chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Genital swelling, Pruritus
Clinical narrative: Patient experienced itching of eyebrows, behind ears and on face and enlargement of genital parts(no itching or soreness in this area).The patient continues to experience itching since incident and has seen primary physician as well as dermatologist. Genital area has returned to normal but even with various treatments face continues to itch and have rash.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis, Rotator cuff syndrome
Clinical narrative: Pt received flu shot in the left deltoid on 10/17/16. Came to office 10/31/16 c/o persistent pain. Pt stated at that time she believed she had SIRVA (shoulder injury related to vaccine administration). Exam seemed c/w rotator cuff strain and possible deltoid tendonitis (ttp over entire deltoid, anterior rotator cuff/shoulder and lateral shoulder joint. Pt noted she had previously had similar sx on the right side. Rec'd conservative management. Pt called 11/7/16 reporting no improvement so PT was ordered. Pt stopped attending PT after ~2 weeks (5 sessions) and requested ortho referral. MRI was done 12/29/16 (see below). Pt came to the office 1/2/17 reporting persistent significant pain limiting function/ROM- this was the first and only time she requested any pain medication. Rec'd pt return to PT (also rec'd over the phone 12/30/16), but to our knowledge pt has not returned. Pt saw ortho 2/22/17. Ortho notes her MRI finding is quite common. The note specifically states they feel it unlikely that the vaccine caused her MRI findings. They note her symptoms and exam are not fully explained by the MRI and are suggestive of adhesive capsulitis. They again recommended further PT, suggesting 6-8 weeks.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Death
Clinical narrative: None stated.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Autopsy, Death, Vomiting
Clinical narrative: None stated.
Age: 24.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Back pain
Clinical narrative: Severe lower back pain.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Palpitations
Clinical narrative: Sore arm, and racing heart.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Ear infection, Irritability, Pyrexia, Rash generalised, Screaming
Clinical narrative: Fever, full body rash lasting 2-3 days. Screaming for several hours after vaccines with fussiness lasting for several days. Mom also stated child came down with ear infections after every imm.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Cough, Headache, Influenza, Pyrexia
Clinical narrative: Case number PHEH2017US005436, is an initial spontaneous report received from a consumer on 15 Feb 2017. This report refers to a 44 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unspecified date in Oct 2016. On 07 Feb 2017, the patient experienced flu, fever, cough/cough lingers, headache, weakness and flu type A. The patient received TAMIFLU for flu and flu Type A. The outcome of fever was reported as complete recovery on 09 Feb 2017 and event cough was reported as condition improving. The outcome of headache and weakness was reported as complete recovery on 10 Feb 2017 and event flu and flu Type A was reported as complete recovery on an unknown date. The seriousness of the event flu and flu Type A was not reported and rest of all events was reported as non serious. The causality of the events was not reported. The seriousness assessment of influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Vaccination failure
Clinical narrative: Case number PHEH2017US005436, is an initial spontaneous report received from a consumer on 15 Feb 2017. This report refers to a 44 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unspecified date in Oct 2016. On 07 Feb 2017, the patient experienced flu, fever, cough/cough lingers, headache, weakness and flu type A. The patient received TAMIFLU for flu and flu Type A. The outcome of fever was reported as complete recovery on 09 Feb 2017 and event cough was reported as condition improving. The outcome of headache and weakness was reported as complete recovery on 10 Feb 2017 and event flu and flu Type A was reported as complete recovery on an unknown date. The seriousness of the event flu and flu Type A was not reported and rest of all events was reported as non serious. The causality of the events was not reported. The seriousness assessment of influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Pain, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced syncope, pain and dizziness. On an unknown date, the outcome of the syncope, pain and dizziness were unknown. It was unknown if the reporter considered the syncope, pain and dizziness to be related to BEXSERO. Additional details were provided as follows: The sales representative heard from the physician that she had at least two patients with the same side effects with BEXSERO. The representative did not have further details. This case has been linked with UG2017023509, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: 12/20 Chills, Fatigue, myalgias, and nausea. Tx: ZOFRAN.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Skin lesion
Clinical narrative: DOS 12/20 7 day HX of erythema, lesion, cellulitis like TX: Cephalexin/BACTROBAN.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: 12/19. 7th day hx of left arm rash, redness, swelling and pain.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot
Clinical narrative: 12/19 erythema, warmth. TX: Prednisone; Ranitidine.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site discolouration, Injection site warmth, Pruritus
Clinical narrative: DOS 12/20. Color change, warm temperature in area. (RT) deltoid. Erythema, itching. TX: Diphenhydramine.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth skin condition, arm pain. TX: Methylprednisolone; Ranitidine.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Rash, Skin discolouration, Swelling
Clinical narrative: DOS/12/18. Rash, joint pain and swelling, color change, erythema. Tx: Methylprednisolone; ZANTAC.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: DOS 12/19 Skin rash in site of injection, itching, arm swelling, color change TX: KEFLEX/BACTROBAN.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: DOS. 12/10/16. Fever, rash. TX: Cephalexin, Ibuprofen.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction to vaccine, subsequent encounter. BACTROBAN.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Dysuria, Erythema, Swelling
Clinical narrative: DOS: 12/19/16. Chills, dysuria on and off, arthralgias and swelling, erythema L upper arm skin. TX: Cold therapy.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Gastrointestinal disorder, Influenza like illness, Joint swelling, Muscular weakness
Clinical narrative: 1/23/17 - reports flu-like symptoms - including GI symptoms. 1/26/17 and 1/27/17 - reports joints swelled - burning pain. 1/28/17 tingling and weakness in legs, calves, wrists, hands. 1/30/17 seen by PCP, sent to ED. Seen by neurologist on 1/31/17. Follow up with PCP 2/14/17.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia, Urine analysis
Clinical narrative: 1/23/17 - reports flu-like symptoms - including GI symptoms. 1/26/17 and 1/27/17 - reports joints swelled - burning pain. 1/28/17 tingling and weakness in legs, calves, wrists, hands. 1/30/17 seen by PCP, sent to ED. Seen by neurologist on 1/31/17. Follow up with PCP 2/14/17.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia, Skin discolouration, Swelling, Tenderness
Clinical narrative: DOS 12/19. Fever, myalgias, color change, tenderness and swelling. TX Cephalexin 500mg.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Haematoma, Injection site bruising, Injection site erythema
Clinical narrative: Redness at site - quarter sized first 24 hr. By 48 hr enlarged approximately 5in x 4in redness with bruising in center. Running and playing OK but felt warm. Seen in ED - felt hematoma. By 3 days later when seen in my office resolved.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Muscular weakness, Peripheral swelling
Clinical narrative: Swollen arm; weak arm.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient describes growing redness, tenderness, and warmth around injection site. Said she will go to doctor to get antibiotics. Called MD, will let him know. 2-18-17: spoke to patient, did not get seen. Claims her arm is completely healed back to normal.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: 4 days after the administration of the shot, patient came back to the pharmacy with redness on his arm 8-9 inches long from the site, down on arm; itching, pain.
Age: 62.0
Sex: U
Vaccine: VARCEL
Symptoms: Laboratory test normal, Petechiae, Rash
Clinical narrative: Petechial rash LUE.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Immediately after receiving the influenza vaccine her right upper arm became red, warm and mildly swollen. Denies pain, or SOB.
Age: 62.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Extra dose administered
Clinical narrative: Tdap given inappropriately - previous had dose of Tdap 7/22/10 (historical dose). Patient stsated needed Tdap, was given missed seeing she had already had dose. Patient was notified.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine
Clinical narrative: Stated she was allergic to vaccine, gave BENADRYL 12.5mg PO prior to injection. Pt went home after injection.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, Pruritus. Diphenhydramine, sulfamethizole/trimethoprim.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt. reported redness to (LT) deltoid area x 1 week post PREVNAR vaccine.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash, redness, burning. Area red and hot to touch. (LT) deltoid area. TX CLARITIN, TYLENOL, Methylprednisolone IM.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. seen in office 01-26-17 for 5yr WCE, rec'd routine vaccinations. Developed S/S and seen again 01/27/17 for erythema, pruritus to (Lt) arm. Afebrile. Area=12 x 18 cm with (+) warmth. No rash. TX=Ibuprofen every 6 hours; BENADRYL PRN; ice packs.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Oedema, Pain, Skin discolouration, Swelling, Tenderness
Clinical narrative: Pain, color change, tenderness, swelling and edema. TX: KEFLEX, NEOSPORIN, CLARITIN.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Swelling
Clinical narrative: 12/21 onset 3 days ago rash, redness, swelling. No rash noted in physical exam.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Pruritus, Rash
Clinical narrative: Lt arm rash, redness, itchiness, joint pain.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: DOS 12/20, 12/21. 3 day hx redness, itching and swelling at vaccine site. TX: Amoxicillin-clavulanate.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blood pressure increased, Erythema, Heart rate increased, Joint swelling, Oedema peripheral
Clinical narrative: 2/23 Armpit-elbow swelling, red, hot - TX W/cold compress. Excessive thirst. 2/24 Hives on neck and chest. Swelling armpit - forearm, red hot - TX W/BENADRYL, increased HR, increased BP, syncope. Went to ER.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin warm, Syncope, Thirst, Urticaria
Clinical narrative: 2/23 Armpit-elbow swelling, red, hot - TX W/cold compress. Excessive thirst. 2/24 Hives on neck and chest. Swelling armpit - forearm, red hot - TX W/BENADRYL, increased HR, increased BP, syncope. Went to ER.
Age: 52.0
Sex: M
Vaccine: HEP, TDAP, TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Muscle spasms, Pain
Clinical narrative: Pt received Hep B and TDaP on 2/15/17. Took 1st dose of oral typhoid on 2/16/17. Took 2nd dose on 2/18/17 and had upset stomach. Had pain and cramping that day. Diarrhea began at 8AM on 2/19. Diarrhea x 6 that day and severe stomach pain. Body aches. Watery diarrhea of 10-15 min. 5x continued and began to subside on 2/22/17.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Oropharyngeal pain, Pain, Upper-airway cough syndrome
Clinical narrative: Approximately 6-8 hours after vaccine administration, patient began feeling "a sore throat" as per patient. This "progressively became worse" as per patient, pt reported difficulty breathing resolved with TYLENOL. Pt also reported body aches, nasal drip, denies fevers or chills, denies rash.
Sex: U
Vaccine: HPV9
Symptoms: Culture, Herpes zoster, Rash vesicular
Clinical narrative: Rash in spinal area suggestive of herpes zoster. Culture done at hospital on 2/24/2017. Pending results. Rash occurred 1 hour after injection.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Abasia, Dysphagia, Ear swelling, Injection site swelling, Pyrexia
Clinical narrative: Presents with c/o vaccine reaction after last visit 1/13/17 mom report on 2/23/17 that patient initially had fever. The next day, she states that his ears and tongue got swollen, and he had difficulty swallowing (they were in route to another state at this time). She says he couldn't walk for 2 weeks afterward and this thighs were swollen also. She says she never took him to a hospital or other health care provider but instead had a person she knows who does natural remedies take care of him and his symptoms resolved. She never took a picture of his reactions.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Swollen tongue, Vaccination complication
Clinical narrative: Presents with c/o vaccine reaction after last visit 1/13/17 mom report on 2/23/17 that patient initially had fever. The next day, she states that his ears and tongue got swollen, and he had difficulty swallowing (they were in route to another state at this time). She says he couldn't walk for 2 weeks afterward and this thighs were swollen also. She says she never took him to a hospital or other health care provider but instead had a person she knows who does natural remedies take care of him and his symptoms resolved. She never took a picture of his reactions.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Seizure, Syncope
Clinical narrative: Patient fainted and has a small seizure shortly after vaccination. Her patents were present and declined treatment. Mom is a nurse. patient regained consciousness after about 1 minute. Was given water and lollipop (sugar). Stayed about 15 minutes til felt well enough to go home. Pt doing well per follow up call at 4:30pm.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, Inappropriate schedule of drug administration, Therapy non-responder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 39-year-old female patient who received TWINRIX Adult. Co-suspect products included TWINRIX Adult, TWINRIX Adult and TWINRIX Adult. On 9th December 2016, the patient received the 1st dose of TWINRIX Adult. On 16th December 2016, the patient received the 2nd dose of TWINRIX Adult. On 30th December 2016, the patient received the 3rd dose of TWINRIX Adult. On 9th January 2017, the patient received the 4th dose of TWINRIX Adult. On 9th January 2017, not applicable after receiving TWINRIX Adult, TWINRIX Adult and TWINRIX Adult, not applicable after receiving TWINRIX Adult, TWINRIX Adult and TWINRIX Adult, not applicable after receiving TWINRIX Adult, TWINRIX Adult and TWINRIX Adult and an unknown time after receiving TWINRIX Adult, the patient experienced drug dose administration interval too short. On 10th February 2017, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too short were unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX Adult, TWINRIX Adult, TWINRIX Adult and TWINRIX Adult. Additional details were provided as follows: The age at vaccination was not reported. The patient was following TWINRIX Adult accelerated schedule. On 9th January 2017, the patient received 4th dose of TWINRIX Adult in error, which led to shortening of the vaccination schedule. On 10th February 2017, blood titer was drawn and it was leading the patient to be a therapy non responder. The healthcare professional did not want to give patient's demographics and did not have vaccine lot and expiration dates for vaccines.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Injection site within normal limits -not red or swollen 2-3 inches below injection site, arm is red and swollen and warm to touch. KEFLEX 500mg, QIDx10 days ordered for cellulitis Dx.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: (L) arm deltoid red/swollen x 2 days. 101 fever x 1 day. Cellulitis- BACTRIM susp 3 tsp BID.
Age: 75.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Nausea, Pyrexia
Clinical narrative: Pt received ENGERIX 2/24/17 - 40mcg IM (L) upper arm - stated experienced  fever, weakness and nausea at home poste vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Induration, Injection site pain
Clinical narrative: Left upper posterior arm pain, at injection site, refers to deltoid. Minimal induration. Headaches. NSAIDs and cold pack.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash on the body 10 days after administration of MMR.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Local swelling (R) deltoid where she had IM Tdap. Rx= ADVIL PRN.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Computerised tomogram head, Facial paralysis
Clinical narrative: Left side of face paralysis began 2/25/17. Diagnosed with Bell's palsy. Treated with oral steroids and antivirals (Acyclovir and Prednisone).
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 68.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Blood test, Nuclear magnetic resonance imaging, Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Bedridden, Dizziness, Fatigue, Injected limb mobility decreased, Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer. This report was received via a Pfizer sales representative.  A female patient of an unspecified age and ethnicity received the PREVNAR 13, via an unspecified route of administration on 17Feb2017 at a single dose for pneumonia and influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration 17Feb2017 at a single dose for influenza. The patient's medical history and concomitant medications were not reported. On an unspecified date on the following day, the patient experienced extreme fatigue and pain localized in the arm which was vaccinated. Therapeutic measures were taken as a result of pain localized in the arm which was vaccinated and included treatment with acetaminophen (TYLENOL) to get relief from the pain. The clinical outcome of the events, extreme fatigue and pain localized in the arm which was vaccinated, was unknown.
Sex: F
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. This report was received via a Pfizer sales representative.  A female patient of an unspecified age and ethnicity received the PREVNAR 13, via an unspecified route of administration on 17Feb2017 at a single dose for pneumonia and influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration 17Feb2017 at a single dose for influenza. The patient's medical history and concomitant medications were not reported. On an unspecified date on the following day, the patient experienced extreme fatigue and pain localized in the arm which was vaccinated. Therapeutic measures were taken as a result of pain localized in the arm which was vaccinated and included treatment with acetaminophen (TYLENOL) to get relief from the pain. The clinical outcome of the events, extreme fatigue and pain localized in the arm which was vaccinated, was unknown.
Sex: F
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. This report was received via a Pfizer sales representative.  A female patient of an unspecified age and ethnicity received the PREVNAR 13, via an unspecified route of administration on 17Feb2017 at a single dose for pneumonia and influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration 17Feb2017 at a single dose for influenza. The patient's medical history and concomitant medications were not reported. On an unspecified date on the following day, the patient experienced extreme fatigue and pain localized in the arm which was vaccinated. Therapeutic measures were taken as a result of pain localized in the arm which was vaccinated and included treatment with acetaminophen (TYLENOL) to get relief from the pain. The clinical outcome of the events, extreme fatigue and pain localized in the arm which was vaccinated, was unknown.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Large hard ball at injection site carrying under the arm and moving toward the neck. Patient instructed to go to er.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year-old (reported also as 6 year-old), black, male patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (dose, frequency, route of  administration, lot# and and expiration date were not reported). On 22-SEP-2016 at 10:15 (am),  the patient was vaccinated with improperly stored second dose of VARIVAX lot # L013068, subcutaneously in the left arm for prophylaxis (dose and expiration date were not reported). The vaccination was in privates doctor's office/ hospital and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1702USA004105:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2008, the patient was vaccinated with the first dose of VAQTA exact dose, route of administration, lot # and expiration date were not provided. The reporter stated that the patient had not received the second dose of suspect vaccine, at six to 18 months after the initial dose and wanted to receive the second dose of VAQTA, at the time of report. There were no adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 16 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-FEB-2017, the patient received the third dose of GARDASIL 9, intramuscularly (dose, anatomical location, lot number and expiration date were not reported) for prophylaxis. On the same day (after receiving the dose), the patient experienced extreme swelling and blistering around the injection site. The patient sought medical attention by contacting the physician. It was unknown if the patient received any treatment for this event. The outcome of the event was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. On an unspecified date in October 2015, the patient was vaccinated with a first dose of ZOSTAVAX (dosage and route of administration were not reported) lot # M033335, expiration date 11-OCT-2017, for prophylaxis. On 15-FEB-2017, the patient was vaccinated with a second dose of ZOSTAVAX, which was considered as extra vaccination. No information regarding concomitant therapies was provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 22-FEB-2017, the patient was vaccinated with a expired dose of VAQTA, lot number L046953, expiration date 14-JAN-2017, (dose number, route and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an 8 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-FEB-2017, the patient was vaccinated with first dose of GARDASIL 9, lot # M035486, expiry: 05-JUN-2019 (dose, route, anatomical location not reported), for immunization. The patient was one month short of his 09th birthday at the time of vaccination (Drug administered to patient of inappropriate age). No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (medical assistant) refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an 10-FEB-2017, the patient was administered vaccinated improperly stored (Incorrect product storage) with GARDASIL 9 (dosage regimen were not reported) for prophylaxis. Drug was administered by patient. Temperature (32 F and 36F) excursion was because of data logger. No adverse effects (no adverse event) noted by reporter. All drop down fields apply to unknown patient. no further information to report. Additional information has been requested.
Sex: F
Vaccine: FLU4, HEPA, HPVX
Symptoms: Abnormal behaviour, Educational problem, Fatigue, Malaise, Thinking abnormal
Clinical narrative: Initial unsolicited report received from a physician on 14-Feb-2017. This case involves a 13-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch no: UI693AA, expiry date: 30-Jun-2017, dose, dose in series, route and site of administration were not reported), with a dose of HEPATITIS A VACCINE and HUMAN PAPILLOMAVIRUS VACCINE (HPV) (lot number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 09-Jan-2017. The illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 09-Jan-2017, same day following vaccination, the patient developed feeling of tiredness as well as unwell and thoughts of death. It was also reported that the patient was an extrovert, happy and straight, prior to vaccination but since vaccination she behaved like not happy, never smiles and grades at school were going down. Also stated that the patient had no social reason for behavior. On an unspecified day, the patient required ER/doctor visit. The lab test and corrective treatment was not reported. The outcome of all the events was not recovered. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Initial unsolicited report received from a non-health care professional on 15 Feb 2017. This case involves a 32-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI643AE, Expiry date: 30-JUN-2017) by intramuscularly in left deltoid on 12 January 2017. Patient had no ongoing illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications. On 12 January 2017, 12 weeks 3 days following the vaccination, the patient had developed influenza A virus infection. It was suspected vaccination failure case. The patient required ER or doctor visit. Lab data included rapid flu test showed positive for A strain and swab sent out to state come back as influenza A/H3. Corrective treatment was not reported. On an unspecified date the patient was recovered from the event. Upon medical review, the case was considered as serious due to important medical event: flu / Influenza A/H3/ flu symptoms and suspected vaccination failure. List of documents held by sender: none. Sender's Comments: This is a case of possible vaccination failure (serology tested positive for group A) in a 32-year-old female patient after INFLUENZA QUADRIVAL A-B VACCINE. As with any vaccine, influenza vaccination may not protect 100% of vaccinated individuals. However, additional information on patient's immune status at the time of vaccination (medical history, concomitant medication), previous vaccinations, infectious work-up results are needed to further assess this case. Based on the available information, vaccination failure cannot be confirmed.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site for pneumococcal 23 was swollen, 3 inch red raised rash developed, skin was warm, and infection developed. Cephalexin 500 mg twice a day prescribed for 7 days.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site for pneumococcal 23 was swollen, 3 inch red raised rash developed, skin was warm, and infection developed. Cephalexin 500 mg twice a day prescribed for 7 days.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site infection, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site for pneumococcal 23 was swollen, 3 inch red raised rash developed, skin was warm, and infection developed. Cephalexin 500 mg twice a day prescribed for 7 days.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Myalgia, Paraesthesia, Pyrexia, Rash erythematous
Clinical narrative: Tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site for pneumococcal 23 was swollen, 3 inch red raised rash developed, skin was warm, and infection developed. Cephalexin 500 mg twice a day prescribed for 7 days.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Muscle rigidity, Syncope
Clinical narrative: Pt was seated in chair and directly after the immunization IM left deltoid pt became rigid and had episode of syncope, slumping in the chair and his mothers arms, lasting approximately 10 seconds.  Dr did assess pt was observed for about 45 min. laying down and transitioning as tolerated to standing position.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MENB, RV1
Symptoms: Crying, Diet refusal, Faeces discoloured, Pyrexia, Regressive behaviour
Clinical narrative: Severe crying/screaming for more than 12 hours. No nursing for more than 18 hours. No stool for 10 days. First bowel movement was black sticky tar like for 2 days. 103 fever for 3 days. Regression with eye contact a smile for a month.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MENB, RV1
Symptoms: Screaming
Clinical narrative: Severe crying/screaming for more than 12 hours. No nursing for more than 18 hours. No stool for 10 days. First bowel movement was black sticky tar like for 2 days. 103 fever for 3 days. Regression with eye contact a smile for a month.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # M012991, expiration date 14-MAR-2018 (dose, strength, frequency, and anatomical localization were not provided) for prophylaxis. The reporter stated that the temperature range  of the vaccine  was -15Celsius (C) but <-10Celsius(C) and the time frame was 1 hour 3 minutes, also she stated that the vaccine had another previous temperature excursion on 14-DEC-2016 was >-10Celsius(C) but <8Celsius(C) during 1 hour and 54 minutes, and then on 23-JAN-2017 temperature range  of the vaccine  was >-10Celsius(C) but <8Celsius(C) and the time frame was 1 hour 2 minutes. This information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On 07-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II, (strength, route of administration, frequency and dose were not reported), lot # L003859 and expiration date 05-FEB-2017 for prophylaxis. Neither an adverse effect nor a product quality complaint were involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-FEB-2017, the patient was vaccinated with one pediatric dose of VAQTA (lot # M027879, expiry date: 24-JAN-2017), intramuscularly. No side effect was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed urticaria within 30 seconds after receiving routine 12 month immunizations including MMR, Hepatitis A, Varicella, and Influenza. Had received influenza vaccine before without issue. Urticaria on face and left thigh, where Hepatitis A and Varicella immunizations were given. Urticaria resolved after giving benadryl. No respiratory distress, angioedema, or other signs of anaphylaxis.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Extreme arm pain at injection site, muscle weakness in arm, inability to use arm fully, weakness lasted ~2 months and pain ~9 months.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Computerised tomogram head normal, Headache, Lumbar puncture normal, Migraine, Pyrexia
Clinical narrative: Fever/headache/runny nose/congestion/sneezing. Symptoms started after recent of 1st dose of LAIV, quadrivalent. LApan immunization activity. 0/19/2015 seen in ER - CT head no acute intracranial findings. Lumbar puncture completed - CSF findings unremarkable. 11/17/2015 - Neurology consult - migraine management plan with Botox injections.  Continued headaches. Now seeing neurologist.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: Fever/headache/runny nose/congestion/sneezing. Symptoms started after recent of 1st dose of LAIV, quadrivalent. LApan immunization activity. 0/19/2015 seen in ER - CT head no acute intracranial findings. Lumbar puncture completed - CSF findings unremarkable. 11/17/2015 - Neurology consult - migraine management plan with Botox injections.  Continued headaches. Now seeing neurologist.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-NOV-2016, the patient was vaccinated with a dose of PROQUAD lot number M017336, expiration date: 05-OCT-2017 (strengh, dose, frequency and route were not reported) for prophylaxis, which was improperly stored at 19 degrees Fahrenheit for 12 hours. Previous temperature excursions were reported as follows:  -From 01-AUG-2016 to 05-AUG-2016, temperature was between 6 degrees Fahrenheit to 17 degrees Fahrenheit for 120 hours. -From 08-AUG-2016 to 12-AUG-2016, temperature was between 6 degrees Fahrenheit to 11 degrees Fahrenheit for 120 hours. -On 25-AUG-2016, temperature was at 14 degrees Fahrenheit for 9 hours. -On 29-AUG-2016, temperature was at 6 degrees Fahrenheit for 8 hours. -On 02-SEP-2016, temperature was at 6 degrees Fahrenheit for 8 hours. -From 07-SEP-2016 to 09-SEP-2016, temperature was at 7 degrees Fahrenheit for 48 hours. -On 16-SEP-2016, temperature was at 5 degrees Fahrenheit for 16 hours. -On 19-SEP-2016, temperature was at 7 degrees Fahrenheit for 24 hours. -On 27-SEP-2016, temperature was at 7 degrees Fahrenheit for 24 hours. -From 30-SEP-2016 to 03-OCT-2016, temperature was at 6 degrees Fahrenheit for 84 hours. -From 06-OCT-2016 to 07-OCT-2016, temperature was between 7 degrees Fahrenheit to 10 degrees Fahrenheit for 36 hours. -From 10-OCT-2016 to 12-OCT-2016, temperature was between 6 degrees Fahrenheit to 9 degrees Fahrenheit for 48 hours. -On 25-OCT-2016, temperature was at 6 degrees Fahrenheit for 24 hours. -From 08-NOV-2016 to 09-NOV-2016, temperature was at 19 degrees Fahrenheit for 32 hours. Additionally, no adverse symptoms were reported and no product quality complaint was involved. Follow up information has been received from the medical assistant on 02-FEB-2017, indicating the patient was a White 4 year-old child with a concurrent condition of functioning heart murmur. The patient was vaccinated with the first dose of PROQUAD on 08-NOV-2016 at 14:00 hours, subcutaneously, on the left deltoid. Additional information is not expected, as the requested information has been obtained.
Sex: F
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown.  On unspecified dates in the past, the patient was vaccinated with M-M-R II (dose, route of administration, Lot # and expiration date were not reported) for prophylaxis. On an unknown date, per company protocol and not due to any illness, the patient was  tested for immunity and she had insufficient titer counts for measles, mumps and/or rubella (viral titre decreased). The patient was not hospitalized. The nurse reported that the patient was healthy and had not experienced any other adverse effects.  The outcome of viral titre decreased was unknown. The causality between the event and vaccination with M-M-R II was not assessed. There was no product quality complaint involved. Additional information has been requested.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 month-old (reported also as 2 year-old), female patient who did not have any known drug reactions or allergies (birth weigh 5lb 2oz reported also as 5lb 20 oz.) There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On 20-OCT-2015 at 09:15 (am), the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068, subcutaneously in the right arm for prophylaxis (dose and expiration date were not reported).        The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1702USA004110: US-009507513-1611USA008278: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1702USA004105:
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative referring to three patients of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with PNEUMOVAX23, (strength, dose, frequency, lot#, expiration date, and route of administration were unknown by the reporter) for pneumonia prevention. On an unknown date, the patients experienced a "swollen arm" around the injection site area. It was unknown by the reporter if the patients received treatment or if a laboratory diagnostics studies were performed and also if the patients sought medical attention. Product quality complaint was not involved. At the time of reporting the outcome of "swollen arm" around the injection site area was unknown. The relatedness between "swollen arm" around the injection site area and PNEUMOVAX23 was not provided. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000250:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection (lot #, expiration date, dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit (also reported as more than 46 but less than 77 degrees Fahrenheit) for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012075:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 08-FEB-2017 (also reported as 09-FEB-2917), the patient was vaccinated with an improperly stored dose of ROTATEQ per oral, lot # M031650 with expiration date 16-MAR-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011981: US-009507513-1702USA011982: US-009507513-1702USA011983: US-009507513-1702USA011984: US-009507513-1702USA011985: US-009507513-1702USA011986: US-009507513-1702USA011987: US-009507513-1702USA011988: