chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. In 2017, the patient was vaccinated with RECOMBIVAX HB lot # M037248 with expiry date 21-FEB-2019, lot # N002914 with expiry date 04-NOV-2019 for prophylaxis. In 2017, the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested. Sender's Comments: US-009507513-1708USA013258: US-009507513-1708USA013259: US-009507513-1708USA009399.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. In 2017, the patient was vaccinated with ROTATEQ lot # M042172 with expiry date 08-JUN-2018, lot # M044399 with expiry date 25-MAY-2018, oral for prophylaxis. In 2017, the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1708USA009399: US-009507513-1708USA013259: US-009507513-1708USA013257.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. In 2017, the patient was vaccinated with VAQTA lot # N005274 with expiry date 03-APR-2018, lot # N005796 with expiry date 26-MAY-2018 for prophylaxis. On 2017 the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1708USA013258: US-009507513-1708USA009399: US-009507513-1708USA013257.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HEPA
Symptoms: Depressed level of consciousness, Dyskinesia, Injection site swelling, Pyrexia, Somnolence
Clinical narrative: Within about 90 minutes of vaccination, patient developed tremors, a very high fever (104.5), and somnolence; he was hard to arouse and wouldn't stay awake for more than a few minutes. About 6 hours later, he also had projectile vomiting and full-body jerks. The fever lasted for more than 24 hours, and the tremors and jerks persisted for about 18 hours. He was also quite swollen at all three injection sites within 30 minutes of vaccination; I know this is a common reaction.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HEPA
Symptoms: Tremor, Vomiting projectile
Clinical narrative: Within about 90 minutes of vaccination, patient developed tremors, a very high fever (104.5), and somnolence; he was hard to arouse and wouldn't stay awake for more than a few minutes. About 6 hours later, he also had projectile vomiting and full-body jerks. The fever lasted for more than 24 hours, and the tremors and jerks persisted for about 18 hours. He was also quite swollen at all three injection sites within 30 minutes of vaccination; I know this is a common reaction.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe pain in multiple joints: Hips, knees, wrist, thumbs. Also shooting pains in palms of hands.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red hot swollen painful injection site.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dyspnoea, Headache, Influenza like illness, Nausea
Clinical narrative: Rash on my arms large bumps on my chest, short of breath, headaches, severe itching, nausea, flu like symptoms, minutes after shot burning sensation like my left side was on fire then it moved to right side of my chest. (I took pictures). I finally made it to doctor since Pharmacy is the one who gave me the shot RPH administer Flares Quad 2017-2018 on 08/13/2017.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash on my arms large bumps on my chest, short of breath, headaches, severe itching, nausea, flu like symptoms, minutes after shot burning sensation like my left side was on fire then it moved to right side of my chest. (I took pictures). I finally made it to doctor since Pharmacy is the one who gave me the shot RPH administer Flares Quad 2017-2018 on 08/13/2017.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Wound secretion
Clinical narrative: Patient states that on 07/27/2017 she noticed small water looking blisters forming on her left leg (ankle up to knee and around knee). Patient then popped some of the blisters before realizing what it could be (she thought it was some kind of reaction to her working outside). Patient did not contact the pharmacy or doctor or go to have the blisters looked at. She then cleaned the area with alcohol and put some zinc ointment on the wounds. That had no effect so patient put on BENADRYL, bacitracin ointment and calamine lotion because the wounds were weeping and itchy. Blisters cleared up around 21 days and patient has recovered.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of ZOSTAVAX (lot # M042504, Expiry date: 30-NOV-2017; lot # M038863, expiry date: 12-DEC-2017; lot # M035692, expiry date: 07-NOV-2017). On an unknown date, the vaccine was exposed to temperature of 6 degree F to 14 degree F for 1 hour 5 minutes. No adverse effects reported. Previous temperature excursions occurred on unknown dates between temperatures of 6 degrees F to 14 degrees F (6F) for 15 hours and 6 degrees F to 14 degrees F (6F) for 26 minutes. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection from lot # M022077 with expiry date of 10-MAR-2019 (dose and frequency not reported; route defaulted to parenteral) for prophylaxis (incorrect product storage). The vaccines were exposed to a temperature excursion ranging between 9 to 25 degree Celsius for a time frame of 12 hours. No adverse effects were reported. There was no previous temperature excursion. This report was because of data logger. Product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to two patients of unknown age and gender. On unknown dates, the patients were vaccinated with incorrectly stored doses of VARIVAX lot # N002204 for prophylaxis. Concomitant therapies included sterile diluent (manufecturer unknown). Sender's Comments: US-009507513-1708USA013407.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX (lot # M032495, expiry date: 06-JUL-2018; lot # M049127, expiry date: 15-DEC-2018) for prophylaxis reconstituted with properly stored sterile diluent (lot # and expiry date unknown). Dosing details and route of administration were not reported. On an unknown date, the vaccine was exposed to temperature of 5.2 F for 30 minutes. No adverse effects reported. No previous temperature excursions occurred. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA013417.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PEDVAXHIB with the following lot numbers and expiration dates: M034189/23-MAY-2019 and M046140/27-SEP-2019 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-707USA005187: US-009507513-1708USA013005: US-009507513-1708USA013007.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old patient. On 16-AUG-2017, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 16-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013250: US-009507513-1708USA013251: US-009507513-1708USA013252: US-009507513-1708USA013253: US-009507513-1708USA013254: US-009507513-1708USA013248: US-009507513-1708USA013243: US-009507513-1708USA013244: US-009507513-1708USA013245: US-009507513-1708USA013246: US-009507513-1708USA013247: US-009507513-1708USA013249: US-009507513-1708USA013255: US-009507513-1708USA013242.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 28-AUG-2017, the patient was inadvertently vaccinated with expired dose of VARIVAX lot # L031066, expiration date: 18-AUG-2017, 0.5 ml, subcutaneous, for prophylaxis. No adverse effects reported. No product quality complaint involved.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, "like Purified Protein Derivative (PPD)", under the skin, not subcutaneously, for immunisation. Other suspect therapies included sterile diluent. On an unknown date, the patient experienced injection site vesicles (little bubbles like after PPD injection, raised skin). The patient sought medical attention by speaking to the pharmacist. The outcome of the injection site vesicles was unknown. The relatedness between the event and both suspect therapies was not assessed by the reporter. Product quality complaint was not involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M032141, expiration date 27-OCT-2017 and lot # M035692, expiration date 07-NOV-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 and 46 degrees Fahrenheit for 2 hours and 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of 2 reports received from the same reporter. Sender's Comments: US-009507513-1707USA005371.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of PROQUAD (lot # M042498, expiry date: 17-APR-2018 and lot # N009773, expiry date: 20-SEP-2018) for prophylaxis reconstituted with properly stored sterile diluent (lot # and expiry date unknown). Dosing details and route of administration were not reported. On an unknown date, the vaccine was exposed to temperature of 5.2 F for 30 minutes. No adverse effects reported. No previous temperature excursions occurred. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA012627.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Loss of consciousness, Malaise, Nausea
Clinical narrative: Pt had vaccines in office 8/29/17-no reactions or symptoms that day. Pt woke up 8/30/17 complained of not feeling well-got dizzy, nauseated, and lost conscience for about 30 sec. No seizure activity noted.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient received his 5 yr immunizations on 8/28/17. Mom had called the clinic on 8/29/17 stating that his upper left thigh (subcutaneous area) is red, swollen and warm to the touch. She reported that there was a lump the size of a plum as well. He was afebrile but there was tenderness at the injection site. After consulting with Dr. parent was informed that it is safe to continue monitoring patient at that time. Mom was advised to apply ice or heat and give Tylenol as needed for pain. If patient develops a high fever (> or equal to 103), swelling continues to increase at 48 and 72 hours, or he overall worsens, mom advised to call back. Mom then called back on 8/30/17 at 5:17 pm and stated that the swelling was about the size of a cucumber and he was having more severe pain. He was still afebrile. Given significant worsening of pain and size of erythema, Dr. was concerned that patient has a local cellulitis from the vaccine. It was advised that he be seen at ED that night. Mom agreed and ended up taking him to the ED. At the ED, they did an ultrasound per mom and there was no abscess, just cellulitis. Patient was put on a course of Cephalexin and sent home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site warmth, Ultrasound scan abnormal
Clinical narrative: Patient received his 5 yr immunizations on 8/28/17. Mom had called the clinic on 8/29/17 stating that his upper left thigh (subcutaneous area) is red, swollen and warm to the touch. She reported that there was a lump the size of a plum as well. He was afebrile but there was tenderness at the injection site. After consulting with Dr. parent was informed that it is safe to continue monitoring patient at that time. Mom was advised to apply ice or heat and give Tylenol as needed for pain. If patient develops a high fever (> or equal to 103), swelling continues to increase at 48 and 72 hours, or he overall worsens, mom advised to call back. Mom then called back on 8/30/17 at 5:17 pm and stated that the swelling was about the size of a cucumber and he was having more severe pain. He was still afebrile. Given significant worsening of pain and size of erythema, Dr. was concerned that patient has a local cellulitis from the vaccine. It was advised that he be seen at ED that night. Mom agreed and ended up taking him to the ED. At the ED, they did an ultrasound per mom and there was no abscess, just cellulitis. Patient was put on a course of Cephalexin and sent home.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Hyperhidrosis, Immediate post-injection reaction, Lethargy, Malaise
Clinical narrative: I did not feel well. I was lethargic and achy immediately following the vaccination. On Tuesday I got the chills and woke up sweaty. I've had multiple episodes of waking up with chills and sweaty.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain
Clinical narrative: I did not feel well. I was lethargic and achy immediately following the vaccination. On Tuesday I got the chills and woke up sweaty. I've had multiple episodes of waking up with chills and sweaty.
Age: 12.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No symptoms at the time of injection.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and Swelling at site of the immunization. There are distinct areas of redness around each injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Patient's body became covered in hives the next day. Went to the ER where he was treated with oral Benadryl and oral steroids.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Myalgia, Pyrexia, Rash
Clinical narrative: Developed arthralgia/myalgias about 6-7 days after injection, fever about the same time, and then rash 10 days after injection.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture negative, Electroencephalogram, Full blood count normal, Respiratory arrest, Seizure
Clinical narrative: Found her in bed turning purple, not breathing. Rushed to hospital stimulating constantly.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Skin discolouration, Temporal lobe epilepsy, X-ray normal
Clinical narrative: Found her in bed turning purple, not breathing. Rushed to hospital stimulating constantly.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Lip swelling, Urticaria
Clinical narrative: Within 10-15 minutes, developed very mild hives but no SOB or other symptoms. She was given BENADRYL in office with good response. Mom reports that she continued with hives for about a week after that and also some lip swelling requiring an ER evaluation.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, PNC13, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient developed a low grade fever and vomiting early am.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 17-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. The reporter also stated that she had a printed report of the patients who received vaccines that had undergone the temperature excursion. The report included vaccine name, date given lot number and the name, gender and birth date of patient. This is one of several reports received from the same reporter. Additional information is not expected as all relevant correspondence has already been received. This report was previously submitted with the incorrect Worldwide unique case identification number US-009507513-1705USA005093', and this new follow-up submission is to provide the correct identification number US-009507513-1706USA003937'. US-009507513-1705USA005093' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique identification number. This is an amended report, as corrected. Company Number was updated to US-009507513-1706USA003937. Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094: US-009507513-1706USA003934: US-009507513-1706USA003935: US-009507513-1706USA003936: US-009507513-1705USA005093: US-009507513-1705USA005086: US-009507513-1705USA005094.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with diabetes and cancer. In 2011 the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis, and in 2015, she was vaccinated with a second dose of ZOSTAVAX (extra dose administered). Concomitant therapies included sterile diluent. On 18-OCT-2016 the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovered/resolved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ lot # M042821, oral for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to  ROTATEQ. Sender's Comments: US-009507513-1708USA013474: US-009507513-1708USA013473: US-009507513-1708USA013475.
Sex: U
Vaccine: MMR
Symptoms: Autism spectrum disorder, Gastric disorder
Clinical narrative: This spontaneous report was received from an employee at pharmaceutical company who came across an online article on a social media newsfeed and refers to an unspecified amount of patient of unknown age. The article from News Network and was posted 29-MAY-2017. The author of the article stated that a physician first publicized the link between stomach disorders and autism, and took the findings one step further, the link between stomach disorders and autism and the Measles, Mumps, and Rubella (MMR) vaccine (manufacturer not specified). In recent months, courts, governments and vaccine manufacturers have quietly conceded the fact that the MMR vaccine most likely does cause autism and stomach diseases. The author quoted the physician as saying "There can be very little doubt that vaccines can and do cause autism. In these children, the evidence for an adverse reaction involving brain injury following the MMR that progresses to autism is compelling". The physician also remarked that back in 1996-1997, he was made aware of children developing autism, regressive autism, following exposure in many cases to the MMR vaccine. Upon internal review, autism was considered medically significant. This is one of several reports from the same source. Additional information is not expected. Sender's Comments: US-009507513-1708USA013471.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with VAQTA lot numbers M036458 and N005274 oral for prophylaxis. On an unknown date, the vaccine was incorrectly storage. Sender's Comments: US-009507513-1708USA012513: US-009507513-1708USA005527.
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Mass
Clinical narrative: This spontaneous report as received from a office manager refers to a 2 year old female patient. On an unknown date, the patient was vaccinated with M-M-R II lot # N009171, expiration date 30-MAR-2019 (dose, route and anatomical location were not reported) for prophylaxis. the vaccine was diluted with sterile diluent (MRK). On an unknown date, the patient developed a lump behind her ear on her neck and swollen glands. The outcome of the events was not reported. The relatedness between the therapy and events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to unspecified number of patient of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M042322, expiration date 21-FEB-2019, for prophylaxis. On 29-AUG-2017, the physician reported that she had no further information to share. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA005530.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of GARDASIL 9 with the following lot numbers and expiration dates: L043213/28-AUG-2017, M009378/23-APR-2018, M024261/30-JUL-2018, M032650/31-MAR-2019, M042853/17-JUL-2019 and M043731/22-JUN-2019 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1707USA005187.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of M-M-R II with the following lot numbers and expiration dates: M016234/31-MAR-2018, M034387/19-JUL-2018, M036543/15-AUG-2018, M039913/26-SEP-2018 and also the one reported as M042846/21-OCT-2018 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot number M042846 has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. Therapy type of recombinant human albumin (rHA) has been added to the case. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1707USA005187: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 with lot number M032635 and expiration date on 05-MAY-2018 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful.; Sender's Comments:  US-009507513-1708USA013008: US-009507513-1707USA005187: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of ROTATEQ with the following lot numbers and expiration dates: M041184/31-MAY-2018 and M042171/07-JUN-2018 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1707USA005187: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PROQUAD with lot number N000336 and expiration date on 03-JUL-2018 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1707USA005187: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # N001007, 1 DF, intramuscular for prophylaxis. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.; Sender's Comments: US-009507513-1708USA013507:
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PROQUAD and VARIVAX for prophylaxis (dosage regimen was unspecified) on the same day. No adverse symptoms reported.
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report was received from an employee at pharmaceutical company who came across an online news article on their social media news feed and refers to a male patient of unknown age. The article from News Network and was posted 29-MAY2017. The patient's medical history and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (manufacturer not reported). The article indicated that hundreds of thousands of dollars were awarded to the patient, whose parents described how MMR vaccinations caused a "severe and debilitating injury to his brain, diagnosed as Autism Spectrum Disorder (ASD)". The outcome of the event was not provided. Upon internal review, autism spectrum disorder was considered medically significant. This is one of several report from the same source. Additional information is not expected. Sender's Comments: US-009507513-1708USA012166.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with RECOMBIVAX HB lot # M035487 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Sender's Comments: US-009507513-1708USA013474: US-009507513-1708USA013475: US-009507513-1708USA011923.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with VAQTA lot # N008823 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA.; Sender's Comments: US-009507513-1708USA011923: US-009507513-1708USA013475: US-009507513-1708USA013473:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL 9 lot # N000326 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1708USA013474: US-009507513-1708USA011923: US-009507513-1708USA013473.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to five patients of unknown age and gender. On an unknown date, the patients were vaccinated with M-M-R II lot # M039913, expiration date 26-SEP-2018 for prophylaxis, reconstituted with sterile diluent (manufacturer unknown).  On an unspecified date, the vaccines and sterile diluent (manufacturer unknown) were exposed to temperature ranges between 47° Fahrenheit (F) to 77°F during a time frame of 12 hours 30 minutes. There was not previous temperature excursion. The temperature excursion was not called by a data logger. Adverse effects were not reported. Follow up information has been received from a medical assistant on 29-AUG-2017. He reported that on 10-JUL-2017, the patient was administered with an improperly stored dose of M-M-R II.; Sender's Comments: US-009507513-1708USA013498: US-009507513-1707USA004550:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to five patients of unknown age and gender. On an unknown date, the patients were vaccinated with M-M-R II lot # M039913, expiration date 26-SEP-2018 for prophylaxis, reconstituted with sterile diluent (manufacturer unknown). On an unspecified date, the vaccines and sterile diluent (manufacturer unknown) were exposed to temperature ranges between 47° Fahrenheit (F) to 77° F during a time frame of 12 hours 30 minutes. There was not previous temperature excursion. The temperature excursion was not called by a data logger. Adverse effects were not reported. Follow up information has been received from a medical assistant on 29-AUG-2017. He reported that on 10-JUL-2017, the patient was administered with an improperly stored dose of M-M-R II. Sender's Comments: US-009507513-1707USA004550: US-009507513-1708USA013497.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M040412 for prophylaxis. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1708USA013405.
Sex: F
Vaccine: MMR
Symptoms: Autism spectrum disorder, Brain injury
Clinical narrative: This spontaneous report was received from an employee at pharmaceutical company who came across an article on a social media news feed and refers to a female patient of unknown age. The article from News Network and was posted 29-MAY-2017.  On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (MMR) vaccine (manufacturer not specified). A court ruling in December 2012 the "young" patient won compensation following vaccine-related brain injury that involved MMR and resulted in autism. The outcome of the event was unknown. Causality assessment was related. Upon internal review, autism was considered medically significant. This is one of several reports from the same source. Additional information is not expected. Sender's Comments: US-009507513-1708USA012166.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Local reaction, Skin lesion, Varicella post vaccine
Clinical narrative: Varicella vaccine administered on 08/14/17, 5 days later had a local reaction at injection site, since then has been getting new lesion on arms, legs, abdomen, back and face.  Seen in Occupational Health on 8/31/17 and referred to Dermatology, was seen by Dermatology on 8/31/17 and confirmed it was chicken pox.  She was started on Valacyclovir 1000mg Q12.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: CSF culture negative, CSF lymphocyte count, Computerised tomogram abnormal, Myelitis, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Pt developed diffuse myelitis 30 days post vaccines. No infectious cause identified to date.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Polymerase chain reaction
Clinical narrative: Pt developed diffuse myelitis 30 days post vaccines. No infectious cause identified to date.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling hot, Headache
Clinical narrative: Swollen lymph nodes on Left clavicle (same side of injection), tingling, "icey-hot" sensation on L side of neck down to clavicle. A sore appeared on my gum on left side, sore throat; felt sick, headache, runny nose (sniffles); feel tired and no energy, loose stool, outbreak of (vaginal) herpes that I haven't had in a long time.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes virus infection, Lymphadenopathy, Malaise, Noninfective gingivitis, Oropharyngeal pain
Clinical narrative: Swollen lymph nodes on Left clavicle (same side of injection), tingling, "icey-hot" sensation on L side of neck down to clavicle. A sore appeared on my gum on left side, sore throat; felt sick, headache, runny nose (sniffles); feel tired and no energy, loose stool, outbreak of (vaginal) herpes that I haven't had in a long time.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia, Rhinorrhoea
Clinical narrative: Swollen lymph nodes on Left clavicle (same side of injection), tingling, "icey-hot" sensation on L side of neck down to clavicle. A sore appeared on my gum on left side, sore throat; felt sick, headache, runny nose (sniffles); feel tired and no energy, loose stool, outbreak of (vaginal) herpes that I haven't had in a long time.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Patient's are swelled and had pain. She had a 102 fever which lasted 2 days. She experienced fatigue, nausea, body aches and headache.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient's are swelled and had pain. She had a 102 fever which lasted 2 days. She experienced fatigue, nausea, body aches and headache.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized reaction. Redness and mild swelling at injection site. Patient has not had a fever or any other symptoms.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Chest X-ray normal, Chest discomfort, Electrocardiogram normal, Feeling abnormal, Injection site discomfort
Clinical narrative: Parent states patient felt fine after receiving the vaccine, was kept 15m after vaccination. She complained only of discomfort at the site rest of the day. At 3 pm began to "feel off" went to volleyball practice, used inhaler just before running laps. While running she experienced tightness in her chest, tingling in her arms and legs.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test normal, Paraesthesia
Clinical narrative: Parent states patient felt fine after receiving the vaccine, was kept 15m after vaccination. She complained only of discomfort at the site rest of the day. At 3 pm began to "feel off" went to volleyball practice, used inhaler just before running laps. While running she experienced tightness in her chest, tingling in her arms and legs.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: 11/2016 -  Injection pain at time of flu shot and progressive worse month to month after that.  4/2017 - 5 month post injection exam discovered limited range of rotator cuff and cortisone shot.  8/2017 - 10 month exam required MRI and confirmation of torn supraspinatis tendon in rotator cuff and bursa sac inflammation due to bursitis.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: 11/2016 -  Injection pain at time of flu shot and progressive worse month to month after that.  4/2017 - 5 month post injection exam discovered limited range of rotator cuff and cortisone shot.  8/2017 - 10 month exam required MRI and confirmation of torn supraspinatis tendon in rotator cuff and bursa sac inflammation due to bursitis.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Full blood count normal, Pyrexia
Clinical narrative: FEVER OF 103. AND DIARRHEA.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Left arm swelled up/raised immediately after giving PREVNAR. The swelling was about 1/2 inch in circumference. No other symptoms. Had patient sit for 15-20 minute. Swelling went down slightly in this time. Still no other symptoms. Advised to patient to take Benadryl if swelling got worse and to contact his doctor or us if it gets worse.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Gait disturbance, Injection site rash
Clinical narrative: Rash around injection site. Reports feeling dizziness, weak, instability.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from other health professional referring to an unknown number of unspecified patients. Information regarding the patients' pertinent medical history, and drug reactions or allergies were not provided. On an unknown date starting on or after 31-JUL-2017, an unknown number of unspecified patients were administered improperly stored (incorrect product storage) doses of VARIVAX (lot M47660, exp 02-DEC-2018; lot N001527, exp 13-JAN-2019; lot N009767, exp 24-MAR-2019). Lot information not available for properly stored sterile diluent (MERCK STERILE DILUENT) used to reconstitute improperly stored varicella virus vaccine live (oka/merck)(VARIVAX). No adverse effect reported. The doses were stored in a temperature of -14 degree Celcius to -10 degree Celcius for 2 hours. Data logger was involved. There was no previous temperature excursion reported. No additional information provided. Lot number M47660 is an invalid lot number for varicella virus vaccine live (oka/merck). This case is cross-referenced with 1708USA013525 (same reporter).; Sender's Comments: US-009507513-1708USA013525: