chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Headache, Mobility decreased, Pain
Clinical narrative: 12:30am (11/15/17) woke to upset stomach, freezing, shaking, body aches, severe headache and  vomiting (6 times) until 5:30am. Headache lasted throughout the day (11/15/17) as well as weakness and body aches. Unable to leave the bed. Next day (Thursday 11/16/17) moves to the couch and was able to move around. Friday 11/17/17 was almost myself.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Tri-iodothyronine free normal, Vomiting
Clinical narrative: 12:30am (11/15/17) woke to upset stomach, freezing, shaking, body aches, severe headache and  vomiting (6 times) until 5:30am. Headache lasted throughout the day (11/15/17) as well as weakness and body aches. Unable to leave the bed. Next day (Thursday 11/16/17) moves to the couch and was able to move around. Friday 11/17/17 was almost myself.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Patient reacted with a localized infection at the injection site. Her prescriber had prescribed Cephalexin 500mg, 1 qid x 1 week on 11/15/17. Patient stopped by pharmacy on 11/19/17 to report infection was resolving itself since being on antibiotic and didn't indicate any other discomfort or issues.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: A few hours after injection, area skin felt itchy, (The injection site was close to my BCG scar). I checked in the mirror and saw a small red bump. The itchiness lasted until the next day and gradually subsided. The last time I checked, the skin was red with a couple of bumps.
Age: 81.0
Sex: M
Vaccine: FLUR4
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm, possible ache in shoulder area, achy legs (my usual negative reaction to Rx), fatigue. Sore arm ceased 11/19/2017.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient continues to experience soreness 2 weeks after the FLUZONE QUAD was administered. Soreness experienced from should to half way down to elbow.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling abnormal, Headache, Neck pain, Pyrexia
Clinical narrative: Swollen, warm-to-touch at the site of the vaccine, fever of 101.0 degrees F, cloudy mind, sore neck/head, dizzy, symptoms lasted a total of 24 hours.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen, warm-to-touch at the site of the vaccine, fever of 101.0 degrees F, cloudy mind, sore neck/head, dizzy, symptoms lasted a total of 24 hours.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Myalgia
Clinical narrative: Pain and redness on bicep after injection in deltoid. I'd be happy to send a photo if desired.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Flatulence, Fluid intake reduced
Clinical narrative: Vaccination at 11:45am. 4:30pm, patient's wife reported chills and nausea and asked if it is a possible side effect of the vaccination and asked for a refill of his omeprazole. 5:00pm, spoke with the patient and he said the needed the omeprazole for gas feeling. The feeling occurs every now and then and is relieved by omeprazole. Per wife: The chills and diarrhea progressively worsened until 2am. Wednesday 8th when was too weak to get up and 911 was called. Patient was taken to the hospital and admitted until Monday 13th. Note: Patient's wife indicated to the pharmacy that the hospital said he was "messed up by the shingles vaccine". The patient's wife said no treatment was given at home and the patient did not drink any or much water.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Vaccination at 11:45am. 4:30pm, patient's wife reported chills and nausea and asked if it is a possible side effect of the vaccination and asked for a refill of his omeprazole. 5:00pm, spoke with the patient and he said the needed the omeprazole for gas feeling. The feeling occurs every now and then and is relieved by omeprazole. Per wife: The chills and diarrhea progressively worsened until 2am. Wednesday 8th when was too weak to get up and 911 was called. Patient was taken to the hospital and admitted until Monday 13th. Note: Patient's wife indicated to the pharmacy that the hospital said he was "messed up by the shingles vaccine". The patient's wife said no treatment was given at home and the patient did not drink any or much water.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: The evening after vaccine was administered the patient says she experienced pain, redness and slight swelling at the injection site. She also said she experience chills and shaking. As time went on the patient said the injection site area become redder and the swelling increased. Patient said the swelling traveled from the injection site down to her forearm and when she presented in the pharmacy, 2 days post vaccination, her arm was red and slightly swollen in the tricep area. The actual area where the injection was administered did not look red or swollen but the patient said it was still painful. The area from her elbow to the upper forearm was very swollen (tennis ball size) and dark in color. Patient says it is painful but she can move her elbow.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin discolouration, Tremor
Clinical narrative: The evening after vaccine was administered the patient says she experienced pain, redness and slight swelling at the injection site. She also said she experience chills and shaking. As time went on the patient said the injection site area become redder and the swelling increased. Patient said the swelling traveled from the injection site down to her forearm and when she presented in the pharmacy, 2 days post vaccination, her arm was red and slightly swollen in the tricep area. The actual area where the injection was administered did not look red or swollen but the patient said it was still painful. The area from her elbow to the upper forearm was very swollen (tennis ball size) and dark in color. Patient says it is painful but she can move her elbow.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Red area around injection site; no soreness, no swelling, no pain.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome, Miller Fisher syndrome
Clinical narrative: GUILLAN BARRE SYNDROME -- MILLER FISHER VARIANT.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Peripheral swelling
Clinical narrative: Patient presented to the pharmacy on 11/16/17 with swollen right arm and stated that she had flu like symptoms the day before (11/15/17).
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: 8inch by 4inch red stripe all around the injection site.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: ARM HAS BEEN SORE SINCE VACCINE GIVEN.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Vaccination complication
Clinical narrative: Patient's wife came in and reported that the patient has suffered from chest congestion following his last immunization. She also claims that the same episode occurred last year after the same immunization. He had not suffered these symptoms when receiving the regular dose. Patient was seen by MD which informed him that his condition as a direct result from the immunization and prescribe cough medication.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling cold, Feeling hot, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediate reaction at time of injection, felt a sense of nerve reaction thru entire body, similar to contrast injection b/4 CT scans. Within a minute, sleepy, fatigued, muscles in neck, shoulders, back became achy. Felt feverish. Ended up with a temp of 100.3 for 24 hours. During the night, awoke hot and sweaty, later awoke freezing cold and shaking from head to toe. Felt ill for 24 hours. NSAID and TYLENOL didn't help.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Nervous system disorder, Pyrexia, Somnolence
Clinical narrative: Immediate reaction at time of injection, felt a sense of nerve reaction thru entire body, similar to contrast injection b/4 CT scans. Within a minute, sleepy, fatigued, muscles in neck, shoulders, back became achy. Felt feverish. Ended up with a temp of 100.3 for 24 hours. During the night, awoke hot and sweaty, later awoke freezing cold and shaking from head to toe. Felt ill for 24 hours. NSAID and TYLENOL didn't help.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Immediate reaction at time of injection, felt a sense of nerve reaction thru entire body, similar to contrast injection b/4 CT scans. Within a minute, sleepy, fatigued, muscles in neck, shoulders, back became achy. Felt feverish. Ended up with a temp of 100.3 for 24 hours. During the night, awoke hot and sweaty, later awoke freezing cold and shaking from head to toe. Felt ill for 24 hours. NSAID and TYLENOL didn't help.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood test, Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram
Clinical narrative: Patient stated a few hours after leaving store, her eyes got red, chest tightened, hard to breath and talk, legs and arms shaking, redness and knot in right arm at sight of injection.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site nodule, Ocular hyperaemia, Speech disorder, Tremor
Clinical narrative: Patient stated a few hours after leaving store, her eyes got red, chest tightened, hard to breath and talk, legs and arms shaking, redness and knot in right arm at sight of injection.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urine analysis
Clinical narrative: Patient stated a few hours after leaving store, her eyes got red, chest tightened, hard to breath and talk, legs and arms shaking, redness and knot in right arm at sight of injection.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Weight decreased
Clinical narrative: Pt describes she got massive/severe headaches. Different that what she usually got as far as location of the headache. Also reported weight loss, without trying to lose weight, lost 35 lbs, currently 107 lbs, (height = 5'7). Pt has recovered on the headache (does not happen anymore), have never regained her weight. Has talked to her MD about it, but they just attribute it to her COPD.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Fall, Head injury, Hyperhidrosis, Incoherent, Nervousness
Clinical narrative: Man received shot and got up to shop and about 2 to 3 minutes later he said he felt real shaky and then fell to the floor. He did not appear to lose consciousness but he was sweating, appeared incoherent and did not appear to be familiar with surroundings. A shopper reported he hit his head on the floor during the fall. As he became more responsive ~ 5 minutes he was sat in a chair at the spot and was given ice to apply to his head. He appeared alert in about 15-20 minutes and left. He said the injection did not hurt and at the time of the injection he did not feel differently. He said he gets shots for his back weekly and has no problems.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pruritus, Injection site urticaria, Lip swelling, Swelling face, Urticaria
Clinical narrative: SYMPTOMS: LEFT FACE AND LIP SWELLING, ITCHING IN EARS, HIVES AROUND SITE ON RIGHT ARM AND ABDOMEN. TREATMENT: BENADRYL 25MG IM X1 DOSE OUTCOME: FACIAL SWELLING GONE, HIVES GONE AND ITCHING GONE WITHIN 30 MINUTES OF ADMINISTRATION. NO OTHER COURSE OF TREATMENT NEEDED.
Age: 54.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Nodule, Pain in extremity
Clinical narrative: Patient called today November 19, 2017 stating she had soreness in her left arm and a small knot appeared on the same arm 2 days ago on Friday 11/18/2017. Pharmacist advised patient it was normal to have soreness after tetanus / Tdap immunization, but knotting would be unusual and any that is of concern should be referred to a doctor or her regular physician.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thyroiditis, Hypothyroidism
Clinical narrative: Hypothyroidism and Hashimoto's. No family history of either.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reported pain in left arm immediately following vaccination with difficulty moving her arm in an outward motion from her side. She had no difficulty moving lifting the arm in a forward motion. There were no signs of inflammation at the injection site. Ice pack was applied for 15 minutes. Patient had already taken ibuprofen before injection. I recommended ice packs, on for 15 minutes, off and on in intervals. Repeat dose of ibuprofen at appropriate interval.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: She came by after a couple hours and told me that she thought her arm was swollen, it did not look too swollen. We had told her to take some MOTRIN and BENADRYL. Next day, I had talked to a member of management about patient. She told me that her shoulder had swelled up to size of tangerine and she took day off to go to Dr. I called patient later at home, she said her doctor told her that she was probably allergic to it. Told her to apply heat every hour or so and continue MOTRIN. I followed up with patient 11/19 and she said her arm was back to normal couple days later after her shot.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Patient has experienced continued soreness and stiffness since the vaccine was administered over 3 weeks ago.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: The patient received her vaccine on 10/27/2017. She called our corporate headquarters on 11/19/2017 stating her arm has been sore for 3 weeks following vaccination. Our pharmacy supervisor is going to follow up with her and recommend she sees her family physician to evaluate the pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: INJECTION SITE RED AND WARM WITH NO PAIN, RECOMMENDED COLD PACK AND BENADRYL OTC.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient states that she has severe pain at site of injection and swelling that starts from site of injection and extends up towards her shoulder. Instructed patient to take BENADRYL for the swelling, acetaminophen for the pain and use a cold compress (ice pack) on affected area for pain and swelling. Called patient back in the afternoon that day (at 3:20 pm) and patient said that she took BENADRYL and used cold compress and feels much better, but still has some swelling.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: SHE INDICATED SHE STILL HAS MILD SORENESS IN HER MUSCLE FROM THE INJECTION AND THAT SHE NOTICED IN THE EVENING OF 11/13/2017 A RED "RASH" AREA NEAR THE SITE OF INJECTION.  SHE STATED THAT IT DID NOT ITCH, BUT SHE WAS CONCERNED ENOUGH TO RETURN TO THE PHARMACY. SHE INITIALLY STATED THAT THE RASH WAS WARM TO THE TOUCH, BUT THEN RECANTED THAT STATEMENT AND SAID HER HANDS ARE USUALLY COLD, THEREFORE SHE WAS NOT SURE IF IT WAS ACTUALLY WARM. WHEN SHE PRESENTED TO THE PHARMACY, THE PHARMACIST NOTED A BRUISE AT THE INJECTION SIGHT THAT HAD A SURROUNDING AREA OF YELLOW COLORED SKIN MARKING THE REABSORPTION OF THE RED BLOOD CELLS. ON THE DISTAL END OF THE INJECTION SITE BRUISE THERE IS A LARGE PINK BLOTCHY COLOR TO THE SKIN. IT IS ABOUT 2 INCHES WIDE AND 3 INCHES IN LENGTH. IT DID NOT FEEL NOTICEABLE WARM, BUT MY HANDS ARE USUALLY WARM. BELOW THE PINKISH AREA THERE WAS A YELLOW COLOR TO THE SKIN, LIKE ANOHER BRUISE WAS REABSORBING. SINCE THE PATIENT THOUGHT IT MIGHT HAVE BEEN WARM TO THE TOUCH, THE PHARMACIST RECOMMENDED SHE APPLY A TOPICAL ANTIBACTERIAL OINTMENT  AND CONTINUE TO WATCH FOR WROSENING SYMPTOMS. THE PATIENT RETURNED TO THE PHARMACY ON 11/17/2017 AND THE PINK AREA SHE REFERED TO AS A "RASH" WAS ALMOST COMPLETELY GONE. SHE SAID SHE HAD BEEN APPLYING THE ANTIBIOTIC OINTMENT AND SHE IS FEELING CONFIDENT SHE WILL NOT HAVE ANY FURTHER COMPLICATIONS.
Age: 44.0
Sex: U
Vaccine: HEP
Symptoms: Angioedema, Lip swelling
Clinical narrative: Angioedema - swelling of lips.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Extreme pain and difficulty in mobility. Took BENADRYL and TYLENOL to no avail. Condition worsened to date... Nov 19.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Malaise, Stupor
Clinical narrative: Headaches and malaise and feeling like in a stupor upon arising the next day after the vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Dyskinesia, Electroencephalogram normal, Eye movement disorder, Muscle spasms, Tremor
Clinical narrative: Not sure of the actual name/brand of each Vaccine. Not long after patient's shots, she started having spasms multiple times a day, almost every day. Mostly while falling asleep. Her eyes would roll back in head & her back would arch. She would start shaking/jerking in one arm, it would then move to her face, then the other arm. Sometimes her trunk would tremor as well as her legs. Lasting anywhere from 5-15 seconds if stopped. This would happen anytime of the day. Video proof available as well.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, swelling covering 3 inch area hot to touch about 1 inch away under vaccine site, lower spread to inner arm. (Left arm). Suggested after inspecting on 11/19 to visit PCP.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient called and presents with itching, rash and flare up on the right arm, extending from shoulder to elbow of arm where FLUZONE HD and PNEUMOVAX were given on 11/3/17. Pt had used Hydrocortisone but no improvement until told to use BENADRYL gel. Condition has improved and patient is okay.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Unusual bruising > 2 weeks.
Age: 38.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient called complaining of stiffness in the arm [upper] radiating to underarm. Started 1 week after shot and increasingly worst after approx. 2 wks.
Age: 38.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Patient called complaining of stiffness in the arm [upper] radiating to underarm. Started 1 week after shot and increasingly worst after approx. 2 wks.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Headache, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Headache and body aches 1-2 hrs after, arm swelled and couldn't bend at elbow and went to ER and diagnosed with cellulitis.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 4 years old patient (currently 5 years old) of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 15-SEP-2016, the patient was administered an expired PROQUAD, lot # L008356 with expiration date on 11-SEP-2016 (dose and route of administration were not reported). The administered dose of vaccine underwent an unknown temperature excursion prior to administration. Concomitant therapies included sterile diluent. The reporter noted the events occurred at another physician's office. No adverse effects were reported.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme pain in the shoulder area all the way to the left hand for several days. Pain didn't subside until strong painkiller prescription medication was ingested. Even after 2 weeks and daily dose of painkillers, I am still not able to lift my left arm (where I got the flu shot) fully.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner referring to a 13 year old female patient. The patient pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 17-OCT-2017, at 13 year-old,  the patient was prescribed and vaccinated with PROQUAD for prophylaxis (strength, dose, route, Lot # and expiration date were not reported). Only FDA approved per 12 "s". No prescription drug treatment was required for the experience and the patient was fine without symptoms ("Sx"). No adverse effects were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 18-OCT-2017 and 19-OCT-2017, were administered for prophylaxis improperly stored doses of VARIVAX with lot number N009768 and expiration date on 24-MAR-2019, M-M-R II with lot number M044350 and expiration date on 04-NOV-2018, and PROQUAD with lot number N009774 and expiration date on 20-SEP-2018. The vaccines were reconstituted with properly stored sterile diluent (MERCK) with lot number M046371 and expiration date on 06-JUL-2019. The reporter also stated that one dose of VARIVAX and M-M-R II were administered concomitantly while one dose of PROQUAD was separately administered. Information regarding dose, dose number and route of administration of the vaccines were not provided. It was reported that on unspecified dates, the vaccines were exposed to a temperature of 16 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA007662.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M011832, expiration date 25-JAN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit (34.4F) for 15 minutes. A digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA007834: US-009507513-1711USA007835: US-009507513-1711USA007836.
Age: 0.33
Sex: M
Vaccine: PPV, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M000592, expiration date 12-JAN-2017 (route of administration and anatomical location were not reported). No adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, No adverse event, Occupational exposure to product
Clinical narrative: This spontaneous report was received from a female nurse of unknown age reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. The reporter stated that on 26-OCT-2017, a dose of VARIVAX and sterile diluent (manufacturer unknown) "squirted" into her "hair, cheek, and eyelashes", while administering vaccine to an unspecified patient, however no adverse events reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to an approximately 17 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In 2011, the patient received his first dose of GARDASIL (route of administration, lot number and expiration date were not provided), for prophylaxis, and the patient was 11 years old. In August-2017, the patient received a dose of GARDASIL 9 for prophylaxis (route of administration, lot number and expiration date were not provided). No adverse effects were reported.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a 4 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. On 31-JUL-2017, the patient received another dose of improperly stored PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00235 with the expiration date of 26-OCT-2019) for prophylaxis. The administered doses of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This one of several reports received from the same reporter.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a 6 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a currently 80 year old female patient with diabetes, elevated creatinine, degenerative joint disease. On 27-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M013156 (dose number and route of administration were not reported), for prophylaxis. Administered vaccine expired on 15-OCT-2017. Concomitant therapies included NAPROSYN, metformin, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), TYLENOL, vitamins (unspecified) and triamcinolone cream. The patient had no laboratory data. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history. On 15-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (frequency and route of administration were not provided) lot # M024700, expiration date 18-JUL-2017 for prophylaxis. Concomitant therapies included sterile diluent. No adverse events were reported.
Age: 65.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 65 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 31-OCT-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB lot number M036156, expiration date 23-FEB-2019, for prophylaxis (route of administration was not reported). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In approximately 2016, the patient was vaccinated with a dose of GARDASIL 9 lot number H013831 (strength, dose, route and expiration date were not reported) for prophylaxis. It was reported that on approximately 08-NOV-2017, the patient was in the office for their second dose of GARDASIL 9. No adverse effects were reported. Lot number H013831 is an invalid lot number for GARDASIL 9. Follow up information has been received from the nurse on 14-NOV-2017. The reporter stated that patient was 12 years old.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Induration, Limb discomfort, Local reaction
Clinical narrative: This spontaneous report was received from a physician referring to a 70 year old female patient. The patient's relevant history, preexisting medical conditions and concomitant medications were reported unknown. On 07-NOV-2017 at 19:30, the patient was vaccinated with PNEUMOVAX 23 (reported as unknown if it was her first or a subsequent dose) (lot # N025656 expiry date 19-APR-2019) in the right deltoid for prophylaxis (dosing details unknown). On 08-NOV-2017, an hour ago, the patient woke from sleep and noted significant discomfort in her upper arm and her arm felt numb and heavy. She went to the emergency room where the physician noted the small red puncture mark on her deltoid and the entire area surrounding it is indurated for 10 centimeters all around so it's about 20 centimeters in diameter. Her shoulder is probably 3 centimeters thickened. There was no bruising or discoloration, no erythema, just tissue edema. As of 08-NOV-2017, it was unknown if she will continue to take PNEUMOVAX 23. The patient's events were considered as localized events. The patient was prescribed with BENADRYL and was told to check in with her primary care physician. The outcome of was reported as ongoing (not recovered). Causality assessment was not reported. The reporter considered the events to be serious (medically significant).
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Sleep disorder
Clinical narrative: This spontaneous report was received from a physician referring to a 70 year old female patient. The patient's relevant history, preexisting medical conditions and concomitant medications were reported unknown. On 07-NOV-2017 at 19:30, the patient was vaccinated with PNEUMOVAX 23 (reported as unknown if it was her first or a subsequent dose) (lot # N025656 expiry date 19-APR-2019) in the right deltoid for prophylaxis (dosing details unknown). On 08-NOV-2017, an hour ago, the patient woke from sleep and noted significant discomfort in her upper arm and her arm felt numb and heavy. She went to the emergency room where the physician noted the small red puncture mark on her deltoid and the entire area surrounding it is indurated for 10 centimeters all around so it's about 20 centimeters in diameter. Her shoulder is probably 3 centimeters thickened. There was no bruising or discoloration, no erythema, just tissue edema. As of 08-NOV-2017, it was unknown if she will continue to take PNEUMOVAX 23. The patient's events were considered as localized events. The patient was prescribed with BENADRYL and was told to check in with her primary care physician. The outcome of was reported as ongoing (not recovered). Causality assessment was not reported. The reporter considered the events to be serious (medically significant).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-NOV-2017, the patient was vaccinated with ZOSTAVAX 1 dose (reported as one single injection), intramuscular, lot # N020942, expiration date 26-OCT-2018. Other suspect therapies included sterile diluent intramuscular, lot# N007932, expiration date 06-MAY-2018 (dose was not reported). On 10-NOV-2017, the patient noticed swelling, redness, and a hard bump around injection site. No treatment was given for the events. The patient did not seek medical attention. The outcome of the events was not recovered. The causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a license practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent(MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD one single injection, lot # N008824 with expiration date: 28-OCT-2019 (strength, route and anatomical location were not reported), for prophylaxis. The reporter denied any adverse effects reported by the patients. The temperature excursion occurred between 6° F to 14° F (9° F) with a time frame of 48 hours. No previous temperature excursions occurred. This is one of two reports received from the same reporter.
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Insomnia, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from the patient's mother referring to his 12 year old son. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, lot number and expiration date were not provided) for prophylaxis. On 13-NOV-2017, after three hours of receiving the PNEUMOVAX 23, the patient experienced injection site pain, fever and difficulty sleeping. The next day on 14-NOV-2017, the patient experienced vomiting, nausea and chills. No treatment was given. At the time of the report, the outcome of pyrexia, vomiting, nausea, chills, insomnia and injection site pain was reported as not recovered. The reporter did not assess the relatedness between pyrexia, vomiting, nausea, chills, insomnia and injection site pain and PNEUMOVAX 23.
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from the patient's mother referring to his 12 year old son. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, lot number and expiration date were not provided) for prophylaxis. On 13-NOV-2017, after three hours of receiving the PNEUMOVAX 23, the patient experienced injection site pain, fever and difficulty sleeping. The next day on 14-NOV-2017, the patient experienced vomiting, nausea and chills. No treatment was given. At the time of the report, the outcome of pyrexia, vomiting, nausea, chills, insomnia and injection site pain was reported as not recovered. The reporter did not assess the relatedness between pyrexia, vomiting, nausea, chills, insomnia and injection site pain and PNEUMOVAX 23.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning an approximately 59 year-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date in 2015 (reported as "sometime in 2015"), the patient was vaccinated with PNEUMOVAX 23 from lot # K020215 with expiration date on 15-MAY-2016 (strength, route of administration, and anatomical location were not reported), one dose was administered for prophylaxis. On an unspecified date after vaccination, the patient began experiencing cellulitis at the injection site as well as swelling and redness at the injection site too; and it lasted approximately four days then resolved (date unspecified). The patient sought medical attention by calling to the pharmacy and was advised to apply ice to the injection site to decrease the redness and swelling but it was unknown if the patient did it. It was unknown if laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The causal relationship between the cellulitis, swelling and redness at the injection site with PNEUMOVAX 23 was not provided. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA007676: US-009507513-1711USA007675.
Age: 42.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 42 year old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 14-NOV-2017, the patient was vaccinated with PROQUAD from lot # M036294 with expiration date on 13-FEB-2018 (strength, dose, and anatomical location were not reported), administered subcutaneously for prophylaxis; which was considered as an inappropriate age at vaccine administration. No side effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 18-OCT-2017 and 19-OCT-2017, were administered for prophylaxis improperly stored doses of VARIVAX with lot number N009768 and expiration date on 24-MAR-2019, M-M-R II with lot number M044350 and expiration date on 04-NOV-2018, and PROQUAD with lot number N009774 and expiration date on 20-SEP-2018. The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The reporter also stated that one dose of VARIVAX and M-M-R II were administered concomitantly while one dose of PROQUAD was separately administered. Information regarding dose, dose number and route of administration of the vaccines were not provided. It was reported that on unspecified dates, the vaccines were exposed to a temperature of 16 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1710USA010582:
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a female patient of an unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date in 2014 (reported as "sometime in 2014"), the patient was vaccinated with PNEUMOVAX 23 from lot # K004207 with expiration date on 13-MAR-2015 (strength, route of administration, and anatomical location were not reported), one dose was administered for prophylaxis. On an unspecified date after vaccination, the patient began experiencing cellulitis at the injection site as well as swelling and redness at the injection site too; and it lasted approximately four days then resolved (date unspecified). The patient sought medical attention by calling to the pharmacy and was advised to apply ice to the injection site to decrease the redness and swelling but it was unknown if the patient did it. It was unknown if laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The causal relationship between the cellulitis, swelling and redness at the injection site with  PNEUMOVAX 23 was not provided. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1711USA007676: US-009507513-1711USA006166:
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a female patient of an unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date in 2014 (reported as "sometime in 2014"), the patient was vaccinated with PNEUMOVAX 23 from lot # M035104 (strength, expiration date, route of administration, and anatomical location were not reported), one dose was administered for prophylaxis. On an unspecified date after vaccination, the patient began experiencing cellulitis at the injection site as well as swelling and redness at the injection site too; and it lasted approximately four days then resolved (date unspecified). The patient sought medical attention by calling to the pharmacy and was advised to apply ice to the injection site to decrease the redness and swelling but it was unknown if the patient did it. It was unknown if laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The causal relationship between the cellulitis, swelling and redness at the injection site with PNEUMOVAX 23 was not provided. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1711USA006166: US-009507513-1711USA007675:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a license practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent(MERCK). On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD one single injection, lot # N008824 with expiration date: 28-OCT-2019 (strength, route and anatomical location were not reported), for prophylaxis. The reporter denied any adverse effects reported by the patients. The temperature excursion occurred between 6° F to 14° F (9° F) with a time frame of 48 hours. No previous temperature excursions occurred. This is one of two reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M011832, expiration date 25-JAN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit (34.4F) for 15 minutes. A digital data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA012988: US-009507513-1711USA007835: US-009507513-1711USA007836:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M011832, expiration date 25-JAN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit (34.4F) for 15 minutes. A digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA012988: US-009507513-1711USA007834: US-009507513-1711USA007836:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M011832, expiration date 25-JAN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit (34.4F) for 15 minutes. A digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA012988: US-009507513-1711USA007834: US-009507513-1711USA007835.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced red swollen, slightly itchy area around the injection site later in the day after the shot. Patient used pain medication and ice and found that it was slightly improved the following day. No other complaints. Pt told to see MD if symptoms worsen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left deltoid swelling/tenderness 2 days after vaccination.