chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a certified medical assistant (C.M.A.) refers to a 37 year old female patient with no pertinent medical history or drug reactions/allergies. On an unspecified date in August 2013, the patient was vaccinated with her first dose of GARDASIL inj (dose, route and lot number not provided). On an unspecified date in October 2013 or November 2013, the patient was vaccinated with her second dose of GARDASIL (dose, route and lot number not provided). No co-suspect therapy was reported. There was no concomitant medication. The reporter stated that the patient became pregnant with last menstrual period (LMP) of 17-FEB-2014 and Estimated Due Date (EDD) of 24-NOV-2014. The vaccine exposure was during the first trimester. The pregnancy outcome was pending and the fetal outcome was unknown. The outcome of vaccine exposure during pregnancy was unknown. The reporter stated that the patient received the first and second doses of GARDASIL from another unspecified facility. No treatment was given for the adverse event. No lab diagnostics studies were performed. The patient sought medical attention by visiting the office. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Rash generalised, Rash vesicular, Skin warm
Clinical narrative: This spontaneous report refers to a 61 year old female patient concern to herself with penicillin allergy, allergy to narcotic medication and latex sensitivity. On 05-MAY-2014, the patient was vaccination with ZOSTAVAX for vaccine, injection for prevention shingles (dose and route not reported). Concomitant therapies included losartan potassium (manufacturer unknown) and WELLBUTRIN. It was reported that the patient began having severe nerve pain on 05-MAY-2014 (reported as last night), that went from her breastbone to her back. On 06-MAY-2014 (reported as this morning), when the patient was showering she noticed a rash similar to chickenpox under her breasts, under her arms, all over her back, and down her face. Her body was warm all over. The patient was not treated. The patient did not sought medical attention. The patient would be calling her physician on 06-MAY-2014 (reported as today). Patient's present status was not improved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 68 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (route, lot number, expiration date, strength and dose not reported). No other relevant medical history and no concomitant medications were reported. The reproter stated that two weeks after being vaccinated with ZOSTAVAX, the patient returned to the office and was diagnosed with "shingles". No other specific symptoms were provided. The reproter also stated that the patient did not have any immune system conditions prior to the administration of the ZOSTAVAX. The outcome of the shingles was reported as recovered/resolved. No further relevant information was provided. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of newborn patients of unknown age and gender. Medical history and concurrent conditions were not reported. Between 18-OCT-2013 to 11-NOV-2013, the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that an unknown number of newborn patients were administered RECOMBIVAX HB, between 18-OCT-2013 to 11-NOV-2013, that had been improperly stored. No adverse effects reported. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an 11 month old patient of unknown gender. No medical history or concurrent conditions were provided. On an unspecified date, the patient was vaccinated with VARIVAX (Merck), subcutaneous route (Dose, strength and lot number not provided). Co-suspect or concomitant therapies were not reported. On an unspecified date, the patient may have received VARIVAX (Merck), two days prior to 12 months of age. No adverse effect was reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received vaccine approved for 4-6 yrs. of age. Pt tolerated the vaccine with no adverse affects post event. Dr spoke with parents, giving then current info, they have appt on 6.5.14.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Feeling hot, Headache, Urticaria
Clinical narrative: Patient told me that she began to have a headache on Sunday (4/27) after taking her first dose. She said that today she has hives and feels hot.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling 3" area, at injection site, told patient to use ice. Patient also contacted her MD and MD agreed with ice. Pt. also complained about area being warm, but not painful.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, swollen, fever.
Age: 40.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Menstruation delayed, Pregnancy test urine positive
Clinical narrative: Pt received MMR vaccine. Following vaccination, patient's niece reports that patient is late for menses. She denied pregnancy to nurse. UPT done and it was positive.
Age: 20.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Local swelling, Pruritus
Clinical narrative: Cellulitis to (R) arm, redness, swelling and itching.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Eye irritation, Lacrimation increased
Clinical narrative: (Bilateral) Sx - watering eyes, burning eyes on 4-28-14. On 5-5-14 progressively worse then given ABX with steroid, on 5-9-14 saw a corneal specialist and was given steroid eye drop and to d/c the ABX. Return to clinic 5-13-14, was currently diagnosed with dry eye.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fall
Clinical narrative: Pt complained of dizziness about 10 minutes after receiving the BOOSTRIX vaccine. Pt fell down and ambulance was summoned.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt received KINRIX on 05/07/14 to left thigh having a reaction of an erythema measurements of a 22 cm long and 15 cm wide. Area warm to touch and hard.
Age: 35.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Pt received varicella vaccine SQ in Rt arm (back) 5-7-14 #1. 5-9-14 pt came to clinic due to a red raised 1.5 x 1.5 inch circle. Warm to touch. Patient says not as bad as earlier this AM. FNP-BC checked site and recomm. cool compresses. Inst. if site worsens to go to ED this weekend. Patient agreed.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Hypopnoea
Clinical narrative: 15 min after administration patient reported HA - feeling weak - some dizziness. 5 min after this reported shallow breathing and difficulty breathing. Treatment: 125mg SOLU-MEDROL IM and BENADRYL 50mg IM. Patient given prednisone 60mg x 3 days - instructed to take BENADRYL 25mg po Q 4-6 hrs for next 24h, ZANTAC 150mg BID x 3 day.
Sex: M
Vaccine: HEP
Symptoms: Anti-cyclic citrullinated peptide antibody negative, C-reactive protein normal, Fatigue, Myalgia, Red blood cell sedimentation rate increased
Clinical narrative: Hep B vaccine #1 given on 2/14/14 2 days later suffered severe full body myalgias and fatigue, still having symptoms at office visit on 4/15. Seen by rheumatology on 4/10.
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: Large area of redness/swelling at injection sites 17 hours after vaccinating. Sites warm to touch. Worsening of symptoms at 48 hours. Swelling subsiding at 72 hours.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Blister
Clinical narrative: 1 x 1 cm clear vesicle.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient said her whole arm swelled and turned red and had turned back to normal today 5/9/14, it was also painful.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Consciousness fluctuating, Feeling abnormal, Syncope
Clinical narrative: Received call from child health clerical dept. States client was fainting in and out. Pt states she felt funny. VS 109/75 P-58 at 11:25 a and again at 11:30 AM 106/75 P-61. Cool cloth applied for 10-15 min. Client able to walk out with no difficulty.
Age: 70.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Fatigue, Headache, Lymph node pain, Lymphadenopathy, Palpitations
Clinical narrative: Client experience tender to swollen lymph nodes in her neck within about 6 hours of time she received the vaccines. She also experienced extreme fatigue, HA, racing heart.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Blood test, Crying, Dizziness, Headache, Pain in extremity
Clinical narrative: pain in  left arm, facial swelling , headache,dizzness, crying , high feavers
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Swelling face
Clinical narrative: pain in  left arm, facial swelling , headache,dizzness, crying , high feavers
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen area at injection site. Hot and itchy. Approximately 3 inches by 6 inches. Applied ice packs and anti-itch cream (hydrocortisone and Sarna).
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Anaemia, Blood test, Constipation, Large intestinal haemorrhage, Pharyngeal oedema
Clinical narrative: Hives, swelling of face and throat. Went to emergency room multiple times to treat continued problems with swelling and hives. Over a course of more than a month he was given epinephrine shot, treated with antihistamines and steroids. Eventually led to problems with constipation that led to bleeding in colon, so much so that he became anemic. Still having problems with that.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives, swelling of face and throat. Went to emergency room multiple times to treat continued problems with swelling and hives. Over a course of more than a month he was given epinephrine shot, treated with antihistamines and steroids. Eventually led to problems with constipation that led to bleeding in colon, so much so that he became anemic. Still having problems with that.
Age: 34.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Pain
Clinical narrative: I woke up to severe shoulder pain. I have had limited used in my left arm. In certain movements cry out in pain. My shoulder pain is nonstop. I am just in my first week of severe shoulder pain when I researched and found this info.  (I was told i needed 4 shots by health dept., not knowing what to do - i agreed to get them if my insurance would pay for them, thinking what could it hurt) the nurse was very tall, "standing above me" in an office not the usual lab area" told me to hand my arm down "almost touching the floor" so my muscle would be loose- i never questioned her except in my own mind, until now!!! I have NEVER had any shoulder injury or pain in my shoulder. I have been explaining to family how it feels more like a shoulder injury rather than a soreness  from a shot- I've been dumbfounded and in PAIN ALL WEEK. I don't even know what to do -Will start by going to the doctor and i imagine have to have a MRI--
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Chicken Pox like rash on legs.
Age: 33.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Back pain, Chills, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Pain in arm immediately following vaccination. Pain spread to neck and back. Followed by fever, chills, extreme fatigue and body soreness, rapid heart beat and some difficulty breathing. Red, bumps on forearm.
Age: 33.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Immediate post-injection reaction, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm immediately following vaccination. Pain spread to neck and back. Followed by fever, chills, extreme fatigue and body soreness, rapid heart beat and some difficulty breathing. Red, bumps on forearm.
Age: 33.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Rash erythematous
Clinical narrative: Pain in arm immediately following vaccination. Pain spread to neck and back. Followed by fever, chills, extreme fatigue and body soreness, rapid heart beat and some difficulty breathing. Red, bumps on forearm.
Age: 33.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Pain in arm immediately following vaccination. Pain spread to neck and back. Followed by fever, chills, extreme fatigue and body soreness, rapid heart beat and some difficulty breathing. Red, bumps on forearm.
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache
Clinical narrative: This spontaneous report was received from a male patient of unknown age with hepatitis c reporting on himself. On an unknown date, the patient was vaccinated with pneumonia vaccine (manufacturer unknown) (dose and frequency unknown). Confirmation could not have been made if the pneumonia vaccine was PNEUMOVAX 23. On an unknown date, the day after vaccination, the patient experienced some mild symptoms. He experienced a slight headache and shivers, but the symptoms had gone away, the patient recovered (date unknown). The relationship between adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that it is possible that ROTATEQ (dose strength, route, was not reported) dose was administered to the patients on an unspecified date after a cumulative temperature excursion of 123 hrs at 10C. No adverse effect reported. The outcome of the events reported is unknown. No product quality complaint was involved. Nurse also informed that with multiple excursion for three different sites with the vaccine reported. Nurse requested letter of evaluation data by e-mail to her. It was also reported that adverse event was filed as one site may have administered product involved in cumulative excursion. No product quality complaint. 10C was sum or total 122.5 hours ROTATEQ no, product was received January 2014. 51 hours at 10C ROTATEQ No.1.2C for 11 hours ROTATEQ yes. This case is linked to the cases 1404USA015151, 1404USA005087, 1405USA005088 via same reporter link. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. No information about medical history concurrent conditions and concomitant medications were reported. On 07-MAY-2014 the patient was vaccinated with an improperly stored ZOSTAVAX dose 0.65 ml, route subcutaneous. The reporter also stated that the ZOSTAVAX reached a high temperature of 19F for a total of 14 hours over multiple excursions. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1405USA005084 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On 05-MAY-2014 the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX dose 0.5 ml, route subcutaneous. The reporter also stated that the (Oka/Merck) VARIVAX reached a high temperature of 19F for a total of 14 hours over multiple excursions. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1405USA004602 via same reporter link. 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 nurse refers to unspecified patients of unkonwn demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that it is possible that GARDASIL (dose, strength, route, was not reported) dose was administered to the patients on an unspecified date after a cumulative temperature excursion of 123 hrs at 10C. No adverse effect reported. The outcome of the events reported is unknown. No product quality complaint was involved. Nurse also informed that with multiple excursion for three different sites with the vaccine reported. Nurse requested letter of evaluation data by e-mailed to her. It was also reported that adverse event was filed as one site may have administered product involved in cumulative excursion. No product quality complaint. 10C was sum or total 122.5 hours GARDASIL. No product was received January 2014. 9C for total 31 hours GARDASIL. No excursion. 1.2C for 11 hours GARDASIL Yes. This case is linked to the cases 1404USA015151, 1405USA005086, 1405USA005088 via same reporter link. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that it is possible that VAQTA (dose strength, route, was not reported) dose was administered to the patients on an unspecified date after a cumulative temperature excursion of 123 hrs at 10C. No adverse effect reported. The outcome of the events reported is unknown. No product quality complaint was involved. Nurse also informed that with multiple excursion for three different sites with the vaccine reported. Nurse requested letter of evaluation data by e-mailed to her. It was also reported that adverse event was filed as one site may have administered product involved in cumulative excursion. No product quality complaint. 10C was sum or total 122.5 hours VAQTA no, product was received January 2014. 9C for total 31 hours VAQTA yes. This case is linked to the cases 1405USA005087, 1405USA005086, 1405USA005088 via same reporter link. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that it is possible that M-M-RR II (dose strength, route, was not reported) dose was administered to the patients on an unspecified date after a cumulative temperature excursion of 123 hrs at 10C. No adverse effect reported. The outcome of the events reported is unknown. No product quality complaint was involved. Nurse also informed that with multiple excursion for three different sites with the vaccine reported. Nurse requested letter of evaluation data by e-mailed to her. It was also reported that adverse event was filed as one site may have administered product involved in cumulative excursion. 51 hours at 10C M-M-R II No1.2C for 11 hours M-M-R II No excursion. This case is linked to the cases 1404USA015151, 1405USA005087, 1405USA005086 via same reporter link. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 3 days after vaccine administration ZOSTAVAX, patient presented to pharmacy w/ a red, tender area approx 2 inches in diameter surrounding the injection site on left arm. He denied swelling, denied that it was spreading/worsening. Advised to use Ibuprofen or NAPROXEN OTC and apply ice x 2-3 days, then seek medical care if no improvement after this time.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site, (+) erythema (9 x 11.5 cm), tenderness.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient presented on 05-09-14 with a red painful area 4 inches diameter around injection site. There also was a dime-sized, raised, black area at center. Pt advised to see dr., who diagnosed shingles and prescribed famciclovir and BACTRIM DS.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented on 05-09-14 with a red painful area 4 inches diameter around injection site. There also was a dime-sized, raised, black area at center. Pt advised to see dr., who diagnosed shingles and prescribed famciclovir and BACTRIM DS.
Age: 1.84
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Herpes zoster
Clinical narrative: Developed shingles at age 2 after receiving varicella vaccine an never having chicken pox.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Echocardiogram, Electroencephalogram, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: Stared off to side. Loss of consciousness, turned blue, not responsive for 3 minutes.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Stared off to side. Loss of consciousness, turned blue, not responsive for 3 minutes.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Swelling face, Urticaria, Vomiting
Clinical narrative: Vomiting, hives started on left leg then moved upward towards the neck and face. Face completely swollen.
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal discomfort, Fatigue, Pyrexia
Clinical narrative: Upset stomach, fatigue, feverish.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at and around injection site on back of arm.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: HIGH FEVER; 103 DEGREES (ARMPIT, DIGITAL) 3 DAYS AND COUNTING...
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Sx: Pt reported rash at injection site. Rash continued to spread and he was seen at ER 5-8-14. On 5-9-14 pt spoke to MD and was admitted to hospital.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and drug reactions were not reported. On 06-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H014561, expiration date 21-MAR-2014, dose, route were unknown). Other Concomitant Medications were not reported. The pharmacist reported that the patient was administered an expired dose of PNEUMOVAX 23. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles, Measles antibody positive, Mumps antibody test negative, Product quality issue, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a physician refers to a now 50 year old female patient with no pertinent medical history or drug reactions/allergies. On an unknown date the patient, as a child, was vaccinated with a dose of MMR II (lot # unknown). There was no concomitant therapy. On an unknown date, about 6 months to 1 year later, the patient got measles. The patient told the physician the MMR II, she may have received as a child at that time there was "a problem with the vaccine lot and it was in the news". The patient's titer currently were as follows: mumps titer was less than 5, measles titer was over 400 and rubella was over 4.5. It was reported the patient was new to this physician's practice and the patient did not have vaccination record dates. The physician stated that his was "historical" information that patient provided that was told to the patient by the patient's mother. The physician did not have any other information. The outcome of the events were unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician refers to unspecified patients of unknown ages and genders. On an unknown dates unspecified patients were vaccinated with ZOSTAVAX (Lot # unspecified) (dose, frequency and route unspecified). The pharmacy technician stated that unspecified patients that received ZOSTAVAX on unspecified dates experienced injection site reactions that involved "a big red bump the size of a lemon that itched" at injections site on unspecified dates. Outcome of the events were unknown. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant via the company representative refers to a 61 year old male patient. On 01- APR-2014 the patient was vaccinated with one dose of ZOSTAVAX (Lot # reported as J010447, Exp date unspecified) shot in the arm for the prevention of shingles (dose, frequency and route unspecified). Concomitant therapies included amoxicillin (manufacturer, dose and frequency unspecified), MOTRIN, 800 mg, atorvastatin (manufacturer, dose and frequency unspecified), and NORVASC dose and frequency unspecified). On 15-APR-2014, after receiving ZOSTAVAX, the patient broke out with shingles. Patient visited to office for medical attention. The event was treated with acyclovir (manufacturer, dose and frequency unspecified). No lab diagnostics studies performed. Seven days after the outbreak of shingles, "the spots were drying up" and that the patient had begun recovering. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itching and burning at injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Pt rec ZOSTAVAX 5/8/14. Pt presented with several small swollen areas (size of small peas) in injection site area on 5/11/14.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Pt received vaccine on 5-9-14. She called on 5-11 complaining of redness and swelling in the area around the where the vaccine was given. Recommended calling family physician on Monday to see if treatment is needed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site reaction, Rash erythematous
Clinical narrative: After 6 to 7 days patient went to urgent care w/dark red rash around injection site (3 inches x 1.5 inches). Dx: Cellulitis and given course of KEFLEX. Strength and frequency not known.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, FLU3, HEPA, HPV4, MNQ
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: Case number PHHY2014US047059 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519780) web site on 14 Apr 2014 with a follow up information received from the quality assurance department (QA reference number: 295259) on 30 Apr 2014. This report refers to a 16 year old female patient. She had no known drug allergy or any medical condition. Her vaccination history included FLUMIST (other manufacturer) in the last year. She was vaccinated with MENVEO, (batch number: M13016, expiry date:Sep 2014) into left arm, FLUZONE (other manufacturer, batch number: UH952AA) into left arm, GARDASIL (other manufacturer, batch number: J014295) into right arm and HAVRIX (other manufacturer, batch number: 494G5) into right arm on 17 Jan 2014. She was vaccinated as per physician's recommendation. On the same day after completion of vaccination, she passed out and slid sideways on the table but did not hit floor. She did not lose consciousness. She was under physician's observation for one hour. On the same day, she was sent home. The outcome of the event was reported as complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH. The causality was not reported. Upon follow up receipt from the quality assurance department (reference number: 295259), it was reported that based on the documents review, the MENVEO batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up information received from the quality assurance department (QA reference number: 295259) on 22 Apr 2014: QA number updated. Follow up information received from the quality assurance department (QA reference number: 295259) on 30 Apr 2014: Expiry date of vaccine and batch summary updated.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, FLU3, HEPA, HPV4, MNQ
Symptoms: Fall, Loss of consciousness
Clinical narrative: Case number PHHY2014US047059 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 519780) web site on 14 Apr 2014 with a follow up information received from the quality assurance department (QA reference number: 295259) on 30 Apr 2014. This report refers to a 16 year old female patient. She had no known drug allergy or any medical condition. Her vaccination history included FLUMIST (other manufacturer) in the last year. She was vaccinated with MENVEO, (batch number: M13016, expiry date:Sep 2014) into left arm, FLUZONE (other manufacturer, batch number: UH952AA) into left arm, GARDASIL (other manufacturer, batch number: J014295) into right arm and HAVRIX (other manufacturer, batch number: 494G5) into right arm on 17 Jan 2014. She was vaccinated as per physician's recommendation. On the same day after completion of vaccination, she passed out and slid sideways on the table but did not hit floor. She did not lose consciousness. She was under physician's observation for one hour. On the same day, she was sent home. The outcome of the event was reported as complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH. The causality was not reported. Upon follow up receipt from the quality assurance department (reference number: 295259), it was reported that based on the documents review, the MENVEO batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up information received from the quality assurance department (QA reference number: 295259) on 22 Apr 2014: QA number updated. Follow up information received from the quality assurance department (QA reference number: 295259) on 30 Apr 2014: Expiry date of vaccine and batch summary updated.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Abdominal X-ray, Barium enema, Enema administration, Haematochezia, Intussusception
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported). No concomitant medication was reported. It was stated that 5 days after received the first dose of ROTATEQ, on an unknown date, the patient developed intussusception. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. The relatedness for intussusception and ROTATEQ was unknown. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Ultrasound abdomen, Vomiting, X-ray gastrointestinal tract
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported). No concomitant medication was reported. It was stated that 5 days after received the first dose of ROTATEQ, on an unknown date, the patient developed intussusception. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. The relatedness for intussusception and ROTATEQ was unknown. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported). No concomitant medication was reported. It was stated that 5 days after received the first dose of ROTATEQ, on an unknown date, the patient developed intussusception. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. The relatedness for intussusception and ROTATEQ was unknown. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Back pain, Chills, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Immediately felt pain radiating up neck and down right arm. Later in day and for two days following, arm to sore to hold up. Pain subsiding now. No redness, no heat at injection site.
Age: 33.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Immediate post-injection reaction, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Immediately felt pain radiating up neck and down right arm. Later in day and for two days following, arm to sore to hold up. Pain subsiding now. No redness, no heat at injection site.
Age: 33.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Rash erythematous
Clinical narrative: Immediately felt pain radiating up neck and down right arm. Later in day and for two days following, arm to sore to hold up. Pain subsiding now. No redness, no heat at injection site.
Age: 33.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Immediately felt pain radiating up neck and down right arm. Later in day and for two days following, arm to sore to hold up. Pain subsiding now. No redness, no heat at injection site.
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a male child patient of unknown age. On 17-MAR-2014, the patient was vaccinated with M-M-R II, route-injection, (dose, strength and lot number not reported). No concomitant medication reported. It was reported that the company representative was in a group setting and was told a story by the reporting physician about a recent unspecified male patient that he administered a vaccine of with M-M-R II to. The child left the office after the injection, but on 17-MAR-2014, the patient came back with hives (Hospitalization) (medically significant). The physician administered epinephrine and sent the child to the hospital. Patient sought medical attention. There was no product quality complaint (PQC) involved. The outcome of hives was reported as improving after epinephrine administration. Causality between M-M-R II and the event hives was not reported. Upon internal review the event of hives was also considered as medically significant. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Blood test, Blood urine present, Haemorrhage subcutaneous, Rash generalised
Clinical narrative: Broke out in rash that was raised starting with legs and arms and spread to back, torso and face. Broken blood vessels behind right knee
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Abasia, Arthralgia, Decreased appetite, Henoch-Schonlein purpura, Injection site rash
Clinical narrative: Broke out in rash that was raised starting with legs and arms and spread to back, torso and face. Broken blood vessels behind right knee
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pain in extremity, Pyrexia, Rash generalised, Red blood cells urine positive, Vascular injury
Clinical narrative: Broke out in rash that was raised starting with legs and arms and spread to back, torso and face. Broken blood vessels behind right knee
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Vomiting, White blood cells urine positive
Clinical narrative: Broke out in rash that was raised starting with legs and arms and spread to back, torso and face. Broken blood vessels behind right knee
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: CSF pressure increased, CSF test normal, Computerised tomogram head normal, Headache, Injection site erythema
Clinical narrative: Local injection site erythema, myalgia, headache with elevated intracranial pressure.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Intracranial pressure increased, Leukocytosis, Myalgia, White blood cell count increased
Clinical narrative: Local injection site erythema, myalgia, headache with elevated intracranial pressure.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest discomfort, Chills, Cold sweat, Computerised tomogram head, Dyspnoea
Clinical narrative: Local injection site erythema, myalgia, headache with elevated intracranial pressure.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: Local injection site erythema, myalgia, headache with elevated intracranial pressure.
Age: 25.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Local injection site erythema, myalgia, headache with elevated intracranial pressure.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient developed redness on the left thigh, that progressively became larger and more painful and pruritic. She was placed on antibiotic and given Claritin for itching.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: Initial case received on 05 May 2014 from a health care professional. A 9-year-old male patient, with no reported medical history and no reported concomitant medication, had received 5 doses of DTaP vaccine: the first dose on 25 August 2004, the second dose on 28 October 2004, the third dose on 28 December 2004, the fourth dose on 29 December 2005 and the fifth dose on 16 June 2008. (Manufacturers, batch numbers, sites and routes of administration were not reported). It was stated that on 29 April 2014, lab results indicated that the patient had pertussis. Complementary investigation results were not reported. Symptoms were not described. The outcome of the event was unknown. This case is linked with case # 2014SA058749, which was reported from the same facility on the same day. Documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Initial generalized itching followed by whole body rash.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray, Computerised tomogram, Condition aggravated, Crepitations, Dyspnoea
Clinical narrative: My arm was burning to the bone, popping, snapping and very painful in left arm behind injection area. I started swelling up my arm and then into my neck area and then started having pain in my throat area. I also was having trouble breathing. This has continued.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Emphysema, Infection, Injection site pain, Laboratory test, Local swelling
Clinical narrative: My arm was burning to the bone, popping, snapping and very painful in left arm behind injection area. I started swelling up my arm and then into my neck area and then started having pain in my throat area. I also was having trouble breathing. This has continued.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Oropharyngeal pain, Oxygen saturation decreased, Pain, Pain in extremity
Clinical narrative: My arm was burning to the bone, popping, snapping and very painful in left arm behind injection area. I started swelling up my arm and then into my neck area and then started having pain in my throat area. I also was having trouble breathing. This has continued.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Scan with contrast, Tendon rupture
Clinical narrative: My arm was burning to the bone, popping, snapping and very painful in left arm behind injection area. I started swelling up my arm and then into my neck area and then started having pain in my throat area. I also was having trouble breathing. This has continued.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Adhesion, Immediate post-injection reaction, Inflammation, Injection site pain
Clinical narrative: Pain during injection of the flu vaccine and extreme pain immediately after injection at the injection site (upper 1/3 of deltoid muscle).  The pain has never gone away. Decreased range of motion. Can not perform simple activities of daily living without help.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Pain during injection of the flu vaccine and extreme pain immediately after injection at the injection site (upper 1/3 of deltoid muscle).  The pain has never gone away. Decreased range of motion. Can not perform simple activities of daily living without help.
Age: 52.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Erythema, Local swelling
Clinical narrative: Patient reports that hours after receiving the injection she developed swelling and redness to her arm.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. Concomitant medication and pertinent medical history is not provided. On 22-APR-2014, an expired dose of ZOSTAVAX (dose and lot number were unknown) was vaccinated on the patient for the first time, subcutaneously. On 02-MAY-2014, a repeat dose of ZOSTAVAX (lot number not reported) was administered 10 days subcutaneously after the first dose. No adverse effect was reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. Medical history and drug reactions or allergies were not specified. On an unknown date in April 2014, reported as last week, the patient might have been vaccinated with a dose of improperly stored ZOSTAVAX lot # J002241, expiry date 21-MAY-2014 (dose, frequency and route not specified). No adverse effects were reported. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 21 year old female patient with no drug reaction and allergies reported. Information regarding concomitant therapy, concurrent conditions and medical history was not reported. On an unknown date the patient started therapy with GARDASIL. On 15-MAY-2014 the patient received an expired dose of GARDASIL (lot #666929/0331Z, expiration: 20-NOV-2012, 0.5 ml, intramuscular) as her third dose in the series. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 3 years and 3 month old male patient. The patient's medical history was not reported. In approximately April 2013 the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, anatomical location, lot#, expiration date not provided). Patient's age at the time of first vaccine dose administration was 2 years and 3 months. On 04-APR-2014 the patient received his second dose of M-M-R II (dose, route of administration, anatomical location, lot#, expiration date not provided). At the time of second vaccine dose administration he was 3 years and 3 months old. No adverse effect reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old female patient. Certified medical assistant called to report temperature excursion involving VARIVAX (Merck) stored at to 9.5F for 2 hours on 11-APR-2014. The patient received injection with involved product VARIVAX (Merck) (0.5 ml, subcutaneously, lot# not reported) on 21-APR-2014. It was not clarified which dose in the complete series of VARIVAX (Merck) was administered on 21-APR-2014. No adverse effect was reported. The case is linked to MARRS# 1404USA013313 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. In December 2013 the patient was vaccinated with GARDASIL (dose strength was not reported) dose 1, intramuscular. On 28-APR-2014 the patient was vaccinated with GARDASIL dose 2, intramuscular. No concomitant medication was reported. No adverse effect reported. No product quality complaint was reported. The outcome of patient received her first dose of GARDASIL in December 2013 and her second dose 28-APR-2014 was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age and gender. On an unknown date, 3 unspecified patients were vaccinated with VARIVAX (Merck) injection, (dose, route of administration and indication were not provided) that was improperly stored. No adverse effects reported. No product quality complaint was involved. The outcome of events was unknown. No further information was provided. Additional information has been requested.