chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain upper, Dysgeusia, Hypophagia, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Decreased po, fever up to 101, stomach ache. Mouth had salt water taste in mouth, body aches.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Decreased po, fever up to 101, stomach ache. Mouth had salt water taste in mouth, body aches.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia oral
Clinical narrative: Patient stated they had some tingling in their tongue following administration. No changes in breathing.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Joint range of motion decreased, Local swelling, Tenderness
Clinical narrative: Pt had swelling of (L) side of neck that started about day 4 after MMR, Tmax 101.2 swelling is tender, decreased ROM of neck rest of exam unremarkable.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Dizziness, Fatigue, Influenza virus test negative, Nausea
Clinical narrative: Nausea, fever 102-103, abdominal pain, fatigue, light sensitivity, dizziness.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Photophobia, Pyrexia, Streptococcus test negative
Clinical narrative: Nausea, fever 102-103, abdominal pain, fatigue, light sensitivity, dizziness.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt developed lump on rt deltoid that is red, warm to the touch, sore, burning sensation, itchy.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia
Clinical narrative: Tingling in arm.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 6 month old patient of unknown gender. On 25-APR-2016, the patient was orally vaccinated with expired dose of ROTATEQ (dose was not reported, lot #K016279 with expiration date: 24-APR-2016). No adverse effects reported. Additional information has been requested.
Age: 1.48
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Activated partial thromboplastin time normal, Full blood count normal, Metabolic function test normal, Prothrombin time normal, Pyrexia
Clinical narrative: Fever, rash and swelling at site of vaccination.
Age: 1.48
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Fever, rash and swelling at site of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist via field representative referring to two patients of unknown age and gender. In April 2016 (also reported as on unknown dates), each of the two patients received a dose of ZOSTAVAX subcutaneously in the back of the arm, above the deltoid (dose and lot# were unknown) for prevention of shingles. In 2016 after getting ZOSTAVAX, the patients went back to the pharmacy because they had developed a reddened area at the injection site. The pharmacist prescribed MEDROL as treatment for both patients. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23, lot # L035687, expiration date- 16-FEB-2017 and lot # L040181, expiration date- 18-AUG-2017 (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was -3 degree Celsius, Time frame was 6 hours and it was back in range. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLUC3, PNC13
Symptoms: Rash
Clinical narrative: Rash. Diphenhydramine 25 mg TID.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria; Pruritus. Methylprednisolone 125 mg once, diphenhydramine, prednisone.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Heart rate increased, Pyrexia, Tunnel vision
Clinical narrative: Dizziness, weakness, rapid heart rate, tunnel vision, fever, feeling as if about to faint.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain
Clinical narrative: Severe pain throughout back.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Neuralgia
Clinical narrative: Radicular nerve pain extending from shoulder blade into the arm. Pain may be related to impingement at the level of the cervical spine. Treat w/Medrol dosepak & therapy.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site oedema, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 11/12/2015 Received the flu vaccination in my right shoulder and had immediate and persistent pain. Approximately 2-3 weeks later I called my doctor to advise the pain still persisted. I was told to apply hot/cold compresses and call back if it did not resolve. I called again in early January to notify my doctor I was still having severe shoulder pain where at times I couldn't lift my arm due to pain. 3/1/2016 I saw Dr. for a sore throat and to follow up on the shoulder pain. She offered to send me to get an MRI. 3/23/2016 I had an MRI. I was notified of the results of my MRI showed edema in my shoulder. At this time I still had persistent shoulder pain. The doctor recommended physical therapy and/or to see an orthopedist. 4/21/2016 I saw PA-C for an orthopedic appointment and he noted my shoulder pain and prescribed an anti-inflammatory.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain
Clinical narrative: 11/12/2015 Received the flu vaccination in my right shoulder and had immediate and persistent pain. Approximately 2-3 weeks later I called my doctor to advise the pain still persisted. I was told to apply hot/cold compresses and call back if it did not resolve. I called again in early January to notify my doctor I was still having severe shoulder pain where at times I couldn't lift my arm due to pain. 3/1/2016 I saw Dr. for a sore throat and to follow up on the shoulder pain. She offered to send me to get an MRI. 3/23/2016 I had an MRI. I was notified of the results of my MRI showed edema in my shoulder. At this time I still had persistent shoulder pain. The doctor recommended physical therapy and/or to see an orthopedist. 4/21/2016 I saw PA-C for an orthopedic appointment and he noted my shoulder pain and prescribed an anti-inflammatory.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: Pt experienced syncopal episodes after remaining in supine position for 15 minutes. After an additional 15 minutes of laying supine, symptoms resolved.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Antinuclear antibody positive, Anxiety, Body temperature fluctuation, Butterfly rash, Cognitive disorder
Clinical narrative: Anxiety, depression, fatigue, cognitive dysfunction, cold hands, inability to regulate body temp, lightheaded, insomnia, light sensitivity and malar face rash. Initiated restrictive eating disorder.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Depression, Dizziness, Eating disorder, Fatigue, Insomnia
Clinical narrative: Anxiety, depression, fatigue, cognitive dysfunction, cold hands, inability to regulate body temp, lightheaded, insomnia, light sensitivity and malar face rash. Initiated restrictive eating disorder.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Peripheral coldness, Photophobia, Systemic lupus erythematosus
Clinical narrative: Anxiety, depression, fatigue, cognitive dysfunction, cold hands, inability to regulate body temp, lightheaded, insomnia, light sensitivity and malar face rash. Initiated restrictive eating disorder.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient has a red, circular patch locally around the injection site area.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain, Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Per email: I just wanted to mention that I woke up at 2am sick with chills, fever and abdominal cramps. My right arm is sore, not the left. I am slow to day for sure.  I didn't want to miss what I needed to do here.  I just didn't know if you needed to know or not.  I'm praying that it will just go away and I won't get sick. I do not think it is the skin test, it is flat and fading. Thank you for being there. Hope you have a good day! Patient denied offer to see Workman's comp provider.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Blepharospasm, Condition aggravated, Dyskinesia, Electroencephalogram, Tic
Clinical narrative: Per patients mother: May 4, 2016 patient stated she had a significant increase of vocal ticks (approx. 50) which started that morning. May 5, 2016 mother called neurologist Dr who increased her Clonidine to 0.1mg BID. May 6 2016 Increase in vocal ticks persist despite increase in Clonidine. May 10, 2016 pt woke up with her eyes twitching and her head jerking. Later that day her mouth started jerking. Saw neurologist that day and EEG was done. He also orderd KLONOPIN 0.5mg BID. May 11, 2016 vocal ticks persist and head and mouth are still jerking.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Pain and redness at injection site, warmth at site, fever; use of NSAIDs and ice to area.  Seen in office for evaluation 5/11/2016.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Local swelling
Clinical narrative: SWELLING NEAR INJECTION SITE, BUT NOT AT IT. HARD SWOLLEN SPOT. NOT HOT, NOT RED.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Epstein-Barr virus antibody, Erythema multiforme, Full blood count, Metabolic function test, Mycoplasma test
Clinical narrative: Fever, rash, Seen in urgent 5/8/16 and diagnosed with erythema multiforme. Seen again in PCP office 5/9/2016 and confirmed rash consistent with erythema multiforme. Fevers > 101 F persistent for 5 days so lab work ordered 5/11/2016.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate, Viral test
Clinical narrative: Fever, rash, Seen in urgent 5/8/16 and diagnosed with erythema multiforme. Seen again in PCP office 5/9/2016 and confirmed rash consistent with erythema multiforme. Fevers > 101 F persistent for 5 days so lab work ordered 5/11/2016.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site joint movement impairment
Clinical narrative: Fever averaging 101 F for 36 hours, muscle aches, headache, chills, painful swelling and restricted movement of shoulder at injection site, red skin 10 sq in around injection site, fatigue, mild nausea
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Fever averaging 101 F for 36 hours, muscle aches, headache, chills, painful swelling and restricted movement of shoulder at injection site, red skin 10 sq in around injection site, fatigue, mild nausea
Age: 40.0
Sex: M
Vaccine: HPVX
Symptoms: Blindness unilateral, Deafness unilateral, Dementia, Hepatitis C, Latent syphilis
Clinical narrative: 3 months after air gun vaccinations I was called to med and told I had protein in my urine a sign of hep c when in med an employee entered and said it was a false positive and to carry on I was donating plasma at a donor center a week later and they pulled me aside and stated I had hep c and was then banned from donating I reported that to medical and a week later myself and all employees that had enrolled were assigned to a special paint detail we had to go through a series of shots a big one of penicillin and not sure what else. 22 years later I was diagnosed with latent syphilis loss of vision in one eye loss of hearing one ear neurosyphilis dementia meningitis.
Age: 40.0
Sex: M
Vaccine: HPVX
Symptoms: Meningitis, Neurosyphilis, Protein urine present
Clinical narrative: 3 months after air gun vaccinations I was called to med and told I had protein in my urine a sign of hep c when in med an employee entered and said it was a false positive and to carry on I was donating plasma at a donor center a week later and they pulled me aside and stated I had hep c and was then banned from donating I reported that to medical and a week later myself and all employees that had enrolled were assigned to a special paint detail we had to go through a series of shots a big one of penicillin and not sure what else. 22 years later I was diagnosed with latent syphilis loss of vision in one eye loss of hearing one ear neurosyphilis dementia meningitis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Excruciating upper arm pain that was significantly more severe than standard sore arm. Chills, headache, worse pain than broken wrist I once suffered.
Age: 11.0
Sex: M
Vaccine: HPV4, IPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: 12 hrs after immunizations pt developed acute fever, body aches, and nausea. Treat Kw/OTC antifebriles and rest. Pt is expected to recover completely.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 104 x 2d now, 11 x 16cm redness, swelling, induration and tenderness contiguous to site of injection.
Age: 47.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 47-year-old female patient who received MENVEO (batch number M15023, expiry date May 2016). Concomitant products included YELLOW FEVER VACCINE. On 20th April 2016, the patient received MENVEO. On 23rd April 2016, 3 days after receiving MENVEO, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site itching to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on unknown arm and the yellow fever vaccine on the opposite arm. Rash (55 mm by 45 min) appeared on the same arm where she received her MENVEO vaccine. It was reported that the rash itched a little bit.
Age: 41.0
Sex: U
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 41-year-old patient who received a BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to BOOSTRIX. Additional details were provided as follows: The patient who received BOOSTRIX couple days ago, was experiencing at the time of reporting severe myalgia of the neck, back, and shoulder area.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Muscle spasms, Rash
Clinical narrative: Pt developed a rash on her face the day following vaccination. She was also camping. The next day the rash spread to the torso. Tx with increased fluids and BENADRYL.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to a 12 month old male patient. He had no pertinent medical history, drug reactions or allergies and his concurrent conditions were not reported. On 29-APR-2016, the patient was vaccinated with VARIVAX, subcutaneously, in the leg (which had a lot # reported as L046885 and an expiration date of 23-NOV-2017; however, dose and dosage number were not reported). On the same day, immediately after the vaccination, the patient developed redness and swelling at the injection site. Therefore, he was administered BENADRYL and treated with an ice pack. One and a half hours later, the events resolved. Subsequently, on 09-MAY-2106, when the patient returned for follow up, the redness and swelling at the injection site had returned along with the formation of a hard lump at the same site. No laboratory diagnostic studies were performed and no product quality complaint was involved. At the time of reporting, the patient had not recovered from the redness, swelling and the hard lump formed at the injection site. Moreover, the reporter did not provide any causal relationship between the events and the vaccination with VARIVAX. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Crying
Clinical narrative: Patient developed temp of 101 and inconsolable crying for three hours resulting in patient being taken to the ER.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swollen painful to (R) upper arm. Prescribed AB Tx as ER could not R/O cellulitis.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from two physicians of the same office refers to an unspecified number of patients of unknown demographics. The concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot details unavailable). The concomitant medication was not reported. On an unknown dates the patients developed shingles. The outcome of shingles was reported as resolved on an unknown date. The causality was unspecified. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right and left thighs with red, raised areas hot to the touch around injection sites noticed by therapist at approx. 1:35 pm when patient was taken out of his seat to begin therapy.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5/9 - Received vaccine. Pt experienced chills day of administration. 5/10 - Redness appeared below injection site; painful to touch; warm to touch; no itching; not around inj site. Dr prescribed Abx for possible infection.
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. In approximately February 2016 (reported as "one or two months ago"), the patient was vaccinated with a dose of PNEUMOVAX23) (route, concentration, dose, dose number, anatomical place of vaccination, lot# and expiration date were not provided), for prevention of pneumonia. Information regarding concomitant therapies were not reported. Then, in approximately 2016, the patient experienced dermal itching (pruritus). Therefore, the patient was treated by their physician with an unknown therapy. Nevertheless, no product quality complaint was involved. At the time of reporting, the outcome of pruritus was unknown. Also, the reporter did not provide a causality assessment between PNEUMOVAX23 and the event. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a patient of unknown age or gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On 01-APR-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB 10 micrograms, 1 ml, via intramuscular, lot # K002327, exp.: 07-FEB-2016. There was no concomitant medications reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Product quality issue, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, while administering a ZOSTAVAX subcutaneously (lot # and dose were not reported) it was reported that it was difficult inserting the needle and penetrating the patients "elderly skin". It was unknown if the patient received the full dose of the ZOSTAVAX. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in July 2015, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, anatomical location, lot # and expiration date were not reported). Subsequently, the patient was vaccinated with the second dose of this vaccine on 09-MAY-2016. Despite this schedule, no adverse effects were reported and no product quality complaint 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 licensed practical nurse and refers to a patient unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot #L038132, expiration date 27-APR-2016 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of -3 degrees Celsius for 6 months. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. 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 licensed practical nurse and refers to unspecified multiple patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot number L038132, expiry date 01-OCT-2017 and L023589, expiry date 26-JUNE-2017, (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of -3 degrees Celsius for 6 months. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 03-MAY-2016 the patient was inadvertently vaccinated with VAQTA injection 50/1.0 U/ml (lot # L018498, expiration date 28-APR-2016, dose and frequency not provided). No adverse effects were reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age or gender. On unknown dates, the patient received an unspecified number of doses of either GARDASIL or GARDASILL 9 (lot #, dosage and route not provided). The patient was late to receive the remaining dose or doses. It was not able to confirm whether the patient received GARDASIL or GARDASIL 9, however the patient would now like to complete the vaccines series. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown gender and age, but possibly a newborn. The patient's medical history and past drug history were unknown. On either 05-MAY-2016 or 06-MAY-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot # L039660 with expiration date 04-FEB-2018), via injection (dose and exact route not reported), which had previously undergone a supported temperature excursion (incorrect product storage). Concomitant medication was not reported. As 0f 06-MAY-2016, it was unknown if the patient continued to take RECOMBIVAX HB. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender, The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (anatomical route of vaccination, dose number, lot number and expiration date were not provided). The patient's concomitant medications were not reported. The physician stated that on an unknown date, the patient suffered from a "peculiar experience with GARDASIL". At the time of the report, the outcome of adverse event was unknown. The relatedness between the adverse event and vaccination with GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection, lot number L031272, expiry date 19-NOV-2016, (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of -3 degrees Celsius for 6 months. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. 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 healthcare worker, and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 09-MAY-2016, the patient was vaccinated with an expired dose of VAQTA (which had a lot number of K001296 and an expiration date of 15-JAN-2016; however, dose, dosage number, route of administration and anatomical location were not reported). No concomitant medications were reported. Despite being vaccinated with an expired dose of the vaccine, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Exposure during pregnancy, Malaise
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician assistant and was referring to a 14 years old female patient which had her last menstrual period (LMP) on an unspecified date in June 2015. The patient's concurrent conditions and medical history were not reported. On 09-SEP-2015, the patient was vaccinated with her first dose of GARDASIL 9 which had a lot # of L011846 (dose, route, anatomical place of vaccination and expiration date were not provided). Other suspect therapies included MENACTRA, which were administered on the same date. Information regarding concomitant therapies were not reported. The reporter also stated that at the moment of the vaccination, she asked to the patient if she could be pregnant and the patient denied it. On 22-SEP-2015, the patient returned to the office for amenorrhea and was scheduled for an unspecified blood work and an ultrasound but her mother never took her. On 17-FEB-2016, the patient went to the office for a sick visit (malaise). As she was visibly pregnant the patient was sent directly to the emergency room. Nevertheless, the patient's family continued denying the pregnancy as a possibility. Finally, the reporter stated that the patient was due to deliver any day. At the time of reporting, the outcome of the malaise was unknown. The reporter did not provide a causality assessment between GARDASIL 9 and the event. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Decreased appetite, Fatigue, Full blood count normal, Headache
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 26-year-old male patient who received RABAVERT (batch 586011AA, expiry date January 2019). On 20th April 2016, the patient received RABAVERT 1 ml. On 21st April 2016, 1 days after receiving RABAVERT, the patient experienced nausea, fever, chills, sweating, headache and dizziness. The patient was treated with ibuprofen. The action taken with RABAVERT was unknown. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, chills, sweating, headache and dizziness were not recovered/not resolved. It was unknown if the reporter considered the nausea, fever, chills, sweating, headache and dizziness to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. On 20th April 2016, the patient received RABAVERT (batch number: 586011AA, expiry date:??-JAN-2019) on right deltoid. On 24th April 2016, the patient visited emergency room for the events, but there was no admission. On the same day, the patient was treated 800 mg of ibuprofen for fever.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Influenza virus test negative, Malaise, Metabolic function test normal, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 26-year-old male patient who received RABAVERT (batch 586011AA, expiry date January 2019). On 20th April 2016, the patient received RABAVERT 1 ml. On 21st April 2016, 1 days after receiving RABAVERT, the patient experienced nausea, fever, chills, sweating, headache and dizziness. The patient was treated with ibuprofen. The action taken with RABAVERT was unknown. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, chills, sweating, headache and dizziness were not recovered/not resolved. It was unknown if the reporter considered the nausea, fever, chills, sweating, headache and dizziness to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. On 20th April 2016, the patient received RABAVERT (batch number: 586011AA, expiry date:??-JAN-2019) on right deltoid. On 24th April 2016, the patient visited emergency room for the events, but there was no admission. On the same day, the patient was treated 800 mg of ibuprofen for fever.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Dizziness, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 26-year-old male patient who received RABAVERT (batch 586011AA, expiry date January 2019). On 20th April 2016, the patient received RABAVERT 1 ml. On 21st April 2016, 1 days after receiving RABAVERT, the patient experienced nausea, fever, chills, sweating, headache and dizziness. The patient was treated with ibuprofen. The action taken with RABAVERT was unknown. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, chills, sweating, headache and dizziness were not recovered/not resolved. It was unknown if the reporter considered the nausea, fever, chills, sweating, headache and dizziness to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. On 20th April 2016, the patient received RABAVERT (batch number: 586011AA, expiry date:??-JAN-2019) on right deltoid. On 24th April 2016, the patient visited emergency room for the events, but there was no admission. On the same day, the patient was treated 800 mg of ibuprofen for fever.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Metabolic function test normal, Mononucleosis heterophile test negative, Nausea, Pyrexia, Streptococcus test negative
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 26-year-old male patient who received RABAVERT (batch 586011AA, expiry date January 2019). On 20th April 2016, the patient received RABAVERT 1 ml. On 21st April 2016, 1 days after receiving RABAVERT, the patient experienced nausea, fever, chills, sweating, headache and dizziness. The patient was treated with ibuprofen. The action taken with RABAVERT was unknown. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, chills, sweating, headache and dizziness were not recovered/not resolved. It was unknown if the reporter considered the nausea, fever, chills, sweating, headache and dizziness to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. On 20th April 2016, the patient received RABAVERT (batch number: 586011AA, expiry date:??-JAN-2019) on right deltoid. On 24th April 2016, the patient visited emergency room for the events, but there was no admission. On the same day, the patient was treated 800 mg of ibuprofen for fever.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 26-year-old male patient who received RABAVERT (batch 586011AA, expiry date January 2019). On 20th April 2016, the patient received RABAVERT 1 ml. On 21st April 2016, 1 days after receiving RABAVERT, the patient experienced nausea, fever, chills, sweating, headache and dizziness. The patient was treated with ibuprofen. The action taken with RABAVERT was unknown. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, chills, sweating, headache and dizziness were not recovered/not resolved. It was unknown if the reporter considered the nausea, fever, chills, sweating, headache and dizziness to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. On 20th April 2016, the patient received RABAVERT (batch number: 586011AA, expiry date:??-JAN-2019) on right deltoid. On 24th April 2016, the patient visited emergency room for the events, but there was no admission. On the same day, the patient was treated 800 mg of ibuprofen for fever.
Age: 26.0
Sex: M
Vaccine: RAB, RAB, RAB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 26-year-old male patient who received RABAVERT (batch 586011AA, expiry date January 2019). On 20th April 2016, the patient received RABAVERT 1 ml. On 21st April 2016, 1 days after receiving RABAVERT, the patient experienced nausea, fever, chills, sweating, headache and dizziness. The patient was treated with ibuprofen. The action taken with RABAVERT was unknown. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, chills, sweating, headache and dizziness were not recovered/not resolved. It was unknown if the reporter considered the nausea, fever, chills, sweating, headache and dizziness to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. On 20th April 2016, the patient received RABAVERT (batch number: 586011AA, expiry date:??-JAN-2019) on right deltoid. On 24th April 2016, the patient visited emergency room for the events, but there was no admission. On the same day, the patient was treated 800 mg of ibuprofen for fever.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, MNQ
Symptoms: Cough, Dry throat, Throat tightness
Clinical narrative: Within 5 minutes of receiving Gardasil 9, first dose, and Menactra, second dose, patient reported throat feeling dry like it was closing and developed a repetitive dry cough. No visible facial, tongue or lip swelling, no hives. Chest clear to auscultation. No tachycardia. Symptoms began to resolve within 15 minutes. Follow up call on 5/6/16, patient doing fine.
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 07 April 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of IMOVAX (batch number, expiration, site and route of administration was not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient experienced high temperature on and off, was not getting better and felt hurting. Lab data was not reported. The patient received corrective treatment with pain medications which she felt were not working. Patient was not yet recovered from the event. List of documents held by sender: none.
Age: 1.58
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint swelling, Juvenile idiopathic arthritis
Clinical narrative: Initial unsolicited report received from a nurse on 28 April 2016. This case involves a 19-months-female patient who was vaccinated with an intramuscular dose of FLUZONE (batch number UL432AA, expiration date, dose was not reported) in left thigh on 08 December 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported as unknown. Concomitant medications were not reported. On 11 December 2015, three days following the vaccination, the patient woke up with a left knee sore and swollen. On an unspecified date, following vaccination, patient was diagnosed with idiopathic juvenile arthritis. It was reported that patient had doses before. Patient required emergency room or doctor visit. Lab data and corrective treatment was not reported. Patient was not recovered from events. Upon internal review the case was considered as serious because of important medical event: idiopathic juvenile arthritis, left knee sore and swollen. List of documents held by sender: none. Sender's Comments: Juvenile idiopathic arthritis is unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. Time to onset is compatible with the role of the vaccine. Further information on patient's medical history, concomitant medications, etc. is needed to fully assess the case. Based on the information available, the role of vaccine cannot be assessed.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Autism, Extra dose administered, Inappropriate schedule of drug administration, Speech disorder developmental
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 3 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in December 2012, the patient received 2 doses of the M-M-R II injection, subcutaneously (exact dose, lot #, expiration date and therapy type were not provided) on the same day. The patient's mother also reported that the patient had a speech delay, on an unknown date after the vaccination and on 14-OCT-2015, was diagnosed with autism. The outcome of the events and causality assessment were not provided. Upon internal review, the event of autism was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from an unspecified event staff worker via field representative refers to a patient of unknown age and gender (the patient was the reporter's cousin's friend). No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with a dose of either GARDASIL or GARDASIL 9, was hospitalized and 'had never been the same'. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. Causality assessment was not provided. The reporter considered the event to be serious due to hospitalization. Additional information has been requested.
Sex: F
Vaccine: MNQ
Symptoms: Bedridden, Confusional state, Hallucination, Meningitis
Clinical narrative: Initial unsolicited report received from a non-health care professional (patient's parent) on 02 May 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination patient had experienced confusion, meningitis symptoms and hallucinations. It was reported that, patient required a lengthy time of bed rest. Patient required emergency room (ER)/doctor visit. Laboratory investigation and corrective treatment were not reported. The outcome of events was unknown. Upon internal review, the company decided to consider the event serious because of important medical events confusion and meningitis symptoms. List of documents held by sender: none. Sender's Comments: The events meningitis symptoms, hallucinations and confusion are unlisted for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Date of administration of vaccine and occurrence of events were not provided, hence, temporal association cannot be established. Very limited information was provided in this case, therefore, causality cannot be assessed for now.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Crying, Dyspnoea, Hypopnoea
Clinical narrative: Inconsolable crying, gasping for air, shallow breathing.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and pain around injection site.
Age: 1.28
Sex: M
Vaccine: MMRV
Symptoms: Nasopharyngitis, Pyrexia, Rash generalised
Clinical narrative: Fever 102, gave Tylenol got cold symtoms after 5/3/16 then on 5/7/2016 broke out in a rash all over body.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Blood test, Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: 1/21/16 seen in ER for DVT (deep venous thrombosis) in left leg. Deep venous thrombosis of the left lower extremity from common femoral through femoral vein, including saphenous vein, poss. related to contraceptive use. COUMADIN prescribed.
Age: 1.0
Sex: F
Vaccine: DTAP, MMRV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Complex Febrile Seizure lasting more than 5 minutes.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Pyrexia, Tremor
Clinical narrative: Shakiness at 9:00 PM on Friday, started running fever of 100.7 at about 3:00 AM which continued up and down for 2 days.  Started developing redness at injection site, which progressed the next couple of days until it circled my upper arm and a rash started to develop after the redness spread.  I still am experiencing some redness and the rash has not gone away yet on today, 5/12/16.
Age: 0.25
Sex: F
Vaccine: DTAPIPV, HEP, PNC13, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 month old female patient. The patient had no pertinent medical history and drug reactions or allergies. She had no concomitant medications. On 03-MAY-2016, the patient was vaccinated with the first dose of ROTATEQ (lot #L029615, expiration date: 15-MAY-2017, dose was not provided). On 03-MAY-2016, immediately following the administration of ROTATEQ the patient vomited. There was no lab diagnostic studies performed. The patient sought medical attention as the adverse event occurred in the office. No treatment was given for the adverse event. The outcome of the event was reported as recovered, on 03-MAY-2016. The relatedness between the event and ROTATEQ was not provided. 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 licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M004116, expiration date 12-OCT-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 30 degrees Fahrenheit for 334 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Middle insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Arm soreness that lead into not being able to lift arm past 90 degrees, pain in upper arm area, that gradually got worse over time, pain at night while waking from sleep. Pain during certain movements of arm extension. I have gone to 3 providers for this. First told nothing was wrong to use heat pad and take ibuprofen which did not solve the problem. I am now seeing an acupuncturist, osteopathic doctor who has helped but I still cannot move my arm in full range of motion. She said I have frozen shoulder. I am also seeing a primary care provider for this.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Arm soreness that lead into not being able to lift arm past 90 degrees, pain in upper arm area, that gradually got worse over time, pain at night while waking from sleep. Pain during certain movements of arm extension. I have gone to 3 providers for this. First told nothing was wrong to use heat pad and take ibuprofen which did not solve the problem. I am now seeing an acupuncturist, osteopathic doctor who has helped but I still cannot move my arm in full range of motion. She said I have frozen shoulder. I am also seeing a primary care provider for this.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on site that was noticed after the Corpsman asked them to remove their blouse so he could check on the site and that's when he saw the swelling and redness.