chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 30-JAN-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not provided), subcutaneous. On 30-JAN-2013 the patient received less than a full dose ZOSTAVAX because of a syringe leakage. No adverse symptoms were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Periarthritis, X-ray normal
Clinical narrative: Soreness to injection site that persisted, causing increased pain & loss of range of motion. Saw doctor on 12/18/2012. Placed on steroids & VICODIN for pain. Pain persisted-seen by orthopod. Placed on NSAIDS & physical therapy. Diagnosis of severe capsulitis. Still in physical therapy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Epistaxis, Headache, Palpitations
Clinical narrative: Mom states child woke up with nosebleed, and headache now states child heart is racing.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: (L) arm redness, pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt noticed red circle where ZOSTAVAX (approximately inch in diameter) was administered about 2d after administration - no pain, itching noted. No treatment was necessary per MD.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram abnormal, Hypoaesthesia oral, Laboratory test normal, Lip swelling, Paraesthesia oral
Clinical narrative: Pt.'s family member phoned clinic from cell phone in car to report pt - c/o lips swelling with numbness/tingling, approx 1 hour after vaccination. Advised to proceed directly to E.R.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Anxiety, Injection site reaction, Rash, Swelling, Type III immune complex mediated reaction
Clinical narrative: Pt reported red swollen rash, arthrus like bump at injection site & anxiety. Used inhaler x2 after getting vaccine.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Acne, Injection site reaction
Clinical narrative: After a month has passed since vaccination, patient states he still has a bump (small pimple like or mosquito bite) at the site of injection.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Eye pain, Headache
Clinical narrative: Took pill #1 & after had headache & eye pain, pill #2, 3 & 4 eye pain & headache increased with each one.
Age: 1.3
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain, Alopecia, Menstruation irregular
Clinical narrative: Patient received HPV#3 and hep A #2 on 12/27/12. Since that time she has had excessive hair loss; abd pain and irregular menses. Parent requested report file.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Bordetella test, Chest X-ray normal, Cough, Infantile apnoeic attack, Laboratory test normal
Clinical narrative: 12 days after immunizations were given, baby had apneic episode. Seen 1 day before apneic event with cough, low grade fever. PE - Ok. Treated with albuterol MDI.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: 12 days after immunizations were given, baby had apneic episode. Seen 1 day before apneic event with cough, low grade fever. PE - Ok. Treated with albuterol MDI.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red warm area around shot site getting better prior visit. Treatment.: ALLEGRA and OTC cortisone cream.
Age: 1.32
Sex: M
Vaccine: MNQ
Symptoms: Injection site inflammation
Clinical narrative: None. MENACTRA given in error, FDA approved for this age. DPH suggested to file report even though no adverse event. Patient had no reactions other than expected mild side effect of inflammation at the vaccine site.
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Rash
Clinical narrative: This spontaneous report refers to a male patient in his 60's years old concern to himself. On an unknown date (over two months ago), the patient as vaccinated with ZOSTAVAX, single 0.65 ml dose, subcutaneous injection for prevention of shingles (lot number not reported). On an unknown date (over two months ago), the patient developed rash on his back that had not gone away yet. The patient sought medical attention and was not treated for this event. Rash tested by unspecified means with result not reported. At the time of the report, the outcome of rash on his back was reported as recovering. The event of rash on his back was unknown related to ZOSTAVAX. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Redness, pain, itching, heat, hard lump at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Redness, pain, itching, heat, hard lump at injection site.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Tired, Sore, Fever.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety
Clinical narrative: PATIENT REPORTED FEELING INCREASE LEVELS OF ANXIETY, WHICH SHE IS ATTRIBUTING TO THE ADMINISTRATION OF THE VACCINE.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Impaired work ability, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Pt states about 3 days after receiving vaccines on 12/28/12, she noted "wavy" mark on (R) upper outer extremity that was not painful, palpable or pruritic but is constant has recovered. About 1 wk later felt "pins/needles" RUE btw shoulder/elbow & then at wrist. Now 5d h/o pain 7.5/10 RUE limiting function at work but not of ADL's. No swelling. Not affecting hand/fingers.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Diplopia, Fatigue, Guillain-Barre syndrome, Paralysis, Plasmapheresis
Clinical narrative: As a result of the influenza vaccine, I developed Guillain-Barre Syndrome. I experienced chronic fatigue, double vision, breathing issues, and minor paralysis. I had plasmapheresis and PT/OT for treatment. This was over the course of a few months.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Respiration abnormal
Clinical narrative: As a result of the influenza vaccine, I developed Guillain-Barre Syndrome. I experienced chronic fatigue, double vision, breathing issues, and minor paralysis. I had plasmapheresis and PT/OT for treatment. This was over the course of a few months.
Age: 25.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Malaise, Musculoskeletal stiffness, Nausea, Skin irritation
Clinical narrative: Feb 6. 2013 about 1 hr after leaving, I started feeling sick/nausea and noticed my arm was irritated, red & stiff.
Age: 19.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient received AFLURIA & PNEUMOVAX on 1/25/2013. Patient came down w/ hi fever that night. The injection site was swollen. Patient (R) arm was tattooed all over. I could only IM on (L) arm.
Age: 0.51
Sex: M
Vaccine: DTAPIPV, HBHEPB, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: KINRIX given on 1-28-13 no adverse effects.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pallor, Rash generalised
Clinical narrative: Pt seen for 2 month well check on 2/5/13. Given 2 month vaccines: DTap-Hep B- IPV, Hib, PCV, Rotavirus. That night pt started having a faint rash which became generalized. Pt was seen again 3 days after vaccines in office. Found to have generalized confluent, blanching rash; Pt otherwise at baseline & afebrile. Given prednisone (15/5) 1.7ml PO BID x 3 days.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Oropharyngeal pain, Pain, Pyrexia, Rash pruritic
Clinical narrative: Received vaccine 1/30/13. On 2/6/13 experienced fever, sore throat, body aches & joint pains, itchy rash. Treated with OTC ADVIL, pushed fluid intake, rest. Wanted report made. No tx required at time of reporting.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Evening after the injection - upper arm pain, swelling, redness pain bad enough to miss work.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever. 100 - nausea.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local swelling, erythema over (L) thigh around area of vaccine about 30 cm in diameter. Began 2/8/13. Per Dad started 2/8/13 and has gotten larger.
Age: 1.53
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Mom states child developed fever of 101.0 (R). 2 days after vaccines/irritable.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Rhinorrhoea, Sneezing
Clinical narrative: Runny nose, feels cold all the time, sneezing since she got the vaccine.
Age: 0.23
Sex: M
Vaccine: DTAPIPV, HBHEPB, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age, Respiratory syncytial virus test positive
Clinical narrative: KINRIX given at 12:00 pm 2-15-13 at 12 wks 1 day old.
Age: 0.32
Sex: F
Vaccine: DTAPIPV, HIBV, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX 0.5 ml given on 1-22-13.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache
Clinical narrative: Pt. with headache and dizziness day after administration. Symptomatic care advised with TYLENOL or Ibuprofen and increased fluids.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction - (+) whelps on arms and legs.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Arm is still sore at site of injection after 4 weeks, still have limited movement of arm.
Age: 0.24
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever 105 degrees F, fussiness, poor feeding.
Age: 0.84
Sex: M
Vaccine: HEP, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever (99-105 degrees) intermittently for 3 days after vaccine. Temp unsure as parent has an unreliable device. However, T max on the parents device was 105 rectally. Child also fussy.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Eczema, Erythema, Oedema peripheral, Urticaria
Clinical narrative: Hives from head to toe. (L) arm swelling & severe redness, eczema occurred 3 days later & is relentless.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Synovial cyst
Clinical narrative: I told nurse shot very painful and she said it would be fine. It began to hurt more than a normal flu shot. Within days I could hardly move my arm. I saw doctor after two months and have torn rotator cuff and ganglion cyst. Pain began with shot and intensified daily.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Tendonitis
Clinical narrative: I told nurse shot very painful and she said it would be fine. It began to hurt more than a normal flu shot. Within days I could hardly move my arm. I saw doctor after two months and have torn rotator cuff and ganglion cyst. Pain began with shot and intensified daily.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Swelling of lips and eyes, treated in emergency room with Benadryl with no further treatment needed.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Erythema, Injection site rash, Musculoskeletal pain
Clinical narrative: Elevated temp. but did not measure, left arm pain especially in joints wrist, elbow shoulder, injection site has raised area approx. .3 cm. up until wk. prior report date of 02/15/2012 noted redness also.  Pain felt like what he would think of as arthritis type.  Left shoulder still aches.  Reports previous flu shots has noted fever and some soreness.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Elevated temp. but did not measure, left arm pain especially in joints wrist, elbow shoulder, injection site has raised area approx. .3 cm. up until wk. prior report date of 02/15/2012 noted redness also.  Pain felt like what he would think of as arthritis type.  Left shoulder still aches.  Reports previous flu shots has noted fever and some soreness.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Asthenia, Blood test, Dysstasia, Erythema, Foaming at mouth
Clinical narrative: Within 5-7 minutes of immunization, patient complained of sore hands & feet, then said, "My body hurts all over."; she became lethargic and weak/unable to stand; a woman who helped said she observed the patient's eyes rolling back into her head and her foaming at mouth; patient then vomited repeatedly; her skin was also red from head to toe.  All of the above happened within approximately 10 minutes of the immunizations. ER doctor attributed to virus. Administered anti-nausea meds and fluids via IV. Released from ER and sent home.  Patient was normal after this. The only other thing I can think of is that I (mom) gave her 3 chewable children's acetaminophen approximately 3 minutes before her immunizations were administered.  Did you ask which immunications she received?  She received three shots:  DTaP, MMRV, Polio.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Gaze palsy, Lethargy, Pain, Pain in extremity, Vomiting
Clinical narrative: Within 5-7 minutes of immunization, patient complained of sore hands & feet, then said, "My body hurts all over."; she became lethargic and weak/unable to stand; a woman who helped said she observed the patient's eyes rolling back into her head and her foaming at mouth; patient then vomited repeatedly; her skin was also red from head to toe.  All of the above happened within approximately 10 minutes of the immunizations. ER doctor attributed to virus. Administered anti-nausea meds and fluids via IV. Released from ER and sent home.  Patient was normal after this. The only other thing I can think of is that I (mom) gave her 3 chewable children's acetaminophen approximately 3 minutes before her immunizations were administered.  Did you ask which immunications she received?  She received three shots:  DTaP, MMRV, Polio.
Age: 1.29
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Blister, Erythema, Immediate post-injection reaction, Injection site vesicles
Clinical narrative: Patient had immediate blistering at the site of injection (R) deltoid area.  After couple of hours the blisters went away, then reappeared 10 days later and was brought back into the office with 4-5 erythematous vesicles.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Blood test normal, Hypotonia, Pyrexia, Somnolence, Speech disorder
Clinical narrative: She was very sleepy, non-verbal, running a fever. By morning she was very limp and fever was 103.7. Took her to hospital fever was same. Was there for about 4 hours. After about a week, she was finally herself.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Urine analysis normal
Clinical narrative: She was very sleepy, non-verbal, running a fever. By morning she was very limp and fever was 103.7. Took her to hospital fever was same. Was there for about 4 hours. After about a week, she was finally herself.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: Headache, intermittent muscle spasms and tingling to my arm down to my fingers, muscle soreness.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Fever 103 degrees orally, severe lethargy, anorexia. No local reaction at injection site. Fever continued x 24 hours.  Lethargy and anorexia x 5-7 days.
Age: 0.52
Sex: F
Vaccine: DTAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Hard lump at injection site noticed this evening while changing her diaper. It is red. Seems to be tender and to cause discomfort.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Kidney infection, Rash generalised
Clinical narrative: Pt. said she developed an infection at the injection and a total body rash.  Also, she developed a bi-lateral kindy infection.  She spoke with Dr. and was told to have the pharmacist submit a VARES Report.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site joint pain, Injection site joint swelling, Injection site pain
Clinical narrative: This spontaneous report as received from a physician reporting on himself a 72 year old male patient with diabetes and CIPRO allergy who on 04-FEB-2013, was vaccinated with PNEUMOVAX23, intramuscular (dose and lot # not provided). Concomitant medications included unspecified medication. The primary physician stated that on 05-FEB-2013, he (the physician) developed an injection site reaction following vaccination with PNEUMOVAX23, the injection site reaction was described as a swollen, painful and tender to the touch. The physician also reported flu like symptoms with general malaise (unspecified time frame development). The physician reported that his shoulder joint was swollen and painful on the side that the PNEUMOVAX23, was administered and that he could not move his arm. The outcome of adverse events was reported as not recovered/not resolved. The relatedness for adverse events was unknown for PNEUMOVAX23. Could not move arm at shoulder was considered to be an significant disability or incapacity event by reporter. Additional information has been requested. This is one of several reports from the same source.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Malaise
Clinical narrative: This spontaneous report as received from a physician reporting on himself a 72 year old male patient with diabetes and CIPRO allergy who on 04-FEB-2013, was vaccinated with PNEUMOVAX23, intramuscular (dose and lot # not provided). Concomitant medications included unspecified medication. The primary physician stated that on 05-FEB-2013, he (the physician) developed an injection site reaction following vaccination with PNEUMOVAX23, the injection site reaction was described as a swollen, painful and tender to the touch. The physician also reported flu like symptoms with general malaise (unspecified time frame development). The physician reported that his shoulder joint was swollen and painful on the side that the PNEUMOVAX23, was administered and that he could not move his arm. The outcome of adverse events was reported as not recovered/not resolved. The relatedness for adverse events was unknown for PNEUMOVAX23. Could not move arm at shoulder was considered to be an significant disability or incapacity event by reporter. Additional information has been requested. This is one of several reports from the same source.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Diplopia, Erythema, Gait disturbance, Oedema peripheral, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer refers to his 51 year old female wife with latex's allergy. The patient's medical history included leukemia and bone marrow transplant. On 18-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number were not reported). Concomitant therapies included TACROLIMUS. The husband's consumer indicated that his wife on an unknown date, experienced redness and swelling in the arms, tingling feet, respiratory failure, double vision and difficulty walking. At the time of the report, the patient's outcome for the adverse events was unknown. The relatedness for the adverse events with PNEUMOVAX23 was unknown. Upon internal review respiratory failure was considered to be an other important medical event. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory failure
Clinical narrative: This spontaneous report as received from a consumer refers to his 51 year old female wife with latex's allergy. The patient's medical history included leukemia and bone marrow transplant. On 18-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number were not reported). Concomitant therapies included TACROLIMUS. The husband's consumer indicated that his wife on an unknown date, experienced redness and swelling in the arms, tingling feet, respiratory failure, double vision and difficulty walking. At the time of the report, the patient's outcome for the adverse events was unknown. The relatedness for the adverse events with PNEUMOVAX23 was unknown. Upon internal review respiratory failure was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who on 03-NOV-2011, the patient was vaccinated with RECOMBIVAX HB dose 1, 1 ml (route and lot # not provided). On 26-JAN-2012, the patient was vaccinated with RECOMBIVAX HB dose 2, 1 ml (route and lot # not provided). On 12-FEB-2013, the patient was vaccinated with RECOMBIVAX HB dose 3, 1 ml (route and lot # not provided). No concomitant medications were reported. The nurse stated there was no adverse effects. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who on 03-NOV-2011, the patient was vaccinated with RECOMBIVAX HB dose 1, 1 ml (route and lot # not provided). On 26-JAN-2012, the patient was vaccinated with RECOMBIVAX HB dose 2, 1 ml (route and lot # not provided). On 12-FEB-2013, the patient was vaccinated with RECOMBIVAX HB dose 3, 1 ml (route and lot # not provided). No concomitant medications were reported. The nurse stated there was no adverse effects. This is one of several reports from same source. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy skin, Skin lesion, Wound
Clinical narrative: Pt states she had wound from a "Bad flu shot" in 2008. She said that her lesion on her arm was from the vaccine.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin irritation, Swelling
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to his 11 years old son. On approximately 06-FEB-2013, "a week ago", the patient was vaccinated with a dose of VARIVAX (Merck) (Lot # H017009 expiration date 12-SEP-2014). The pharmacist reported that on approximatley 13-FEB-2013, "after a week" of vaccination, the patient experienced significant skin irritation and swelling. The outcome of significant skin irritation and swelling was unknown. The pharmacist would like to know if there were some reported problems with this particular lot. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site dryness, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 66 year old female consumer with no pertinent medical history and no drug reactions or allergies reporting on herself. On JAN-2013, the consumer was vaccinated with a dose of ZOSTAVAX (route and lot # not reported) in the right arm, and a dose of influenza virus vaccine (route and lot # not reported). The consumer reported that "a few days after the injection", she experienced an adverse experience with ZOSTAVAX. Consumer reported that she had a dry patch that was itchy at the injection site. The patient did not receive treatment for the adverse event. There were no Lab diagnostics or studies performed. The outcome of dry itchy patch at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dizziness, Headache, Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer reporting her daughter a 14 year old female patient with a medical history of heart murmur who on 14-AUG-2012, was vaccinated with GARDASIL dose 1 (dose, route and lot # not provided). On 15-OCT-2012, was vaccinated with GARDASIL dose 2 (dose, route and lot # not provided). On 02-DEC-2012, was vaccinated with GARDASIL dose 3 (dose, route and lot # not provided). No concomitant medications were reported. The Consumer stated that on 09-DEC-2012 (1 week after 3rd dose of GARDASIL), her daughter was coughing a lot for 1-2 months, had a headache, was dizzy, and the arm hurt so bad for several hours after receiving the 3rd dose of GARDASIL. The patient sought medical attention by office visit. The patient was treated with a medication with codeine for cough. On unspecified date, the patient recovered from adverse events. The relatedness adverse events was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient had swelling the size of a baseball at the injection site shortly after administration of PNEUMOVAX 23, in January 2013 sometime that week. No treatment information was reported. The patient outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pt was being seen at clinic for a LAC on his scalp and was given a TDAP shot. The Lt arm was slightly painful after getting the shot, which patient figured was normal, the Sunday night he noticed that when he extended his arm there was pain in the lt arm where he got the shot, the pain has gotten worse since. He does have a hx of getting tetanus shots in the past w/no reaction.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus generalised
Clinical narrative: Influenza vaccine given around 8 AM. Within 30 to 40 minutes started itching all over & felt like throat was swelling. Seen at clinic, SOLU-MEDROL & BENADRYL given which relieved symptoms.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Dyskinesia, Electroencephalogram, Hypotonia, Unresponsive to stimuli
Clinical narrative: Received shots 2/13/13, at dinner time she "slumped over" in high chair, would not respond, when pulled from high chair had jerking movement.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever & seizures. Taken to hospital - no paperwork.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Next day, when showering in the morning saw left part of arm swollen like a bee bite and itchy.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 year old patient. On 12-FEB-2013 the patient was vaccinated with PROQUAD dose 1 (lot # not reported) subcutaneously along with VARIVAX (Merck) dose 1 (lot # not reported0 subcutaneously. No adverse effect reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age. The patient was vaccinated with an initial dose of VAQTA (lot number, dose, route and injection site were not reported) in March of 2007 or 2008. No other co-suspects were reported. No concomitant medications were reported. The patient was received a booster dose 2 weeks prior to 6 month interval in August of 2007 or 2008. The consumer was not sure exactly which year her daughter received the 2 doses of VAQTA. No adverse effect reported. The action taken and outcome was not provided. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Dysphagia, Rash, Urticaria
Clinical narrative: Pt was given varicella vax at 7:30 am. Reported back to employee Heath at 1355 with rash- Rash was located bilaterally on arms, below elbow. No SOB, problems swallowing large whelps. No other area BENADRYL 50mg po given.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Pt was given varicella vax at 7:30 am. Reported back to employee Heath at 1355 with rash- Rash was located bilaterally on arms, below elbow. No SOB, problems swallowing large whelps. No other area BENADRYL 50mg po given.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin irritation
Clinical narrative: Symptoms started same day as vaccine.Patient called Saturday, Feb. 16, 2013 to state he was a red, irritated rash that was painful to the touch. Pt, had no trouble breathing or swallowing. He was told to use a marker around the rash & use a cold compress and consider an oral antihistamine. Pharmacist and doctor had the same recommendations. Has not called back since Sat. morning.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 11-FEB-2013 the patient was received an expired dose of VARIVAX (merk) (lot number reported as 1706Z, expired date 09-DEC-2012) (dose, route and injection site were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. The action taken and outcome were not provided. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Contusion, Diarrhoea
Clinical narrative: Information has been received from a 62 year old male consumer with hypertension, "cholesterol" and allergy to antihistamines who on 16-APR-2012 was vaccinated with a dose of zoster vaccine live (Merck) (dose and lot# were unknown). Concomitant therapy included DIAZEPAM. The patient stated that, on 16-APR-2012, after an unspecified length of time after receiving zoster vaccine live (Merck), he experienced diarrhea, he also experienced bruising inside his mouth, on his sternum area and near his pectoral area. On his left side, he also had five quarter-sized bruises. No treatment was given. Blood tests were performed (results unknown). On 18-APR-2012, the patient went to his doctor for medical attention. At the time of reporting, the outcome of both events were unknown. Follow up information was received from the physician which stated that the patient was vaccinated with the first dose of zoster vaccine live (Merck) (lot# 672557/1601AA) on left arm on 16-APR-2012. Then the patient described that on 18-APR-2012, he waking up with bruising on chest and left rib cage. At the time of reporting, the outcome of this event was unknown. It was also reported that the patient did not seek medical attention. Follow up information has been received on 11-FEB-2013 by a physician. The reporter stated that patient was vaccinated with ZOSTAVAX in the left deltoid. Also, it was reported that patient described the experience as wake up with bruising on chest and left rib cage, on 18- APR-2012. The outcome for bruises was reported as recovered. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a physician refers to his 72 year old wife. On 04-FEB-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) intramuscularly. The physician reported that on 05-FEB-2013, the patient developed a lump in her arm at the site of the PNEUMOVAX23 vaccination. The lump in the arm was traveling down her arm to her elbow. There were no Lab diagnosis or studies performed. The outcome of lump in her arm at the site of vaccination was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, FLU3, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R thigh has red raised bump. Minor.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Eye swelling, Feeling abnormal, Lacrimation increased, Oropharyngeal pain
Clinical narrative: Case number PHHY2012US111083 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 465421) on 04 Dec 2012 with a follow-up received from Quality Assurance Department on 14 Feb 2013. This case refers to 41-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: 07049211A) intramuscularly in left arm on 13 Sep 2012. On 13 Sep 2012, after the vaccination, the patient's eye started to get watery. His eyes started to swell and started feeling bad sore throat. He also experienced shortness of breath and had a worse feeling. The patient was given a prescription for prednisone, EPI injection and steroid eye drops. The outcome of events was reported as complete recovery as of 18 Sep 2012. The causality of the events was not reported. QA department stated that, the reported batch number is not a FLUVIRIN valid batch, therefore considered as unknown and QA would not be proceeding with the request. Follow-up received from Quality Assurance Department on 14 Feb 2013: Information regarding invalid batch number updated.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Pain, Pyrexia, Vaccination site cellulitis
Clinical narrative: Case number PHHY2012US111501, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467338) website on 04 Dec 2012 with a follow-up received from Quality Assurance Department on 14 Feb 2013. This report refers to a 51-year-old polymedicated female patient. She was vaccinated with FLUVIRIN (batch number: 1206707) intramuscularly to left arm and PNEUMOVAX (other manufacturer, batch number H009826) intramuscularly to right arm on 27 Sep 2012. On 28 Sep 2012, the patient experienced cellulitis, redness and swelling of right upper arm with warmth to touch around vaccine site. The patient also developed fever, fatigue and body aches. Patient visited emergency room. Outcome of the events were reported as complete recovery. QA department stated that, the reported batch number is not a FLUVIRIN valid batch, therefore considered a QA investigation will not be possible. Follow-up received from Quality Assurance Department on 14 Feb 2013: Information from QA department regarding invalid batch number of FLUVIRIN was updated.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2012US111501, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467338) website on 04 Dec 2012 with a follow-up received from Quality Assurance Department on 14 Feb 2013. This report refers to a 51-year-old polymedicated female patient. She was vaccinated with FLUVIRIN (batch number: 1206707) intramuscularly to left arm and PNEUMOVAX (other manufacturer, batch number H009826) intramuscularly to right arm on 27 Sep 2012. On 28 Sep 2012, the patient experienced cellulitis, redness and swelling of right upper arm with warmth to touch around vaccine site. The patient also developed fever, fatigue and body aches. Patient visited emergency room. Outcome of the events were reported as complete recovery. QA department stated that, the reported batch number is not a FLUVIRIN valid batch, therefore considered a QA investigation will not be possible. Follow-up received from Quality Assurance Department on 14 Feb 2013: Information from QA department regarding invalid batch number of FLUVIRIN was updated.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site pain in a 57-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to NSAID. Historic vaccination included influenza virus vaccine ;GlaxoSmithKline;unknown;unknown given on an unspecified date. The reporter stated that the subject had received FLUARIX vaccine several times on previous years without side effects. On 7 December 2012 the subject received a dose of FLUARIX (.5 ml, intramuscular, right deltoid). In December 2012, less than one month after vaccination with FLUARIX, the subject experienced injection site pain and muscle weakness of upper arm at injection site. Per the nurse, the subject described her pain by stating "when she tried to hold an empty cup of coffee, she has to use her other arm." The subject visited the immediate care center at work. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included an x-ray of the right shoulder on 31 December 2012 that "did not show anything". The subject was treated with physical therapy and LYRICA. The immediate care center advised that the subject "take time off work for a couple of days" and referred her to the "ortho that ordered physical therapy for the patient." The subject also visited a physician that prescribed LYRICA. At the time of reporting the events were unresolved. The reporter stated that she reported these adverse events "already through an online form for vaccine"; however, she did not specify which website was used.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Injection site reaction, Muscular weakness, X-ray limb normal
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site pain in a 57-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to NSAID. Historic vaccination included influenza virus vaccine ;GlaxoSmithKline;unknown;unknown given on an unspecified date. The reporter stated that the subject had received FLUARIX vaccine several times on previous years without side effects. On 7 December 2012 the subject received a dose of FLUARIX (.5 ml, intramuscular, right deltoid). In December 2012, less than one month after vaccination with FLUARIX, the subject experienced injection site pain and muscle weakness of upper arm at injection site. Per the nurse, the subject described her pain by stating "when she tried to hold an empty cup of coffee, she has to use her other arm." The subject visited the immediate care center at work. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included an x-ray of the right shoulder on 31 December 2012 that "did not show anything". The subject was treated with physical therapy and LYRICA. The immediate care center advised that the subject "take time off work for a couple of days" and referred her to the "ortho that ordered physical therapy for the patient." The subject also visited a physician that prescribed LYRICA. At the time of reporting the events were unresolved. The reporter stated that she reported these adverse events "already through an online form for vaccine"; however, she did not specify which website was used.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from an other health professional refers to a 70 year old female patient. On 31-JAN-2013 at 10:45, the patient was vaccinated with a dose of ZOSTAVAX (lot number H02000) (route and dose not provided) in the right arm. On 02-FEB-2013, the patient experienced rash at injection site and swollen the size of a silver dollar. The outcome of swollen the size of a silver dollar and rash at injection site was unknown. The patient was advised to apply cold compress and use BENADRYL as directed. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Alanine aminotransferase increased, Aspiration bone marrow abnormal, Biopsy bone marrow abnormal, Biopsy liver abnormal, Bone marrow failure
Clinical narrative: Information has been received from a published literature article. Vaccination with attenuated varicella zoster virus (VZV) could lead to infectious complications in immunodeficient patients. It was reported two immunocompromised patients who developed initial or reactivated vaccine strain varicella, leading to unique vesicular rashes involving the vaccinated limbs, without becoming wide-spread or remaining limited to a single dermatome. Case 1 - A 5 year old female presented with fever, jaundice, epistaxis and petechiae which began 2 weeks after receiving a second VARIVAX vaccination. Diagnostic testing revealed pancytopenia and hepatitis with a peak ALT of 1712 unit/L. A liver biopsy showed diffuse portal and lobular hepatocellular inflammation with prominent lymphohistiocytic infiltrate. A bone marrow aspirate and biopsy revealed hypocellularity and hemophagocytosis. She soon developed vesicles on her right arm and shoulder in a non-dermatomal pattern. The lesions remained localized to the entire right upper extremity, which was the site of the earlier VARIVAX vaccination. A vesicle was unroofed and the fluid tested positive for VZV by PCR. Further analysis revealed the virus to be vaccine strain varicella. She was hospitalized and treated with intravenous acyclovir and the lesions crusted over 21 days from presentation. Outcome of events were unknown. These two cases highlighted unusual presentations of vaccine strain varicella in immunocompromised patients. Vaccine strain varicella could cause a vesicular rash in a non-classical distribution. It was also notable that vaccine strain virus can trigger hemophagocytic lymphohistiocytosis in immune deficient patients. This is one of two reported received from the same literature. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Epistaxis, Hepatitis, Hepatocellular injury, Histiocytosis haematophagic, Inflammation
Clinical narrative: Information has been received from a published literature article. Vaccination with attenuated varicella zoster virus (VZV) could lead to infectious complications in immunodeficient patients. It was reported two immunocompromised patients who developed initial or reactivated vaccine strain varicella, leading to unique vesicular rashes involving the vaccinated limbs, without becoming wide-spread or remaining limited to a single dermatome. Case 1 - A 5 year old female presented with fever, jaundice, epistaxis and petechiae which began 2 weeks after receiving a second VARIVAX vaccination. Diagnostic testing revealed pancytopenia and hepatitis with a peak ALT of 1712 unit/L. A liver biopsy showed diffuse portal and lobular hepatocellular inflammation with prominent lymphohistiocytic infiltrate. A bone marrow aspirate and biopsy revealed hypocellularity and hemophagocytosis. She soon developed vesicles on her right arm and shoulder in a non-dermatomal pattern. The lesions remained localized to the entire right upper extremity, which was the site of the earlier VARIVAX vaccination. A vesicle was unroofed and the fluid tested positive for VZV by PCR. Further analysis revealed the virus to be vaccine strain varicella. She was hospitalized and treated with intravenous acyclovir and the lesions crusted over 21 days from presentation. Outcome of events were unknown. These two cases highlighted unusual presentations of vaccine strain varicella in immunocompromised patients. Vaccine strain varicella could cause a vesicular rash in a non-classical distribution. It was also notable that vaccine strain virus can trigger hemophagocytic lymphohistiocytosis in immune deficient patients. This is one of two reported received from the same literature. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles, Jaundice, Lymphocytic infiltration, Pancytopenia, Petechiae
Clinical narrative: Information has been received from a published literature article. Vaccination with attenuated varicella zoster virus (VZV) could lead to infectious complications in immunodeficient patients. It was reported two immunocompromised patients who developed initial or reactivated vaccine strain varicella, leading to unique vesicular rashes involving the vaccinated limbs, without becoming wide-spread or remaining limited to a single dermatome. Case 1 - A 5 year old female presented with fever, jaundice, epistaxis and petechiae which began 2 weeks after receiving a second VARIVAX vaccination. Diagnostic testing revealed pancytopenia and hepatitis with a peak ALT of 1712 unit/L. A liver biopsy showed diffuse portal and lobular hepatocellular inflammation with prominent lymphohistiocytic infiltrate. A bone marrow aspirate and biopsy revealed hypocellularity and hemophagocytosis. She soon developed vesicles on her right arm and shoulder in a non-dermatomal pattern. The lesions remained localized to the entire right upper extremity, which was the site of the earlier VARIVAX vaccination. A vesicle was unroofed and the fluid tested positive for VZV by PCR. Further analysis revealed the virus to be vaccine strain varicella. She was hospitalized and treated with intravenous acyclovir and the lesions crusted over 21 days from presentation. Outcome of events were unknown. These two cases highlighted unusual presentations of vaccine strain varicella in immunocompromised patients. Vaccine strain varicella could cause a vesicular rash in a non-classical distribution. It was also notable that vaccine strain virus can trigger hemophagocytic lymphohistiocytosis in immune deficient patients. This is one of two reported received from the same literature. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Pyrexia, Varicella virus test positive
Clinical narrative: Information has been received from a published literature article. Vaccination with attenuated varicella zoster virus (VZV) could lead to infectious complications in immunodeficient patients. It was reported two immunocompromised patients who developed initial or reactivated vaccine strain varicella, leading to unique vesicular rashes involving the vaccinated limbs, without becoming wide-spread or remaining limited to a single dermatome. Case 1 - A 5 year old female presented with fever, jaundice, epistaxis and petechiae which began 2 weeks after receiving a second VARIVAX vaccination. Diagnostic testing revealed pancytopenia and hepatitis with a peak ALT of 1712 unit/L. A liver biopsy showed diffuse portal and lobular hepatocellular inflammation with prominent lymphohistiocytic infiltrate. A bone marrow aspirate and biopsy revealed hypocellularity and hemophagocytosis. She soon developed vesicles on her right arm and shoulder in a non-dermatomal pattern. The lesions remained localized to the entire right upper extremity, which was the site of the earlier VARIVAX vaccination. A vesicle was unroofed and the fluid tested positive for VZV by PCR. Further analysis revealed the virus to be vaccine strain varicella. She was hospitalized and treated with intravenous acyclovir and the lesions crusted over 21 days from presentation. Outcome of events were unknown. These two cases highlighted unusual presentations of vaccine strain varicella in immunocompromised patients. Vaccine strain varicella could cause a vesicular rash in a non-classical distribution. It was also notable that vaccine strain virus can trigger hemophagocytic lymphohistiocytosis in immune deficient patients. This is one of two reported received from the same literature. Additional information has been requested.