING AREA FOR HALF AN HOUR. HE THEN LEFT BECAUSE HE FELT BETTER.
Age: 84.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Back pain, Erythema, Pyrexia, Rash pustular
Clinical narrative: Redness spreading with pustules which as stop and pain radiating to back. Pain and fever remains of and on.
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Petit mal epilepsy
Clinical narrative: Developed Absent Seizures within an hour of vaccination.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Feeling cold, Loss of consciousness, Nausea
Clinical narrative: Patient said that she went home after receiving the FLUZONE HD vaccine.  Between 5:45PM 12/4/16 and 2:00am 12/5/16, the patient said that she felt extremely cold, and "Blacked Out" for approximately 5 minutes, while in her bathroom.  She felt nauseated.  She said that her body temperature was 96.2F.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Employee contacted center and stated allergic reaction to Hepatitis B. Employee instructed to return with paperwork and meet with MSA(Medical Staff Associate). Employee has not returned to center.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: PATIENT DEVELOPED ITCHING, SWELLING, REDNESS AND PAIN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen red injection site that spread as time passed. Emergency room doctor gave antibiotics in case it was an infection.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Chills, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Vaccine given 12/19/16 3:56pm. 12/20/16 approx 6:00pm began chilling, shaking and nausea.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Neutrophil percentage increased, Tachycardia, Tremor, White blood cell count increased
Clinical narrative: Vaccine given 12/19/16 3:56pm. 12/20/16 approx 6:00pm began chilling, shaking and nausea.
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Seizure
Clinical narrative: This is a spontaneous report a contactable consumer reporting for the mother. An elderly female patient received pneumococcal 7-val conj vac (dipht crm197 protein) (unknown manufacturer) on an unspecified date in 2000, at single dose. Medical history included preservatives intolerance, it was a influenza vaccine shot that had thimerosal, her throat closed up but she never stopped breathing. This was 15 or more years before the report. The patient's concomitant medications were not reported. The patient experienced seizure on an unspecified date after vaccination with outcome of unknown. Pfizer is the Marketing Authorization Holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. No follow up attempts needed. No further information expected. Follow-up (14SEP2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Pleural effusion, Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for herself. This female patient of unknown age received in Jul2016 a single dose of PREVNAR 13. The patient medical history and concomitant medications were not reported. In Sep2016, in the week before this report, the patient reported that developed pneumonia. Her doctor told her that she had fluid in her left lung and it looked like pneumonia. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Headache, Scan
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist, who is also the patient. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 12Aug (of an unspecified year) at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, 10 days after the vaccination, the patient experienced headaches. He informed his doctor, who admitted him to the hospital to do scans in order to determine the cause of the headaches. Results of the scans were not provided. The clinical outcome of the event, headache, was unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose back in December. The patient medical history and concomitant medications were not reported. The patient developed pneumonia on an unspecified date with outcome of unknown. Follow-up (31MAY2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. Medical history included pneumonia. The patient's concomitant medications were not reported. It was reported that the patient got PREVNAR 13 six months ago and had pneumonia on an unspecified date with outcome of unknown. Follow-up (17Jun2016): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Cough, Inappropriate schedule of drug administration, Malaise, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician who reported for himself. This 71-year-old male patient received PREVNAR 13 via intramuscular route of administration, in left deltoid, at the age of 70 years, on 19Oct2015, at 15:00, at 0.5 ml single. It was given 9 days too early. Medical history was not reported. No vaccines were given on same date along with suspect vaccine. Vaccination given within four weeks included influenza vaccine. He concomitantly received a lot of medications and took cardiac stuff like a beta blocker. The patient received PNEUMOVAX 23 after the age of 65-years, but prior to receiving PREVNAR 13. The patient experienced early pneumonia in Feb2016 with outcome of resolved in Mar2016. The primary infection site was in lungs. Clinical course was reported as follows: The patient stated that he received PREVNAR 13 and he became severely ill several months after the vaccine. No cultures were done but it might have been early pneumonia. He was given 10 days of LEVAQUIN as treatment. The patient was diagnosed with early pneumonia in early Feb2016. He was treated by a physician at an emergency care center. No admission to hospital was involved. A chest X-ray done at the emergency care center in Feb2016 showed either atelectasis or a little pneumonia. The patient had no fever, just had terrible cough and phlegm that would not stop. Phlegm was always clear. He had symptoms for 10 days before seeing the doctor. The cough lasted a month. After two weeks, he started to feel better and his symptoms gradually reduced. The physician did not feel the early pneumonia was related to PREVNAR 13. Follow up (23Jun2016): New information from the same contactable physician includes: vaccination time, route of administration, details about treatment received and lab data details. Follow-up attempts completed. No further information expected. Follow-up (14Jul2016): Follow-up attempts completed. No further information expected.