chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a female patient of unknown age. The pharmacist reported that an anonymous woman developed shingles after kissing an anonymous patient that on an unknown date, was vaccinated with ZOSTAVAX (dose, route and lot not reported. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician refers to a 28 year old female patient. On 28-FEB-2013, the patient was vaccinated with GARDASIL lot # 0420AE, intramuscular (dose not reported0. On 05-MAR-2013, the patient developed prolonged arm pain and generalized burning pain in the right arm and shoulder, as well as a dull headache. The patient was treated with a NEURONTIN LIKE medication. There was no significant mobility loss in the right arm. The outcome of the events was unknown. The relatedness between the events and GARDASIL were unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who reported that unknown numbers of patients might have received improperly stored VARIVAX (Merck) (dose, route of administration and lot # not provided), because a provider did not record the temperature of freezer since November-2012. No adverse effect reported. No PQC involved. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: DT, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Palpitations
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 66 year old female patient. The patient's medical history included hypothyroidism. There was no drug reaction or allergies. In 2000, the patient was vaccinated with PNEUMOVAX23 (lot#, dose and route not reported) with no adverse events. On 01-MAR-2013, the patient was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX23 (lot# H013399; exp. date: 07-MAR-2014). Concomitant therapy included levothyroxine sodium and tetanus toxoid immunization. On 01-MAR-2013, the patient experienced headache, heart palpitations and redness, warmth, and tenderness of her hip at the injection site. The patient sought medical attention; she sent an e-mail to the office. The patient was treated with ice to injection site. At the time of the report the patient was recovering from the events. The relatedness of the events with the PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Condition aggravated
Clinical narrative: This spontaneous report as received from a physician and a 22 year old female patient with genital warts. The patient's medical history included Lyme disease. On 19-JAN-2013, the patient was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapies included ethinyl estradiol, ALTAVERA. The physician and the consumer reported that on 29-JAN-2013, the patient experienced aggravation of genital warts. The patient reported that she increased a rapid increase in genital wart growth within 10 days of vaccination. The patient did not receive treatment for the adverse event. The outcome of aggravation of genital warts was reported as not recovered/not resolved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site joint pain
Clinical narrative: Severe elbow joint pain to the arm of injection site. Last shot in opposite arm same effect lasted 4 months.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Upper extremity mass
Clinical narrative: Redness, itching, lump in arm, pain.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Cough, Rash, Rhinorrhoea, Skin lesion
Clinical narrative: Woke up from nap with hives on face and chest/abdomen.  Resolved within 2 hours without medication.  Also has developed mild URI symptoms since vaccines given - cough on the night of 3/8 and rhinorrhea on 3/9 with lowgrade temps of 100-100.7 degrees.  Parents brought her in for eval of rash but all lesions gone by time of exam.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Upper respiratory tract infection, Urticaria
Clinical narrative: Woke up from nap with hives on face and chest/abdomen.  Resolved within 2 hours without medication.  Also has developed mild URI symptoms since vaccines given - cough on the night of 3/8 and rhinorrhea on 3/9 with lowgrade temps of 100-100.7 degrees.  Parents brought her in for eval of rash but all lesions gone by time of exam.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Non-stop pain at injection site. (And I have never had a problem with injections, including prior flu-shots. Over the next few days post-injection, (and increasing over the next several months), the pain spread throughout my tricep. The pain was at the surface of my skin and deep in the tissue. Even a normal shower was too painful to bear at the site for many months. Eventually, the pain radiated to my left shoulder. Now I have chronic pain in deep in my tricep and in my left shoulder. I cannot sleep on that side of my body.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Injection site erythema, Neuralgia, Presyncope
Clinical narrative: Neuropathic pain syncope, redness at sight, light head near syncope high fever redness over body.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Syncope
Clinical narrative: Neuropathic pain syncope, redness at sight, light head near syncope high fever redness over body.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Severe pain at injection site for 7-10 days following the vaccination. Patient treated with ibuprofen and BENADRYL. Symptoms gradually improved, but a lump remains at site and it occasionally itches at the injection site.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site inflammation, Injection site pallor
Clinical narrative: March 6, 2013 - patient states rash all over my body that worsen over two days. Fever 99.1 smallpox site is red and inflamed with rash.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Pyrexia, Rash generalised
Clinical narrative: March 6, 2013 - patient states rash all over my body that worsen over two days. Fever 99.1 smallpox site is red and inflamed with rash.
Age: 14.0
Sex: M
Vaccine: HPVX, MEN, VARCEL
Symptoms: Abdominal pain upper, Burning sensation, Dyspnoea, Malaise, Pain
Clinical narrative: Skin on back tingling and burning. Diffuculty breathing, fever, body aches, all over ill feeling, and stomach ache.
Age: 14.0
Sex: M
Vaccine: HPVX, MEN, VARCEL
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Skin on back tingling and burning. Diffuculty breathing, fever, body aches, all over ill feeling, and stomach ache.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Hot flush, Influenza like illness, Pyrexia, Rash erythematous
Clinical narrative: Red rash, hot flashes, dizziness, low grade fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Raised, red rash on tricep area. Approximately 1inx 2 in. Warm to touch. No pain noted.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Pt. came in 2 days after administration complaining of rash and mild pruritus. Said she had itching about an  hour after administration but went away. Rash was about 3 inches wide by 6 inches long, advised her to take BENADRYL and to f/u with MD if does not improve.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported). It was reported that the patient was administered expired ZOSTAVAX. No side effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 22 October 2012. A 06-year old male patient, who had no known allergies and concomitant medications were not reported, had received an intramuscular dose of FLUZONE (lot number: UH745AD) in left thigh and an intramuscular dose of "Hep" A vaccine, Merck (lot number: 0699AE) in right thigh, both on 01 October 2012. On 01 October 2012, the patient still had 100.4 fever On unspecified dates, the patient developed diarrhea and loss of appetite. The patient was prescribed acetaminophen and alternating with ibuprofen for every three hours. The patient was advised to continue the supportive treatment. Complementary investigations were not reported. The patient's outcome was recovered on unspecified date. Documents held by sender: none.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Dyspnoea, Hypotonia, Myelitis transverse
Clinical narrative: Completely hypo-tonic, labored breathing,weak cry. Dx of transverse myelitis was made.
Age: 38.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Injection site pruritus, Oedema peripheral, Pain in extremity
Clinical narrative: PAIN, SWELLING & REDNESS ALONG UPPER ARM FROM SHOULDER TO ELBOW, ITCHY AROUND SITE.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to an immunocompetent patient of unknown age or gender who developed zoster like rash 24 hours after received a dose of ZOSTAVAX. The rash developed along the dermatome down the arm. Patient route of administration and lot no information were not provided. The outcome of zoster like rash is unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Laboratory test normal, Myoclonus
Clinical narrative: Started having myoclonic jerk within few months after shots. Reported to physician who said may be stress. Jerks continued then grand mal seizures started. Continue to have myoclonic jerks and grand mal seizures. Have had other hospitalizations due to seizure complications.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site cellulitis
Clinical narrative: (L) arm cellulitis. KEFLEX got Clindamycin in hospital.
Age: 52.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Arthralgia, Condition aggravated, Groin pain, Muscular weakness, Pain
Clinical narrative: Received the vaccine at 1100 that day, symptoms began at 1400. She bagan to have pain in her right groin region that spread to her posterior right hip that was progressively worsening. Pain 5/10, sharp. Feels like leg is going to give out. Also has increase in hot flashes.
Age: 52.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Arthralgia, Gait disturbance, Groin pain, Muscular weakness, Weight bearing difficulty
Clinical narrative: Received the vaccine at 1100 that day, symptoms began at 1400. She bagan to have pain in her right groin region that spread to her posterior right hip that was progressively worsening. Pain 5/10, sharp. Feels like leg is going to give out. Also has increase in hot flashes.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Tdap injection was given during a school based program. Child reported to the nurses office approximately two hours after her injection and c/o numbness in her right hand.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Skin tightness, Swelling
Clinical narrative: Tdap was given during a school clinic on 3/8/13. Approximately two hours following the immunization patient reported to the nurses office with c/o tightness and feeling of fullness in the fatty area between the thumb and forfinger of the left hand. No redness or edema was noted by the nurse at that time.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Arm swollen and sore, fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain, Rash, Skin induration
Clinical narrative: RASH, REDDNESS, PAIN, INFLAMMATION SKIN WAS HARD.
Age: 0.18
Sex: M
Vaccine: RVX
Symptoms: Bacterial test negative, Blood test normal, Chest X-ray normal, Diarrhoea, Diet refusal
Clinical narrative: 105.6 rectal fever, irritability, refusal to eat/drink, diarrhea.
Age: 0.18
Sex: M
Vaccine: RVX
Symptoms: Infection, Irritability, Pyrexia, Respiratory syncytial virus test negative, Urine analysis normal
Clinical narrative: 105.6 rectal fever, irritability, refusal to eat/drink, diarrhea.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Anxiety, Chest discomfort, Electrocardiogram T wave inversion, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: This study case was received on 25 February 2013 from the investigator in a trial. A 28-year-old male subject with no relevant past medical history, developed a transient elevated Troponin level and chest pressure 16 days after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 05 March 2012. On 21 March 2012, sixteen days later, the subject developed transient elevated Troponin and chest pressure, considered mild in severity. On 16 March 2012, a Troponin I level was reported as 0.26 ng/mL (also reported as date of 02 April 2012); repeat Troponin level was reported as normal on 02 April 2012 with result < 0.10 ng/mL. An electrocardiogram on 02 April 2012 was reported as normal ECG (also reported as abnormal, inverted T waves; asymptomatic). The subject reported "chest pressure" when thinking about elevated Troponin; no other time. According to the investigator, chest pressure was likely anxiety and no further work-up was needed. Treatments were reported as none. The stop date of adverse events was reported as recovered/resolved on 02 April 2012. According to the investigator, the events of transient elevated Troponin and chest pressure were considered an other important medical event and possibly related to the trial product. This represents a case of potential myopericarditis per the investigator and has subsequently been referred to the  Adjudication Committee for assessment. Documents held by sender: Medical records.
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Feeding disorder of infancy or early childhood, Hypotonia, Joint range of motion decreased, X-ray
Clinical narrative: Knees - unable to extend. Hypotonia. Feeding problem.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Patient is in Nurse Clinic for evaluation of rashes to left arm. Noted with maculopapular rash to anterior left arm from wrist to elbow and to left side of neck. C/o itching, no pain noted. No fever. Took BENADRYL last night. Methylprednisolone 4 mg.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram normal, Palpitations
Clinical narrative: This study case was received on 27 February 2013 from the investigator in a trial. A male subject (age and birth date not reported) with no relevant past medical history, developed possible myopericarditis six days after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site and side not reported); TYPHOID VACCINE, Manufacturer unknown, (lot number, route, site and side not reported) and ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 12 January 2011. On 18 January 2011, six days post vaccination, the subject developed possible myopericarditis, considered moderate in severity, with a 30 minute episode of moderate chest pain, pressure, palpitations, tachycardia and severe shortness of breath (also reported as fifth evening post smallpox vaccination). The subject did not seek care. "Troponins" and electrocardiogram (ECG) were reported as normal on unspecified date. The subject was referred for possible myopericarditis. No follow-up was available. No treatments medications were prescribed. The stop date of adverse event and outcome was reported as recovered, resolved on 18 January 2011. According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP
Symptoms: Tachycardia, Troponin normal
Clinical narrative: This study case was received on 27 February 2013 from the investigator in a trial. A male subject (age and birth date not reported) with no relevant past medical history, developed possible myopericarditis six days after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site and side not reported); TYPHOID VACCINE, Manufacturer unknown, (lot number, route, site and side not reported) and ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 12 January 2011. On 18 January 2011, six days post vaccination, the subject developed possible myopericarditis, considered moderate in severity, with a 30 minute episode of moderate chest pain, pressure, palpitations, tachycardia and severe shortness of breath (also reported as fifth evening post smallpox vaccination). The subject did not seek care. "Troponins" and electrocardiogram (ECG) were reported as normal on unspecified date. The subject was referred for possible myopericarditis. No follow-up was available. No treatments medications were prescribed. The stop date of adverse event and outcome was reported as recovered, resolved on 18 January 2011. According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: This study case was received on 27 February 2013 from the investigator in a trial. A male subject (age and birth date not reported) with no relevant past medical history, developed possible myopericarditis on same day after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 18 January 2012. On same day post vaccination, 18 January 2013, the subject developed possible myopericarditis, considered mild severity, with onset of mild shortness of breath (SOB) and moderate palpitations. Palpitations were exercise-associated and resolved 20 seconds post exercise. SOB occurred randomly approximately (~) three times a day (3x/day). The symptoms had not resolved six days post vaccine. The subject also had a single episode of dizziness with exercise, five days post vaccine; and subject was referred for care. No treatment medications were prescribed. No laboratory or diagnostic tests were reported. The stop date of adverse event and outcome were reported as recovered/resolved on an unspecified day in February 2012. According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest discomfort, Electrocardiogram normal, Laboratory test normal, Palpitations, Troponin normal
Clinical narrative: This study case was received on 27 February 2013 from the investigator in a trial. A female subject (age and birth date not reported) with no relevant past medical history, developed possible myopericarditis two days after she received the following vaccines on 07 April 2011: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported); and concomitantly, an injection of TYPHOID VACCINE, manufacturer unknown, (lot number, route, site and side not reported) and an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported). On 09 April 2011, two days post vaccination the subject developed possible myopericarditis of moderate severity. The subject reported onset of chest tightness and palpations felt in neck and chest bilaterally while lying down two days post vaccination, with no known triggering or exacerbating factors. The subject self-referred to Urgent Care and subject reported labs, electrocardiogram (ECG) there were normal; and diagnosis (dx) was "awareness of own heart beat". Study ECG and Troponin were reported as normal. According to investigator, there was low suspicion for myopercarditis. No treatments were prescribed. The stop date of adverse event and outcome were reported as recovered/resolved on 10 April 2011. According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
Sex: M
Vaccine: SMALL, TYP
Symptoms: Chest pain, Electrocardiogram normal, Troponin normal
Clinical narrative: This study case was received on 27 February 2013 from the investigator in a trial. A male subject (age and birth date not reported) with no relevant past medical history, developed possible myopericarditis five days after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of TYPHOID VACCINE, manufacturer unknown, (lot number, route, site and side not reported) on 18 January 2012. On 23 January 2012, five days post vaccination, the subject developed possible myopericarditis, considered moderate severity, with reported moderate on/off left sided sharp chest pain, occurring "a couple times per day" and present two days later. The subject was referred for care for possible myopericarditis. Study "Troponins" and electrocardiogram (ECG) were reported as normal on unspecified dates. According to investigator, there was low suspicion for myopericarditis. The doctor (MD) at clinic reported chest pain. No treatments were prescribed. The stop date of adverse event and outcome was reported as resolved on an unspecified date in 2012 (and outcome was also reported as lost to follow-up). According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cough, Dyspnoea, Electrocardiogram ST segment depression, Electrocardiogram abnormal, Respiratory tract congestion
Clinical narrative: This study case was received on 27 February 2013 from the investigator in a trial. A male subject (age and birth date not reported) with no relevant past medical history, had an abnormal electrocardiogram (ECG), two days after he received the following vaccines (also reported as 10 days post vaccination): an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 04 February 2013. On 06 February 2013, two days post vaccination, the subject developed moderate shortness of breath, considered moderate severity, with intermittent one minute episodes of shortness of breath with no identified exacerbating factors. The subject had an abnormal electrocardiogram (ECG) noted to have ST segment depression at visit two on 14 February 2013, 10 days post vaccination (also reported as start date 06 February 2013). Troponin was reported as normal times two (x2) on unspecified dates. The subject also reported congestion and cough with onset six days post vaccine, resolving three days later. The subject was referred for care. No treatments medications were prescribed. The adverse event and outcome of abnormal ECG was considered not resolved, not recovered and outcome was also reported as lost to follow-up. According to the investigator, the event of abnormal ECG (potential myopericarditis) was considered an other important medical event and possibly related to the trial product. Documents held by sender: Medical Record.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin normal
Clinical narrative: This study case was received on 27 February 2013 from the investigator in a trial. A male subject (age and birth date not reported) with no relevant past medical history, had an abnormal electrocardiogram (ECG), two days after he received the following vaccines (also reported as 10 days post vaccination): an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 04 February 2013. On 06 February 2013, two days post vaccination, the subject developed moderate shortness of breath, considered moderate severity, with intermittent one minute episodes of shortness of breath with no identified exacerbating factors. The subject had an abnormal electrocardiogram (ECG) noted to have ST segment depression at visit two on 14 February 2013, 10 days post vaccination (also reported as start date 06 February 2013). Troponin was reported as normal times two (x2) on unspecified dates. The subject also reported congestion and cough with onset six days post vaccine, resolving three days later. The subject was referred for care. No treatments medications were prescribed. The adverse event and outcome of abnormal ECG was considered not resolved, not recovered and outcome was also reported as lost to follow-up. According to the investigator, the event of abnormal ECG (potential myopericarditis) was considered an other important medical event and possibly related to the trial product. Documents held by sender: Medical Record.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an medical assistant refers to a female patient of unknown age. On 04-MAR-2013 the patient was vaccinated with VARIVAX (merck) in error, instead of ZOSTAVAX. No product confusion discovered, just medication error. ZOSTAVAX (Merck). No adverse event reported. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given ZOSTAVAX. Patient was due to receive VARIVAX at 0930 on 2/26/13. Patient mother notified of event at 1435. Mother reports no adverse reactions at time of call. Mother was informed dose will count and will not need to be repeated at this time.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Body temperature increased, Headache, Injection site pain, Injection site swelling
Clinical narrative: Painful swollen stiff (L) arm. Elbow to shoulder. Temp 101.3. BP elevated 142/82. Earlier in day during physical 118/78. Slight headache and abd. nausea within 4 hours. Prednisone was prescribed.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Nausea
Clinical narrative: Painful swollen stiff (L) arm. Elbow to shoulder. Temp 101.3. BP elevated 142/82. Earlier in day during physical 118/78. Slight headache and abd. nausea within 4 hours. Prednisone was prescribed.
Age: 21.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Feeling hot, Infection, Myositis, Swelling
Clinical narrative: Pt developed very deep "IM" swelling & warmth, tenderness, deep cellulitis maybe infected muscle/myositis". All vac with this lot # pulled & company contacted.
Age: 21.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tenderness
Clinical narrative: Pt developed very deep "IM" swelling & warmth, tenderness, deep cellulitis maybe infected muscle/myositis". All vac with this lot # pulled & company contacted.
Age: 21.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Pt developed very deep "IM" swelling & warmth, tenderness, deep cellulitis maybe infected muscle/myositis". All vac with this lot # pulled & company contacted.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Impaired work ability, Pain in extremity
Clinical narrative: Aches & pains, especially in my left arm. Numerous Dr. visits / tested for Guillain Barre / lost numerous days off work. Had to go to the E.R.
Age: 0.58
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, IPV, RV1
Symptoms: Incorrect dose administered
Clinical narrative: None known.
Age: 0.11
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting 6x.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Chest pain
Clinical narrative: Patient woke up w/ chest pain, continued to have chest pain 3-4 times per week.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Eyelid oedema, Pyrexia, Rash, Swelling
Clinical narrative: Rash, fever, swelling, puffy eyes.
Age: 1.11
Sex: F
Vaccine: HEP, HIBV, IPV, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None known.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Rash, Rhinorrhoea
Clinical narrative: Vaccine administered 12/21/12, states "rash started "around" Christmas Day." Reported: 1/18/13 to EHS to report rash, cough, runny nose, sore throat.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning unknown number of patients (age and gender unspecified). On an unknown date in 2012 (reported as from August of 2012 through September 2012) (exact dates unspecified), the patients were vaccinated with a dose of an improperly stored MMR II (lot number, expiry date, dose and route unspecified) at a clinic associated with a hospital. No adverse event was reported. This is one of the three reports from the same source. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: TYP
Symptoms: Dysphonia
Clinical narrative: Patient prescribed oral typhoid Vivitof vaccine. Patient reports 1hour after taking first pill developed hoarse voice which subsided within 24h. On 2nd dose of vaccine severe hoarseness again within 1hour with increased severity. Patient reported this prior to 3rd dose and then finished last 2 doses of vaccine.  There was no associated shortness of breath, rash, fever or difficulty swallowing. Of note wife who also started oral typhoid vaccine the same day noted hoarseness after first dose but not subsequent doses. Please note this vaccine was purchased through a commercial pharmacy by the patient. Patient was given hep A vaccine in MD office 2/5/13, but oral typhoid not started by pt until 2/28/13.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Patient in first trimester of pregnancy and recieved TDAP against ACIP recommendations.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were unknown). On an unknown date, the patient had a line below the injection site after getting ZOSTAVAX. The patient was treated with BENADRYL. The outcome of the event was unknown. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, International normalised ratio normal, Metabolic function test normal
Clinical narrative: Parent reported usual site swelling, erythema until 2/25/13 (evening) when "rash" noted on upper (R) back. Took to ER & then f/u with PCP. Dx with purpura, petechia (of unknown origin).
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Petechiae, Prothrombin time normal, Purpura, Rash
Clinical narrative: Parent reported usual site swelling, erythema until 2/25/13 (evening) when "rash" noted on upper (R) back. Took to ER & then f/u with PCP. Dx with purpura, petechia (of unknown origin).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. No information regarding the patient's medical history was provided. In January 2013 (reported as about a month ago) the patient was vaccinated with ZOSTAVAX. No concomitant medication was provided. A day after the injection the patient experienced a hive at the injection site, accompanied by redness, itching and swelling. The patient reported that the reaction mostly went away after 10 days, however on date of this report she still had a faint red ring around the injection site. No causality assessment was provided. Additional information is not expected.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old male patient with no drug reactions or allergies. Patients pertinent medical history was none. On 05-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H108091, expiry date was 04-JAN-2014 and dose was not reported), subcutaneously. Concomitant medication was none. On 05-MAR-2013, the patient experienced nausea, headaches, fever and vomiting. On 05-MAR-2013, the patient also had pain down to his left side and left arm. Laboratory test performed was none. The patient sought medical attention (saw the pharmacist) and the patient was treated with ibuprofen. The outcome of nausea, headaches, vomiting, fever, pain down to his left side and left arm was reported as not recovered/not resolved. The pharmacist also reported that last time he had seen a different patient with an adverse event with an unspecified vaccine in 1990s. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old male patient with no drug reactions or allergies. Patients pertinent medical history was none. On 05-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H108091, expiry date was 04-JAN-2014 and dose was not reported), subcutaneously. Concomitant medication was none. On 05-MAR-2013, the patient experienced nausea, headaches, fever and vomiting. On 05-MAR-2013, the patient also had pain down to his left side and left arm. Laboratory test performed was none. The patient sought medical attention (saw the pharmacist) and the patient was treated with ibuprofen. The outcome of nausea, headaches, vomiting, fever, pain down to his left side and left arm was reported as not recovered/not resolved. The pharmacist also reported that last time he had seen a different patient with an adverse event with an unspecified vaccine in 1990s. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. The reporter reported that the patient had received 3 doses of VARIVAX (Merck). On 20-AUG-2012, the patient had the first dose of VARIVAX (Merck) (lot number and expiry date was not reported) 0.5 milliliter (ml) subcutaneously. On 06-AUG-2012, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot number and expiry date was not reported) 0.5 ml, subcutaneous and on 06-MAR-2013 was vaccinated with the third dose of VARIVAX (Merck) (lot number and expiry date was not reported) 0.5 ml, subcutaneously. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning unknown number of patients (age and gender unspecified). On an unknown date in 2012 (reported as from August of 2012 through September of 2012) (exact dates unspecified), the patients were vaccinated with a dose of an improperly stored RECOMBIVAX HB (lot number, expiry date, dose and route unspecified0 at a clinic associated with a hospital. No adverse event was reported. This is one of three reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning unknown number of patients (age and gender unspecified). On an unknown date in 2012 (reported as from August of 2012 through September of 2012) (exact dates unspecified), the patients were vaccinated with a dose of an improperly stored PNEUMOVAX 23 (lot number, expiry date, dose and route unspecified) at a clinic associated with a hospital. No adverse event was reported. This is one of the three reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt said she noticed several weeks after getting flu shot -1 she said her arm was sore in the same area as where she got the flu shot. Almost like she had gotten the flu shot again.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Influenza like illness, Injection site nodule, Oedema peripheral
Clinical narrative: Pt came in and got shot earlier on in the day. Later that night it started to really hurt she started to have flu like symtoms (fever, fatigue) so she went to bed. When the patient woke up the next morning her arm was swollen and red and warm to touch. She came into the Dr office on 3-11-13 and was seen by Dr the area was red and swollen and warm to touch. The redness was 7 inches in length by 6.5 wide. She has a knot where the injection was given.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Skin warm
Clinical narrative: Pt came in and got shot earlier on in the day. Later that night it started to really hurt she started to have flu like symtoms (fever, fatigue) so she went to bed. When the patient woke up the next morning her arm was swollen and red and warm to touch. She came into the Dr office on 3-11-13 and was seen by Dr the area was red and swollen and warm to touch. The redness was 7 inches in length by 6.5 wide. She has a knot where the injection was given.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Hives and rash starting various parts of body. Itchiness. Increased in afternoon. Phoned doctor at 5:30 PM and sent to facility. Eased somewhat after treatment and then at 3:30AM on 02/13 went to hospital Emergency Room with large patches of vivid redness in many places.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. The patient fainted after administration. The physician stated that the patient was seated at the time and recovered from the syncope. No treatment was given for the adverse event. The causality is unknown. Additional information is not expected.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, Crying, Diarrhoea, Full blood count normal, Irritability
Clinical narrative: Severe vomiting & diarrhea 12 stools 6 vomit. Excessive crying & irritability, inconsolable. No fever. No blood in stools. No WBC in stool last 24h. hospitalized.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rotavirus test positive, Vomiting, White blood cell count normal
Clinical narrative: Severe vomiting & diarrhea 12 stools 6 vomit. Excessive crying & irritability, inconsolable. No fever. No blood in stools. No WBC in stool last 24h. hospitalized.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Live vaccine provided to transplant patient, no adverse reaction noted.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Top left arm red, raised, swollen, hot to touch.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Normal injection site pain for 1st 2wks then started to move to shoulder then base of neck. Now only have sore shoulder on left side. I exercise and becomes very painful in different positions.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin discolouration, Urticaria
Clinical narrative: Raised red, itchy welts. Similar to bug bites but no signs of punctures a few weeks after vaccination. Welts shrink until gone. Leaves dark mark. Prescribed prednisone 03/01/2013. Prednisone calmed down breakouts until prescription was finished.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Blood pressure increased, Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site induration
Clinical narrative: Pt seen and examined and chart reviewed and agree with H&P, assessment and plan, addendum, and level of care. Pt is a 4yr old male w/ hx of asthma admitted w/left arm cellulitis vs large local reaction   after administration of immunizations. Per mom, pt did move when a shot was given in affected arm and was scratched by the needle while shot was being given. When swelling began and mother alerted PMD, she was instructed to apply an ice pack and give ibuprofen q6 for pain and to prevent fever.  Mom stated last dose of ibuprofen she gave was at 10 am yesterday. Pt has been afebrile since admission but was given ibuprofen this am for pain/discomfort.  Pt's BP has been elevated but renal function good, U/A essentially normal, diastolics wnl but will cont to monitor.  On exam pt clingy but comforted by mom, L. arm- erythematous > at lower arm decreased at shoulder, arm is warm, swollen and indurated/ tense w/ no drainage.  Erythema did not spread past marked area. Plan: will cont to monitor BP, ID on consult, to see this pm- will follow recs. Plan d/w housestaff and pt's mother- questions answered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local reaction, Renal function test normal
Clinical narrative: Pt seen and examined and chart reviewed and agree with H&P, assessment and plan, addendum, and level of care. Pt is a 4yr old male w/ hx of asthma admitted w/left arm cellulitis vs large local reaction   after administration of immunizations. Per mom, pt did move when a shot was given in affected arm and was scratched by the needle while shot was being given. When swelling began and mother alerted PMD, she was instructed to apply an ice pack and give ibuprofen q6 for pain and to prevent fever.  Mom stated last dose of ibuprofen she gave was at 10 am yesterday. Pt has been afebrile since admission but was given ibuprofen this am for pain/discomfort.  Pt's BP has been elevated but renal function good, U/A essentially normal, diastolics wnl but will cont to monitor.  On exam pt clingy but comforted by mom, L. arm- erythematous > at lower arm decreased at shoulder, arm is warm, swollen and indurated/ tense w/ no drainage.  Erythema did not spread past marked area. Plan: will cont to monitor BP, ID on consult, to see this pm- will follow recs. Plan d/w housestaff and pt's mother- questions answered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Scratch, Urine analysis normal
Clinical narrative: Pt seen and examined and chart reviewed and agree with H&P, assessment and plan, addendum, and level of care. Pt is a 4yr old male w/ hx of asthma admitted w/left arm cellulitis vs large local reaction   after administration of immunizations. Per mom, pt did move when a shot was given in affected arm and was scratched by the needle while shot was being given. When swelling began and mother alerted PMD, she was instructed to apply an ice pack and give ibuprofen q6 for pain and to prevent fever.  Mom stated last dose of ibuprofen she gave was at 10 am yesterday. Pt has been afebrile since admission but was given ibuprofen this am for pain/discomfort.  Pt's BP has been elevated but renal function good, U/A essentially normal, diastolics wnl but will cont to monitor.  On exam pt clingy but comforted by mom, L. arm- erythematous > at lower arm decreased at shoulder, arm is warm, swollen and indurated/ tense w/ no drainage.  Erythema did not spread past marked area. Plan: will cont to monitor BP, ID on consult, to see this pm- will follow recs. Plan d/w housestaff and pt's mother- questions answered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Soreness started late Thursday 3/7 then became red and swollen and painful at site on outside of left arm. Pain and swelling moved down arm around inside of arm and swollen around elbow. It is now Monday evening and arm is still sore, swollen and red especially around inside of elbow. Have not called dr. yet. But pharmacist said to use ice pack for swelling and take Claritin for itch (itches off and on).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Soreness started late Thursday 3/7 then became red and swollen and painful at site on outside of left arm. Pain and swelling moved down arm around inside of arm and swollen around elbow. It is now Monday evening and arm is still sore, swollen and red especially around inside of elbow. Have not called dr. yet. But pharmacist said to use ice pack for swelling and take Claritin for itch (itches off and on).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling and redness to left medial thigh. 4-5 cm of induration.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly on 27-OCT-2011, the second dose of GARDASIL on 30-JAN-2012, and was in the office on 03-MAR-2013, to receive the third dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Computerised tomogram head, Disturbance in attention, Dizziness, Feeling abnormal
Clinical narrative: Employee seen for HBV #2. She felt dizzy, lightheaded within 10-15 min then better but "off" x an hr. Midmorning had difficulty concentrating/focusing. About 4:45 PM - weak, dizzy, pale "world spinning" because nauseated, pulse faint thready. 5:20 PM EVAC to ER. Released about 11 PM. Weak, dizzy next day.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Nausea, Pallor, Pulse abnormal, Pulse pressure decreased
Clinical narrative: Employee seen for HBV #2. She felt dizzy, lightheaded within 10-15 min then better but "off" x an hr. Midmorning had difficulty concentrating/focusing. About 4:45 PM - weak, dizzy, pale "world spinning" because nauseated, pulse faint thready. 5:20 PM EVAC to ER. Released about 11 PM. Weak, dizzy next day.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Urticaria rash & fever 101.2.