chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Feeling abnormal, Pallor, Tremor
Clinical narrative: Mom woke pt up to come for vaccines (HPV & Flu shot).  Pt had pretzels for breakfast.  After giving vaccines pt looked fine & asked for a popsicle when offered.  RN was coming back with popsicle when brother came out of room asking for help because pt's arms, legs & feet were shaking.  Pt told mom & brother prior to this that she felt funny.  After event pt sd she was dreaming.  Pt wanted to know what happened.  Mom was in front of pt who was sitting in chair where vaccines were given.  Helped pt to exam table after shaking stopped.  Checked VS.  MD examined pt.  Pt was awake the whole time.  She did look pale during event.  Her coloring returned.  Checked on pt later in day.  Spoke to dad who sd pt was doing better & resting.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema /heat injection site 10cm X5cm.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came back to the pharmacy on 11-3-15 and wanted to show me the red spot on her arm where the Zostavax was given. The spot was the size of a quarter and very red. She comented that it was sore and felt hot.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood urine present
Clinical narrative: PATIENT IS COMPLAINING OF BLOOD IN URINE.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None reported.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into public health on 11/3/2015 to report redness, warmth and erythema around injection site.  Prior to administering Prevnar 13, nurse observed a yellowish tinted small bruise about the size of a penny on the left deltoid.  Patient preferred to receive vaccine on the left deltoid after educating on preferences with increased risk of injection site irritation post vaccination.  Nurse outlined the redness as it was raised and warm measuring approximately 7cm x 4.5cm.  Patient was instructed to follow up with primary care doctor is symptoms did not resolve after icing over the next day or two.  Patient verbalized understanding and agreed to plan.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of extremity in which vaccine was administered.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm, Tenderness
Clinical narrative: 6cm x 8 cm raised red rash warm and tender to palpation. No evidence of phlebitis.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Unknown.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swollen (almost double the size of the right arm), redness from shoulder to elbow, fever in arm, itching.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dry skin, Pain, Pyrexia, Swelling face
Clinical narrative: Facial swelling with dry skin, fever, chills and body aches. Took OTC Tylenol and Claritin and symptoms resided.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Peripheral swelling, Pruritus, Rhinorrhoea
Clinical narrative: Hives, dizziness, runny nose, nausea, swelling of arm (severe), itching. Treated in ER with with Benadryl, Pepcid, and later, steroids.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives, dizziness, runny nose, nausea, swelling of arm (severe), itching. Treated in ER with with Benadryl, Pepcid, and later, steroids.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient had pain in site of injection, it went away, but she said it came back again after couple of weeks.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Tremor
Clinical narrative: After the patient received the vaccination, I drove her home and she ate supper. Within an hour of the injection, pt. began having severe chills, accompanied by violent shaking -- so bad that pt. could not hold a glass of water to take the Tylenol (two, 500-mg. tablets) I gave her, just in case she had a fever (though her forehead was not unusually warm to the touch). Patient also reported feeling nauseous. The patient went to bed, lying on a heated mattress pad, with a heating pad on her back, and covered with a sheet, a warm blanket, two comforters, and a terrycloth bathrobe atop the foregoing layers. The chills subsided after a while, but she had a second, equally severe bout later this evening (into the wee hours of the next morning, lasting until after 1:35 AM October 10).
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at the site of injection during the injection and post 1 month.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Malaise, Pain, Peripheral swelling
Clinical narrative: Patient felt sick with feverish chills, body aches. Large swollen, red mark extending down upper arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient felt sick with feverish chills, body aches. Large swollen, red mark extending down upper arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swollen red and became tender the next day. Talked to patient and she said the area is about 4" by 5" and says it is getting better.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Laboratory test normal
Clinical narrative: Achy joints, migraines, dizziness, severe fatigue, weakness, nausea, sensitivity to light, unable to get out of bed.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Mobility decreased, Nausea, Photophobia
Clinical narrative: Achy joints, migraines, dizziness, severe fatigue, weakness, nausea, sensitivity to light, unable to get out of bed.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood lactic acid decreased, Pyrexia, Tachycardia, White blood cell count increased
Clinical narrative: Tachycardia and fever of 102.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Peripheral swelling, Rash generalised, Skin lesion
Clinical narrative: Pt woke up an his arm was very stiff, swollen; he could not lift his left arm.  Patient had lesions/spots on the left arm.  Progressively over the next six days, the spots spread over his legs, calves, feet, hands, and torso.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Bursitis, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site bruising
Clinical narrative: Flu shot was given on top of shoulder, causing bruising with in 24 hrs. Shoulder pain increased with time, 2wks later I could not lift my arm. Reported injury to primary care, they had me come in immediately and sent me directly to the ER. Xrays were taken and I was sent home with a tramadol & Flexeril. Followed up with ortho & hospital. MRI approval is pending- initial diagnosis is bursitis.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, X-ray
Clinical narrative: Flu shot was given on top of shoulder, causing bruising with in 24 hrs. Shoulder pain increased with time, 2wks later I could not lift my arm. Reported injury to primary care, they had me come in immediately and sent me directly to the ER. Xrays were taken and I was sent home with a tramadol & Flexeril. Followed up with ortho & hospital. MRI approval is pending- initial diagnosis is bursitis.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Headache, Malaise, Nasal congestion
Clinical narrative: Nausea (not throwing up); Headache; Chills; malaise; Stuffy nose; Loss of appetite.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Nausea (not throwing up); Headache; Chills; malaise; Stuffy nose; Loss of appetite.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth, Oedema peripheral, Skin warm
Clinical narrative: Right arm at injection site and right axilla swollen and warm to touch.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Pruritus, Swelling
Clinical narrative: I began to feel itchy, but didn't think anything of it until my entire body started swelling up by Friday. My blood sugars were getting higher and not going down.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: Pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, rash, and fever tem @100.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, rash, and fever tem @100.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, rash, and fever tem @100.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Complex regional pain syndrome, Impaired gastric emptying, Postural orthostatic tachycardia syndrome
Clinical narrative: Developed CRPS, POTS, gastroparesis ongoing.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: NONE REPORTED.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Bump in shot, red, hot and swollen skin. It was painful and lasted a week.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin infection, Skin warm
Clinical narrative: PATIENT'S ARM WAS RED THAT NIGHT.  THEN IT BECAME HOT AND SWOLLEN.  SHE DID NOT HAVE A FEVER.  SHE WAS ADVISED TO SEE A DOCTOR.  DOCTOR STATES THAT SHE HAS A SKIN INFECTION AND WAS GIVEN AUGMENTIN ON 10/28/15.
Age: 1.74
Sex: M
Vaccine: HEPA, MMR, UNK
Symptoms: Blood test normal, Decreased appetite, Feeling abnormal, Foaming at mouth, Influenza virus test negative
Clinical narrative: That morning patient ran a very high temp of 103.7. After giving him a fever reducer his temp had spiked up again to 105. Patient had a seizure. He turned purple, was shaking and staring, and foaming at the mouth. He was rushed to the hospital by ambulance. The hospital checked his ears, ran a strep test, did an X-ray, took blood work, did a urine sample. The doctor told us everything came back fine. Patient continued to run a high fever up until Sunday. Then ran a low grade temp on Monday.  His temp was 104.4 Sunday morning at 4am. In his sleep he would wake up screaming and would act as if he wanted to roll or move but seemed as if he couldn't like his body just wouldn't move. He would not eat or drink anything. He was very lethargic at daycare on Monday Nov 2nd his teachers said he would sit and watch the other kids play. Mother did ask pediatrician Saturday Oct 31 at the follow up appt if his sickness could be related to the vaccines he received 10 days earlier. The doctor said it very well could be but she can't say and to keep an eye on him and that if he is still running a fever as of Tuesday Nov 3rd to bring him back in for more blood work.
Age: 1.74
Sex: M
Vaccine: HEPA, MMR, UNK
Symptoms: Lethargy, Mobility decreased, Pyrexia, Screaming, Seizure
Clinical narrative: That morning patient ran a very high temp of 103.7. After giving him a fever reducer his temp had spiked up again to 105. Patient had a seizure. He turned purple, was shaking and staring, and foaming at the mouth. He was rushed to the hospital by ambulance. The hospital checked his ears, ran a strep test, did an X-ray, took blood work, did a urine sample. The doctor told us everything came back fine. Patient continued to run a high fever up until Sunday. Then ran a low grade temp on Monday.  His temp was 104.4 Sunday morning at 4am. In his sleep he would wake up screaming and would act as if he wanted to roll or move but seemed as if he couldn't like his body just wouldn't move. He would not eat or drink anything. He was very lethargic at daycare on Monday Nov 2nd his teachers said he would sit and watch the other kids play. Mother did ask pediatrician Saturday Oct 31 at the follow up appt if his sickness could be related to the vaccines he received 10 days earlier. The doctor said it very well could be but she can't say and to keep an eye on him and that if he is still running a fever as of Tuesday Nov 3rd to bring him back in for more blood work.
Age: 1.74
Sex: M
Vaccine: HEPA, MMR, UNK
Symptoms: Skin discolouration, Staring, Streptococcus test negative, Tremor, Urine analysis normal
Clinical narrative: That morning patient ran a very high temp of 103.7. After giving him a fever reducer his temp had spiked up again to 105. Patient had a seizure. He turned purple, was shaking and staring, and foaming at the mouth. He was rushed to the hospital by ambulance. The hospital checked his ears, ran a strep test, did an X-ray, took blood work, did a urine sample. The doctor told us everything came back fine. Patient continued to run a high fever up until Sunday. Then ran a low grade temp on Monday.  His temp was 104.4 Sunday morning at 4am. In his sleep he would wake up screaming and would act as if he wanted to roll or move but seemed as if he couldn't like his body just wouldn't move. He would not eat or drink anything. He was very lethargic at daycare on Monday Nov 2nd his teachers said he would sit and watch the other kids play. Mother did ask pediatrician Saturday Oct 31 at the follow up appt if his sickness could be related to the vaccines he received 10 days earlier. The doctor said it very well could be but she can't say and to keep an eye on him and that if he is still running a fever as of Tuesday Nov 3rd to bring him back in for more blood work.
Age: 1.74
Sex: M
Vaccine: HEPA, MMR, UNK
Symptoms: X-ray normal
Clinical narrative: That morning patient ran a very high temp of 103.7. After giving him a fever reducer his temp had spiked up again to 105. Patient had a seizure. He turned purple, was shaking and staring, and foaming at the mouth. He was rushed to the hospital by ambulance. The hospital checked his ears, ran a strep test, did an X-ray, took blood work, did a urine sample. The doctor told us everything came back fine. Patient continued to run a high fever up until Sunday. Then ran a low grade temp on Monday.  His temp was 104.4 Sunday morning at 4am. In his sleep he would wake up screaming and would act as if he wanted to roll or move but seemed as if he couldn't like his body just wouldn't move. He would not eat or drink anything. He was very lethargic at daycare on Monday Nov 2nd his teachers said he would sit and watch the other kids play. Mother did ask pediatrician Saturday Oct 31 at the follow up appt if his sickness could be related to the vaccines he received 10 days earlier. The doctor said it very well could be but she can't say and to keep an eye on him and that if he is still running a fever as of Tuesday Nov 3rd to bring him back in for more blood work.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Pt reported pain on injection, then 3 hours later, had swelling on the deltoid about the size of an egg and hot, took an ibuprofen, 2 hours later, swelling expanded down to elbow and covered most of the upper arm, the next morning swelling was past the elbow so went to ER and received cephalexin 500mg qid, swelling started to diminish the 2 nights after starting the antibiotic (approx 5-6 doses abx), 2 days after that the swelling was completely gone; patient had received Fluvirin in the same arm 5 days prior.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Diarrhoea, Nausea, Vomiting
Clinical narrative: Rapid onset of severe nausea, diarrhea, vomiting. Vomiting occurring every 4-7 minutes, quickly dehydrated and began only vomiting bile. Admitted to ER and kept for 48 hours. ER physicians denied possibility of adverse drug reaction, even though vaccine had been administered earlier that day. Ate all the exact same foods as significant other the entire day (split lunch and dinner, no breakfast), with no illness in significant other (ruling out food poisoning).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye discharge, Eyelid margin crusting, Injection site reaction, Pyrexia, Rash
Clinical narrative: Fever, Itchy painful rash at injection site. However, most unusual reaction was crusty eyes with a film/fluid minimizing eye sight for a few days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Fever, Itchy painful rash at injection site. However, most unusual reaction was crusty eyes with a film/fluid minimizing eye sight for a few days.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain
Clinical narrative: Flu shot was injected to high on my shoulder so I have had horrible pain trying to move the arm at the shoulder it was injected into.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with improperly stored ROTATEQ lot # L008053 (expiration date 30-NOV-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 12 month old patient (gender was not reported). The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 23-OCT-2015, the patient was vaccinated with the first dose of M-M-R II (lot number, expiration date, dose and route of administration were not reported) and with the first dose of PROQUAD (Merck) (lot number, expiration date, dose and route of administration were not reported) (overdose). There was no concomitant medication reported and no adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date 10-NOV-2016, dose and route not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from an office manager via a field representative referring to a 60 year old male patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 20-JUN-2015 the patient was vaccinated with his first dose of ZOSTAVAX (strength, dosage, frequency and route unspecified) and the second injection was administered on 28-OCT-2015 (extra dose administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On 27-OCT-2015, the patients received doses of improperly stored PNEUMOVAX 23, (Lot # L003227, exp. date on 13-OCT-2016), (strength, route of administration and dose were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to a patient of unknown age and gender. On 04-SEP-2015, the patient was vaccinated with an expired and improperly stored dose of PNEUMOVAX 23 lot # K004542, expiration date: 19-AUG-2015 (dose and route were not reported). No adverse effect reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 27-OCT-2015, the patients received doses of improperly stored RECOMBIVAX HB, (Lot # reported as K009745, exp. date on 17-FEB-2016), (strength, route of administration and dose were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: RUB
Symptoms: Abdominal discomfort, Chills, Pyrexia, Rash generalised, Rash rubelliform
Clinical narrative: This spontaneous report was received from a registered nurse concerning on herself, a currently 79 year old female patient with Guillain-Barre syndrome (diagnosed in about 1989 or 1990 after received a dose of an unspecified Flu vaccine). The patient's medical history included muscular weakness and palpitations (in about 1989 or 1990 after received a dose of an unspecified Flu vaccine). On an unknown date, reported as "in the early 1990's", the patient was vaccinated with an unspecified dose of MERUVAX II (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On an unknown date, about 1 hour after vaccination, the patient felt stomach sickness (abdominal discomfort). On an unspecified date, 1 week after vaccination, the patient recovered from abdominal discomfort. Then, starting about 1 week of vaccination, the patient developed chills, fever of 102.6F (pyrexia) and she also broke out in a rubella rash all over the body (rash rubelliform). The outcome of pyrexia, rash rubelliform and chills was reported as recovered, on an unspecified date, 2 weeks after vaccination. The reporter did not assess the relatedness of abdominal discomfort, pyrexia, rash rubelliform and chills with MERUVAX II. This is one of several cases from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager concerning a male patient over the age of 15 years old. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (lot # L004014 (exp. date, strength, route of administration, and dose were not provided) (Inappropriate schedule of vaccine administered). No adverse events had been reported. 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 Licensed Practical Nurse (L.P.N.) refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 30-OCT-2015, the patient was vaccinated with an expired and improperly stored dose of improperly stored dose of PNEUMOVAX23 lot # K004542, expiration date: 19-AUG-2015 (dose and route were not reported). No adverse effect reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of three reports received from the same reporter. 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 Licensed Practical Nurse (L.P.N.) refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 30-SEP-2015, the patient was vaccinated with an expired and improperly stored dose of PNEUMOVAX23 lot # K004542, expiration date: 19-AUG-2015 (dose and route were not reported). No adverse effect reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of three reports received from the same reporter. 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 a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ, lot # L008053, expiration date 30-NOV-2015 (dose and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient without history of drug reactions or allergies. On 24-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # was reported as "L017165" and exp. date 13-AUG-2016, dose of 0.65 ml, subcutaneous. On the same date "reported as immediately after receiving ZOSTAVAX", the patient developed swelling, redness, "soreness" and "hot" at the injection site. The pharmacist informed the patient to take BENADRYL and ibuprofen (manufacturer unknown). No lab diagnostics studies were performed. At the time of this report, the outcome of the events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The medical assistant reported that on an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ oral, lot#: K017526, expiration date: 12-JUN-2016. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on 26-OCT-2015, the patient was vaccinated with an expired dose of GARDASIL 0.5 ml intramuscular, lot # H021861, expiration date 09-OCT-2015. No adverse effects reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Patient received Hepatitis B vaccine from Employee Health on 8/9/13. About 30 minutes following administration, she reports rash and itching. Given diphenhydramine 25mg x 1 in employee health. Given another dose to take if needed later in the day.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: 10-27-15 Two weeks after getting varicella vaccine broke out with rash (small, raised bug bite-like) on hands, arms, feet and knees. Less than 50 spots. Itched. No fever or breathing problems.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site scab, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 01-OCT-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unspecified date in October 2015 (reported as 24 hours of the vaccination), the patient experienced "redness and warmth at the injection site", and on an unknown date in October 2015 (reported as "within another 24 hours"), a vesicle appeared at the injection site and it crusted over. The reporter stated that the patient called her unspecified primary care physician to notify the reaction and was advised to go to the emergency room. The patient went to the emergency room of an unspecified medical center, but was informed "the reaction was fine" and was sent home without being admitted. No treatment was given to the patient. On an unknown date in October 2015, the outcome of the injection site erythema, injection site vesicles and injection site warmth was reported as recovered. The relatedness between injection site erythema, injection site vesicles and injection site warmth and VARIVAX (Merck) was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, referring to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unspecified date in October 2015, (reported as "between 05-OCT-2015 and 26-OCT-2015) the patients were vaccinated with improperly stored doses of PROQUAD (route, dosage, strength and lot# were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of two report received from the same reporter. 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 certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of GARDASIL lot # K008931, expiration date 04-MAR-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema multiforme, Pyrexia
Clinical narrative: Erythema multiforme and fever/chills, cellulitis requiring AUGMENTIN. Amoxicillin/clavulanate 1000/62.5 mg BID.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Confusional state, Diarrhoea, Faeces discoloured, Fatigue
Clinical narrative: 2 hours after vaccine patient had confusion, got lost while driving in familiar area, belted into parked car, green diarrhea, nausea, vomiting, feeling weak and run down. Patient came to pharmacy on 11/1/15 to report reaction. At this time he was feeling better. No longer had diarrhea or confusion.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Vomiting
Clinical narrative: 2 hours after vaccine patient had confusion, got lost while driving in familiar area, belted into parked car, green diarrhea, nausea, vomiting, feeling weak and run down. Patient came to pharmacy on 11/1/15 to report reaction. At this time he was feeling better. No longer had diarrhea or confusion.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Pt. not seen -> states: fever 102 degrees and chills, arm red and swollen - started day after injection - all sx. gone in 2 days.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Pt given MMR 9-28-15. States LMP 9-21-15. Signed consent form and live vaccine consent. Called 10-17-15 stating home preg. test (+). Did not see Dr. Was advised to contact someone else for options counseling.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: Pt started feeling faint and nauseous after immunization. Did not improve with time and laying down. VS stable. Pt given 25 mg IM BENADRYL without improvement. Transport to hospital via ambulance.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient got PREVNAR 13 inj on 10-22-15, on 10-28-15, patient stated she has redness and pain below area of injection site. Area is warm to touch and has spread. Diagnosed with cellulitis and treated with KEFLEX 250 mg 1 capsule, PO, 4 x day for 10 days, on Nov 2nd patient states symptoms have resolved. (No fever). (localised redness).
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 101 degrees F and chills within 24 hours of vaccination - lasted 48 hours. Injection site - swelling and burning, swelling subsided but burning sensation still active as of 10/28/15. Took TYLENOL first day.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Right deltoid 5cm x 5 1/2cm rounded firm erythema, slightly tender.
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt noticed surrounding injection site which was also hot and raised. it continued to progress and grow more painful and larger in size over the next 24 hours. Pt also developed fever approximately 48h following vaccination. Pt at this point visited MD who prescribed prednisone and recommended follow up visit and if symptoms don't improve may prescribe antibiotic.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Headache, Pain
Clinical narrative: Patient had gotten flu shot 2 days prior to this vaccine - got chills, aches, reduced appetite, and headache.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Monoplegia, Pain in extremity
Clinical narrative: (L) total arm was paralyzed for almost 3 days and I had extreme pain in the arm, pain as I had never felt before. I took VICODIN for the pain it didn't touch it, and chest pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: (L) arm I had an immediate migraine headache and redness over the area of the site and then, soreness, swelling, itching, blistering and feeling of skin from 10-9 to 10-19 2015. It kept me from doing normal activities, as usual.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Migraine, Skin exfoliation
Clinical narrative: (L) arm I had an immediate migraine headache and redness over the area of the site and then, soreness, swelling, itching, blistering and feeling of skin from 10-9 to 10-19 2015. It kept me from doing normal activities, as usual.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K021581, expiration date 24-OCT-2016 and lot # J012520, expiration date 30-JAN-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # K006133, expiration date 29-APR-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Varicella
Clinical narrative: Developed chicken pox from taking a booster injection of shingles vaccine. It took a little after (one month) after taking vaccine.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema to (L) upper arm down to just above elbow; hot to touch, painful 4/10 pain.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L015417, expiration date 01-AUG-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site. Diphenhydramine mg qid, methylprednisolone, doxycycline 100 mg bid.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of VAQTA lot # K012456, expiration date 28-APR-2017 nad lot # L002717, expiration date 02-JUN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Skin rash and swelling in arm with injection. Diphenhydramine 25-50 mg QID, methylprednisolone, acetaminophen/hydrocodone 5 mg other.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of (L) upper arm 4-5 days after administration.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dizziness, Nausea, Pain
Clinical narrative: 15 min after vaccine given - pt c/o nausea, tightness in chest, pain down (R) and dizziness. O2 given via mask and epinephrine administered. IV started and NS started. Pt tx to ER via ambulance.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain/swelling at injection site.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient complained of redness, warm to touch and itch on left arm below injection site about 2-3 inches below on the day after injection.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Myalgia
Clinical narrative: C/o persistent pain to (L) deltoid s/p flu vaccine. Administered 10/13/15 no pain at time. 10/14/15 c/o "ache" at site. 10/15/15 c/o pain deep in muscle. Used ice and ibuprofen.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Infection, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Day of vaccination, Monday, patient states he have blurred vision, nausea within 30 mins of receiving vaccine. Later that evening, the injection site was very sore, red, and painful to touch and movement of arm. Next day, Tuesday, the redness was spreading and increase pain to area of injection. Also, area very hot feeling, especially to touch. Third day, Wednesday, symptoms not being relieved, getting worse. Area of injection site now enlarged to 6" x 6" area. Came to pharmacy for advice. Advice given by pharmacist on duty, confirmed a true allergic reaction and recommended patient go to PCP or emergency room. Patient went to ER and treated for cellulitis. Given DEMEROL injection for pain and an injection for inflammation and infection. Also given Rxs for oral KEFLEX, Loratadine, and Ibuprofen. If condition not better or worsens in 7 days, return to hospital.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pain, Vision blurred
Clinical narrative: Day of vaccination, Monday, patient states he have blurred vision, nausea within 30 mins of receiving vaccine. Later that evening, the injection site was very sore, red, and painful to touch and movement of arm. Next day, Tuesday, the redness was spreading and increase pain to area of injection. Also, area very hot feeling, especially to touch. Third day, Wednesday, symptoms not being relieved, getting worse. Area of injection site now enlarged to 6" x 6" area. Came to pharmacy for advice. Advice given by pharmacist on duty, confirmed a true allergic reaction and recommended patient go to PCP or emergency room. Patient went to ER and treated for cellulitis. Given DEMEROL injection for pain and an injection for inflammation and infection. Also given Rxs for oral KEFLEX, Loratadine, and Ibuprofen. If condition not better or worsens in 7 days, return to hospital.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Sunday chills/fever. Monday/Tuesday redness, soreness, itch on left arm. Pt. will see MD on 11-4-15.
Age: 33.0
Sex: F
Vaccine: FLUR3
Symptoms: Rash
Clinical narrative: Patient reported rash on face one day after vaccine administration.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Rash, Tenderness
Clinical narrative: Noticed on Nov. 1, 2015 red, rash left arm w/no itch. A little tender w/touch.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Neuralgia, Pain in extremity
Clinical narrative: Developed pain in both arms. Nerve pain with fatigue in both arms.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin infection
Clinical narrative: Skin infection. Pt was put on cephalexin. Rash on patient arm appear after shot and pt was seen by a physician two days after.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test abnormal, Chest X-ray abnormal, Cough, Diarrhoea, Pneumonia
Clinical narrative: Subject received HPV vaccine dose #1 on 10/30/15. On 10/31/15, subject developed severe cough, vomiting and fever to 104 degrees F. Subject seen in ER and diagnosed with pneumonia, received IV antibiotics and fluids and discharged home. On 11/1/15, subject continued to experience fever (to 103 degrees F) , severe cough and vomiting; she took prescribed oral antibiotics and over-the-counter cough medications and remained at home. On 11/2/15, subject continued with fever to 102.7, severe vomiting and cough, and developed severe diarrhea. Subject's mother advised to return child to the ER for further evaluation and management.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Subject received HPV vaccine dose #1 on 10/30/15. On 10/31/15, subject developed severe cough, vomiting and fever to 104 degrees F. Subject seen in ER and diagnosed with pneumonia, received IV antibiotics and fluids and discharged home. On 11/1/15, subject continued to experience fever (to 103 degrees F) , severe cough and vomiting; she took prescribed oral antibiotics and over-the-counter cough medications and remained at home. On 11/2/15, subject continued with fever to 102.7, severe vomiting and cough, and developed severe diarrhea. Subject's mother advised to return child to the ER for further evaluation and management.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Headache, Rash, Urticaria
Clinical narrative: Constant headache, dizziness, short of breath also rash/hives symptoms started within 24 hrs after shot.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Pain
Clinical narrative: Headache x 24 hrs onset 12 hrs after shot, chills, body aches, lightheaded for 2 days and still present.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site paraesthesia, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: 4 hrs injection site arm became swollen, hot to touch, tingling aches, felt as if a tourniquet was above elbow, fingers swollen, wrist and top of hand swollen. Required MD evaluation. Dx - cellulitis most likely from flu vaccine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: 4 hrs injection site arm became swollen, hot to touch, tingling aches, felt as if a tourniquet was above elbow, fingers swollen, wrist and top of hand swollen. Required MD evaluation. Dx - cellulitis most likely from flu vaccine.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: 1014 7:30 PM nauseous, headache, fever 101, vomited at 11 PM. 10/15 7 AM - nauseous, achy.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headaches, fatigue, fever - 8 hr post.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Rash
Clinical narrative: Nausea, Torso rash, and fatigue.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever 102.
Age: 0.84
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 10 month old patient of unknown gender. No concurrent conditions or medical history were reported. On 01-SEP-2015, the patient was vaccinated with an improper stored dose of RECOMBIVAX HB (Lot # L004754 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Headache, Vomiting
Clinical narrative: Upset stomach. Headache. Dizzy. Threw up once.