chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Feeling abnormal, Gait disturbance, Pain, Spinal pain, Vertigo
Clinical narrative: I received the Hep A and Hep B vaccine around 5pm. Hep A was in the Right arm and Hep B was in the left arm. Also got a PPD in left forearm.The nurse who gave me the vaccines was very thorough - I commented on it to her - she checked and rechecked the vaccine bottles before drawing them up and administering them to me. I did not feel good after the vaccines, but that was to be expected. Wed (next day) I just did not feel good at all. That afternoon I started having bad aches on and off, but I just ignored them. Wed nite between 12am and 3am, I had a horrific pain to my mid spine area (like I had never had before- it woke me up) and it radiated around to my belly button and I had horrible abdominal pain in that area of my abdomen.  I remember thinking to myself - "Every fiber of my being hurts." AND, it was not like the flu, it was different, but hard to describe. I continued feeling very bad on Thursday and called out of work for the first 12 hrs of my shift. I was hoping to get better and go in the last 12 hrs.  Again, I cannot describe how horrible I Felt. Thursday nite about 4am, I got out of the bed to go to the bathroom and could not stand up. At first my head spun a little bit, but then stopped. (Note - I am used to getting up quickly and abruptly out of bed ALL the time with my job.) As I tried to walk, I fell to the left and could not walk. My husband heard me banging around falling on things and woke up. I said I cant walk right. He had to help me to the bathroom and back. I was concerned that I might be having a stroke and did the stroke scale tests. I passed them, but was still concerned what if this was just the early stages and I didnt want to miss that 3-4 hr window of getting to the hospital. I consulted a friend, an NP and she suggested I go to the hospital. I told her I owed the hospital enough and unless I was sure I was having a stroke I would rather not go. We talked about it more and decided it was not a stroke. I kept watch and tried to walk after that and it got better. I still could not walk straight. I felt sure it wasnt a stroke and therefore went to sleep. I woke up the next morning and a small amount of it was still there and called out the last 12 hrs of my shift. I was told I could take a benedryl and it may help, so I did and went bk to sleep. By the next morning I was doing much better all the way around.  I noticed I was a little weak when I tried to do alot, but otherwise I was ok.  NOTE: A co-worker of mine, who is in school stated he also has taken the Hep B vaccine a couple of times and he had the same horrific pains that I did. He did not have the Vertigo or inability to walk that I did.
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Administered MMR/V vaccine outside of recommended guidelines. Child is over the age of 12 years. Child had no signs and symptoms to report.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a unspecified patient of unknown age and gender. Information regarding pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not provided. On 01-FEB-2017,  the patient was vaccinated with an improperly stored dose of ZOSTAVAX, lot number reported as M037013 with expiration date of 22-NOV-2017 (strength, dose, frequency, and route of administration were not provided) for prophylaxis. The reporter stated that the administered dose experienced a temperature excursion of >14°F but <46°F (>-10° Celsius (C) but <8° Celsius (C)  and the time frame was 166 hours, also she stated that previous temperature excursion was not involved, this information was no registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Sunburn
Clinical narrative: This spontaneous report was received from a 39 year old male patient, who is also a pharmacist reporting on himself. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. The patient's concurrent conditions were not reported. On unspecified dates, the patient administered an unspecified number of doses ZOSTAVAX to an unspecified number of patients, for prophylaxis. The reporting pharmacist stated that he never had ZOSTAVAX administered to him but he administered a lot of ZOSTAVAX doses to his patients. On 01-FEB-2017, the patient began experiencing the feeling of a bad sunburn on his back and side and at times it felt like someone punched me in the side about 10 times for the first couple nights". On an unspecified date in February 2017 (reported as after a couple of days), the patient started to develop a rash so he went to his physician and was diagnosed with shingles. It was reported that the patient received an unspecified treatment for the adverse events. At the time of reporting, the outcome of the events was unknown. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information is not expected because the reporter refused additional contact.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Pruritus
Clinical narrative: Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2016552260) on 09-FEB-2017. This case involves a female patient (onset age was unknown) who was vaccinated with dose of TETANUS TOXOID (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to tetanus-itching. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (manufacturer report number 2016557662) on 09-FEB-2017. This case involves an 86-year-old female patient who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (batch number, expiry date, dose, dose in series, route and site of administration were not reported), on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had allergy to vaccine. Lab data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: FLUC4, HEP, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Pain, Swelling, Tenderness
Clinical narrative: Pain, swelling, tender, redness, redness moving from shoulder to arm.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: Woke up from nap covered in hives. Mom brought pt back into office to be seen. We dosed him with Benadryl 3.75 ml po @ 3:15pm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reporter stated that improperly stored doses of PROQUAD, Lot number M014302, expiration date 22-SEP-2017 (dose, route, and anatomical location were not reported), were administered to an unspecified number of patients on unspecified dates since 19-OCT-2016, for prophylaxis. The vaccine was exposed to a temperature of 10.8 Fahrenheit (F) for 4 hours and 56 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA006080.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified number of patients of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reported stated that improperly stored doses (incorrect product storage) of GARDASIL 9, lot number M004116, expiration date 12-OCT-2017 (dose, route, and anatomical location were not reported), were administered to the multiple unspecified number of patients on unspecified dates, for prophylaxis. The vaccines were exposed to a range of temperature of more than 8 degrees Celsius but less than 25 degrees Celsius for 1 hour and 30 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007055: US-009507513-1702USA007056.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 6 year old patient of unknown gender. The patient's medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not provided. On 01-FEB-2017, the patient was vaccinated with a third dose of RECOMBIVAX HB, 5/0.5 mcrg/ml intramuscularly, (frequency was not provided)  lot # M023718 and expiration date 08-SEP-2018,for prophylaxis. The vaccine was diluted with sterile diluent (manufacturer unknown), intramuscularly,(strength, frequency, and dose were not reported) lot # reported as M029027 and expiration date 14-MAR-2019. The reporter stated that she "was busy, and she did not know why she made the error". No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bradycardia, Headache, Hypotension
Clinical narrative: Violent vomiting, headache, high fever, nausea, low BP, bradycardia.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Pyrexia, Soft tissue injury, Vomiting
Clinical narrative: Violent vomiting, headache, high fever, nausea, low BP, bradycardia.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyspnoea, Eye disorder, Feeling abnormal, Hyperhidrosis, Pyrexia
Clinical narrative: Severe fussiness, rashes, fever, sweating, eye problems, breathing problems.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Severe fussiness, rashes, fever, sweating, eye problems, breathing problems.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Facial paralysis, Nuclear magnetic resonance imaging
Clinical narrative: Symptoms began previous Friday with loss of taste. Facial paralysis occurred on 2/20/17.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Chills, Erythema, Headache, Nausea
Clinical narrative: Within three hours developed left arm swelling, pain, itching and redness. Fevers, chills, nausea, headache and body aches. Upset stomach but no diarrhea or vomiting.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Within three hours developed left arm swelling, pain, itching and redness. Fevers, chills, nausea, headache and body aches. Upset stomach but no diarrhea or vomiting.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Hypoaesthesia, Injection site erythema, Injection site reaction
Clinical narrative: 1 to 2 days after administration, pt had large, red welt at injection site that was hot to the touch. Also had fever, headache, earache on left side andnumb pinky and ring fingers left side.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia, Urticaria
Clinical narrative: 1 to 2 days after administration, pt had large, red welt at injection site that was hot to the touch. Also had fever, headache, earache on left side andnumb pinky and ring fingers left side.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Worsening rash that began at local sites of immunizations on both thighs. This has happened before with the 2 previous vaccinations that child has received but the rash appears worse to mother on this event.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Dizziness, Pyrexia, Rash erythematous, Varicella post vaccine
Clinical narrative: Started with small red bumps & dizziness. Bumps increased & got larger. By 2/18/17 she had 102.5 fever & appearance of full blown chicken pox. Confirmed case of chicken pox w/ 2 doctors at Urgent Care on 2/19/17. Patient will be out of school, dance and tutoring for up to 2 weeks due to chicken pox caused by vaccine. I am caring for her & missing work due to this.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was administered PREVNAR 13 instead of PNEUMOVAX 23. Patient did not have a reaction to the vaccination.
Age: 12.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Diarrhoea, Eczema, Eyelid oedema, Hypersensitivity, Migraine
Clinical narrative: Chronic Migraine, Persistent Diarrhea, Allergies (Nasal), Eczema on face and neck, swollen eyelids.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was administered PREVNAR 13 instead of PNEUMOVAX 23. Patient did not have a reaction to the vaccination.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea
Clinical narrative: Was fighting to breathe. Rushed to the ER and was put on a nebulizer.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Hypoacusis, Nuclear magnetic resonance imaging normal, Pain in jaw, Tinnitus
Clinical narrative: After receiving the vaccines (days following) the patient pain in left jaw and ringing in left ear. Pt had tests done w/50% hearing loss in lft ear by a physician. MRI was clear.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Aphasia, Fall, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Case number PHEH2017US004421, is an initial spontaneous report received from a consumer on 09 Feb 2017. This report refers to a 49 year old non pregnant female patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer) on an unknown date (reported as last year) with no side effects. Medical history and concomitant medication were not reported. She was vaccinated with single dose of FLUVIRIN (batch number: 1619521) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017. On the same day after vaccination, she developed a golf ball size swelling at injection site immediately after receiving vaccine, then immediately felt warm, sweating profusely, lost ability to speak and muscle control and dropped onto floor, could not walk. It was reported that she never lost consciousness and was on floor for 30 minutes and sat in chair until paramedics came and took vitals. She was then was able to stand and speak. She felt queasy on 06 Feb 2017 and was continued the next few days and the queasiness had subsided on 9 Feb 2017. It was reported that the swelling resolved on 06 Feb 2017 and the arm at injection site continued to hurt. She fully recovered from hyperhidrosis, aphasia and syncope on 05 Feb 2017, vaccination site swelling on 06 Feb 2017 and nausea on 09 Feb 2017. The outcome of the events skin warm, coordination abnormal and abasia was not reported and for the event vaccination site pain was reported as condition unchanged. The events were considered as non serious by the reporter and causality of the events was not reported. Seriousness assessment of the event abasia (medically significant) was upgraded based on the Novartis Important Medical Event List.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Muscle disorder, Nausea
Clinical narrative: Case number PHEH2017US004421, is an initial spontaneous report received from a consumer on 09 Feb 2017. This report refers to a 49 year old non pregnant female patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer) on an unknown date (reported as last year) with no side effects. Medical history and concomitant medication were not reported. She was vaccinated with single dose of FLUVIRIN (batch number: 1619521) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017. On the same day after vaccination, she developed a golf ball size swelling at injection site immediately after receiving vaccine, then immediately felt warm, sweating profusely, lost ability to speak and muscle control and dropped onto floor, could not walk. It was reported that she never lost consciousness and was on floor for 30 minutes and sat in chair until paramedics came and took vitals. She was then was able to stand and speak. She felt queasy on 06 Feb 2017 and was continued the next few days and the queasiness had subsided on 9 Feb 2017. It was reported that the swelling resolved on 06 Feb 2017 and the arm at injection site continued to hurt. She fully recovered from hyperhidrosis, aphasia and syncope on 05 Feb 2017, vaccination site swelling on 06 Feb 2017 and nausea on 09 Feb 2017. The outcome of the events skin warm, coordination abnormal and abasia was not reported and for the event vaccination site pain was reported as condition unchanged. The events were considered as non serious by the reporter and causality of the events was not reported. Seriousness assessment of the event abasia (medically significant) was upgraded based on the Novartis Important Medical Event List.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Prolonged pain in shoulder/upper arm. Trouble lifting arm.
Age: 23.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient developed redness, heat, and swelling in the local area of vaccination on night of 2/17/17.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Vaccination site pain
Clinical narrative: Vaccine area very red and painful, doctor thought it was not administered deep enough or high enough on arm per mother. Dr. recommended ice packs and BENADRYL, if not better in a few days come see Dr. again.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody negative, Arthritis, Full blood count normal, Injection site pain, Musculoskeletal pain
Clinical narrative: 76 Y.O. female who got (L) upper arm pain after flu vaccine pain radiating down the arm and shoulder. No rash, swelling or fever. Pt noted problem right after vaccine but mentioned to MD in December when it did not resolve. Was still having symptoms in late December/early January.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Spinal X-ray abnormal, X-ray limb abnormal
Clinical narrative: 76 Y.O. female who got (L) upper arm pain after flu vaccine pain radiating down the arm and shoulder. No rash, swelling or fever. Pt noted problem right after vaccine but mentioned to MD in December when it did not resolve. Was still having symptoms in late December/early January.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing
Clinical narrative: Vaccine admi at 1245, patient returned at 300 c/o flushed feeling and dizziness that started at 230. No SOB, hives, swelling noted, injection site w/o redness or swelling. Vital signs stable. BENADRYL 25mg PO given. By 325 symptoms resolved.
Age: 1.25
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Pt. developed "tiny little red bumps starting Sat. eve to L ear and has now spread to her entire body but she does not seem bothered by it".
Age: 79.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: Patient had (R) arm pain at time of injection which has persisted since injection in October.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling
Clinical narrative: Approximately 22 hours after PPV23 vaccine patient C/O headache, left upper arm pain, left upper arm swelling and diffuse joint pains. No treatment, patient took naproxen at home.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: Felt faint after MCV4, HPV vaccines. Rested, drank juice.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on one side of back. Pt MD prescribed VALTREX.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient walked into clinic today with red circle at site vaccines was given.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Asthenia, Dizziness, Electrocardiogram, Hypoaesthesia oral
Clinical narrative: Anaphylaxis: swollen numb lips, lightheaded and weakness. Pt. given 80 mgs. Depo-Medrol, I.M. right deltoid, EKG, and vital signs frequently. 911 called, pt. transported to E.R. via ambulance.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test, Lip swelling
Clinical narrative: Anaphylaxis: swollen numb lips, lightheaded and weakness. Pt. given 80 mgs. Depo-Medrol, I.M. right deltoid, EKG, and vital signs frequently. 911 called, pt. transported to E.R. via ambulance.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness of arms in a adult female patient who received BOOSTRIX. Concomitant products included FLUARIX Quadrivalent. On 12th November 2016, the patient received BOOSTRIX. On an unknown date, less than a year after receiving BOOSTRIX and an unknown time after receiving FLUARIX Quadrivalent, the patient experienced weakness of arms, pain in arm, muscle pain and pain in elbow. On an unknown date, the outcome of the weakness of arms, pain in arm, muscle pain and pain in elbow were unknown. It was unknown if the reporter considered the weakness of arms, pain in arm, muscle pain and pain in elbow to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in general good health and received the vaccines for preventive care. The patient received BOOSTRIX in left arm. Since the patient received the vaccine, the patient was feeling weakness and pain in biceps area, elbow and lower arms and noticed that extreme muscle ache was caused by simple and normal activities. When lifting anything, including a coffee pot the patient felt an ache. The patient could not twist a bottle top off without pain. The patient patiently waited for the pain to stop, but it had not and patient was very concerned. The patient had discussed this with the physician recently. The reporter asked to contact and to let them know what should be done. This case had been linked case is relevant to the wife US2017GSK014333, reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness of arms in a adult female patient who received BOOSTRIX. Concomitant products included FLUARIX Quadrivalent. On 12th November 2016, the patient received BOOSTRIX. On an unknown date, less than a year after receiving BOOSTRIX and an unknown time after receiving FLUARIX Quadrivalent, the patient experienced weakness of arms, pain in arm, muscle pain and pain in elbow. On an unknown date, the outcome of the weakness of arms, pain in arm, muscle pain and pain in elbow were unknown. It was unknown if the reporter considered the weakness of arms, pain in arm, muscle pain and pain in elbow to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in general good health and received the vaccines for preventive care. The patient received BOOSTRIX in left arm. Since the patient received the vaccine, the patient was feeling weakness and pain in biceps area, elbow and lower arms and noticed that extreme muscle ache was caused by simple and normal activities. When lifting anything, including a coffee pot the patient felt an ache. The patient could not twist a bottle top off without pain. The patient patiently waited for the pain to stop, but it had not and patient was very concerned. The patient had discussed this with the physician recently. The reporter asked to contact and to let them know what should be done. This case had been linked case is relevant to the wife US2017GSK014333, reported by the same reporter.
Age: 60.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Arthralgia, Pain in extremity, Tendon pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness of arms in a adult male patient who received FLUARIX Quadrivalent. Co-suspect products included BOOSTRIX. On 12th November 2016, the patient received FLUARIX Quadrivalent and BOOSTRIX. On an unknown date, less than a year after receiving FLUARIX Quadrivalent and BOOSTRIX, the patient experienced weakness of arms, pain in arm, muscle pain and pain in elbow. On an unknown date, the outcome of the weakness of arms, pain in arm, muscle pain and pain in elbow were unknown. It was unknown if the reporter considered the weakness of arms, pain in arm, muscle pain and pain in elbow to be related to FLUARIX Quadrivalent and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's wife. The patient was in general good health and received the vaccines for preventive care. The patient received FLUARIX QIV and BOOSTRIX in right arm. Since the patient received the vaccine, the patient was feeling weakness and pain in biceps area, elbow and lower arms an noticed that extreme muscle ache was caused by simple and normal activities. The patient  patiently waited for the pain to stop, but it had not and patient was very concerned. The patient experienced the feeling in his right arm where both shots were administered. The patient had discussed this with the physician recently. The reporter asked to contact and to let them know what should be done. This case has been linked case is relevant to the wife US2017GSK014333, reported by same reporter.
Age: 60.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Arthralgia, Injection site pain, Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness of arms in a adult male patient who received FLUARIX Quadrivalent. Co-suspect products included BOOSTRIX. On 12th November 2016, the patient received FLUARIX Quadrivalent and BOOSTRIX. On an unknown date, less than a year after receiving FLUARIX Quadrivalent and BOOSTRIX, the patient experienced weakness of arms, pain in arm, muscle pain and pain in elbow. On an unknown date, the outcome of the weakness of arms, pain in arm, muscle pain and pain in elbow were unknown. It was unknown if the reporter considered the weakness of arms, pain in arm, muscle pain and pain in elbow to be related to FLUARIX Quadrivalent and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's wife. The patient was in general good health and received the vaccines for preventive care. The patient received FLUARIX QIV and BOOSTRIX in right arm. Since the patient received the vaccine, the patient was feeling weakness and pain in biceps area, elbow and lower arms an noticed that extreme muscle ache was caused by simple and normal activities. The patient  patiently waited for the pain to stop, but it had not and patient was very concerned. The patient experienced the feeling in his right arm where both shots were administered. The patient had discussed this with the physician recently. The reporter asked to contact and to let them know what should be done. This case has been linked case is relevant to the wife US2017GSK014333, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Hypoaesthesia, Peripheral coldness, Peripheral swelling
Clinical narrative: 30 minutes after administration, patient experienced swelling and tingling in arm in addition to arm feeling cold to touch.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Paraesthesia, Peripheral coldness, Peripheral swelling
Clinical narrative: 30 minutes after administration, patient experienced swelling and tingling in arm in addition to arm feeling cold to touch.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Hypoaesthesia, Pain, Peripheral coldness, Peripheral swelling
Clinical narrative: 30 minutes after administration, patient experienced swelling and tingling in arm in addition to arm feeling cold to touch.
Age: 1.58
Sex: M
Vaccine: HEPA, IPV, MMR, PPV, VARCEL
Symptoms: Abasia, Aphasia, Attention deficit/hyperactivity disorder, Body temperature increased, Pyrexia
Clinical narrative: Fever, could not talk, seizures, temperature 101.1 and rising.
Age: 1.58
Sex: M
Vaccine: HEPA, IPV, MMR, PPV, VARCEL
Symptoms: Seizure, Speech disorder
Clinical narrative: Fever, could not talk, seizures, temperature 101.1 and rising.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: Started with measles like rash to trunk then spread to arms and legs. Fevers. PCP prescribed Medrol dose pack.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 25-JAN-2017, the patient received a pediatric dose of VAQTA Lot # M022924 and expiration date: 24-JAN-2018 (dose and route of administration were not reported) for prophylaxis, instead of an adult dose. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a female 15 year old patient. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not reported. On an unknown dates in 2011, the patient was vaccinated with the first and the second dose of GARDASIL, (strength, route of administration, frequency, lot# and expiration date were not provided) for prophylaxis. Then on 25-JUN-2013, the patient was vaccinated with the third dose of GARDASIL (strength, route of administration, frequency, lot# and expiration date were not provided) for prophylaxis. Also it was stated by the reporter that on 19-AUG-2016, the patient received a dose of GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-FEB-2017, the patient was vaccinated with M-M-R II subcutaneously (dose was not reported), (lot number L003855, therapy type unknown) that had expired on 05-FEB-2017, for prophylaxis. No adverse effects were reported. Additional information is not expected as there was no consent for contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report from a pharmacy Intern concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. There was no Product Quality Complaint (PQC) involved nor adverse effects reported. The temperature and the time of the excursion were unknown by the reporter and also it was unknown if a data logger was involved. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a License practitioner nurse regarding a 18 month old female patient with no known allergies.   On 17-NOV-2016 at 12:58 P.M  the patient was vaccinated with  expired dose of VARIVAX (lot# K006134, expiry: 29-APR-2016) dose 1, subcutaneous route in the right arm for prophylaxis and expired dose of hepatitis A vaccine, inactivated(Manufacturer unknown)(Lot# L015460) dose 1, intramuscular route in left arm for prophylaxis. Concomitantly the patient was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (Manufacturer unknown) and influenza virus vaccine (unspecified) (Manufacturer unknown) on the same day. The reporter was checking for efficacy. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169:
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information was received via Pfizer from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot#, expiration date, concentration, route and frequency were unknown) for prophylaxis. On an unknown date, the patient had allergic reaction to PNEUMOVAX23. The outcome of allergic reaction was unknown, and the causality between PNEUMOVAX23 and allergic reaction was reported as related. Additional information is not expected, because the reporter declined to provide further demographics.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 29 unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, medical history and concomitant therapy provided. On an unspecified multiple dates, the patients were administered an improperly stored dose of PROQUAD (lot number M033908, expiration date 16-JAN-2018), (route, dose and frequency not reported) for prophylaxis. The call was because of Digital Data Logger, the temperature excursion was reported as > -15 Celsius degrees but < -10 Celsius degrees, for the time frame of 38 minutes. There was no previous temperature excursion reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received adult dose of Hepatitis A vaccine before age 19 years. No adverse reaction noted.
Age: 0.5
Sex: F
Vaccine: DTAP, RVX
Symptoms: Lethargy, Vomiting
Clinical narrative: Vomiting, several times in night and into following day.  No fever or other issues noted.  Lethargic but not unusually fussy.  Would nap and take some breastmilk.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Musculoskeletal pain
Clinical narrative: Prolonged shoulder pain.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Human chorionic gonadotropin decreased, Ultrasound antenatal screen normal
Clinical narrative: I was 6 weeks pregnant and had a miscarriage. I started bleeding 3 days after receiving the flu shot. I had had one ultrasound and Beta HCG the week prior to the shot which both depicted a normal intrauterine pregnancy prior to the injection. I have no prior history of miscarriage, I have 2 living children from my 2 prior pregnancies.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Skin reaction
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history or concomitant medications reported. On an unspecified date In November 2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) for prevention of shingles. On an unknown date in November 2016, after getting ZOSTAVAX, the patient had skin a reaction and fever that were recovered after 2 days. The causality between the adverse events and ZOSTAVAX was unknown.  No product quality complaint was involved (PQC). Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 77 year old male patient. The patient's concurrent conditions included hypertension. The patient's medical history and concomitant therapies were not reported. On 09-FEB-2017 (reported as "last Thursday"), the patient was vaccinated with ZOSTAVAX 19400 "PFU" (dose, route, lot validation and expiration date were not reported) for prophylaxis. The physician reported that the patient presented in an unspecified emergency room on an unknown date in February 2017 (reported as "during the weekend") with facial paralysis. Therefore, the patient was prescribed acyclovir and an unspecified anti-inflammatory medication when discharged from the emergency room and was released without being admitted to the hospital. Additionally, on 13-FEB-2017, the patient went to the office, as a follow up from the emergency room visit. The physician recommended to the patient to seek a physical therapist for the facial paralysis. At the time of reporting, the patient was "recuperating". No product quality complain was reported. Upon internal review, the event facial paralysis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 16-FEB-2017, the patient was vaccinated with an expired dose of PROQUAD with lot # L014405 and expiration date on 30-OCT-2016 (anatomical route of vaccination was not provided) for prophylaxis. Furthermore, it was reported that on adverse effect were suffered and that no product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions, allergies and concomitant therapies were not provided. On unknown dates since October or November 2016, the patient were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). Administered doses of vaccines experienced the temperature excursion of more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit for 15 hours on unknown dates. There were no previous temperature excursions. A Digital Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On approximately 22-JAN-2017 (reported as "between 22-JAN-2017 and 20-FEB-2017"), the patients were vaccinated with improperly stored doses of VARIVAX (lot # L045956, expiration date 12-SEP-2017) (lot # M024680, expiration date: 18-MAY-2018) for prophylaxis (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: refrigerator: 49.8 Fahrenheit for 2 hours 30 minutes; freezer: 30.3 Fahrenheit for 4 hours. The previous temperature excursion reported was: refrigerator: 49.6 Fahrenheit for 31 minutes; freezer: 11.2 Fahrenheit for 48 minutes. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009652: US-009507513-1702USA009653: US-009507513-1702USA009654:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On approximately 22-JAN-2017 (reported as "between 22-JAN-2017 and 20-FEB-2017"), the patients were vaccinated with improperly stored doses of PROQUAD (lot # M035690, expiration date: 06-FEB-2018) for prophylaxis (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: refrigerator: 49.8 Fahrenheit for 2 hours 30 minutes; freezer: 30.3 Fahrenheit for 4 hours. The previous temperature excursion reported was: refrigerator: 49.6 Fahrenheit for 31 minutes; freezer: 11.2 Fahrenheit for 48 minutes. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009653: US-009507513-1702USA009654: US-009507513-1702USA009133:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On approximately 22-JAN-2017 (reported as "between 22-JAN-2017 and 20-FEB-2017"), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M020100, expiration date 07-MAR-2019) (lot # M001811, expiration date: 04-NOV-2018) (lot # L042835, expiration date: 19-AUG-2018) for prophylaxis (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: refrigerator: 49.8 Fahrenheit for 2 hours 30 minutes; freezer: 30.3 Fahrenheit for 4 hours. The previous temperature excursion reported was: refrigerator: 49.6 Fahrenheit for 31 minutes; freezer: 11.2 Fahrenheit for 48 minutes. Digital data logger was involved. No adverse effects were reported.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA009652: US-009507513-1702USA009654: US-009507513-1702USA009133:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On approximately 22-JAN-2017 (reported as "between 22-JAN-2017 and 20-FEB-2017"), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M017514, expiration date 07-NOV-2017) for prophylaxis (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: refrigerator: 49.8 Fahrenheit for 2 hours 30 minutes; freezer: 30.3 Fahrenheit for 4 hours. The previous temperature excursion reported was: refrigerator: 49.6 Fahrenheit for 31 minutes; freezer: 11.2 Fahrenheit for 48 minutes. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009652: US-009507513-1702USA009653: US-009507513-1702USA009133:
Sex: F
Vaccine: MEN
Symptoms: Migraine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016593013) on 06-Feb-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of MENINGOCOCCAL VACCINE (Meningitis Vaccine) (Batch number, expiry date, dose and dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient had developed migraine. Laboratory investigations and corrective treatments were not reported. On an unknown date,15 days after patient recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Swelling
Clinical narrative: Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2016400975) on 07-FEB-2017. This case involves a female patient (onset age was unknown) who was vaccinated with dose of TETANUS TOXOID (TETANUS TOXOID) (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to vaccine which was symptomatized by severe swelling. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling, rash and pain over site, pt has not been seen yet for reaction.
Age: 25.0
Sex: F
Vaccine: DT
Symptoms: Anxiety, Food allergy, Psoriasis
Clinical narrative: Food sensitivities, psoriasis, anxiety.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling in pain in arm, pt seen 02/21/17 by Dr and given prednisone and asked to monitor for s/s infection.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus, Swelling
Clinical narrative: REDNESS, HARD NODULE AND ITCHING AT THE INJECTION SITE THAT STARTED LATER IN THE EVENING AFTER THE INJECTION. TOOK IBUPROFEN AND THE SWELLING DECREASED. EXAMINED ON 2/20/2017 AND NON TENDER, REDNESS DECREASED.