chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Prior to my visit to the hospital this past October 18, 2016 to visit my primary care physician Dr. at Clinic, and after receiving the flu vaccine and the Tdap vaccine on that visit, I felt in perfect health. As the evening of Oct 18th approached I could feel the onset of body chills. By the morning of Oct 19th I had chills, headache and a fever that rose to 102 degrees. By Friday, Oct 21st, The headache, chills and fever had subsided but was replaced by a sore throat and, most troubling, by burning/pins-and-needles sensations in my left hand finger tips. By Saturday the sore throat continued and the burning/pins-and-needles sensation in the finger tips of my left hand was now also in my right hand and beginning in the toes of both feet. Yesterday, Oct 22, I still had the minor sore throat and I still had the sensation of painful/burning sensation in the finger tips of both hands and the toes and balls of both feet and visible were small red spots, some almost blister like in appearance. This morning, Sunday Oct 23, I still have the same symptoms as yesterday but they seem to be somewhat lessened. I feel that my symptoms are a direct result of the vaccines that I were administered at the clinic on Oct 18th.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness/Swelling/Pain at injection site. Patient self treated with OTC pain medications (tylenol/aleve) and ice pack.
Age: 14.0
Sex: M
Vaccine: FLUX, HPVX, MEN
Symptoms: Blood test normal, Dizziness, Headache, Inflammation, Lethargy
Clinical narrative: My son began experiencing severe headaches and body aches approx. 5 hrs after the meningitis vaccine was administered in his right arm. The next day he stayed home because he was having terrible headaches, body aches and the affected arm was very inflamed, swollen (the size of a grapefruit) red and hot to the touch. There was no fever but we wouldn't know because we were giving him Advil to help with the aches and pains. 24 hours after the administration of the vaccine we had to take him to the ER because he was complaining of dizziness and experiencing lethargy. At the hospital they ran blood tests which came back negative and gave him an IV bag of saline and pain meds were administered intravenously. By midnight he was feeling much better so he was sent home. Friday he stayed home from school as well. He was feeling better but was still having some headaches and was a bit sore and his arm was still swollen but 50% smaller than the day before. By Saturday, (72 hrs after he got the vaccine) he was back to normal.
Age: 14.0
Sex: M
Vaccine: FLUX, HPVX, MEN
Symptoms: Pain, Pain in extremity, Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: My son began experiencing severe headaches and body aches approx. 5 hrs after the meningitis vaccine was administered in his right arm. The next day he stayed home because he was having terrible headaches, body aches and the affected arm was very inflamed, swollen (the size of a grapefruit) red and hot to the touch. There was no fever but we wouldn't know because we were giving him Advil to help with the aches and pains. 24 hours after the administration of the vaccine we had to take him to the ER because he was complaining of dizziness and experiencing lethargy. At the hospital they ran blood tests which came back negative and gave him an IV bag of saline and pain meds were administered intravenously. By midnight he was feeling much better so he was sent home. Friday he stayed home from school as well. He was feeling better but was still having some headaches and was a bit sore and his arm was still swollen but 50% smaller than the day before. By Saturday, (72 hrs after he got the vaccine) he was back to normal.
Age: 14.0
Sex: M
Vaccine: FLUX, HPVX, MEN
Symptoms: White blood cell count increased
Clinical narrative: My son began experiencing severe headaches and body aches approx. 5 hrs after the meningitis vaccine was administered in his right arm. The next day he stayed home because he was having terrible headaches, body aches and the affected arm was very inflamed, swollen (the size of a grapefruit) red and hot to the touch. There was no fever but we wouldn't know because we were giving him Advil to help with the aches and pains. 24 hours after the administration of the vaccine we had to take him to the ER because he was complaining of dizziness and experiencing lethargy. At the hospital they ran blood tests which came back negative and gave him an IV bag of saline and pain meds were administered intravenously. By midnight he was feeling much better so he was sent home. Friday he stayed home from school as well. He was feeling better but was still having some headaches and was a bit sore and his arm was still swollen but 50% smaller than the day before. By Saturday, (72 hrs after he got the vaccine) he was back to normal.
Age: 0.83
Sex: F
Vaccine: FLUX
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large raised, red, hot to the touch hardened induration at the vaccine site, spreading outward. Fever.
Age: 0.83
Sex: F
Vaccine: FLUX
Symptoms: Metabolic function test, Pyrexia, Ultrasound scan, Vaccination site swelling
Clinical narrative: Large raised, red, hot to the touch hardened induration at the vaccine site, spreading outward. Fever.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: Patient presented to pharmacy with blue/black, painful injection site.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Lethargy, Malaise, Pollakiuria, Pyrexia
Clinical narrative: Fever, felt ill, lethargy, upset stomach, increased urination.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dysstasia, Malaise, Pyrexia
Clinical narrative: Very sick, chills high fever, dizzy could not stand or walk. This lasted three days.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness,rash at injection site appeared later in the day. Tylenol and ice pack treatment. Patient also put anti-itch cream on 10/22/16.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Arm was swollen, red and warm to the touch.  Also patient complained of pain.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Nausea, Pain
Clinical narrative: Severe chills. Nausea. Body aches. Weakness. Need to sleep.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Complex febrile seizure (brief generalized tonic-clonic seizure activity within approx one hour while rapid rate of rise of fever eventually >40C).
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Malaise
Clinical narrative: Injection site hurt, malaise, joint pain in all joints especially those that have hurt before vaccine. Treatment consisted of Mortrin 600 mg PO and rest.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Heart rate increased, Palpitations, Paraesthesia, Tremor
Clinical narrative: Blood rushed to head, both hands tingling, racing heart and face turned bright red. Fast pulse and shaking. Racing heart lasted the rest of the day and through the night.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Muscle strain
Clinical narrative: Pt has muscle soreness at injection site. This soreness is persisting now, a month after the vaccination. Feels like strained muscle in bicep and shoulder, improves during the day but is worse ever morning. No numbness or tingling in the arm. Pt has received flu shots in past without problems.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Arm sore and then arm bruised from shoulder to elbow over the next couple of days.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme shoulder pain..ache like a toothache that radiates down arm.  Reported to Dr in April of 2016.  Still remains painful today 10/23/2016.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Chills, fever, vomiting.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Hyperhidrosis, Injection site erythema, Injection site mass
Clinical narrative: Patient woke up on 10/21/16 with a knot and redness at injection site.  Patient then developed a fever that peaked at 103.5 F.  By Saturday, patient had a red rash, swelling and a lump at injection sites.  She also had malaise and fever, sweating and chills.  She then developed a sore left hip.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site nodule, Injection site reaction, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Patient woke up on 10/21/16 with a knot and redness at injection site.  Patient then developed a fever that peaked at 103.5 F.  By Saturday, patient had a red rash, swelling and a lump at injection sites.  She also had malaise and fever, sweating and chills.  She then developed a sore left hip.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Patient woke up on 10/21/16 with a knot and redness at injection site.  Patient then developed a fever that peaked at 103.5 F.  By Saturday, patient had a red rash, swelling and a lump at injection sites.  She also had malaise and fever, sweating and chills.  She then developed a sore left hip.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Headache, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Sore arm, shoulder and neck. headache, joint pain, fatigue. Fingers on left hand (side of injection) became numb.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Sore arm, shoulder and neck. headache, joint pain, fatigue. Fingers on left hand (side of injection) became numb.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT MENTIONED REDNESS AND SWELLING ALONG WITH A "HOT TO THE TOUCH" FEELING AT INJECTION SITE OF UPPER RIGHT DELTOID.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme soreness, swelling, red inflammation down the arm.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Extreme soreness, swelling, red inflammation down the arm.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Father says that his son has developed a lump on the arm he received his flu shot in.  It is slightly red and the arm is mildly sore. Instructed him to apply ice to the area, give Tylenol for pain/fever, and Benadryl for reaction.  If condition worsens go to the ER. They have no primary care physician to contact.
Age: 22.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Chest pain, Dyspnoea, Flushing, Urticaria
Clinical narrative: Approximately 30 seconds after administering the Hep A and Influenza vaccine the patient started to experience shortness of breath, facial flushing, hives, and chest pain. Epinephrine administered immediately at 1515. EMS also activated at that time. Patient felt almost full relief of symptoms after administration of epi pen. Patient still however reported slight chest pain. Vital signs stable. EMS arrived at 1520 and transported patient to Hospital. Patient ambulated to ambulance.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: 8:15 PM headache, Next day fever 101 for next 4 days. Aching joints stabbing pains began on 4th day. Stiff neck started upper neck moved to mid back to lower back and down to 4 inches past elbows on 5th day, Fever lower 99 tingling right foot, chest pain, with severe stiff neck and difficulty breathing, headache returned and nausea very tired and sick.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Musculoskeletal stiffness, Nausea, Pain, Paraesthesia
Clinical narrative: 8:15 PM headache, Next day fever 101 for next 4 days. Aching joints stabbing pains began on 4th day. Stiff neck started upper neck moved to mid back to lower back and down to 4 inches past elbows on 5th day, Fever lower 99 tingling right foot, chest pain, with severe stiff neck and difficulty breathing, headache returned and nausea very tired and sick.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: 8:15 PM headache, Next day fever 101 for next 4 days. Aching joints stabbing pains began on 4th day. Stiff neck started upper neck moved to mid back to lower back and down to 4 inches past elbows on 5th day, Fever lower 99 tingling right foot, chest pain, with severe stiff neck and difficulty breathing, headache returned and nausea very tired and sick.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Hyperhidrosis
Clinical narrative: Pt said upon asking for immunization that she was a"scaredy cat".  After I gave the AFLURIA she asked to stay seated so she could calm down for a little bit.  I asked her if she was ok, she just said she needed a minute.  I checked on her every couple of minutes because she got more upset if I hovered.  She said she was sweaty and anxious, but it was what happened every time she got a shot.  I offered her a bottle of water after a few minutes which she accepted.  She sat for about 15 minutes until she calmed down.  She said that it was a better experience than normal, but i thought it should be reported.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Not sure if exact time, but hives developed all over upper left arm where injection occurred. Administered Benadryl, and hives continued to get worse.  Is now Sunday night, still has hives after multiple Benadryl doses, and NP suggested we submit report.  We are supposed to follow up with his ped and possibly a derm tomorrow or Tuesday.I have photos of his arm on Sat and Sun.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria, Wheezing
Clinical narrative: Hives, body swelling, wheezing.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain
Clinical narrative: Patient received the FLUARIX QUAD vaccination, administered by this reporter Rph, on 09/30/2016. At the time of administration, there were no issues or complications with the injection, patient felt fine before leaving the store. On 10/23/2016, patient returned to the pharmacy to report that on the day of receiving the vaccination, she felt fine afterwards but a few hours later started feeling soreness on her right shoulder (where she received the injection). She reported that she continued to feel soreness and pain and that because she usually sleeps on that side of her arm it was inconvenient. She thought that it would go away after a while, as soreness is common as a side effect of flu vaccinations, but even after a few weeks, she is still feeling the soreness and slight pain. On the day of reporting, she showed her shoulder to RPH: there were no visible signs of distress or damage on the shoulder. Patient agreed that her shoulder and arm looked normal, she only felt the discomfort. Patient was advised to take over-the-counter pain medicine and possibly a cold pack for the discomfort, and to report back if symptoms still do not resolve.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Child a a fever two on 10/18/2016. 10/20/2016 am child broke out in terrible rash, starting on face, trunk, and then all over the rest of the body. Resembled measles/German measles/ rubella rashes. Rash was present for 4 days, 2nd day being the worst, 4th day rash is fading.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Heart rate increased, Syncope, Tremor
Clinical narrative: Dizzy, faint, shaking, pulse over 200, not making sense.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Malaise, Musculoskeletal pain, Nausea
Clinical narrative: Egg size swelling, redness, and very painful shoulder, pain not relieved by Ibuprofen and Tylenol-ongoing. Redness and swelling have deminished. Extreme fatigue, ongoing nausea, aches, and malaise. All ongoing today.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Swelling
Clinical narrative: Egg size swelling, redness, and very painful shoulder, pain not relieved by Ibuprofen and Tylenol-ongoing. Redness and swelling have deminished. Extreme fatigue, ongoing nausea, aches, and malaise. All ongoing today.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, MMRV
Symptoms: Cough, Malaise, Nausea, Pyrexia, Varicella
Clinical narrative: Fever, malaise, nausea, cough, chicken pox.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Malaise, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received influenza vaccine unspecified. On an unknown date, 21 days after receiving influenza vaccine unspecified, the patient experienced vaccination failure (serious criteria GSK medically significant) and flu symptoms. On an unknown date, the outcome of the vaccination failure and flu symptoms were unknown. It was unknown if the reporter considered the vaccination failure and flu symptoms to be related to influenza vaccine unspecified. Additional details were provided as follows: The case was considered as the suspected vaccination failure as the laboratory confirmation of the event was not reported. The age at vaccination was not reported. The patient was unknown about the flu that cover four flu viruses until came on the site. The patient had all the symptoms of flu as patient got a flu shot three weeks before experiencing sickness.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient returned to pharmacy one day post vaccination both arms red, swollen, itchy painful. Recommended 10cc BENADRYL and follow up with MD. Patient consulted MD, given antibiotic.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: AFLURIA 2016-2017 was administered around approximately 7pm on 10/21/16 and patient states she had severe dizziness around 9pm on 10/21/16. On the morning of 10/22/16 patient states she had a headache. The dizziness was resolved on 10/22/2016.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea, Swollen tongue, Urticaria
Clinical narrative: Pt was given PREVNAR and FLUZONE HD around 6:30pm. Around 10-11pm woke up w/horrible hives/welts and tongue swelling. Contacted PCP and was told to go to ER via ambulance due to difficulty breathing.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Nausea, Vomiting
Clinical narrative: Got FLUZONE-HD 10/12/16; few days later pt and spouse experienced: Nausea, Vomiting , Diarrhea and Weakness. Symptoms lasted 3-4 days.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Nausea, Vomiting
Clinical narrative: Got FLUZONE HD 10-12-16; few days later pt and spouse experience: Nausea, vomiting, diarrhea and weakness. Symptoms lasted 3-4 days.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: (R) arm is hurting with red spots from the flu shot.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Within 1 hour of administration patient became nauseous and started vomiting. Symptoms resolved by next day.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vision blurred
Clinical narrative: Patient described dizziness, blurred vision about 1/2 hour after ALFURIA vaccine. Symptoms lasted about 1/2 hour.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, intramuscularly, which had lot # K023328 with expiry date: 23-JUN-2016. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX, intramuscularly, which had lot # L024999 with expiry: 06-OCT-2016. No adverse effects reported. No further information reported. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 23-OCT-2015, the patient was vaccinated with the first dose in the series of three GARDASIL (dose, route, lot # and expiration date were not reported). It was reported that the second dose was administered of GARDASIL 9 (dose, route, lot # and expiration date were not reported) on 01-FEB-2016, and the third dose in the three doses series was administered of GARDASIL 9 on 06-APR-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of  unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M005714 with expiration date 03-OCT-2017; lot # L040054 with expiration date 26-DEC-2017; dose and route were 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M007125 with expiration date 06-OCT-2017; dose not reported; oral). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Headache
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of impending doom in a adult female patient who received DTaP (Reduced antigen). On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced impending doom. On an unknown date, the outcome of the impending doom was unknown. It was unknown if the reporter considered the impending doom to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that 2 years ago she got a PNEUMOVAX and recently PREVNAR 13, reported headache at night after vaccination, however was not sure if that was related to the vaccination because she gets frequent headaches. In the past years, the patient received TDaP and she thought that she was going to die. The reporter declined to provide additional information to document that. The reporter called to inquire about if PREVNAR 13 also indicated for children. The reporter wanted to make sure that she got the right vaccine that, she was wondering if there is more than one formulation of PREVNAR 13.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL (lot # K011562 with expiration date 08-APR-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site pain
Clinical narrative: Information has been received from a 67 years old male concerning himself. The patient's concurrent condition included blood pressure abnormal and allergic to penicillin. Concomitant therapy included blood pressure medication. On an unknown date, the patient was vaccinated with VARIVAX (Lot number, expired date, dosage and frequency were unknown), subcutaneously. On an unknown date, the patient experienced "injection site pain and headaches". The patient did not seek medical attention. No lab test was performed. No treatment was given for the events. The outcome of injection site of pain and headache was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M020101 with expiration date 07-MAR-2019; dose and route were 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L025738, expiry date: 14-AUG-2017 and lot # M013639, expiry date: 15-NOV-2017). No adverse effects were reported. Excursion information: Time: 30 Minutes, Temperature: 9C and Time: 30 Minutes, Temperature: 11C. The call was because of a data logger. The improperly stored doses were administered. The were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: On 6/28/16 patient received hepatitis B vaccine at the thigh. On 6/29/16 a red, blotchy, confluent rash was noted on the face, extremities, and torso. The rash was initially most prominent on the thighs. However, the patient remained clinically stable on room air, appetite did not decrease, urine output remained adequate. She had no blood pressure instability. On 6/30/16 the rash became more prominent on the face and torso (though decreased in intensity on the extremities).
Age: 0.08
Sex: F
Vaccine: HEP, HEP
Symptoms: Blood culture negative, C-reactive protein increased, CSF culture negative, CSF test normal, Culture urine negative
Clinical narrative: On 6/28/16 patient received hepatitis B vaccine at the thigh. On 6/29/16 a red, blotchy, confluent rash was noted on the face, extremities, and torso. The rash was initially most prominent on the thighs. However, the patient remained clinically stable on room air, appetite did not decrease, urine output remained adequate. She had no blood pressure instability. On 6/30/16 the rash became more prominent on the face and torso (though decreased in intensity on the extremities).
Age: 0.08
Sex: F
Vaccine: HEP, HEP
Symptoms: Enterovirus test negative, Herpes simplex test negative, Polymerase chain reaction, Rash, Rash erythematous
Clinical narrative: On 6/28/16 patient received hepatitis B vaccine at the thigh. On 6/29/16 a red, blotchy, confluent rash was noted on the face, extremities, and torso. The rash was initially most prominent on the thighs. However, the patient remained clinically stable on room air, appetite did not decrease, urine output remained adequate. She had no blood pressure instability. On 6/30/16 the rash became more prominent on the face and torso (though decreased in intensity on the extremities).
Age: 0.08
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash macular, White blood cell count normal
Clinical narrative: On 6/28/16 patient received hepatitis B vaccine at the thigh. On 6/29/16 a red, blotchy, confluent rash was noted on the face, extremities, and torso. The rash was initially most prominent on the thighs. However, the patient remained clinically stable on room air, appetite did not decrease, urine output remained adequate. She had no blood pressure instability. On 6/30/16 the rash became more prominent on the face and torso (though decreased in intensity on the extremities).
Age: 42.0
Sex: M
Vaccine: MMR, HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Received 3rd and final Hep. B vaccine on 9-1-16. 4 days later came down with peripheral neuropathy in both arms, hands, legs, feet, tongue and lips. Numbness, tingling, burning, pins and needles sensations.
Age: 42.0
Sex: M
Vaccine: MMR, HEP, HEP
Symptoms: Blood test, Burning sensation, Electromyogram, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: Received 3rd and final Hep. B vaccine on 9-1-16. 4 days later came down with peripheral neuropathy in both arms, hands, legs, feet, tongue and lips. Numbness, tingling, burning, pins and needles sensations.
Age: 42.0
Sex: M
Vaccine: MMR, HEP, HEP
Symptoms: Paraesthesia
Clinical narrative: Received 3rd and final Hep. B vaccine on 9-1-16. 4 days later came down with peripheral neuropathy in both arms, hands, legs, feet, tongue and lips. Numbness, tingling, burning, pins and needles sensations.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Nausea, Oropharyngeal pain
Clinical narrative: SORE THROAT, CHANGE IN VISION, HEADACHE, DIZZINESS, NAUSEA.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Visual impairment
Clinical narrative: SORE THROAT, CHANGE IN VISION, HEADACHE, DIZZINESS, NAUSEA.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Dizziness, Headache, Nausea, Oropharyngeal pain, Streptococcus test positive
Clinical narrative: SORE THROAT, CHANGE IN VISION, HEADACHE, DIZZINESS, NAUSEA.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, C-reactive protein normal, Complement factor C3, Complement factor C4
Clinical narrative: SORE THROAT, CHANGE IN VISION, HEADACHE, DIZZINESS, NAUSEA.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Complement factor normal, Full blood count normal, Headache, Liver function test normal, Metabolic function test normal
Clinical narrative: SORE THROAT, CHANGE IN VISION, HEADACHE, DIZZINESS, NAUSEA.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Myalgia, Oropharyngeal pain, Pain, Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: SORE THROAT, CHANGE IN VISION, HEADACHE, DIZZINESS, NAUSEA.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Thyroid function test normal, Tic
Clinical narrative: SORE THROAT, CHANGE IN VISION, HEADACHE, DIZZINESS, NAUSEA.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 48-year-old female patient who received FLULAVAL QUADRIVALENT (batch number A3AD2, expiry date 31st May 2017). On 13th October 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 13th October 2016, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced diarrhea. On 14th October 2016, the outcome of the diarrhea was recovered/resolved. The reporter considered the diarrhea to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient received the FLULAVAL QUADRIVALENT in right deltoid in the afternoon. Same day at 9:00 PM the patient experienced diarrhea for 3 hours. At the time of reporting the patient was feeling fine. The reporter was also filling the VAERS report.
Age: 41.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Joint swelling, Paraesthesia, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hand swelling in a 41-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2994A, expiry date 30th June 2017). On 4th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 8th October 2016, 4 days after receiving FLUARIX QUADRIVALENT, the patient experienced hand swelling, swollen joints, numbness of limbs and tingling. The patient was treated with MEDROL. On an unknown date, the outcome of the hand swelling, swollen joints, numbness of limbs and tingling were recovering/resolving. It was not reported if the reporter considered the hand swelling, swollen joints, numbness of limbs and tingling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. On 4th October 2016, at 10:30, the patient received a dose of FLUARIX QUADRIVALENT in her left deltoid. On 8th October 2016, at 12:30, the patient experienced swelling of the left hand and joints and numbness. On 10th October 2015, the patient reported episodes of numbness in left arm, right arm and legs. On 11th October 2016, the patient was seen in emergency room and diagnosed with paresthesia and prescribed MEDROL DOSEPAK. On 12th October 2016, the patient was seen by a neurologist and the steroid dose was increased. As of reporting date, the patient was improving.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Burning sensation, Dyspnoea
Clinical narrative: Intense pain to bilateral legs, hips, feet w/burning, unsteady gait, weakness,shortness of breath. Worsening pain when sitting/lying down. Unable to do household chores, pain 10/10, pain medication taken w/o complete relief. Unable to sleep more than 2 hrs waking up w/pain. Still having intense pain. Saw ARNP at pain clinic for scheduled appt, set up epidural appt.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Insomnia, Pain, Pain in extremity
Clinical narrative: Intense pain to bilateral legs, hips, feet w/burning, unsteady gait, weakness,shortness of breath. Worsening pain when sitting/lying down. Unable to do household chores, pain 10/10, pain medication taken w/o complete relief. Unable to sleep more than 2 hrs waking up w/pain. Still having intense pain. Saw ARNP at pain clinic for scheduled appt, set up epidural appt.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is liked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (same source/site, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number, expiry date, route and site of administration: not reported) on an unspecified date (reported as in last year). Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced worst pain in thighs, it felt like patient had clamps tightening on thighs which was not intermittent, was horrible and constant and patient could not sleep at night. The patient described the reaction as bad and painful. Patient's lab data and corrective treatment was not reported. The reactions lasted for months, and on an unspecified date patient recovered from the events. List of documents held by sender: none.
Age: 0.67
Sex: F
Vaccine: DTP
Symptoms: Crying, Lethargy
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016454043) on 11 October 2016. This case involves a 10-months-old female patient who was vaccinated with an injection of DPT (batch number, expiry date, dose, dose in series, route and site of administration and manufacturer were not reported) in an unknown site on 27 October 1994 (reported as possibly on 27 October 1994). The patient's medical history and concomitant medications were not reported. On an unknown date, unspecified time following the vaccination, the patient experienced lethargy and crying. The patient's laboratory data and corrective treatment was not reported. The patient's outcome was not reported. List of documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016452123) on 10-OCT-2016. This case involves a 67-year-old male patient who was vaccinated with a dose of FLU VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient had a medical history of metastatic renal cell carcinoma (no surgery) with 2 tumors found in Liver 'and??', small nodules in Lungs, Congestive Heart Failure, Atrial fibrillation (has pacemaker), hypertension, neuropathies and history of testicular cancer 1981. Concomitant medications included Coumadin, Allopurinol, Coreg, Gabapentin, Prilosec, Pravastatin, Niaspan, Pristiq, Ferrous Sulfate, Levothyroxine, Oxycodone, hydralazine, Proscar, Ativan, Lasix, probiotic and vitamin C. On an unspecified date, following the vaccination, the patient had fever. Lab data and corrective treatment were not reported. The outcome of the event was not reported. Diagnosis: Metastatic Renal cell carcinoma. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Initial unsolicited report received from a pharmacist (director of pharmacy) on 12 Oct 2016. This case was linked to 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same lot number). This case involves a patient (age, gender unknown) who was vaccinated with a dose of Fluzone Quadrivalent (batch number- UI669AA, expiry date: 30 Jun 2017) by intramuscular route on 04 Oct 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On 06-Oct-2016, 2 days following the vaccination the patient had terrible muscle pain in neck in that morning and was progressively getting worse. On 08-Oct-2016, 4 days following vaccination patient and 09-Oct-2016, 5 days following vaccination, patient had nerve and joint pain and was not able to lift (may) arms past a certain height. On 10-Oct-2016, 6 days post vaccination, the patient had pain in both shoulder blades up into neck. The patient's lab tests were not reported. Patient did not sought out any treatment. The outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Neuralgia
Clinical narrative: Initial unsolicited report received from a pharmacist (director of pharmacy) on 12 Oct 2016. This case was linked to 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same lot number). This case involves a patient (age, gender unknown) who was vaccinated with a dose of Fluzone Quadrivalent (batch number- UI669AA, expiry date: 30 Jun 2017) by intramuscular route on 04 Oct 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On 06-Oct-2016, 2 days following the vaccination the patient had terrible muscle pain in neck in that morning and was progressively getting worse. On 08-Oct-2016, 4 days following vaccination patient and 09-Oct-2016, 5 days following vaccination, patient had nerve and joint pain and was not able to lift (may) arms past a certain height. On 10-Oct-2016, 6 days post vaccination, the patient had pain in both shoulder blades up into neck. The patient's lab tests were not reported. Patient did not sought out any treatment. The outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiration date: 30 June 2017 and site of administration was not reported) intramuscularly, on an unspecified date (over the past month). Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medication was not reported. On an unspecified date (over the past month), following the vaccination, patient had large circle at injection site swelling and sore. It was reported that the patient required emergency room or doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Contusion, Erythema, Injection site induration, Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (same vaccine). This case involves a patient of unknown age and gender, who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiry date: 30-JUN-2017 and site of administration was not reported) via intramuscularly on 04 October 2016 (also reported as over the past month). Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On unspecified date (also reported as over the past month), following vaccination, the patient experienced small bruise, followed by triangular area of raised, red, and hot to touch. Entire area tender to touch, firmer skin at site. It was reported that the patient required emergency room or doctor visit. Lab data was not reported. Corrective treatment was reported as no. The outcome of the events was reported as unknown. List of documents held by sender: none.