chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient at age 12, was vaccinated with a dose of GARDASIL (HPV4) (dates of administration, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient at age 17, was vaccinated with a dose of GARDASIL 9 (dates of administration, dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse events were reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to 8 patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies was provided. On unknown dates in 2017, since July 2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection (lot # N010494, expiration date: 16-MAR-2018; dose and route of administration were not reported). Concomitant therapy included sterile diluent (MERCK STERILE DILUENT) injection (lot # reported as N047667; expiration date: 25-JUL-2019). The reporter stated that the administered doses of ZOSTAVAX were stored at temperature of 26.4 degrees Fahrenheit (F) for 1 hour and 45 minutes. Data logger was used to detect temperature excursions. Previous temperature excursions included storage at the temperature of 23.1 degrees F for 1 hour and 45 minutes on unknown date. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # M041213, expiration date 22-JUN-2019, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from same reporter. Sender's Comments: US-009507513-1708USA003070.
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a 23 year old female consumer enrolled in a market research program concerning unspecified patients. The concurrent condition, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. It was reported that "the vaccine killed girls". The reporter denied taking this vaccine it from her doctor the whole life and would continue to do so. The action taken was not applicable. The causality was unspecified.
Age: 24.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Anxiety, Dizziness, Head injury, Headache, Immediate post-injection reaction
Clinical narrative: Patient with hx of needle phobia and seizures unrelated to vaccine was vaccinated at 10:30 am in preparation to travel. He had his last T-dap in 2006  and had not had a prior Typhoid vaccine. Patient was vaccinated in the supine position and observed for 20 minutes after vaccination. He reported a tingling sensation in both hands immediately following vaccination, which was attributed to anxiety at the time. I subsided within a few minutes. Bp=128/75 P=87 pre and Bp=118/74, P=76 post. He left the medical office to have lunch and returned to his work station. At 1:25 pm he felt an intense headache and dizziness followed by "fainting", striking his Left frontal/Templar area on his disk on the way down. Medical staff responded within 5 minutes and the patient was found face down with body tremors, holding his head but not initially responding to verbal commands. Bp=106/64, P=90 in the supine position. 911 was called. He was able to turn over and sit with assistance and became more alert while waiting for EMS to arrive, but tremors remained until transport to the local hospital. Apparent seizure possibly related to vaccination.
Age: 24.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Paraesthesia, Seizure, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Patient with hx of needle phobia and seizures unrelated to vaccine was vaccinated at 10:30 am in preparation to travel. He had his last T-dap in 2006  and had not had a prior Typhoid vaccine. Patient was vaccinated in the supine position and observed for 20 minutes after vaccination. He reported a tingling sensation in both hands immediately following vaccination, which was attributed to anxiety at the time. I subsided within a few minutes. Bp=128/75 P=87 pre and Bp=118/74, P=76 post. He left the medical office to have lunch and returned to his work station. At 1:25 pm he felt an intense headache and dizziness followed by "fainting", striking his Left frontal/Templar area on his disk on the way down. Medical staff responded within 5 minutes and the patient was found face down with body tremors, holding his head but not initially responding to verbal commands. Bp=106/64, P=90 in the supine position. 911 was called. He was able to turn over and sit with assistance and became more alert while waiting for EMS to arrive, but tremors remained until transport to the local hospital. Apparent seizure possibly related to vaccination.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Mobility decreased
Clinical narrative: Patient's daughter called to complain that her mother was "sick" and couldn't get out of bed.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient's arm was hot and swollen, she required antibiotic treatment after visiting a doctor.
Sex: F
Vaccine: HPV9
Symptoms: Chest discomfort, Lip swelling, Pain in extremity, Swollen tongue
Clinical narrative: I had a negative reaction to GARDASIL 9 the first shot and got a swollen arm and a lump. The second time the doctor recommended I take BENADRYL (we did) before the shot. About 12 hours later I was in excruciating arm pain and my tongue and lips were swollen and my chest tightened. I required an EPIPEN, steroids, and a 6 hour hour observation in the ER.
Age: 35.0
Sex: M
Vaccine: ANTH, IPV, MMR, TYP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swelling, redness, hot to touch, itching on right arm. Visited urgent care Sunday 6 August. Prescribed Amoxicillin and Prednisone. Patient reports symptoms have improved.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain, Poor quality sleep, Skin warm
Clinical narrative: Severe shoulder pain to L shoulder with onset at 2:15 a.m., in the morning after receipt IIV on 16 Oct 2016. She states the pain awoke her, was severe, burning, hot across her shoulder blade and shoulder the size of her palm. It was worsened by motion. It came in waves with periods of improvement followed by exacerbation. She was seen in Urgent Care 18 OCT 2016 and treated with MOTRIN and tramadol. Required PT. Symptoms: Pain in left shoulder.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Pt developed mild swelling, erythema and tenderness with some warmth to LUE. Seen in clinic 8/4/17 and recommended ice, motrin and benadryl PRN. Mom to f/u if needed. F/u call on 8/8/17 with no answer, mom to call back for any concerns.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV9, TDAP
Symptoms: Confusional state, Headache, Lethargy, Pyrexia
Clinical narrative: Confusion headache fever lethargy.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV9, TDAP
Symptoms: Confusional state, Fatigue
Clinical narrative: Confusion headache fever lethargy.
Age: 0.42
Sex: M
Vaccine: DTAP, IPV
Symptoms: Body temperature increased, Depressive symptom, Hyporesponsive to stimuli, Lethargy
Clinical narrative: 4 hours after receiving vaccines infant ran temp up to 102, lethargic and less responsive. Dad reports depression type symptoms lasting one week, states lake a zombie then resolved. Dad states he did this after first DTap which infant received 03/21/2017, but this was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Vaccination error
Clinical narrative: NO ADVERSE EVENT AS YET. VACCINE ERROR.
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 with prophylaxis. On an unknown date the patient was vaccinated with VARIVAX lot # N009766 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. This is one of two reports from the same.; Sender's Comments: US-009507513-1708USA002980:
Sex: U
Vaccine: MMRV
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 with prophylaxis. On an unknown date the patient was vaccinated with PROQUAD lot # N010865 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. This is one of two reports from the same source. Sender's Comments: US-009507513-1708USA002868.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 05-JUN-2017,  the patient was vaccinated with an expired dose of M-M-R II lot # L020189 with expiration date of 03-JUN-2017, status albumin: RHA, (strength, dose, frequency, route of administration, were not provided) for prophylaxis. No adverse effects reported. No further details were available. Follow up information has been received from the licensed practical nurse on 02-AUG-2017, referring to the 14 months old male patient with 3 siblings. The patient's did not have illness at time of vaccination, and neither any pre-existing allergies, birth defects and/or medical conditions. The patient's concomitant therapies included VARIVAX, PREVNAR 13, HAVRIX A, PEDVAXHIB and INFANRIX DTPA-IPV+HIB. This is one of two reports received from the same source. Sender's Comments: US-009507513-1706USA002819.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 30 yo M w/Rx HIV, seasonal allergies and flow murmur, was seen in clinic 3/24 for appointment, and received vaccination with PNEUMOVAX 23 as per the CDC recommendations. Patient called on 3/25 reporting left arm redness and pain originating from the site of the injection and extending to his elbow. Photo of the reaction was sent to the provider. Provider prescribed cephalexin to treat presumed cellulitis, and the patient was advised to go to the nearest ED if the redness increases, or if he develops a fever, chills, rigors or the erythema starts to spread. No further follow up noted at this time to be seen in outpatient clinic 4/17/17.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Lethargy, Malaise
Clinical narrative: Nightly fevers and shaking rigors with sweats for 2 nights after 3rd vaccine injection. Persistent nausea, malaise, lethargy and anorexia.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Nightly fevers and shaking rigors with sweats for 2 nights after 3rd vaccine injection. Persistent nausea, malaise, lethargy and anorexia.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling to injection site.
Age: 71.0
Sex: U
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Injection site pain, Peripheral swelling
Clinical narrative: Fatigue, joint pain, arm swelling, pain at site of shot.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Patient developed rash/hives on upper arm at injection site (shoulder - elbow).
Age: 20.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Pain
Clinical narrative: 20 yo male with PMR of HIV, primary syphilis, and gonorrhea presented for a follow-up visit. On 1/11/2017 he was given PNEUMOVAX 23 IM (left deltoid muscle) and PREVNAR IM (right deltoid muscle). During a follow up visit on 1/13/17 he complained of a red, sore streak on his left arm. Per the patient, the left upper arm erythema developed in the evening on 1/11/17 and was initially very tender, but the soreness had been resolving over the next two days. His ROS was notable for LUE redness. The patient denied fevers, chills, or swollen lymph nodes, and he was afebrile (T 97.9 F). He was prescribed cephalexin 500 mg Q6H x 7 days for the treatment of cellulitis. Per a telephone follow-up call on 1/19/17, the patient reported the redness and swelling to be completely resolved.
Age: 20.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Swelling
Clinical narrative: 20 yo male with PMR of HIV, primary syphilis, and gonorrhea presented for a follow-up visit. On 1/11/2017 he was given PNEUMOVAX 23 IM (left deltoid muscle) and PREVNAR IM (right deltoid muscle). During a follow up visit on 1/13/17 he complained of a red, sore streak on his left arm. Per the patient, the left upper arm erythema developed in the evening on 1/11/17 and was initially very tender, but the soreness had been resolving over the next two days. His ROS was notable for LUE redness. The patient denied fevers, chills, or swollen lymph nodes, and he was afebrile (T 97.9 F). He was prescribed cephalexin 500 mg Q6H x 7 days for the treatment of cellulitis. Per a telephone follow-up call on 1/19/17, the patient reported the redness and swelling to be completely resolved.
Age: 84.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: There is a big red circle on the right arm and painful.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given a dose of meningococcal conjugate instead of the scheduled HPV dose. No adverse effects reported.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given a dose of meningococcal conjugate instead of the scheduled HPV dose. No adverse effects reported.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Pt. was given vaccine aprox. 12PM, had eaten breakfast that morning. Once Pt. was home about 4pm patient felt faint, lightheaded and nauseas. Injection site and arm were in pain for several days following. Mother found patient on floor the same day, patient was feeling faint, was given TUMS and rested. Patient felt faint about 24hrs. after injection.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Headache, Injection site rash, Pain
Clinical narrative: Immunizations given on 7/26/17, mom reports patient complained of headache since vaccines and dizziness. Woke up 8/1/17 with rash at injection site. Also complains of pain.
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Abasia, Myalgia
Clinical narrative: Patient complained of muscle soreness to the point of being unable to walk. Patient also had a high fever. Symptoms lasted about 12 hours. No treatment provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 8/2/17 (L) AT erythema 9x10cm warm, swollen, 5c, tender nodule.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Pt. came to pharmacy on 8/6/17 about 1 wk. after vaccination, her R arm was red and warm to touch. Asked pt. to go to urgent care.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Syncope
Clinical narrative: Syncope, minor fall, no concussion or bruising, called pt. next day (8/1/17), no complaints.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling, mild induration at site at injection noted on exam 24 hrs later. No systemic sx.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient loss consciousness upon administering vaccine, regain after 10-15 sec. responded to question. BP 99/55, called 911-EMT said pt. is ok to go home. BP normal 115/77.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: The next day patient fell asleep in the car while dad was at the grocery store. Car was running0he returned after 20 min and could not wake her up. Helped by someone to shake car, called police, ambulance came, slept though all and finally awoke-police jimmying the door.
Age: 79.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 7 days.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site swelling, Insomnia, Pain
Clinical narrative: I was given Pneumococcal Vaccine 23-Valent on August 2, 2017. In 4 hours, I had a golf ball size area just below site of injection. Four days later (August 6, 2017 ) side effect of this drug have moved almost to wrist area. I have experienced these side effects: redness, much swelling almost to wrist, areas itch, much pain, rash and tenderness to touch, and discoloration (yellow) on underside of elbow, and some joint pain. I have been unable to sleep and have to elevate arm. The affected area was also underneath armpit. I was not told of any side-effects, and I would definitely NOT take this vaccine had I know about these side-effects. I had Pneumococcal 13 in 2012 and had no side-effects. These are the worst side-effects I have ever had. I am a healthy female, age 70, do not take any medications for any health issues. Thank you.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Skin discolouration, Tenderness
Clinical narrative: I was given Pneumococcal Vaccine 23-Valent on August 2, 2017. In 4 hours, I had a golf ball size area just below site of injection. Four days later (August 6, 2017 ) side effect of this drug have moved almost to wrist area. I have experienced these side effects: redness, much swelling almost to wrist, areas itch, much pain, rash and tenderness to touch, and discoloration (yellow) on underside of elbow, and some joint pain. I have been unable to sleep and have to elevate arm. The affected area was also underneath armpit. I was not told of any side-effects, and I would definitely NOT take this vaccine had I know about these side-effects. I had Pneumococcal 13 in 2012 and had no side-effects. These are the worst side-effects I have ever had. I am a healthy female, age 70, do not take any medications for any health issues. Thank you.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella
Clinical narrative: Had chicken pox as a child and got the shingles vaccine to prevent/lessen an outbreak event. Within a few days I had full blown case of chicken pox from head to toe. Never had shingles before the vaccine but since have had one minor outbreak a month mainly located to the small of my back but has shown elsewhere. When given the vaccine I was in good health. No known allergies.
Age: 22.0
Sex: F
Vaccine: HEPA, MENB, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given Hep A Ped/ADOL Dose. Patient notified and per CDC info will return to receive Hep A adult dosage. No adverse events reported by patient.
Age: 23.0
Sex: F
Vaccine: ADEN_4_7, HEPA, MNQ, TDAP
Symptoms: Pruritus generalised
Clinical narrative: Patient stated after her vaccination started a little itchy went to lunch ate cereal and than started itchy every where. Patient also received Z PEN G Benzathine after vaccination and Azithromycin right before vaccination in female wellness. Nurse gave Benadryl  and patient was monitored by nurse practitioner . Patient was put SIQ and sent with zyrtec.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Contusion, Fall, Headache, Heart rate decreased, Injection site pain
Clinical narrative: Patient received vaccines MENACTRA and Men B. After receiving vaccines patient was alert and talking then stood up and fell onto floor face first. Fell onto right cheek, had a bruise forming. Patient went unconscious and starting having a seizure. Dr and RNs at bedside. Oxygen was placed on patient and he came back to full consciousness. Patient was alert and oriented at that time. EMS called. Vitals were done. Initially 74 HR, pulse ox 96 BP 160/80 on 6L. HR dropped to 52. After a few minutes BP went to 138/62, HR 56, Pulse ox 100. Patient complained of right shoulder soreness, back of his head hurting, nauseated. Patient sat up in the chair as he awaited for EMS. Glucose and IV started in room.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Patient received vaccines MENACTRA and Men B. After receiving vaccines patient was alert and talking then stood up and fell onto floor face first. Fell onto right cheek, had a bruise forming. Patient went unconscious and starting having a seizure. Dr and RNs at bedside. Oxygen was placed on patient and he came back to full consciousness. Patient was alert and oriented at that time. EMS called. Vitals were done. Initially 74 HR, pulse ox 96 BP 160/80 on 6L. HR dropped to 52. After a few minutes BP went to 138/62, HR 56, Pulse ox 100. Patient complained of right shoulder soreness, back of his head hurting, nauseated. Patient sat up in the chair as he awaited for EMS. Glucose and IV started in room.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product
Clinical narrative: Patient was due to receive 5th dose in Dtap series. By accident, Tdap was administered to patient. State Immunization Registry notified and clinical nurse with IR informed me that no adverse events are to be expected. Tdap given to patient accidentally counts as 5th Dtap and no repeat is needed. Mother of patient notified.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: Vaccines prepared, not given, wasted.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling at vaccination site left thigh that started 8-1-17. Tender to the touch. Fever of 100.3. Otherwise behaving normally.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches and fever.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Decreased appetite, Dizziness, Impaired work ability, Nausea, Vertigo
Clinical narrative: Patient reported signs and symptoms of nausea including vomiting (every 15 minutes for a while), vertigo and dizziness, loss of appetite. Patient reports that he is rarely sick and believes that this could be due to the flu shot he received the day before. Patient had to miss a day of work - has not missed a day in a very long time.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Patient reported signs and symptoms of nausea including vomiting (every 15 minutes for a while), vertigo and dizziness, loss of appetite. Patient reports that he is rarely sick and believes that this could be due to the flu shot he received the day before. Patient had to miss a day of work - has not missed a day in a very long time.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified amount of patients (gender and age unknown). The patients' medical histories, concurrent conditions and concomitant medication were not provided. On unspecified dates the patients were administered M-M-R II via intramuscular route for prophylaxis. No adverse events were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patient's current conditions and medical history were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored M-M-R II (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003605: US-009507513-1708USA003607: US-009507513-1708USA003604: US-009507513-1708USA003603: US-009507513-1708USA003606.
Sex: M
Vaccine: VARZOS
Symptoms: Product use issue
Clinical narrative: This spontaneous report as received from a physician refers to a 52 year old male patient with multiple sclerosis. On 04-AUG-2017 the immunosuppressed patient was vaccinated with a dose of ZOSTAVAX lot # N015628 with expiration date 30-JUL-2018, for prophylaxis. Concomitant therapies included fingolimod hydrochloride, losartan potassium (manufacturer unknown), methylphenidate, and BACTRIM. On 04-AUG-2017, 1 day after onset of therapy the patient experienced product use issue. The outcome of product use issue is unknown. The reporter considered product use issue to be not related to ZOSTAVAX.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from the patient's mother referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced product use issue and no adverse event. The outcome of product use issue and no adverse event is unknown. The reporter considered product use issue and no adverse event to be not related to VARIVAX.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patient's current conditions and medical history were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored GARDASIL 9 (strength, dose, route of administration,lot/batch# and expiration date were not reported) for prophylaxis.The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint(PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003015: US-009507513-1708USA003605: US-009507513-1708USA003606: US-009507513-1708USA003607: US-009507513-1708USA003604.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored ROTATEQ (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003015: US-009507513-1708USA003603: US-009507513-1708USA003605: US-009507513-1708USA003607: US-009507513-1708USA003606.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored PNEUMOVAX 23 (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003603: US-009507513-1708USA003015: US-009507513-1708USA003604: US-009507513-1708USA003606: US-009507513-1708USA003607.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored PEDVAXHIB (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003603: US-009507513-1708USA003015: US-009507513-1708USA003604: US-009507513-1708USA003605: US-009507513-1708USA003607.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored VAQTA (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003015: US-009507513-1708USA003603: US-009507513-1708USA003604: US-009507513-1708USA003606: US-009507513-1708USA003605.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Asthenia, Chills, Dysstasia, Eye pain
Clinical narrative: This is a spontaneous report from a contactable consumer (parent of the patient). A 17-years-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 31Jul2017 at 16:00 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 31Jul2017 at 16:20 (20 minutes after vaccination) the patient began feeling pain in her which got worse as time passed, which progressed to fever/chills and muscle/joint/skin/eye pain and general weakness, with trouble standing and difficulty moving her fingers, but no difficulty breathing. The patient was worst at 18:30-19:00 she had nausea and a periodic headache, and was extremely pale in her extremities. At 19.00 temperature was 100.7 hence the parents took her to the emergency room. Upon arrival they took her vitals. During the 2-3hr after, her symptoms lessened to the point of her wanting to go home. They immediately gave her TYLENOL and after about 1hr released her. At reporting time the patient was feeling much better, but tired. Tiredness started on unspecified date in 2017 and the outcome was unknown. The final outcome of the other events was recovering.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Mobility decreased, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (parent of the patient). A 17-years-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 31Jul2017 at 16:00 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 31Jul2017 at 16:20 (20 minutes after vaccination) the patient began feeling pain in her which got worse as time passed, which progressed to fever/chills and muscle/joint/skin/eye pain and general weakness, with trouble standing and difficulty moving her fingers, but no difficulty breathing. The patient was worst at 18:30-19:00 she had nausea and a periodic headache, and was extremely pale in her extremities. At 19.00 temperature was 100.7 hence the parents took her to the emergency room. Upon arrival they took her vitals. During the 2-3hr after, her symptoms lessened to the point of her wanting to go home. They immediately gave her TYLENOL and after about 1hr released her. At reporting time the patient was feeling much better, but tired. Tiredness started on unspecified date in 2017 and the outcome was unknown. The final outcome of the other events was recovering.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain of skin, Pallor, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (parent of the patient). A 17-years-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 31Jul2017 at 16:00 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 31Jul2017 at 16:20 (20 minutes after vaccination) the patient began feeling pain in her which got worse as time passed, which progressed to fever/chills and muscle/joint/skin/eye pain and general weakness, with trouble standing and difficulty moving her fingers, but no difficulty breathing. The patient was worst at 18:30-19:00 she had nausea and a periodic headache, and was extremely pale in her extremities. At 19.00 temperature was 100.7 hence the parents took her to the emergency room. Upon arrival they took her vitals. During the 2-3hr after, her symptoms lessened to the point of her wanting to go home. They immediately gave her TYLENOL and after about 1hr released her. At reporting time the patient was feeling much better, but tired. Tiredness started on unspecified date in 2017 and the outcome was unknown. The final outcome of the other events was recovering.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other HCP (medical assistant) on behalf of a contactable physician. A female patient of an unspecified age and ethnicity received TRUMENBA (lot number: S26962, NDC number: 00005010001, Expiration Date: 30Jan2019), via an unspecified route of administration on an unspecified date as a single dose in the arm for immunization. The patient's medical history and concomitant medications were not reported. The girl (patient) experienced pain of the injected arm, pain of the neck regarding the same side of the body that she received the injection, and pain of the leg on the same side of the body that she received the injection. Outcome of the events was unknown.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Dark circles under eyes, Erythema of eyelid, Hypoaesthesia, Injection site erythema, Injection site pruritus
Clinical narrative: According to the patient's mother: Patient began itching at the site of injection and then redness at the site of injection and down to her elbow, fingers started to become tingly and then numb in the evening. As the evening progressed, the patient's eyes started to become dark under the eyes and then red. Patient began to say that her throat was tingly. Mother of patient took patient to the emergency room at 9pm yesterday due to the symptoms and her knowledge of the patient's former reaction to foods with eggs in them. The ER physician administered ibuprofen, BENADRYL, and a steroid dose.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Pharyngeal paraesthesia
Clinical narrative: According to the patient's mother: Patient began itching at the site of injection and then redness at the site of injection and down to her elbow, fingers started to become tingly and then numb in the evening. As the evening progressed, the patient's eyes started to become dark under the eyes and then red. Patient began to say that her throat was tingly. Mother of patient took patient to the emergency room at 9pm yesterday due to the symptoms and her knowledge of the patient's former reaction to foods with eggs in them. The ER physician administered ibuprofen, BENADRYL, and a steroid dose.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Discomfort, Fatigue, Headache, Insomnia
Clinical narrative: Patient reported aching from waist up/pain/discomfort. Arrival home, several hours later, patient got a headache, couldn't sleep, and eventually in the AM hours about 14 hours after the IMZ,  had the diarrhea. Patient took IBU. Next day patient was extremely fatigued. 48 hours later patient reports feeling a lot better, but still is tired. She was able to go to work as well.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Patient reported aching from waist up/pain/discomfort. Arrival home, several hours later, patient got a headache, couldn't sleep, and eventually in the AM hours about 14 hours after the IMZ,  had the diarrhea. Patient took IBU. Next day patient was extremely fatigued. 48 hours later patient reports feeling a lot better, but still is tired. She was able to go to work as well.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: On 8/7 afternoon:  Pt walks in to clinic today complaining of being able to move her left arm without significant pain after receiving her PNEUMOVAX 23 vaccine this am. Pt is sitting quietly with arm by her side. The pain starts in her neck and radiates to her finger. Pt states that the pain has been progressively worse this afternoon, so she walked into clinic for help. Pt states that if she is still her arm pain level is 3-4/10, and if she tries to move her arm it goes to a 9/10. On 8/8 AM, patient reports she was able to move her L arm a little more than she had been able to do the day before.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash, Rash erythematous
Clinical narrative: Swollen lymph nodes in neck, and red spots on face and legs.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to pharmacy 72 hours post-vaccination with redness, slight swelling, redness and warmth on injection site.  Patient's provider who issued prescription for injection was consulted and requested patient to visit office for evaluation.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Posture abnormal, Seizure like phenomena, Somnolence, Unresponsive to stimuli
Clinical narrative: Seizure-like episode lasting 10 to 12 seconds occurring 10 minutes after receiving vaccines, while sitting in chair; right arm became stiffened and flexed at 90 degree angle, student slumped in chair. Eyes remained opened. Was verbally unresponsive. Symptoms completely self-resolved after 10 to 12 seconds. VSS were normal and stable (T=98.5, RR=18, AP=88, BP 110/70) and student was in NAD except felt drowsy and wanted to go to sleep. Mother drove to ER for evaluation.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Induration, Nodule
Clinical narrative: Left shoulder Lump, hard.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, International normalised ratio increased, Malaise
Clinical narrative: She got the vaccine and claims the next day she felt "sick". Symptoms were described as nausea, shortness of breath, increase in blood pressure, increase in pulse. Doctor says her increase in INR was also from her immunization.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Nausea
Clinical narrative: She got the vaccine and claims the next day she felt "sick". Symptoms were described as nausea, shortness of breath, increase in blood pressure, increase in pulse. Doctor says her increase in INR was also from her immunization.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt. came in on 8/6/2017 complaining of rash on her face and forehead. Pt. went to dermatologist and he confirmed that she had episode of shingles. Pt. came back on 8/6/17 after receiving vaccine (ZOSTAVAX) on 8/2/17 complaining of rash on her upper face and forehead. The pharmacist on duty advised the patient to see MD for further evaluation. Pt. came back on 8/6/17 and stated that she was seen by her dermatologist and he did confirm that the rash was shingles and did say that it was most likely due to vaccine. Pt. was prescribed VALTREX and prednisone for treatment.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Lip swelling, Malaise
Clinical narrative: Sick, lips swelling, chest pains, all occurred the following morning after receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: No adverse event
Clinical narrative: None.
Age: 30.0
Sex: U
Vaccine: MNQ
Symptoms: Dyspnoea, Muscular weakness, Pharyngeal oedema, Pyrexia
Clinical narrative: Fever, weakness in the arm where shot was given, when woke up she had difficulty breathing, swollen throat.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site erythema; Injection site induration (approximately 2 inches diameter); Injection site pain; Injection site pruritus; Injection site warmth.
Age: 9.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Headache, Malaise, Pallor, Skin warm, Somnolence
Clinical narrative: At approximately 1030 RN in room to give vaccines, Hep A, Varicella and HPV #1 (administered 1042) vaccine. After administering vaccines mom reported child was not feeling well and looked pale. Upon assessment RN noted patient's drowsy, face and lips were pale. Vital signs taken at 1100, BP 88/51, T 36.4. Patient reported not feeling well, per mom his face was hot and child c/o headache. Provider notified and assessed patient. Snacks and soda given to patient and started to feel better after. Nurse noted face and lip color were back to baseline. Patient was alert and reported feeling better. RN rechecked BP at 1119, 93/56. RN notified Provider. Patient discharged home in stable condition according to staff.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: After giving vaccine went to enter into electronic record and noticed pt had received same shot 4/2015 called pt and she does not remember getting that shot and thinks it was reported in error.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: REDNESS AND FEELS HOT TO TOUCH, ITCHING. PT STARTED BENADRYL AND ACETAMINOPHEN TODAY.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Flushing, Herpes zoster, Impaired work ability
Clinical narrative: RP retrieved the vial from a freezer, I waited 20 minutes was called into receive single dose shot on July 5, 2017. On Aug 6 I had flu like symptoms of achy, flush, tired.  I went to bed at 530 p.m.  The next Day Aug 7 when my foot hit the floor it felt fat, sore, and had a rash. I called in sick for work, spent the day in bed with foot elevated. Aug 8 symptoms worsened so I went to my doctor and she said that I in fact had shingles just below my calf on my left leg. UNBELIEVABLE.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pain in extremity, Rash
Clinical narrative: RP retrieved the vial from a freezer, I waited 20 minutes was called into receive single dose shot on July 5, 2017. On Aug 6 I had flu like symptoms of achy, flush, tired.  I went to bed at 530 p.m.  The next Day Aug 7 when my foot hit the floor it felt fat, sore, and had a rash. I called in sick for work, spent the day in bed with foot elevated. Aug 8 symptoms worsened so I went to my doctor and she said that I in fact had shingles just below my calf on my left leg. UNBELIEVABLE.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Differential white blood cell count, Full blood count, Hypophagia, Metabolic function test, Pyrexia
Clinical narrative: 16 month with tactile fever, took ibuprofen, then febrile seizure. Diagnosed in ER setting at Hospital. Seizure lasted 2 minutes. Seizure was 9 days after immunizations, and a few days of decreased solid intake. On PE TM's not visible in ER T max 103.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Seizure, Urine analysis
Clinical narrative: 16 month with tactile fever, took ibuprofen, then febrile seizure. Diagnosed in ER setting at Hospital. Seizure lasted 2 minutes. Seizure was 9 days after immunizations, and a few days of decreased solid intake. On PE TM's not visible in ER T max 103.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports left upper arm skin red and hot (large area) and swollen since receiving vaccine 6 days ago. MD prescribed Cetirizine 10mg daily and taper dose of prednisone for 5 days.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Full blood count normal, Irritability, Pityriasis rosea, Pyrexia, Rash
Clinical narrative: Skin rash (pityriasis rosea)? 8/4/17. 8/7/17 Fever - high at 101.0 fussy - rash improving.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Streptococcus test negative
Clinical narrative: Skin rash (pityriasis rosea)? 8/4/17. 8/7/17 Fever - high at 101.0 fussy - rash improving.