chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Nausea, Pallor, Vertigo, Vomiting
Clinical narrative: Pt. did fine after immunization.  Blood drawn in clinic by MA, approximately 30 minutes after vaccine.  Patient became dizzy and nauseated after blood draw.  Stated room was spinning.  He appeared pale.  He was placed in a supine position lying in the venipuncture chair and monitored.  He continued to feel nauseated on/off for up to 3 hours after the blood draw.  We monitored blood pressure and pulse and offered fluids including grape juice, water, and apple juice.  He had some crackers and grape juice prior to vaccine.  He was awake, alert, and oriented.  After approximately 2 1/2 hours he was offered to go to the ER for IV fluids and nausea medication.  He declined stating he was feeling better but that the nausea kept returning.  While we were speaking he sat forward and vomited approximately 30 cc.  He stated after vomiting he immediately began to feel better.  He was monitored for another 30 minutes, got up to use the restroom without incident, and denied wanting to go to the ER or needing nause medications prescribed from our clinic.  He requested to go home with his daughter, who was able to drive him home with her driver's permit.  He declined needing a wheelchair transport to his car.  He was instructed to call with any worsening of symptoms or should he have any neurologic symptoms such as weakness fatigue or loss of strength in any extremeties, or difficulty breathing or shortness of breath.  He voiced understanding.  Vital signs throughout the day were:  11:59 96/70 pulse 60, 2:35 110/80 pulse 54, 2:45 118/80 pulse 66, 3:04 110/80 pulse 54, 3:27 124/78 pulse 66.  Left at 1600.
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Dizziness, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: .Pt returned from gym 3/2 3 pm c/o dizzy, weak and took acetaminophen 500 mg 2 tab. At 10 pm fever at 102.5. 3/3 temp at 9 am 100.0 (repeated TYLENOL) and 11:30 temp 98.0. slight rt. arm pain/swelling and muscle ache. (ice, TYLENOL or ibuprofen) and f/u).
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: .Pt returned from gym 3/2 3 pm c/o dizzy, weak and took acetaminophen 500 mg 2 tab. At 10 pm fever at 102.5. 3/3 temp at 9 am 100.0 (repeated TYLENOL) and 11:30 temp 98.0. slight rt. arm pain/swelling and muscle ache. (ice, TYLENOL or ibuprofen) and f/u).
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Local reaction
Clinical narrative: Localized reaction with a 5 inches tall x 4 inches wide redness area to right arm. Patient received this within 24hours the localized reaction.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Youth complains of a headache and pain at injection site. Redness to upper arm and shoulder. Warm to touch. No swelling noted.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Youth complains of body aches.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Discomfort, Limb discomfort, Vomiting
Clinical narrative: In ED report on 1/16/2016 patient presented with sensation of weakness and heaviness in bilateral lower extremities. After dinner patient began having vomiting and diarrhea which was not red. Patient denied fever, abdominal pain, or shortness of breath. Then patient had another ED visit on 2/9/16 and reported progressive weakness.  That was when the patient reported "that she felt that her symptoms began towards the beginning of January when she received a flu shot and was treated with Augmentin for possible sinusitis." Clinic was not notified about patients adverse reaction until March 3, 2016 when patient called clinic.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Skin infection at injection site.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Electrocardiogram, Electroencephalogram, Endotracheal intubation, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: 3 weeks after vaccine the patient developed panic attack which then turned in to seizures. Patient was admitted and had complete workup and was diagnosed with Pseudoseizures.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Panic attack, Psychogenic seizure, Seizure, Ultrasound pelvis
Clinical narrative: 3 weeks after vaccine the patient developed panic attack which then turned in to seizures. Patient was admitted and had complete workup and was diagnosed with Pseudoseizures.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Hair disorder, Infertility female, Premature menopause
Clinical narrative: Diagnosed in August of 2012 with premature ovarian failure and early menopause, recurrent miscarriages and infertility major hairloss. NO FAMILY HISTORY. 6 miscarriages between 2009-2014.
Age: 58.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Headache
Clinical narrative: Headache per the patient's wife.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Blood pressure decreased, Exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: Patient came in yesterday and related that she has had a positive pregnancy test at her PCP's office on 02.24.2016. LMP 01.08.2016. I gave her MMR at her appointment on 01.22.2016 as she stated that she was not pregnant at that time. I had given her instructions to be careful to not get pregnant in the next 28 days. Patient came in yesterday with family for additional vaccines and reported that she is currently pregnant.  She was not ill subsequent to the MMR injection and has felt fine except a brief decrease in blood pressure in the last one week, probably related to the nausea during early pregnancy. She did have this concern for 7 months in the previous pregnancy. Reassurance given that the MMR has not been directly linked with birth defects and is a theoretical risk concern. Additionally, it is less likely for problems due to the earliness of pregnancy and the set up of implantation. However, I recommended that she contact her PCP and explain that she did receive the vaccine on 01.22.2016. VAERS report done.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Warm, red, swollen L arm.
Age: 25.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Eye movement disorder, Loss of consciousness, Muscle contracture, Seizure
Clinical narrative: Gave client Td, MMR, and Hepatitis B. Client had seizure within seconds of after administering the last vaccine, Hepatitis B. She had her eyes rolled and muscle contracted. Seizure lasted about a minute. Client gained her conscious back. Client didn't remember her having a seizure. Client went to E.R. by ambulance.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal disorder
Clinical narrative: Pt was pregnant at time of vaccine and suffered a miscarriage 2 months after. Dr stated the baby stopped growing prior to miscarriage.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthropathy, Asthenia, Dyspepsia, Fatigue, Feeling abnormal
Clinical narrative: Past digestion issues, Chronic Fatigue, Muscle loss, bone/teeth weakening, joint problems.....feels like body has been under attack for many years. Possible Auto Immune disorder, aches, pains, no muscle gain in late 20s early 30s could be severe in 50s 60s....All from Anthrax shot when immune system was already compromised as I was in recovery from a hepatitis B infection....I have battled on my own naturally with no help for over a decade.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Muscle atrophy
Clinical narrative: Past digestion issues, Chronic Fatigue, Muscle loss, bone/teeth weakening, joint problems.....feels like body has been under attack for many years. Possible Auto Immune disorder, aches, pains, no muscle gain in late 20s early 30s could be severe in 50s 60s....All from Anthrax shot when immune system was already compromised as I was in recovery from a hepatitis B infection....I have battled on my own naturally with no help for over a decade.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Activities of daily living impaired, Asthenia, Dyspepsia, Feeling abnormal, Hyperhidrosis
Clinical narrative: Past digestion issues, Chronic Fatigue, Muscle loss, bone/teeth weakening, joint problems.....feels like body has been under attack for many years. Possible Auto Immune disorder, aches, pains, no muscle gain in late 20s early 30s could be severe in 50s 60s....All from Anthrax shot when immune system was already compromised as I was in recovery from a hepatitis B infection....I have battled on my own naturally with no help for over a decade.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Past digestion issues, Chronic Fatigue, Muscle loss, bone/teeth weakening, joint problems.....feels like body has been under attack for many years. Possible Auto Immune disorder, aches, pains, no muscle gain in late 20s early 30s could be severe in 50s 60s....All from Anthrax shot when immune system was already compromised as I was in recovery from a hepatitis B infection....I have battled on my own naturally with no help for over a decade.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Impaired work ability, Malaise, Neurological symptom
Clinical narrative: Got extremely sick, uncontrolled puking, diarrhea. Admitted to the hospital. 2 weeks later. On Dec. 11 I woke up with dizziness, and many neurological symptoms. I have not worked since Dec. 15th. My Neurologist diagnosed with a post infectious phenomenon. Directly relates it to the flu vaccine. Still suffer to this day.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Post procedural complication, Vomiting
Clinical narrative: Got extremely sick, uncontrolled puking, diarrhea. Admitted to the hospital. 2 weeks later. On Dec. 11 I woke up with dizziness, and many neurological symptoms. I have not worked since Dec. 15th. My Neurologist diagnosed with a post infectious phenomenon. Directly relates it to the flu vaccine. Still suffer to this day.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood thyroid stimulating hormone, Burning sensation, C-reactive protein, HIV test
Clinical narrative: Numbness, tingling, slight burning sensation, and weakness starting with my feet worked its way up into legs and then from the hands into arms. The severity persisted through the night along with body tremors, which was thought to have been due to nervousness. The next morning symptoms of tingling and weakness in arms and legs remained, and have since been present with back pain, heart palpitations, rapid heart beat, and swollen lymph nodes. Some days it is more pronounced than others.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hypoaesthesia, Lymphadenopathy, Muscular weakness, Nervousness
Clinical narrative: Numbness, tingling, slight burning sensation, and weakness starting with my feet worked its way up into legs and then from the hands into arms. The severity persisted through the night along with body tremors, which was thought to have been due to nervousness. The next morning symptoms of tingling and weakness in arms and legs remained, and have since been present with back pain, heart palpitations, rapid heart beat, and swollen lymph nodes. Some days it is more pronounced than others.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Paraesthesia, Red blood cell sedimentation rate, Smear test, Tremor
Clinical narrative: Numbness, tingling, slight burning sensation, and weakness starting with my feet worked its way up into legs and then from the hands into arms. The severity persisted through the night along with body tremors, which was thought to have been due to nervousness. The next morning symptoms of tingling and weakness in arms and legs remained, and have since been present with back pain, heart palpitations, rapid heart beat, and swollen lymph nodes. Some days it is more pronounced than others.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Treponema test, Vitamin B12
Clinical narrative: Numbness, tingling, slight burning sensation, and weakness starting with my feet worked its way up into legs and then from the hands into arms. The severity persisted through the night along with body tremors, which was thought to have been due to nervousness. The next morning symptoms of tingling and weakness in arms and legs remained, and have since been present with back pain, heart palpitations, rapid heart beat, and swollen lymph nodes. Some days it is more pronounced than others.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Area of injection sight is very sore, red and covers about a 2 inch across span and is 5 inches down from shoulder. Patient was told to take ibuprofen daily and rub the area with rubbing alcohol.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Bone pain, Chills, Vomiting
Clinical narrative: Severe chills, bone aches, vomiting, body weakness.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Back pain, Chills, Decreased appetite, Headache, Lethargy
Clinical narrative: Initial Fever, chills, all over muscle aches, but my lower back really ached. Then a terrible headache, nausea, vomiting, lethargic, couldn't hold anything down, whole body in pain. This lasted 24 hours, fitful sleep the next night, vomiting was done, could sip water, still a terrible headache/ low grade fever. On 3/2/2016 I did return to work, but was falling asleep in my office. Food was of no interest, I was working on rehydrating. On 3/3/2016 I was better, I slept I had an egg, my headache was gone.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Sleep disorder
Clinical narrative: Initial Fever, chills, all over muscle aches, but my lower back really ached. Then a terrible headache, nausea, vomiting, lethargic, couldn't hold anything down, whole body in pain. This lasted 24 hours, fitful sleep the next night, vomiting was done, could sip water, still a terrible headache/ low grade fever. On 3/2/2016 I did return to work, but was falling asleep in my office. Food was of no interest, I was working on rehydrating. On 3/3/2016 I was better, I slept I had an egg, my headache was gone.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Somnolence, Vomiting
Clinical narrative: Initial Fever, chills, all over muscle aches, but my lower back really ached. Then a terrible headache, nausea, vomiting, lethargic, couldn't hold anything down, whole body in pain. This lasted 24 hours, fitful sleep the next night, vomiting was done, could sip water, still a terrible headache/ low grade fever. On 3/2/2016 I did return to work, but was falling asleep in my office. Food was of no interest, I was working on rehydrating. On 3/3/2016 I was better, I slept I had an egg, my headache was gone.
Age: 1.58
Sex: M
Vaccine: HEPA, MMR
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever of 100.5. Extremely irritable. Rash on back, then stomach, neck and face.
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Herpes zoster, Neoplasm malignant, Radiotherapy
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, strength and route unknown). On an unknown date after receiving ZOSTAVAX the patient was diagnosed with an unspecified cancer diagnosis. Treatment was unspecified chemotherapy and radiation. On an unknown date of 2016 (reported as "recently"), the patient was diagnosed with a case of the shingles. Outcome of the events were unknown. Causality was not provided. Upon internal review, cancer was determined to be medically significant. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA, MENB, MNQ
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Administered BEXSERO, HAVRIX, and FLUZONE in LD. Administered MENACTRA in RD and pt head slumped and briefly passed out. VS at 1555 94/59 HR 144 and water given. VIS at 1603 117/71 HR 78 water given, still pale and diaphoretic. VIS at 1611 122/81 HR 79 color WNL, left w/parents.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with improperly stored doses (number of doses unspecified) of VAQTA (dose and route not reported, lot # L023936 with expiration date 15-MAR-2017). The reporter mentioned that the vaccines were stored at 52.2F for 2 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-JAN-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route for prophylaxis), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 14-JAN-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 02-FEB-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 10-FEB-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Client came into nurse of the clinic for a TST read and c/o (R) arm was hurting some. PHN observed said arm (R) to have a big red area, that was warm to touch. Client was advised to use ice and treating with BENADRYL. Is not resolved. Please contact physician. Size 3.5 in/4.5 inches.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Rash
Clinical narrative: About 15 minutes after receiving Tdap vaccine patient c/o rash to chest and feeling "hot." Pt denied SOB or breathing difficulty. Vital signs 116/74, HR 88, RR 18. Pt given 25 mg BENADRYL PO and pt rested. Denied complaints after resting x 20 minutes.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (who was a sister of one of the physician's patient). The patient's pertinent medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, route and dosage not reported). On an unknown date 6 weeks after administration of vaccine, the patient developed shingles. No demographics were provided for the patient, who was not affiliated with the physician's practice. No further details were noted. The outcome of the event was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Hyporeflexia, Paraesthesia
Clinical narrative: Right sided paresthesia UE/torso/LE decreased platellar DTR on right normal strength/no weakness. Down right arm to his leg that started today. All his right side is numb to his toes he got his shot yesterday HPV#3 on his right arm no cough/cold/fever here with mom.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were administered with improperly stored ZOSTAVAX (dose and route not reported, lot # L035506 and expiration date 15-DEC-2016). The vaccines were exposed to 1.6 degree centigrade for 5 hours and 51 minutes, and -8.6 degree centigrade for 4 hours and 46 minutes (two different days in February 2016). There was a previous temperature excursion with 4.1 degree centigrade and 20.1 degree centigrade for a total time frame out of range of 15 minutes in January 2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The healthcare worker reported that on unspecified dates since 15-OCT-2015 the patients were vaccinated with doses of ROTATEQ (dose not reported, lot # L008059 with expiration date 18-DEC-2016 and lot # L013202 with expiration date 27-JAN-2017, orally), which were exposed to the temperatures outside of the recommended range (temperature: 31F and time frame: 838 hours 59 minutes). The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with improperly stored doses (number of doses unspecified) of ROTATEQ (dose not reported, lot # L022447 with expiration date 26-FEB-2017 and lot # L027726 with expiration date 10-MAY-2017) orally. The reporter mentioned that the vaccines were stored at 52.2F for 2 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with improperly stored doses (number of doses unspecified) of RECOMBIVAX HB (dose and route not reported, lot # L033343 with expiration date 13-SEP-2017). The reporter mentioned that the vaccines were stored at 52.2F for 2 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
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. No information regarding the patient's medical history, concurrent conditions and concomitant medication was provided. On 23-FEB-2016, the patient was inadvertently administered an expired dose of M-M-R II (lot # K002527, expiration date: 18-FEB-2016, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 29-FEB-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose unknown, strength: 25 (unit unknown), lot # K010523, expiry date: 25-FEB-2016, intramuscular). No known adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a female patient of unknown age (also reported age as 0.021918). No medical history was reported. On 21-DEC-2015, the patient was vaccinated with a dose of an improperly stored oral, ROTATEQ dose, route and frequency: unknown, lot number: L002042, expiry date: 28-JUL-2016). No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 17-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 15 year old female patient. No medical history was reported. Approximately on 23-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to an 11 year old female patient. No medical history was reported. Approximately on 25-DEC-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route not reported) that was reconstituted with cyanocobalamin (manufacturer unspecified) instead of the supplied diluent. No adverse effects reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old female patient. On 18-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to an 11 year old female patient. No medical history was reported. Approximately on 21-DEC-2015, the patient was vaccinated withy a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old female patient. On 18-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Age: 1.4
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: A week after receiving a vaccine of Hep A peds and varicella on the left thigh. Pt presented with redness and a small bump of a size of a nickel. Negative for fever, pt advised to put a warm compress on the site and monitor the child for any sign of fever and increase of the site, and on any case of that to go to the closest urgent care.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-JAN-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with doses of improperly stored (temperature -9.8 C for 15 hours and 42 minutes total cumulative, because of data logger) (Merck) VARIVAX, lot # K002921, expiry date 26-FEB-2016; lot # L013827, expiry date 27-APR-2017 (dose, frequency and route of administration not reported). Previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and an a Medical Assistance referring to three patients of unknown age and unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ (lot # L035276: expiration date: 09-JUN-2017), oral (dose was not provided). Concomitant therapy included M-M-R II (Lot No: L024268; expiration date: 01-JUL-2017). The physician reported that the patients received improperly stored ROTATEQ. The vaccine was improperly stored for a time frame of 17.5 hours. There was not previous temperature excursion. No adverse effects were reported. The M-M-R II remained in recommended storage range. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refer to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with doses of improperly stored (temperature -9.8 C for 15 hours and 42 minutes total cumulative, because of data logger) PROQUAD (Merck), lot # L030592, expiry date 12-FEB-2017; lot # L023111, expiry date 24-DEC-2016, (dose, frequency and route of administration not reported). Previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016, regarding a 4 year old female patient. On 07-JAN-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Fatigue, Ultrasound antenatal screen, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's mother and refers to a 20 year old female patient with no drug reactions or allergies. The patient's concurrent conditions included high cholesterol and fatigue. The patient was also a mononucleosis carrier. On approximately 13-AUG-2015, the patient became pregnant with LMP (last menstrual period) of 30-JUL-2015 and EDD (estimated date of delivery) of 05-MAY-2016. At the time of the report on 25-FEB-2016, the patient was 30 weeks pregnant. The pregnancy outcome was pending. On 11-FEB-2016 (reported as "2 weeks ago"), the patient had visited her physician for her 28-week examination. The physician advised the patient, that she should take a "whooping cough vaccine". On an unknown date in February 2016, the patient was erroneously vaccinated with a dose of GARDASIL 9 (lot # was not provided) first injection, 0.5 ml, intramuscularly for prophylaxis instead of receiving a "whooping cough vaccine". Concomitant therapies included prenatal vitamins. The patient sought medical attention and was given an ultrasound to check progress of the baby in uterus (results were not provided). Since an unknown date in February 2016 (reported as "since that time"), the patient seemed more fatigued than normal and noted that the baby had "flipped" and felt less active (captured in MARRS # 1603USA001784). The outcome of the event of fatigue was unknown. The relatedness between the events and GARDASIL 9 was not reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Foetal hypokinesia, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's mother and refers to a 20 year old female patient with no drug reactions or allergies. The patient's concurrent conditions included high cholesterol and fatigue. The patient was also a mononucleosis carrier. On approximately 13-AUG-2015, the patient became pregnant with LMP (last menstrual period) of 30-JUL-2015 and EDD (estimated date of delivery) of 05-MAY-2016. At the time of the report on 25-FEB-2016, the patient was 30 weeks pregnant. The pregnancy outcome was pending. On 11-FEB-2016 (reported as "2 weeks ago"), the patient had visited her physician for her 28-week examination. The physician advised the patient, that she should take a "whooping cough vaccine". On an unknown date in February 2016, the patient was erroneously vaccinated with a dose of GARDASIL 9 (lot # was not provided) first injection, 0.5 ml, intramuscularly for prophylaxis instead of receiving a "whooping cough vaccine". Concomitant therapies included prenatal vitamins. The patient sought medical attention and was given an ultrasound to check progress of the baby in uterus (results were not provided). Since an unknown date in February 2016 (reported as "since that time"), the patient seemed more fatigued than normal and noted that the baby had "flipped" and felt less active (captured in MARRS # 1603USA001784). The outcome of the event of fatigue was unknown. The relatedness between the events and GARDASIL 9 was not reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Fatigue, Ultrasound antenatal screen, Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's grandmother and refers to an unborn patient. The patient's mother was 20 year of age with no drug reactions or allergies. Her concurrent conditions included high cholesterol and fatigue and she was also a mononucleosis carrier. At the time of the report on 25-FEB-2016, the patient's mother was 30 weeks pregnant with LMP (last menstrual period) of 30-JUL-2015, EDD (estimated date of delivery) of 05-MAY-2016 and date of conception of 13-AUG-2015. The pregnancy outcome was pending. On 11-FEB-2016 (reported as "2 weeks ago"), the patient's mother had visited her physician for her 28-week examination. The physician advised, that she should take a "whooping cough vaccine". On an unknown date in February 2016, the patient's mother was erroneously vaccinated with a dose of GARDASIL 9 (lot # was not provided) first injection, 0.5 ml, intramuscularly instead of receiving a "whooping cough vaccine". Concomitant therapy included prenatal vitamins. The patient's mother sought medical attention and was given an ultrasound to check progress of the baby (patient) in uterus (results were not provided). Since an unknown date in February 2016 (reported as "since that time"), the patient's mother noted that the baby (patient) had "flipped" and felt less active. The outcome of the events was unknown. The relatedness between the events of GARDASIL 9 was not reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Foetal hypokinesia, Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's grandmother and refers to an unborn patient. The patient's mother was 20 year of age with no drug reactions or allergies. Her concurrent conditions included high cholesterol and fatigue and she was also a mononucleosis carrier. At the time of the report on 25-FEB-2016, the patient's mother was 30 weeks pregnant with LMP (last menstrual period) of 30-JUL-2015, EDD (estimated date of delivery) of 05-MAY-2016 and date of conception of 13-AUG-2015. The pregnancy outcome was pending. On 11-FEB-2016 (reported as "2 weeks ago"), the patient's mother had visited her physician for her 28-week examination. The physician advised, that she should take a "whooping cough vaccine". On an unknown date in February 2016, the patient's mother was erroneously vaccinated with a dose of GARDASIL 9 (lot # was not provided) first injection, 0.5 ml, intramuscularly instead of receiving a "whooping cough vaccine". Concomitant therapy included prenatal vitamins. The patient's mother sought medical attention and was given an ultrasound to check progress of the baby (patient) in uterus (results were not provided). Since an unknown date in February 2016 (reported as "since that time"), the patient's mother noted that the baby (patient) had "flipped" and felt less active. The outcome of the events was unknown. The relatedness between the events of GARDASIL 9 was not reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions, and concomitant medication were not reported. On an unknown dates, patients were vaccinated with improperly stored (temperature 47.1 F for 10 minutes, because of data logger) doses of ROTATEQ, lot #L020865, expiry date, 09-FEB-2017, (dose, frequency and route of administration not reported). No previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. GARDASIL 9, and GARDASIL appeared on the product list as temperature stability questions were asked, however, no doses of improperly stored GARDASIL 9 or GARDASIL were administered to patients. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored (temperature 47.1 F for 10 minutes, because of data logger) doses of PNEUMOVAX 23, lot # L014420, expiry date, 23-FEB-2017, (dose, frequency and route of administration not reported). No previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. GARDASIL 9, and GARDASIL appeared on the product list as temperature stability questions were asked, however, no doses of improperly stored GARDASIL 9 or GARDASIL were administered to patients. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.