chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Lip swelling, Pruritus generalised, Pyrexia, Rash erythematous, Skin warm
Clinical narrative: All over itching. Red rash on feet, legs, hands, arms, chest, neck, back, and scalp. Skin very warm to the touch. Puffy lips. fever. Used cold compress to alleviate itching. Took 10mg loratadine at 11pm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site swelling, Nasopharyngitis
Clinical narrative: Patient stated that she felt cold/flu like symptoms and hasn't slept well. Her arm is also bright red and swollen in about a 6 inch diameter from where she received the shot.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Poor quality sleep
Clinical narrative: Patient stated that she felt cold/flu like symptoms and hasn't slept well. Her arm is also bright red and swollen in about a 6 inch diameter from where she received the shot.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: Patient developed a fever of 101 degrees the evening after vaccination was administered.  She stated the fever lasted for one and a half days.  Her upper arm also became swollen and red.  She stated her upper arm felt really hot and sensitive to touch.  Patient came in 3 days later and showed me her arm.  The red/swollen site is not where injection site was.  It as on the inside of her upper arm, and not where the deltoid muscle is where the vaccination was administered.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Red band around arm in area of administration about 2 inches in height, and 4 or 5 inches in length. Patient presented to physician where they were prescribed a steroid cream, and cephalexin oral antibiotic.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza, Pain, Pneumonia
Clinical narrative: FLU, CHILLS, BODY ACHE AND PNEUMONIA.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Hip arthroplasty, Hip fracture, Hypoaesthesia, Malaise
Clinical narrative: My father called me from his car in the parking lot saying that he needed help, he wasn't feeling well and he could not move his legs. He was in a minor car accident right before he arrived in the parking lot coming from pharmacy to try to pick up his medication, but he could not gain control of the car because he said he could not feel his legs. I proceeding to the car and he wanted to get up. He got out of the car and leaned on it for support. Then his legs gave out and he fainted. I was able to catch him and laid him on the ground to break his fall. I proceeded to call 911. he was hospitalized from 10/24 to 10/30, on 10/30 he fell in his bathroom as a result of leg weakness again and fractured his hip. He had to get a partial left hip replacement, he is still currently in the hospital.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Movement disorder, Muscular weakness, Road traffic accident, Syncope
Clinical narrative: My father called me from his car in the parking lot saying that he needed help, he wasn't feeling well and he could not move his legs. He was in a minor car accident right before he arrived in the parking lot coming from pharmacy to try to pick up his medication, but he could not gain control of the car because he said he could not feel his legs. I proceeding to the car and he wanted to get up. He got out of the car and leaned on it for support. Then his legs gave out and he fainted. I was able to catch him and laid him on the ground to break his fall. I proceeded to call 911. he was hospitalized from 10/24 to 10/30, on 10/30 he fell in his bathroom as a result of leg weakness again and fractured his hip. He had to get a partial left hip replacement, he is still currently in the hospital.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Aggression, Incoherent, Mental disorder
Clinical narrative: Son received flu shot. Within days, a phycological breakdown occured. Became incoherent, and violent. This had happened about 5 years ago as well, and I reported it to you also.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Dizziness, Muscular weakness, Pruritus generalised
Clinical narrative: Extreme muscle weakness in lower extremities-unable to walk for about a day, generalized itchiness, and dizziness.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Hypersomnia, Nausea
Clinical narrative: Awoke congested with sinus pressure and a runny nose.  Throughout the day this has progressed to nausea, dizziness, intense fatigue, and headache at present.  I have slept most of the day, but symptoms continue to worsen.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Paranasal sinus discomfort, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Awoke congested with sinus pressure and a runny nose.  Throughout the day this has progressed to nausea, dizziness, intense fatigue, and headache at present.  I have slept most of the day, but symptoms continue to worsen.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient experienced dizziness. She sat down for around 30 minutes. During this time, she stated the dizziness went away. Her daughter arrived to pick her up. She went home with her daughter.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Muscular weakness
Clinical narrative: Pt presented to pharmacy 11/4/16 c/o of persistant arm discomfort and weakness. Stated it started around the time she received her shot.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red raised 3.5inch x 2inch area around injection site and warm to touch.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, continued for 2 days until patient presented to ED with complaint of malaise, fever, and chills. Patient reports induration has decreased but redness has increased. He is being admitted to the hospital and treated for presumed cellulitis.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Pyrexia
Clinical narrative: Redness and swelling at injection site, continued for 2 days until patient presented to ED with complaint of malaise, fever, and chills. Patient reports induration has decreased but redness has increased. He is being admitted to the hospital and treated for presumed cellulitis.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Areflexia, Ear pain, Insomnia, Muscle spasms, Muscular weakness
Clinical narrative: Fever, ear pain, muscle spasms and pain in shoulders and neck, arm pain and muscle weakness, body aches and pain, sleeplessness, loss of reflexes in legs and ankles.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pyrexia
Clinical narrative: Fever, ear pain, muscle spasms and pain in shoulders and neck, arm pain and muscle weakness, body aches and pain, sleeplessness, loss of reflexes in legs and ankles.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Psoriasis
Clinical narrative: Patient has Psoriasis on her arms and after receiving this years flu vaccine her Psoriasis became worse with breaking out on other areas her body but especially both sides of her neck.
Age: 24.0
Sex: M
Vaccine: ANTH, FLU3, TDAP, TYP
Symptoms: Tongue discolouration, Tongue discomfort
Clinical narrative: Immunizations given on 9/17/16. Reported on 9/18/16 with c/o burning tongue. Denies any sort of tightness, swelling, diff. breathing. Symptoms resolved after 4 days, stain on tongue until slough off on the 4th day. No further symptoms noted. Pt. evaluated 11/5/16 by Doctor.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Local reaction
Clinical narrative: Localized reaction (L) arm at injection site - 10 cm x 10 cm. Redness started several hrs after injection and worsened for several days. Guardian reported that after flu vaccine in 2015, he developed a "golf ball" sized red area but this was never reported to clinic.
Age: 90.0
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: Pt presented to pharmacy 6 days post-vaccine administration C/O soreness of upper arm/shoulder w/swelling.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, heat, soreness 2 days after administered. RXN 1 inch below injection site.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Flu vaccine administered on 9-28-16. Pain in left arm began about 2hrs later. It continues to this date and is also in shoulder and neck. I have limited arm movement.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Pain in extremity, Tenderness
Clinical narrative: Pt. has been experiencing pain and tenderness in her left arm since receiving her influenza vaccine. Pt. described the pain as being like bursitis.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 3x4-5 inch oval shape red patch, warm to the touch, soreness.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Eye movement disorder, Feeling abnormal, Hypoacusis, Loss of consciousness, Tremor
Clinical narrative: Within 5 min of 2nd vaccine (flu) pt stated she didn't feel good. Passed out in chair. Shaking, eyes rolling approximately 1 min. When cane too, c/o not being able to hear or see.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Visual impairment
Clinical narrative: Within 5 min of 2nd vaccine (flu) pt stated she didn't feel good. Passed out in chair. Shaking, eyes rolling approximately 1 min. When cane too, c/o not being able to hear or see.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Lethargy, Pruritus
Clinical narrative: Pt very lethargic for 48 hours after receiving PREVNAR 13. On third day developed rash. Swelling and erythema at injection site as well as hard nodule. Rash and itching continued down arm to elbow and continues for 7 days even with pt taking BENADRYL.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Pt very lethargic for 48 hours after receiving PREVNAR 13. On third day developed rash. Swelling and erythema at injection site as well as hard nodule. Rash and itching continued down arm to elbow and continues for 7 days even with pt taking BENADRYL.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Arm swollen taking Ibuprofen for swelling-tender, and heated to touch, local soreness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient came to our pharmacy complaining of a swollen arm. She showed me her left arm and it was swollen with a red center and a light red surrounding.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Asthenia, Blood test, Laboratory test, Loss of consciousness
Clinical narrative: October 22: Woke up with body aches. Went to bed early due to it. October 23: Went to ER for migraine and body aches. Was treated for migraine and blood was taken. Had fever and was told it was viral. October 24: Returned to ER for severe body aches. More labs were ran and I was kept for observation that night. I was given Morphine and NORCO for pain. October 25: Was discharged to go home. Once home body aches crept back. October 26: Woke up unable to move or walk. Attempted to walk but passed out and was taken to ER.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Mobility decreased, Pain, Pyrexia, Rhabdomyolysis
Clinical narrative: October 22: Woke up with body aches. Went to bed early due to it. October 23: Went to ER for migraine and body aches. Was treated for migraine and blood was taken. Had fever and was told it was viral. October 24: Returned to ER for severe body aches. More labs were ran and I was kept for observation that night. I was given Morphine and NORCO for pain. October 25: Was discharged to go home. Once home body aches crept back. October 26: Woke up unable to move or walk. Attempted to walk but passed out and was taken to ER.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Viral myositis
Clinical narrative: October 22: Woke up with body aches. Went to bed early due to it. October 23: Went to ER for migraine and body aches. Was treated for migraine and blood was taken. Had fever and was told it was viral. October 24: Returned to ER for severe body aches. More labs were ran and I was kept for observation that night. I was given Morphine and NORCO for pain. October 25: Was discharged to go home. Once home body aches crept back. October 26: Woke up unable to move or walk. Attempted to walk but passed out and was taken to ER.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: WOKE UP WITH HEADACHE, ARM WAS SORE AND SWELLING AT THE INJECTION SITE, REDNESS WAS 1 INCH WIDE AND 2 INCHES LONG AND IT ITCHED MILDLY. FOR THE NEXT 3 DAYS I WOKE UP WITH A HEADACHE, IT STAYED SORE AND THE REDNESS KEPT MOVING DOWN MY ARM AND STOPPED AT MY ELBOW TODAY. THE REDNESS IS MUCH BETTER TONIGHT AND NOT NEAR AS SORE. I DID NOT REPORT THIS TO MY DOCTOR.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Redness swelling at injection site, size of plum on 3rd day after injection, then over next 3 days the redness and swelling spread to cover most of upper arm. Diagnosed with allergic cellulitis by doctor on 6/27. Time course until healed 2 weeks.  Treatment was benadryl and ice.
Age: 66.0
Sex: M
Vaccine: DTP
Symptoms: Headache, Muscular weakness, Pain in extremity
Clinical narrative: Continued weakness and aching of wrists and hands and multiple onset severe headaches every day since.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: Pt received MENACTRA vaccine and sat for a few minutes. He went shopping with his mom and came back about 10 minutes later saying he felt dizzy and said it started shortly after receiving the vaccine. Pt was suggested to sit and drink water. The mom said she wanted to take him home to rest.  I followed up with them (about 2 hours later when I could get ahold of the mom) and they said he was feeling better sligtly tired.  I followed up with them 11/6 and he said he was feeling fine just his arm was sore.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Bed rest, Feeling cold, Headache, Lethargy
Clinical narrative: Backache, ache all over upper body, lethargic, chills, headache.  Took Acetaminophen, bed rest.  Almost all symptoms gone next afternoon.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Backache, ache all over upper body, lethargic, chills, headache.  Took Acetaminophen, bed rest.  Almost all symptoms gone next afternoon.
Age: 28.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Nodule
Clinical narrative: APRROX 2 INCH NODULE AND REDNESS.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour
Clinical narrative: Talking incoherently "Vaccines work, GMO's are safe, everything is a chemical."
Age: 12.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Headache, Influenza like illness, Pain, Pyrexia, Vomiting
Clinical narrative: High fever, vomit, body and headaches, flulike suymtoms. Lasted three days.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Cough, Wheezing
Clinical narrative: Significant bruise (diameter of golf ball), cough, wheezing. No pain, warmth, swelling in arm.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and knot at injection site, hot to touch, pain.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Pt reported severe pain and swelling in upper right arm.  Reported immobility in right shoulder.  Went to orthopedic urgent care 2 days later.  States she received a steroid shot and pain meds.  States she will have out patient therapy.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray normal, Cough, Laryngitis, Productive cough
Clinical narrative: Started coughing with lots of thick phlegm continued to get worse during the week, went to the Dr the following Sunday (10/30). Tuesday (11/1) developed laryngitis and still have today (11/6).
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: After eating, I began to get a scratchy throat and feeling fatigued.  After going to bed, I woke up at 3:00 am coughing, and could not go back to sleep. I eventually fell back asleep, and woke feeling terrible, and congested in the chest.  I took airborne and throat lozenges for most of the day at work.  After work, on my drive home, I began to feel worse.  My skin was sore, and I felt feverish.  Once I got home, I laid down and did not want to move at all.  I woke up 3 hours later and was very ill with flu like symptoms.  I went to the store and bought some Alka Seltzer for cold and cough.  I took it before bed, and felt much better the next day.  I still have mild symptoms of congestion and fatigue on Sunday, 11/06/2016.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Pain of skin, Pyrexia, Respiratory tract congestion, Sleep disorder, Throat irritation
Clinical narrative: After eating, I began to get a scratchy throat and feeling fatigued.  After going to bed, I woke up at 3:00 am coughing, and could not go back to sleep. I eventually fell back asleep, and woke feeling terrible, and congested in the chest.  I took airborne and throat lozenges for most of the day at work.  After work, on my drive home, I began to feel worse.  My skin was sore, and I felt feverish.  Once I got home, I laid down and did not want to move at all.  I woke up 3 hours later and was very ill with flu like symptoms.  I went to the store and bought some Alka Seltzer for cold and cough.  I took it before bed, and felt much better the next day.  I still have mild symptoms of congestion and fatigue on Sunday, 11/06/2016.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: When I am in a stressful situation, I feel a tingling, burning sensation at the injection site that hurts.  I thought it might last a couple of weeks, but I still have these symptoms.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Large red circle around administration site, hot, and itchy.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Computerised tomogram thorax, Electrocardiogram, Fatigue, Headache
Clinical narrative: Fatigue, headache, and fever at 3:30 pm; rapid heart rate at 8:30 pm;  Received IV fluids and MOTRIN at emergency room.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Fatigue, headache, and fever at 3:30 pm; rapid heart rate at 8:30 pm;  Received IV fluids and MOTRIN at emergency room.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: High fever, chills, aches day after vaccine given.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus generalised, Urticaria
Clinical narrative: (L) arm swelling/welts, red ears, whole body pruritus.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site pruritus
Clinical narrative: Local reaction (itching, redness, numbness spread to fingers on left arm) and around the injected site. Observe patient every 15-20mins x 1 hour. Follow up with patient within 24hrs.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Pruritus
Clinical narrative: Local reaction (itching, redness, numbness spread to fingers on left arm) and around the injected site. Observe patient every 15-20mins x 1 hour. Follow up with patient within 24hrs.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had a redness at site of injection after 2 days then it swelling for couples day and ended with itching at site of injection. Patient visited emergency department and doctor prescribe BENADRYL 25 mg.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Myalgia
Clinical narrative: Approx. 2 days after shot shoulder and neck area turned red for 24 hrs. Pt. experienced muscle aches for next 24 hours. Symptoms disappeared.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history and concomitant medications were not reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had six temperature excursions:80 hours (Lowest recorded temperature was 30F (-1.111111111 Celsius); 24 hours (Highest recorded temperature was 48 F (8.888888889 Celsius); 168 hours (Highest 49 F(9.44444444 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); hours (Highest recorded temperature was 59 F (15 Celsius); 416 hours (Highest recorded temperature was 47 F (8.333333333 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates,  the RECOMBIVAX HB had six temperature excursions: 80 hours (Lowest recorded temperature was 30 F (-1.111111111 Celsius); 24 hours (Highest temperature was 48 F (8.888888889 Celsius); 168 hours (Highest 49 F (9.444444444 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); 336 hours (Highest recorded temperature was 59 F (15 Celsius); 416 hours (Highest recorded temperature was 47 F (8.333333333 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), (route of administration and anatomical location of administration were not reported). On an unspecified dates, the RECOMBIVAX HB had one temperature excursion of 120 hours and the lowest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a consumer, via company representative, referring to an unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The consumer reported that her husband (unspecified physician) mentioned that unspecified vaccines that may have been improperly stored on unspecified dates and may have been administered to unspecified patients on unspecified dates. No adverse effects were reported. Additional information is not expected, due to lack of contact details. The case was created as duplicate of case1608USA005743 that was mistakenly deleted from our database. Therefore, case # 1608USA005743 is being deleted from our flies and all the case information was consolidated in case 1610USA004920.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received on 17-OCT-2016 from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concomitant therapy were not reported. On 07-MAY-2015 the patient was vaccinated with ZOSTAVAX (lot # K012786, expiration 28-NOV-2015), 0.65 ml subcutaneous. On 13-JUL-2016, the patient was inadvertently vaccinated with ZOSTAVAX (lot # L035285, expiration 12-DEC-2016), 0.65 ml subcutaneous. No adverse effects reported. No further information was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from Pfizer, via medical record and was assigned manufacturer report number (2016474292) referring to a currently 85 year old female patient. The patient's concurrent condition and medical history were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dosage, route, frequency, indication and lot# were not provided). Concomitant therapies were not reported. On an unknown date, the patient experienced an unspecified allergy to PNEUMOVAX 23. The outcome of allergy to vaccine was unknown. It was considered allergy to vaccine to be related to PNEUMOVAX 23. This was originally reported by a physician. All available medical records will be provided upon request. This is one of two 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 registered nurse referring to two patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (Lot # M013156, expiration date 15-OCT-2017) dose, route and frequency were not reported. The temperature and time frame were unknown (thermometer was not calibrated). There was no previous temperature excursion reported and data logger was reported as yes. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with M-M-R II lot # L043704, expiration date 04-NOV-2017, by intramuscular routed instead of subcutaneous route. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 18 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 03-OCT-2016 the patient was vaccinated with an "adult dose" of VAQTA (50 U/ml, lot # M022556, expiration date 26-MAY-2017, 1 ml, route unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to three patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # L014878, expiration date 17-JAN-2018) dose, route and frequency were not reported. The temperature and time frame were unknown (thermometer was not calibrated). There was no previous temperature excursion reported and data logger was reported as yes. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional via Pfizer refers to a patient of unknown age. The patient had hypertension and atrial fibrillation. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. Other suspect therapies included LYRICA. Concomitant therapies included folic acid, hydrocodone, levothyroxine sodium, pravastatin, ramipril, cyanocobalamin and vitamin D (unspecified). On an unknown date the patient experienced an adverse event. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, pertinent medical history or drug reactions/allergies. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M021407 with expiration date 30-APR-2018; dose unknown, route was not reported). The vaccine was exposed at 35 Fahrenheit for 24 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of two 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 (reported also as radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified number of patients were vaccinated with improperly stored dose of GARDASIL lot # K010215 and expiration date 05-MAY-2017 (dose and anatomical location were not reported). No adverse effects were reported. Excursion details: Temperature/time" -0.1 C for 8 hours and 15 minutes. No previous excursions. With a data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified patient. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. The unspecified patient received the first and second dose of VAQTA (lot #, expired date, dose and frequency were unknown) on 22-JAN-2008 and 16-JUL-2008 respectively (inappropriate schedule of drug administration). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, pertinent medical history or drug reactions/allergies. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M025192 with expiration date 21-MAR-2019; dose unknown, route was not reported). The vaccine was exposed at 35 Fahrenheit for 24 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Pain in extremity, Swelling
Clinical narrative: Pt received the PNEUMOVAX 23 around 3pm and around 2 hours later her arm began hurting very bad. Her pain was under her arm as well. Redness and puffiness was also an issue.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling, Tenderness
Clinical narrative: Pt. received PNEUMOVAX 23 approximately 3 pm and approximately 5 pm (2 hours later) his arm began hurting very bad. His pain was so that he could not touch the arm. Also had redness and puffiness.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Red band of raised skin about 5 inches below injection site extending about 4 inches. Appeared in the morning of 11-6-16. Patient did not complain of pain, itching, difficulty breathing, or warmth of rash.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 56-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 30Jul2015 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, general body ache, and nausea on 30Jul2015 with outcome of unknown.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS/CIDP - Transverse myelitis - paralysis in Left Cheek then from the waist down - severe pain in lower and upper back going through chest, spells of shakiness, unable to use hands part-time have to have help with shower and all housework, cooking - cannot drive and unable to stand or walk - confined to bed and wheelchair. Taking IVIG treatments every 4 wks and taking steroids.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Activities of daily living impaired, Back pain, Bedridden, Chest pain
Clinical narrative: GBS/CIDP - Transverse myelitis - paralysis in Left Cheek then from the waist down - severe pain in lower and upper back going through chest, spells of shakiness, unable to use hands part-time have to have help with shower and all housework, cooking - cannot drive and unable to stand or walk - confined to bed and wheelchair. Taking IVIG treatments every 4 wks and taking steroids.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysstasia, Facial paralysis, Guillain-Barre syndrome, Immunoglobulin therapy, Impaired driving ability
Clinical narrative: GBS/CIDP - Transverse myelitis - paralysis in Left Cheek then from the waist down - severe pain in lower and upper back going through chest, spells of shakiness, unable to use hands part-time have to have help with shower and all housework, cooking - cannot drive and unable to stand or walk - confined to bed and wheelchair. Taking IVIG treatments every 4 wks and taking steroids.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal disorder, Myelitis transverse, Paralysis, Tremor, Wheelchair user
Clinical narrative: GBS/CIDP - Transverse myelitis - paralysis in Left Cheek then from the waist down - severe pain in lower and upper back going through chest, spells of shakiness, unable to use hands part-time have to have help with shower and all housework, cooking - cannot drive and unable to stand or walk - confined to bed and wheelchair. Taking IVIG treatments every 4 wks and taking steroids.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Computerised tomogram head normal, Concussion, Head injury, Loss of consciousness
Clinical narrative: This is a spontaneous report obtained from a contactable physician (patient's father).  A male patient of an unspecified age (reported as 17, units unknown) and race received the first dose of TRUMENBA single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced syncope, fell, hit his head, and suffered a concussion. The patient recovered at time of this report.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Concussion, Fall, Head injury, Syncope
Clinical narrative: This is a spontaneous report obtained from a contactable physician (patient's father).  A male patient of an unspecified age (reported as 17, units unknown) and race received the first dose of TRUMENBA single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced syncope, fell, hit his head, and suffered a concussion. The patient recovered at time of this report.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Lip swelling, Rash pustular
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Asthenia, Bone disorder, Cervical radiculopathy, Fear of death, Grip strength decreased
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.