chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site erythema, Pyrexia
Clinical narrative: Pt received Prevnar vaccine on 11/25/15 and c/o chills, fever to 102, severe fatigue and extreme redness in left arm where vaccine given.  Pt's daughter called MD office on 11/26/15 about symptoms.  Pt went to MD office on 11/30/15 for follow-up.  MD stated pt will recover completely.
Age: 25.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Local reaction
Clinical narrative: Local reaction to left upper arm, 6x4cm erythema with 4x2cm target wheal.  Ice applied and advised to apply ice x24 hour. If s/s persist or worsen to return to HC.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Discomfort, Pyrexia
Clinical narrative: Child was administered an additional MMRV. FOC reported low-grade fever and discomfort following the administration.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local swelling, Pruritus, Tenderness
Clinical narrative: Right arm 6cm x 4 cm raised red hard area, tender to touch, localized itching.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre
Clinical narrative: Right arm 6cm x 4 cm raised red hard area, tender to touch, localized itching.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Culture, Febrile convulsion
Clinical narrative: Febrile seizure -> 911 -> ED.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blindness transient, Chronic fatigue syndrome, Emotional disorder, Fatigue
Clinical narrative: This spontaneous report was received from the consumer's mother on a newspaper article and refers to a 12 year old female patient. The patient's medical history and concurrent condition were not reported. The patient on an unknown date in 2010 was vaccinated with quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. After the first shot on an unknown date in 2010, it was reported that the patient had sore glands, headaches and tiredness, all normal symptoms which had subsided after a few days. Following the second shot on an unknown date, the patient had profuse bleeding from the injection site and then developed severe headaches. On an unknown date within eleven months the patient was barely able to get out of bed. She was surviving on rice cakes and water yet had piled on 3 stones in two months. Every inch of her body had ached. Numerous trips to the General Physician (GP) and tests conducted at the hospital (unspecified) failed to get a diagnosis other than teenage hormones or emotional problems. On an unknown date in 2013 the patient was diagnosed with chronic fatigue syndrome by a pediatrician (unspecified). It was reported that the patient didn't feel right after the vaccine. The patient had coped with initial symptoms but now on an unknown date had chronic pains, her left leg has started to turn in. It was reported that the patient on an unknown date 18 months ago had lost her eyesight. It came back but the peripheral sight in her left eye never came back. The patient was under a neurologist (unspecified) for ice pick headaches. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of activities of daily living impaired, visual field defect, chronic fatigue syndrome, pain (chronic pain), injection site hemorrhage and headache (severe headache and ice pick headache) was unknown. The outcome of lymphadenopathy, headache and fatigue was reported as recovered on an unknown date. The patient was recovering from blindness. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). The event "barely able to get out of bed" was considered serious due to disability and upon internal review the event visual field defect, blindness were considered serious as medically significant. This case is linked to the case 1512USA001052 and 1512USA001053. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Headache, Injection site haemorrhage, Lymph node pain, Mobility decreased
Clinical narrative: This spontaneous report was received from the consumer's mother on a newspaper article and refers to a 12 year old female patient. The patient's medical history and concurrent condition were not reported. The patient on an unknown date in 2010 was vaccinated with quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. After the first shot on an unknown date in 2010, it was reported that the patient had sore glands, headaches and tiredness, all normal symptoms which had subsided after a few days. Following the second shot on an unknown date, the patient had profuse bleeding from the injection site and then developed severe headaches. On an unknown date within eleven months the patient was barely able to get out of bed. She was surviving on rice cakes and water yet had piled on 3 stones in two months. Every inch of her body had ached. Numerous trips to the General Physician (GP) and tests conducted at the hospital (unspecified) failed to get a diagnosis other than teenage hormones or emotional problems. On an unknown date in 2013 the patient was diagnosed with chronic fatigue syndrome by a pediatrician (unspecified). It was reported that the patient didn't feel right after the vaccine. The patient had coped with initial symptoms but now on an unknown date had chronic pains, her left leg has started to turn in. It was reported that the patient on an unknown date 18 months ago had lost her eyesight. It came back but the peripheral sight in her left eye never came back. The patient was under a neurologist (unspecified) for ice pick headaches. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of activities of daily living impaired, visual field defect, chronic fatigue syndrome, pain (chronic pain), injection site hemorrhage and headache (severe headache and ice pick headache) was unknown. The outcome of lymphadenopathy, headache and fatigue was reported as recovered on an unknown date. The patient was recovering from blindness. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). The event "barely able to get out of bed" was considered serious due to disability and upon internal review the event visual field defect, blindness were considered serious as medically significant. This case is linked to the case 1512USA001052 and 1512USA001053. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Visual field defect, Weight increased
Clinical narrative: This spontaneous report was received from the consumer's mother on a newspaper article and refers to a 12 year old female patient. The patient's medical history and concurrent condition were not reported. The patient on an unknown date in 2010 was vaccinated with quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. After the first shot on an unknown date in 2010, it was reported that the patient had sore glands, headaches and tiredness, all normal symptoms which had subsided after a few days. Following the second shot on an unknown date, the patient had profuse bleeding from the injection site and then developed severe headaches. On an unknown date within eleven months the patient was barely able to get out of bed. She was surviving on rice cakes and water yet had piled on 3 stones in two months. Every inch of her body had ached. Numerous trips to the General Physician (GP) and tests conducted at the hospital (unspecified) failed to get a diagnosis other than teenage hormones or emotional problems. On an unknown date in 2013 the patient was diagnosed with chronic fatigue syndrome by a pediatrician (unspecified). It was reported that the patient didn't feel right after the vaccine. The patient had coped with initial symptoms but now on an unknown date had chronic pains, her left leg has started to turn in. It was reported that the patient on an unknown date 18 months ago had lost her eyesight. It came back but the peripheral sight in her left eye never came back. The patient was under a neurologist (unspecified) for ice pick headaches. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of activities of daily living impaired, visual field defect, chronic fatigue syndrome, pain (chronic pain), injection site hemorrhage and headache (severe headache and ice pick headache) was unknown. The outcome of lymphadenopathy, headache and fatigue was reported as recovered on an unknown date. The patient was recovering from blindness. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). The event "barely able to get out of bed" was considered serious due to disability and upon internal review the event visual field defect, blindness were considered serious as medically significant. This case is linked to the case 1512USA001052 and 1512USA001053. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Hypoaesthesia, Pain, Pain in extremity, Swelling
Clinical narrative: Patient started noticing soreness in left arm the evening after receiving the vaccine. 12/01/15 redness, soreness, and swelling noted. 12/02/15 worsening redness, swelling, and pain accompanied with numbness in left hand. Right arm also noted to have a small red swollen area about 3 inches below deltoid injection site. Patient denies pain the that arm.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash erythematous
Clinical narrative: RED BUMPS ON FACE, HEAD, BACK AND CHEST. STARTING AS RED DOTS, DEVELOPING TO SMALL VESICLES AND THEN BURSTING. C/O OF INTENSE ITCHING.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia
Clinical narrative: Four minutes or less after receiving the Tdap shot I sense a weird taste in my mouth, like metallic, acid, and like at times is like tasting antibacterial soap. Salty, metallic, acid, and chemical like antibacterial soap or like ear wax. I still have that taste in my mouth.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Computerised tomogram, Culture urine, Electrocardiogram, Electroencephalogram
Clinical narrative: My daughter was @ school and I @ wrk when I received a call that she was being transported to the ER via ambulance because she had had a seizure! She had app 51 seizures from that Fri till Monday. And still if exposed to flashing lights, she has them. She's only had 2 since that Mon, one being on Sept 25th and the other being today.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Urine analysis
Clinical narrative: My daughter was @ school and I @ wrk when I received a call that she was being transported to the ER via ambulance because she had had a seizure! She had app 51 seizures from that Fri till Monday. And still if exposed to flashing lights, she has them. She's only had 2 since that Mon, one being on Sept 25th and the other being today.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Ophthalmological examination, Uveitis
Clinical narrative: Severe uveitis in left eye.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, MEN, TDAP
Symptoms: Abdominal discomfort, Activities of daily living impaired, Allergy test, Blindness, Blood heavy metal test
Clinical narrative: His symptoms began with dizziness about once a week.  The spells seemed minor at the time and was very random so we thought it might be related to his growth spurts.  This child never complains so as the dizzy spells got worse he just dealt with them without letting us know how frequent they were.  When he got concerned and aggravated that the spells were daily and sometimes multiple times a day he asked me to call the doctor.  We saw Dr. at the clinic and he referred us to a cardiologist.  Cardiologist did mention that he has seen similar symptoms following vaccinations. He performed multiple tests and seemed to think his heart was fine so he sent us home.  About this time, his symptoms worsened again and starting affecting his martial arts training. The dizzy spells seemed to worsen with cardio and then he experienced an blood pressure drop that caused convulsions and blacking out.  We were treated at the ER but all they would treat was a panic attack. He did NOT have just a panic attack.  Dr was consulted again and he performed a stress test and started patient on blood pressure medications.  After trying different prescriptions and natural suggestion from Dr, he was given a diagnosis of POTS.  We decided to reach out to a doctor who has worked with vaccine injuries.  Many tests were ordered one of which included heavy metal testing. Now we also have a Heavy Metal Toxicity diagnosis.  These symptoms despite treatment have not gotten better but have continued to progress.  His hands now tremor so badly that he cannot perform certain tasks easily.  Even something as simple as buttoning his shirts is frustrating.  Doable but frustrating.  He has had to give up part of his martial arts and struggles with what he continues to train for.  Dizzy spells, loss of vision, hand tremors, stomach upset, and headaches are all things that patient deals with on a weekly and daily basis.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, MEN, TDAP
Symptoms: Blood pressure decreased, Cardiac stress test, Dizziness, Electrocardiogram, Full blood count
Clinical narrative: His symptoms began with dizziness about once a week.  The spells seemed minor at the time and was very random so we thought it might be related to his growth spurts.  This child never complains so as the dizzy spells got worse he just dealt with them without letting us know how frequent they were.  When he got concerned and aggravated that the spells were daily and sometimes multiple times a day he asked me to call the doctor.  We saw Dr. at the clinic and he referred us to a cardiologist.  Cardiologist did mention that he has seen similar symptoms following vaccinations. He performed multiple tests and seemed to think his heart was fine so he sent us home.  About this time, his symptoms worsened again and starting affecting his martial arts training. The dizzy spells seemed to worsen with cardio and then he experienced an blood pressure drop that caused convulsions and blacking out.  We were treated at the ER but all they would treat was a panic attack. He did NOT have just a panic attack.  Dr was consulted again and he performed a stress test and started patient on blood pressure medications.  After trying different prescriptions and natural suggestion from Dr, he was given a diagnosis of POTS.  We decided to reach out to a doctor who has worked with vaccine injuries.  Many tests were ordered one of which included heavy metal testing. Now we also have a Heavy Metal Toxicity diagnosis.  These symptoms despite treatment have not gotten better but have continued to progress.  His hands now tremor so badly that he cannot perform certain tasks easily.  Even something as simple as buttoning his shirts is frustrating.  Doable but frustrating.  He has had to give up part of his martial arts and struggles with what he continues to train for.  Dizzy spells, loss of vision, hand tremors, stomach upset, and headaches are all things that patient deals with on a weekly and daily basis.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, MEN, TDAP
Symptoms: Headache, Laboratory test, Loss of consciousness, Metal poisoning, Panic attack
Clinical narrative: His symptoms began with dizziness about once a week.  The spells seemed minor at the time and was very random so we thought it might be related to his growth spurts.  This child never complains so as the dizzy spells got worse he just dealt with them without letting us know how frequent they were.  When he got concerned and aggravated that the spells were daily and sometimes multiple times a day he asked me to call the doctor.  We saw Dr. at the clinic and he referred us to a cardiologist.  Cardiologist did mention that he has seen similar symptoms following vaccinations. He performed multiple tests and seemed to think his heart was fine so he sent us home.  About this time, his symptoms worsened again and starting affecting his martial arts training. The dizzy spells seemed to worsen with cardio and then he experienced an blood pressure drop that caused convulsions and blacking out.  We were treated at the ER but all they would treat was a panic attack. He did NOT have just a panic attack.  Dr was consulted again and he performed a stress test and started patient on blood pressure medications.  After trying different prescriptions and natural suggestion from Dr, he was given a diagnosis of POTS.  We decided to reach out to a doctor who has worked with vaccine injuries.  Many tests were ordered one of which included heavy metal testing. Now we also have a Heavy Metal Toxicity diagnosis.  These symptoms despite treatment have not gotten better but have continued to progress.  His hands now tremor so badly that he cannot perform certain tasks easily.  Even something as simple as buttoning his shirts is frustrating.  Doable but frustrating.  He has had to give up part of his martial arts and struggles with what he continues to train for.  Dizzy spells, loss of vision, hand tremors, stomach upset, and headaches are all things that patient deals with on a weekly and daily basis.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, MEN, TDAP
Symptoms: Postural orthostatic tachycardia syndrome, Seizure, Tilt table test, Tremor
Clinical narrative: His symptoms began with dizziness about once a week.  The spells seemed minor at the time and was very random so we thought it might be related to his growth spurts.  This child never complains so as the dizzy spells got worse he just dealt with them without letting us know how frequent they were.  When he got concerned and aggravated that the spells were daily and sometimes multiple times a day he asked me to call the doctor.  We saw Dr. at the clinic and he referred us to a cardiologist.  Cardiologist did mention that he has seen similar symptoms following vaccinations. He performed multiple tests and seemed to think his heart was fine so he sent us home.  About this time, his symptoms worsened again and starting affecting his martial arts training. The dizzy spells seemed to worsen with cardio and then he experienced an blood pressure drop that caused convulsions and blacking out.  We were treated at the ER but all they would treat was a panic attack. He did NOT have just a panic attack.  Dr was consulted again and he performed a stress test and started patient on blood pressure medications.  After trying different prescriptions and natural suggestion from Dr, he was given a diagnosis of POTS.  We decided to reach out to a doctor who has worked with vaccine injuries.  Many tests were ordered one of which included heavy metal testing. Now we also have a Heavy Metal Toxicity diagnosis.  These symptoms despite treatment have not gotten better but have continued to progress.  His hands now tremor so badly that he cannot perform certain tasks easily.  Even something as simple as buttoning his shirts is frustrating.  Doable but frustrating.  He has had to give up part of his martial arts and struggles with what he continues to train for.  Dizzy spells, loss of vision, hand tremors, stomach upset, and headaches are all things that patient deals with on a weekly and daily basis.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Pharyngeal oedema, Rash
Clinical narrative: Swelling of throat, bruise at injection site, rash on opposite forearm. Patient did not seek any medical attention, returned to pharmacy today.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Peripheral coldness, Sleep disorder
Clinical narrative: Arm soreness, can not lift arm without pain in left arm, can't sleep on left side, some times cold/numb hand.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Brain neoplasm, Brain stem glioma, Computerised tomogram, Death, Dizziness
Clinical narrative: In 10/2013 she said I don't fell well, I have something in my head. She have CT scan, but in 11/25/2013 she awoke with nausea, dizzy she get another CT scan. But on January 13, 2014 I bring her E.R. in Hospital and they Dx with Pontine Glioma Tumor Brain.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Malaise, Nausea
Clinical narrative: In 10/2013 she said I don't fell well, I have something in my head. She have CT scan, but in 11/25/2013 she awoke with nausea, dizzy she get another CT scan. But on January 13, 2014 I bring her E.R. in Hospital and they Dx with Pontine Glioma Tumor Brain.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: High fever. x 1 day T max 103. Fever at office 105 rectal. Pt is irritable and cranky. Patient referred  to hospital ER for further evaluation on f/u phone call made to parents - baby's feer is ok now 12/1/15.
Age: 73.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Dehydration, Erythema, Haematoma, Inflammation, Pain
Clinical narrative: Inflammation, area red, pain.
Sex: U
Vaccine: PNC
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR, via an unspecified route of administration, on an unspecified date, as single dose. Medical history and concomitant medications were not reported. The patient experienced cellulitis like reactions on an unspecified date, with outcome of unknown.
Age: 13.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: VIIth nerve paralysis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 21 November 2015. This case involves a 13-year-old female patient who was vaccinated with a dose of MENOMUNE and first dose of HPV vaccine (batch number, dose in series, route and site of administration were not reported for both vaccines) on unspecified date in 2007. Patient previously received 2 doses of MMR and 2 doses of varicella and a dose of Hepatitis B vaccines and patient denied any other reactions to vaccine in the past. It was reported that patient would like to start Hepatitis A vaccine prior to her trip and prefers to take oral typhoid. Concomitant medications were not reported. On unspecified date in 2007, on same day shortly after receiving vaccination, the patient developed Bell's palsy. Lab data and corrective treatments were not reported. Outcome of event was not reported. It was reported that its never determined for certain that Bell's palsy was a result of the vaccines but she had no subsequent HPV vaccines. Upon internal review, the case was considered to be serious due to important medical events: Bells' Palsy. List of documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Activities of daily living impaired, Blood pressure decreased, Hypersomnia, Hypotension, Loss of consciousness
Clinical narrative: This spontaneous report was received from the consumer's father on a newspaper article and refers to a 15 year old female patient. The patient's medical history and concurrent condition were not reported. The patient on an unknown date was vaccinated with Quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. The patient on an unknown date five months ago had collapsed on GAA pitch and was out cold for thirteen minutes. After that on an unknown date the fits kept occurring even when she was sitting on a chair. The patient would sleep for 20 hours a day and could no longer go to school. Medical tests had revealed low blood pressure but no definite reason had been uncovered for the dramatic change in her health. The reporter reported that the patient's personality had changed completely. She could not do anything now. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of loss of consciousness, seizure and personality change were unknown. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). Upon internal review the event seizure and loss of consciousness were considered serious as medically significant. This case is linked to the case 1512USA000013 and 1512USA001053. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Personality change due to a general medical condition, Seizure, Syncope
Clinical narrative: This spontaneous report was received from the consumer's father on a newspaper article and refers to a 15 year old female patient. The patient's medical history and concurrent condition were not reported. The patient on an unknown date was vaccinated with Quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. The patient on an unknown date five months ago had collapsed on GAA pitch and was out cold for thirteen minutes. After that on an unknown date the fits kept occurring even when she was sitting on a chair. The patient would sleep for 20 hours a day and could no longer go to school. Medical tests had revealed low blood pressure but no definite reason had been uncovered for the dramatic change in her health. The reporter reported that the patient's personality had changed completely. She could not do anything now. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of loss of consciousness, seizure and personality change were unknown. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). Upon internal review the event seizure and loss of consciousness were considered serious as medically significant. This case is linked to the case 1512USA000013 and 1512USA001053. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Sleep disorder
Clinical narrative: A pharmacist gave me the highest dosage flu shot high on my left shoulder on Oct. 6, 2014. It really hurt then and has continued to be painful for over a year. I've seen my doctor, had an MRI, took medicine for inflammation, and had 4 months of physical therapy. It is better then it was, but I still have pain with various arm movements - mostly sideways and backward movements and it still aches at night affecting my sleep. I filed a claim with pharmacy on July 23, 2015 and sent to to claims management so they have all my information. I was informed by the claims examiner that I needed to file a claim with VICP because my medical treatment has lasted more than 6 months after the vaccine was given.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Pruritus, Rash
Clinical narrative: This spontaneous report was received from the consumer's husband referring to an 84 year old female patient. The patient presented allergies to sulfa drugs, but his pertinent medical history was unspecified. On 16-APR-2009, the patient was vaccinated with ZOSTAVAX vial, 0.65 ml, single dose subcutaneous (lot number was not reported). Concomitant medication reported as many by unspecified. On 19-OCT_2015, the patient experienced shingles and the husband added that she had shingle rash on her scalp, forehead and in her left eye. The wife stated also that shingles were very painful and very itchy. Patient sought medical attention via doctor office visit and received treatment with VALTREX for 7 days and an unspecified eye drops. No lab diagnostics studies were performed and no hospitalization was required. The outcome of herpes zoster and ophthalmic herpes zoster was reported as not recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Patient went to a Primary Urgent Care. Experienced pain, swelling, redness and injection site. Patient told by MD at Urgent care facility that the injection site may be infected and give antibiotics to treat.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Ophthalmological examination, Uveitis
Clinical narrative: Severe uveitis in both eyes.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Arthralgia, Bone pain, Eye discharge, Eye pruritus
Clinical narrative: The reaction began with itchy/red eyes and progressed to extremely red & itchy with discharge to almost swollen shut. Pain progressed from a dull ache/soreness to excruciating muscle, joint and bone pain. I also became extremely exhausted and could not move, and I could barely speak. My tongue became thick, swollen and I developed a headache that was the worst I had ever felt. I also lost all sensation of taste, only some of which has returned. I wanted to go to the ER but could not voice the request. My husband talked to my doctor who suggested Motrin which did not help. The pain was worse than natural childbirth. I was curled up on the couch in a fetal position for hours.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: The reaction began with itchy/red eyes and progressed to extremely red & itchy with discharge to almost swollen shut. Pain progressed from a dull ache/soreness to excruciating muscle, joint and bone pain. I also became extremely exhausted and could not move, and I could barely speak. My tongue became thick, swollen and I developed a headache that was the worst I had ever felt. I also lost all sensation of taste, only some of which has returned. I wanted to go to the ER but could not voice the request. My husband talked to my doctor who suggested Motrin which did not help. The pain was worse than natural childbirth. I was curled up on the couch in a fetal position for hours.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia, Speech disorder, Swollen tongue, Tongue disorder
Clinical narrative: The reaction began with itchy/red eyes and progressed to extremely red & itchy with discharge to almost swollen shut. Pain progressed from a dull ache/soreness to excruciating muscle, joint and bone pain. I also became extremely exhausted and could not move, and I could barely speak. My tongue became thick, swollen and I developed a headache that was the worst I had ever felt. I also lost all sensation of taste, only some of which has returned. I wanted to go to the ER but could not voice the request. My husband talked to my doctor who suggested Motrin which did not help. The pain was worse than natural childbirth. I was curled up on the couch in a fetal position for hours.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, MENB
Symptoms: Bradycardia, Confusional state, Pallor, Speech disorder, Syncope
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 12-year-old male patient received, on 16Nov2015, TRUMENBA intramuscular, in the left deltoid, at 0.5 ml, single dose. Relevant medical history was unknown. Concomitant medications included flu vaccine received in the left deltoid and HPV vaccine received in the right deltoid, both on 16Nov2015. The vaccines were administered at the private doctor's office and was purchased with commercial funds. On 16Nov2015, the patient was pale, had bradycardia, and fainted in office. On the same evening, family reported the patient was confused and was talking gibberish. No hospitalization, emergency room or doctor visit were required. Clinical outcome was unknown at time of this report.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Cellulitis, Erythema, Hyperhidrosis, Injection site infection
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself. This 66-year-old male patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on 16Nov2015. Medical history included blood pressure, cancer, neuropathy. Concomitant medication included gabapentin at 600 mg 1x/day for nerve pain and losartan at 50 mg 1x/day for blood pressure. The patient previously took pneumococcal vaccine. On an unspecified date, the patient experienced the following events: its swollen then it developed to cellulitis, joint pain, become red, fever, some kind of infection at the site/area of infection was getting wider, the area is getting wider it is not as high now but it was about 4 inches in diameter and its very hot to touch, sweating, could not sleep. The outcome for the event could not sleep was unknown and the outcome for all other events was not recovered. Therapeutic measures were taken as a result of its swollen then it developed to cellulitis, joint pain included ibuprofen at 200 mg, two tablets twice a day.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site warmth, Pyrexia, Sleep disorder, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself. This 66-year-old male patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on 16Nov2015. Medical history included blood pressure, cancer, neuropathy. Concomitant medication included gabapentin at 600 mg 1x/day for nerve pain and losartan at 50 mg 1x/day for blood pressure. The patient previously took pneumococcal vaccine. On an unspecified date, the patient experienced the following events: its swollen then it developed to cellulitis, joint pain, become red, fever, some kind of infection at the site/area of infection was getting wider, the area is getting wider it is not as high now but it was about 4 inches in diameter and its very hot to touch, sweating, could not sleep. The outcome for the event could not sleep was unknown and the outcome for all other events was not recovered. Therapeutic measures were taken as a result of its swollen then it developed to cellulitis, joint pain included ibuprofen at 200 mg, two tablets twice a day.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. The patients medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of oral, ROTATEQ lot # K024700, expiration date: 30-JUL-2016, (dose was not provided), which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Inflammation
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient had a central catheter peripherally inserted since an unknown date. No other relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# and expiration date not reported) intravenously through the patient's peripherally inserted central catheter. On an unknown date the patient "had inflammatory throughout the body". The outcome of the event "inflammation throughout the body" was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as in past six months), the patients was vaccinated with ZOSTAVAX (unknown route and dose) in left arm. Concomitant medications were not reported. The patients had come to pharmacy to complain of injection site adverse events post vaccination with ZOSTAVAX. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Psoriasis, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a 23-year-old male healthcare student refers to himself. No medical history was reported. On an unknown date (patient reported "as an infant"), the patient was vaccinated with two doses of M-M-R II (dose, route of administration and lot number were not reported). No concomitant medications were reported. On approximately 23-OCT-2015 (reported as "three weeks ago"), the patient had titers drawn and the results for the measles, rubella and mumps antibody tests were negative. On an unknown date, the patient was diagnosed with psoriasis and was treated with STELARA. The outcome of psoriasis, rubella antibody negative, mumps antibody test negative and measles antibody negative is unknown. The relatedness between the events and M-M-R II was not reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. From an unspecified date in June 2015, the patients were administered an unspecified number of improperly stored doses ROTATEQ orally (lot # K016263, expiration date 26-JUN-2016; lot # L008574, expiration date 22-NOV-2016; strength and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. 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 healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L010144, expiry: 24-MAR-2017) (incorrect product storage). No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. This case is also related to MARRS# 1511USA014841 (same reporter link). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Cold sweat, Decreased appetite
Clinical narrative: Nausea prevented me from sleeping. The next morning (11/17/2015) I woke up at 6AM with extreme nausea and after attempting to vomit but being unable to, went back to sleep. Then, I woke up again at 8AM with extreme nausea and vomited. I felt faint and still nauseous but slightly better after. I did not have any appetite and did not eat, but drank a glass of water. At 9AM I vomited the water. I felt extremely weak and faint, but no longer nauseous. The rest of the day I had no appetite and did not eat anything. I almost became very faint and dizzy, cool, pale and clammy around 1PM. I did not actually go unconscious because I sat down in time. Around 3PM I started getting chills and my body ached. Specifically, my knees and pelvis joints were severely aching. All afternoon and into the evening the chills and aches became worse and I ran a fever. I went to sleep that night and took an ibuprofen to diminish the aching. I woke up the next morning (11/18/2015) feeling normal. Nothing happened since.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling cold, Hypophagia, Insomnia, Nausea
Clinical narrative: Nausea prevented me from sleeping. The next morning (11/17/2015) I woke up at 6AM with extreme nausea and after attempting to vomit but being unable to, went back to sleep. Then, I woke up again at 8AM with extreme nausea and vomited. I felt faint and still nauseous but slightly better after. I did not have any appetite and did not eat, but drank a glass of water. At 9AM I vomited the water. I felt extremely weak and faint, but no longer nauseous. The rest of the day I had no appetite and did not eat anything. I almost became very faint and dizzy, cool, pale and clammy around 1PM. I did not actually go unconscious because I sat down in time. Around 3PM I started getting chills and my body ached. Specifically, my knees and pelvis joints were severely aching. All afternoon and into the evening the chills and aches became worse and I ran a fever. I went to sleep that night and took an ibuprofen to diminish the aching. I woke up the next morning (11/18/2015) feeling normal. Nothing happened since.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Nausea prevented me from sleeping. The next morning (11/17/2015) I woke up at 6AM with extreme nausea and after attempting to vomit but being unable to, went back to sleep. Then, I woke up again at 8AM with extreme nausea and vomited. I felt faint and still nauseous but slightly better after. I did not have any appetite and did not eat, but drank a glass of water. At 9AM I vomited the water. I felt extremely weak and faint, but no longer nauseous. The rest of the day I had no appetite and did not eat anything. I almost became very faint and dizzy, cool, pale and clammy around 1PM. I did not actually go unconscious because I sat down in time. Around 3PM I started getting chills and my body ached. Specifically, my knees and pelvis joints were severely aching. All afternoon and into the evening the chills and aches became worse and I ran a fever. I went to sleep that night and took an ibuprofen to diminish the aching. I woke up the next morning (11/18/2015) feeling normal. Nothing happened since.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Lymph node pain
Clinical narrative: Started having stabbing pain in my lymph node in the groin area for two days. Then it moved to the lymph node in my throat and I had pain for three days.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Injection site erythema, Injection site hypoaesthesia, Injection site induration
Clinical narrative: Redness at injectin site, chills but no fever. Next day, increase in size at injection site, itchy. Next day injection site still firm, left pain numbness, dizziness X 1 hour-unclear if related to injection.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Redness at injectin site, chills but no fever. Next day, increase in size at injection site, itchy. Next day injection site still firm, left pain numbness, dizziness X 1 hour-unclear if related to injection.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Bad headaches, lo-grade fever and chills, body aches and pains.  I hadn't had any headaches for many years before this event.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Pt complains of injection site pain and muscle pain after vaccine administered.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Eye swelling, Heart rate increased, Hyperhidrosis
Clinical narrative: 5:30 pm dry cough, wheeze fast heart beat, chest tightness,  6:30 pm rash shoulder to shoulder chest took 1 Benadryl, called MD friend at approx 7 pm.  8pm sweating took 2nd Benadryl, 1-2am woke up eyes, lips swollen, rash worse and vommited three times, morning of 12/2 lethargic but no rash, no cough.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Lip swelling, Rash, Vomiting, Wheezing
Clinical narrative: 5:30 pm dry cough, wheeze fast heart beat, chest tightness,  6:30 pm rash shoulder to shoulder chest took 1 Benadryl, called MD friend at approx 7 pm.  8pm sweating took 2nd Benadryl, 1-2am woke up eyes, lips swollen, rash worse and vommited three times, morning of 12/2 lethargic but no rash, no cough.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Reports Left Deltoid area soreness/pain with movement, edema, redness, hard lump and tenderness at injection site. Scarring of skin at injection site.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site scar, Pain
Clinical narrative: Reports Left Deltoid area soreness/pain with movement, edema, redness, hard lump and tenderness at injection site. Scarring of skin at injection site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Loss of consciousness, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Night of vaccination: blood red eyes, throat swelled, chills, heart racing,  tried to call 911 and passed out. Next morning: sore throat, red eyes, weak, called physician's office and described symptoms and was told they would let the doctor know and would call her back if the doctor wanted to make an appointment.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Pharyngeal oedema
Clinical narrative: Night of vaccination: blood red eyes, throat swelled, chills, heart racing,  tried to call 911 and passed out. Next morning: sore throat, red eyes, weak, called physician's office and described symptoms and was told they would let the doctor know and would call her back if the doctor wanted to make an appointment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Started with redness, lump and warmth at the site. Ice and Motrin. Spread to inner elbow, lump size of key lime by 11/19. Saw doctor 11/19 started antibiotics. 11/20 spread to mid forearm. 11/20 almost to wrist. Antibiotic injection given.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Pruritus, Rash erythematous
Clinical narrative: Began with itching and red bumps on wrists.  Patient woke up at 2:00 am on 11/3/15 with severe itching under chin, swollen eyes, and a bumpy red rash in streaks on his face.  Dr. prescribed oral and injected steroids.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased appetite, Fatigue, Hemiparesis, Pain in extremity, Pyrexia
Clinical narrative: Right side weakness, rt arm aches, tired, fever, no nausea, lack of appetite.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pain, Rash
Clinical narrative: Abdomen and lower back rash ( inflamed and painful, no itching to report.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Joint swelling, Peripheral coldness, Peripheral swelling
Clinical narrative: Patient returned to nurse who administered vaccine to report that his right hand and wrist area were swelling and his right 4th and 5th finger and outer side of hand and wrist were cool to touch.  This area was also darker in color than the rest of his hand.  25mg of Benadryl was administered and parent notified.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient was mistakenly given a Fluzone HD ( nstead of Prevnar).
Age: 0.61
Sex: F
Vaccine: 6VAX-F
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine area was hard, swollen, red, hot to the touch and the redness was spreading.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Eyelid oedema, Lip swelling
Clinical narrative: SWELLING STARTED IN LIPS AND AFTER A COUPLE OF HOURS EYES BECAME SEVERELY SWOLLEN BY 2:00 AM THEY WERE ALMOST SWOLLEN SHUT. AFTER 4 BENADRYL THEY ARE STILL SWOLLEN AND LOOK LIKE I HAVE BLACK EYES 24 HOURS LATER.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Arthralgia, Blood urine present, Full blood count normal, Henoch-Schonlein purpura, Metabolic function test normal
Clinical narrative: Palpable purpuric rash, Joint pain, blood and protein in urine. Diagnosed with Henoch Schonlein purpura.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Protein urine present, Purpura
Clinical narrative: Palpable purpuric rash, Joint pain, blood and protein in urine. Diagnosed with Henoch Schonlein purpura.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: SAID SHE HAS DIZZINESS AND THEN FAINTED IMMEDIATELY.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Myalgia
Clinical narrative: Extreme muscle soreness that has gotten worse as time went on.  After two months I contacted my Dr. and if it doesn't subside in a month will follow up with her.