chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.29
Sex: F
Vaccine: HEPA, MMR
Symptoms: Injection site rash, Rash generalised
Clinical narrative: RASH @ INFECTION SITE THEN SPREAD TO KNEES R FOOT LESS ON THE TRUNK AND ARMS.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint pain, Injection site joint swelling, Injection site pain, Injection site swelling, Swelling
Clinical narrative: Pain, swelling in the afternoon in the area of the injection (upper arm). Next day pain and swelling moving down to the area of the elbow. Third day (today 12/14/2012). some pain and some swelling below the elbow to about mid-forearm but mostly around elbow.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Guillain-Barre syndrome
Clinical narrative: Acute Infective polyneuritis/ Guillain-Barre Syndrome.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Rash
Clinical narrative: Patient developed a rash following DTAP administration.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PT STATES THAT SHE HAD "ONE SPOT" OF SHINGLES IN MARCH/APRIL, THEN A MILD CASE OF SHINGLES IN NOVEMBER THAT SURFACED ON HER LEFT SIDE (THE OPPOSITE SIDE OF HER SHINGLE CASES PRE-ZOSTAVAX.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: Face swelling: face becomes apparently greater in size with slight red coloring. Hives: big red rash-like bumps formed whenever I scratched the surface of my skin. These have been reappearing for the past 7 weeks or since the flu was received.
Age: 23.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Abdominal pain, Adrenal insufficiency, Amnesia, Dizziness, Gait disturbance
Clinical narrative: Lightheaded within a few hours of injection. Dizzines, lightheaded, flu symptoms, abdominal pain, nausea, vomiting, weight loss, adrenal insufficiency, memory loss, leg paralysis, difficulty walking, limb weakness.
Age: 23.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Influenza, Monoplegia, Muscular weakness, Nausea, Vomiting
Clinical narrative: Lightheaded within a few hours of injection. Dizzines, lightheaded, flu symptoms, abdominal pain, nausea, vomiting, weight loss, adrenal insufficiency, memory loss, leg paralysis, difficulty walking, limb weakness.
Age: 23.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Weight decreased
Clinical narrative: Lightheaded within a few hours of injection. Dizzines, lightheaded, flu symptoms, abdominal pain, nausea, vomiting, weight loss, adrenal insufficiency, memory loss, leg paralysis, difficulty walking, limb weakness.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itching, swelling at injection site and approx. 5in down upper arm.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Body temperature increased, Rash
Clinical narrative: PT REPORTED TO SITE WITH C/O A RASH COVERING TORSO AND FACE AND A MILD TEMP, WITH THE RASH BEGINNING TO SPREAD TO UPPER LEGS. PT WAS PREVIOUSLY SEEN IN THE ER AND AT CLINIC BY PCM. PT STATED THAT HE BEGAN USING CORTISONE CREAM FOR THE ITCHING.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Flushing
Clinical narrative: Facial flushing.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Patient states she was diagnosed as having the Flu (Type A) by her doctor's office.  They performed a nasal swab.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Culture, Influenza, Influenza A virus test positive
Clinical narrative: Patient states she was diagnosed as having the Flu (Type A) by her doctor's office.  They performed a nasal swab.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Cough, Decreased appetite, Diarrhoea
Clinical narrative: I started on 11-16-12 with a severe scratchy throat then followed by body aches and pains all over, headache, lightheadedness, dizziness, no appetite, not able to hold anything down but water, extreme fatigue, extreme weakness, chest tightness, congestion, severe coughing spells with sputum, vomiting, diarrhea, wheezing, thick phlegm, rib pain and fever.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Increased upper airway secretion, Musculoskeletal chest pain
Clinical narrative: I started on 11-16-12 with a severe scratchy throat then followed by body aches and pains all over, headache, lightheadedness, dizziness, no appetite, not able to hold anything down but water, extreme fatigue, extreme weakness, chest tightness, congestion, severe coughing spells with sputum, vomiting, diarrhea, wheezing, thick phlegm, rib pain and fever.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Productive cough, Pyrexia, Respiratory tract congestion, Throat irritation
Clinical narrative: I started on 11-16-12 with a severe scratchy throat then followed by body aches and pains all over, headache, lightheadedness, dizziness, no appetite, not able to hold anything down but water, extreme fatigue, extreme weakness, chest tightness, congestion, severe coughing spells with sputum, vomiting, diarrhea, wheezing, thick phlegm, rib pain and fever.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, Wheezing
Clinical narrative: I started on 11-16-12 with a severe scratchy throat then followed by body aches and pains all over, headache, lightheadedness, dizziness, no appetite, not able to hold anything down but water, extreme fatigue, extreme weakness, chest tightness, congestion, severe coughing spells with sputum, vomiting, diarrhea, wheezing, thick phlegm, rib pain and fever.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody positive, Arthralgia, Arthritis, Bursitis, Pain in extremity
Clinical narrative: Hip and knee excruciating pain in Right leg...went to hospital for blood work the next morning...eventually determined after many specialists  that I had an attack of arthritis, hip bursitis, knee arthritis, psoriatic arthritis.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Psoriatic arthropathy
Clinical narrative: Hip and knee excruciating pain in Right leg...went to hospital for blood work the next morning...eventually determined after many specialists  that I had an attack of arthritis, hip bursitis, knee arthritis, psoriatic arthritis.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the clinic on 14 Dec 2012 with redness, swelling, and heat in the upper right arm from the shoulder extending all the way down to the elbow.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Tinnitus
Clinical narrative: Terrible tinnitus, feel faint and wobbly.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 45 minutes afer shot (1:45 - 4:30) from wrist down through hands bilaterally were itchy, red; approximately 5:00 PM while in waiting room at urgent care, reported scalp itching and some sign of hives.  Treatment at urgent care between 5:00 - 6:00 PM: reported an IM injection and Benadryl given.  Symptoms resolved with no reoccurence when questions 2 days later.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT NOTED, OBSERVED, ASSESSED OR STATED.  AFTER CHILD HAD RECEIVED HIS DOSE OF MCV4 AND FLU, WHICH WERE CONSENTED FOR, I WAS NOTIFIED BY A PARTNER NURSE THAT THIS SAME CHILD HAD RECEIVED A DOSE OF MCV4 ON 12/12/2012, WHICH HAD NOT BEEN CONSENTED FOR AND WAS NOT DOCUMENTED ON THE PREVIOUS CONSENT OR IN CAIR.  CHILD SHOWED NO ADVERSE RESPONSE AND WAS CHECKED ON IN THE CLASSROOM AND WAS WITHOUT NEGATIVE SYMPTOM OR DISTRESS OF ANY KIND, AS WELL.  MOTHER WAS IMMEDIATELY NOTIFIED AND SITUATION WAS EXPLAINED TO HER IN DETAIL AND STATED UNDERSTANDING.  ADVISED HER TO FOLLOW UP WITH THE CHILD'S PMD FOR ANY CONCERNS. COMMUNICABLE DISEASE LEAD NURSE WAS ALSO NOTIFIED FOR FURTHER DIRECTION.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Generalised oedema, Lethargy, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever, hives, congestion, runny nose, lethargy, facial swelling, generalized edema. Treated with Benadryl and Pediacare. Symptoms persisted for three days.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Swelling face, Urticaria
Clinical narrative: Fever, hives, congestion, runny nose, lethargy, facial swelling, generalized edema. Treated with Benadryl and Pediacare. Symptoms persisted for three days.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Gastrointestinal inflammation, Headache, Laboratory test
Clinical narrative: Severe abdominal pain, nausea, headache, treated at local hospital for nausea and pain. Labwork done, and CT scan. CT scan showed inflamed intestines and bowels. Given IV fluids, nausea meds and pain meds. Released and sent home.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Nausea, Ultrasound abdomen abnormal, X-ray gastrointestinal tract abnormal
Clinical narrative: Severe abdominal pain, nausea, headache, treated at local hospital for nausea and pain. Labwork done, and CT scan. CT scan showed inflamed intestines and bowels. Given IV fluids, nausea meds and pain meds. Released and sent home.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt feel dizzy and sweat.
Age: 30.0
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Chest X-ray, Chills, Full blood count, Lymphadenopathy, Pain
Clinical narrative: Enlarged lymph node near right clavicle, chest X-ray and CBC was performed to rule out lymphoma.  The following day, I experienced fever, chills and body aches.
Age: 30.0
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Pyrexia
Clinical narrative: Enlarged lymph node near right clavicle, chest X-ray and CBC was performed to rule out lymphoma.  The following day, I experienced fever, chills and body aches.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a physician assistant concerning a patient of unknown age who on an unspecified date was vaccinated with a dose of PNEUMOVAX23 (dose and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician assistant reported that on an unknown date the patient had experienced an adverse effect after administration of PNEUMOVAX23 was evaluated at the urgent care clinic over the weekend. No treatment information was reported. The outcome of adverse effect was unknown. The relatedness for adverse effect was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Amylase increased, Chemotherapy, Lymphocytic leukaemia, Mumps, Parotid gland enlargement
Clinical narrative: This spontaneous report as received from a physician refers to a 2 years old patient of unknown gender with allergy to lidocaine, prilocaine (EMLA) cream allergy and contact dermatitis. The patient was vaccinated with dose 1 MMR II (lot #, dose and route not reported) on 09-JUN-2009. No other co-suspects were reported. Concomitant medications included prednisone (manufacturer unknown), sulfamethoxazole, BACTRIM, methotrexate, mercaptopurine, amoxicillin, AUGMENTIN and PREVACID. The physician reported that the patient had a collapsed lung on an unspecified date and was then diagnosed with Lymphoclastic Leukemia on 26-APR-2011 and was currently on chemotherapy. The patient under his care who received a single dose of MMR II at one year of age was now presenting to his practice with "classic symptoms of Mumps." He reports that the patient had enlarged parotid glands and elevated Amylase levels. The patient received MMR II at another physician's practice, so he did not have the lot number. At the time of the report, the patient was currently in the physician's practice and was not recovered. The outcome of collapsed lung was unknown. The relatedness for the reported events was not provided for MMR II. Upon internal review, the event of lymphoblastic leukaemia was considered medically significant. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Pneumothorax
Clinical narrative: This spontaneous report as received from a physician refers to a 2 years old patient of unknown gender with allergy to lidocaine, prilocaine (EMLA) cream allergy and contact dermatitis. The patient was vaccinated with dose 1 MMR II (lot #, dose and route not reported) on 09-JUN-2009. No other co-suspects were reported. Concomitant medications included prednisone (manufacturer unknown), sulfamethoxazole, BACTRIM, methotrexate, mercaptopurine, amoxicillin, AUGMENTIN and PREVACID. The physician reported that the patient had a collapsed lung on an unspecified date and was then diagnosed with Lymphoclastic Leukemia on 26-APR-2011 and was currently on chemotherapy. The patient under his care who received a single dose of MMR II at one year of age was now presenting to his practice with "classic symptoms of Mumps." He reports that the patient had enlarged parotid glands and elevated Amylase levels. The patient received MMR II at another physician's practice, so he did not have the lot number. At the time of the report, the patient was currently in the physician's practice and was not recovered. The outcome of collapsed lung was unknown. The relatedness for the reported events was not provided for MMR II. Upon internal review, the event of lymphoblastic leukaemia was considered medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLUN3
Symptoms: Vertigo
Clinical narrative: Vertigo.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site induration, Somnolence
Clinical narrative: Red, indurated area at injection site, fatigue, somnolence. Began within hours of injection, persisted over 24 hrs. Patient advised to treat with ice and acetaminophen and return if not improved in 24 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abasia, Injection site erythema, Injection site swelling
Clinical narrative: Pt received vaccine 12/7/12. Developed redness swelling of left thigh so severe she couldn't walk for a day was seen at our office 12/10/12. Still red & swollen. Entire left anterior thigh, walking ok treated w/ibuprofen, hydrocortisone cream.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Swelling
Clinical narrative: Swelling, bruising immediate. Ice pack applied immediately (checked by provider).
Age: 1.37
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to clinic c/o redness and swelling of right thigh at vaccine injection site. Provider notes 15 cm x 15 cm area of erythema and mild bluish discoloration at right thigh, warm to touch. Prescribed BENADRYL and ibuprofen to treat.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria. Rx BENADRYL.
Age: 66.0
Sex: F
Vaccine: HEPAB, IPV, TDAP, TYP
Symptoms: Pruritus generalised
Clinical narrative: Noted anal itching the night after 1st dose. Continued through all 4 pills. Itching continued in anal area, on (L) palm of hand, (L) sole of foot, and along spine called 12/7/12. Still having the itching but is better. 12/11/12 Most itching has stopped.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Decreased appetite, Diarrhoea, Faeces discoloured, Mucous stools
Clinical narrative: Probable reaction to rotavirus given 12/8/12 per CPNP. 12/11/12 decreased appetite throughout day, inconsolable crying throughout night 12/12. "9" green loose to watery stools with mucus with continued decreased freq. in breastfeeding. 12/13 - stools & appetite normalizing. Patient not in day care. No illness exposure in family.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: Probable reaction to rotavirus given 12/8/12 per CPNP. 12/11/12 decreased appetite throughout day, inconsolable crying throughout night 12/12. "9" green loose to watery stools with mucus with continued decreased freq. in breastfeeding. 12/13 - stools & appetite normalizing. Patient not in day care. No illness exposure in family.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling abnormal, Injection site erythema
Clinical narrative: Later in day after receiving flu shot, redness lower area where shot was given, approximately 3" x 3" area marked. 12/14/12 at 1315, pt to observe & report increase in symptoms, felt bad yest (chills), T 97.9 (T) today.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Red sunburn like rash on chest & neck causing itching started 3 days ago (12-10/12) rash is localized does not seem to be spreading. Patient using ALEVE 220mg twice daily.
Age: 35.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Left arm, 80 cm x 80 cm area of redness, swelling. Warm to touch.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dysphagia, Hyperhidrosis, Insomnia
Clinical narrative: Approx 8-10 minutes after receiving FLUZONE became diaphoretic, complained of "trouble swallowing" and elevated B/P. Received BENADRYL 25 mg po and Epinephrine 1:1000 .3 mL SQ (Lt) arm. Within 7 minutes symptoms improved (after BENADRYL and Epinephrine). No other complaints.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mother discovered on 12/14/12 at about 1:30pm that pt.'s (L) arm has swelling, redness, and severe pain. She describes "a cluster under the skin where the injection was given and the beginnings of an abscess. Referred pt. to urgent care or ER.
Sex: U
Vaccine: HPVX
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a published article. Abstract: The human papillomavirus quadrivalent (types 6, 11, 16, and 18) recombinant vaccine is effective in preventing cervical, vulva, vaginal and anal cancer. Maximal protection is achieved with completion of all three recommended doses. A retrospective chart review was performed to assess the current vaccine series completion rates in a private practice multispecialty suburban setting and identify factors associated with failure to complete the vaccine series. Chi-square and independent samples t test were used for data analysis. A total of 4,117 patients out of 10,821 eligible patients received at least one dose of the HPV vaccine between 01-OCT-2006 and 30-APR-2010. Overall, 69.5% (n = 2,863) of patients who received one dose of the HPV vaccine completed all three doses in a valid time frame, representing 26.5% of all eligible patients. Patients who completed the series were younger (16.8 vs. 18.2, p < 0.05), less likely to have a sexually transmitted disease diagnosis prior to initiation of the series (57.7 vs. 69.8%, p < 0.05), and more likely to have visited the pediatrics department compared to family medicine, internal medicine, and OB/GYN departments (75.9, 65.7, 57.0, 60.9%, respectively, p < 0.05). Deaths, pregnancies, and adverse drug reactions were not identified as independent factors impacting completion rates. The results indicate that adolescents, patients visiting the pediatrics department and those without a prior STD diagnosis completed the vaccination series more frequently than adults managed in family medicine, internal medicine, and OB/GYN departments. Result: The review of the randomly selected 10% sample of 411 patient charts for adverse reactions identified four patients (less than one percent) who experienced an adverse event within 30 days of vaccine administration. Two patients reported an injection site reaction, which is the most common documented ADR for HPV vaccination. One patient reported a systemic viral infection and one patient reported a genital HPV infection, neither of which was determined to be related to the vaccine. Of the four patients who experienced an adverse event, one completed the series and three patients did not. This report concerns the 2 patients that reported injection site reaction which is most common documented ADR for HPV vaccination. Event outcome was not mentioned. No further information is available.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: No therapeutic response
Clinical narrative: This spontaneous report as received from a nurse refers to a 41 year old male patient. The patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, route and dose were not reported) twice on an unspecified dates but still had not seroconverted. No concomitant medications were reported. The outcome of the event was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This spontaneous report was received from a 66 year old male patient with coronary heart disease regarding himself. Patient had no drug reactions/allergies. On 03-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route unspecified). There was no concomitant therapy. On 04-DEC-2012, after receiving ZOSTAVAX, the patient experienced muscle/joint pain. He did not seek any medical attention. No treatment was provided. No laboratory tests were performed. The outcome of muscle/joint pain was unknown. The relatedness for muscle/joint pain was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). No concomitant medications were reported. On an unknown date, the patient experienced red swollen grazed area defined as cellulitis after receiving the ZOSTAVAX. Treatment rendered for the event was antibiotics. The outcome of the event was unknown. The patient sought medical attention (doctors visit). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug dose omission, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 07-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 07-DEC-2012 the patient experienced drug dose omission, 1 day after onset of therapy and syringe leakage. No treatment information was reported. The outcome of drug dose omission and syringe leakage is unknown. The relatedness for drug dose omission and syringe leakage is unknown for ZOSTAVAX. No adverse effect reported. No further information is available. This pharmacist was transferred from a member of the PQC team who had already confirmed that there was no PQC with ZOSTAVAX in the case; therefore no PQC filed. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to a 49 years old female patient. The patient medical history included shingles. The patient was vaccinated with 1 ZOSTAVAX on SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 28-SEP-2012 the patient experienced inappropriate schedule. No treatment information was reported. The outcome of inappropriate schedule is unknown. The relatedness for inappropriate schedule is unknown for ZOSTAVAX. No further information was provided.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Injection site scab, Injection site scar, Mumps antibody test negative, Serology negative
Clinical narrative: This spontaneous report was received from a currently 48 years old female consumer reporting on herself sensitive to medication. The patient was vaccinated with a dose of M-M-R II (lot #, dose and route not reported) on an unspecified date when the patient was 5 years old. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unspecified date she developed a scab at the injection site and now had a scar. Recently on an unspecified date she had 2 titers done for measles, mumps and rubella. Both titers were low for mumps. The patient was seen in the physicians office. No treatment information was reported. The outcome of the events was reported as not recovered. The relatedness for the reported events was not provided for M-M-R II. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient's medical history included allergies to iodine, KEFLEX, penicillin, sulfa. The patient was vaccinated with ZOSTAVAX on 05-DC-2012. No other co-suspects were reported. Concomitant medications included estrogens, PREMARIN, propranolol hydrochloride and NORVASC. On 06-DEC-2012 the patient experienced injection site vesicles, 2 days after onset of therapy. Patient developed a "large, blistery area about the size of a potato" around the injection site. No treatment information was reported. The outcome of injection site vesicles was reported as not recovered/not resolved. The relatedness for injection site vesicles is unknown for ZOSTAVAX. No further information provided. VZVID packet faxed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a other healthcare professional, author of the abstract. Background: Sepsis was a leading cause of mortality in pediatric SLE with increased susceptibility to Streptococcus pneumoniae infection. We routinely vaccinate with the 23-va lent pneumococcal polysacchride vaccine (PPV) to protect against infection. Response to vaccination may vary due to disease-specific factors and immunosuppressant use. The appropriate time to assess antibody response to PPV is unknown. Our study objectives were to describe the clinical and immunological response to PPV in pediatric systemic lupus erythematosus (SLE) and to determine predictors of decline in immunogenicity after PPV. Methods: the author evaluated 54 pediatric SLE subjects who received the PPV at diagnosis with vaccine titers obtained as varying intervals. Change in disease activity after vaccination was assessed by the SLE Disease Activity Index (SLEDAI). A positive antibody response was defined as 7 of the 14 titers measured having a value > = 1 ug/ml. They used Cox proportional hazards to evaluate factors associated with lack of immunological response to PPV. Results: The majority of the cohorts were female (79) and 52% were another group. Nephritis (74%), cytopenias (57%), and arthritis (50%) were the most common clinical features at baseline presentation. In the month prior to vaccination, 54% of the cohort received pulse methylprednisolone, and 20% received cyclophosphamide or mycophenolate mofetil. There was no change in the median SLEDAI score after vaccination (8 vs. 6, P =0.2). One subject experienced an adverse reaction after initial vaccination, and two subjects developed severe pneumococcal disease despite vaccination. After initial vaccination, 59% of subjects did not achieve protective titers. The median time to inadequate response after initial vaccine was 0.73 years (0.16 to 3.1). In unadjusted models, age (HR + 1.2, P = 0.02, 95% Cl = 1.02 to 1.4) and hydroxychloroquine use (HR = 2.4, P = 0.05, 95% Cl = 1.0 to 5.7) were associated with decreased response. However, after adjustment for age, sex, and ethnicity, disease characteristics and medication use were not associated with lack of immunologic response to PPV. Conclusion:PPV was well tolerated in our cohort, but the majority of subjects failed to demonstrate adequate immunologic response to initial vaccination. Disease characteristics and medication use did not explain the lack of response. Pneumococcal infection may occur despite vaccination. PPV vaccination is recommended for patients with pediatric SLE but future studies in larger cohorts are needed to delineate risk factors for lack of immunogenicity. Relationship between severe pneumococcal disease despite vaccination and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unspecified) therapy was unknown. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant who reported that on 11-DEC-2012 inadvertently administered a dose on an 60 year old male patient of VARIVAX (route, dose, lot number and expiration date were not provided) instated of ZOSTAVAX. No adverse effects has been observed or reported. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist who received the following information from a nurse, refers to 2 patients (demographics unspecified) who developed swelling, pain and suspected cellulitis after receiving PNEUMOVAX23 (route not reported) in the past. It was unspecified what lot of 23this 2 patients received. It was unspecified what date PNEUMOVAX23 was received in these 2 patients. All other information of this 2 patient was unspecified. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Flushing, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a company representative refers to a nurse/patient of unknown age. The patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown the date of the nurse experienced itchy, hands, prickleness, flushing and redness after she administers ZOSTAVAX to patient. And redness on her neck. Patient is the nurse who told the rep she received ZOSTAVAX a few years ago and is experiencing adverse reaction when she administers ZOSTAVAX to patients, the reactions have occurred 30 to 40 minutes after reconstitutioning and administering ZOSTAVAX to patients and has happened four or fives times even when the nurse wears gloves. The outcome of itchy, hands, prickleness, flushing and redness after she administers ZOSTAVAX to patient. And redness on her back is unknown. The relatedness for itchy, hands, prickleness, flushing and redness after she administers ZOSTAVAX to patient. And redness on her neck is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Product quality issue
Clinical narrative: This spontaneous report as received from a other health professional states clients were vaccinated with VARIVAX Lot H015135 Exp 08-09-2014 and MMRII Lot 0425AE Exp 02/27/2014, that was discolored and clients complained of more pain than usual. Unspecified what type of pain. Unspecified how many clients had this experience. The patient was vaccinated with VARIVAX (merck). Other suspect therapies included M-M-R II. No concomitant medications were reported. On an unknown date the patient experienced more pain than usual. No treatment information was reported. The outcome of more pain than usual is recovered. The relatedness for more pain than usual is unknown for M-M-R II and VARIVAX (Merck). Caller has no other information. This SR sent to product quality complaint department. Additional information has been requested. 12/07/2012 Follow up AE information; Physician reports that he is concerned of not only the darker yellow color of the final solution of VARIVAX (lot # H015135) and M-M-R II (lot # 0425AE), but also an apparent increase in reports of the recipient of stinging or burning when receiving the injection. No specific patient referred. No additional information currently available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a other health professional refers to a 72 years old female patient. The patient was vaccinated with ZOSTAVAX on 14-NOV-2012. No other co-suspects were reported. Concomitant medications included vitamin D (unspecified), omega-3 marine triglycerides, flaxseed, calcium (unspecified), BENADRYL and red yeast. On 16-NOV-2012 the patient experienced redness, 3 days after onset of therapy and injection site swelling. Patient was treated with Prednisone for events redness and injection site swelling. The outcome of redness and injection site swelling is recovered. The relatedness for redness and injection site swelling is unknown for ZOSTAVAX. No further information was provided.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On an unknown date in 2004 (reported as at least 8 years ago) the patient had completed the hepatitis b vaccine (recombinant) (manufacturer unspecified) (lot number, expiry date, route and dose were not reported) vaccination series the patient had a titer test which was nonresponsive for hepatitis b surface antibody approximately on an unknown date in November 2012 (reported as within last month). No concomitant medications were reported. The patient sought medical attention (contacted the pharmacist). No adverse event reported other than the non-responsive titer test for hepatitis b surface antibody. The patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 13-NOV-2012, the patient was vaccinated with a dose of GARDASIL (lot number was reported as 0636AE and expiry date was 09-JAN-2015, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003713 and 1212USA004285) Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age. The patients were vaccinated with ZOSTAVAX that was stored over an unknown period of time at temperatures as high as 12F. The overall storage temperature may not have been 5F. No adverse events were reported. No treatment information was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain of skin, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a consumer refers to a 65 years old female patient. The patient was vaccinated with ZOSTAVAX on 04-DEC-2012. No other co-suspects were reported. Concomitant medications included ADVAIR, SINGULAIR, paroxetine and pravastatin sodium. On 04-DEC-2012 the patient experienced itchy, warm red patch on her skin that is painful to the touch after receiving ZOSTAVAX, 1 day after onset of therapy, painful to the touch, red patch and warm. No treatment information was reported. The outcome of itchy, warm red patch on her skin that is painful to the touch after receiving ZOSTAVAX, painful to the touch, red patch and warm is unknown. The relatedness for itchy, warm red patch on her skin that is painful to the touch after receiving ZOSTAVAX, painful to the touch, red patch and warm is unknown for ZOSTAVAX. No further AE information was provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX approximately 5 years ago in 2007. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient had shingles infection an unspecified number of times on unspecified number of dates. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of shingles infection was unknown. The relatedness for shingles infection was not provided for ZOSTAVAX. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Generalized urticarial rash.
Age: 0.34
Sex: F
Vaccine: DTAP, HEP, RV5
Symptoms: Injection site nodule
Clinical narrative: Nodule formation at injection site.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Cough, Henoch-Schonlein purpura, Rash, Rhinorrhoea
Clinical narrative: HSP, Rash on bottom and legs, cough runny nose, stomach pains, vomiting.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: HSP, Rash on bottom and legs, cough runny nose, stomach pains, vomiting.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Hyperhidrosis, Paraesthesia, Pruritus generalised
Clinical narrative: Skin felt on fire and itching over intire body (no welts). Itchiness worse on scalp & other places that grow hair. Belly button & ears were red, itchy & sweaty. Took Benadryl and finally went to sleep waking up many times throughout the night.  Arms and hands had tingling sensation (like they were asleep) all night and still that way if not moving them on 12/15/12 at noon. Extreme tiredness & did not get out of bed until 11:30 AM on 12/15/12.  Itchiness is still there but not as severe, will continue taking Benadryl until symptoms go away.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Skin burning sensation
Clinical narrative: Skin felt on fire and itching over intire body (no welts). Itchiness worse on scalp & other places that grow hair. Belly button & ears were red, itchy & sweaty. Took Benadryl and finally went to sleep waking up many times throughout the night.  Arms and hands had tingling sensation (like they were asleep) all night and still that way if not moving them on 12/15/12 at noon. Extreme tiredness & did not get out of bed until 11:30 AM on 12/15/12.  Itchiness is still there but not as severe, will continue taking Benadryl until symptoms go away.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy Hives on wrists and ankle. (Thought at first it was mosquito bites.) Later in the night a few more. Took Benadryl and hives disappeared after about 30 minutes.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema normal, Intussusception, Ultrasound scan abnormal, Vomiting
Clinical narrative: Vomiting, later presented to outside facility, ultrasound showed intussusception.  Transferred to Med Ctr, barium enema done and negative, assumed intussusception self-resolved.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain, Pruritus, Swelling
Clinical narrative: Redness, soreness, swelling, itching, and headache.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Laboratory test, Muscular weakness, Syncope
Clinical narrative: Total muscle collapse.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Blood potassium decreased, Blood test normal, Chest pain, Computerised tomogram normal, Dehydration
Clinical narrative: I began having chest pains, trouble breathing, dizziness, finally at 10:45 AM I passed out and fell to the floor at work.  I was then sent to the emergency room at the hospital in an ambulance.  Where they diagnosed me with dehydration and an elevated white blood cell count as if my body were under attack by a serious virus.  After giving me an EKG and blood tests to rule out a heart attack, they then gave me a CAT scan to rule out a pulmanary embolism.  Theses tests came back negative.  They gave me baby aspirin and 2 large potassium pills because I was very low.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Fall, Loss of consciousness
Clinical narrative: I began having chest pains, trouble breathing, dizziness, finally at 10:45 AM I passed out and fell to the floor at work.  I was then sent to the emergency room at the hospital in an ambulance.  Where they diagnosed me with dehydration and an elevated white blood cell count as if my body were under attack by a serious virus.  After giving me an EKG and blood tests to rule out a heart attack, they then gave me a CAT scan to rule out a pulmanary embolism.  Theses tests came back negative.  They gave me baby aspirin and 2 large potassium pills because I was very low.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count increased
Clinical narrative: I began having chest pains, trouble breathing, dizziness, finally at 10:45 AM I passed out and fell to the floor at work.  I was then sent to the emergency room at the hospital in an ambulance.  Where they diagnosed me with dehydration and an elevated white blood cell count as if my body were under attack by a serious virus.  After giving me an EKG and blood tests to rule out a heart attack, they then gave me a CAT scan to rule out a pulmanary embolism.  Theses tests came back negative.  They gave me baby aspirin and 2 large potassium pills because I was very low.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Vertigo
Clinical narrative: Sudden onset of nausea and vertigo. Worst with bodily movement or bending. Continuing at time of this report. Reviewed forum posting. Apparently this is being reported by others.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Mobility decreased
Clinical narrative: Per patient's husband, the patient had difficulty moving her arms, legs and hands. The patient also experienced some discomfort in these extremities. The patient contacted her physician who instructed her to go to the emergency room.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reports soreness in arm that has persisted since getting the vaccine. She felt no pain during vaccine administration, only after.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: The patient received Influenza vaccine. Indicated no prior history of fainting or getting dizzy with shots. Also didn't claim any medical conditions. The pt lost consciousness for seconds after shot. He awoke and said he had not eaten. Ambulance came and vitals were ok. Pt had somebody pick him up to take him home.
Age: 80.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: CSF protein increased, Electrophoresis protein abnormal, Guillain-Barre syndrome, Muscular weakness, Sensory loss
Clinical narrative: AIDP, treated with IVIG.
Age: 80.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: AIDP, treated with IVIG.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dyspnoea, Pain, Poor quality sleep
Clinical narrative: First, mild chest/bronchial tightening, and mild difficulty breathing.  As these reactions eased, at about 10:00 PM, I began to have very significant chills and shivering with mild achiness which lasted about two hours.  Then uneasy tossing and turning the rest of the night.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site exfoliation, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Reaction was not immediately observed, but was well developed after 24 hours.  Injection site for flu shot developed a red, hard, hot area about 2 inches by 3 inches that was painful and itching.  Once noticed, it did not spread or become worse, but maintained redness and soreness for three days before subsiding.  As of today, 8 days later, the area is only pinkish, but the skin is scaly. Never had any such reaction to a vaccination before.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Reaction was not immediately observed, but was well developed after 24 hours.  Injection site for flu shot developed a red, hard, hot area about 2 inches by 3 inches that was painful and itching.  Once noticed, it did not spread or become worse, but maintained redness and soreness for three days before subsiding.  As of today, 8 days later, the area is only pinkish, but the skin is scaly. Never had any such reaction to a vaccination before.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Myalgia, Nausea, Pyrexia
Clinical narrative: Day 1: Severe Chills and muscle aches/102 fever.  Day 2 101 fever, muscle aches, nausea, Day 3 100 fever muscle aches, nausea, Day 4 nausea, diarrhea.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local site reaction, approximately 1 and 1/2 inch redness, hot and swollen.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Asthenia, Body temperature increased, Headache, Influenza like illness
Clinical narrative: Started feeling ill soon after taking the vaccine.  Temperature rose to 101.8 by next morning, remaining over 101 all day, decreasing to over 100 next day.  Felt like I had the flu the entire next day, joint pain, head ache, weakness and muscle pain.  Welt about 1.5 inches in diameter and .5 inches high.  Extreme soreness at injection site.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Malaise, Myalgia, Urticaria
Clinical narrative: Started feeling ill soon after taking the vaccine.  Temperature rose to 101.8 by next morning, remaining over 101 all day, decreasing to over 100 next day.  Felt like I had the flu the entire next day, joint pain, head ache, weakness and muscle pain.  Welt about 1.5 inches in diameter and .5 inches high.  Extreme soreness at injection site.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Demyelination, Facial paresis, Hemiparesis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Right face weakness, loss of cough, right sided weakness.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patient had rash and hives over entire body. Mostly on the extremities, face and ears. Some rash on trunk. Happened approximately 12 hours after vaccination. No fever reported. Seen at ER and give steroids then referred to allergist.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Cough, Dizziness, Headache, Increased bronchial secretion
Clinical narrative: Fluid in lungs, persistent rattling cough, excess mucous, headache, fever, dizziness, ....
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Pleural effusion, Pyrexia
Clinical narrative: Fluid in lungs, persistent rattling cough, excess mucous, headache, fever, dizziness, ....
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pyrexia, Skin reaction, Upper respiratory tract congestion
Clinical narrative: Chronic fever, heavy draining and chest congestion, skin reaction, persistent cough and fever still.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Insomnia, Pain, Pain in extremity, Tenderness
Clinical narrative: Unable to move or lay on arm without pain. Unable to sleep due to pain. unable to dress, lift objects without pain.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Patient called to complain because of pain from flu shot. Patient stated pain was caused by pharmacist giving injection too high on arm. Doctor visit was done.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain, Periarthritis, X-ray normal
Clinical narrative: Patient called to complain because of pain from flu shot. Patient stated pain was caused by pharmacist giving injection too high on arm. Doctor visit was done.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient describes a delayed onset rash that developed (approx 1 1/2 inch diameter) around the injection site. Rash has since resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: About a 2-3 inch in diameter rash with heat emitting from surface. It has been 60 hours, and patient is taking ibuprofen with antihistamine.