chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Mother noticed pt. was limping this morning. Pt. showed mother the area on her left thigh. Mother stopped by the clinic with the pt. requesting someone asses the area where she received her vaccines yesterday. Mom states that pt. has a large red circle that is hot. Pt. received 2 injections yesterday, Kinrix and Proquad. The site of the Proquad injection is red and inflamed, warm to touch and measures 5 cm in diameter. No treatment given.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Erythema, Local swelling, Pain, Skin warm
Clinical narrative: STARTED HAVING CHILLS AND ACHY WHICH SHE ATTRIBUTED TO THE AFLURIA SHOT ON THE MORNING OF 12/11/14, BUT THE REDNESS, SWELLING, AND WARM TO THE TOUCH ON HER RIGHT ARM DID NOT START UNTIL NOON OF 12/11/2014 AND HAS GOTTEN WORST TODAY 12/12/2014.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Pain
Clinical narrative: Greater discomfort than usual at time of vaccine administration; later experienced pain radiating to shoulder and upper back and chest; later experienced pain from shoulder to hand.  Evaluated in person by health care provider on 11/24/14, 12/1/14 and by phone by health care provider on 12/10/14.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema
Clinical narrative: Left upper arm has erythema, approx. 2 in by 6 in encircling front part of upper arm distally from deltoid.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red rash on cheeks and fore head of patient.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Dyspnoea, Mass, Papule, Rash
Clinical narrative: Patient experienced extreme shortness of breath and asthma attacks for 2 days, as well as series of rashes that started off as papules (non-leaking) and turned to a hard solid mass that was tender, red and itchy.  Currently the rash is still present but not raised.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: Patient experienced extreme shortness of breath and asthma attacks for 2 days, as well as series of rashes that started off as papules (non-leaking) and turned to a hard solid mass that was tender, red and itchy.  Currently the rash is still present but not raised.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Condition aggravated, Dyspnoea, Hyperaesthesia, Injection site reaction
Clinical narrative: Patient experienced extreme shortness of breath and asthma attacks for 2 days, as well as series of rashes that started off as papules (non-leaking) and turned to a hard solid mass that was tender, red and itchy.  Currently the rash is still present but not raised.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Papule, Rash, Rash erythematous
Clinical narrative: Patient experienced extreme shortness of breath and asthma attacks for 2 days, as well as series of rashes that started off as papules (non-leaking) and turned to a hard solid mass that was tender, red and itchy.  Currently the rash is still present but not raised.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site mass, Injection site warmth, Pain
Clinical narrative: Patient presented with lump on arm, on or near injection site. No discoloration noted, but warm to touch. Patient complaining of some pain, but not too bad.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pins and needles in right foot, acute severe pain, with no previous nerve pain or diagnosis of neuropathy. Did not take any medication after vaccination before pain started.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Severe pain right upper arm/shoulder spreading around area of injection. Difficulty lifting arm and moving arm certain directions. Tingling skin on forearm/hand. Worsening as time goes by. Scheduled an orthopedic appointment for Monday 12/15/2014.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REPORTED TO PHARMACY THAT SHE WAS NOT FEELING WELL, HAVING FEVER, AND HAD SOME INJECTION SITE SWELLING APPROXIMATELY 24 HOURS AFTER RECEIVING THE VACCINE. SHE CONTINUED TO RUN A FEVER AND HAVE PAIN IN HER ARM OVER THE FOLLOWING 48 HOURS. ON THE FOURTH DAY FOLLOWING THE VACCINE, SHE CAME IN TO THE PHARMACY WITH A RASH AROUND THE INJECTION, WHICH SHE DESCRIBED AS BEING WARM AND PAINFUL. SHE WAS TOLD TO GO URGENT CARE, WHICH SHE DID. THERE SHE WAS DIAGNOSED WITH CELLULITIS AND GIVEN ANTIBIOTICS.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: PATIENT REPORTED TO PHARMACY THAT SHE WAS NOT FEELING WELL, HAVING FEVER, AND HAD SOME INJECTION SITE SWELLING APPROXIMATELY 24 HOURS AFTER RECEIVING THE VACCINE. SHE CONTINUED TO RUN A FEVER AND HAVE PAIN IN HER ARM OVER THE FOLLOWING 48 HOURS. ON THE FOURTH DAY FOLLOWING THE VACCINE, SHE CAME IN TO THE PHARMACY WITH A RASH AROUND THE INJECTION, WHICH SHE DESCRIBED AS BEING WARM AND PAINFUL. SHE WAS TOLD TO GO URGENT CARE, WHICH SHE DID. THERE SHE WAS DIAGNOSED WITH CELLULITIS AND GIVEN ANTIBIOTICS.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Little red on site of shingle vaccination.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Vomiting
Clinical narrative: Vomiting, body aches.  Vomiting from 3:00am until 7:00am.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Eye pain, Feeling cold, Hypersensitivity, Myalgia
Clinical narrative: Skin hypersensitivity, chills, muscle aches, dizziness, sore eye muscles, cerebral pulsing sensation, but no headache. 500mg acetaminophen taken at 8:00pm. Awaiting results of improvement.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Sensory disturbance
Clinical narrative: Skin hypersensitivity, chills, muscle aches, dizziness, sore eye muscles, cerebral pulsing sensation, but no headache. 500mg acetaminophen taken at 8:00pm. Awaiting results of improvement.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a healthcare worker (the patient's father) via company representative refers to a female patient of unknown age. On an unknown date (approximately 3-5 years ago), the patient was vaccinated with the first and second dose of GARDASIL (dose, lot #, expiration date, route and site of administration were not reported). On an unknown date, after the second dose of GARDASIL, the patient started having seizures. The patient was treated with unknown seizure medication (and continued taking the medications at the time of the report). The patient sought medical attention, she was having follow up appointments with a physician. It was unknown if the patient was ever admitted to the hospital. The outcome of seizures was unknown. The relatedness between the event and therapy with GARDASIL was not reported. Upon internal review, seizures were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient "in her 80's". Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneously in the "back part of her arm". Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On an unknown date the patient developed swelling at injection site. The patient sought medical attention. Patient was admitted to unknown hospital on an unknown date and treated and released to home. The outcome of swelling at injection site was reported as recovered (on an unknown date). Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site only.
Age: 85.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Pt stated his arm became red, hot and itchy by the afternoon the day he received his vaccine. Pt evaluated 7 days later sx still visible.
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient came in 12/12/14 and reported the fact that she has been her Dr now 3 times since 10/9/14 d/T ill effects. Patient complained of arm soreness, radiating from shoulder up to neck. Dr seems to believe related to vaccine and recommends physical therapy.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: The patient says his left shoulder area has been hurting with pain since 10/4/2014. He just told me today 12/12/2014. He said the area where the shot was given does not have a lump or discoloration and does not hurt to touch. He said the worst pain is when he sleeps on it or putting on a shirt. The patient will check with his doctor 12/19/14.
Age: 0.43
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Exposure during breast feeding
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of diarrhea in a female infant exposed to FLULAVAL in utero. The parent received the product. The patient's medical history included hiccups. Concurrent medical conditions included food allergy (Allergy to dairy, soy, corn and egg diagnosed by an allergist but not considered as true allergies) and dietary control (strict diet due to food intolerance). On 24th October 2014, the mother received FLULAVAL. On 24th October 2014, the dose was an unknown dose. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was diagnosed with diarrhea (serious criteria clinically significant/ intervention required). On an unknown date, the infant experienced vaccine exposure via breast milk. The infant was treated with medication unknown (Hydration (Unknown)). On an unknown date, the outcome of the diarrhea was not recovered/not resolved and the outcome of the vaccine exposure via breast milk was unknown. It was unknown if the reporter considered the diarrhea and vaccine exposure via breast milk to be related to FLULAVAL. Additional information: The patient was exposed to FLULAVAL via breast milk. Patient's mother (physician) received the vaccine at the hospital she works at on 24th October 2014 between 10 am and 1 pm because of standard work protocol. On 25 October 2014 in the evening, 1 day after patient's mother received the vaccine, the patient was fed with the milk her mother pumped and experienced diarrhea. She had to be changed twice. The patient received additional breast milk since she refused to take formula.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site joint pain, Insomnia, Neuralgia, X-ray normal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Current condition of patient included osteoporosis and thyroid. No relevant medical history was reported. Drug reactions or allergies were reported as none. On 09-OCT-2014, patient was administered with ZOSTAVAX (subcutaneous, lot # K008880, expiry date 09-SEP-2015). On an unknown date approximately in 2014, 4 weeks prior to administration of ZOSTAVAX the patient was administered with a dose of an unspecified Influenza virus vaccine (manufacturer unknown), in an unspecified arm. Concomitant medication reported was unspecified osteoporosis and thyroid medication. Patient began to experience severe pain in the elbow of her injection arm, on an unspecified date, following the vaccination. Pharmacist reports that the patient cannot sleep because of the pain. Also patient clarified that she was not actually having pain in her elbow, she believes that she can pinpoint the nerve in which she feels the pain. The patient was seen by unspecified physician on an unspecified date due to the severe elbow pain. The physician administered a cortisone (manufacturer unknown) injection to the patient's elbow to treat the pain and also an x-ray of her elbow was performed, on an unspecified date. Pharmacist reported that the cortisone (manufacturer unknown) injection did nothing to treat the patient's pain and nothing was found on the x-ray. Sought medical attention was reported as yes. The pharmacist does not know if the patient had consulted the physician since she realized that the cortisone (manufacturer unknown) injection did not relieve her pain in her elbow. The patient had not recovered, and no additional information was provided. The outcome of cannot sleep because of pain, severe pain in elbow of her injection arm and she can pinpoint the nerve in which she feels the pain was reported as not resolved. This is one of the 2 reports from the same source related via same patient link (MARRS case # 1411USA012759). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLUX, MMR, TD, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer (patient's husband) refers to a 28 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. In 2012 (exact date unspecified, during October and November of 2012) the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # unspecified), M-M-R II (dose, route and lot # unspecified), TD vaccine (manufacture unknown) (dose, route and lot # unspecified) and influenza virus vaccine (unspecified) (manufacture unknown) while pregnant with LMP (last menstrual period) of approximately 23-OCT-2012 (reported as about 5 weeks ago) and an EDD (estimated delivery date) of 30-JUL-2013. Initial exposure to VARIVAX (Merck), M-M-R II, TD (manufacture unknown) and influenza virus vaccine (unspecified) (manufacture unknown) was at 5 weeks. The patient was "fine" and had not experienced any adverse effects. No treatment was given for adverse events. The patient was maintaining the pregnancy. The patient had done home pregnancy test (in 2012, exact date unspecified) and did not seek medical attention. Follow-up attempt has been made but the correspondence was returned due to not deliverable as addressed unable to forward. Additional information has been requested.
Age: 0.65
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 7 and a half months year male patient. On 16-SEP-2014 the patient was vaccinated with a first dose of ROTATEQ oral, 1 dose (lot # not reported). On 16-SEP-2014 the patient received his first dose of oral ROTATEQ at age of 7 and a half months. no adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date in 2014 (reported as after 24-NOV-2014), the patients were vaccinated with doses of improperly stored ROTATEQ (lot#, expiry date, dose, frequency unspecified). No adverse events were reported. No PQC involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a pharmacist who reported that a 62 year old male consumer who on 04-NOV-2014 received a dose of ZOSTAVAX (lot number K012921, expiry 29-NOV-2015) 0.65 ml subcutaneously (location not specified). Concomitant medications included lisinopril (manufacturer unknown) 20 mg. The pharmacist reported that the patient contacted him on 24-NOV-2014 and reported that he had developed a rash with lesions that started on his left leg on 24-NOV-2014 and then spread to his right leg and up his trunk on an unspecified date after receiving a dose of ZOSTAVAX. The pharmacist stated that the "lesions" that are on both of the patient's legs and up his trunk are "about an inch long and a half and an inch wide". The pharmacist also stated that the patient reported that the lesions are painful (unspecified date of when the pain started). The pharmacist reported that the patient also received AFLURIA on the same day he received a dose of ZOSTAVAX. As of the time of reporting, the patient had not yet recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Nausea, Vomiting
Clinical narrative: Patient received Hep B vaccine at place of employment. Approximately 20 minutes later patient began complaining of low energy. Shortly after she became nauseated and had 2 episodes of vomiting. At this point patient was released from duty and was driven home by a coworker. patient states she did not seek any further medical attention.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Muscle spasms
Clinical narrative: A spontaneous report was received from an 83 year old male consumer who on 11-NOV-2014 received an injection of ZOSTAVAX for the prevention of shingles. Concomitant medications included DELTAZINE and ramipril. The patient stated he had no pertinent medical history. On 14-NOV-2014 (reported as three days after receiving ZOSTAVAX, he began experiencing muscle cramps in his neck and shoulders and he had difficulty sleeping. He was treated with hot/cold packs and went to a massage therapist. The outcome of the events was recovering. Additional information is not expected as the patient did not provided contact details.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Myalgia
Clinical narrative: Hives, erythema, warmth/redness at site of injection. Muscle soreness on entire arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: 11/14/14 12 pm Redness, swelling and hardness - extending about size of softball. Itchy, arm was hot to touch. Applied lavender essential oil to site through out day and Epson salt bath in evening (800pm) juiced many vegetables and gave probiotics. 11/15/14 Arm swell to 25 cm circumference compared to other ar, at 7 cm. 11/16/14 Redness decreased swelling decreasing at top of arm and increasing at elbow joint. 11/23/14 arm almost back to normal.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: 11/14/14 12 pm Redness, swelling and hardness - extending about size of softball. Itchy, arm was hot to touch. Applied lavender essential oil to site through out day and Epson salt bath in evening (800pm) juiced many vegetables and gave probiotics. 11/15/14 Arm swell to 25 cm circumference compared to other ar, at 7 cm. 11/16/14 Redness decreased swelling decreasing at top of arm and increasing at elbow joint. 11/23/14 arm almost back to normal.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: 12/5/14 - PC from mom, states that pt had severe abdominal pain resulting in MD visit with Dr. Mom states pt was given something to drink with lidocaine in it. Abd. pain x 48 hrs. Mom states looking back this occurred after 1st dose also no MD visit. Same adverse events also occurred with pt's sister - no MD visit needed.
Age: 79.0
Sex: M
Vaccine: VARZOS, FLU3
Symptoms: Herpes zoster, Injection site erythema, Injection site infection, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old patient. The patient's medical history included weight loss in 2013 (exact date unspecified) which was discovered to be related to low testosterone level and had been corrected since. Patient's historical medication included AFLURIA on 14-OCT-2014. The patient had none drug reactions or allergies. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, subcutaneous, lot # K012921, expiry date: 29-NOV-2015, in the arm). Concomitant therapies included fluoxetine, fentanyl, zolpidem tartrate, methimazole and metoprolol XL. On 04-DEC-2014 the patient showed pharmacist his arm, where injection was administered: arm was swollen, red, sore, hurt, looked like infection like shingles but no blisters or pustules showing. On 13-NOV-2014 the patient received cortisone injection for unspecified reason. The reporter stated, that on an unknown date, the patient underwent screening for ZOSTAVAX administration and never had serious reaction to vaccines. The outcome of events was reported as not recovered. The patient sought medical attention via contacting the pharmacist. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS, FLU3
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old patient. The patient's medical history included weight loss in 2013 (exact date unspecified) which was discovered to be related to low testosterone level and had been corrected since. Patient's historical medication included AFLURIA on 14-OCT-2014. The patient had none drug reactions or allergies. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, subcutaneous, lot # K012921, expiry date: 29-NOV-2015, in the arm). Concomitant therapies included fluoxetine, fentanyl, zolpidem tartrate, methimazole and metoprolol XL. On 04-DEC-2014 the patient showed pharmacist his arm, where injection was administered: arm was swollen, red, sore, hurt, looked like infection like shingles but no blisters or pustules showing. On 13-NOV-2014 the patient received cortisone injection for unspecified reason. The reporter stated, that on an unknown date, the patient underwent screening for ZOSTAVAX administration and never had serious reaction to vaccines. The outcome of events was reported as not recovered. The patient sought medical attention via contacting the pharmacist. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS, FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old patient. The patient's medical history included weight loss in 2013 (exact date unspecified) which was discovered to be related to low testosterone level and had been corrected since. Patient's historical medication included AFLURIA on 14-OCT-2014. The patient had none drug reactions or allergies. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, subcutaneous, lot # K012921, expiry date: 29-NOV-2015, in the arm). Concomitant therapies included fluoxetine, fentanyl, zolpidem tartrate, methimazole and metoprolol XL. On 04-DEC-2014 the patient showed pharmacist his arm, where injection was administered: arm was swollen, red, sore, hurt, looked like infection like shingles but no blisters or pustules showing. On 13-NOV-2014 the patient received cortisone injection for unspecified reason. The reporter stated, that on an unknown date, the patient underwent screening for ZOSTAVAX administration and never had serious reaction to vaccines. The outcome of events was reported as not recovered. The patient sought medical attention via contacting the pharmacist. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 82 year old female with allergies to NSAIDS ANAPROX, ZOMAX, and TOLECTIN. Concomitant medications include hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), LEVOXYL, omeprazole (manufacturer unknown) and simvastatin (manufacturer unknown). Pertinent medical history was reported as none. On 18-NOV-2014 the patient received a dose of PNEUMOVAX 23 (lot # K009874, expiration 21-JAN-2016) 0.5 mg intramuscularly in the left arm for prevention of pneumonia. The same night after receiving her dose of the vaccine, the patient developed swelling and warmth in her left shoulder. The swelling had spread to the patient's left upper breast and there was red "streaking" from the patient's left upper arm to her left upper breast. The patient sought medical attention on 20-NOV-2014 and the nurse reported that the patient was diagnosed with cellulitis by the nurse practitioner after the patient had been seen. The patient was treated with KEFLEX and the patient was instructed to apply warm compresses to the area. The outcome of cellulitis was not reported. Intervention to prevent serious criteria was no. The initial lot number was reported as K009105 expiring 21-JN-2015. However, lot was corrected to K009874 expires 21-JAN-2016 by registered nurse. Additional information is expected.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 82 year old female with allergies to NSAIDS ANAPROX, ZOMAX, and TOLECTIN. Concomitant medications include hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), LEVOXYL, omeprazole (manufacturer unknown) and simvastatin (manufacturer unknown). Pertinent medical history was reported as none. On 18-NOV-2014 the patient received a dose of PNEUMOVAX 23 (lot # K009874, expiration 21-JAN-2016) 0.5 mg intramuscularly in the left arm for prevention of pneumonia. The same night after receiving her dose of the vaccine, the patient developed swelling and warmth in her left shoulder. The swelling had spread to the patient's left upper breast and there was red "streaking" from the patient's left upper arm to her left upper breast. The patient sought medical attention on 20-NOV-2014 and the nurse reported that the patient was diagnosed with cellulitis by the nurse practitioner after the patient had been seen. The patient was treated with KEFLEX and the patient was instructed to apply warm compresses to the area. The outcome of cellulitis was not reported. Intervention to prevent serious criteria was no. The initial lot number was reported as K009105 expiring 21-JN-2015. However, lot was corrected to K009874 expires 21-JAN-2016 by registered nurse. Additional information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number, expiration date were not reported). On an unknown date, the patient experienced vesicular rash at the injection site. The outcome of vesicular rash at the injection site was unknown. Relatedness between vesicular rash at the injection site and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rubella
Clinical narrative: Pt was given MMR vaccine on 11/24/14 (Neg Rubeola titer 11/5/14 - Mumps and Rubella were +); reports that on 12/6/14 she developed rash to chest and trunk, was diagnosed with "German Measles" (Rubella) by PCP on 12/8/14. Reports fever of 102.8; no meds from PCP per pt.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3" x 3" erythremic swollen warm/tender area (R) deltoid. Fatigue, fever, headache, nausea.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: 3" x 3" erythremic swollen warm/tender area (R) deltoid. Fatigue, fever, headache, nausea.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: (R) arm red, swollen and tender. Fever 102.8. No diarrhea or vomiting. Appetite is good.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis, received antibiotic treatment.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Nausea, Nervousness, Vomiting
Clinical narrative: Patient received Hep B vaccine at place of employment. Approximately 15 minutes later patient began complaining of nausea and feeling shaky. Within 10 minutes she stated she vomited. Shortly after she began having trouble breathing, and EMS was contacted. Patient refused transport and patient was released from duty. Patient states she did not seek any further medical attention.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the certified medical assistant (healthcare worker) refers to a patient of unknown age and gender. On 26-NPV-2014 improperly stored PEDVAXHIB (lot # K002746, dose, frequency and expiration date not reported) was administered to the patient. No adverse events were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received on 20-NOV-2014 from a pharmacist refers to a female patient of unknown age. On 03-NOV-2014 the patient was vaccinated with an expired dose ZOSTAVAX (lot # H016762, expiration date 11-DEC-2013), 0.65 ml, subcutaneous. No adverse experience was reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the certified medical assistant (healthcare worker) refers to a patient of unknown age and gender. On 26-NOV-2014 improperly stored LIQUID PEDVAXHIB (lot # K002746, dose, frequency and expiration date not reported) was administered to the patient. No adverse events were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-DEC-2014 the patient was vaccinated with MMR II dose, expiry in April 2013 (lot #, route not reported). On 04-DEC-2014 the patient was administered an expired dose of MMR II. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from the patient's mother refers to a 4 year old (also reported as "3 and a half years old") male patient. Concurrent conditions, medical history and allergies were not reported. On an unspecified date approximately in 2011, the patient received the first dose of (Merck) VARIVAX, strength, dose, route, frequency, anatomical location, lot number and expiration date were not reported), when he was one and a half years old. The patient however experienced a mild case of chickenpox where there was an outbreak at his preschool in the spring of 2014 when the patient was three and a half years of age (conflicting information). Patient's mother took the patient to this physician and the patient was vaccinated with (Merck) VARIVAX, (strength, dose, route, frequency, anatomical location, lot number and expiration date were not reported), second dose at three and a half years of age (conflicting information). Lab diagnostics studies were not performed and treatment was not given. No further information was provided. The outcome of the above mentioned events was unknown. Additional information is not expected, patient's mother and physician contact information were not provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date in 2014 (reported as after 24-NOV-2014), the patients were vaccinated with doses of improperly stored GARDASIL (lot#, expiry date, dose, frequency unspecified). No adverse events were reported. No PQC involved. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the certified medical assistant (healthcare worker) refers to a patient of unknown age and gender. On 26-NOV-2014 improperly stored GARDASIL (lot # K004205, expiration date 12-JAN-2017, dose and frequency not reported) was administered to the patient. No adverse events were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 04-DEC-2014 the patient was vaccinated with an expired dose of ZOSTAVAX lot # K000455, expiry date: 30-OCT-2014, 0.65 ml subcutaneously. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with GARDASIL 9dose, route, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with doses of GARDASIL that had been exposed to supported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Muscle strain, Rash
Clinical narrative: A spontaneous report was received from a 65 year old female consumer who on 27-AUG-2014 received ZOSTAVAX in her upper arm (lot # not reported). Concomitant medications included tramadol, amlodipine besylate, alprazolam, carisoprodol and omeprazole. She is allergic to sulfa. She stated she had no pertinent medical history. in the first week of November 2014, she developed rash like bumps. She explained that she has a curvature in her back and she strained her back doing gardening in September 2014. Since then, she was always able to use ice or heating pads on her back to ease the pain. But in the first week of November 2014, whenever she used the ice packs she would get a strong burning sensation. She would have to stop using them immediately. This has been going on for about two weeks now. The female described the rash and "little pimple-like bumps" on her back from the spine going up her side. It is about five or six inches long in length. She stated her chiropractor stated that it looked like a rash on her back. She did not seek medical attention for the events. The outcome of the events were unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from 67 year old male patient reporting on himself with high cholesterol and none drug reactions or allergies. On unknown date reported as "a few years ago" the patient was vaccinated with a single dose of ZOSTAVAX injection (dose, lot #, expiration date and route not reported). Concomitant therapy included ZOCOR. On 08-NOV-2014 reported as "this past Saturday" the patient developed shingles after receiving ZOSTAVAX. The patient was treated with prednisone (manufacturer unknown) and acyclovir. The patient sought medical attention office visit. There were no laboratories diagnostic test performed. At the time of the report the patient had not recovered from shingles. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with PNEUMOVAX 23 (dose, route, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with doses of PNEUMOVAX 23 that had been exposed to supported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with VAQTA (dose, route, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with doses of VAQTA that had been exposed to supported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with MMR II (dose, route, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with MMR II that had been exposed to unsupported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with sulfonamide allergy. On 18-NOV-2014 the patient was vaccinated with ZOSTAVAX (lot # K009199, expiration 27-SEP-2015), 0.65 ml, subcutaneous. Concomitant therapies included metoprolol (manufacturer unknown), lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), amlodipine (manufacturer unknown), ABILIFY, LUVOX, FLECTOR, LUMIGAN, OXYCONTIN, PERCOCET, EPIPEN, albuterol (manufacturer unknown), LYRICA, AMRIX, baclofen (manufacturer unknown), AMBIEN and lidocaine (manufacturer unknown). On 19-NOV-2014, the patient developed redness, warmth and hard "knot" at the injection site after receiving ZOSTAVAX. On 20-NOV-2014, the patient went in to the pharmacy to show the pharmacist her symptoms. The outcome of redness, warmth and hard "knot" at the injection site was reported as not recovered. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was receivd from a nurse regarding a 12 year old male patient. There was no information on medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with M-M-R II (dose, route, product lot#, expiry date not reported) and two measles virus vaccine live (product details not provided). No adverse effects had been observed or reported. The reporter did not clarify in which location or on which dates the immunization were administered and did not agree that there was any misuse. The reporter also enquired about administrating PROQUAD (Merck) to the patient to complete the rubella and mumps vaccinations so that the patient would receive 2 doses of mumps and rubella vaccine. There was no product quality complaint involved. The outcome of the event was unknown. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a other health professional concerning a patient of unspecified age and gender. It was reported that on 17OCT0214 a patients was vaccinated with an expired dose of VARIVAX (Merck). No adverse events were reported. The outcome of the event was unknown. Additional information is expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with ROTATEQ oral (dose, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with doses ROTATEQ that had been exposed to supported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-NOV-2014, an expired dose of ZOSTAVAX (lot # 0168AE, expiration date: 13-SEP-2013)(Dose and route not reported) was inadvertently administered to the patient. No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical receptionist refers to a 80 year old female patient. In March 2008 the patient was vaccinated with ZOSTAVAX (lot # 659323/1613U) (dose and route not reported). On 05-NOV-2014 the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention in the emergency room and was treated with VALTREX. The outcome of the event was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a patient's parent via a research as part of a marketing research program, refers to a 16 year old female patient. Concurrent conditions, medical history and allergies were not reported. Patient's parent indicated that husband's fraternity brother from college days, had a 16 year old daughter who recently (date not specified) was vaccinated with GARDASIL, (strength, route, dose, frequency, anatomical location, lot number and expiration date were not reported) and "was not the same afterwards". No specific details were reported. Additional information was not provided. The outcome of the event was unknown. The reporter stated that it was unknown if the event was related to GARDASIL. Additional information is not expected, because the reporter did not consent further follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a publicist representative refers to a female patient of unknown age. Information about concurrent conditions and medical history was not provided. On 07-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, lot, batch # and expiration date not reported) subcutaneously. Therapy reason for use reported as vaccination. Co-suspect and concomitant therapies were not reported. On 10-NOV-2014 the patient called the pharmacist and stated that she had redness and swelling in the same arm in which she received a dose of ZOSTAVAX although it was not around the injection site. As a treatment for the event  were applied warm compress. Lab diagnostics studies were not performed. The patient sought medical attention by calling the pharmacist. The outcome of the events was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult female patient (exact age was not provided). Patient's medical history was not reported. On an unknown dates also reported as when "she was 20 years old", the patient was vaccinated with her first two doses of GARDASIL (frequency, route of administration and lot # were not provided). Concomitant medication was not reported. The patient stated that she would like to receive her third dose of GARDASIL. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 31 patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, 31 patients were vaccinated with improperly stored GARDASIL (dose, route, lot# were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a 42 year old female patient refers to herself. Information about concurrent conditions, concomitant medication and medical history was not provided. On 09-DEC-2014 the patient was inadvertently given GARDASIL (injection, 1 single shot, lot#, expiry date and route were not provided) instead of an unspecified "whooping cough" vaccine. The single shot of GARDASIL was administered by an unspecified nurse. The patient was 35 weeks pregnant at the time of the vaccination. The last menstrual period (LMP) date was approximately 08-APR-2014 and estimated delivery date (EDD) was approximately 13-JAN-2015. The pregnancy outcome was outcome pending. The patient said that she had an anxiety attack on 09-DEC-2014 when she was told of this by a physician at the practice. No other side effects were indicated. The outcome of "anxiety attack" was not provided. Additional information is not expected because no contact information was provided.
Sex: U
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The healthcare worker stated that on 09-JUN-2011 the patient was vaccinated with GARDASIL, intramuscular injection, dose 1, (strength, dose, anatomical location, lot number and expiration date were not reported). On 05-JAN-2012 the patient was vaccinated with GARDASIL, intramuscular injection, dose 2, (strength, dose, anatomical location, lot number and expiration date were not reported) and on 26-NOV-2014 the patient was vaccinated with GARDASIL, intramuscular injection, dose 3, (strength, dose, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. No further information was provided. Additional information is not expected, because the reporter not consent additional follow up.