chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, C-reactive protein, Full blood count, Injection site pain, Injection site rash
Clinical narrative: Developed fever 99.9F and left upper arm pain for 1st 3 days after getting the vaccines; resolved. Developed rash to right upper arm; resolved. Developed body-aches and moderate-severe muscle and joint pain that has lasted for ~3 weeks and still persists, which caused patient to make an appointment today. Affected joints: bilateral knees and hips. Affected muscles: bilateral biceps and quadriceps. Tried aleve, ibuprofen, and tylenol with mild improvement. Prescribed short-course of prednisone. Outcome pending.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Metabolic function test, Myalgia, Pain, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Developed fever 99.9F and left upper arm pain for 1st 3 days after getting the vaccines; resolved. Developed rash to right upper arm; resolved. Developed body-aches and moderate-severe muscle and joint pain that has lasted for ~3 weeks and still persists, which caused patient to make an appointment today. Affected joints: bilateral knees and hips. Affected muscles: bilateral biceps and quadriceps. Tried aleve, ibuprofen, and tylenol with mild improvement. Prescribed short-course of prednisone. Outcome pending.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Urine analysis
Clinical narrative: Developed fever 99.9F and left upper arm pain for 1st 3 days after getting the vaccines; resolved. Developed rash to right upper arm; resolved. Developed body-aches and moderate-severe muscle and joint pain that has lasted for ~3 weeks and still persists, which caused patient to make an appointment today. Affected joints: bilateral knees and hips. Affected muscles: bilateral biceps and quadriceps. Tried aleve, ibuprofen, and tylenol with mild improvement. Prescribed short-course of prednisone. Outcome pending.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: Patient states he has loss of feeling in the thumb and pins and needles sensation in the arm and rest of the fingers
Age: 67.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysphonia, Dyspnoea, Throat tightness
Clinical narrative: Tightness, Shortness of breath and throat hoarseness.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: Patient fainted minutes after receiving their vaccine while watching his mother receive her influenza vaccine.  Patient was allowed to remain and rest on the ground for many minutes before moving to a sitting upright position and eventually moving to a chair.  Patient vomited several minutes after sitting in the chair.  Water was provided.  After 30-45 minutes, the patient was able to walk out on their own.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash, Rash erythematous
Clinical narrative: Patient daughter called today about an allergic reaction to the Shringrix vaccine her mom received on 11/29/19. She has red spots on her body and face. I asked her did she experience any difficulty breathing and she said no. I told her to contact her Dr. and we would follow up on the following day.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site urticaria
Clinical narrative: developed hives at injection site 2 minutes after injection. patient was given 12.5mg Benadryl hives and redness receeded within 20 minutes
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Pt states warm, pinky and slightly swollen area below the injection sites the night after he got the vaccines. Also low grade fever that went away on 12/02/19.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Dizziness, Pallor
Clinical narrative: Pt felt she was going to faint, had a white skin, pale and almost passed out after getting the shot, paramedics came pt's vitals were ok when they came. Mom said paramedics advised to call pediatrician since mom had a history of Basal Vagal she said and most likely her daughter might have it too.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: 1 day after vaccination described severe radicular neuropathic pain in left leg. Has improved but not resolved
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Induration, Pain in extremity, Swelling
Clinical narrative: Pt described a raised, reddened large circular area that appeared a few hours after both shots were administered.  She stated that the redness was above and below where the injection site was but did not seem to affect the immediate injection site.  She said the arm became firm to the touch and very sore.  She had a nurse friend observe it who recommended ice, advil and benadryl.  She took all and the redness became increasingly better over the course of the next few days.  As of today it is nearly resolved (3 days later) although still slightly red.  Patient did have Hodkins Lymphoma over 15 years ago and per the patient she has had 2 previous Pneumovax vaccines in her liftetime.  She thinks the first was in 2005 and is unsure when her last one was.  I cannot find any record in the State immunization registry of any previous pneumonia vaccines.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Headache, Muscle spasms, Nausea
Clinical narrative: Intense abdominal cramping, headache, thigh cramping, nausea one hour after injection
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: low fever of 99.6 F, very tired, slight nausea, soreness at injection site
Age: 18.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptoms.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Muscle spasms, Muscle twitching
Clinical narrative: I had the flu shot on 10/15/19 at my workplace. The person who administered the shot was a college student (which we were not informed in any way that they were using students).   The female young student was like 5ft 10? tall who administered the shot while I was sitting and she was standing.  I was sitting on a normal folding chair.  She made my arm twitch twice.  As the day followed my arm started to feel in so much pain by 7pm.  By 10pm I couldn?t move my arm and the pain was not bearable so I took pain pills.  I work at my desk on my computer for 8hrs.  So the next morning I was good but as the day progressed my right arm started hurting.  And the pain went from my right back neck all the way to my right palm.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: I had the flu shot on 10/15/19 at my workplace. The person who administered the shot was a college student (which we were not informed in any way that they were using students).   The female young student was like 5ft 10? tall who administered the shot while I was sitting and she was standing.  I was sitting on a normal folding chair.  She made my arm twitch twice.  As the day followed my arm started to feel in so much pain by 7pm.  By 10pm I couldn?t move my arm and the pain was not bearable so I took pain pills.  I work at my desk on my computer for 8hrs.  So the next morning I was good but as the day progressed my right arm started hurting.  And the pain went from my right back neck all the way to my right palm.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Blood test, Chills, Hypoaesthesia, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Neuralgia, Pyrexia
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Blood test normal, CSF protein increased, Cardiac function test normal, Chest X-ray normal, Chest pain
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Chills, Demyelination, Electrocardiogram normal, Fatigue, Feeling cold
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Gait inability, Headache, Hyperhidrosis, Hypertension, Hypoaesthesia
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Influenza like illness, Insomnia, Mental impairment, Mobility decreased, Muscle spasms
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Nerve conduction studies, Nerve stimulation test
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Neuralgia, Pain, Pain in extremity, Paraesthesia, Paranasal sinus discomfort
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Pyrexia, Tremor, Viral infection, White blood cell count increased, X-ray normal
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Blood test, Burning sensation, Chest X-ray, Chest pain, Chills
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Cough, Electrocardiogram, Hypoaesthesia, Insomnia, Lumbar puncture
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Malaise, Muscle spasticity, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Pyrexia, Sinusitis, Tremor, Upper-airway cough syndrome, Viral infection
Clinical narrative: Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash, Rash & UrticariaPruritus
Age: 67.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: & Guillan Barre
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Scab
Clinical narrative: Pt stated, on 11/26 - 11/27, starting noticed rash on the lower center back. They were itching. Pt presented today to let us know. The rash looks red, small bump and scabbed. Pt was instructed to call Md to report the adverse effects
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient had received the first dose of the suspect medication on 04/09/2019. Upon receiving second dose on 07/18/2019 came to ER on 07/19/2019 because of vomiting, nausea and fever.  Fever & NauseaVomiting
Age: 18.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Fatigue, nausea, vomiting, headaches, Fever
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: The patient came to the pharmacy on 12/2/19 and reported that she was having muscle pain and some shoulder pain that started after she received the flu vaccination. She stated that the symptoms started after receiving the vaccine on 9/17/19, and have not resolved. She had not received any treatment for the pain, at this time but was counseled to contact her doctor and schedule an appointment. She said she has an appointment next month, but was told to contact her doctor as soon as possible to describe her current symptoms.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: & CELLULITIS DIPHENHYDRAMINE 50 MG TID 1 cap q 8 hours prn for allergy
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea vomiting x4 diarrhea x1 abdominal pain  Treated with oral rehydration & Zofran symptoms started 3 hours after ingestion. Symptoms gradually improved over the next day
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Myalgia, Pain
Clinical narrative: Myalgia & pain, limited range of motion at shoulder joint
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling of vaccine site (tennis ball size), hot to touch, itching. Parents encouraged to give Tylenol, apply ice to site and monitor for serious reaction. ie high fever, weakness, behavior changes, or difficulty breathing. Mom reported on 11/26/19 that pts leg vaccine site was apparent for "4 wks."
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Dyspnoea, Hypersensitivity, Swollen tongue, Throat tightness
Clinical narrative: Patient return to pharmacy on 11/30/19 at 5:23pm with a prescription for Prednisone 20 mg and Epi Pen Auto Injector. Patient stated she had allergic reaction to the vaccine. She stated she had problems breathing, bottom of tongue was swollen and throat closed up. She stated she went o the ER. Talked with staff in ER on 11/30/19 at 6:05pm. He stated patient was treated with Bolus IV dose of Prednisone 60mg and patient was released.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Pain Right after Injection - all the way down arm to elbow - Pain continued next day (THurs) reported Friday pm. Noticed Round circle (6" from injection site), size of 50 cent piece. Red & Hot to touch - No itching. Next day (Saturday) still red and "spot" starting to diffuse. Noticing a "Hive" center of spot - itching. used Hydrocortisone cream - 2 days later, bruised at spot site. This redness continued x 12 days
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Skin warm
Clinical narrative: Pain Right after Injection - all the way down arm to elbow - Pain continued next day (THurs) reported Friday pm. Noticed Round circle (6" from injection site), size of 50 cent piece. Red & Hot to touch - No itching. Next day (Saturday) still red and "spot" starting to diffuse. Noticing a "Hive" center of spot - itching. used Hydrocortisone cream - 2 days later, bruised at spot site. This redness continued x 12 days
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Sensory loss
Clinical narrative: Patient stated he was not able to feel his (L) arm after the vaccination. After about 15-30 minutes the sensation started to come back.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Nodule
Clinical narrative: quarter size knot in leg, looked red.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Less than four hours after injection pt. developed a local cellulitis around injection site. Redness to site, Right deltoid. Warm, induration measuring 19cm x 12cm at margins. Boarders are poorly demarcated. No streaking. Tender to palpation. As of 11-7-2019 at 1445. Pt. did not attend scheduled Follow up, but was prescribed 7 days of clindamycin HCL 150mg 3x daily. On 11/22/19 pt called clinic and let staff know that symptoms resolved 3 days ago which would be 11-19-2019.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Dry mouth, Dry throat, Pain in extremity, Parosmia
Clinical narrative: Itchy Back, Burning smell (Phantom smell) when air conditioning was circulating, burning in sinuses and nose, dry throat, sensitivity to food in mouth and throat.  As of today-Still having Phantom smell, but it has lessened since air conditioning is not on. Nasal burn and dry throat has lessened. Sensitivity to food still remains.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Itchy Back, Burning smell (Phantom smell) when air conditioning was circulating, burning in sinuses and nose, dry throat, sensitivity to food in mouth and throat.  As of today-Still having Phantom smell, but it has lessened since air conditioning is not on. Nasal burn and dry throat has lessened. Sensitivity to food still remains.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antinuclear antibody, Burning sensation, Dry throat, Food intolerance, Parosmia
Clinical narrative: Itchy Back, Burning smell (Phantom smell) when air conditioning was circulating, burning in sinuses and nose, dry throat, sensitivity to food in mouth and throat.  As of today-Still having Phantom smell, but it has lessened since air conditioning is not on. Nasal burn and dry throat has lessened. Sensitivity to food still remains.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Sjogren's syndrome
Clinical narrative: Itchy Back, Burning smell (Phantom smell) when air conditioning was circulating, burning in sinuses and nose, dry throat, sensitivity to food in mouth and throat.  As of today-Still having Phantom smell, but it has lessened since air conditioning is not on. Nasal burn and dry throat has lessened. Sensitivity to food still remains.
Age: 7.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Erythema, Pharyngeal disorder
Clinical narrative: Anaphylaxis within minutes of injection requiring epinephrine injection. Subsequent positive allergy testing at allergist office. Interestingly a possible biphasic reaction 2 days and 4 days after the reaction that led to home administration of epinephrine on each of those days.
Age: 7.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Allergy test positive, Anaphylactic reaction
Clinical narrative: Anaphylaxis within minutes of injection requiring epinephrine injection. Subsequent positive allergy testing at allergist office. Interestingly a possible biphasic reaction 2 days and 4 days after the reaction that led to home administration of epinephrine on each of those days.
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site swelling, Pain, Swelling
Clinical narrative: soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle; soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who experienced soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle (inflammation and vaccination site reaction), while she received vaccines HPV VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6220AA via unknown route in the left deltoid. On 14-Nov-2019, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious soreness and swelling at the injection site and suddenly reappear sore and swollen left deltoid muscle (inflammation and vaccination site reaction), unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and HPV VACCINE.  It was reported that patient initially had soreness and swelling at the injection site which went away. 8 days after the vaccination she had swollen deltoid muscle and sore left deltoid muscle. The left deltoid was obviously swollen, the patient, there was no redness, warmth, or tingling sensation at the injection site.  Other relevant tests were not reported.  Final diagnosis was inflammation and vaccination site reaction.   The patient was treated with IBUPROFEN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL, SODIUM CITRATE (BENADRYL [AMMONIUM CHLORIDE;DIPHENHYDRAMINE HYDROCHLORIDE;MENTHOL;SODIUM CITRATE]).  The outcome of the event was not reported.
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle; soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who experienced soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle (inflammation and vaccination site reaction), while she received vaccines HPV VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6220AA via unknown route in the left deltoid. On 14-Nov-2019, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious soreness and swelling at the injection site and suddenly reappear sore and swollen left deltoid muscle (inflammation and vaccination site reaction), unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and HPV VACCINE.  It was reported that patient initially had soreness and swelling at the injection site which went away. 8 days after the vaccination she had swollen deltoid muscle and sore left deltoid muscle. The left deltoid was obviously swollen, the patient, there was no redness, warmth, or tingling sensation at the injection site.  Other relevant tests were not reported.  Final diagnosis was inflammation and vaccination site reaction.   The patient was treated with IBUPROFEN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL, SODIUM CITRATE (BENADRYL [AMMONIUM CHLORIDE;DIPHENHYDRAMINE HYDROCHLORIDE;MENTHOL;SODIUM CITRATE]).  The outcome of the event was not reported.
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site swelling
Clinical narrative: soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle; soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who experienced soreness and swelling at the injection site, and suddenly reappear sore and swollen left deltoid muscle (inflammation and vaccination site reaction), while she received vaccines HPV VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6220AA via unknown route in the left deltoid. On 14-Nov-2019, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious soreness and swelling at the injection site and suddenly reappear sore and swollen left deltoid muscle (inflammation and vaccination site reaction), unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and HPV VACCINE.  It was reported that patient initially had soreness and swelling at the injection site which went away. 8 days after the vaccination she had swollen deltoid muscle and sore left deltoid muscle. The left deltoid was obviously swollen, the patient, there was no redness, warmth, or tingling sensation at the injection site.  Other relevant tests were not reported.  Final diagnosis was inflammation and vaccination site reaction.   The patient was treated with IBUPROFEN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL, SODIUM CITRATE (BENADRYL [AMMONIUM CHLORIDE;DIPHENHYDRAMINE HYDROCHLORIDE;MENTHOL;SODIUM CITRATE]).  The outcome of the event was not reported.
Age: 46.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Anxiety, Burning sensation, Electromyogram, Migraine, Pain in extremity
Clinical narrative: pain in area, hot and cold sensation. symptoms ongoing all day. unable to sleep from pain
Age: 46.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Paraesthesia, X-ray
Clinical narrative: pain in area, hot and cold sensation. symptoms ongoing all day. unable to sleep from pain
Age: 46.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Feeling cold, Insomnia, Nerve conduction studies, Pain, Skin warm
Clinical narrative: pain in area, hot and cold sensation. symptoms ongoing all day. unable to sleep from pain
Age: 46.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: X-ray
Clinical narrative: pain in area, hot and cold sensation. symptoms ongoing all day. unable to sleep from pain
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain, Insomnia
Clinical narrative: Patient has thin skin already. The first shot did NOT cause this extensive bruising/bleeding like this 2nd shot did.  The bruising extends from below her shoulder down to her elbow, almost encircling the entire upper arm.  She said it was definitely subsiding and she didn't feel like she needed to go to the doctor.  She had more pain with this injection and couldn't sleep on that side.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms; The patient was vaccinated with PEDVAX on 31-JUL-2019, 25-SEP-2019, and 04-NOV-2019. Nurse stated an unspecified medical assistant, who vaccinated the patient, got the dosing schedule for PEDV AX confused with the dosing schedule for ACTHIB; This spontaneous report as received from a nurse who referred to a patient of unknown age, gender, and ethnicity. No information on patient's pertinent medical history, concomitant medications, and drug reactions or allergies was provided.  On 21-JUL-2019, the patient was vaccinated with a first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, lot#, expiration date, and route of administration were not provided) as prophylaxis. The patient was vaccinated with a second and third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, lot#, expiration date, and route of administration were not provided) as prophylaxis, on 25-SEP-2019 and 04-NOV-2019, respectively (inappropriate schedule of product administration). It was reported that an unspecified medical assistant, who vaccinated the patient, got the dosing schedule for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) confused with the dosing schedule for Hib conj vaccine (tet toxoid) (ACTHIB). No adverse symptoms were reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: The patient repeted titers which were still too low.; The patient was given one dose o f VARI AX on 21-JUN-2019 and one dose of VARIVAX on 22-JUL-2019.; Physician reported the patient had varicella titer checked on  and it was too low; This spontaneous report was received from a physician referring to a 24 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis, at age 1 year and 4 years and required titers for medical school in 2019.   On 20-APR-2019, the physician reported the patient had varicella titer checked and it was too low(viral titre decreased) and the patient was given one dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) on 21-JUN-2019 and one dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) on 7/22-JUL-2019  and had repeat titers done on  24-OCT-2019 which were still too low.   At the time of the report, the outcome of viral titre decreased was unknown. The physician did not mention the causality assessment between the event and varicella virus vaccine live (oka/merck)(VARIVAX) vaccination.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: the physician administered a dose of GARDASIL 9 to an unspecified pregnant patient.; No adverse effects reported; This spontaneous prospective pregnancy report has been received from a nurse via company representative referring to a unspecified pregnant female patient of unknown age. The patient became pregnant with last menstrual period (LMP) of 20-MAR-2019 and estimated date of delivery(EDD) of 25-DEC-2019. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 06-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, frequency, route, lot # and expiration date were not reported) for prophylaxis due to human error(exposure during pregnancy). Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 33 weeks. The pregnancy outcome was outcome pending. The fetal outcome was unknown. No adverse effects reported.
Age: 1.25
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported.; 15-month-old patient was administered GARDASIL 9; This spontaneous report has been received from a physician referring to a 15 months old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 11-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # reported as 161498 but upon internal validation established as 1614898, expiration date: 15-NOV-2021; frequency, route and dose details were unknown) for prophylaxis (product administered to patient of inappropriate age). No adverse effects reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error, Wrong technique in product usage process
Clinical narrative: no adverse effect; Patient was administered a dose of MMR II that was frozen in a syringe overnight and then thawed under hot water; Wrong technique in product usage; This spontaneous report was received from a Medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.  On 19-NOV-2019 (also reported as last night), the medical assistant reconstituted a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, lot # S005248 and expiry date 20-FEB-2021 (strength, dose, anatomical location not reported), with sterile diluent (lot # S000977 and expiry date 14-SEP-2021), which was drawn up into the syringe to be administered to the unspecified patient, however, the patient changed the mind. The medical assistant reported that the syringe containing the reconstituted measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was placed in the freezer over night (product storage error). On 20-NOV-2019 (also reported as today), the syringe was thawed under hot water and administered to the patient (wrong technique in product usage process). No adverse symptoms were reported. No product quality complaint was involved in this report.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patient was inadvertently administered a dose Varivax, that was improperly stored; This spontaneous report has been received from a research coordinator (physician) referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, and drug allergies were not reported.  On 14-NOV-2019 the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection,  lot number S005084, expiration date 19-FEB-2021 for prophylaxis (concentration, frequency, and  administration route were not reported), that had been improperly stored in a temperature of -13.8C for a time frame of 51minutes. The vaccine was reconstituted with properly stored sterile diluent. No adverse events were reported. Additionally it was reported that a data logger was involved.  The outcome of the event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Fall, Gait disturbance, Hypoaesthesia
Clinical narrative: thalamic infarct on the left lateral thalamus; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's concurrent conditions and medical history were not provided.  In or around 12-DEC-2016 the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (herpes zoster). On an unknown date (reported as " Shortly after receiving vaccine"), the pt experienced shortness of breath, chest pain and numbness and tingling on the right side of his arm extending to his fingers. The patient was also having weakness on the right lower extremity which was causing him to walk tilted and fall. The pt was hospitalized and diagnosed with thalamic infarct on the left lateral thalamus. In addition, it was reported that the pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury (disability). At the time of the report, the outcome of thalamic infarction was not recovered.  The reporter considered thalamic infarction and emotional distress to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, thalamic infarction was considered to be an important medical event , and due to the limiting, permanent and incurable injuries was also considered disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Paraesthesia, Thalamic infarction
Clinical narrative: thalamic infarct on the left lateral thalamus; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's concurrent conditions and medical history were not provided.  In or around 12-DEC-2016 the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (herpes zoster). On an unknown date (reported as " Shortly after receiving vaccine"), the pt experienced shortness of breath, chest pain and numbness and tingling on the right side of his arm extending to his fingers. The patient was also having weakness on the right lower extremity which was causing him to walk tilted and fall. The pt was hospitalized and diagnosed with thalamic infarct on the left lateral thalamus. In addition, it was reported that the pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury (disability). At the time of the report, the outcome of thalamic infarction was not recovered.  The reporter considered thalamic infarction and emotional distress to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, thalamic infarction was considered to be an important medical event , and due to the limiting, permanent and incurable injuries was also considered disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Vaccination failure
Clinical narrative: was diagnosed as vision loss; The vaccine did not prevent shingles as intended; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported) as recommended for routine adult health maintenance for prevention of shingles. However the vaccine did not prevent shingles as intended (vaccination failure and herpes zoster).   The patient was treated for an outbreak that was diagnosed as vision loss (blindness). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.   As further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering other damages.   The outcome of blindness, herpes zoster and vaccination failure was unknown. The reporter considered vaccination failure, blindness and herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, blindness was considered a medically significant event.  Additional information has been requested.  This is one of seven reports received by the same reporter.; Sender's Comments:  US-009507513-1911USA011066: US-009507513-1911USA011701: US-009507513-1911USA011702: US-009507513-1911USA011705: US-009507513-1911USA011706:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles; persisitent strain of herpes zoster, also known as shingles/ blistering vesicular outbreak diagnosed as severe herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose #, route and anatomical location were not specified) for routine adult health maintenance for the prevention of shingles. On an unspecified date, the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Additional information has been requested.; Sender's Comments:  US-009507513-0506USA02718: US-009507513-0510USA07841:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: the vaccine did not prevent shingles as intended; diagnosed as severe herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications.   On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, anatomical location and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles.   It was reported that the vaccine did not prevent shingles as intended (vaccination failure) and subsequently on an unspecified date, the patient contracted a persistent strain of herpes zoster and other complications. The patient went to a local pharmacy and he received treatment for a blistering vesicular outbreak that was diagnosed as a severe herpes zoster with unspecified medications.   It was reported that the patient suffered painful injuries and damages and required extensive medical care. He suffered and would continue to suffer significant medical expenses as well as pain and other damages. The patient had not recovered from shingles.. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Retinal disorder, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; Shingles; neuropathic pain; retinal issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 16-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose #, route and anatomical location were not specified) for routine adult health maintenance for the prevention of shingles. On an unspecified date, the vaccine did not prevent shingles as intended, and the patient experienced neuropathic pain, retinal issues and shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment.   The outcome of the events vaccination failure, retinal disorder, neuralgia and herpes zoster was unknown. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).     Additional information has been requested.