chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22 year old patient of unknown gender. On 01-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L026602 with expiration date 19-OCT-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. 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.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling
Clinical narrative: ARM SWELLING AT SITE OF INJECTION.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given immunizations at 4wks.
Age: 38.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Burning sensation, Feeling hot, Hypoaesthesia, Muscular weakness
Clinical narrative: Numbness and weakness in both upper extremeties. Joint soreness in right shoulder. Extreme pain and warm/burning sensation both extremities.
Age: 38.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Numbness and weakness in both upper extremeties. Joint soreness in right shoulder. Extreme pain and warm/burning sensation both extremities.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red, hot, itchy, swelling like the size of 2 baseballs together.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Palpitations, Pruritus
Clinical narrative: Racing heart and itchiness on both forearms.
Age: 82.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Dizzy and light-headed. Methylprednisolone 4MG Dospak21's.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Vaccination site discharge, Vaccination site pustule, Vaccination site swelling
Clinical narrative: Swollen and red area around vaccine administration, per patient yellow pus was coming out, none seen on day of visit 09/12/2016. Only redness observed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 83.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: OFF-LABEL ADMINISTRATION OF VACCINE. INADVERTENTLY ADMINISTERED MENACTRA INSTEAD OF MENOMUNE. MENACTRA IS USED FOR PERSONS AGED 55-YEARS-OLD AND YOUNGER.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Nausea, Visual impairment
Clinical narrative: Approximately, 1 minute after vaccine was given pt. stated she felt nauseous and saw black spots. Pt. started swaying, blacked out and passed out.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Diarrhoea, Hypoaesthesia, Limb discomfort, Mobility decreased
Clinical narrative: 0830-approx 1300: Nausea, vomiting, severe cramps & diarrhea. 0900- one episode of syncope lasting less than 5 minutes. 0900-approx 1230: numbness/difficulty moving legs & "feeling like arms are heavy". 0830-approx 1700: general weakness pallor & nausea.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Muscle spasms, Nausea, Pallor, Syncope, Vomiting
Clinical narrative: 0830-approx 1300: Nausea, vomiting, severe cramps & diarrhea. 0900- one episode of syncope lasting less than 5 minutes. 0900-approx 1230: numbness/difficulty moving legs & "feeling like arms are heavy". 0830-approx 1700: general weakness pallor & nausea.
Age: 14.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Pt. felt lightheaded. Fell, hit head on metal garbage can and passed out.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash to mostly trunk front and back, with mildly to thighs, hands, breast area up to neck and genitalia.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen warm to touch 1/4 way down arm.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abasia, Otitis media, Pyrexia
Clinical narrative: Patient came to clinic 09/02/2016 complaining of fever and inability to walk 2 days after vaccine was given. Fever started within 24 hours of vaccine administration, T-max unknown. Inability to walk presented the next day. Patient was diagnosed in office on 09/02/2016 with suppurative otitis media (ear infection).
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Headache, low grade fever, one episode of vomiting and body aches.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Mouth swelling, Oral discomfort, Oral mucosal eruption, Pruritus, Rash
Clinical narrative: Patient states that last evening she noted a burning sensation around her mouth with associated swelling and rash around her mouth. She also noted shortly thereafter that she noted a rash on her upper extremity bilaterally. Reports associated pruritus. She denies any associated SOB, difficulty breathing, sensation of her throat closing in on her.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Body aches.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Migraine, Nausea, Nuclear magnetic resonance imaging normal, Peripheral swelling, Scan with contrast normal
Clinical narrative: 1st swelling Right Arm Deltoid area 2x normal size. 2nd week  Migraines with Nausea and Vomiting. Intractable Migraines continue.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Vomiting
Clinical narrative: 1st swelling Right Arm Deltoid area 2x normal size. 2nd week  Migraines with Nausea and Vomiting. Intractable Migraines continue.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Injection site swelling, Migraine, Nausea, Vomiting
Clinical narrative: 1st swelling Right Arm Deltoid area 2x normal size. 2nd week  Migraines with Nausea and Vomiting. Intractable Migraines continue.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever and body aches.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash vesicular
Clinical narrative: Patient presented to clinic 2 days after receiving vaccine with swelling, redness, warm to touch skin, and vesicular rash on upper left arm. Patient was seen by MD and prescribed Triamcinolone Acetonide 0.1%. Patient to have follow up visit in 4 days with MD.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Nightmare, Sleep terror
Clinical narrative: I had bizarre night terrors or nightmares. Zombies were chasing me and my family and I remember a constant black bile substance that was ubiquitous in my environment. I awoke suddenly at 6:45 AM.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Injection site pruritus, Injection site rash, Nausea
Clinical narrative: Nausea, headache, dizzy, rash and itching at sight of injection.
Age: 23.0
Sex: M
Vaccine: FLU3, HEP, MENB
Symptoms: Asthenia, Dizziness, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Immediately after receiving the vaccine (recombivax), patient reported feeling dizzy. After a few minutes he also had a bit of nausea and weakness and started to look pale. After sitting for about 10 minutes, having a glass of water, and using the bathroom, patient felt better. Patient reported feeling fine and back to normal after sitting for 20 minutes.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with a warm, slightly raised, red area starting from the injection area and radiating down arm.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site reaction, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Immediately the injection site began to puff up and swell. Patient reported back to the pharmacy 9/12/16 with a localized red rash around the injection site about the size of a baseball. The area was warm to the touch. Local soreness that has gone away.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Immediately the injection site began to puff up and swell. Patient reported back to the pharmacy 9/12/16 with a localized red rash around the injection site about the size of a baseball. The area was warm to the touch. Local soreness that has gone away.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth, Pain
Clinical narrative: Patient states she has had some pain the last couple of days, but this morning she woke up with a raised, hot rash on the arm  a couple inches below the injection site.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm is red , swollen and hot.  Still red, swollen and hot two days later.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Local reaction
Clinical narrative: Patient developed a local reaction at the site of the injection (right proximal arm); arm was erythematous & hot to touch, slight wheal formed.  Treated with Benadryl and Ibuprofen.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Received flu and PNEUMOVAX23 shots at upper right arm. No swelling at injection sites the day received nor following days. However, the next  morning, right arm, swelling beneath the skin of biceps and from underside of elbow 2/3rds way down the forearm as if there was liquid in that area.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Nausea, Vomiting
Clinical narrative: Patient reported that she experienced chills, malaise, and nausea and vomiting the night of her vaccine. Spoke with patient 8:15 pm on 9/13/2016 and she reports that she is starting to feel better with some intermittant chills.
Age: 24.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received 3 vaccines and began feeling light headed and then fainted.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MEN
Symptoms: Dizziness, Electrocardiogram, Injection site pain, Nausea, Road traffic accident
Clinical narrative: Pt felt nauseated and as though she might faint while stopped at redlight and planned to pull into adjacent parking lot as soon as the light turned green, but had syncopal episode and drove through the light, veering into the opposing traffic lanes, hitting 3 cars. No injuries, no airbag deployment, did not hit head. Pt denies any pain other than some soreness at injection site.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MEN
Symptoms: Syncope
Clinical narrative: Pt felt nauseated and as though she might faint while stopped at redlight and planned to pull into adjacent parking lot as soon as the light turned green, but had syncopal episode and drove through the light, veering into the opposing traffic lanes, hitting 3 cars. No injuries, no airbag deployment, did not hit head. Pt denies any pain other than some soreness at injection site.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MEN
Symptoms: Blood glucose, Electrocardiogram, Loss of consciousness, Neurological examination, Road traffic accident
Clinical narrative: Pt felt nauseated and as though she might faint while stopped at redlight and planned to pull into adjacent parking lot as soon as the light turned green, but had syncopal episode and drove through the light, veering into the opposing traffic lanes, hitting 3 cars. No injuries, no airbag deployment, did not hit head. Pt denies any pain other than some soreness at injection site.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue, Headache, Muscle spasticity, Myalgia
Clinical narrative: She has been to the ER twice with severe convulsions muscle pain ringing of ears nausea she was admitted to hospital with spasticity as her discharge reference she continues to struggle with severe joint pain headaches and fatigue.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Seizure, Tinnitus, Urine aluminium, Urine mercury
Clinical narrative: She has been to the ER twice with severe convulsions muscle pain ringing of ears nausea she was admitted to hospital with spasticity as her discharge reference she continues to struggle with severe joint pain headaches and fatigue.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Laboratory test
Clinical narrative: Patient said he has abdominal pain about 24 hours later after getting the flu shot 1 day (24 hours) earlier. Patient said he went to ER to find out what it was they ruled out appendicitis and checked for kidney stones, which has yet to be determined once he gets the results back. Pain has subsided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis right thigh s/p vaccines x2d.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient received TDAP (BOOSTRIX) in right arm on 9/8/16. Returned to pharmacy complaining of pain and swelling at site and upward arm 9/13/16. She said it started 9/9/16.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 4 year old patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-AUG-2016, the patient was supposed to be vaccinated with a dose of PROQUAD and KINRIX (lot #, expiry date, dose, strength, dose number, vaccination site, route not provided). However, the nurse grabbed wrong tray of vaccines and the patient was inadvertently administered with a dose of GARDASIL 9 and a third dose of VAQTA on 17-AUG-2016 (lot #, expiry date, dose, strength, vaccination site, route not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: This initial report was received from a nurse practitioner concerning a 62 year old female patient. The patient's medical history included chronic maxillary sinusitis, unspecified mycosis, leukoplakia oral, anxiety, insomnia an elevated cholesterol. The patient did not have allergies. The patient's concomitant therapies included LIPITOR, AMBIEN, COMPAZINE and amitriptyline hydrochloride (manufacturer unknown). On 01-SEP-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously for prevention of shingles (dose, strength, anatomical location and lot number were not provided). On the same date, the patient experienced tachycardia with a heart rate of 108 (unit not provided). No laboratory diagnostic studies were performed and the patient did not receive treatment for the event. At the reporting time, the outcome of tachycardia was unknown. The reporter did not assess the causal relationship between therapy with ZOSTAVAX and the reported event. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, HEPA, HPV9, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from physician refers to a 13 year old patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant medication were not reported. It was reported that, the patient was supposed to be vaccinated with a  dose of GARDASIL 9 and a dose of VAQTA (lot #, expiry date, dose, strength, vaccination site, route not provided). However, the nurse grabbed wrong tray of vaccines and the patient was inadvertently administered with a dose of (Oka-Merck) PROQUAD and KINRIX (lot #, expiry date, dose, strength, dose number, vaccination site, route not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This initial report was received from a pharmacist via company representative, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, dose 1 (dose, strength, route of administration, anatomical location and lot number were not reported). At the time of administration, the PNEUMOVAX 23 had expired. At the time of reporting, the patients outcome was unknown. Additional information is not expected since the reporter did not give consent to be contact.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: And erythema. Acetaminophen.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule
Clinical narrative: 3-4 days after injection, patient developed a 1 cm nodule right upper arm at site of injection.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Erythema, Headache, Injection site pain, Injection site reaction
Clinical narrative: Chills and fever and achey, headache forehead, arms and legs and back and no joint swelling. Immunized with BEXSERO and GARDASIL on 5 days ago. Lt arm was twitchy in area of injection the day after the immunization and has pain at injection site. Reddened area about baseball diameter warm and tender, for 3 days and now not red, nos swelling.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Muscle twitching, Pain, Pyrexia, Skin warm, Tenderness
Clinical narrative: Chills and fever and achey, headache forehead, arms and legs and back and no joint swelling. Immunized with BEXSERO and GARDASIL on 5 days ago. Lt arm was twitchy in area of injection the day after the immunization and has pain at injection site. Reddened area about baseball diameter warm and tender, for 3 days and now not red, nos swelling.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Localized redness, hard, warm erythema 11 cm x 6 cm size, left deltoid.
Age: 6.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt was given PROQUAD on the outer left thigh. About 12 hrs later area was quite swollen and red. Low grade fever. BENADRYL was given.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal pain, Gait disturbance, Guillain-Barre syndrome, Hyperhidrosis, Muscular weakness
Clinical narrative: Pt was administered both FLUZONE HD and PNEUMOVAX 23 on 8/30/16. He was admitted to hospital for Guillain-Barre Syndrome. Sx: profound weakness in both legs, sweating, unsteady gait, fever 101 degree F, vomiting 2 times this week, abdominal pain. Pt can swallow; speech is normal.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt was administered both FLUZONE HD and PNEUMOVAX 23 on 8/30/16. He was admitted to hospital for Guillain-Barre Syndrome. Sx: profound weakness in both legs, sweating, unsteady gait, fever 101 degree F, vomiting 2 times this week, abdominal pain. Pt can swallow; speech is normal.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient presented to office today with a pruritic, indurated, erythematous rash measuring 18cm. She states on 9/9/16 she felt warm and shortly after developed rash. The rash hurts and itches only at night. She had an ultrasound appt today with Dr. He recommended patient apply hydrocortisone cream to area.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Hypoaesthesia, Monoplegia, Muscle spasms, Muscular weakness
Clinical narrative: Muscle cramps in legs and numbness in sole of feet. Imbalance, leg weakness. Legs feel warm. Leg paralysis.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Myelitis, Skin warm
Clinical narrative: Muscle cramps in legs and numbness in sole of feet. Imbalance, leg weakness. Legs feel warm. Leg paralysis.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth to the touch-about 4 in. in diameter.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Syncope
Clinical narrative: Patient fainted within a few minutes of vaccine administration. Patient rested and had a couple pieces of candy and water.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Two days after having PNEUMOVAX 23 injection patient reported to her MD for visit due to swelling and redness at injection site.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Febrile convulsion, Pyrexia
Clinical narrative: Developed fever on 8/25 of 101.5. Had a couple febrile seizure at 7:10 pm, 8/25/16, lasted for 30 minutes.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history, concomitant therapy and concurrent conditions were not reported. In August 2016 (also reported as 26-AUG-2016 to 30-AUG-2016), the patients were vaccinated with VAQTA (Lot number, expiration date, concentration, dose, frequency and route of administration were not provided), which was improperly stored, this excursion was detected due to a digital data logger, it was also reported that VAQTA was exposed to a temperature of 35 Fahrenheit degrees for 32 hours. No adverse effects were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient's medical history and concurrent conditions were unknown. On 21-AUG-2016, the patient was vaccinated with ZOSTAVAX lot # M019645, single dose: 0.65 ml, via subcutaneous in the left arm (expiration date was not reported). Information regarding concomitant medication was not provided. On 21-AUG-2016, the patient developed lesions and one bump at the injection site, then on 29-AUG-2016, the patient experienced rash in both arms the number of lesions were 3-5. At the time of the report, the outcome of the injection site mass and rash were unknown. The causality between ZOSTAVAX and the adverse events was unknown. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Exposure via body fluid, Human papilloma virus test positive, Secondary transmission, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. No concomitant medications were provided. On an unspecified date in 2012, the patient's boyfriend was vaccinated with the first dose of GARDASIL, (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). The reporter indicated that the patient's boyfriend completed the GARDASIL series on unspecified dates, but within the recommended dosage schedule. After the patient's boyfriend finished his vaccine scheme, on an unknown date, the patient and her boyfriend became sexually active (exposure via body fluid). Subsequently, on an unspecified date in 2016, she was performed a Papanicolaou (PAP) smear and tested positive for Human papillomavirus (HPV). The physician stated that both, the patient and her boyfriend "have not had other sexual partners" and the patient's boyfriend "dose not have HPV". In addition, the patient had never been administered any HPV vaccines. The outcome of the HPV and the relatedness between the event and therapy with GARDASIL were not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L050909, expiration date: 14-JUN-2017 (exact dose, route of administration and therapy type were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 13 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 17-AUG-2016, the patient was vaccinated with a dose of PROQUAD (strength and frequency were unknown; lot number and expiration date were M004893 and 26-JUN-2017) 0.5 ml subcutaneously in error (inappropriate age at vaccine administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-AUG-2016, the patient received a dose of improperly stored VARIVAX (strength, dose, and frequency were unknown; lot number and expiration date were M004662 and 28-JAN-2018). No adverse reactions reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warm, sore, swollen at site of injection (right arm).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions, medical histories and drug reactions/allergies were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # L0248854, expiration date 31-AUG-2017), doses and routes were not provided. There was no concomitant medication reported. The temperature/time frame was 33F for 60 hours. No data logger was involved and no previous excursions were reported. No adverse effects were reported. This is one of three cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-AUG-2016, the patient received a dose of improperly stored VARIVAX (strength, dose, and frequency were unknown; lot number and expiration date were M004662 and 28-JAN-2018). No adverse reactions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Accidental exposure to product, Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) refers to a 37 year old patient of an unknown gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was inadvertently administered a dose of (Oka-Merck) PROQUAD lot # L024497, expiration date: 01-JAN-2017, subcutaneously (dose was not reported). No adverse effect reported. There was no concomitant medication provided. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history, concomitant therapy and concurrent conditions were not reported. In August 2016 (also reported as 22-AUG-2016 until 30-AUG-2016) the patients were vaccinated with GARDASIL 9 (Lot number, expiration date, concentration, dose, frequency and route of administration were not provided), which was improperly stored on 30-AUG-2016, this excursion was detected due to digital data logger. It was also reported that the GARDASIL 9 was exposed to a temperature of 34 Fahrenheit degrees for 56 hours. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The injection site pink, warm and not swollen. The pink area that surrounds the injection site is the size of a grapefruit.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. On 13-JAN-2016, the patient was vaccinated with an improperly stored dose of the GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L027282 with expiration date 21-SEP-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. 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.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 10-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L037339 with an expiration date 09-FEB-2018). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. 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.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Culture urine negative, Febrile convulsion, Specific gravity urine normal, Tremor, Urine analysis normal
Clinical narrative: Patient began shaking while in car. Mom pulled over and noticed her upper and lower extremities shaking lasted less than 15 minutes. Went to ER, ADVIL given, and diagnosed with febrile seizure.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Induration, Lymphadenopathy, Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a 11-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced pain, induration and lymphadenopathy. On an unknown date, the outcome of the pain, induration and lymphadenopathy were recovered/resolved. the reporter considered the pain, induration and lymphadenopathy to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. the patient experienced pain and induration within two days of receiving the BEXSERO vaccine. She also developed lymphadenopathy after the other symptoms and all symptoms were resolved within 3 to 4 days. the field representative was unable to provide any further details.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from physician via other company (Pfizer) on 31 August 2016. Manufacturer Report Number: 2016146577. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had experienced allergies to influenza vaccines. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from physician via other company (Pfizer) on 31 August 2016. Manufacturer Report Number: 2016146577. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had experienced allergies to influenza vaccines. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Diarrhoea, Headache, Injection site pain, Joint range of motion decreased, Myalgia
Clinical narrative: Extreme pain and immobility of left arm where the injection site was, very bad headache, nausea, diarrhea for two days and continued extreme arm and immobility pain.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nausea
Clinical narrative: Extreme pain and immobility of left arm where the injection site was, very bad headache, nausea, diarrhea for two days and continued extreme arm and immobility pain.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Diarrhoea, Headache, Injected limb mobility decreased, Injection site pain, Nausea
Clinical narrative: Extreme pain and immobility of left arm where the injection site was, very bad headache, nausea, diarrhea for two days and continued extreme arm and immobility pain.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Abasia, Activities of daily living impaired, Asthenia, Back pain, Computerised tomogram normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Decreased appetite, Headache, Hypoaesthesia, Injection site pain, Intensive care
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Lumbar puncture, Nausea, Neck pain, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Post lumbar puncture syndrome, Pyrexia, Viral infection, Visual impairment
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.