chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 33 year old female patient with no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of M-M-R II (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient had positive titers for measles and mumps, however she had negative titers for rubella. The patient was unsure whether she ever received vaccination against measles, mumps and rubella as a combination vaccine or monovalent vaccines. The titer results were returned to the pharmacist on 01-JUL-2013. The pharmacist did not report that the patient had any adverse effects other than the negative rubella titer. The patient sought medical attention by seeing the pharmacist. The outcome of all the reported events was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test abnormal, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. The patient had no pertinent medical history or drug allergies. On 07-DEC-2012, the patient was vaccinated with first dose of GARDASIL (lot # 0477AA, expiry date 29-JUN-2013 given in the left arm). On 25-JUN-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL (lot # H020901, expiry date 05-JUL-2015 given in the left arm). Concomitant therapies included Prenatal vitamins (unspecified). The patient's last menstrual period was on 28-APR-2013 and Estimated Delivery Date of 02-FEB-2014. On 25-JUN-2013, the patient had blood work done which showed that the patient was pregnant and the urine pregnancy test was positive. The patient sought medical attention. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin swelling, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old female patient who had 2 siblings. On 30-APR-2013 the patient was vaccinated subcutaneously in the right thigh with a first dose of VARIVAX (lot # H018457, exp. date: 05-OCT-2017). On 09-MAY-2013, almost 10 days after giving vaccine, the patient developed a quarter-sized red, raised spot. His mom stated it felt hot. This was the third reaction like this in this lot of vaccine. There was no illness at time of vaccination. There were no pre-existing allergies, birth defects and medical conditions. The outcome of the events was reported as recovered on "10-SEP-2013". This is one several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: Left arm erythema, swelling, cellulitis.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2012 the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 24-SEP-2012, the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). On 19-NOV-2012, the patient was vaccinated with dose 3, GARDASIL (lot#, expiration date and route not reported). No adverse effects reported. Additional information is not expected.
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 an unspecified number of patients of unknown age and gender. It was reported that on an unknown date, patients may have vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date, dose and route unspecified) which was exposed to 28 degrees Fahrenheit (F) for possible one month. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash papular, Scab
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient with allergy to morphine and ACE inhibitors. The patient's medical history included seizure, chickenpox at age of 5, eczema, congestive heart failure (CHF), aortic femoral bypass (AFRB) and hypertension. On 20-JAN-2011 the patient was vaccinated with a dose of ZOSTAVAX (lot #06972) (0.5 ml in the left arm, route not reported). Concomitant therapies included warfarin, diltiazem hydrochloride, lisinopril and phenytoin. On 21-JUN-2013 (also reported as 3 days ago, on 23-JUN-2013), the patient experienced a severe case of shingles and was hospitalized in June 2013. The patient had a rash (vesicle/papule type) in clusters distributed in the right lower abdomen and in lower back (dermatome T8). On 23-JUN-2013, the patient also experienced pain and rash. It was reported that the patient did not experience a rash at the site of injection post vaccination. On 27-JUN-2013, a sample of VZVIP specimen was obtained from vesicle/papule and scab. The patient sought medical attention at hospital and on 24-JUN-2013 was treated with VALTREX 1000mg, three times a day for 7 days (also reported as concurrent medication). At the time of the report, the patient's outcome was not recovered. This case was considered serious due to hospitalization. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 16-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Inflammation, Injection site pain
Clinical narrative: Diffuse pain upon examination of (R) deltoid muscle on 7/2/13. Pain with activation of deltoid muscle only. Ordered PT and started on oral steroid to decrease inflammation.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Patient had redness, swelling and pain shortly after receiving Tdap vaccine, redness and swelling worsened the next day and had fevers up to 103.7. Was given 1 gram of ROCEPHIN in office and Rx for KEFLEX x 10 days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Feeling abnormal, Nausea, Pallor
Clinical narrative: Gave GARDASIL shot and 1-2 min. later pt had clammy, pale skin and said she didn't feel good. C/o mild nausea. I put cold paper towels on her forehead and back of neck - and laid her on the floor. She felt better after 15 min. BP: 102/60. Went home with mom.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness of the forearm where vaccine was administered. Patient seen in my office on 7/3/13 as swelling was increasing--started the pt on Motrin, warm compresses and antibiotics as a precaution.
Age: 37.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Asthenia, Dyspnoea, Mental status changes
Clinical narrative: Abdominal, shortness of breath, general weakness. Mild Altered Mental Status.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Bedtime: Fever of 100.3   Chills, Body aches, headache. 11:30 temp higher, but thermometer not used. 1:30 felt better, but sl. headache and weakness.
Age: 0.52
Sex: M
Vaccine: HEP, HIBV, IPV, PNC, RV5
Symptoms: Convulsion, Hypersensitivity
Clinical narrative: Seizure after Dtap. Seen at ED on 6/17/2013.
Age: 0.44
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 21.0
Sex: M
Vaccine: SMALL, YF
Symptoms: Chest pain, Dyspnoea, Feeling abnormal, X-ray
Clinical narrative: Pt sates, "Went to take a pt test this morning and when it came time to running the mile and a half, about 10 seconds after starting it felt like my whole body was telling me to stop. I had trouble keep my breathing under control and pain in my chest. I pushed myself to finish, but the entire time I could keep control of my breathing and the pain continued".
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Contusion, Hyperaesthesia, Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node upper armpit (where arm connects to shoulder) extremely sore, swollen.   For one week pain continued and  progressed down inner arm to elbow.  There is a yellowish stripe, like a bruise, that runs down inner aspect of arm to elbow.  Elbow area is still slightly sensitive now, 3 weeks later. Tylenol taken for pain.
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Pain in extremity
Clinical narrative: Lymph node upper armpit (where arm connects to shoulder) extremely sore, swollen.   For one week pain continued and  progressed down inner arm to elbow.  There is a yellowish stripe, like a bruise, that runs down inner aspect of arm to elbow.  Elbow area is still slightly sensitive now, 3 weeks later. Tylenol taken for pain.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Doctor ordered Tdap vaccine. Pt was given DTaP vaccine in error. MD was informed. Parent was informed. No known adverse reactions. (No need to repeat a Tdap vaccine per MMRW).
Age: 0.8
Sex: F
Vaccine: PPV
Symptoms: Cough, Crying, Emotional distress, Irritability, Nasal congestion
Clinical narrative: Received Prevnar shot at approx. 2pm. Night 1: fever of 100.9 for 24 hours. Nights 2-3: formerly sound sleeper was very restless; woke up every hour crying inconsolably as if she was in pain. Post-vaccine day 3: developed a respiratory issue with a severely stuffy/runny nose and cough; symptoms lasted two weeks. Since the vaccine: my formerly happy baby is very fussy and irritable; hard to console, cries randomly. She was also saying "name" and "dada" before the vaccine but we haven't heard her articulate those words since.
Age: 0.8
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Respiratory disorder, Restlessness, Rhinorrhoea, Speech disorder
Clinical narrative: Received Prevnar shot at approx. 2pm. Night 1: fever of 100.9 for 24 hours. Nights 2-3: formerly sound sleeper was very restless; woke up every hour crying inconsolably as if she was in pain. Post-vaccine day 3: developed a respiratory issue with a severely stuffy/runny nose and cough; symptoms lasted two weeks. Since the vaccine: my formerly happy baby is very fussy and irritable; hard to console, cries randomly. She was also saying "name" and "dada" before the vaccine but we haven't heard her articulate those words since.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown gender and age. On 10-JUN-2013 the patient was vaccinated with an expired dose of M-M-R II (HSA) (Lot # 0705AA, Expiration date 11-MAY-2013) (route not provided). No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Fatigue, Pain, Upper extremity mass
Clinical narrative: (L) arm redness; (+) fatigue (+) body aches (+) joint pain; (+) lump on LA.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Chills, Injection site rash, Pruritus, Pyrexia
Clinical narrative: 6-21-13 VARIVAX was given subq in lt arm. Approx 8 days after inject rash appeared at site of inject and increased over next 4 days. Pt. called on day 12. Previous night had fever and chills. Random blister-like pox on body today, itchy; rash hot, red, itchy.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: 6-21-13 VARIVAX was given subq in lt arm. Approx 8 days after inject rash appeared at site of inject and increased over next 4 days. Pt. called on day 12. Previous night had fever and chills. Random blister-like pox on body today, itchy; rash hot, red, itchy.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Blindness, Dizziness, Loss of consciousness
Clinical narrative: Patient complained of not being able to see. Felt faint and lost consciousness for 1 minute, then regained consciousness.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness
Clinical narrative: Client stated he felt "light headed" approx. 10 min after immunizations. Client placed in supine position with legs elevated while vitals obtained - vitals WNL; client given H2O and stated "I feel much better." Client and client's mother advised to seek medical attention for further s/s - both were negative.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Erythema, Pyrexia, Skin warm
Clinical narrative: Day after vaccines only had fever and red and worse 2 days later and very warm. Seen in ER and Dx with cellulitis marked on leg 90 x 102 mm size now resolved and tx with Abx - (R) anterior thigh.  Given DTaP, IPV.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M increased, Varicella post vaccine
Clinical narrative: Developed, what seems to be, vaccine induced varicella.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Oedema peripheral
Clinical narrative: Swelling of (R) arm 24 hours after shot was given.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh swelling and erythema 1 hr. after injection.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Discomfort
Clinical narrative: Pt. received 3rd HPV vaccine in (R) deltoid 6/27/13, swelling started 6-27-13. Two days later 6/29/13, was evaluated by physician c/o mild discomfort with movement. Pt. had been swimming as well. No fever, no URI. Tx ice, ibuprofen, BENADRYL.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Presyncope
Clinical narrative: Pt had near syncope after IM injections. BP 100/75 No problems breathing no syncope no skin rash. Does not appear to be allergic reaction. Pt observed in office 15 min.
Sex: U
Vaccine: HEP, HEPA, MMR, PPV, RV5, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients unknown age and gender. Nurse reported that the temperature on the freezer/refrigerator unit was not recorder between the dates of 29-APR-2013 to 28-MAY-2013 (reported as 28-MAY-2012). The vaccines involved were: Refrigerated vaccines: M-M-R II, RECOMBIVAX HB, VAQTA, ROTATEQ and PNEUMOVAX23. Freezer vaccines: (Oka/Merck) VARIVAX and ZOSTAVAX. Concomitant medications were not reported. It was not known whether the vaccines stored in the unit underwent any type of temperature excursion, or any doses of the vaccines were administered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately a 66 year old male patient with diabetes. There were no drug reactions or allergies. On 18-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J001006 and 24-APR-2014 respectively, dose unspecified), intramuscular. No concomitant medications were reported. On 18-JUN-2013 (subsequently), the patient developed an injection site reaction. The injection site was warm, hard and itchy. The patient sought medical attention (contacted pharmacist). No treatment was given. The outcome of the events was reported as not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 24 year old female patient. On 19-JUL-1990 the patient was vaccinated with the first dose of M-M-R II (route, lot number and expiration date not reported). On 31-AUG-1994 the patient was vaccinated with a second dose of M-M-R II (route, lot number and expiration date not reported). There was no concomitant medication reported. The pharmacist reported that an unspecified physician stated that the patient had titers drawn on 14-JUN-2013 as evidence of measles, mumps and rubella immunity. The outcome of the event 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 registered nurse refers to an unspecified number of patients (age and gender were not reported) who received GARDASIL lot # H017698 exp. date 02-JUL-2015 (dose and route not reported) on an unknown administration dates that was exposed to less than 31f for 8 days. The GARDASIL in question was found to be unsupported by in-house stability data. No adverse symptoms reported. the patient's outcomes were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced shingles "2 weeks after" having received ZOSTAVAX. The outcome of shingles was not reported. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, after the vaccination, the patient developed a case of chickenpox. It was unspecified if the patient sought any medical attention. It was unspecified if any treatment was provided or if any lab test were performed. The outcome of the event was unknown. The relatedness for the event was unknown for VARIVAX. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with an unspecified dose of GARDASIL (lot# unspecified) for human papillomavirus prevention. On an unspecified date after receiving the vaccine series, the patient discovered a bald spot on her head. The outcome of a bald spot on her head was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a certified nurse practitioner who is a nurse midwife refers to a 19 year old female patient with no known drug reactions/allergies and no other pertinent medical history. On 26-JUN-2013 the patient was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscular (site and lot number not provided). There was no concomitant medication. On 26-JUN-2013, the patient fainted after being administered the GARDASIL, this happened in the physician's office. It was given oxygen to the patient as a treatment for the adverse event. No lab diagnostic tests were performed. HCP office sent the patient to the emergency room at a local hospital. The HCP office was not sure if patient would stay overnight at the hospital. The outcome of the patient was reported as recovering. The causal relationship was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. About 20 years previously, she had allergic reaction of hives and trouble breathing when she received iodine dye for an unspecified test. The patient had no other pertinent medical history. On 24-JUN-2013 the patient was vaccinated with ZOSTAVAX. Lot# was not provided. Concomitant vaccine included PNEUMOVAX23 administered on 24-JUN-2013. Concomitant medications included thyroid and blood pressure medications. On 26-JUN-2013, two days later, the patient had a sore, itchy red welt on the arm she received ZOSTAVAX. When seen on 29-JUN-2013, the patient showed improvement at the ZOSTAVAX injection site. The ZOSTAVAX injection site had no welt and just little bit of redness. No treatment was given. No lab test was done. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager (also reported as healthcare worker) concerning a male patient of unknown age. Approximately on an unknown date in 2013 (reported as over one year ago), the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and would be receiving his second dose in the series in the near future. No concomitant medications were reported. No adverse effects were reported. 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 registered nurse (R.N.) refers to an unknown number of unidentified patients. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. It was reported that the ZOSTAVAX administered was improperly stored. The nurse requested when safety follows up with their office to put a statement that there were no adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health professional, refers to a female patient of unknown age. Pertinent medical history, drug reaction/allergies were not provided. On an unspecified date, reported as several years ago, the patient received the first and second doses of GARDASIL, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that the patient would now like to receive her third dose. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB, HEP, HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB injection 10 (dose, therapy and lot number were not reported). Other suspect therapies included LIQUID PEDVAX HIB and COMVAX. Concomitant medications was not reported. On an unknown date, RECOMBIVAX HB; LIQUID PEDVAX HIB and COMVAX might have been administered to unspecified number of patients after being exposed to 30F for 6 hours. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4, TD
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unknown number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with LIQUID PEDVAXHIB (lot number and expiration date not reported) (dose and route not specified). Other suspect therapies included GARDASIL (lot number and expiration date not reported) (dose and route not specified), and tetanus and diphtheria toxoids, adsorbed (manufacturer unknown) (lot number and expiration date not reported) (dose and route not specified). The reporter stated that doses of LIQUID PEDVAXHIB, GARDASIL and tetanus and diphtheria toxoids, adsorbed (manufacturer unknown) were administered to an unspecified number of patients on unspecified date after being exposed to 30F for 1 hour. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a pediatric patient of unknown age and gender. Pertinent medical history, drug reaction/allergies were not provided. On an unknown date, the patient received a first dose of VAQTA (Lot number and expiration date were not provided). Co-suspect therapy and concomitant medication were not provided. On an unspecified date, a second dose of VAQTA was recently administered at a 5 month interval from the first dose. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 53 year old female patient with no pertinent medical history reported and no known allergies. On 24-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number reported as J001693, expiration date 08-MAY-2014) (dose and route not reported0. Concomitant medications included furosemide (manufacturer unknown), fluticasone nasal, norethindrone and hydrocodone with acetaminophen. The pharmacist reported that approximately in June 2013 the patient developed a single spot (like a bug bite) on the right elbow, another single spot on the left arm (site unspecified) and swelling and redness on the neck, following vaccination with ZOSTAVAX. The patient went to the physician yesterday (also reported as 27-JUN-2013). The outcome for the above mentioned events was reported as Not recovered. Treatment with Caladryl topically and BENADRYL orally was given. It was reported that the patient sought medical attention by contacting pharmacy and physician. The reporter did not assess the causality between ZOSTAVAX and the above mentioned events. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 14 year old patient (gender unknown) with no pertinent medical history reported. On 28-JUN-2013 the patient was vaccinated with a dose of (Merck) PROQUAD (lot # H020134, expiration date 07-MAY-2014), (subcutaneous, dose not reported). No concomitant medications were reported. The nurse reported that PROQUAD (merck) was inadvertently administered to a 14 year old patient. The patient had an "unknown vaccination history" and it was unspecified if this was the first dose of varicella vaccine that the patient ever received. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown age and gender. On 01-JUL-2013 the patients were vaccinated with a dose of MMR II (Lot # H018181, exp date 05-OCT-2014) (dose and route not reported). Concomitant therapy was not reported. It was reported that the patients received MMR II that was exposed to 70F for 16 hours. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. On 21-MAR-2013 the patient was vaccinated with the first dose of RECOMBIVAX (10 Microgram, route not reported) and then received a second dose of RECOMBIVAX HB (10 Microgram, route not reported) on 17-JUN-2013. Concomitant therapy was not reported. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Off label use
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a currently 56 years old female patient with HPV since approximately July 2011. On an unknown the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported) for treatment of HPV infection. Concomitant medication were not reported. After doing some research, the patient and her physician, decided to see if this vaccine would be of any help for the patient. Patient has been fighting HPV for the last year and 10 months (since approximately July 2011), also reported as "it had been 2 years she have it has been fighting this". Patient had had the warts cut off, burned off, and frozen off. With very little results,a and they were back within a few months. Patient was not sure that it was because GARDASIL, but patient stated that within two weeks after taking the first shot, noticed a large difference. Patient stated she will be taking the other 2 doses. The outcome of the patient at the moment of the report was not reported. The relationship between GARDASIL and the event was not reported. Additional information has been requested.
Age: 0.89
Sex: M
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Blister, Skin lesion
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a 3 years old male patient. On an unknown date 2 years ago in June 2011 the patient was vaccinated unspecified varicella zoster virus (VZV) against. On 11-JUN-2013, VZVIP sample was obtained from axilla vesicle/lesion. The outcome of axilla vesicle/lesion was unknown. Additional information is not expected.
Sex: F
Vaccine: PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a company refers to a female patient of unknown age who presented a claim to the client of the company. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # reported as H018340, exp. date March 2014. On 28-DEC-2012 (reported as date of loss), the patient experienced an adverse reaction to the PNEUMOVAX 23. The outcome of adverse reaction was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Infection, Injection site pain, Oedema, Surgery
Clinical narrative: This spontaneous report as received from a company refers to a female patient of unknown age who presented a claim to the client of the company. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # reported as H018340, exp. date March 2014. On 28-DEC-2012 (reported as date of loss), the patient experienced an adverse reaction to the PNEUMOVAX 23. The outcome of adverse reaction was unknown. Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever Lethargy Seriousness Criteria: Other - Medically Significant  Initial report was received from a consumer on 21 June 2013.  A 7-month-old male patient received a first dose of Daptacel vaccine, sanofi pasteur, lot number unknown (route, site, and side of administration not reported), and a dose of ActHiB vaccine, sanofi pasteur, lot number unknown (route, site, and side of administration not reported) on 20 May 2008. On the same day, the patient experience fever of 104 degrees Fahrenheit (40 degrees Celsius) and lethargy. The patient's outcome was not reported.  This case was linked to case 2013 07208.  Documents hold by sender: None.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 67 year old male patient with no pertinent medical history and allergies to penicillin, methadone and naproxen. On 10-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H013581, expiration date 03-MAR-2014), 0.5 ml, (anatomical location unspecified) subcutaneously for prophylaxis. Concomitant therapies included albuterol, clonidine, FLONASE, FLOVENT, gabapentin, acetaminophen, hydrocodone bitartrate, tamsulon hydrochloride, SPIRIVA, trazodone hydrochloride, milk thistle, inositol and oxymetazoline hydrochloride. On 10-OCT-2012, the patient complained of swollen arm and diagnosed with cellulitis after receiving a dose of PNEUMOVAX 23. The reporter is requesting a lot check of this vaccine due to the patient having adverse experience. The patient sought medical attention and was treated with BACTRIM, lab diagnostics studies were not performed. The outcome of cellulitis was reported as not recovered/not resolved. At the time of the report the relationship between therapy with PNEUMOVAX 23 and the events and the action taken for this therapy were unknown. Additional information has been requested.
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Coma, Malaise
Clinical narrative: This spontaneous report as received from a "third party representative for Pharmacy" refers to a male patient of unknown age. On 31-AUG-2012 the patient was vaccinated with PNEUMOVAX23 (lot # 1947AA, expiry date on 20-OCT-2013). On an unknown date the patient was hospitalized after receiving PNEUMOVAX23. The reporter did not have any information about the dates, length of time or site of hospitalization. The outcome of event was unknown. Additional information has been requested.
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a "third party representative for Pharmacy" refers to a male patient of unknown age. On 31-AUG-2012 the patient was vaccinated with PNEUMOVAX23 (lot # 1947AA, expiry date on 20-OCT-2013). On an unknown date the patient was hospitalized after receiving PNEUMOVAX23. The reporter did not have any information about the dates, length of time or site of hospitalization. The outcome of event was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTP, MMRV
Symptoms: Gait disturbance, Mobility decreased, Somnolence
Clinical narrative: Patient showed signs of limping with his right leg. Appears to not be able to bend the leg at the knee. No significant pain seems to be present. No swelling, no redness or bruises. Shots were administered on both arms. Two on left arm and 1 on right arm. I was only able to see the "limping" after he woke up late the following day after the shots. He also slept more then usual. Did not show signs of fever or the such.  As per doctor, I applied cold compresses on the knee area and muscle ointment to see if any improvement would occur with in the following 24 hrs. A day and a half after seeing the effects there is little improvement, still limping, no bending of knee when walking. He is able to fold/bend knee when sitting down and does not complain of pain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Swelling, pain and redness at immunization site. Approximately 2 inches x 3 inches red welt.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Gingivitis
Clinical narrative: Pt has bacterial gingivitis, had pharyngitis (unknown etiology, negative strep-rapid and culture, cough (known RSV only in 5 months age, no known resp since. Given amoxicillin, IM Kinrix (Tdap+IPV), Varicella, and MMR.
Age: 0.34
Sex: F
Vaccine: HIBV, MMR
Symptoms: Abasia, Feeling hot, Pyrexia, Tongue paralysis
Clinical narrative: Could not walk, could not seat, fever, sticking out her tongue, the back of her legs get heat up. Treated fever with infant fever-reducer. The fever came down but she still could not walk or seat up straight.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Blood glucose normal, Convulsion, Fall, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Approx 5 min. after receiving immunizations, fell to floor and began seizing. Legs stiff, hands clenched, elbows bent with forearms up to chest. Lasted approx 15-20 sec. Alert as soon as "came to" 140/80 pulse 85 SPO2 98% BS - 85 had not eaten lunch. (Guardian reported pt has seized in past when coming down with flu). EMS called and arrived.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, Incorrect dose administered, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report as received from a 30 year old nursing student regarding herself who was possibly allergic to anesthesia. Pertinent medical history was none. On 19-JUN-2013, the patient went to her physician's office to receive Dose 2 of VARIVAX (Merck) (Lot number was not reported, expired date 14-JUN-2013, dose was not reported) subcutaneously in the arm. After it was administered the office nurse realized the dose had already expired. When the office nurse realized the VARIVAX (Merck) was expired, she administered another dose of VARIVAX (Lot number, expiry date and dose were not reported) which was not expired during the same visit but in the nursing student's opposite arm subcutaneously. Concomitant therapies included NUVARING. Approximately on 20-JUN-2013 (reported as the following day), the patient developed hives at the injection site of both arms that were round, raised, itchy and hot to the touch. The patient sought medical attention, went to a clinic and was prescribed prednisone, hydroxyzine, and BENADRYL. The patient mentioned that she had also received a Purified Protein Derivative (PPD) test on 19-JUN-2013, prior to receiving VARIVAX (Merck). She was told by the clinic not to start the medications until after she received the results of her PPD test. Lab diagnostic test performed was none. Currently the injection site areas were not raised but were sometimes itchy. The patient also stated that when she received first dose of VARIVAX (Merck) on an unspecified date, she did not have any adverse symptoms. The event developed hives at the injection site of both arms that were round, raised, itchy and hot to the touch was reported as recovering/resolving. Legal issue was involved and the adverse event was sent to legal team. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Tuberculin test
Clinical narrative: This spontaneous report as received from a 30 year old nursing student regarding herself who was possibly allergic to anesthesia. Pertinent medical history was none. On 19-JUN-2013, the patient went to her physician's office to receive Dose 2 of VARIVAX (Merck) (Lot number was not reported, expired date 14-JUN-2013, dose was not reported) subcutaneously in the arm. After it was administered the office nurse realized the dose had already expired. When the office nurse realized the VARIVAX (Merck) was expired, she administered another dose of VARIVAX (Lot number, expiry date and dose were not reported) which was not expired during the same visit but in the nursing student's opposite arm subcutaneously. Concomitant therapies included NUVARING. Approximately on 20-JUN-2013 (reported as the following day), the patient developed hives at the injection site of both arms that were round, raised, itchy and hot to the touch. The patient sought medical attention, went to a clinic and was prescribed prednisone, hydroxyzine, and BENADRYL. The patient mentioned that she had also received a Purified Protein Derivative (PPD) test on 19-JUN-2013, prior to receiving VARIVAX (Merck). She was told by the clinic not to start the medications until after she received the results of her PPD test. Lab diagnostic test performed was none. Currently the injection site areas were not raised but were sometimes itchy. The patient also stated that when she received first dose of VARIVAX (Merck) on an unspecified date, she did not have any adverse symptoms. The event developed hives at the injection site of both arms that were round, raised, itchy and hot to the touch was reported as recovering/resolving. Legal issue was involved and the adverse event was sent to legal team. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lethargy
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. The patient's medical history include depression. On an unknown date the patient was vaccinated with GARDASIL dose 1, 0.5 ml, (lot number and expiry date not provided) intramuscular. The physician also noted that the patient had received an unspecified vaccine at the same time. On an unknown date the patient experienced feeling lethargic (hospitalization). The physician reported that the patient/consumer was seen at the unspecified hospital and released. It was not specified whether or not the hospital treatment was an ER visit or an admission to the hospital. The outcome of feeling lethargic is unknown. The reporter did not assess the relationship between the event and GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. It was reported that on an unknown date, the patient may have vaccinated with a dose of an improperly stored M-M-R II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse event was reported. This is one of the two reports from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hearing impaired, Pain of skin, Skin burning sensation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On approximately 17-MAY-2013, reported as about 6 weeks ago, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). Concomitant therapy was not reported. It was reported that recently, in 2013, the patient developed stinging and burning in her scalp and felt it was affecting her hearing. The patient sought medical attention by contact the pharmacy and no treatment was given for the adverse events. At the time of the report, the patient's outcome was reported as not recovered. Upon internal review the adverse event affecting her hearing was considered an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. On 15-NOV-2012, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 24-JAN-2013, the patient was vaccinated with the second dose of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 22-MAR-2013 (about 5 weeks early), the patient was vaccinated with the third dose of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 74.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 74 year old patient. On 28-JUN-2013 the patient was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (Lot # not reported), instead of ZOSTAVAX. No adverse effect reported. It was not known if the patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Fungal test
Clinical narrative: This spontaneous report as received from a mother regarding her 15 year old daughter who is allergic to BACTRIM. Pertinent medical history was none. On 03-FEB-2013, the patient was vaccinated with a second dose of GARDASIL. Concomitant medications were none. Approximately on an unknown date in March 2013 (reported as 4-6 weeks later) the patient experienced alopecia. The patient did not receive her third dose of vaccine. Therapy with GARDASIL was discontinued. Patient sought medical attention (seen a dermatologist) Alopecia has gotten worse. Swab was taken to see if there was any fungal infection (results were not provided). The patient was treated with scalpel injections and was wearing a human hair wig. The outcome of alopecia was reported as not recovered/not resolved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose, frequency and indication unspecified). On an unknown date the patient inadvertently received ZOSTAVAX instead of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Viral infection
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old female child patient. On an unknown date in June 2013 the patient was vaccinated with PROQUAD (merck) (lot # not reported) injection, 0.5 ml, subcutaneous. On an unknown date in June 2013 (also reported as "within past month"), the child ran fever after receiving vaccination and demonstrated signs of a viral infection that resolved itself within a few days. The patient had been in the office for a wellness exam. No treatment was given to the patient. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date (reported as more than a year ago), the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date was not reported, route was intramuscular). On 27-JUN-2013, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date was not reported, route was intramuscular) which was off schedule. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 year old female patient. On 03-AUG-2011, the patient was vaccinated with a first dose of GARDASIL (lot number was reported as 0306AA, expiry date: 10-MAY-2013, dose and route were not reported) and on 24-JUN-2013, the patient was vaccinated with a second dose of GARDASIL (lot # H021861, expiry date: 09-OCT-2015, dose and route were not reported). No adverse effect reported. Additional information has been requested.