chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB (lot # N000238, expiry date: 25-OCT-2019) for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 50 degree Fahrenheit for 30 minutes. No data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA009647.
Age: 46.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician on 10-AUG-2017.This case involves a 46-year-old male patient who was vaccinated with a dose of MENACTRA (Batch number: U5260AA) (expiry date, dose and dose in series were not reported) and first dose of HEPATITIS A VACCINE (Batch number and expiry date were not reported) via intramuscularly in the right deltoid for both vaccines on 07-AUG-2017. It was also reported that the patient had seasonal allergies. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies including other medical history was none. Concomitant medications were not reported. On 07-AUG-2017, same day following the vaccination, the patient experienced a fever of 102 Fahrenheit (38.88 Degree Celsius), myalgia, and nausea. Other laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as unknown. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Severe pain in arm at injection site.
Age: 17.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Dizziness, Head injury, Headache, Lumbar puncture, Meningitis
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of meningitis in a 17-year-old male patient who received MENVEO. Co-suspect products included Measles Mumps Rubella Vaccine and Varicella Vaccine. On 8th August 2017, the patient received the 1st dose of MENVEO, Measles Mumps Rubella Vaccine and Varicella Vaccine. On 14th August 2017, 6 days after receiving MENVEO, Measles Mumps Rubella Vaccine and Varicella Vaccine, the patient experienced dizziness and head injury. In August 2017, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant), neck pain, fever, headache and increased white cell count. In August 2017, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the meningitis, neck pain, dizziness, headache and head injury were unknown and the outcome of the increased white cell count was recovering/resolving. It was unknown if the reporter considered the meningitis, neck pain, dizziness, fever, headache, increased white cell count and head injury to be related to MENVEO. Additional details were reported as follows: This case was reported by an emergency staff member to the pharmacist at the medical center requesting potential side effects after MENVEO vaccination. Approximately one week earlier, the patient had hit his head on a roll bar while driving in a demo derby car race. On 8th August 2017, the patient  also received MMR and Varicella vaccine (unknown brands) concomitantly. On 14th August 2017, the patient presented to Emergency Room, he stood up, felt dizzy and hit his head on a shelf. Less than a week after receiving the vaccines, the patient also experienced neck pain, dizziness, fever, headache and an elevated white count. The emergency room staff were concerned that, patient might have meningitis, so a spinal tap was performed (results unavailable at time of report). The reporter stated that the fluid was clear and the patient was admitted in the hospital. As of 15th August 2017, the patient's fever was gone and the elevated white count had started to decrease. Now, the reporter did not think the patient had meningitis, but still waiting for the spinal tap results. The reporter gave consent to follow up. It was unknown if the reporter considered the meningitis, neck pain, dizziness, fever, headache, increased white cell count and head injury to be related to Measles Mumps Rubella vaccine and Varicella vaccine as well.
Age: 17.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Neck pain, Pyrexia, White blood cell count increased
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of meningitis in a 17-year-old male patient who received MENVEO. Co-suspect products included Measles Mumps Rubella Vaccine and Varicella Vaccine. On 8th August 2017, the patient received the 1st dose of MENVEO, Measles Mumps Rubella Vaccine and Varicella Vaccine. On 14th August 2017, 6 days after receiving MENVEO, Measles Mumps Rubella Vaccine and Varicella Vaccine, the patient experienced dizziness and head injury. In August 2017, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant), neck pain, fever, headache and increased white cell count. In August 2017, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the meningitis, neck pain, dizziness, headache and head injury were unknown and the outcome of the increased white cell count was recovering/resolving. It was unknown if the reporter considered the meningitis, neck pain, dizziness, fever, headache, increased white cell count and head injury to be related to MENVEO. Additional details were reported as follows: This case was reported by an emergency staff member to the pharmacist at the medical center requesting potential side effects after MENVEO vaccination. Approximately one week earlier, the patient had hit his head on a roll bar while driving in a demo derby car race. On 8th August 2017, the patient  also received MMR and Varicella vaccine (unknown brands) concomitantly. On 14th August 2017, the patient presented to Emergency Room, he stood up, felt dizzy and hit his head on a shelf. Less than a week after receiving the vaccines, the patient also experienced neck pain, dizziness, fever, headache and an elevated white count. The emergency room staff were concerned that, patient might have meningitis, so a spinal tap was performed (results unavailable at time of report). The reporter stated that the fluid was clear and the patient was admitted in the hospital. As of 15th August 2017, the patient's fever was gone and the elevated white count had started to decrease. Now, the reporter did not think the patient had meningitis, but still waiting for the spinal tap results. The reporter gave consent to follow up. It was unknown if the reporter considered the meningitis, neck pain, dizziness, fever, headache, increased white cell count and head injury to be related to Measles Mumps Rubella vaccine and Varicella vaccine as well.
Age: 20.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Axillary pain, CSF culture negative, CSF protein increased, Dermatitis contact, Full blood count normal
Clinical narrative: Pt seen in Medical Center on 8 Aug 2017 for the 7 day post vaccine follow-up. Upon assessment, pt noted to have some topical contact dermatitis due to irritants from bandage, hypoallergenic bandages provided. Pt also noted some localized (left axillary) lymphadenopathy. Pt denied fever, SOB, chest pain. Pt released from public health clinic with instructions to return to clinic if symptoms continue or worsen. On 11 Aug. pt admitted to medical ward via ER due to fever (although afebrile in ER and ward), headache and pain with tenderness to left axillary. Pt diagnosed with lymphadenitis. 12 Aug, pt discharged with follow up appt to ID.
Age: 20.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Headache, Lymphadenitis, Lymphadenopathy, Metabolic function test normal, Monocyte count increased
Clinical narrative: Pt seen in Medical Center on 8 Aug 2017 for the 7 day post vaccine follow-up. Upon assessment, pt noted to have some topical contact dermatitis due to irritants from bandage, hypoallergenic bandages provided. Pt also noted some localized (left axillary) lymphadenopathy. Pt denied fever, SOB, chest pain. Pt released from public health clinic with instructions to return to clinic if symptoms continue or worsen. On 11 Aug. pt admitted to medical ward via ER due to fever (although afebrile in ER and ward), headache and pain with tenderness to left axillary. Pt diagnosed with lymphadenitis. 12 Aug, pt discharged with follow up appt to ID.
Age: 20.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Neutrophil count normal, Pyrexia, Tenderness
Clinical narrative: Pt seen in Medical Center on 8 Aug 2017 for the 7 day post vaccine follow-up. Upon assessment, pt noted to have some topical contact dermatitis due to irritants from bandage, hypoallergenic bandages provided. Pt also noted some localized (left axillary) lymphadenopathy. Pt denied fever, SOB, chest pain. Pt released from public health clinic with instructions to return to clinic if symptoms continue or worsen. On 11 Aug. pt admitted to medical ward via ER due to fever (although afebrile in ER and ward), headache and pain with tenderness to left axillary. Pt diagnosed with lymphadenitis. 12 Aug, pt discharged with follow up appt to ID.
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Chills, Dizziness, Dyspnoea, Nausea, Pain
Clinical narrative: Elevated temp/ fever reporting 101-103 degrees F - chills, nausea, dizziness, achy and shortness of breath.
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Pyrexia
Clinical narrative: Elevated temp/ fever reporting 101-103 degrees F - chills, nausea, dizziness, achy and shortness of breath.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Syncope
Clinical narrative: Fainted almost fell over, had a seizure for 20 seconds following the GARDASIL shot.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. On 16-AUG-2017, the patient was vaccinated with RECOMBIVAX HB, dose 4, lot number M045653, expiration date 03-JUL-2018 (also reported as 03-JUL-2019), for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to 13 unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX lot # M035147 with expiry date: 25-OCT-2017 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 15 F to 46F (18.3F) for a duration of 7 hours and 45 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 6 F to 14 F (10.6F) for 1 hour and 15 minutes and 15F to 46F (19.2F) for 14 hours and 30 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1708USA009634:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to 3 unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # M027344 with expiry date: 01-JUN-2018 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 15 F to 46F (18.3F) for a duration of 7 hours and 45 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 6 F to 14 F (10.6F) for 1 hour and 15 minutes and 15F to 46F (19.2F) for 14 hours and 30 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is second of the two reports from the same reporter.; Sender's Comments: US-009507513-1708USA009630:
Age: 21.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 6 unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 12-JUL-2017 and 13-JUL-2017, the patients were administered 3 different doses of VARIVAX injection (lot # N014366 with expiration date at 09-MAY-2019, for prophylaxis; dose, route of administration and anatomical location were not reported), reconstituted with sterile diluent (STERILE DILUENT) (lot # N003192 with expiration date at 05-JUL-2019). The administered doses of vaccine were exposed to a temperature excursion between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) on 09-JUL-2017, which lasted for a 12 hours and 10 minutes. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Lot number N014366 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck). Follow up information has been received on 22-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1707USA002673:
Age: 63.0
Sex: M
Vaccine: RAB, TDAP
Symptoms: Blindness transient, Blindness unilateral, Macular oedema, Retinal artery occlusion
Clinical narrative: Initial unsolicited case received from a nurse on 10 Aug 2017. This case involves 63-year-old male patient who was vaccinated with dose one (also reported as day 0) of IMOVAX, dose one of IMOGAM, and a dose of ADACEL (Batch number, expiry date, dose, route, and site of administration were not reported for all the vaccines) on 07 Aug 2017. The patient medical history illness at the time of vaccination, and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 07 Aug 2017, same day after the vaccinations, the patient experienced 30 minutes of vision loss in one eye, and the patient went to ER (emergency room) and was seen by ophthalmologist who diagnosed the patient with central retinal artery occlusion with macular edema. It was reported that patient had intermittent vision loss. The patient relevant lab tests and corrective treatment were not reported. The outcome of the events were reported as not recovered. Upon internal review the company decided to consider the case as serious due to important medical event central retinal artery occlusion. List of documents held by sender: none. Sender's Comments: The patient experienced 30 mins of vision loss in one eye, macular edema and central retinal artery occlusion post vaccination with IMOVAX, IMOGAM and ADACEL. No information regarding patient's medical history, concurrent medical condition or was reported. Time to onset is compatible but events are unlisted with the vaccine. Sudden evolution of events suggests that there might be underlying alternate etiology as retinal occlusion is likely to take time to evolve and in this case the events presented on the same day of vaccination. Also, vaccination with multiple products makes it difficult to assess the relationship with respect to one. Based upon reported information the role of the vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a health care professional (physician assistant) on 11-Aug-2017. This case involves a 46 year old female patient who was vaccinated with a first dose of ADACEL via intramuscular route (Batch number: U5593AA, expiry date: 07-Mar-2019, dose not reported) in left deltoid on 11-Jul-2017. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as patient had no known allergy. Illness at the time of vaccination was also reported as none. Any other vaccinations within four weeks of vaccinations was not reported. On 12-Jul-2017, one day following the vaccination, the patient had soreness in left arm and tingling in left arm going to 5th and 4th fingers and 1/2 of 3rd finger. 2-3 weeks the tingling persists. Patient required emergency room (ER)/ doctor visit as patient was referred to a neurologist. Laboratory investigations were not reported. Patient had warm compress which relieved the soreness. On an unknown date patient was recovered from soreness in left arm. Outcome of the tingling of extremity was not recovered. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Fatigue, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer on 11-Aug-2017 and additional information received on 14-Aug-2017. This case involves a 70-year-old female patient who was vaccinated with a third intramuscular dose of IMOVAX and intramuscular dose of PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (IMOGAM) on 4-Aug-2017. The patient had a medical history of Bactrim and Psorasis. Concomitant medications was not reported. On 11-Aug-2017, seven days following the vaccination, the patient developed muscle pain in her neck and shoulders, she felt weakness in her legs and arms which is resolved now. The patient was generally exhausted feeling. The patient spoke with her Doctor about if she should take the last 2 vaccines if she is having this discomfort and the bat is now considered to be negative. The patient said her Doctor encouraged her to finish the series but, she is reluctant to take more shots as she has a vacation coming up at the end of the series. Encouraged to have her symptoms physically evaluated by her Doctor. On 11-Aug-2017, seven days following the vaccination, the patient developed redness and swelling of her big toes and she wants us to know she feels much better she decided not to complete the series. She does have some residual stiffness in her neck that is more of a bother than a complaint. The patient required ER visit. Relevant diagnostic tests/laboratory data reported as none. The patient did not received corrective treatment. The patient recovered from event weakness in extremity, had not recovered from event neck stiffness and recovering from other events. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: RAB
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer on 11-Aug-2017 and additional information received on 14-Aug-2017. This case involves a 70-year-old female patient who was vaccinated with a third intramuscular dose of IMOVAX and intramuscular dose of PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (IMOGAM) on 4-Aug-2017. The patient had a medical history of Bactrim and Psorasis. Concomitant medications was not reported. On 11-Aug-2017, seven days following the vaccination, the patient developed muscle pain in her neck and shoulders, she felt weakness in her legs and arms which is resolved now. The patient was generally exhausted feeling. The patient spoke with her Doctor about if she should take the last 2 vaccines if she is having this discomfort and the bat is now considered to be negative. The patient said her Doctor encouraged her to finish the series but, she is reluctant to take more shots as she has a vacation coming up at the end of the series. Encouraged to have her symptoms physically evaluated by her Doctor. On 11-Aug-2017, seven days following the vaccination, the patient developed redness and swelling of her big toes and she wants us to know she feels much better she decided not to complete the series. She does have some residual stiffness in her neck that is more of a bother than a complaint. The patient required ER visit. Relevant diagnostic tests/laboratory data reported as none. The patient did not received corrective treatment. The patient recovered from event weakness in extremity, had not recovered from event neck stiffness and recovering from other events. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Breast pain, Joint range of motion decreased, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: Left arm pain, left breast pain, left chest wall pain. Also left scapula/rhomboid pain. Began about 24 hr after Tdap injection. Initially had low-grade fevers as well as significant pain- moderate relief with TYENOL. Also had weakness/ decreased range of motion.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left arm pain, left breast pain, left chest wall pain. Also left scapula/rhomboid pain. Began about 24 hr after Tdap injection. Initially had low-grade fevers as well as significant pain- moderate relief with TYENOL. Also had weakness/ decreased range of motion.
Age: 10.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Arthropod sting, Urticaria
Clinical narrative: Patient arrived in office 3 hrs after getting vaccination with hives on face, arms, back and stomach.. Patient was also stung by a wasp prior to arrival. We are unclear what caused the reaction.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Malaise, Pyrexia, Upper respiratory tract infection, Vomiting
Clinical narrative: Patient became ill 4 days after receiving the vaccine dose. Fevers, chills, vomiting and severe URI symptoms. Has not resolved at this time. I have contacted his PCP and will bring him for a sick visit if he is not better by tomorrow.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Deep vein thrombosis
Clinical narrative: DVT in the leg. Patient went to ER and put on XARELTO for treatment.
Age: 13.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Flushing, Hyperhidrosis, Vomiting
Clinical narrative: Had flushing of his cheeks, chills, diaphoresis, vomited once.  Gave 50mg of diphenhydramine in the office.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Culture throat, Culture urine, Diarrhoea, Fatigue
Clinical narrative: Child developed a fever of 106F on 6/1/17. Fever down to 102F after spongebath and tylenol. Patient with slight rash on forehead and cheek. Temp 101.5F by evening of 6/1/17 and fever resolved by 6/2/17. 6/3/17: Fever up to 104F, resolved by 6/4/17. 6/12/17: Left upper thigh with a cluster of lesions mildly erythematous. 4 scattered raised lesions, painful to touch. Widespread rash noted.  8/22/17: patient presented with 4 days of low grade temp around 100F, vomiting post bottles and looser stool a few times day. Rash present for 4 days. Parents report since vaccination the patient has been more tired, she has not been crawling, talking, or walking. As of 8/22/17 she is slowly returning to her usual self.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Irritability, Pyrexia
Clinical narrative: Child developed a fever of 106F on 6/1/17. Fever down to 102F after spongebath and tylenol. Patient with slight rash on forehead and cheek. Temp 101.5F by evening of 6/1/17 and fever resolved by 6/2/17. 6/3/17: Fever up to 104F, resolved by 6/4/17. 6/12/17: Left upper thigh with a cluster of lesions mildly erythematous. 4 scattered raised lesions, painful to touch. Widespread rash noted.  8/22/17: patient presented with 4 days of low grade temp around 100F, vomiting post bottles and looser stool a few times day. Rash present for 4 days. Parents report since vaccination the patient has been more tired, she has not been crawling, talking, or walking. As of 8/22/17 she is slowly returning to her usual self.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash generalised, Skin lesion, Streptococcus test, Urine analysis
Clinical narrative: Child developed a fever of 106F on 6/1/17. Fever down to 102F after spongebath and tylenol. Patient with slight rash on forehead and cheek. Temp 101.5F by evening of 6/1/17 and fever resolved by 6/2/17. 6/3/17: Fever up to 104F, resolved by 6/4/17. 6/12/17: Left upper thigh with a cluster of lesions mildly erythematous. 4 scattered raised lesions, painful to touch. Widespread rash noted.  8/22/17: patient presented with 4 days of low grade temp around 100F, vomiting post bottles and looser stool a few times day. Rash present for 4 days. Parents report since vaccination the patient has been more tired, she has not been crawling, talking, or walking. As of 8/22/17 she is slowly returning to her usual self.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Child developed a fever of 106F on 6/1/17. Fever down to 102F after spongebath and tylenol. Patient with slight rash on forehead and cheek. Temp 101.5F by evening of 6/1/17 and fever resolved by 6/2/17. 6/3/17: Fever up to 104F, resolved by 6/4/17. 6/12/17: Left upper thigh with a cluster of lesions mildly erythematous. 4 scattered raised lesions, painful to touch. Widespread rash noted.  8/22/17: patient presented with 4 days of low grade temp around 100F, vomiting post bottles and looser stool a few times day. Rash present for 4 days. Parents report since vaccination the patient has been more tired, she has not been crawling, talking, or walking. As of 8/22/17 she is slowly returning to her usual self.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of PROQUAD lot # M036295 or lot # M040143. The PROQUAD was reconstituted with properly stored sterile diluent (MERCK). No adverse effects were reported. The digital data logger was involved in recording the excursion. This is one of six reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA001493: US-009507513-1708USA005168: US-009507513-1708USA005169: US-009507513-1708USA005166: US-009507513-1708USA005167.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 3 unspecified patients of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012488, expiration date 20-APR-2019,  for prophylaxis. Concomitant therapies included sterile diluent(DILUENT MRK). No adverse events. The vaccines were exposured to 6.2 degrees Celsius.; Sender's Comments: US-009507513-1708USA008324:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as office manager) regarding unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were unknown. On 02-JUN-2017, 05-JUN-2017, 06-JUN-2017, 07-JUN-2017, 08-JUN-2017, 09-JUN-2017, 10-JUN-2017, 12-JUN-2017, 13-JUN-2017, 14-JUN-2017, 15-JUN-2017, 16-JUN-2017, 19-JUN-2017, 20-JUN-2017, 21-JUN-2017, 22-JUN-2017, 23-JUN-2017, 24-JUN-2017, 26-JUN-2017, 27-JUN-2017, 28-JUN-2017, 29-JUN-2017, and 30-JUN-2017, the patients were vaccinated with improperly GARDASIL 9 lot # M040412 (expiration date 30-JUN-2019) (route and dose unknown) for prophylaxis. No adverse effects were reported. There was no previous temperature excursion. The temperature excursion was from 32 degrees Fahrenheit (F) to 35 degrees F (34 degrees F) for 300 hours and 47 degrees F to 77 degrees F (52 degrees F) for 250 hours. This is one of two reports from the same reporter (1708USA010032).
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Rash papular, Skin warm
Clinical narrative: This spontaneous report as received from a female patient of unknown age and refers to herself. The patient's pertinent medical history included migraine. The patient's concomitant therapies included sumatriptan (IMITREX). The patient had no drug reactions/allergies. On 17-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (lot# and dosing details were not reported) for prophylaxis. Within 24 hours of being administered PNEUMOVAX 23, the patient experienced warmth and red spots on her left arm and shoulder. The patient also reported red spots that look like cellulitis. Her arm pit has another red spot. The patient reported she has never had a reaction to a vaccine before and her physician said he had no other report of adverse reactions from the stock he has. On 18-AUG-2017, the patient saw the physician. Diphenhydramine (BENADRYL) was prescribed and the patient was given a prescription for an unspecified antibiotic in the event the reaction does not subside. The outcome of cellulitis, skin warm and rash papular was reported as not recovered/not resolved. No product quality complaint (PQC) was involved. The reporter did not provide the causality of cellulitis, skin warm and rash popular with PNEUMOVAX 23. Upon internal review, cellulitis was determined to be medically significant.
Sex: U
Vaccine: VARCEL
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 19-AUG-2017 the patient was vaccinated with improperly stored dose of VARIVAX lot # N009767, .5 ml, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse effects were reported. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 11-year, 9-month-old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 21-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (lot # reported as M12093 with expiry date on 13-JAN-2020) to prevent human papillomavirus. Concomitant therapies included MENACTRA and ADACEL. On the same day, within 1 minute of receiving the GARDASIL 9, the patient experienced tonic clonic seizures, which lasted approximately 2 minutes. No treatment was given for the event and no laboratory diagnostic studies were performed. The patient sought an unspecified medical attention. The outcome of the event was considered as recovered/resolved on the same day. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of tonic clonic seizures was determined to be medically significant. Lot number M12093 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 11-year, 9-month-old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 21-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (lot # reported as M12093 with expiry date on 13-JAN-2020) to prevent human papillomavirus. Concomitant therapies included MENACTRA and ADACEL. On the same day, within 1 minute of receiving the GARDASIL 9, the patient experienced tonic clonic seizures, which lasted approximately 2 minutes. No treatment was given for the event and no laboratory diagnostic studies were performed. The patient sought an unspecified medical attention. The outcome of the event was considered as recovered/resolved on the same day. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of tonic clonic seizures was determined to be medically significant. Lot number M12093 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not reported. On an unknown dates, in August 2017, the patients were vaccinated with improperly stored doses of ROTATEQ, (lot # M043562, expiry date 03-JUN-2018). The vaccines were stored at a temperature excursion between 9°C to 25°C for a cumulative total of 6 hours and 35 minutes (first for 4 hours and 33 minutes and then for 2 hours and 2 minutes) (incorrect product storage). It was called because of a data logger. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of three reports from the same reporter source (linked to cased #s 1708USA010054 and 1708USA010055). Additional information has been requested. Sender's Comments: US-009507513-1708USA010054: US-009507513-1708USA010055.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 62-year-old female patient with no drug reactions or allergies. On 15-AUG-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU), injected subcutaneously (lot # N012615 with expiration date at 16-MAR-2018, for prevention of shingles; dose and anatomical location were not reported), reconstituted with sterile diluent (STERILE DILUENT) (lot # reported as N001807 with expiration date at 31-JUL-2019). On an unspecified date in August 2017 (reported as "on an unspecified date after receiving the vaccine"), the patient began experiencing pain, redness and tenderness at the injection site. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. The outcome of the aforementioned events was unknown at the time of the report. No product quality complaint (PQC) was involved. The causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-AUG-2017, the patient was administered an expired dose of PNEUMOVAX 23 injection (lot # L036437 with expiration date at 18-MAY-2017; dose, route of administration and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 8 week old male patient. On 17-AUG-2017, the patient was inadvertently vaccinated with VAQTA, intramuscular, instead of an unspecified hepatitis B vaccine (manufacturer unknown) for prophylaxis (wrong drug administered, inappropriate age at vaccine administration). The patient was showing "no untoward side effects" (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 21-AUG-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. On 21-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. The outcome of expired product administered is unknown. The reporter considered expired product administered to be not related to ZOSTAVAX.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as office manager) regarding unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were unknown. On 02-JUN-2017, 05-JUN-2017, 06-JUN-2017, 07-JUN-2017, 08-JUN-2017, 09-JUN-2017, 10-JUN-2017, 12-JUN-2017, 13-JUN-2017, 14-JUN-2017, 15-JUN-2017, 16-JUN-2017, 19-JUN-2017, 20-JUN-2017, 21-JUN-2017, 22-JUN-2017, 23-JUN-2017, 24-JUN-2017, 26-JUN-2017, 27-JUN-2017, 28-JUN-2017, 29-JUN-2017, and 30-JUN-2017, the patients were vaccinated with improperly stored M-M-R II lot # M039913 (expiration date 26-SEP-2018) (route and dose unknown) for prophylaxis. No adverse effects were reported. There was no previous temperature excursion. The temperature excursion was from 32 degrees Fahrenheit (F) to 35 degrees F (34 degrees F) for 300 hours and 47 degrees F to 77 degrees F (52 degrees F) for 250 hours. This is one of two reports from the same reporter (1708USA008995).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not reported. On an unknown dates, in August 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, (lot # N005096, expiry date 22-OCT-2018). The vaccines were stored at a temperature excursion between 9°C to 25°C for a cumulative total of 6 hours and 35 minutes (first for 4 hours and 33 minutes and then for 2 hours and 2 minutes) (incorrect product storage). It was called because of a data logger. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of three reports from the same reporter source (linked to case #s 1708USA009475 and 1708USA010054). Additional information has been requested. Sender's Comments: US-009507513-1708USA009475: US-009507513-1708USA010054.
Sex: F
Vaccine: PNC13
Symptoms: Biopsy, Rash, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age (reported as 65 unknown units) and ethnicity started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced rash developed over neck and chest, further spreading to other parts of body. Rash started several days after patient received the vaccine. Initial visit to the nurse practitioner resulted in the thought that the rash was due to some form of external factor (i.e. plants in yard). However rash continued to develop and did not have classic symptoms of such a rash. The action taken in response to the event for 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. Therapeutic measures were taken as a result of rash developed over neck and chest, further spreading to other parts of body and included treatment with an unspecified cortisone shot and a biopsy was taken on an unknown date. The clinical outcome for the event was unknown. It was reported that the patient visited dermatology clinic today and their assessment was it is likely related to the PREVENAR 13 vaccine.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever for 3 days on an unspecified date with outcome of recovered.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Company representative. The pharmacist reported for two patients. This is the second of two reports. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient had a red circle on the administration site on an unspecified date, and it lasted for a week. The outcome of the event was recovered on unspecified date.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received PREVNAR 13 via an unspecified route of administration on 16Aug2017 at single dose for immunization. Patient medical history included blood pressure high, diabetes and asthma. Concomitant medications included metformin for diabetes, VENTOLIN for asthma and lisinopril for blood pressure high. It was confirmed that the patient received a single shot of PREVNAR 13 on Wednesday, 16Aug2017 at approximately 2:30. The patient stated "everything was fine and the next day I woke up, I had a huge soft ball size hot red at the site and then the whole lymph node in my armpit is swollen". The patient went to work and then she got fever of 100.8 so she took ibuprofen and stated that normally she took ibuprofen every 6 hours otherwise she will get fever of 100 and site was still extremely painful, hot and red. The patient experienced flu like symptoms and just feeling terrible. It was further stated that if she do not take the Ibuprofen, she gets flu like symptoms and sweaty. All events occurred on 17Aug2017 at about 8:00 am, and stated that she woke up with that. The nurse stated that events: huge softball size hot red at the site, whole lymph node in my armpit is swollen, got fever of 100.8 and extremely painful hot and red were related to PREVNAR 13. She further stated it was 100% the vaccine; events were like specifically at the site and underneath her arm. Outcome of events were ongoing, not recovered. Nurse mentioned that it was more painful. If she do not take the Ibuprofen (treatment), it was just like, she get the flu and sweaty and fever.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received PREVNAR 13 via an unspecified route of administration on 16Aug2017 at single dose for immunization. Patient medical history included blood pressure high, diabetes and asthma. Concomitant medications included metformin for diabetes, VENTOLIN for asthma and lisinopril for blood pressure high. It was confirmed that the patient received a single shot of PREVNAR 13 on Wednesday, 16Aug2017 at approximately 2:30. The patient stated "everything was fine and the next day I woke up, I had a huge soft ball size hot red at the site and then the whole lymph node in my armpit is swollen". The patient went to work and then she got fever of 100.8 so she took ibuprofen and stated that normally she took ibuprofen every 6 hours otherwise she will get fever of 100 and site was still extremely painful, hot and red. The patient experienced flu like symptoms and just feeling terrible. It was further stated that if she do not take the Ibuprofen, she gets flu like symptoms and sweaty. All events occurred on 17Aug2017 at about 8:00 am, and stated that she woke up with that. The nurse stated that events: huge softball size hot red at the site, whole lymph node in my armpit is swollen, got fever of 100.8 and extremely painful hot and red were related to PREVNAR 13. She further stated it was 100% the vaccine; events were like specifically at the site and underneath her arm. Outcome of events were ongoing, not recovered. Nurse mentioned that it was more painful. If she do not take the Ibuprofen (treatment), it was just like, she get the flu and sweaty and fever.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: Patient report nausea, diarrhea "feeling ill" to point of needing to miss work. Started yesterday did not feel well enough to eat dinner and is still feeling ill this am. After dose # 2 had diarrhea resolving within 48hrs.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient had redness, swelling, and warm touch 3 days after injection. She approached the pharmacy on 8/23/17 about the signs of allergic reaction; she received the vaccine on 8/20/2017.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional dose of HPV vaccine.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: The patient came in today for a flu shot. The patient informed us that after he received the PNEUMOVAX vaccination in April, 2017 his left arm swelled up. He said it was warm and swollen for about a week and then improved. He shared no residual issues from the vaccination since it improved..
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Ear swelling, Grunting, Hypersensitivity, Lip swelling, Peripheral swelling
Clinical narrative: Systemic Allergic Reaction: mom called, symptoms began with swelling of lips, ears, hands, fingers, wheezing. Mom was advised to bring patient to ER, mom declined , came to office. By the time the patient arrived at the office at 11:40 am, he had welts, grunting while breathing, very swollen bottom lip, ears, rash on extremities, poor peripheral perfusion, unable to speak, not moving air well. Pt was immediately brought back to exam room, vitals taken, provider entered room to assess, was given Epi 1:1000  0.2cc IM Left lateral thigh at 11:44am. Started Albuterol neb 0.083% at 11:47 am. Vitals reassessed every 5 minutes, were stable throughout other than the normal side effects of EPI (shaky, Tachycardia) and Albuterol (Tachy and shaky). Pt was kept in office for 2 hrs to ensure reaction did not reoccur once medications wore off. RX for Epi pen JR called into pharmacy, educated mom on the seriousness of allergic reaction. Allergist contacted to ensure patient gets appointment.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Poor peripheral circulation, Rash, Speech disorder, Tachycardia, Tremor
Clinical narrative: Systemic Allergic Reaction: mom called, symptoms began with swelling of lips, ears, hands, fingers, wheezing. Mom was advised to bring patient to ER, mom declined , came to office. By the time the patient arrived at the office at 11:40 am, he had welts, grunting while breathing, very swollen bottom lip, ears, rash on extremities, poor peripheral perfusion, unable to speak, not moving air well. Pt was immediately brought back to exam room, vitals taken, provider entered room to assess, was given Epi 1:1000  0.2cc IM Left lateral thigh at 11:44am. Started Albuterol neb 0.083% at 11:47 am. Vitals reassessed every 5 minutes, were stable throughout other than the normal side effects of EPI (shaky, Tachycardia) and Albuterol (Tachy and shaky). Pt was kept in office for 2 hrs to ensure reaction did not reoccur once medications wore off. RX for Epi pen JR called into pharmacy, educated mom on the seriousness of allergic reaction. Allergist contacted to ensure patient gets appointment.